MPEP 1846

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1846 Sections of the Articles, Regulations, and Administrative Instructions Under the PCT Relevant to the International Searching Authority[edit | edit source]

PCT Articles 15 - 20 (Appendix T);

PCT Rules 33 - 47 (Appendix T); and

Administrative Instructions Sections 501 - 518

(Appendix AI).

1847Refund of International Search Fee[R-5]

37 CFR 1.446. Refund of international application filing and processing fees.

(a)Money paid for international application fees, where paid by actual mistake or in excess, such as a payment not required by law or treaty and its regulations, may be refunded. A mere change of purpose after the payment of a fee will not entitle a party to a refund of such fee. The Office will not refund amounts of twenty- five dollars or less unless a refund is specifically requested and will not notify the payor of such amounts. If the payor or party requesting a refund does not provide the banking information necessary for making refunds by electronic funds transfer, the Office may use the banking information provided on the payment instrument to make any refund by electronic funds transfer.

(b)Any request for refund under paragraph (a) of this section must be filed within two years from the date the fee was paid. If the Office charges a deposit account by an amount other than an amount specifically indicated in an authorization under § 1.25(b), any request for refund based upon such charge must be filed within two years from the date of the deposit account statement indicating such charge and include a copy of that deposit account statement. The time periods set forth in this paragraph are not extendable.

(c)Refund of the supplemental search fees will be made if such refund is determined to be warranted by the Director or the Director’s designee acting under PCT Rule 40.2(c).

(d)The international and search fees will be refunded if no international filing date is accorded or if the application is withdrawn before transmittal of the record copy to the International Bureau (PCT Rules 15.6 and 16.2). The search fee will be refunded if the application is withdrawn before transmittal of the search copy to the International Searching Authority. The transmittal fee will not be refunded.

(e)The handling fee (§ 1.482(b)) will be refunded (PCT Rule 57.6) only if:

(1)The Demand is withdrawn before the Demand has been sent by the International Preliminary Examining Authority to the International Bureau, or

(2)The Demand is considered not to have been submitted (PCT Rule 54.4(a)).

Although 37 CFR 1.446(a) indicates that a “mere change of purpose after the payment of a fee will not entitle a party to a refund of such fee,” 37 CFR 1.446(d) and (e) contain exceptions to this general statement.

According to 37 CFR 1.446(d), the search fee will be refunded if no international filing date is accorded or if the application is withdrawn before the search copy is transmitted to the International Searching Authority. The transmittal fee will not be refunded.

According to 37 CFR 1.446(e), the handling fee will be refunded if the Demand is withdrawn before the Demand has been sent by the International Preliminary Examining Authority to the International Bureau.

Refund of the supplemental search fee will be made if the applicant is successful in a protest (filed pursuant to 37 CFR 1.477) to a holding of lack of unity of invention. The supplemental search fee must be paid and be accompanied by (1) a protest and (2) a request for refund of the supplemental search fee.

Any request for refund of the search fee made after the search copy has been transmitted to the International Searching Authority must be directed to the International Searching Authority and not to the Receiving Office. This is clearly necessary where applicant has chosen the European Patent Office or the Korean Intellectual Property Office as the International Searching Authority.

1848Sequence Listings and Tables Related to Sequence Listings [R-3]

PCT Rule 13ter.

Nucleotide and/or Amino Acid Sequence Listings


13ter.1.Procedure Before the International Searching Authority

(a)Where the international application contains disclosure of one or more nucleotide and/or amino acid sequences, the International Searching Authority may invite the applicant to furnish to it, for the purposes of the international search, a sequence listing in electronic form complying with the standard provided for in the Administrative Instructions, unless such listing in electronic form is already available to it in a form and manner acceptable to it, and to pay to it, where applicable, the late furnishing fee referred to paragraph (c), within a time limit fixed in the invitation.

(b)Where at least part of the international application is filed on paper and the International Searching Authority finds that the description does not comply with Rule 5.2(a), it may invite the



applicant to furnish, for the purposes of the international search, a sequence listing in paper form complying with the standard provided for in the Administrative Instructions, unless such listing in paper form is already available to it in a form and manner acceptable to it, whether or not the furnishing of a sequence listing in electronic form is invited under paragraph (a), and to pay, where applicable, the late furnishing fee referred to in paragraph (c), within a time limit fixed in the invitation.

(c)The furnishing of a sequence listing in response to an invitation under paragraph (a) or (b) may be subjected by the International Searching Authority to the payment to it, for its own benefit, of a late furnishing fee whose amount shall be determined by the International Searching Authority but shall not exceed 25% of the international filing fee referred to in item 1 of the Schedule of Fees, not taking into account any fee for each sheet of the international application in excess of 30 sheets, provided that a late furnishing fee may be required under either paragraph (a) or (b) but not both.

(d)If the applicant does not, within the time limit fixed in the invitation under paragraph (a) or (b), furnish the required sequence listing and pay any required late furnishing fee, the International Searching Authority shall only be required to search the international application to the extent that a meaningful search can be carried out without the sequence listing.

(e)Any sequence listing not contained in the international application as filed, whether furnished in response to an invitation under paragraph (a) or (b) or otherwise, shall not form part of the international application, but this paragraph shall not prevent the applicant from amending the description in relation to a sequence listing pursuant to Article 34(2)(b).

(f)Where the International Searching Authority finds that the description does not comply with Rule 5.2(b), it shall invite the applicant to submit the required correction. Rule 26.4 shall apply mutatis mutandis to any correction offered by the applicant. The International Searching Authority shall transmit the correction to the receiving Office and to the International Bureau.

PCT Administrative Instruction Section 513.

Sequence Listings


(a)Where the International Searching Authority receives a correction of a defect under Rule 13ter.1(f), it shall:

(i)indelibly mark, in the upper right-hand corner of each replacement sheet, the international application number and the date on which that sheet was received;


(ii)indelibly mark, in the middle of the bottom margin of each replacement sheet, the words “SUBSTITUTE SHEET (RULE 13ter.1(f))” or their equivalent in the language of publication of the international application;

(iii)indelibly mark on the letter containing the correction, or accompanying any replacement sheet, the date on which that letter was received;

(iv)keep in its files a copy of the letter containing the correction or, when the correction is contained in a replacement sheet, the replaced sheet, a copy of the letter accompanying the replacement sheet, and a copy of the replacement sheet;

(v)promptly transmit any letter and any replacement sheet to the International Bureau, and a copy thereof to the receiving Office.


(b)Where the international search report and the written opinion of the International Searching Authority are based on a sequence listing that was not contained in the international application as filed but was furnished subsequently to the International Searching Authority, the international search report and the written opinion of the International Searching Authority shall so indicate.

(c)Where a meaningful international search cannot be carried out and a meaningful written opinion, as to whether the claimed invention appears to be novel, to involve an inventive step (to be non-obvious) and to be industrially applicable, cannot be established because a sequence listing is not available to the International Searching Authority in the required form, that Authority shall so state in the international search report or declaration referred to in Article 17(2)(a), and in the written opinion.

(d)The International Searching Authority shall indelibly mark, in the upper right-hand corner of the first sheet of any sequence listing on paper which was not contained in the international application as filed but was furnished subsequently to that Authority, the words “SUBSEQUENTLY FURNISHED SEQUENCE LISTING” or their equivalent in the language of publication of the international application.

(e)The International Searching Authority shall keep in its files:


(i)any sequence listing on paper which was not contained in the international application as filed but was furnished subsequently to that Authority; and

(ii)any sequence listing in electronic form furnished for the purposes of the international search.

Where an international application contains disclosure of a nucleotide and/or amino acid sequence, the description must contain a listing of the sequence complying with the standard specified in Annex C of the Administrative Instructions. See MPEP § 1823.02. If the International Searching Authority finds that an international application contains such a disclosure but that the description does not include such a listing or that the listing included does not comply with that standard, the International Searching Authority may invite the applicant to furnish a listing complying with that standard.

If the International Searching Authority finds that a sequence listing is not in an electronic form provided for in the Administrative Instructions, it may invite the applicant to furnish a listing to it in such a form.



An invitation from the International Searching Authority to furnish a sequence listing complying with the standard specified in the Administrative Instructions, will specify a time limit for complying with the invitation. Any sequence listing furnished by the applicant in response to the invitation must be accompanied by a statement to the effect that the listing does not include matter which goes beyond the disclosure in the international application as filed. If the applicant does not comply within that time limit, the search undertaken by the International Searching Authority may be restricted.

If the applicant wishes to include such a listing in the text of the description itself, appropriate amendments may be made later under PCT Article 34, provided that the applicant files a Demand for international preliminary examination.

The United States Receiving Office has not notified the International Bureau under Administrative Instructions Section 801(b) that it is prepared to accept the filing in electronic form of the sequence listing and/or any tables related to the sequence listing of international applications under Administrative Instructions Section 801(a). However, Administrative Instructions Section 801(c) permits a receiving Office that has not notified the IB under Administrative Instructions Section 801(b) to decide in a particular case to accept such sequence listing filings. The RO/US will accept applications where the sequence listing and/or table is filed using CD-R or CD-ROM as the electronic medium, and where no paper copy of the sequence listing part is submitted. The application must be filed in accordance with the Guidelines set forth in MPEP § 1823.02, subsection II. A in order to be accepted. There may be significant cost savings if such a submission is accepted. If accepted under the USPTO’s Guidelines, the electronic submission counts as 400 sheets in addition to the actual number of sheets of the Request, description excluding the sequence listing part thereof, claims, abstract and drawings. Four copies of the electronic submission of the sequence listing are required. One copy goes to the IB as part of the Record copy; the second copy becomes part of the Home copy; the third copy becomes part of the Search copy; and the fourth copy goes to the Scientific and Technical Information Center (STIC) as the electronic form (also known as the computer readable form (CRF). Three copies of the electronic submission of any table related to the sequence listing are required. One copy goes to the IB as part of the record copy; the second copy becomes part of the home copy; the third copy becomes part of the search copy. See MPEP § 1823.02.

1850Unity of Invention Before the International Searching Authority [R-5]

PCT Rule 13.

Unity of Invention

13.1.Requirement

The international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”).

13.2.Circumstances in Which the Requirement of Unity of Invention Is To Be Considered Fulfilled

Where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.

13.3.Determination of Unity of Invention Not Affected Manner of Claiming

The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim.

13.4.Dependent Claims

Subject to Rule 13.1, it shall be permitted to include in the same international application a reasonable number of dependent claims, claiming specific forms of the invention claimed in an independent claim, even where the features of any dependent claim could be considered as constituting in themselves an invention.

13.5.Utility Models

Any designated State in which the grant of a utility model is sought on the basis of an international application may, instead of Rules 13.1 to 13.4, apply in respect of the matters regulated in those Rules the provisions of its national law concerning utility models once the processing of the international application has started in that State, provided that the applicant shall be allowed at least two months from the expiration of the time limit applicable under Article 22 to adapt his application to the requirements of the said provisions of the national law.



PCT Rule 40.

Lack of Unity of Invention (International Search)

40.1Invitation to Pay Additional Fees; Time Limit

The invitation to pay additional fees provided for in Article 17(3)(a) shall:

(i)specify the reasons for which the international application is not considered as complying with the requirement of unity of invention;

(ii)invite the applicant to pay the additional fees within one month from the date of the invitation, and indicate the amount of those fees to be paid; and

(iii)invite the applicant to pay, where applicable, the protest fee referred to in Rule 40.2(e) within one month from the date of the invitation, and indicate the amount to be paid.

40.2.Additional Fees

(a)The amount of the additional fees due for searching under Article 17(3)(a) shall be determined by the competent International Searching Authority.

(b)The additional fees due for searching under Article 17(3)(a) shall be payable direct to the International Searching Authority.

(c)Any applicant may pay the additional fees under protest, that is, accompanied by a reasoned statement to the effect that the international application complies with the requirement of unity of invention or that the amount of the required additional fees is excessive. Such protest shall be examined by a review body constituted in the framework of the International Searching Authority, which, to the extent that it finds the protest justified, shall order the total or partial reimbursement to the applicant of the additional fees. On the request of the applicant, the text of both the protest and the decision thereon shall be notified to the designated Offices together with the international search report. The applicant shall submit any translation thereof with the furnishing of the translation of the international application required under Article 22.

(d)The membership of the review body referred to in paragraph (c) may include, but shall not be limited to, the person who made the decision which is the subject of the protest.

(e)The examination of a protest referred to in paragraph (c) may be subjected by the International Searching Authority to the payment to it, for its own benefit, of a protest fee. Where the applicant has not, within the time limit under Rule 40.1(iii), paid any required protest fee, the protest shall be considered not to have been made and the International Searching Authority shall so declare. The protest fee shall be refunded to the applicant where the review body referred to in paragraph (c) finds that the protest was entirely justified.

40.3. [Deleted]

37 CFR 1.475. Unity of invention before the International Searching Authority, the International Preliminary Examining Authority and during the national stage.

(a)An international and a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.

(b)An international or a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:

(1)A product and a process specially adapted for the manufacture of said product; or

(2)A product and a process of use of said product; or

(3)A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or

(4)A process and an apparatus or means specifically designed for carrying out the said process; or

(5)A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.

(c)If an application contains claims to more or less than one of the combinations of categories of invention set forth in paragraph (b) of this section, unity of invention might not be present.

(d)If multiple products, processes of manufacture or uses are claimed, the first invention of the category first mentioned in the claims of the application and the first recited invention of each of the other categories related thereto will be considered as the main invention in the claims, see PCT Article 17(3)(a) and § 1.476(c).

(e)The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim.

I.THE REQUIREMENT FOR “UNITY OF INVENTION”

Any international application must relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (PCT Article 3(4)(iii) and 17(3)(a), PCT Rule 3.1, and 37 CFR 1.475). Observance of this requirement is checked by the International Searching Authority and may be relevant in the national (or regional) phase.

The decision in Caterpillar Tractor Co. v. Commissioner of Patents and Trademarks, 650 F. Supp. 218, 231 USPQ 590 (E.D. Va. 1986) held that the Patent



and Trademark Office interpretation of 37 CFR 1.141(b)(2) as applied to unity of invention determinations in international applications was not in accordance with the Patent Cooperation Treaty and its implementing regulations. In the Caterpillar international application, the USPTO acting as an International Searching Authority, had held lack of unity of invention between a set of claims directed to a process for forming a sprocket and a set of claims drawn to an apparatus (die) for forging a sprocket. The court stated that it was an unreasonable interpretation to say that the expression “specifically designed” as found in former PCT Rule 13.2(ii) means that the process and apparatus have unity of invention if they can only be used with each other, as was set forth in MPEP § 806.05(e).

Therefore, when the Office considers international applications as an International Searching Authority, as an International Preliminary Examining Authority, and during the national stage as a Designated or Elected Office under 35 U.S.C. 371, PCT Rule 13.1and 13.2 will be followed when considering unity of invention of claims of different categories without regard to the practice in national applications filed under 35 U.S.C. 111. No change was made in restriction practice in United States national applications filed under 35 U.S.C. 111 outside the PCT.

In applying PCT Rule 13.2 to international applications as an International Searching Authority, an International Preliminary Examining Authority and to national stage applications under 35 U.S.C. 371, examiners should consider for unity of invention all the claims to different categories of invention in the application and permit retention in the same application for searching and/or preliminary examination, claims to the categories which meet the requirements of PCT Rule 13.2.

PCT Rule 13.2, as it was modified effective July 1, 1992, no longer specifies the combinations of categories of invention which are considered to have unity of invention. Those categories, which now appear as a part of Chapter 10 of the International Search and Preliminary Examination Guidelines, may be obtained from WIPO’s website (www.wipo.int/pct/en/texts/ gdlines.htm). The categories of invention in former PCT Rule 13.2 have been replaced with a statement describing the method for determining whether the requirement of unity of invention is satisfied. Unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more special technical features. The term “special technical features” is defined as meaning those technical features that define a contribution which each of the inventions considered as a whole, makes over the prior art. The determination is made based on the contents of the claims as interpreted in light of the description and drawings. Chapter 10 of the International Search and Preliminary Examination Guidelines also contains examples concerning unity of invention.

II.DETERMINATION OF “UNITY OF INVENTION”

An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is only permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description and drawings (if any).

Whether or not any particular technical feature makes a “contribution” over the prior art, and therefore constitutes a “special technical feature,” should be considered with respect to novelty and inventive step. For example, a document discovered in the international search shows that there is a presumption of lack of novelty or inventive step in a main claim, so that there may be no technical relationship left over the prior art among the claimed inventions involving one or more of the same or corresponding special technical features, leaving two or more dependent claims without a single general inventive concept.

Lack of unity of invention may be directly evident “a priori,” that is, before considering the claims in relation to any prior art, or may only become apparent “a posteriori,” that is, after taking the prior art into



consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.

Although lack of unity of invention should certainly be raised in clear cases, it should neither be raised nor maintained on the basis of a narrow, literal or academic approach. There should be a broad, practical consideration of the degree of interdependence of the alternatives presented, in relation to the state of the art as revealed by the international search or, in accordance with PCT Article 33(6), by any additional document considered to be relevant. If the common matter of the independent claims is well known and the remaining subject matter of each claim differs from that of the others without there being any unifying novel inventive concept common to all, then clearly there is lack of unity of invention. If, on the other hand, there is a single general inventive concept that appears novel and involves inventive step, then there is unity of invention and an objection of lack of unity does not arise. For determining the action to be taken by the examiner between these two extremes, rigid rules cannot be given and each case should be considered on its merits, the benefit of any doubt being given to the applicant.

From the preceding paragraphs it is clear that the decision with respect to unity of invention rests with the International Searching Authority or the International Preliminary Examining Authority. However, the International Searching Authority or the International Preliminary Examining Authority should not raise objection of lack of unity of invention merely because the inventions claimed are classified in separate classification groups or merely for the purpose of restricting the international search to certain classification groups.

Unity of invention has to be considered in the first place only in relation to the independent claims in an international application and not the dependent claims. By “dependent” claim is meant a claim which contains all the features of one or more other claims and contains a reference, preferably at the beginning, to the other claim or claims and then states the additional features claimed (PCT Rule 6.4). The examiner should bear in mind that a claim may also contain a reference to another claim even if it is not a dependent claim as defined in PCT Rule 6.4. One example of this is a claim referring to a claim of a different category (for example, “Apparatus for carrying out the process of Claim 1 ...,” or “Process for the manufacture of the product of Claim 1 ...”). Similarly, a claim to one part referring to another cooperating part, for example, “plug for cooperation with the socket of Claim 1 ...”) is not a dependent claim.

If the independent claims avoid the prior art and satisfy the requirement of unity of invention, no problem of lack of unity arises in respect of any claims that depend on the independent claims. In particular, it does not matter if a dependent claim itself contains a further invention. For example, suppose claim 1 claims a turbine rotor blade shaped in a specified manner such that it avoids the prior art, while claim 2 is for a “turbine rotor blade as claimed in claim 1” and produced from alloy Z. Then no objection under PCT Rule 13 arises either because alloy Z was new and its composition was not obvious and thus the alloy itself already contains the essential features of an independent possibly later patentable invention, or because, although alloy Z was not new, its application in respect of turbine rotor blades was not obvious, and thus represents an independent invention in conjunction with turbine rotor blades. As another example, suppose that the main claim defines a process avoiding the prior art for the preparation of a product A starting from a product B and the second claim reads: “Process according to claim 1 characterized by producing B by a reaction using the product C.” In this case, too, no objection arises under PCT Rule 13, whether or not the process for preparation of B from C is novel and inventive, since claim 2 contains all the features of claim 1. Equally, no problem arises in the case of a genus/species situation where the genus claim avoids the prior art, provided the genus claim is directed only to alternatives of a similar nature and the species falls entirely within the genus. To determine if a genus claim is directed only to alternatives “of a similar nature,” see subsection “B. Markush Practice” under “ILLUSTRATIONS OF PARTICULAR SITUATIONS” below. Moreover, no problem



arises in the case of a combination/subcombination situation where the subcombination claim avoids the prior art and the combination claim includes all the features of the subcombination.

If, however, an independent claim does not avoid the prior art, then the question whether there is still an inventive link between all the claims dependent on that claim needs to be carefully considered. If there is no link remaining, an objection of lack of unity a posteriori (that is, arising only after assessment of the prior art) may be raised. Similar considerations apply in the case of a genus/species or combination/subcombination situation.

This method for determining whether unity of invention exists is intended to be applied even before the commencement of the international search. Where a search of the prior art is made, an initial determination of unity of invention, based on the assumption that the claims avoid the prior art, may be reconsidered on the basis of the results of the search of the prior art.

Alternative forms of an invention may be claimed either in a plurality of independent claims, or in a single claim. In the latter case, the presence of the independent alternatives may not be immediately apparent. In either case, however, the same criteria should be applied in deciding whether there is unity of invention. Accordingly, lack of unity of invention may exist within a single claim. Where the claim contains distinct embodiments that are not linked by a single general inventive concept, the objection as to lack of unity of invention should be raised. PCT Rule 13.3 does not prevent an Authority from objecting to alternatives being contained within a single claim on the basis of considerations such as clarity, the conciseness of claims or the claims fee system applicable in that Authority.

Objection of lack of unity of invention does not normally arise if the combination of a number of individual elements is claimed in a single claim (as opposed to distinct embodiments as discussed in the paragraph immediately above), even if these elements seem unrelated when considered individually.

III.ILLUSTRATIONS OF PARTICULAR SITUATIONS

There are three particular situations for which the method for determining unity of invention contained in PCT Rule 13.2 is explained in greater detail:

(A)Combinations of different categories of claims;

(B)So-called “Markush practice”; and

(C)Intermediate and final products.

Principles for the interpretation of the method contained in PCT Rule 13.2, in the context of each of those situations are set out below. It is understood that the principles set out below are, in all instances, interpretations of and not exceptions to the requirements of PCT Rule 13.2.

Examples to assist in understanding the interpretation on the three areas of special concern referred to in the preceding paragraph are set out in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/gdlines.htm).

A.Combinations of Different Categories of Claims

The method for determining unity of invention under PCT Rule 13 shall be construed as permitting, in particular, the inclusion of any one of the following combinations of claims of different categories in the same international application:

(A)In addition to an independent claim for a given product, an independent claim for a process specially adapted for the manufacture of the said product, and an independent claim for a use of the said product; or

(B)In addition to an independent claim for a given process, an independent claim for an apparatus or means specifically designed for carrying out the said process; or

(C)In addition to an independent claim for a given product, an independent claim for a process specially adapted for the manufacture of the said product and an independent claim for an apparatus or means specifically designed for carrying out the said process.



A process is specially adapted for the manufacture of a product if it inherently results in the product and an apparatus or means is specifically designed for carrying out a process if the contribution over the prior art of the apparatus or means corresponds to the contribution the process makes over the prior art.

Thus, a process shall be considered to be specially adapted for the manufacture of a product if the claimed process inherently results in the claimed product with the technical relationship being present between the claimed product and claimed process. The words “specially adapted” are not intended to imply that the product could not also be manufactured by a different process.

Also an apparatus or means shall be considered to be specifically designed for carrying out a claimed process if the contribution over the prior art of the apparatus or means corresponds to the contribution the process makes over the prior art. Consequently, it would not be sufficient that the apparatus or means is merely capable of being used in carrying out the claimed process. However, the expression “specifically designed” does not imply that the apparatus or means could not be used for carrying out another process, nor that the process could not be carried out using an alternative apparatus or means.

More extensive combinations than those set forth above should be looked at carefully to ensure that the requirements of both PCT Rule 13 (unity of invention) and PCT Article 6 (conciseness of claims) are satisfied. In particular, while a single set of independent claims according to one of (A), (B), or (C) above is always permissible, it does not require the International Authority to accept a plurality of such sets which could arise by combining the provisions of PCT Rule 13.3 (which provides that the determination of unity of invention be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim), with the provisions set out above (thus resulting in a set based on each of a number of independent claims in the same category under PCT Rule 13.3). The proliferation of claims arising from a combined effect of this kind should be accepted only exceptionally. For example, independent claims are permissible for two related articles such as a transmitter and receiver; however, it does not follow that an applicant may include also, in the one international application, four additional independent claims: two for a process for the manufacture of the transmitter and the receiver, respectively, and two for use of the transmitter and receiver, respectively.

A single general inventive concept must link the claims in the various categories and in this connection the wording above should be carefully noted. The link between product and process in (A) is that the process must be “specially adapted for the manufacture of” the product. Similarly, in (B), the apparatus or means claimed must be “specifically designed for” carrying out the process. Likewise, in (C), the process must be “specially adapted for the manufacture of” the product and the apparatus must be “specifically designed for” carrying out the process. In combinations (A) and (C), the emphasis is on, and the essence of the invention should primarily reside in, the product, whereas in combination (B) the emphasis is on, and the invention should primarily reside in, the process. (See Examples in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/ gdlines.htm.))

B.“Markush Practice”

The situation involving the so-called Markush practice wherein a single claim defines alternatives (chemical or non-chemical) is also governed by PCT Rule 13.2. In this special situation, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in PCT Rule 13.2, shall be considered to be met when the alternatives are of a similar nature.

When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled:

(A)All alternatives have a common property or activity; and

(B)(1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or

(B)(2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.



In paragraph (B)(1), above, the words “significant structural element is shared by all of the alternatives” refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together.

In paragraph (B)(2), above, the words “recognized class of chemical compounds” mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.

The fact that the alternatives of a Markush grouping can be differently classified should not, taken alone, be considered to be justification for a finding of a lack of unity of invention.

When dealing with alternatives, if it can be shown that at least one Markush alternative is not novel over the prior art, the question of unity of invention should be reconsidered by the examiner. Reconsideration does not necessarily imply that an objection of lack of unity shall be raised. (See Examples in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/gdlines.htm.))

C.Intermediate and Final Products

The situation involving intermediate and final products is also governed by PCT Rule 13.2.

The term “intermediate” is intended to mean intermediate or starting products. Such products have the ability to be used to produce final products through a physical or chemical change in which the intermediate loses its identity.

Unity of invention shall be considered to be present in the context of intermediate and final products where the following two conditions are fulfilled:

(A)The intermediate and final products have the same essential structural element, in that:

(1)The basic chemical structures of the intermediate and the final products are the same, or

(2)The chemical structures of the two products are technically closely interrelated, the intermediate incorporating an essential structural element into the final product; and

(B)The intermediate and final products are technically interrelated, this meaning that the final product is manufactured directly from the intermediate or is separated from it by a small number of intermediates all containing the same essential structural element.

Unity of invention may also be considered to be present between intermediate and final products of which the structures are not known, for example, as between an intermediate having a known structure and a final product the structure of which is not known, or as between an intermediate of unknown structure and a final product of unknown structure. In order to satisfy unity in such cases, there must be sufficient evidence to lead one to conclude that the intermediate and final products are technically closely interrelated as, for example, when the intermediate contains the same essential element as the final product or incorporates an essential element into the final product.

It is possible to accept in a single international application different intermediate products used in different processes for the preparation of the final product, provided that they have the same essential structural element.

The intermediate and final products shall not be separated, in the process leading from one to the other, by an intermediate which is not new.

If the same international application claims different intermediates for different structural parts of the final product, unity shall not be regarded as being present between the intermediates.

If the intermediate and final products are families of compounds, each intermediate compound shall correspond to a compound claimed in the family of the final products. However, some of the final products may have no corresponding compound in the family of the intermediate products so that the two families need not be absolutely congruent.

As long as unity of invention can be recognized applying the above interpretations, the fact that, besides the ability to be used to produce final products, the intermediates also exhibit other possible



effects or activities shall not affect the decision on unity of invention. (See Examples in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/gdlines.htm.))

IV.SEARCH OF ADDITIONAL INVENTIONS WITHOUT PAYMENT OF FEES

If little or no additional search effort is required, reasons of economy may make it advisable for the examiner, while making the search for the main invention, to search at the same time, despite the nonpayment of additional fees, one or more additional inventions in the classification units consulted for the main invention. The international search for such additional inventions will then have to be completed in any further classification units which may be relevant, when the additional search fees have been paid. This situation may occur when the lack of unity of invention is found either “a priori” or “a posteriori.”

When the examiner finds lack of unity of invention, normally, the applicant is invited to pay fees for the search of additional inventions. In exceptional circumstances, however, the examiner may be able to establish both an international search (and for international applications having a filing date on or after January 1, 2004, a written opinion) covering more than one invention with negligible additional work, in particular, when the inventions are conceptually very close. In those cases, the examiner may decide to complete the international search (and where applicable, the written opinion of the International Searching Authority) for the additional invention(s) together with that for the invention first mentioned. For international applications having a filing date on or after January 1, 2004, in considering the amount of work involved, the examiner should take into account the time needed to create the written opinion as well as that needed to perform the search, since even when the additional work with regard to the search is negligible, the opposite may be the case for the written opinion of the International Searching Authority and therefore justify requesting the additional fees. If it is considered that the total additional work does not justify requesting additional fees, all results are included in the international search report without inviting the applicant to pay an additional search fee in respect of the additional inventions searched but stating the finding of lack of unity of invention.

V.INVITATION TO PAY ADDITIONAL FEES

The search fee which the applicant is required to pay is intended to compensate the International Searching Authority for carrying out an international search (and for international applications having a filing date on or after January 1, 2004, for preparing a written opinion), but only where the international application meets the “requirement of unity of invention”. That means that the international application must relate to only one invention or must relate to a group of inventions which are so linked as to form a single general inventive concept (PCT Articles 3(4)(iii) and 17(3)(a)).

If the International Searching Authority finds that the international application does not comply with the requirement of unity of invention, the applicant will be informed of the lack of unity of invention by a communication preceding the issuance of the international search report (and for international applications having a filing date on or after January 1, 2004, a written opinion of the International Searching Authority), which contains an invitation to pay additional search fees. (Form PCT/ISA/206 or USPTO/299 (telephone practice), see below). This invitation specifies the reasons the international application is not considered to comply with the requirement of unity of invention, identifies the separate inventions, and indicates the number of additional search fees and the amount to be paid (PCT Rules 40.1, 40.2(a) and (b)). The International Searching Authority cannot consider the application withdrawn for lack of unity of invention, nor invite the applicant to amend the claims, but informs the applicant that, if the international search report is to be drawn up in respect of those inventions present other than the first mentioned, then the additional fees must be paid within one month from the date of the invitation to pay additional fees (PCT Rule 40.1). Such additional fees are payable directly to the International Searching Authority which is conducting the search, i.e., either the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), or the Korean Intellectual Property Office (KIPO). The search fee amounts for the USPTO, EPO, and



KIPO are found in each weekly edition of the Official Gazette.

In the invitation to pay additional fees, the International Searching Authority should set out a logically presented, technical reasoning containing the basic considerations behind the finding of lack of unity (PCT Rule 40.1).

Since these payments must take place within the time limit set by the International Searching Authority so as to enable the observation of the time limit for establishing the international search report set by PCT Rule 42, the International Searching Authority should endeavor to ensure that international searches be made as early as possible after the receipt of the search copy. The International Searching Authority finally draws up the international search report (and for international applications having a filing date on or after January 1, 2004, the written opinion of the International Searching Authority) on those parts of international application which relate to the “main invention,” that is, the invention or the group of inventions so linked as to form a single general inventive concept first mentioned in the claims (PCT Article 17(3)(a)). Moreover, the international search report (and for international applications having a filing date on or after January 1, 2004, the written opinion of the International Searching Authority) will be established also on those parts of the international application which relate to any invention (or any group of inventions so linked as to form a single general inventive concept) in respect of which the applicant has paid any additional fee within the prescribed time limits.

Where, within the prescribed time limit, the applicant does not pay any additional fees or only pays some of the additional fees indicated, certain parts of the international application will consequently not be searched. The lack of an international search report in respect of such parts of the international application will, in itself, have no influence on the validity of the international application and processing of the international application will continue, both in the international and in the national (regional) phases. The unsearched claims, upon entry into the national stage, will be considered by the examiner and may be the subject of a holding of lack of unity of invention.

VI.PREPARATION OF THE INVITATION TO PAY ADDITIONAL FEES

Form PCT/ISA/206 is used to invite the applicant to pay additional search fees. In the space provided on form PCT/ISA/206, the examiner should indicate the number of inventions claimed in the international application covering which particular claims and explain why the international application is not considered to comply with the requirements of unity of invention. The examiner should then indicate the total amount of additional fees required for the search of all claimed inventions.

In the box provided at the top of the form, the time limit of one month for response is set according to PCT Rule 40.1. Extensions of time are not permitted.

Since the space provided on Form PCT/ISA/206 is limited, supplemental attachment sheets, supplied by the examiner, with reference back to the specific section, should be incorporated whenever necessary.

VII.AUTHORIZED OFFICER

Form PCT/IPEA/206 must be signed by an examiner with at least partial signatory authority.

VIII.TELEPHONIC UNITY PRACTICE

Telephone practice may be used to allow applicants to pay additional fees if

(A)Applicant or applicant’s legal representative has a USPTO deposit account,

(B)Applicant or the legal representative orally agrees to charge the additional fees to the account, and

(C)A complete record of the telephone conversation is included with the international search report including:

(1)Examiner’s name;

(2)Authorizing attorney’s name;

(3)Date of conversation;

(4)Inventions for which additional fees paid; and

(5)Deposit account number and amount to be charged.



When the telephone practice is used in making lack of unity requirements, it is critical that the examiner orally inform applicant that there is no right to protest the holding of lack of unity of invention for any group of invention(s) for which no additional search fee has been paid.

The examiner must further orally advise applicant that any protest to the holding of lack of unity or the amount of additional fee required must be filed in writing no later than 15 days from the mailing date of the international search report. The examiner should fill in the information on Form USPTO/299 “Chapter I PCT Telephone Memorandum for Lack of Unity” as a record of the telephonic holding of lack of unity.

If the applicant or the legal representative or agent refuses to either restrict the claims to one invention or authorize payment of additional fees over the telephone, or if applicant does not have a deposit account, the examiner should send a written invitation using the Chapter I form, PCT/ISA/206.

If a written invitation is required, the examiner should, if possible, submit the written invitation to the TC for review and mailing within 7 days from the date the international application is charged to the examiner.

IX.FORM PARAGRAPHS FOR LACK OF UNITY IN INTERNATIONAL APPLICATIONS

¶ 18.05 Heading for Lack of Unity Action (Not Involving Species)

This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In order for all inventions to be examined, the appropriate additional examination fees must be paid.

Examiner Note:

Begin all Lack of Unity actions with this heading.

¶ 18.06 Lack of Unity - Three Groups of Claims

Group [1], claim(s) [2], drawn to [3].

Group [4], claim(s) [5], drawn to [6].

Group [7], claim(s) [8], drawn to [9].

Examiner Note:

1.In brackets 1, 4 and 7, insert Roman numerals for each Group.

2.In brackets 2, 5 and 8, insert respective claim numbers.

3.In brackets 3, 6 and 9, insert respective names of grouped inventions.

¶ 18.06.01 Lack of Unity - Two (or Additional) Groups of Claims

Group [1], claim(s) [2], drawn to [3].

Group [4], claim(s) [5], drawn to [6].

Examiner Note:

This form paragraph may be used alone or following form paragraph 18.06.

¶ 18.06.02 Lack of Unity - One Additional Group of Claims

Group [1], claim [2], drawn to [3].

Examiner Note:

This form paragraph may be used following either form paragraph 18.06 or 18.06.01.

¶ 18.07 Lack of Unity - Reasons Why Inventions Lack Unity

The inventions listed as Groups [1] do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: [2]

Examiner Note:

1.In bracket 1, insert appropriate Roman numerals for Groups involved.

2.In bracket 2, insert reasoning.

¶ 18.16 Lack of Unity - Species - Heading

This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.

In order for more than one species to be examined, the appropriate additional examination fees must be paid. The species are as follows:

[1]

Examiner Note:

In bracket 1, list each species by Fig. No. or embodiment.

¶ 18.17 Lack of Unity - Species - Correspondence of the Claims to the Species

The claims are deemed to correspond to the species listed above in the following manner:

[1]

The following claim(s) are generic: [2]

Examiner Note:

1.This form paragraph is to be used immediately following 18.16.

2.In bracket 1, for each species, list the claims, e.g., Fig.1 - claims 1, 3 and 6.

3.In bracket 2, identify each generic claim by number or insert the word --NONE--.



¶ 18.18 Lack of Unity - Species - Reasons Why Unity Is Lacking

The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: [1]

Examiner Note:

1.This form paragraph is to be used immediately following form paragraph 18.17.

2.In bracket 1, insert reasoning.

X.PROTEST PROCEDURE

PCT Administrative Instruction Section 502.

Transmittal of Protest Against Payment of Additional Fees and Decision Thereon Where International Application Is Considered to Lack Unity of Invention

The International Searching Authority shall transmit to the applicant, preferably at the latest together with the international search report, any decision which it has taken under Rule 40.2(c) on the protest of the applicant against payment of additional fees where the international application is considered to lack unity of invention. At the same time, it shall transmit to the International Bureau a copy of both the protest and the decision thereon, as well as any request by the applicant to forward the texts of both the protest and the decision thereon to the designated Offices.

37 CFR 1.477. Protest to lack of unity of invention before the International Searching Authority.

(a)If the applicant disagrees with the holding of lack of unity of invention by the International Searching Authority, additional fees may be paid under protest, accompanied by a request for refund and a statement setting forth reasons for disagreement or why the required additional fees are considered excessive, or both (PCT Rule 40.2(c)).

(b)Protest under paragraph (a) of this section will be examined by the Director or the Director’s designee. In the event that the applicant’s protest is determined to be justified, the additional fees or a portion thereof will be refunded.

(c)An applicant who desires that a copy of the protest and the decision thereon accompany the international search report when forwarded to the Designated Offices may notify the International Searching Authority to that effect any time prior to the issuance of the international search report. Thereafter, such notification should be directed to the International Bureau (PCT Rule 40.2(c)).

The applicant may protest the allegation of lack of unity of invention or that the number of required additional fees is excessive and request a refund of the additional fee(s) paid. If, and to the extent that, the International Searching Authority finds the protest justified, the fee(s) are refunded (PCT Rule 40.2(c)). (The additional search fees must be paid for any protest to be considered.)

Protest of allegation of lack of unity is in the form of a reasoned statement accompanying payment of the additional fee, explaining why the applicant believes that the requirements of unity of invention are fulfilled and fully taking into account the reasons indicated in the invitation to pay additional fees issued by the International Searching Authority. Any such protest filed with the U.S. International Searching Authority will be decided by a Technology Center Director (MPEP § 1002.02(c) item (2)). To the extent applicant’s protest is found to be justified, total or partial reimbursement of the additional fee will be made. On the request of the applicant, the text of both the protest and the decision thereon is sent to the designated Offices together with the international search report (37 CFR 1.477(c)).

XI.NOTIFICATION OF DECISION ON PROTEST

Form PCT/ISA/212 is used by the Technology Center (TC) to inform the applicant of the decision regarding applicant’s protest on the payment of additional fees concerning unity of invention. The TC checks the appropriate box, i.e., 1 or 2. If box 2 is checked, a clear and concise explanation as to why the protest concerning the unity of invention was found to be unjustified must be given. Since the space is limited, supplemental attachment sheet(s) should be incorporated whenever necessary.

XII.AUTHORIZED OFFICER

Form PCT/ISA/212 must be signed by a TC Director. See MPEP § 1002.02 (c), item (2).

XIII.UNITY OF INVENTION - NUCLEOTIDE SEQUENCES

Under 37 CFR 1.475 and 1.499 et seq., when claims do not comply with the requirement of unity of invention, i.e., when the claimed subject matter does not involve “one or more of the same or corresponding special technical features,” 37 CFR 1.475(a), an additional fee is required to maintain the claims in the same application. 37 CFR 1.476 (b).

The USPTO has decided sua sponte to partially waive 37 CFR 1.475 and 1.499 et seq. to permit applicants to claim up to ten (10) nucleotide sequences that do not have the same or corresponding special technical feature without the payment of an additional fee.



The PCT permits inventions that lack unity of invention to be maintained in the same international application for payment of additional fees. Thus, in international applications, for each group for which applicant has paid additional international search and/ or preliminary examination fees, the USPTO has determined that up to four (4) such additional sequences per group is a reasonable number for examination. Further, claims directed to the selected sequences will be examined with claims drawn to any sequence combinations which have a common technical feature with the selected sequences. Nucleotide sequences encoding the same protein are considered to satisfy the unity of invention standard and will continue to be examined together.

See MPEP § 803.04 for examples of nucleotide sequence claims impacted by this partial waiver of 37 CFR 1.475 and 1.499 et seq.

Examples concerning Unity of Invention involving biotechnological inventions may be found in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from the WIPO’s web site (www.wipo.int/pct/en/texts/ gdlines.htm).

1851Identification of Patent Documents[R-5]

The examiner, in completing the international search report as well as the written opinion and international preliminary examination report, is required to cite the references in accordance with the provisions of Administrative Instructions Sections 503 and 611and WIPO Standard ST.14. These sections of the Administrative Instructions require reference citations to include, in addition to other information which is apparent from the forms which the examiner fills out, an indication of the two-letter country code of the country or entity issuing or publishing the document and the standard code for identifying the kind of patent document. The discussion which follows is limited to the identification of patent documents (and nonpatent publications) and a listing of the two-letter country codes for countries or other entities which issue or publish industrial property information.

The standard codes for identifying different kinds of patent documents are found in the “WIPO Handbook on Industrial Property Information and Documentation” - WIPO Standard ST.16 which is published by the World Intellectual Property Organization. The listing is extensive. The Special Program Examiners in each Technology Center (TC) have a complete copy of Standard ST.16. It is also accessible on WIPO’s web site (http://www.wipo.int/scit/en/) under the heading “WIPO Standards and Other Documentation.” Provided herein is an abbreviated version representing the countries and codes commonly used by the examiner in preparing search reports.

U.S. patents published before January 2, 2001, are Code A documents generally. Beginning with patents published on January 2, 2001, U.S. patents are Code B documents. Patent Application Publications, first published on March 15, 2001, are Code A documents. Reexamination certificates published before January 2, 2001, are Code B documents. Reexamination certificates published on or after January 2, 2001, are Code C documents. Tables providing a complete list of the kind codes of patents and other documents published by the USPTO are included in MPEP § 901.04(a). All nonpatent literature documents are Code N. Numerical designations are sometimes found on published documents along with the letter code designation. These should be used by the examiner only if such numerical designation is on the document. Numerical codes along with letter codes can be found, for example, on certain published patent documents such as the German Offenlegungsschrift and published international applications. If numerical designations are not provided, the examiner should use only the letter code designation.

The most commonly cited documents are patents and published patent applications. A guideline for the citation of such documents is listed below. The listing is indicated in the order in which the elements should be listed.

In the case of a patent or published patent application:

(A)The Office that issued the document, by the two letter code (WIPO Standard ST.3);

(B)The number of the document as given to it by the Office that issued it (for Japanese patent documents the indication of the year of the reign of the Emperor must precede the serial number of the patent document);

(C)The kind of document, by the appropriate symbols as indicated on the document under WIPO



Standard ST.16 or, if not indicated on that document, as provided in that Standard, if possible;

(D)The name of the patentee or applicant (in capital letters, where appropriate, abbreviated);

(E)The date of publication of the cited patent document or, in case of a corrected patent document, the date of issuance of the corrected patent document as referred to under INID code (48) of WIPO Standard ST.9 and, if provided on the document, the supplementary correction code as referred to under INID code (15);

(F)Where applicable, the pages, columns, lines or paragraph numbers where the relevant passages appear, or the relevant figures of the drawings.

The following examples illustrate the citation of a patent document as indicated above:

JP 10-105775 A (NCR INTERNATIONAL INC.) 24 April 1998 (24.04.1998) paragraphs 26 to 30.

DE 3744403 A1 (JOSEK, A.) 29 August 1991 (29- 08-1991), page 1, abstract.

US 5,635,683 A (MCDERMOTT, R. M. et al.) 03 June 1997 (03/06/1997), column 7, lines 21 to 40.

STANDARD CODE FOR THE IDENTIFICATION OF DIFFERENT KINDS OF PATENT DOCUMENTS

The Code, WIPO Standard ST.16, is subdivided into mutually exclusive groups of letters. The groups characterize patent documents, nonpatent literature documents (N), and restricted documents (X). Groups 1-7 comprise letters enabling identification of documents pertaining to different publication levels.

Group 1

Use for documents resulting from a patent application and being identified as the primary or major series (excluding the utility model documents of Group 2 and the special series of patent documents of Group 3, below)

A

First publication level

B

Second publication level

C

Third publication level



Group 2

Use for utility model documents having a numbering series other than the documents of Group 1

U

First publication level

Y

Second publication level

Z

Third publication level



Group 3

Use for special series of patent documents

M

Medicament patent documents (e.g., documents previously published by FR)

P

Plant patent documents (e.g., published by US)

S

Design patent documents (e.g., published by US)



Group 4

Use for special types of patent documents or documents derived from/relating to patent applications and not covered by Groups 1 to 3 above, as specified below:

L

Documents, not covered by letter code W, relating to patent documents and containing bibliographic information and only the text of an abstract and/or claim(s) and, where appropriate, a drawing.

R

Separately published search reports

T

Publication, for information or other purposes, of the translation of the whole or part of a patent document already published by another office or organization





W

Documents relating to utility model documents falling in Group 2 and containing bibliographic information and only the text of an abstract and/or claim(s) and, where appropriate, a drawing



Group 5

Use for series of patent documents not covered by Groups 1 to 4, above

E

First publication level

F

Second publication level

G

Third publication level



Group 6

Use for series of patent documents or documents derived from/relating to patent applications not covered by Groups 1 to 5 above, according to the special requirements of each industrial property office

H

I



Group 7

Other

N

Non-patent literature documents

X

Documents restricted to the internal use of industrial property offices



List of Examples of Patent Documents, Previously and Currently Published, or Intended To Be Published, Divided According to Code

CODE: A

Patent Documents Identified as Primary or Major Series — First Publication Level

Country Codes

The two-letter country codes listed below are set forth in WIPO Standard ST.3, which is published in the “WIPO Handbook on Industrial Property Information and Documentation” and is accessible via the internet at the WIPO website (www.wipo.int/scit/en/ standards/standards.htm). WIPO Standard ST.3 provides, in Annex A, Section 1, a listing of two-letter country codes and/or organizational codes in alphabetic sequence of their short names for the states, other entities and intergovernmental organizations issuing or publishing industrial property documents. Codes for states or organizations that existed on January 1, 1978, but that no longer exist are provided in Annex B, Section 2. Annex B, Section 1 (not reproduced below) lists States for which the Codes have changed.

Annex A, Section 1 List of States, Other Entities and Intergovernmental Organizations, in Alphabetic Sequence of Their Short Names, and Their Corresponding Codes

Afghanistan

AF

African Intellectual Property Organization (OAPI)

OA

African Regional Intellectual Property Organization (ARIPO)

AP

Albania

AL

Algeria

DZ

Andorra

AD

Angola

AO

Anguilla

AI

Antigua and Barbuda

AG

Argentina

AR

Armenia

AM

Aruba

AW

Australia

AU

Austria

AT

Azerbaijan

AZ

Bahamas

BS

Bahrain

BH

Bangladesh

BD

Barbados

BB

Belarus

BY

Belgium

BE

Belize

BZ

Benelux Trademark Office (BBM) and Benelux Designs Office (BBDM)

BX

Benin

BJ

Bermuda

BM

Bhutan

BT

Bolivia

BO

Bosnia and Herzegovina

BA

Botswana

BW

Bouvet Island

BV

Brazil

BR

Brunei Darussalam

BN

Bulgaria

BG

Burkina Faso

BF

Burundi

BI

Cambodia

KH

Cameroon

CM

Canada

CA

Cape Verde

CV

Cayman Islands

KY

Central African Republic

CF





Chad

TD

Chile

CL

China

CN

Colombia

CO

Comoros

KM

Congo

CG

Cook Islands

CK

Costa Rica

CR

Côte d’Ivoire

CI

Croatia

HR

Cuba

CU

Cyprus

CY

Czech Republic

CZ

Democratic People’s Republic of Korea

KP

Democratic Republic of the Congo

CD

Denmark

DK

Djibouti

DJ

Dominica

DM

Dominican Republic

DO

East Timor

TP

Ecuador

EC

Egypt

EG

El Salvador

SV

Equatorial Guinea

GQ

Eritrea

ER

Estonia

EE

Ethiopia

ET

Eurasian Patent Organization (EAPO)

EA

European Community Plant Variety Office (CPVO )

QZ

European Community Trademark Office (See Office for Harmonization in the Internal Market)

EM

European Patent Office (EPO)

EP

Falkland Islands (Malvinas)

FK

Faroe Islands

FO

Fiji

FJ

Finland

FI

France

FR

Gabon

GA

Gambia

GM

Georgia

GE

Germany

DE

Ghana

GH

Gibraltar

GI

Greece

GR

Greenland

GL

Grenada

GD

Guatemala

GT

Guinea

GN

Guinea-Bissau

GW

Gulf Cooperation Council (see Patent Office of the Cooperation Council for the Arab States of the Gulf)

Guyana

GY

Haiti

HT

Holy See

VA

Honduras

HN





Hong Kong (See The Hong Kong Special Administrative Region of The People’s Republic of China)

Hungary

HU

Iceland

IS

India

IN

Indonesia

ID

International Bureau of the World Intellectual Property Organization (WIPO)

IB, WO

Iran (Islamic Republic of)

IR

Iraq

IQ

Ireland

IE

Israel

IL

Italy

IT

Jamaica

JM

Japan

JP

Jordan

JO

Kazakhstan

KZ

Kenya

KE

Kiribati

KI

Korea (See Democratic People’s Republic of Korea; Republic of Korea)

Kuwait

KW

Kyrgyzstan

KG

Laos

LA

Latvia

LV

Lebanon

LB

Lesotho

LS

Liberia

LR

Libya

LY

Liechtenstein

LI

Lithuania

LT

Luxembourg

LU

Macau

MO

Madagascar

MG

Malawi

MW

Malaysia

MY

Maldives

MV

Mali

ML

Malta

MT

Mauritania

MR

Mauritius

MU

Mexico

MX

Monaco

MC

Mongolia

MN

Montserrat

MS

Morocco

MA

Mozambique

MZ

Myanmar

MM

Namibia

NA

Nauru

NR

Nepal

NP

Netherlands

NL

Netherlands Antilles

AN

New Zealand

NZ

Nicaragua

NI

Niger

NE

Nigeria

NG

Northern Mariana Islands

MP





Norway

NO

Office for Harmonization in the Internal Market (Trademarks and Designs) (OHIM)

EM

Oman

OM

Pakistan

PK

Palau

PW

Panama

PA

Papua New Guinea

PG

Paraguay

PY

Patent Office of the Cooperation Council for the Arab States of the Gulf (GCC)

GC

Peru

PE

Philippines

PH

Poland

PL

Portugal

PT

Qatar

QA

Republic of Korea

KR

Republic of Moldova

MD

Romania

RO

Russian Federation

RU

Rwanda

RW

Saint Helena

SH

Saint Kitts and Nevis

KN

Saint Lucia

LC

Saint Vincent and the Grenadines

VC

Samoa

WS

San Marino

SM

Sao Tome and Principe

ST

Saudi Arabia

SA

Senegal

SN

Serbia and Montenegro

YU

Seychelles

SC

Sierra Leone

SL

Singapore

SG

Slovakia

SK

Slovenia

SI

Solomon Islands

SB

Somalia

SO

South Africa

ZA

South Georgia and the South Sandwich Islands

GS

Spain

ES

Sri Lanka

LK

Sudan

SD

Suriname

SR

Swaziland

SZ

Sweden

SE

Switzerland

CH

Syria

SY

Taiwan, Province of China

TW

Tajikistan

TJ

Tanzania (see United Republic of Tanzania)

Thailand

TH

The Former Yugoslav Republic of Macedonia

MK

The Hong Kong Special Administrative Region of The People’s Republic of China

HK

Timor-Leste

TL





Togo

TG

Tonga

TO

Trinidad and Tobago

TT

Tunisia

TN

Turkey

TR

Turkmenistan

TM

Turks and Caicos Islands

TC

Tuvalu

TV

Uganda

UG

Ukraine

UA

United Arab Emirates

AE

United Kingdom

GB

United Republic of Tanzania

TZ

United States of America

US

Uruguay

UY

Uzbekistan

UZ

Vanuatu

VU

Vatican City State (See Holy See)

Venezuela

VE

Viet Nam

VN

Virgin Islands (British)

VG

Western Sahara

EH

World Intellectual Property Organization (WIPO) (International Bureau of)

WO, IB

Yemen

YE

Yugoslavia

YU

Zambia

ZM

Zimbabwe

ZW

Annex B, Section 2

List of States or Organizations That Existed on January 1, 1978, but That No Longer Exist

Czechoslovakia

CS

Democratic Yemen

SY/YD

German Democratic Republic

DL/DD

International Patent Institute

IB

Soviet Union

SU



1852International-Type Search

PCT Rule 41.

Earlier Search Other Than International Search

41.1.Obligation to Use Results; Refund of Fee

If reference has been made in the request, in the form provided for in Rule 4.11, to an international-type search carried out under the conditions set out in Article 15(5) or to a search other than an international or international-type search, the International Searching Authority shall, to the extent possible, use the results of the said search in establishing the international search report on the international application. The International Searching Authority shall refund the search fee, to the extent and under the conditions provided for in the agreement under Article 16(3)(b) or in a communication addressed to and published in the Gazette by the International Bureau, if the international search report could wholly or partly be based on the results of the said search.

37 CFR 1.104. Nature of examination.

(a) Examiner’s action.


(3)An international-type search will be made in all national applications filed on and after June 1, 1978.

(4)Any national application may also have an international- type search report prepared thereon at the time of the national examination on the merits, upon specific written request therefor and payment of the international-type search report fee set forth in § 1.21(e). The Patent and Trademark Office does not require that a formal report of an international-type search be prepared in order to obtain a search fee refund in a later filed international application.


PCT Rule 41 provides that the applicant may request in a later filed international application that the report of the results of the international-type search, i.e., a search similar to an international search, but carried out on a national application (37 CFR 1.104(a)(3) and (a)(4)), be used in establishing an international search report on such international



application. An international-type search is conducted on all U.S. national nonprovisional applications filed after June 1, 1978. Upon specific request, at the time of the examination of a U.S. national nonprovisional application and provided that the payment of the appropriate international-type search report fee has been made (37 CFR 1.21(e)) an international-type search report Form PCT/ISA/201 will also be prepared.

1853Amendment Under PCT Article 19 [R-5]

PCT Article 19.

Amendment of the Claims before the International Bureau

(1)The applicant shall, after having received the international search report, be entitled to one opportunity to amend the claims of the international application by filing amendments with the International Bureau within the prescribed time limit. He may, at the same time, file a brief statement, as provided in the Regulations, explaining the amendments and indicating any impact that such amendments might have on the description and the drawings.

(2)The amendments shall not go beyond the disclosure in the international application as filed.

(3)If the national law of any designated State permits amendments to go beyond the said disclosure, failure to comply with paragraph (2) shall have no consequence in that State.

PCT Rule 46.

Amendment of Claims Before the International Bureau

46.1.Time Limit

The time limit referred to in Article 19 shall be two months from the date of transmittal of the international search report to the International Bureau and to the applicant by the International Searching Authority or 16 months from the priority date, whichever time limit expires later, provided that any amendment made under Article 19 which is received by the International Bureau after the expiration of the applicable time limit shall be considered to have been received by that Bureau on the last day of that time limit if it reaches it before the technical preparations for international publication have been completed.

46.2.Where to File

Amendments made under Article 19 shall be filed directly with the International Bureau.

46.3.Language of Amendments

If the international application has been filed in a language other than the language in which it is published, any amendment made under Article 19 shall be in the language of publication.

46.4.Statement

(a)The statement referred to in Article 19(1) shall be in the language in which the international application is published and shall not exceed 500 words if in the English language or if translated into that language. The statement shall be identified as such by a heading, preferably by using the words “Statement under Article 19(1)” or their equivalent in the language of the statement.

(b)The statement shall contain no disparaging comments on the international search report or the relevance of citations contained in that report. Reference to citations, relevant to a given claim, contained in the international search report may be made only in connection with an amendment of that claim.

46.5.Form of Amendments

The applicant shall be required to submit a replacement sheet for every sheet of the claims which, on account of an amendment or amendments under Article 19, differs from the sheet originally filed. The letter accompanying the replacement sheets shall draw attention to the differences between the replaced sheets and the replacement sheets. To the extent that any amendment results in the cancellation of an entire sheet, that amendment shall be communicated in a letter.

37 CFR 1.415. The International Bureau.

(a)The International Bureau is the World Intellectual Property Organization located at Geneva, Switzerland. It is the international intergovernmental organization which acts as the coordinating body under the Treaty and the Regulations (PCT Art. 2 (xix) and 35 U.S.C. 351(h)).

(b)The major functions of the International Bureau include:

(1)Publishing of international applications and the International Gazette;

(2)Transmitting copies of international applications to Designated Offices;

(3)Storing and maintaining record copies; and

(4)Transmitting information to authorities pertinent to the processing of specific international applications.

PCT Administrative Instruction Section 205.

Numbering and Identification of Claims Upon Amendment

(a)Amendments to the claims under Article 19 or Article 34(2)(b) may be made either by cancelling one or more entire claims, by adding one or more new claims or by amending the text of one or more of the claims as filed. All the claims appearing on a replacement sheet shall be numbered in Arabic numerals. Where a claim is cancelled, no renumbering of the other claims shall be required. In all cases where claims are renumbered, they shall be renumbered consecutively.

(b)The applicant shall, in the letter referred to in the second and third sentences of Rule 46.5(a) or in the second and fourth sentences of Rule 66.8(a), indicate the differences between the claims as filed and the claims as amended. He shall, in particular, indicate in the said letter, in connection with each claim appearing in the international application (it being understood that identical indications concerning several claims may be grouped), whether:



(i)the claim is unchanged;

(ii)the claim is cancelled;

(iii)the claim is new;

(iv)the claim replaces one or more claims as filed;

(v)the claim is the result of the division of a claim as filed.

The applicant has one opportunity to amend the claims only of the international application after issuance of the Search Report. The amendments to the claims must be filed directly with the International Bureau, usually within 2 months of the date of mailing of the Search Report. If the amendments to the claims are timely received by the International Bureau, such amendments will be published as part of the publication of the international application directly following the claims as filed. Article 19 offers applicants the opportunity to generally amend the claims before entering the designated Offices. The national laws of some designated Offices may grant provisional protection on the invention from the date of publication of the claims. Therefore, some applicants take advantage of the opportunity under Article 19 to polish the claims anticipating provisional protection. See PCT Rule 46.5.

1857International Publication [R-5]

PCT Article 21.

International Publication

(1)The International Bureau shall publish international applications.

(2)(a)Subject to the exceptions provided for in subparagraph (b) and in Article 64(3), the international publication of the international application shall be effected promptly after the expiration of 18 months from the priority date of that application.

(b)The applicant may ask the International Bureau to publish his international application any time before the expiration of the time limit referred to in subparagraph (a). The International Bureau shall proceed accordingly, as provided in the Regulations.

(3)The international search report or the declaration referred to in Article 17(2)(a) shall be published as prescribed in the Regulations.

(4)The language and form of the international publication and other details are governed by the Regulations.

(5)There shall be no international publication if the international application is withdrawn or is considered withdrawn before the technical preparations for publication have been completed.

(6)If the international application contains expressions or drawings which, in the opinion of the International Bureau, are contrary to morality or public order, or if, in its opinion, the international application contains disparaging statements as defined in the Regulations, it may omit such expressions drawings, and statements, from its publications, indicating the place and number of words or drawings omitted, and furnishing, upon request, individual copies of the passages omitted.

PCT Article 29.

Effects of the International Publication

(1)As far as the protection of any rights of the applicant in a designated State is concerned, the effects, in that State, of the international publication of an international application shall, subject to the provisions of paragraphs (2) to (4), be the same as those which the national law of the designated State provides for the compulsory national publication of unexamined national applications as such.

(2)If the language in which the international publication has been effected is different from the language in which publications under the national law are effected in the designated State, the said national law may provide that the effects provided for in paragraph (1) shall be applicable only from such time as:

(i)a translation into the latter language has been published as provided by the national law, or

(ii)a translation into the latter language has been made available to the public, by laying open for public inspection as provided by the national law, or

(iii)a translation into the latter language has been transmitted by the applicant to the actual or prospective unauthorized user of the invention claimed in the international application, or

(iv)both the acts described in (i) and (iii), or both the acts described in (ii) and (iii), have taken place.

(3)The national law of any designated State may provide that, where the international publication has been effected, on the request of the applicant, before the expiration of 18 months from the priority date, the effects provided for in paragraph (1) shall be applicable only from the expiration of 18 months from the priority date.

(4)The national law of any designated State may provide that the effects provided for in paragraph (1) shall be applicable only from the date on which a copy of the international application as published under Article 21 has been received in the national Office of or acting for such State. The said Office shall publish the date of receipt in its gazette as soon as possible.

PCT Administrative Instruction Section 404.

International Publication Number of International Application

The International Bureau shall assign to each published international application an international publication number which shall be different from the international application number. The international publication number shall be used on the published international application and in the Gazette entry. It shall consist of the two-letter code “WO” followed by a four-digit indication of the year of publication, a slant, and a serial number consisting of six digits (e.g., “WO 2004/123456”).

35 U.S.C. 374. Publication of international application.

The publication under the treaty defined in section 351(a) of this title, of an international application designating the United



States shall be deemed a publication under section 122(b), except as provided in sections 102(e) and 154(d) of this title.

The publication of international applications currently occurs every Thursday. Under PCT Article 20and PCT Rules 47.1(a) and 93bis.1, the International Bureau sends copies of published international applications to each of the designated Offices that have requested to receive such documents on the date specified by that Office. The U.S. Patent and Trademark Office, as a designated Office, has requested the International Bureau to effect communication of the published application on the day of publication. Until October 1, 1995, as a PCT member country, the U.S. Patent and Trademark Office received copies of all published international applications in printed form for inclusion in the examiner search files. The U.S. Patent and Trademark Office now receives the published international applications on CD-ROM disks and in other electronic formats. For information on obtaining copies of these applications, see MPEP § 901.05(c). Published international application information is also available from the PCT Gazette, which can be accessed electronically through The Intellectual Property Digital Library Web site (http://ipdl.wipo.int/) of the World Intellectual Property Organization. In addition, published international applications may be obtained online from the European Patent Office web site (http://ep.espacenet.com).

PUBLICATION OF SEQUENCE LISTING AND/ OR TABLES FILED IN ELECTRONIC FORM

PCT Administrative Instruction Section 805.

Publication and Communication of International Applications Containing Sequence Listings and/or Tables; Copies; Priority Documents

(a)Notwithstanding Section 406, an international application containing sequence listings and/or tables may be published under Article 21, in whole or in part, in electronic form as determined by the Director General.

(b)Paragraph (a) shall apply mutatis mutandis in relation to:

(i)the communication of an international application under Article 20;

(ii)the furnishing of copies of an international application under Rules 87 and 94.1;

(iii)the furnishing under Rule 17.1, as a priority document, of a copy of an international application containing sequence listings and/or tables filed under Section 801(a);

(iv)the furnishing under Rules 17.2 and 66.7 of copies of a priority document.

As of August 2, 2001, WIPO began to publish sequence listing parts of the description on the Internet where the sequence listing was filed under PCT Administrative Instructions Section 801 as authorized by PCT Administrative Instructions Section 805(a). On September 6, 2002, the PCT Administrative Instructions were further amended to include electronic submissions of tables related to sequence listings. Sequence listing parts of the description and tables may be viewed and downloaded at http:// www.wipo.int/pct/en/sequences/index.htm. Thus, an international application containing a sequence listing or table filed under Part 8 of the Administrative Instructions comprises two elements published on the same day:

(A)a first element including all parts of the application that were not filed in electronic format under Part 8 of the Administrative Instructions; and

(B)a second element consisting of an electronic publication of the sequence listing and/or tables that were filed in electronic format under Part 8 of the Administrative Instructions.

Cross-references between the two elements are included for the sake of clarity. The bibliographic page of a published international application filed under Administrative Instructions Section 801includes the statement: “Published with sequence listing part of description published separately in electronic form and available upon request from the International Bureau.” Conversely, the electronic publication of the sequence listing part of the international application on WIPO’s web site (www.wipo.int/ pct/en/sequences/index.htm) contains a link to the remainder of the published international application in the electronic PCT Gazette.

1857.01Prior Art Effect of the International Publication [R-2]

35 U.S.C. 374. Publication of international application.

The publication under the treaty defined in section 351(a) of this title, of an international application designating the United States shall be deemed a publication under section 122(b), except as provided in sections 102(e) and 154(d) of this title.

35 U.S.C. 102. Conditions for patentability; novelty and loss of right to patent.

A person shall be entitled to a patent unless —




(e)the invention was described in — (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or


An international application may be used as prior art as of its international filing date, or an earlier U.S. filing date for which benefit is properly claimed, under 35 U.S.C. 102(e) if the international application:

(A)was filed on or after November 29, 2000;

(B)designated the United States; and

(C)was published under PCT Article 21(2) in the English language.

If such an international application properly claims benefit under 35 U.S.C. 119(e), 120, or 365(c) to an earlier-filed U.S. national or international application designating the U.S. , the international application can be applied as prior art under 35 U.S.C. 102(e) as of the earlier filing date, assuming all the conditions of 35 U.S.C. 102(e), 119(e), 120, or 365(c) are met. Note, where the earlier application is also an international application, the earlier international application must satisfy the same three conditions (i.e., filed on or after November 29, 2000, designated the U.S. and had been published in English under PCT Article 21(2)) for the earlier international filing date to be a U.S. filing date for prior art purposes under 35 U.S.C. 102(e).

If any of the above conditions have not been satisfied, the publication of the international application and the U.S. application publication of the national stage after compliance with 35 U.S.C. 371 may only be used as prior art as of its publication date under 35 U.S.C. 102(a) or (b). See MPEP § 706.02(a) and § 2136.03. A later filed U.S. application that properly claimed the benefit under 35 U.S.C. 120 or 365(c) of such an international application will have its own U.S. filing date for purposes of 35 U.S.C. 102(e). In addition, international applications, which: (1) were filed prior to November 29, 2000, (2) did not designate the U.S., or (3) were not published in English under PCT Article 21(2) by WIPO, may not be used to reach back (bridge) to an earlier filing date through a benefit claim for prior art purposes under 35 U.S.C. 102(e).

For more information, see MPEP § 706.02(a) and § 706.02(f)(1).

1859Withdrawal of International Application, Designations, or Priority Claims [R-2]


PCT Rule 90bis.

Withdrawals

90bis.1.Withdrawal of the International Application

(a)The applicant may withdraw the international application at any time prior to the expiration of 30 months from the priority date.

(b)Withdrawal shall be effective on receipt of a notice addressed by the applicant, at his option, to the International Bureau, to the receiving Office or, where Article 39(1) applies, to the International Preliminary Examining Authority.

(c)No international publication of the international application shall be effected if the notice of withdrawal sent by the applicant or transmitted by the receiving Office or the International Preliminary Examining Authority reaches the International Bureau before the technical preparations for international publication have been completed.

90bis.2.Withdrawal of Designations

(a)The applicant may withdraw the designation of any designated State at any time prior to the expiration of 30 months from the priority date. Withdrawal of the designation of a State which has been elected shall entail withdrawal of the corresponding election under Rule 90bis.4.

(b)Where a State has been designated for the purpose of obtaining both a national patent and a regional patent, withdrawal of the designation of that State shall be taken to mean withdrawal of only the designation for the purpose of obtaining a national patent, except where otherwise indicated.

(c)Withdrawal of the designations of all designated States shall be treated as withdrawal of the international application under Rule 90bis.1.

(d)Withdrawal shall be effective on receipt of a notice addressed by the applicant, at his option, to the International Bureau, to the receiving Office or, where Article 39(1) applies, to the International Preliminary Examining Authority.

(e)No international publication of the designation shall be effected if the notice of withdrawal sent by the applicant or transmitted by the receiving Office or the International Preliminary Examining Authority reaches the International Bureau before the technical preparations for international publication have been completed.



90bis.3.Withdrawal of Priority Claims

(a)The applicant may withdraw a priority claim, made in the international application under Article 8(1), at any time prior to the expiration of 30 months from the priority date.

(b)Where the international application contains more than one priority claim, the applicant may exercise the right provided for in paragraph (a) in respect of one or more or all of the priority claims.

(c)Withdrawal shall be effective on receipt of a notice addressed by the applicant, at his option, to the International Bureau, to the receiving Office or, where Article 39(1) applies, to the International Preliminary Examining Authority.

(d)Where the withdrawal of a priority claim causes a change in the priority date, any time limit which is computed from the original priority date and which has not already expired shall, subject to paragraph (e), be computed from the priority date resulting from that change.

(e)In the case of the time limit referred to in Article 21(2)(a), the International Bureau may nevertheless proceed with the international publication on the basis of the said time limit as computed from the original priority date if the notice of withdrawal sent by the applicant or transmitted by the receiving Office or the International Preliminary Examining Authority reaches the International Bureau after the completion of the technical preparations for international publication.


90bis.5.Signature

(a)Any notice of withdrawal referred to in Rules 90bis.1 to 90bis.4 shall, subject to paragraph (b), be signed by the applicant or, if there are two or more applicants, by all of them. An applicant who is considered to be the common representative under Rule 90.2(b) shall, subject to paragraph (b), not be entitled to sign such a notice on behalf of the other applicants.

(b)Where two or more applicants file an international application which designates a State whose national law requires that national applications be filed by the inventor and where an applicant for that designated State who is an inventor could not be found or reached after diligent effort, a notice of withdrawal referred to in Rules 90bis.1 to 90bis.4 need not be signed by that applicant (“the applicant concerned”) if it is signed by at least one applicant and.

(i)a statement is furnished explaining, to the satisfaction of the receiving Office, the International Bureau, or the International Preliminary Examining Authority, as the case may be, the lack of signature of the applicant concerned, or

(ii)in the case of a notice of withdrawal referred to in Rule 90bis.1(b), 90bis.2(d), or 90bis.3(c), the applicant concerned did not sign the request but the requirements of Rule 4.15(b) were complied with, or

(iii)in the case of a notice of withdrawal referred to in Rule 90bis.4(b), the applicant concerned did not sign the demand but the requirements of Rule 53.8(b) were complied with.

90bis.6.Effect of Withdrawal

(a)Withdrawal under Rule 90bis of the international application, any designation, any priority claim, the demand or any election shall have no effect in any designated or elected Office where the processing or examination of the international application has already started under Article 23(2) or Article 40(2).

(b)Where the international application is withdrawn under Rule 90bis.1, the international processing of the international application shall be discontinued.

(c)Where the demand or all elections are withdrawn under Rule 90bis.4, the processing of the international application by the International Preliminary Examining Authority shall be discontinued.

90bis.7.Faculty Under Article 37(4)(b)

(a)Any Contracting State whose national law provides for what is described in the second part of Article 37(4)(b) shall notify the International Bureau in writing.

(b)The notification referred to in paragraph (a) shall be promptly published by the International Bureau in the Gazette, and shall have effect in respect of international applications filed more than one month after the date of such publication.

For a discussion of the withdrawal of the demand or of elections (PCT Rule 90bis.4 ), see MPEP § 1880.

Form PCT/IB/372 may be used by the applicant to make a withdrawal under any of PCT Rules 90bis.1, 90bis.2, 90bis.3, and 90bis4. The form is available from WIPO’s web site (www.wipo.int/pct/en/forms/ ib/ib372.pdf).

The applicant may withdraw the international application, the designation of any state, or a priority claim by a notice addressed to the International Bureau or to the receiving Office and received before the expiration of 30 months from the priority date. Where Article 39(1) applies, the notice may also be addressed to the International Preliminary Examining Authority. Any such withdrawal is free of charge. A notice of withdrawal must be signed by all the applicants. The provisions for waiver of a power of attorney set forth in PCT Rules 90.4(d) and 90.5(c) do not apply in the case of withdrawals under PCT Rule 90bis. An appointed agent or appointed common representative may sign such a notice on behalf of the applicant or applicants who appointed him, but an applicant who is considered to be the common representative may not sign such a notice on behalf of the other applicants. As to the case where an applicant inventor for the United States of America cannot be found or reached see PCT Rule 90bis.5(b).



The applicant may prevent international publication by withdrawing the international application, provided that the notice of withdrawal reaches the International Bureau before the completion of technical preparations for that publication. The notice of withdrawal may state that the withdrawal is to be effective only on the condition that international publication can still be prevented. In such a case the withdrawal is not effective if the condition on which it was made cannot be met that is, if the technical preparations for international publication have already been completed.

If all designations are withdrawn, the international application will be treated as withdrawn.


Where the withdrawal of a priority claim causes a change in the priority date of the international application, any time limit which is computed from the original priority date and which has not yet expired— for example, the time limit before which processing in the national phase cannot start—is computed from the priority date resulting from the change. (It is not possible to extend the time limit concerned if it has already expired when the priority claim is withdrawn.) Thus, international publication may be postponed by withdrawing the priority claim prior to publication. However, if the notice of withdrawal reaches the International Bureau after the completion of the technical preparations for international publication, the International Bureau may proceed with the international publication on the basis of the time limit for international publication as computed from the original priority date.

1860International Preliminary Examination Procedure for Applications Having an International Filing Date On or After January 1, 2004 [R-2]

[Note: The regulations under the PCT were changed effective January 1, 2004. A corresponding change was made to Title 37 of the Code of Federal Regulations. See January 2004 Revision of Patent Cooperation Treaty Application Procedure, 68 FR 59881 (Oct. 20, 2003), 1276 O.G. 6 (Nov. 11, 2003). All international applications having an international filing date before January 1, 2004, will continue to be processed under the procedures in effect on the international filing date. For the international preliminary examination procedure applicable to international applications having an international filing date before January 1 2004, see MPEP § 1860.01 for the information that previously appeared in this section].

EXAMINATION PROCEDURE

The international preliminary examination is to be carried out in accordance with PCT Article 34 and PCT Rule 66. After the demand is checked for compliance with PCT Rules 53-55, 57 and 58, the first step of the examiner is to study the description, the drawings (if any), the claims of the international application, the documents describing the prior art as cited in the international search report, and the written opinion established by the International Searching Authority.

A further written opinion is usually not mandatory where the written opinion of the International Searching Authority is treated as the first written opinion of the International Preliminary Examining Authority. The United States International Preliminary Examining Authority will treat any written opinion established by the United States International Searching Authority or the European Patent Office International Searching Authority as the first written opinion of the International Preliminary Examining Authority.

Assuming the written opinion of the International Searching Authority is treated as the first written opinion of the International Preliminary Examining Authority, as noted above, no further written opinion need be issued before the international preliminary examination report, even if there are objections outstanding. The examiner takes into consideration any comments or amendments made by the applicant when establishing the international preliminary examination report.

FURTHER WRITTEN OPINION SHOULD BE ISSUED

A further written opinion should be prepared by the examiner if applicant files a response which includes a persuasive argument that the written opinion issued by the International Searching Authority was improper because of a negative opinion with respect to a lack of novelty, inventive step (non-obviousness)



or industrial applicability as described in PCT Article 33(2)-(4); and which results in the examiner considering any of the claims to lack novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2)-(4) based on new art not necessitated by any amendment.

Any further written opinion established by the International Preliminary Examining Authority should set forth, as applicable:

(A)Any defects in the international application as described in PCT Article 34(4) concerning subject matter which is not required to be examined or which is unclear or inadequately supported;

(B)Any negative findings with respect to any of the claims because of a lack of novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2)-(4);

(C)Any defects in the form or contents of the international application;

(D)Any finding by the examiner that an amendment goes beyond the disclosure in the international app lication as originally filed;

(E)Any observation which the examiner wishes to make on the clarity of the claims, the description, the drawings or to the question whether the claims are fully supported by the description (PCT Rule 66.2);

(F)Any decision by the examiner not to carry out the international preliminary examination on a claim for which no international search report was issued; or

(G)If the examiner considers that no acceptable nucleotide and/or amino acid sequence listing is available in a form that would allow a meaningful international preliminary examination to be carried out.

The further written opinion is prepared on Form PCT/IPEA/408 to notify applicant of the defects found in the international application. The examiner is further required to fully state the reasons for his/her opinion (PCT Rule 66.2(b)) and invite a written reply, with amendments where appropriate (PCT Rule 66.2(c)), normally setting a 2 month time limit for the reply.

The applicant may reply to the invitation by making amendments or, if applicant disagrees with the opinion of the examiner, by submitting arguments, as the case may be, or both.

The U.S. Rules of Practice pertaining to international preliminary examination of international applications permit a second written opinion in those cases where sufficient time is available. Normally only one written opinion will be issued. Any reply received after the expiration of the set time limit will not normally be considered in preparing the international preliminary examination report. In situations, however, where the examiner has requested an amendment or where a later amendment places the application in better condition for examination, the amendment may be considered by the examiner.

If the applicant does not reply to any further written opinion established by the International Preliminary Examining Authority within the set time period, the international preliminary examination report will be prepared after expiration of the time limit plus sufficient time to have any reply clear the Mail Center.

1860.01 International Preliminary Examination Procedure for Applications Having an International Filing Date Before January 1, 2004 [R-2]

[Note: For the international preliminary examination procedure applicable to international applications having an international filing date on or after January 1, 2004, see MPEP § 1860.]

EXAMINATION PROCEDURE

The International Preliminary Examination is to be carried out in accordance with PCT Article 34 and PCT Rule 66. After the Demand is checked for compliance with PCT Rules 53 - 55, 57 and 58, the first step of the examiner is to study the description, the drawings (if any), and the claims of the international application and the documents describing the prior art as cited in the international search report.

A written opinion must be prepared if the examiner:

(A)Considers that the international application has any of the defects described in PCT Article 34(4) concerning subject matter which is not required to be examined or which is unclear or inadequately supported;




(B)Considers that the report should be negative with respect to any of the claims because of a lack of novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2) - (4);

(C)Notices any defects in the form or contents of the international application;

(D)Considers that any amendment goes beyond the disclosure in the international application as originally filed;

(E)Wishes to make an observation on the clarity of the claims, the description, the drawings or to the question whether the claims are fully supported by the description (PCT Rule 66.2);

(F)Decides not to carry out the international preliminary examination on a claim for which no international search report was issued; or

(G)Considers that no acceptable amino acid sequence listing is available in a form that would allow a meaningful international preliminary examination to be carried out.

The written opinion is prepared on form PCT/ IPEA/408 to notify applicant of the defects found in the international application. The examiner is further required to fully state the reasons for his/her opinion (PCT Rule 66.2(b)) and invite a written reply, with amendments where appropriate (PCT Rule 66.2(c)), normally setting a 2 month time limit for the reply.

The applicant may reply to the invitation by making amendments or, if applicant disagrees with the opinion of the examiner, by submitting arguments, as the case may be, or both.

The U.S. Rules of Practice pertaining to international preliminary examination of international applications permit a second written opinion in those cases where sufficient time is available. Normally only one written opinion will be issued. Any reply received after the expiration of the set time limit will not normally be considered in preparing the international preliminary examination report. In situations, however, where the examiner has requested an amendment or where a later amendment places the application in better condition for examination, the amendment may be considered by the examiner.

If the applicant does not reply to the written opinion within the set time period, the international preliminary examination report will be prepared after expiration of the time limit plus sufficient time to have any reply clear the Mail Center.

If, after initial examination of the international application, there is no negative statement or comment to be made, then only the international preliminary examination report will issue without a written opinion having been issued.


1862Agreement With the International Bureau To Serve as an International Preliminary Examining Authority [R-2]

PCT Article 32.

The International Preliminary Examining Authority

(1)International preliminary examination shall be carried out by the International Preliminary Examining Authority

(2)In the case of demands referred to in Article 31(2)(a), the receiving Office, and, in the case of demands referred to in Article 31(2)(b), the Assembly, shall, in accordance with the applicable agreement between the interested International Preliminary Examining Authority or Authorities and the International Bureau, specify the International Preliminary Examining Authority or Authorities competent for the preliminary examination.

(3)The provisions of Article 16(3) shall apply, mutatismutandis, in respect of the International Preliminary Examining Authorities.

PCT Article 34.

Procedure before the International Preliminary Examining Authority

(1)Procedure before the International Preliminary Examining Authority shall be governed by the provisions of this Treaty, the Regulations, and the agreement which the International Bureau shall conclude, subject to this Treaty and the Regulations, with the said Authority.


37 CFR 1.416. The United States International Preliminary Examining Authority.


(a)Pursuant to appointment by the Assembly, the United States Patent and Trademark Office will act as an International Preliminary Examining Authority for international applications filed in the United States Receiving Office and in other Receiving Offices as may be agreed upon by the Director, in accordance with agreement between the Patent and Trademark Office and the International Bureau.

(b)The United States Patent and Trademark Office, when acting as an International Preliminary Examining Authority, will be identified by the full title “United States International Preliminary Examining Authority” or by the abbreviation “IPEA/US.”



(c)The major functions of the International Preliminary Examining Authority include:

(1)Receiving and checking for defects in the Demand;

(2)Forwarding Demands in accordance with PCT Rule 59.3;

(3)Collecting the handling fee for the International Bureau and the preliminary examination fee for the United States International Preliminary Examining Authority;

(4)Informing applicant of receipt of the Demand;

(5)Considering the matter of unity of invention;

(6)Providing an international preliminary examination report which is a nonbinding opinion on the questions whether the claimed invention appears to be novel, to involve inventive step (to be nonobvious), and to be industrially applicable; and

(7)Transmitting the international preliminary examination report to applicant and the International Bureau.

An agreement was concluded between the United States Patent and Trademark Office (USPTO) and the International Bureau under which the USPTO agreed to serve as an International Preliminary Examining Authority for those applications filed in the USPTO as a Receiving Office and for those international applications filed in other receiving Offices for which the USPTO has served as an International Searching Authority.

The agreement is provided for in PCT Articles 32(2) & (3) and 34(1), and in PCT Rules 59.1, 63.1, 72.1, and 77.1(a). Authority is given in 35 U.S.C. 361(c), 362(a) & (b) and in 364(a). 37 CFR 1.416(a) and PCT Administrative Instructions Section 103(c) are also relevant.

1864The Demand and Preparation forFiling of Demand [R-2]

37 CFR 1.480. Demand for international preliminary examination.


(a)On the filing of a proper Demand in an application for which the United States International Preliminary Examining Authority is competent and for which the fees have been paid, the international application shall be the subject of an international preliminary examination. The preliminary examination fee (§ 1.482(a)(1)) and the handling fee (§ 1.482(b)) shall be due within the applicable time limit set forth in PCT Rule 57.3.

(b)The Demand shall be made on a standardized form (PCT Rule 53). Copies of the printed Demand forms are available from the United States Patent and Trademark Office. Letters requesting printed Demand forms should be marked “Mail Stop PCT.”

(c)Withdrawal of a proper Demand prior to the start of the international preliminary examination will entitle applicant to a refund of the preliminary examination fee minus the amount of the transmittal fee set forth in § 1.445(a)(1).

(d)The filing of a Demand shall constitute the election of all Contracting States which are designated and are bound by Chapter II of the Treaty on the international filing date (PCT Rule 53.7).

(e)Any Demand filed after the expiration of the applicable time limit set forth in PCT Rule 54bis.1.(a) shall be considered as if it had not been submitted (PCT Rule 54bis.1(b)).

Once applicant has filed an international application under Chapter I of the PCT, applicant has the right to file a demand for preliminary examination under Chapter II of the Treaty. The use of the term “Demand” distinguishes Chapter II from the “Request” under Chapter I. It is not possible to file a demand unless a proper Chapter I “Request” for an international application has been filed. Chapter I affords applicant the benefit of an international search, which includes an international search report and for international applications having an international filing date on or after January 1, 2004, a written opinion established by the International Searching Authority. The filing of a demand affords applicant examination of the application and allows applicant to file amendments to the description, claims and drawings to correct any defects, respond to any observations, or address negative findings with respect to any of the claims because of a lack of novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2)-(4) mentioned in the written opinion (Form PCT/ISA/237) established by the International Searching Authority. Thus, examination enables applicant to attempt to obtain a positive international preliminary examination report, which in some elected Offices is used as a basis for the issuance of a patent.

The demand should be filed on Form PCT/IPEA/ 401 along with the fee calculation sheet. For information on obtaining these forms free of charge, see MPEP § 1730.



1864.01Amendments Filed Under PCT Article 34 [R-2]


PCT Article 34.

Procedure Before the International Preliminary Examining Authority


(2)(b)The applicant shall have a right to amend the claims, the description, and the drawings, in the prescribed manner and within the prescribed time limit, before the international preliminary examination report is established. The amendment shall not go beyond the disclosure in the international application as filed.



PCT Rule 66.

Procedure Before the International Preliminary Examining Authority


66.8.Form of Amendments

(a)Subject to paragraph (b), the applicant shall be required to submit a replacement sheet for every sheet of the international application which, on account of an amendment, differs from the sheet previously filed. The letter accompanying the replacement sheets shall draw attention to the differences between the replaced sheets and the replacement sheets and shall preferably also explain the reasons for the amendment.

(b)Where the amendment consists in the deletion of passages or in minor alterations or additions, the replacement sheet referred to in paragraph (a) may be a copy of the relevant sheet of the international application containing the alterations or additions, provided that the clarity and direct reproducibility of that sheet are not adversely affected. To the extent that any amendment results in the cancellation of an entire sheet, that amendment shall be communicated in a letter which shall preferably also explain the reasons for the amendment.


37 CFR 1.485. Amendments by applicant during international preliminary examination.

(a)The applicant may make amendments at the time of filing the Demand. The applicant may also make amendments within the time limit set by the International Preliminary Examining Authority for reply to any notification under § 1.484(b) or to any written opinion. Any such amendments must:

(1)Be made by submitting a replacement sheet in compliance with PCT Rules 10 and 11.1 to 11.13 for every sheet of the application which differs from the sheet it replaces unless an entire sheet is cancelled; and

(2)Include a description of how the replacement sheet differs from the replaced sheet. Amendments that do not comply with PCT Rules 10 and 11.1 to 11.13 may not be entered.

(b)If an amendment cancels an entire sheet of the international application, that amendment shall be communicated in a letter.

Under PCT Article 34(2)(b), the applicant has a right to amend the claims, the description, and the drawings in the application before the International Preliminary Examining Authority (IPEA) before the international preliminary examination report is established. The amendment may be filed with the demand (PCT Article 34), within the period for reply to the written opinion of the International Searching Authority (ISA), or within the period for reply to the written opinion of the IPEA.

See MPEP § 1871 or MPEP § 1871.01, as appropriate, regarding the processing of amendments filed prior to or at the start of international preliminary examination. See MPEP 1878.02 regarding amendments filed in reply to the written opinion of the ISA or IPEA. Amendments under PCT Article 34, like amendments under PCT Article 19 (see MPEP § 1853), may not include new matter and must be accompanied by a description of how the replacement sheet differs from the replaced sheet.

1864.02Applicant’s Right To File a Demand

PCT Article 31.

Demand for International Preliminary Examination


(2)(a)Any applicant who is a resident or national, as defined in the Regulations, of a Contracting State bound by Chapter II, and whose international application has been filed with the receiving Office of or acting for such State, may make a demand for international preliminary examination.


PCT Rule 54.

The Applicant Entitled to Make a Demand

54.1.Residence and Nationality

(a)Subject to the provisions of paragraph (b), the residence or nationality of the applicant shall, for the purposes of Article 31(2), be determined according to Rule 18.1(a) and (b).

(b)The International Preliminary Examining Authority shall, in the circumstances specified in the Administrative Instructions, request the receiving Office or, where the international application was filed with the International Bureau as receiving



Office, the national Office of, or acting for, the Contracting State concerned to decide the question whether the applicant is a resident or national of the Contracting State of which he claims to be a resident or national. The International Preliminary Examining Authority shall inform the applicant of any such request. The applicant shall have an opportunity to submit arguments directly to the Office concerned. The Office concerned shall decide the said question promptly.

54.2.Right to Make a Demand

The right to make a demand under Article 31(2) shall exist if the applicant making the demand or, if there are two or more applicants, at least one of them is a resident or national of a Contracting State bound by Chapter II and the international application has been filed with a receiving Office of or acting for a Contracting State bound by Chapter II.

(i)[Deleted]

(ii)[Deleted]

54.3 International Applications Filed with the International Bureau as Receiving Office

Where the international application is filed with the International Bureau as receiving Office under Rule 19.1(a)(iii), the International Bureau shall, for the purposes of Article 31(2)(a), be considered to be acting for the Contracting State of which the applicant is a resident or national.

54.4.Applicant Not Entitled to Make a Demand

If the applicant does not have the right to make a demand or, in the case of two or more applicants, if none of them has the right to make a demand under Rule 54.2, the demand shall be considered not to have been submitted.

If there is a sole applicant, he or she must be a resident or national of a Contracting State bound by Chapter II of the PCT. If there are two or more applicants, it is sufficient that one of them be a resident or national of a Contracting State bound by Chapter II, regardless of the elected State(s) for which each applicant is indicated. Only applicants for the elected States are required to be indicated in the Demand. The detailed requirements for the various indications required in connection with each applicant (name and address, telephone number, facsimile machine number or teleprinter address, nationality and residence) are the same as those required under PCT Rule 4 in connection with the Request. Note that any inventor who is not also an applicant is not indicated in the Demand.

If the recording of a change in the name or person has been requested under PCT Rule 92bis.1 before the Demand was filed, it is the applicant(s) of record at the time when the Demand is filed who must be indicated in the Demand.

1864.03States Which May Be Elected[R-2]

PCT Article 31.

Demand for International Preliminary Examination


(4)(a)The demand shall indicate the Contracting State or States in which the applicant intends to use the results of the international preliminary examination (“elected States”). Additional Contracting States may be elected later. Election may relate only to Contracting States already designated under Article 4.

(b)Applicants referred to in paragraph (2)(a) may elect any Contracting State bound by Chapter II. Applicants referred to in paragraph (2)(b) may elect only such Contracting States bound by Chapter II as have declared that they are prepared to be elected by such applicants.


The filing of a demand on or after January 1, 2004, shall constitute the election of all Contracting States which are designated and are bound by Chapter II of the Treaty on the international filing date (PCT Rule 53.7). For demands filed before January 1, 2004, only those eligible states pursuant to PCT Article 31 indicated as being elected are elected. Only PCT member states which have ratified or acceded to Chapter II and which were designated in the Request may be elected under Chapter II. The Assembly has taken no action to allow persons who are residents or nationals of a State not party to the PCT or not bound by Chapter II to make a Demand under Article 31(2)(b).

1864.04Agent’s Right To Act [R-2]

Any agent entitled to practice before the receiving Office where the international application was filed may represent the applicant before the international authorities (PCT Article 49).

If for any reason, the examiner needs to question the right of an attorney or agent to practice before the International Preliminary Examining Authority (IPEA), the USPTO roster of registered attorneys and agents should be consulted. If the international application was filed with a receiving Office other than the United States, Form PCT/IPEA/410 may be used by the requesting IPEA to ask the receiving Office with which the international application was filed, whether the agent named in the international application has the right to practice before that Office.



The PCT Article and Regulations governing the right to practice are PCT Article 49 and PCT Rule 83.

1865Filing of Demand [R-5]

PCT Article 31.

Demand for International Preliminary Examination

(1)On the demand of the applicant, his international application shall be the subject of an international preliminary examination as provided in the following provisions and the Regulations.


(3)The demand for international preliminary examination shall be made separately from the international application. The demand shall contain the prescribed particulars and shall be in the prescribed language and form.


(6)(a) The demand shall be submitted to the competent International Preliminary Examining Authority referred to in Article 32.


Applicants should mail the Demand and appropriate fees directly to the International Preliminary Examining Authority (IPEA) they desire to prepare the International Preliminary Examination Report. United States applicants who have had the international search prepared by the European Patent Office (EPO) may request the EPO to act as the IPEA with some exceptions. See MPEP § 1865.01.

Demands filed in the European Patent Office should be delivered to the European Patent Office Headquarters at Munich:

Location:

Erhardstr. 27

D-80331 Munchen

Germany

Mailing address:

D-80298 Munchen

Germany

United States applicants may also request the Korean Intellectual Property Office (KIPO) to act as the IPEA. Demands filed in the KIPO should be delivered to the KIPO Headquarters:

Location and mailing address:

920 Dunsan-dong

Seo-gu, Daejeon Metropolitan City 302-701

Republic of Korea

Demands filed in the United States Patent and Trademark Office (USPTO) should be addressed as follows:

Mailing address for delivery by the U.S. Postal Service:

Mail Stop PCT

Commissioner for Patents

P.O. Box 1450

Alexandria, VA 22313-1450.

OR

If hand-carried directly to the USPTO:

Customer Service Window, Mail Stop PCT

Randolph Building

401 Dulany Street

Alexandria, VA 22314

The “Express Mail” provisions of 37 CFR 1.10may be used to file a Demand under Chapter II in the USPTO. Applicants are advised that failure to comply with the provisions of 37 CFR 1.10 will result in the paper or fee being accorded the date of receipt and not the date of deposit. See MPEP § 513.

Demand for international preliminary examination may be submitted to the USPTO via facsimile. The Certificate of Mailing or Transmission practice under 37 CFR 1.8 CANNOT be used to file a Demand if the date of deposit is desired. If used, the date of the Demand will be the date of receipt in the USPTO. See MPEP § 513, § 1834, and § 1834.01.

All Demands filed in the USPTO must be in the English language.

PCT Rule 59.3 was amended July 1, 1998 to provide a safeguard in the case of a Demand filed with an International Preliminary Examining Authority which is not competent for the international preliminary examination of a particular international application. The USPTO will forward such a Demand to the International Bureau and the International Bureau will forward the Demand to a competent International Preliminary Examining Authority pursuant to PCT



Rule 59.3(c). The competent International Preliminary Examining Authority will process the Demand based on the date of receipt in the USPTO. See 37 CFR 1.416(c)(2).

CHOICE OF EXAMINING AUTHORITY

For most applications, U.S. residents and nationals may choose to have the international preliminary examination done by the EPO if the EPO served as the International Searching Authority (ISA). However, for certain applications including one or more claims directed to the field of biotechnology, the field of business methods or the field of telecommunication, the EPO will not act as a competent IPEA. See MPEP § 1865.01.

U.S. residents and nationals may also choose to have the international preliminary examination done by the KIPO.

The IPEA/US will serve as International Preliminary Examining Authority for U.S. residents and nationals if the U.S. or EPO served as ISA and the international application was filed in the U.S. Receiving Office or the International Bureau as receiving Office.

The IPEA/US will also serve as International Preliminary Examining Authority for residents or nationals of Barbados, Brazil, Egypt, India, Israel, Mexico, New Zealand, the Philippines, Saint Lucia, South Africa, and Trinidad and Tobago if the U.S. was the International Searching Authority.



Form PCT/IPEA/401Form PCT/IPEA/401




Form PCT/IPEA/401(second sheet)Form PCT/IPEA/401(second sheet)




Form PCT/IPEA/401(last sheet)Form PCT/IPEA/401(last sheet)




Form PCT/IPEA/401 Fee Calculation SheetForm PCT/IPEA/401 Fee Calculation Sheet




1865.01The European Patent Office as an International Preliminary Examining Authority [R-5]

The European Patent Office (EPO) has expressed the following limitations concerning its competency to act as an International Preliminary Examining Authority (IPEA). For updates or possible changes to these limitations, applicants should consult the PCT Newsletter which is available in electronic form from the web site (www.wipo.int/pct/en/newslett/) of the World Intellectual Property Organization.

I.FIELD OF BIOTECHNOLOGY

The EPO is not a competent authority within the meaning of PCT Article 16(3)(b) and PCT Article 32(3), and will not carry out international preliminary examination in respect of any international application filed before January 1, 2004, where the corresponding demand was filed with the EPO on or after March 1, 2002, if the application: (A) was filed with the USPTO as receiving Office by a national or resident of the U.S.; or (B) was filed in the International Bureau (IB) as receiving Office by a national or resident of the U.S. (provided the application did not also identify as an applicant at its time of filing a national or resident of a European Patent Convention (EPC) Contracting State); where the application contains one or more claims relating to the field of biotechnology as defined by the following units of the International Patent Classification:

C12M

Apparatus for enzymology or microbiology

C12N

Micro-organisms or enzymes; compositions thereof

C12P

Fermentation or enzyme-using processes to synthesise a desired chemical compound or composition or to separate optical isomers from a racemic mixture

C12Q

Measuring or testing processes involving enzymes or micro- organisms; compositions or test papers therefor; processes of preparing such compositions; condition- responsive control in microbiological or enzymological processes

C07K

Peptides

G01N 33/50 (including subdivisions)

Chemical analysis of biological material, e.g. blood, urine; testing involving biospecific ligand binding methods; immunological testing

A61K 39

Medicinal preparations containing antigens or antibodies

A61K 48

Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy

A01H

New plants or processes for obtaining them; plant reproduction by tissue culture techniques





For information, U.S. classes covering the corresponding subject matter are listed below:

424

Drug, bio-affecting and body treating compositions

435

Chemistry: molecular biology and microbiology

436

Chemistry: analytical and immunological testing

514

Drug, bio-affecting and body treating compositions

530

Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof

536

Organic compounds–part of the class 532-570 series

800

Multicellular living organisms and unmodified parts thereof

930

Peptide or protein sequence



II.FIELD OF BUSINESS METHODS

The EPO is not a competent authority within the meaning of PCT Article 16(3)(b) and PCT Article 32(3), and will not carry out international preliminary examination in respect of any international application where the corresponding demand was filed with the EPO on or after March 1, 2002, if the application: (A) is filed with the USPTO as receiving Office by a national or resident of the U.S.; or (B) is filed in the IB as receiving Office by a national or resident of the U.S. (provided the application does not also identify as an applicant at its time of filing a national or resident of an EPC Contracting State); where the application contains one or more claims relating to the field of business methods as defined by the following units of the International Patent Classification:

G06Q

Data processing systems or methods, specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes; systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes, not otherwise provided for

G06Q 10/00

Administration, e.g., office automation or reservations; Management, e.g., resource or project management

G06Q 30/00

Commerce, e.g., marketing, shopping, billing, auctions or e-commerce

G06Q 40/00

Finance, e.g., banking, investment or tax processing; Insurance, e.g., risk analysis or pensions

G06Q 50/00

Systems or methods specially adapted for a specific business sector, e.g., health care, utilities, tourism or legal services

G06Q 90/00

Systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes, not involving significant data processing

G06Q 99/00

Subject matter not provided for in other groups of this subclass.



For information, the U.S. class covering the corresponding subject matter is listed below:

705

Data processing: financial, business practice, management, or cost/price determination





III.FIELD OF TELECOMMUNICATION

The EPO is not a competent authority within the meaning of PCT Article 16(3)(b) and PCT Article 32(3), and will not carry out international preliminary examination in respect of any international application where the corresponding demand is filed with the EPO on or after March 1, 2002, and before July 1, 2004, where the application: (A) is filed with the USPTO as receiving Office by a national or resident of the U.S.; or (B) is filed in the IB as receiving Office by a national or resident of the U.S. (provided the application does not also identify as an applicant at its time of filing a national or resident of an EPC Contracting State); where the application contains one or more claims relating to the field of telecommunication as defined by the following unit of the International Patent Classification:

H04

Electric communication technique with the exception of H04N: Pictorial communication, e.g. television



For information, the U.S. classes covering the corresponding subject matter are listed below:

370

Multiplex communications

375

Pulse or digital communications

379

Telephonic communication

380

Cryptography

381

Electrical audio signal processing systems and devices

455

Telecommunications



Demands for international preliminary examination submitted to a non-competent authority are subject to PCT Rule 59.3. Applicants filing demands with the EPO in applications directed to the above subject matter will receive a notice from the EPO indicating that the demand is being forwarded to the IPEA/US under PCT Rule 59.3(f). Any fees paid by the applicant to the EPO will be refunded to the applicant. Applicants have one month from the date of receipt of the demand transmitted to the IPEA under PCT Rule 59.3to pay the handling fee (PCT Rule 57 and 37 CFR 1.482(b)) and the preliminary examination fee (PCT Rule 58 and 37 CFR 1.482(a)). See PCT Rules 57.3and 58.1(b).

1866Filling in of Headings on Chapter II Forms [R-5]

The examiner will encounter several different forms for use in the Chapter II preliminary examination phase and most of the forms will have the same “header” information to be provided.

The notes below list the common identifying information requested on the top of the first page of most of the forms:

Applicant’s mailing address - this is usually the attorney’s address taken from the file wrapper. The examiner should check the Patent Application Locating and Monitoring (PALM) system and Box No. III of the demand, Form PCT/IPEA/401, to see if a more recent address should be used.

Applicant’s or Agent’s File Reference - this is the applicant’s or agent’s application reference (or docket number) which is composed of either letters or numbers, or both, provided this reference does not exceed twelve characters. This reference may be found in the upper right hand box on the first sheet of the Demand, Form PCT/IPEA/401. See Administrative Instructions Section 109.

International Application Number - this is the PCT application number as stamped and typed on the international application file wrapper and may also be found on the first page of the Demand, Form PCT/ IPEA/401.

International Filing Date - this is the filing date printed on the international application file wrapper and may also be found on the first page of the Demand, Form PCT/IPEA/401.

Applicant (Name) - the first named applicant as set forth on the international application file wrapper and may also be found in box II of the Demand, Form PCT/IPEA/401.



1867Preliminary Examination Fees[R-2]

37 CFR 1.481. Payment of international preliminary examination fees.


(a)The handling and preliminary examination fees shall be paid within the time period set in PCT Rule 57.3. The handling fee or preliminary examination fee payable is the handling fee or preliminary examination fee in effect on the date of payment.

(1)If the handling and preliminary fees are not paid within the time period set in PCT Rule 57.3, applicant will be notified and given one month within which to pay the deficient fees plus a late payment fee equal to the greater of:

(i)Fifty percent of the amount of the deficient fees, but not exceeding an amount equal to double the handling fee; or

(ii)An amount equal to the handling fee (PCT Rule 58bis.2).

(2)The one-month time limit set in this paragraph to pay deficient fees may not be extended.

(b)If the payment needed to cover the handling and preliminary examination fees, pursuant to paragraph (a) of this section, is not timely made in accordance with PCT Rule 58bis.1(d), the United States International Preliminary Examination Authority will declare the Demand to be considered as if it had not been submitted.

The preliminary examination fee is for the benefit of the International Preliminary Examining Authority and the amount for the USPTO doing the preliminary examination is specified in 37 CFR 1.482. The fee is somewhat higher if the international search was performed by an authority other than the USPTO.

The handling fee is a fee for the benefit of the International Bureau and is collected by the International Preliminary Examining Authority. The amount of the handling fee is set out in the PCT schedule of fees which is annexed to the PCT Regulations.

The current amount of both the preliminary examination fee and the handling fee can be found in each weekly issue of the Official Gazette. Since supplements to the handling fee were deleted, no additional Chapter II fees are required other than any additional preliminary examination fee where additional inventions are determined to be present. The amount of this fee is also specified in 37 CFR 1.482 and in the weekly issues of the Official Gazette. See also PCT Rules 57 and 58.

The time limit for paying the preliminary examination fee and the handling fee is set forth in PCT Rules 57.3 and 58.1(b). Effective January 1, 2004, for demands filed on or after January 1, 2004, 37 CFR 1.481(a) provides that the preliminary examination fee or handling fee payable is the preliminary examination fee or handling fee in effect on the date of payment. For demands filed before January 1, 2004, former 37 CFR 1.481(a) provides that the preliminary examination fee or handling fee payable is the preliminary examination fee or handling fee in effect on the date of receipt of the Demand in the United States International Preliminary Examining Authority. Effective July 1, 1998, PCT Rule 58bis.1(c) was added to consider the preliminary examination fee and handling fee to have been received before the expiration of the time limit set in PCT Rule 57.3 if the fees were submitted prior to the sending of an invitation to pay the fees.

Effective July 1, 1998, PCT Rule 58bis.1(a) was added to permit the International Preliminary Examining Authority to collect a late payment fee set forth in PCT Rule 58bis.2 if the fees for preliminary examination are not paid prior to the sending of the invitation to pay the fees. If the preliminary examination fee and handling fee are not paid within the time set in PCT Rule 57.3, applicants will be notified and given 1 month within which to pay the deficient fees plus a late payment fee equal to the greater of: (1) 50% of the amount of the deficient fees, but not exceeding an amount equal to double the handling fee; or (2) an amount equal to the handling fee. See 37 CFR 1.481(a)(1)(i) and (ii). The 1 month time limit set forth in 37 CFR 1.481(a)(1) to pay deficient fees may not be extended. See 37 CFR 1.481(a)(2).

If the payment needed to cover the preliminary examination fee and handling fee is not timely made in accordance with PCT Rule 58bis.1(d), the United States International Preliminary Examining Authority will declare the Demand to be considered as if it had not been submitted. In this regard, where the Authority sends a notification that the Demand is considered not to have been made and applicant’s payment is received on the same date the notification is sent, the fee is considered to be late and the notification remains effective. The fee must antedate the notice in order for the notice not to be effective. See 37 CFR 1.481(b).



1868Correction of Defects in the Demand[R-2]

PCT Rule 60.

Certain Defects in the Demand or Elections

60.1.Defects in the Demand


(a)Subject to paragraphs (a-bis) and (a-ter), if the demand does not comply with the requirements specified in Rules 53.1, 53.2(a)(i) to (iii), 53.2(b), 53.3 to 53.8 and 55.1, the International Preliminary Examining Authority shall invite the applicant to correct the defects within a time limit which shall be reasonable under the circumstances. That time limit shall not be less than one month from the date of the invitation. It may be extended by the International Preliminary Examining Authority at any time before a decision is taken.

(a-bis) For the purposes of Rule 53.4, if there are two or more applicants, it shall be sufficient that the indications referred to in Rule 4.5(a)(ii) and (iii) be provided in respect of one of them who has the right according to Rule 54.2 to make a demand.

(a-ter) For the purposes of Rule 53.8, if there are two or more applicants, it shall be sufficient that the demand be signed by one of them.

(b)If the applicant complies with the invitation within the time limit under paragraph (a), the demand shall be considered as if it had been received on the actual filing date, provided that the demand as submitted permitted the international application to be identified; otherwise, the demand shall be considered as if it had been received on the date on which the International Preliminary Examining Authority receives the correction.

(c)If the applicant does not comply with the invitation within the time limit under paragraph (a), the demand shall be considered as if it had not been submitted and the International Preliminary Examining Authority shall so declare.

(d)[Deleted]

(e)If the defect is noticed by the International Bureau, it shall bring the defect to the attention of the International Preliminary Examining Authority, which shall then proceed as provided in paragraphs (a) to (c).

(f)If the demand does not contain a statement concerning amendments, the International Preliminary Examining Authority shall proceed as provided for in Rules 66.1 and 69.1(a) or (b).

(g)Where the statement concerning amendments contains an indication that amendments under Article 34 are submitted with the demand (Rule 53.9(c)) but no such amendments are, in fact, submitted, the International Preliminary Examining Authority shall invite the applicant to submit the amendments within a time limit fixed in the invitation and shall proceed as provided for in Rule 69.1(e).


Defects in the Demand may be corrected. The type of correction determines whether the filing date of the Demand must be changed. The most common defects which result in the mailing of an invitation to correct are found in PCT Rules 53 and 55. If the applicant complies with the invitation, the Demand is considered as if it had been received on the actual filing date, i.e., the original date of receipt. See PCT Rule 60.1(b).

1869Notification to International Bureauof Demand

PCT Article 31.

Demand for International Preliminary Examination


(7)Each elected Office shall be notified of its election.

The International Preliminary Examining Authority, pursuant to PCT Rule 61, promptly notifies the International Bureau and the applicant of the filing of any Demand. The International Bureau in turn notifies each elected Office of their election and also notifies the applicant that such notification has been made.

1870Priority Document and TranslationThereof [R-2]

PCT Rule 66.

Procedure before the International Preliminary Examining Authority


66.7.Priority Document


(a)If the International Preliminary Examining Authority needs a copy of the earlier application whose priority is claimed in the international application, the International Bureau shall, on request, promptly furnish such copy. If that copy is not furnished to the International Preliminary Examining Authority because the applicant failed to comply with the requirements of Rule 17.1, and if that earlier application was not filed with that Authority in its capacity as a national Office or the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, the international preliminary examination report may be established as if the priority had not been claimed.

(b)If the application whose priority is claimed in the international application is in a language other than the language or one of the languages of the International Preliminary Examining Authority, that Authority may, where the validity of the priority claim is relevant for the formulation of the opinion referred to in Article 33(1), invite the applicant to furnish a translation in the said language or one of the said languages within two months from the date of the invitation. If the translation is not furnished



within that time limit, the international preliminary examination report may be established as if the priority had not been claimed.


A copy of the priority document and/or a translation thereof, if the priority document is not in English may be required by the examiner if necessary because of an intervening reference .

1871Processing Amendments Filed Under Article 19 and Article 34 Prior to or at the Start of International Preliminary Examination in International Applications Having an International Filing Date On or After January 1, 2004 [R-5]

[Note: The regulations under the PCT were changed effective January 1, 2004. Corresponding changes were made to Title 37 of the Code of Federal Regulations. See January 2004 Revision of Patent Cooperation Treaty Application Procedure, 68 FR 59881 (Oct. 20, 2003), 1276 O.G. 6 (Nov. 11, 2003). International applications filed before January 1, 2004, will continue to be processed under the procedures in effect on their international filing date. The discussion of the procedures in effect prior to January 1, 2004, has been moved from this section to MPEP § 1871.01.]

PCT Rule 62.

Copy of the Written Opinion by the International Searching Authority and of Amendments Under Article 19 for the International Preliminary Examining Authority

62.1.Copy of Written Opinion by International Searching Authority and of Amendments Made Before the Demand Is Filed

Upon receipt of a demand, or a copy thereof, from the International Preliminary Examining Authority, the International Bureau shall promptly transmit to that Authority.

(i)a copy of the written opinion established under Rule 43bis.1, unless the national Office or intergovernmental organization that acted as International Searching Authority is also acting as International Preliminary Examining Authority; and

(ii)a copy of any amendment under Article 19, and any statement referred to in that Article, unless that Authority has indicated that it has already received such a copy.

62.2.Amendments Made After the Demand Is Filed

If, at the time of filing any amendments under Article 19, a demand has already been submitted, the applicant shall preferably, at the same time as he files the amendments with the International Bureau, also file with the International Preliminary Examining Authority a copy of such amendments and any statement referred to in that Article. In any case, the International Bureau shall promptly transmit a copy of such amendments and statement to that Authority.

PCT Rule 62bis.

Translation for the International Preliminary Examining Authority of the Written Opinion of the International Searching Authority

62bis.1. Translation and Observations

(a)Upon request of the International Preliminary Examining Authority, the written opinion established under Rule 43bis.1 shall, when not in English or in a language accepted by that Authority, be translated into English by or under the responsibility of the International Bureau.

(b)The International Bureau shall transmit a copy of the translation to the International Preliminary Examining Authority within two months from the date of receipt of the request for translation, and shall at the same time transmit a copy to the applicant.

(c)The applicant may make written observations as to the correctness of the translation and shall send a copy of the observations to the International Preliminary Examining Authority and to the International Bureau.

The documents making up the international application may include amendments of the claims filed by the applicant under PCT Article 19. Article 19 amendments are exclusively amendments to the claims and these amendments can only be made after the search report has been established. Article 19 amendments will be transmitted to the International Preliminary Examining Authority (IPEA) by the International Bureau. The International Bureau marks, in the upper right-hand corner of each replacement sheet submitted under PCT Article 19, the international application number, the date on which that sheet was received under PCT Article 19 and, in the middle of the bottom margin, the words “AMENDED SHEET (ARTICLE 19).” If a demand for international preliminary examination has already been submitted, the applicant should preferably, at the time he/she files the Article 19 amendments, also file a copy of the amendments with the IPEA.

The IPEA starts the international preliminary examination when it is in possession of the demand; the required fees; if the applicant is required to furnish a translation under PCT Rule 55.2, that translation; either the international search report or a notice of the declaration by the International Searching Authority



under PCT Article 17(2)(a) that no international search report will be established; and the written opinion established under PCT Rule 43bis.1, provided that the IPEA shall not start the international preliminary examination before the expiration of the later of three months from the transmittal of the international search report and written opinion or of the declaration that no international search report will be established; or the expiration of 22 months from the priority date unless the applicant expressly requests an earlier start, with the exception of the following situations:

(A)If the competent IPEA is part of the same national Office or intergovernmental organization as the competent International Searching Authority, the international preliminary examination may, if the IPEA so wishes, start at the same time as the international search, provided that the examination is not to be postponed according to the statement concerning PCT Article 19 amendments (PCT Rule 53.9(b));

(B)Where the statement concerning amendments contains an indication that amendments made with the International Bureau under PCT Article 19 are to be taken into account (PCT Rule 53.9(a)(i)), the IPEA does not start the international preliminary examination before it has received a copy of the amendments concerned. These will be transmitted to the IPEA by the International Bureau. The applicant should preferably, at the time he/she files the demand, also file a copy of the amendments with the IPEA;

(C)Where the statement concerning amendments contains an indication that the start of the international preliminary examination is to be postponed (PCT Rule 53.9(b)), the IPEA does not start the international preliminary examination before:

(1)it has received a copy of any amendments made under PCT Article 19;

(2)it has received a notice from the applicant that he/she does not wish to make amendments under PCT Article 19; or

(3)the later of two months from the transmittal of the international search report or the expiration of 16 months from the priority date;

whichever occurs first; and

(D)Where the statement concerning amendments contains an indication that amendments under PCT Article 34 are submitted with the demand (PCT Rule 53.9(c)) but no such amendments are, in fact, submitted, the IPEA does not start the international preliminary examination before it has received the amendments or before the time limit fixed in the invitation referred to in PCT Rule 60.1(g) has expired, whichever occurs first.

The applicant has the right to amend the claims, the description, and the drawings, in the prescribed manner and before the start of international preliminary examination. The amendment must not go beyond the disclosure in the international application as filed. These amendments are referred to as PCT Article 34(2)(b) amendments. It should be noted that PCT Article 19 amendments are strictly amendments to the claims made during the Chapter I search phase while PCT Article 34(2)(b) amendments to the description, claims, and drawings are made during the Chapter II examination phase.

When amendments to the description, claims, or drawings are made under PCT Rule 66.8, they may be accompanied by an explanation. These amendments may have been submitted to avoid possible objections as to lack of novelty or lack of inventive step in view of the citations listed in the international search report and the observations on novelty, inventive step, and industrial applicability set forth in the written opinion established by the International Searching Authority; to meet any objections noted by the International Searching Authority under PCT Article 17(2)(a)(ii) (i.e., that all or at least some claims do not permit a meaningful search) or under PCT Rule 13 (i.e., that there is a lack of unity of invention); or to meet objections that may be raised for some other reason, e.g., to remedy some obscurity which the applicant himself/ herself has noted in the original documents.

The amendments are made by the applicant of his/ her own volition. This means that the applicant is not restricted to amendments necessary to remedy a defect in his/her international application. It does not, however, mean that the applicant should be regarded as free to amend in any way he/she chooses. Any amendment must not add subject matter which goes beyond the disclosure of the international application as originally filed. Furthermore, it should not itself cause the international application as amended to be objectionable under the PCT, e.g., the amendment should not introduce obscurity.

As a matter of policy and to ensure consistency in handling amendments filed under PCT Articles 19



and 34 of the PCT, the following guidelines for processing these amendments have been established:

(A)Any argument or amendment which complies with 37 CFR 1.485(a) will be considered;

(B)Amendments filed after the demand:

(1)will be considered if filed before the later of: three months from the transmittal of either the international search report or a notice of the declaration by the International Searching Authority under PCT Article 17(2)(a) that no international search report will be established, and the written opinion established under PCT Rule 43bis.1; or the expiration of 22 months from the priority date, unless the applicant expressly requests an earlier start to international preliminary examination,

(2)will be considered if filed before the application is docketed to the examiner,

(3)may be considered if filed after docketing. The examiner has discretion to consider such amendments if the examiner determines that the amendment places the application in better condition for examination or the examiner determines that the amendment should otherwise be entered;

(C)Amendments and/or arguments filed after expiration of the period for response to the written opinion:

(1)will be considered if the amendment was requested by the examiner,

(2)need not be taken into account for the purposes of a further written opinion or the international preliminary examination report if they are received after the examiner has begun to draw up that opinion or report. The applicant may file an amendment to the description, the claims and the drawings in the prescribed manner, even if this is outside the time period set for reply in PCT Rule 66.2(d). Since the examiner may begin to draw up the final report once the time period set for reply in PCT Rule 66.2(d) expires, amendments filed after the expiration of the time period set in for reply in PCT Rule 66.2(d) may or may not be considered. There may be situations where it is advisable, to the extent possible, to take such amendments or arguments into account, for example, where the international preliminary examination report has not yet been completed and it is readily apparent to the examiner that consideration of the late-filed response would result in the issuance of a favorable report.

It is expected, due to the relatively short time period for completion of preliminary examination, that the Chapter II application will be taken up promptly after docketing to the examiner for preparation of either a further written opinion, if necessary, or the final report.

Amendments timely filed but misdirected or otherwise late reaching the examiner will be considered as in the case of regular domestic applications and may require a supplemental written opinion and/or final report.

Clearly, these guidelines offer the examiner flexibility. The examiner should be guided by the overriding principle that the international preliminary examination report (Form PCT/IPEA/409) should be established with as few written opinions as possible and resolution of as many issues as possible consistent with the goal of a timely and quality report.

See also Administrative Instructions Section 602regarding processing of amendments by the IPEA.

1871.01 Processing Amendments Filed Under Article 19 and Article 34 Prior to or at the Start of International Preliminary Examination in International Appli- cations Having an International Filing Date Before January 1, 2004 [R-2]

[Note: If the international filing date is on or after January 1, 2004, the amendments are processed as indicated in MPEP § 1871 rather than as indicated in this section.]

Former

PCT Rule 62.

Copy of Amendments Under Article 19 for the International Preliminary Examining Authority

62.1.Amendments Made Before the Demand Is Filed

Upon receipt of a demand, or a copy thereof, from the International Preliminary Examining Authority, the International Bureau shall promptly transmit a copy of any amendments under Article 19, and any statement referred to in that Article, to that Authority, unless that Authority has indicated that it has already received such a copy.



62.2.Amendments Made After the Demand Is Filed

If, at the time of filing any amendments under Article 19, a demand has already been submitted, the applicant shall preferably, at the same time as he files the amendments with the International Bureau, also file with the International Preliminary Examining Authority a copy of such amendments and any statement referred to in that Article. In any case, the International Bureau shall promptly transmit a copy of such amendments and statement to that Authority.

The documents making up the international application may include amendments of the claims filed by the applicant under PCT Article 19. PCT Article 19amendments are exclusively amendments to the claims and these amendments can only be made after the search report has been established. PCT Article 19amendments will be transmitted to the International Preliminary Examining Authority by the International Bureau. If a Demand for international preliminary examination has already been submitted, the applicant should preferably, at the time he files the PCT Article 19 amendments, also file a copy of the amendments with the International Preliminary Examining Authority. In the event that the time limit for filing amendments under PCT Article 19, as provided in PCT Rule 46.1, has not expired and the Demand includes a statement that the start of the international preliminary examination is to be postponed under PCT Rule 53.9(b), the international preliminary examination should not start before the examiner receives a copy of any amendments made under PCT Article 19 or a notice from the applicant that he does not wish to make amendments under PCT Article 19, or before the expiration of 20 months from the priority date, whichever occurs first.

The applicant has the right to amend the claims, the description, and the drawings, in the prescribed manner and before the start of international preliminary examination. The amendment must not go beyond the disclosure in the international application as filed. These amendments are referred to as PCT Article 34(2)(b) amendments. It should be noted that PCT Article 19 amendments are strictly amendments to the claims made during the Chapter I search phase while PCT Article 34(2)(b) amendments to the description, claims, and drawings are made during the Chapter II examination phase.

When amendments to the description, claims, or drawings are made under PCT Rule 66.8, they may be accompanied by an explanation. These amendments may have been submitted to avoid possible objections as to lack of novelty or lack of inventive step in view of the citations listed in the international search report; to meet any objections noted by the International Searching Authority under PCT Article 17(2)(a)(ii) (i.e., that all or at least some claims do not permit a meaningful search) or under PCT Rule 13(i.e., that there is a lack of unity of invention); or to meet objections that may be raised for some other reason, e.g., to remedy some obscurity which the applicant himself/herself has noted in the original documents.

The amendments are made by the applicant of his/ her own volition. This means that the applicant is not restricted to amendments necessary to remedy a defect in his/her international application. It does not, however, mean that the applicant should be regarded as free to amend in any way he/she chooses. Any amendment must not add subject matter which goes beyond the disclosure of the international application as originally filed. Furthermore, it should not itself cause the international application as amended to be objectionable under the PCT, e.g., the amendment should not introduce obscurity.

As a matter of policy and to ensure consistency in handling amendments filed under PCT Articles 19and 34 of the PCT, the following guidelines for processing these amendments have been established:

(A)Any amendment which complies with 37 CFR 1.485(a) will be considered;

(B)Amendments filed after the Demand

(1)will be considered if filed before the application is docketed to the examiner,

(2)may be considered if filed after docketing. The examiner has discretion to consider such amendments if the examiner determines that the amendment places the application in better condition for examination or the examiner determines that the amendment should otherwise be entered;

(C)Amendments filed after expiration of the period for response to the written opinion

(1)will be considered if the amendment was requested by the examiner,

(2)may be considered if the examiner determines that the amendment places the application in better condition for examination or the examiner determines that the amendment should otherwise be entered.



It is expected, due to the relatively short time period for completion of preliminary examination, that the Chapter II application will be taken up for preparation of the written opinion promptly after docketing to the examiner and taken up for preparation of the final report promptly after the time expires for response to the written opinion (i.e., after allowing for mail processing). The examiner is not obliged to consider amendments or arguments which are filed after he/she has taken up the case for preparation of the written opinion or the final report.

Amendments timely filed but misdirected or are otherwise late reaching the examiner will be considered as in the case of regular domestic applications and may require a supplemental written opinion and/ or final report.

Clearly, these guidelines offer the examiner flexibility. The examiner should be guided by the overriding principle that the final report (the PCT/IPEA/409) should be established with as few written opinions as possible and resolution of as many issues as possible consistent with the goal of a timely and quality report.

See also Administrative Instructions Section 602regarding processing of amendments by the International Preliminary Examining Authority.

1872Transmittal of Demand to the Examining Corps

PCT Administrative Instruction Section 605.

File to be used for International Preliminary Examination

Where the International Preliminary Examining Authority is part of the same national Office or intergovernmental organization as the International Searching Authority, the same file shall serve the purposes of international search and international preliminary examination.

When the PCT International Application Processing Division has finished processing of the papers and fees filed with a complete Demand, a copy of the Demand and other papers are forwarded to the appropriate Technology Center for examination. The documents will be placed in the Search Copy file wrapper before forwarding to the examiner.


1874Determination if International Preliminary Examination Is Required and Possible [R-2]

PCT Article 34.

Procedure Before the International Preliminary Examining Authority


(4)(a) If the International Preliminary Examining Authority considers

(i)that the international application relates to a subject matter on which the International Preliminary Examining Authority is not required, under the Regulations, to carry out an international preliminary examination, and an international preliminary examination, and in the particular case decides not to carry out such examination, or

(ii)that the description, the claims, or the drawings, are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the novelty, inventive step (non-obviousness), or industrial applicability, of the claimed invention, the said authority shall not go into the questions referred to in Article 33(1) and shall inform the applicant of this opinion and the reasons therefor.

(b)If any of the situations referred to in subparagraph (a) is found to exist in, or in connection with, certain claims only, the provisions of that subparagraph shall apply only to the said claims.

There are instances where international preliminary examination is not required because of the nature of the subject matter claimed and also because the claims are so indefinite that no examination is possible. Such instances should seldom occur, especially since most problems of this nature would have already been discovered and indicated at the time of the international search.

If it is found that certain claims of an international application relate to subject matter for which no international preliminary examination is required, check the appropriate box on a Form PCT/IPEA/ 408 in an application having an international filing date before January 1, 2004, or on a Form PCT/IPEA/ 408 or a Form PCT/IPEA/409, as appropriate, in an application having an international filing date on or after January 1, 2004 (see MPEP § 1860). It should be noted that subject matter which is normally examined under U.S. national procedure should also be examined as an International Preliminary Examining Authority.

The examiner should check the appropriate box if it is found that the description, claims or drawings are



so unclear, or the claims are so inadequately supported by the description that no opinion could be formed as to the novelty, inventive step (nonobviousness) and industrial applicability of the claimed invention.

Subject matter not searched under Chapter I will not be the subject of a preliminary examination under Chapter II. This is so even if claims which were not searched under Chapter I are modified to be acceptable for examination.

1875Unity of Invention Before the International Preliminary Examining Authority [R-2]

PCT Article 34.

Procedure before the International Preliminary Examining Authority


(3)(a)If the International Preliminary Examining Authority considers that the international application does not comply with the requirement of unity of invention as set forth in the Regulations, it may invite the applicant, at his option, to restrict the claims so as to comply with the requirement or to pay additional fees.


(c)If the applicant does not comply with the invitation referred to in subparagraph (a) within the prescribed time limit, the International Preliminary Examining Authority shall establish an international preliminary examination report on those parts of the international application which relate to what appears to be the main invention and shall indicate the relevant facts in the said report. The national law of any elected State may provide that, where its national Office finds the invitation of the International Preliminary Examining Authority justified, those parts of the international application which do not relate to the main invention shall, as far as effects in that State are concerned, be considered withdrawn unless a special fee is paid by the applicant to that Office.


37 CFR 1.488. Determination of unity of invention before the International Preliminary Examining Authority.

(a)Before establishing any written opinion or the international preliminary examination report, the International Preliminary Examining Authority will determine whether the international application complies with the requirement of unity of invention as set forth in § 1.475.

(b)If the International Preliminary Examining Authority considers that the international application does not comply with the requirement of unity of invention, it may:

(1)Issue a written opinion and/or an international preliminary examination report, in respect of the entire international application and indicate that unity of invention is lacking and specify the reasons therefor without extending an invitation to restrict or pay additional fees. No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority.

(2)Invite the applicant to restrict the claims or pay additional fees, pointing out the categories of invention found, within a set time limit which will not be extended. No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority, or

(3)If applicant fails to restrict the claims or pay additional fees within the time limit set for reply, the International Preliminary Examining Authority will issue a written opinion and/or establish an international preliminary examination report on the main invention and shall indicate the relevant facts in the said report. In case of any doubt as to which invention is the main invention, the invention first mentioned in the claims and previously searched by an International Searching Authority shall be considered the main invention.

(c)Lack of unity of invention may be directly evident before considering the claims in relation to any prior art, or after taking the prior art into consideration, as where a document discovered during the search shows the invention claimed in a generic or linking claim lacks novelty or is clearly obvious, leaving two or more claims joined thereby without a common inventive concept. In such a case the International Preliminary Examining Authority may raise the objection of lack of unity of invention.

The examiner will usually begin the preliminary examination by checking the international application for unity of invention. The international preliminary examination will only be directed to inventions which have been searched by the International Searching Authority. All claims directed to inventions which have not been searched by the International Searching Authority will not be considered by the International Preliminary Examining Authority. If the examiner in the International Preliminary Examining Authority finds lack of unity of invention in the claims to be examined, an invitation is normally prepared and sent to the applicant requesting the payment of additional fees or the restriction of the claims on Form PCT/ IPEA/405. Such an invitation will include the identification of what the examiner considers to be the “main invention” which will be examined if no additional fees are paid or restriction is made by the applicant.

The procedure before the International Preliminary Examining Authority regarding lack of unity of invention is governed by PCT Article 34(3)(a) through (c), PCT Rule 68 (see also PCT Rule 70.13), and 37 CFR 1.475 and 1.488. It should be noted that



in most instances lack of unity of invention will have been noted and reported upon by the International Searching Authority which will have drawn up an international search report (and for international applications having a filing date on or after January 1, 2004, a written opinion) based on those parts of the international application relating to the invention, or unified linked group of inventions, first mentioned in the claims (“main invention”) , unless the applicant has paid additional fees. If the applicant has paid additional search fees, additional inventions would also have been searched. No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority (37 CFR 1.488(b)(2)).


If the examiner determines that unity of invention is lacking, there are two options:

(A)The examiner may conduct an international preliminary examination covering all the claimed and previously searched inventions and indicate that unity of invention is lacking and specify the reasons therefor without extending an invitation to restrict or pay additional fees (PCT Rule 68.1), or

(B)The examiner may invite the applicant to restrict the claims, so as to comply with the requirement, or pay additional fees, pointing out the categories of invention found using Form PCT/IPEA/405 or USPTO/499 (telephone practice). See MPEP § 1875.01. The invitation to restrict or pay additional fees shall state the reasons for which the international application is considered as not complying with the requirement of unity of invention. (PCT Rule 68.2). Inventions not previously searched will not be considered or included in the invitation.

The written opinion, if any, and the international preliminary examination report must be established on all inventions for which examination fees have been paid.

If the applicant fails to reply to the invitation to restrict the claims or pay additional examination fees due to lack of unity of invention (by not paying the additional fees or by not restricting the claims either sufficiently or at all), the written opinion, if any, and international preliminary examination report must be established on the claims directed to what appears to be the main invention (PCT Article 34(3)(c)). The main invention, in case of doubt, is the first claimed invention for which an international search report has been issued by the International Searching Authority. The main invention, as viewed by the examiner, must be set forth on Form PCT/IPEA/405.

If the applicant timely complies with the invitation to pay additional fees even under protest, or to restrict the claims, the examiner carries out international preliminary examination on those claimed inventions for which additional fees have been paid or to which the claims have been restricted. It should be noted that the national law of any elected State may provide that, where its national Office finds the invitation of the International Preliminary Examining Authority justified, those parts of the international application which do not relate to the main invention shall, as far as effects in that State are concerned, be considered withdrawn unless a special fee is paid by the applicant to that Office (PCT Article 34(3)(c)). Whether or not the question of unity of invention has been raised by the International Searching Authority, it may be considered by the examiner when serving as an authorized officer of the International Preliminary Examining Authority. In the examiner’s consideration, all documents cited by the International Searching Authority should be taken into account and any additional relevant documents considered. However, there are cases of lack of unity of invention, where, compared with the procedure of inviting the applicant to restrict the international application or pay additional fees (PCT Rule 68.2), little or no additional effort is involved in establishing the written opinion, if any, and the international preliminary examination report for the entire international application. Then reasons of economy may make it advisable for the examiner to use the option referred to in PCT Rule 68.1 by choosing not to invite the applicant to restrict the claims or to pay additional fees.

Unity of invention is defined by 37 CFR 1.475which describes the circumstances in which the requirement of unity of invention is considered fulfilled.

1875.01Preparation of Invitation Concerning Unity [R-3]

The “Invitation to restrict or pay additional fees” Form PCT/IPEA/405 is used to invite the applicant, at his/her option, to restrict the claims to comply with



the requirements of unity of invention or to pay additional examination fees. In addition, the examiner must explain the reasons why the international application is not considered to comply with the requirement of unity of invention. The examiner must also specify, on Form PCT/IPEA/405, at least one group or groups of claims which, if elected, would comply with the requirement for unity of invention.


I. INVITATION TO RESTRICT OR PAY ADDITIONAL FEES

In the space provided on form PCT/IPEA/405, the examiner should identify the disclosed inventions by claim numerals and indicate which disclosed inventions are so linked as to form a single general inventive concept, thereby complying with the requirement of unity of invention. For example, claims to different categories of invention such as a product, claims to a process specifically adapted for the manufacture of the product and a claim for a use of the product would be considered related inventions which comply with the unity of invention requirement, whereas a claim to an apparatus for making the product in the same application would be considered a second invention for which additional fees would be required. The reasons for holding that unity of invention is lacking must be specified. See 37 CFR 1.475 and Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/gdlines.htm).

Also, the examiner should specify the main invention and claims directed thereto which will be examined if the applicant fails to restrict or pay additional fees. The main invention, in case of doubt, is the first claimed invention or related invention before the International Preliminary Examining Authority for which a search fee has been paid and an international search report has been prepared.

The examiner should indicate the total amount of additional fees required for examination of all claimed inventions.

In the box provided at the top of the form, the time limit of one month for response is set according to PCT Rule 68.2. Extensions of time are not permitted.

Since the space provided on Form PCT/IPEA/405 is limited, supplemental attachment sheets, supplied by the examiner, with reference back to the specific section, should be incorporated whenever necessary.


II. AUTHORIZED OFFICER

Form PCT/IPEA/405 must be signed by an examiner with at least partial signatory authority.


III. TELEPHONIC RESTRICTION PRACTICE

Telephone practice may be used to allow applicants to elect an invention to be examined or to pay additional fees if:

(A)Applicant or applicant’s legal representative has a USPTO deposit account,

(B)Applicant or the legal representative or agent orally agrees to charge the additional fees to the account, and

(C)A complete record of the telephone conversation is included with the written opinion, if any, or the international preliminary examination report, including:

(1)Examiner’s name;

(2)Authorizing attorney’s name;

(3)Date of conversation;

(4)Invention elected and/or inventions for which additional fees paid; and

(5)Deposit account number and amount to be charged.

When the telephone practice is used in making lack of unity requirements, it is critical that the examiner orally inform applicant that there is no right to protest the holding of lack of unity of invention for any group of invention(s) for which no additional examination fee has been paid.

The examiner must further orally advise applicant that any protest to the holding of lack of unity or the amount of additional fee required must be filed in writing no later than one month from the mailing date of the written opinion or the international preliminary examination report if the lack of unity holding is first mailed with the IPER because there was no written opinion. The examiner should fill in the information on Form USPTO/499 “Chapter II PCT Telephone Memorandum for Lack of Unity” as a record of the telephonic holding of lack of unity.



If applicant refuses to either restrict the claims to one invention or authorize payment of additional fees, or if applicant does not have a deposit account, Form PCT/IPEA/405 should be prepared and mailed to applicant.

If a written invitation is required, the examiner should, if possible, submit that written invitation to the TC for review and mailing within 7 days from the date the international application is charged to the examiner.

See MPEP § 1850 for form paragraphs for lack of unity in international applications.

1875.02Reply to Invitation Concerning Lack of Unity of Invention [R-3]

PCT Administrative Instruction Section 603.

Transmittal of Protest Against Payment of Additional Fees and Decision Thereon Where International Application Is Considered to Lack Unity of Invention

The International Preliminary Examining Authority shall transmit to the applicant, preferably at the latest together with the international preliminary examination report, any decision which it has taken under Rule 68.3(c) on the protest of the applicant against payment of additional fees where the international application is considered to lack unity of invention. At the same time, it shall transmit to the International Bureau a copy of both the protest and the decision thereon, as well as any request by the applicant to forward the texts of both the protest and the decision thereon to the elected Offices.

37 CFR 1.489. Protest to lack of unity of invention before the International Preliminary Examining Authority.

(a)If the applicant disagrees with the holding of lack of unity of invention by the International Preliminary Examining Authority, additional fees may be paid under protest, accompanied by a request for refund and a statement setting forth reasons for disagreement or why the required additional fees are considered excessive, or both.

(b)Protest under paragraph (a) of this section will be examined by the Director or the Director’s designee. In the event that the applicant’s protest is determined to be justified, the additional fees or a portion thereof will be refunded.

(c)An applicant who desires that a copy of the protest and the decision thereon accompany the international preliminary examination report when forwarded to the Elected Offices, may notify the International Preliminary Examining Authority to that effect any time prior to the issuance of the international preliminary examination report. Thereafter, such notification should be directed to the International Bureau.

Applicant may reply by paying some or all additional fees or by restricting the claims to one invention. If applicant makes no reply within the set time limit, the international preliminary examination will proceed on the basis of the main invention only.

If applicant has paid an additional fee or fees, a protest to the holding of lack of unity of invention may be filed with the International Preliminary Examining Authority.


I. NOTIFICATION OF DECISION ON PROTEST

Form PCT/IPEA/420 is used by the Technology Center (TC) to inform the applicant of the decision regarding applicant’s protest on the payment of additional fees concerning unity of invention.


II. NOTIFICATION

The TC checks the appropriate box, i.e., 1 or 2. If box 2 is checked, a clear and concise explanation as to why the protest concerning the unity of invention was found to be unjustified must be given.

Since the space is limited, supplemental attachment sheet(s) should be incorporated whenever necessary.


III. AUTHORIZED OFFICER

Form PCT/IPEA/420 must be signed by a TC Director. See MPEP § 1002.02(c), item (2).

1876Notation of Errors and Informalities by the Examiner [R-2]

PCT Administrative Instruction Section 607.

Rectifications of Obvious Errors Under Rule 91.1

Where the International Preliminary Examining Authority authorizes a rectification of an obvious error under Rule 91.1, Rule 70.16 and Section 602(a) and (b) shall apply mutatis mutandis, provided that, where a sheet is marked as indicated in Section 602, the words “RECTIFIED SHEET (RULE 91)” shall be used.

Although the examiner is not responsible for discovering errors in the international application, if any errors come to the attention of the examiner, they may be noted and called to the applicant’s attention. The examiner may invite applicant to rectify obvious errors using Form PCT/IPEA/411. Errors that



are not obvious may be called to applicant’s attention in Box VII of PCT/IPEA/408.

AUTHORIZED OFFICER

Form PCT/IPEA/408 and Form PCT/IPEA/411 must be signed by an examiner having at least partial signatory authority.

1876.01Request for Rectification and Notification of Action Thereon [R-3]


I. NOTIFICATION OF DECISION CONCERNING REQUEST FOR RECTIFICATION

The rectification of obvious errors is governed by PCT Rules 91.1 and 66.5.


II. NOTIFICATION

If the applicant requests correction of any obvious errors in the international application or in any paper submitted to the International Preliminary Examining Authority, other than in the request, any acceptable correction should be authorized by using Form PCT/ IPEA/412.

The procedure governing the rectification of obvious errors is set forth in PCT rules 91.1(d) and 26.4. Rectification may be made on the request of the applicant. Any rectification offered to the international preliminary examining authority may be stated in a letter addressed to the international preliminary examining authority if the rectification is of such a nature that it can be transferred from the letter to the international application without adversely affecting the clarity and direct reproducibility of the sheet on to which the rectification is to be transferred; otherwise, the applicant is required to submit a replacement sheet embodying the rectification and the letter accompanying the replacement sheet must draw attention to the differences between the replaced sheet and the replacement sheet.

The examiner after fully considering applicant’s Request for Rectification of an obvious error, will notify applicant of the action taken on Form PCT/ IPEA/412. Since the space provided is limited, supplemental sheet(s) should be incorporated whenever necessary.


III. AUTHORIZED OFFICER

Form PCT/IPEA/412 must be signed by an examiner having at least partial signatory authority.

1877Nucleotide and/or Amino Acid Sequence Listings During the International Preliminary Examination [R-3]

If the International Preliminary Examining Authority finds that the international application contains disclosure of one or more nucleotide and/or amino acid sequences but (A) the international application does not contain a sequence listing complying with the standard provided for in the Administrative Instructions, or (B) applicant has not furnished a sequence listing in computer readable form complying with the standard provided for in the Administrative Instructions, the International Preliminary Examining Authority may request the applicant to furnish such sequence listing or listing in computer readable form in accordance with the Administrative Instructions. PCT Rule 13ter.2.

1878Preparation of the Written Opinion of the International Preliminary Examining Authority in International Applications Having an International Filing Date On or After January 1, 2004 [R-5]

[Note: The regulations under the PCT were changed effective January 1, 2004. Corresponding changes were made to Title 37 of the Code of Federal Regulations. See January 2004 Revision of Patent Cooperation Treaty Application Procedure, 68 FR 59881 (Oct. 20, 2003), 1276 O.G. 6 (Nov. 11, 2003). The discussion of the procedures in effect for international applications filed prior to January 1, 2004, has been moved from this section to MPEP § 1878.01.]



PCT Article 34.

Procedure Before the International Preliminary Examining Authority


(2)(c) The applicant shall receive at least one written opinion from the International Preliminary Examining Authority unless such Authority considers that all of the following conditions are fulfilled:

(i)the invention satisfies the criteria set forth in Article 33(1),

(ii)the international application complies with the requirements of this Treaty and the Regulations in so far as checked by that Authority,

(iii)no observations are intended to be made under Article 35(2), last sentence.


37 CFR 1.484. Conduct of international preliminary examination.

(a)An international preliminary examination will be conducted to formulate a non-binding opinion as to whether the claimed invention has novelty, involves an inventive step (is non- obvious) and is industrially applicable.

(b)International preliminary examination will begin in accordance with PCT Rule 69.1.

(c)No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority.

(d)The International Preliminary Examining Authority will establish a written opinion if any defect exists or if the claimed invention lacks novelty, inventive step or industrial applicability and will set a non-extendable time limit in the written opinion for the applicant to reply.

(e)The written opinion established by the International Searching Authority under PCT Rule 43bis.1 shall be considered to be a written opinion of the United States International Preliminary Examining Authority for the purposes of paragraph (d) of this section.

(f)The International Preliminary Examining Authority may establish further written opinions under paragraph (d) of this section.

(g)If no written opinion under paragraph (d) of this section is necessary, or if no further written opinion under paragraph (f) of this section is to be established, or after any written opinion and the reply thereto or the expiration of the time limit for reply to such written opinion, an international preliminary examination report will be established by the International Preliminary Examining Authority. One copy will be submitted to the International Bureau and one copy will be submitted to the applicant.

(h)An applicant will be permitted a personal or telephone interview with the examiner, which may be requested after the filing of a Demand, and must be conducted during the period between the establishment of the written opinion and the establishment of the international preliminary examination report. Additional interviews may be conducted where the examiner determines that such additional interviews may be helpful to advancing the international preliminary examination procedure. A summary of any such personal or telephone interview must be filed by the applicant or, if not filed by applicant be made of record in the file by the examiner.

(i)If the application whose priority is claimed in the international application is in a language other than English, the United States International Preliminary Examining Authority may, where the validity of the priority claim is relevant for the formulation of the opinion referred to in Article 33(1), invite the applicant to furnish an English translation of the priority document within two months from the date of the invitation. If the translation is not furnished within that time limit, the international preliminary report may be established as if the priority had not been claimed.

PCT Rule 66.

Procedure Before the International Preliminary Examining Authority


66.1bis Written Opinion of the International Searching Authority


(a)Subject to paragraph (b), the written opinion established by the International Searching Authority under Rule 43bis.1 shall be considered to be a written opinion of the International Preliminary Examining Authority for the purposes of Rule 66.2(a).


66.4 Additional Opportunity for Submitting Amendments or Argument

(a)If the International Preliminary Examining Authority wishes to issue one or more additional written opinions, it may do so, and Rules 66.2 and 66.3 shall apply.


In applications having an international filing date on or after January 1, 2004, a written opinion must be prepared by the International Searching Authority at the same time the international search report is prepared. The United States International Preliminary Examining Authority (IPEA) will consider the written opinion of the International Searching Authority to be the first written opinion of the IPEA and as such in most instances no further written opinion need be issued by the U.S. examiner handling the international preliminary examination before establishment of the international preliminary examination report, even if there are objections outstanding. The examiner is to take into consideration any comments or amendments made by the applicant when he/she establishes the



international preliminary examination report. However, a further written opinion must be prepared if applicant files a response which includes a persuasive argument that the written opinion issued by the International Searching Authority was improper because of a negative opinion with respect to a lack of novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2)-(4); and which results in the examiner considering any of the claims to lack novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2)-(4) based on new art not necessitated by any amendment. Such a further written opinion should be established on the Written Opinion of the International Preliminary Examining Authority (Form PCT/IPEA/408).

I.BOX NO. I. — BASIS OF OPINION

Box I of the Form PCT/IPEA/408 should be filled out in accordance with the instructions for Box I of Form PCT/ISA/237 provided in MPEP § 1845.01.

Additionally, for the purpose of completing Box I, item 2, of Form PCT/IPEA/408, substitute and/or rectified sheets of the specification and drawings filed during Chapter I proceedings are considered to be originally filed/furnished pages and should be listed as originally filed/furnished pages. Only those amendments or rectifications to the specification and drawings filed on the date of demand or after the filing of a demand should be listed as pages “received by this Authority on____.” Substitute and/or rectified sheets of claims filed during the Chapter I proceedings are also considered to be originally filed/furnished pages and should be listed as originally filed/furnished pages. However, amended sheets of claims filed under PCT Article 19 in response to the international search report are to be indicated as pages as amended (together with any statement) under PCT Article 19. The International Bureau (IB) marks, in the upper right-hand corner of each replacement sheet submitted under PCT Article 19, the international application number, the date on which that sheet was received under PCT Article 19 and, in the middle of the bottom margin, the words “AMENDED SHEET (ARTICLE 19).” See Administrative Instructions Section 417. Only those pages of claims filed on the date of demand or after the filing of a demand should be listed as pages “received by this Authority on____.”

The examiner must also indicate, in Box I, item 3, if any of the amendments filed resulted in the cancellation of any pages of the description, any of the claims or drawings, or any pages of the sequence listing and/or any tables related to the sequence listing. If the examiner considers any of the amendments to go beyond the original disclosure, the examiner must point this out in Box I, item 4 and explain the reasons for this determination in the Supplemental Box. New matter which appears on a replacement sheet will be disregarded for the purpose of establishing the opinion. However, the remainder of the replacement sheet, including any amendments which do not constitute new matter, will be taken into consideration for the purpose of establishing the opinion.

II.BOX NO. II. — PRIORITY

Where the priority document is provided by the applicant in compliance with PCT Rule 17.1 after the preparation of the search report and the written opinion of the ISA, any written opinion of the IPEA and/or the international preliminary examination report should reconsider the validity of the priority claim. Where the priority document is a foreign document and it is not already in the file, the IPEA may request a copy of the document from the IB and, if necessary, a translation from the applicant. In the meantime, if the outcome of the examination requires the issuing of an opinion, that opinion should be issued without waiting to obtain the priority document and/or the translation. An appropriate comment should be made under the heading “Additional observations, if necessary” in Box II of the written opinion. If such a copy of the priority document and/or the translation is not available because of non-compliance by the applicant with PCT Rule 17.1 and/or PCT Rule 66.7(b) within the relevant time period, and if the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, any written opinion of the IPEA and/or the IPER may be established as if the priority had not been claimed where there is a pertinent intervening reference. This is indicated by checking the appropriate boxes in item 1 of Box No. II in the opinion or report.



III.BOX NO. III. — NON-ESTABLISHMENT OF OPINION ON NOVELTY, INVENTIVE STEP AND INDUSTRIAL APPLICABILITY

Box III of Form PCT/IPEA/408 is intended to cover situations where some or all claims of an application are so unclear or inadequately supported by the description that the question of novelty, inventive step (nonobviousness), and industrial applicability cannot be considered, or where the international application or claims thereof relate to subject matter which does not require international preliminary examination, or where no international search report has been established for the claims.

Box III of Form PCT/IPEA/408 should be filled out in accordance with the instructions for Box III of Form PCT/ISA/237 provided in MPEP § 1845.01.

IV.BOX NO. IV. — LACK OF UNITY OF INVENTION

Box IV of Form PCT/IPEA/408 should be used by the examiner to notify applicant that lack of unity of invention has been found.

If in reply to an invitation to restrict, applicant restricted the claims to a particular group, check the first box under subsection 1. If applicant paid additional fees for examination of additional inventions, check the second box under subsection 1. If the additional fees were paid under protest, check the third box under subsection 1. If applicant neither restricted nor paid additional fees in reply to the objection of lack of unity of invention, check the fourth box under subsection 1.

Subsection 2 of Box IV is to be completed if the examiner determines that unity of invention is lacking but chooses not to invite the applicant to restrict or pay additional fees.

Subsection 3 of Box IV is to be completed to indicate which claims were the subject of international preliminary examination. If all claims are to be examined, check the first box under subsection 3. If only some of the claims were the subject of international preliminary examination, check the second box under subsection 3 and identify the claim numbers.

V.BOX NO. V. — REASONED STATEMENT WITH REGARD TO NOVELTY, INVENTIVE STEP, AND INDUSTRIAL APPLICABILITY OF CLAIMS

In Box V, the examiner must list in summary form all claims with regard to the criteria of novelty (N), inventive step (IS), and industrial applicability (IA), and should be filled out in accordance with the instructions for Box V of Form PCT/ISA/237 provided in MPEP § 1845.01.

In applications where the examiner has determined that an additional written opinion is required, the application should be searched by the examiner at least to the point of bringing the previous search up to date. Prior art discovered in a search and applied in a reasoned statement in Box V must be made of record in Box V. Prior art already cited on the international search report need not again be cited on the written opinion or international preliminary examination report. The subsequently discovered prior art is to be cited in compliance with PCT Rule 43.5 and Administrative Instructions Section 503 using the same citation format used on the international search report. Two copies of each newly cited reference should be included in the PCT Chapter II file when it is sent to PCT Operations for the mailing of the form PCT/ IPEA/408. One of the copies of the newly cited reference will be sent to the applicant and one copy will be retained in the Chapter II file.

VI.BOX NO. VI. — CERTAIN DOCUMENTS CITED

Box VI provides a convenient manner of listing two different types of newly discovered documents which were not applied in Box V:

(A)Published documents - by the application number or patent number as well as the publication date, filing date and priority date; and

(B)Nonwritten disclosure - by the kind of disclosure, date of the disclosure and the date of the written disclosure referring to the nonwritten disclosure.

As with the newly cited art in Box V, the subsequently discovered prior art is to be cited in compliance with PCT Rule 43.5 and Administrative Instructions Section 503 using the same citation format used on the international search report. Two copies of each newly cited reference should be included



in the PCT Chapter II file when it is sent to PCT Operations for the mailing of the Form PCT/IPEA/ 408. One of the copies of the newly cited reference will be sent to the applicant and one copy will be retained in the Chapter II file.

VII.BOX VII. — CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION

In Box VII, defects in the form and content of the international application are identified. Box VII should be filled out in accordance with the instructions for Box No. VII of Form PCT/ISA/237 provided in MPEP § 1845.01.

VIII.BOX NO. VIII. — CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION

In Box VIII, the examiner notifies the applicant of observations made as to the clarity of the claims, the description, the drawings, or on the question whether the claims are fully supported by the description. Box VIII should be filled out in accordance with the instructions for Box VIII of Form PCT/ISA/237 provided in MPEP § 1845.01.

IX.TIME TO REPLY

An invitation by the International Preliminary Examining Authority (IPEA) to applicant to reply to the examiner’s written opinion will normally set a 2- month time limit for reply.

However, PCT Rule 69.2 sets forth time limits for the IPEA to establish the international preliminary examination report (IPER). Accordingly, in applications filed on or after January 1, 2004, a 1-month time limit should be set by the examiner in situations when a 2-month time limit would risk delaying the date of establishment of the IPER beyond:

(A)28 months from the priority date; or

(B)6 months from the time provided under PCT Rule 69.1 for the start of international preliminary examination; or

(C)6 months from the date of receipt by the IPEA of the translation furnished under PCT Rule 55.2.

As a general rule, a 1-month time limit for reply to the written opinion should be set by the examiner if the written opinion (Form PCT/IPEA/408) has not been completed by the examiner within 24 months following the application’s “priority date” as defined in PCT Article 2.

The United States rules pertaining to international preliminary examination of international applications do not provide for any extension of time to reply to a written opinion. See 37 CFR 1.484 (d)-(f) and MPEP § 1878.02.

X.AUTHORIZED OFFICER

Every written opinion must be signed by an examiner having at least partial signatory authority.

1878.01Preparation of the Written Opinion in International Applications Having an International Filing Date Before January 1, 2004 [R-5]

[Note: In international applications filed on or after January 1, 2004, the first written opinion is usually prepared by the International Searching Authority (see MPEP §§ 1845-1845.01), and a further written opinion may be prepared by the International Preliminary Examining Authority (see MPEP § 1878).]

PCT Article 34.

Procedure Before the International Preliminary Examining Authority


(2)(c) The applicant shall receive at least one written opinion from the International Preliminary Examining Authority unless such Authority considers that all of the following conditions are fulfilled:

(i)the invention satisfies the criteria set forth in Article 33(1),

(ii)the international application complies with the requirements of this Treaty and the Regulations in so far as checked by that Authority,

(iii)no observations are intended to be made under Article 35(2), last sentence.


Former

37 CFR 1.484. Conduct of international preliminary examination.

(a)An international preliminary examination will be conducted to formulate a non-binding opinion as to whether the claimed invention has novelty, involves an inventive step (is non- obvious) and is industrially applicable.



(b)International preliminary examination will begin promptly upon receipt of a proper Demand in an application for which the United States International Preliminary Examining Authority is competent, for which the fees for international preliminary examination (§ 1.482) have been paid, and which requests examination based on the application as filed or as amended by an amendment which has been received by the United States International Preliminary Examining Authority. Where a Demand requests examination based on a PCT Article 19amendment which has not been received, examination may begin at 20 months without receipt of the PCT Article 19 amendment. Where a Demand requests examination based on a PCT Article 34amendment which has not been received, applicant will be notified and given a time period within which to submit the amendment.

(1)Examination will begin after the earliest of:

(i)Receipt of the amendment;

(ii)Receipt of applicant’s statement that no amendment will be made; or

(iii)Expiration of the time period set in the notification.

(2)No international preliminary examination report will be established prior to issuance of an international search report.

(c)No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority.

(d)The International Preliminary Examining Authority will establish a written opinion if any defect exists or if the claimed invention lacks novelty, inventive step or industrial applicability and will set a non-extendable time limit in the written opinion for the applicant to reply.

(e)If no written opinion under paragraph (d) of this section is necessary, or after any written opinion and the reply thereto or the expiration of the time limit for reply to such written opinion, an international preliminary examination report will be established by the International Preliminary Examining Authority. One copy will be submitted to the International Bureau and one copy will be submitted to the applicant.

(f)An applicant will be permitted a personal or telephone interview with the examiner, which must be conducted during the non-extendable time limit for reply by the applicant to a written opinion. Additional interviews may be conducted where the examiner determines that such additional interviews may be helpful to advancing the international preliminary examination procedure. A summary of any such personal or telephone interview must be filed by the applicant as a part of the reply to the written opinion or, if applicant files no reply, be made of record in the file by the examiner.

(g)If the application whose priority is claimed in the international application is in a language other than English, the United States International Preliminary Examining Authority may, where the validity of the priority claim is relevant for the formulation of the opinion referred to in Article 33(1), invite the applicant to furnish an English translation of the priority document within two months from the date of the invitation. If the translation is not furnished within that time limit, the international preliminary examination report may be established as if the priority had not been claimed.

A written opinion must be prepared if the examiner:

(A)Considers that the international application has any of the defects described in PCT Article 34(4);

(B)Considers that the report should be negative with respect to any of the claims because of a lack of novelty, inventive step (non-obviousness) or industrial applicability;

(C)Notices any defects in the form or contents of the international application under the PCT;

(D)Considers that any amendment goes beyond the disclosure in the international application as originally filed;

(E)Wishes to make an observation on the clarity of the claims, the description, the drawings or to question whether the claims are fully supported by the description;

(F)Decides not to carry out the international preliminary examination on a claim for which no international search report was issued; or

(G)Considers that no acceptable amino acid sequence listing is available in a form that would allow a meaningful international preliminary examination to be carried out.

The applicant must be notified on Form PCT/IPEA/ 408 of the defects found in the application. The examiner is further required to fully state the reasons for his/her opinion (PCT Rule 66.2(b)) and invite a written reply, with amendments where appropriate (PCT Rule 66.2(c)), setting a time limit for the reply of normally 2 months.

The examiner should insert the words “first” or “second”, as the case may be, in the space provided on page 1 of the written opinion.

I.ITEM I. BASIS OF OPINION

Applicant has two opportunities to amend the international application prior to international preliminary examination. Under PCT Article 19, the applicant is entitled to one opportunity to amend the claims of the international application by filing amendments with the International Bureau within 2 months of the mailing of the international search report. See PCT Rule 46.1. Applicant is also permitted to make amendments before the International Preliminary Examining Authority under PCT Article 34(2)(b) and PCT Rule 66.1. Any amendment, however, that does not accompany the filing of the Demand but is filed later may



not be considered unless it reaches the examiner before he/she takes up the application for examination.

When completing Box I, item 1, of Form PCT/ IPEA/408, the examiner must indicate whether or not the opinion has been established on the basis of the international application in the language in which it was filed. If a translation was furnished for the purpose of the search, this must be indicated. For the purpose of completing Box I, Item 1, substitute and/or rectified sheets of the specification and drawings filed during Chapter I proceedings are considered to be originally filed pages/sheets and should be listed as originally filed pages/sheets. Only those amendments or rectifications to the specification and drawings filed on the date of Demand or after the filing of a Demand should be listed as later filed pages/sheets. Substitute and/or rectified sheets of claims filed during the Chapter I proceedings are also considered to be originally filed pages/sheets and should be listed as originally filed pages/sheets. However, amended sheets of claims filed under Article 19 in response to the international search report are to be indicated as pages/sheets as amended under Article 19. Only those amendments, or rectifications to the claims filed on the date of Demand or after the filing of a Demand should be listed as later filed pages/sheets. The examiner must also indicate, in Box I, item 3, if any of the amendments filed resulted in the cancellation of any pages of the description, any of the claims or drawings, or any pages of the sequence listing and/or any tables related to the sequence listing. If the examiner considers any of the amendments to go beyond the original disclosure, the examiner must point this out in Box I, item 4 and explain the reasons for this determination in the Supplemental Box. New matter which appears on a replacement sheet will be disregarded for the purpose of establishing the opinion. However, the remainder of the replacement sheet, including any amendments which do not constitute new matter, will be taken into consideration for the purpose of establishing the opinion.

II.ITEM II. PRIORITY

Item II of Form PCT/IPEA/408 is to inform applicant of non-establishment of a request for priority.

If applicant fails to furnish a copy or translation of the earlier application, whose priority has been claimed, within the time limit set by the examiner pursuant to PCT Rule 66.7, check box No. 1 and then check the first box of the subsection if applicant failed to furnish a copy of the earlier application whose priority has been claimed, and check the second box in the subsection if applicant failed to furnish a translation of the earlier application whose priority has been claimed.

When the claim for priority has been found invalid (e.g., the claimed priority date is more than one year prior to the international filing date and the notification under PCT Rule 4.10(d) has been provided or all claims are directed to inventions which were not described and enabled by the earlier application), check box No. 2 of Item II and indicate why the claim for priority has been found invalid following No. 3 “Additional observations”. The examiner is reminded that when some claims in an international application are directed to an invention which was disclosed in the earlier application, the priority claim is valid provided that a copy and/or translation of the earlier application have/has been filed and the filing date of the earlier application is one year or less from the filing date of the international application.

III. ITEM III. NON-ESTABLISHMENT OF OPINION ON NOVELTY, INVENTIVE STEP AND INDUSTRIAL APPLICABILITY

Item III of Form PCT/IPEA/408 is intended to cover situations where some or all claims of an application are so unclear or inadequately supported by the description that the question of novelty, inventive step (nonobviousness), and industrial applicability cannot be considered, or where the international application or claims thereof relate to subject matter which does not require international preliminary examination, or where no international search report has been established for the claims.

If some or all of the claims of an application relate to subject matter which does not require international preliminary examination, check the appropriate box, indicate which claims relate to that subject matter and specify the reasons.

If some or all of the claims of an application are so unclear that no meaningful opinion could be formed, check the appropriate box, indicate which claims are unclear and specify the reasons.



If some or all of the claims are so inadequately supported by the description that no meaningful opinion could be formed, check the appropriate box.

If no international search report has been established for certain claims, check the appropriate box and indicate the claim numbers.

IV.ITEM IV. LACK OF UNITY OF INVENTION

Item IV of Form PCT/IPEA/408 should be used by the examiner to notify applicant that lack of unity of invention has been found.

If in reply to an invitation to restrict, applicant restricted the claims to a particular group, check the first box under subsection 1.

If applicant paid additional fees for examination of additional invention, check the second box under subsection 1.

If the additional fees were paid under protest, check the third box under subsection 1.

If applicant neither restricted nor paid additional fees in reply to the objection of lack of unity of invention, check the fourth box under subsection 1.

Subsection 2 of Item IV is to be completed if the examiner determines that unity of invention is lacking but chooses not to invite the applicant to restrict or pay additional fees.

Subsection 3 of Item IV is to be completed to indicate which claims were the subject of international preliminary examination.

If all claims are to be examined, check the first box under subsection 3.

If only some of the claims were the subject of international preliminary examination, check the second box under subsection 3 and identify the claim numbers.

V.ITEM V. REASONED STATEMENT WITH REGARD TO NOVELTY, INVENTIVE STEP, AND INDUSTRIAL APPLICABILITY OF CLAIMS

In Item V, the examiner must list in summary form all claims with regard to the criteria of novelty (N), inventive step (IS), and industrial applicability (IA).

Item V is the main purpose of the Written Opinion. All claims without fatal defects are treated on the merits in Item V as to novelty, inventive step (nonobviousness) and industrial applicability.

The treatment of claims in Item V is similar in format to an Office action in a U.S. national patent application except that the words “rejection” and “patentability” are never used in a written opinion. On the international level, all written opinions are nonbinding and a patent does not issue; what does issue is an international preliminary examination report (IPER), which is nonbinding on the Elected States.

Examiner statements in Item V can be positive or negative. If the claims define over the prior art and meet the test of novelty, inventive step (nonobviousness) and industrial applicability, a statement equivalent to detailed reasons for allowance in a corresponding U.S. national application should be provided, indicating how the claims meet the tests of novelty, inventive step and industrial applicability. Form paragraphs 18.04 and 18.04.01 may be used for this purpose.

¶ 18.04 Meets Novelty and Inventive Step

Claim [1] the criteria set out in PCT Article 33(2)-(3), because the prior art does not teach or fairly suggest [2].

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and insert the verb --meet-- or --meets--, as appropriate.

2.In bracket 2, insert the details of the claimed subject matter that render it unobvious over the prior art.

3.If the claims also meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.04.01.

4.If the claims do not meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.03.

¶ 18.04.01 Meets Industrial Applicability

Claim [1] the criteria set out in PCT Article 33(4), and thus [2] industrial applicability because the subject matter claimed can be made or used in industry.

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --meet-- or -- meets--, as appropriate.

2.In bracket 2, insert --have-- or --has--, as appropriate.

3.If the claims meet all of the requirements of PCT Article 33(2)-(4), use form paragraph 18.04 before this form paragraph to provide positive statements for novelty and inventive step under PCT Article 33(2)-(3).

4.If the claims have industrial applicability but lack novelty and inventive step, use this form paragraph and additionally use form paragraph 18.01.

5.If the claims have industrial applicability and novelty but lack inventive step, use this form paragraph and additionally use one or more of form paragraphs 18.02, 18.02.01 and 18.02.02, as appropriate.



6.If the claims do not have industrial applicability, use form paragraph 18.03 instead of this form paragraph.

If, on the other hand it is the opinion of the examiner that some or all claims lack novelty, inventive step, or industrial applicability, specific reasons must be given similar to those used in U.S. national applications. If the claims lack inventive step over a combination of references, the reasons must explain why one of ordinary skill in the art would have been motivated to combine the teachings of the applied references.

Form paragraphs 18.01, 18.02, 18.02.01, 18.02.02, and 18.03 may be used, as appropriate, to explain the negative statements listed in Item V.

¶ 18.01 Lacks Novelty

Claim [1] novelty under PCT Article 33(2) as being anticipated by [2].

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.

2.In bracket 2, insert name of prior art relied upon.

¶ 18.02 Lacks Inventive Step - One Reference

Claim [1] an inventive step under PCT Article 33(3) as being obvious over [2]. [3]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.

2.In bracket 2, insert name of prior art relied upon.

3.In bracket 3, add reasoning.

¶ 18.02.01 Lacks Inventive Step - Two References

Claim [1] an inventive step under PCT Article 33(3) as being obvious over [2] in view of [3]. [4]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.

2.In bracket 2, insert name of PRIMARY prior art relied upon.

3.In bracket 3, insert name of SECONDARY prior art relied upon.

4.In bracket 4, add reasoning.

¶ 18.02.02 Lacks Inventive Step - Additional Reference

Claim [1] an inventive step under PCT Article 33(3) as being obvious over the prior art as applied in the immediately preceding paragraph and further in view of [2]. [3]

Examiner Note:

1.This form paragraph may follow either 18.02 or 18.02.01.

2.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.

3.In bracket 2, insert name of additional prior art relied upon.

4.In bracket 3, add reasoning.

¶ 18.03 Lacks Industrial Applicability

Claim [1] industrial applicability as defined by PCT Article 33(4). [2]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.

2.In bracket 2, add reasoning.

Examiners are encouraged to indicate any amendments which applicant could present which would avoid a negative statement in the international preliminary examination report.

All international applications where an examination has been demanded should be searched by the examiner at least to the point of bringing the previous search up to date. Prior art discovered in a search and applied in an Item V statement must be made of record in Item V. Prior art already cited on the international search report need not again be cited on the written opinion or international preliminary examination report. The subsequently discovered prior art is to be cited in compliance with PCT Rule 43.5 and Administrative Instructions Section 503 using the same citation format used on the international search report. Two copies of each newly cited reference should be included in the PCT Chapter II file when it is sent to PCT Operations for the mailing of the form PCT/IPEA/408. One of the copies of the newly cited reference will be sent to the applicant and one copy will be retained in the Chapter II file.

VI.ITEM VI. CERTAIN DOCUMENTS CITED

Item VI provides a convenient manner of listing two different types of documents:

(A)Published documents - by the application number or patent number as well as the publication date, filing date and priority date; and

(B)Nonwritten disclosure - by the kind of disclosure, date of the disclosure and the date of the written disclosure referring to the nonwritten disclosure.

VII.ITEM VII. CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION

In Item VII, defects in the form and content of the international application are identified.



Examples of defects that would be listed in Item VII are:

(A)Informalities such as misplaced and/or omitted drawing numerals, misspelled words, grammatical errors, etc.

(B)Improper multiple-dependent claims (PCT Rule 6.4) if not indicated under Item III.

The following form paragraphs are used in Box VII of PCT/IPEA/408 or PCT/IPEA/409 “Certain defects in the international application” for noting technical defects.

¶ 18.08 Drawing Objections - Defects

The drawings are objected to under PCT Rule 66.2(a)(iii) as containing the following defect(s) in the form or content thereof: [1]

Examiner Note:

In bracket 1, insert identification of defects in drawings.

¶ 18.08.01 Drawing Is Required

The subject matter of this application admits of illustration by drawing to facilitate understanding of the invention. Applicant is required under PCT Article 7(1) to furnish a drawing.

¶ 18.09 Description Defective

The description is objected to as containing the following defect(s) under PCT Rule 66.2(a)(iii) in the form or contents thereof: [1]

Examiner Note:

In bracket 1, insert the technical problem, e.g., misspelled word.

¶ 18.10 Claims Defective

Claim [1] objected to under PCT Rule 66.2(a)(iii) as containing the following defect(s) in the form or contents thereof: [2]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.

2.In bracket 2, identify the technical deficiency.

VIII. ITEM VIII. CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION

In Item VIII, the examiner notifies the applicant of observations made as to the clarity of the claims, the description, the drawings, or on the question whether the claims are fully supported by the description.

If the claims, the description, or the drawings are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the question of novelty, inventive step (nonobviousness) or industrial applicability, the applicant is so informed in Item III (PCT Article 34(4)(a)(ii)). Reasons for the examiner’s opinion that the claims, description and drawings, etc., lack clarity must also be provided.

If the above situation is found to exist in certain claims only, the provisions of PCT Article 34(4)(ii) shall apply to those claims only.

If the lack of clarity of the claims, the description, or the drawings is of such a nature that it is possible to form a meaningful opinion on the claimed subject matter, then it is required that the examiner consider the claims and render a written opinion on novelty, inventive step, and industrial applicability in Item V of Form PCT/IPEA/408.

Since the claims of an international application are not subject to a rejection on either art or indefiniteness consistent with U.S. practice, observations by the examiner with regard to clarity of the claims, the description and the drawings will be treated in the form of an objection in the written opinion in Item VIII.

The following form paragraphs are used in Box VIII “Certain observations on the international application” of PCT/IPEA/408 and PCT/IPEA/409 for noting objections which are substantive rather than merely technical in nature.

¶ 18.11 Drawing Objections - Lack Clarity

The drawings are objected to under PCT Rule 66.2(a)(v) as lacking clarity under PCT Article 7 because: [1]

Examiner Note:

In bracket 1, insert reasons why the drawings lack clarity, e.g., inaccurate showing.

¶ 18.12.01 Claims Objectionable - Inadequate Written Description

Claim [1] objected to as lacking clarity under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The application, as originally filed, did not describe: [3]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s), and the verb --is-- or --are--, as appropriate.

2.In bracket 2, pluralize “claim” if needed, and insert the verb - -is-- or --are--.

3.In bracket 3, identify subject matter not described in the application as filed.



¶ 18.13.01 Claims Objectionable - Non-Enabling Disclosure

Claim [1] objected to as lacking clarity under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The description does not disclose the claimed invention in a manner sufficiently clear and complete for the claimed invention to be carried out by a person skilled in the art because: [3]

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.

2.In bracket 2, pluralize “claim” if needed, insert the verb --is-- or --are--.

3.In bracket 3, identify the claimed subject matter that is not enabled and explain why it is not enabled.

¶ 18.14.01 Claims Objectionable - Lack of Best Mode

Claim [1] objected to under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The description fails to set forth the best mode contemplated by the applicant for carrying out the claimed invention as required by PCT Rule 5.1(a)(v) because: [3].

Examiner Note:

1.In bracket 1, pluralize “claim” if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.

2.In bracket 2, pluralize “claim” if needed, and insert the appropriate verb --is-- or --are--.

3.In bracket 3, insert the objection and reasons.

¶ 18.15 Claims Objectionable - Indefiniteness

Claim [1] objected to under PCT Rule 66.2(a)(v) as lacking clarity under PCT Article 6 because claim [2] indefinite for the following reason(s): [3]

Examiner Note:

1.In brackets 1 and 2, pluralize “claim” if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.

2.In bracket 3, insert reasons.

IX.TIME TO REPLY

An invitation by the International Preliminary Examining Authority (IPEA) to applicant to reply to the examiner’s written opinion will normally set a 2- month time limit for reply.

However, PCT Rule 69.2 sets forth time limits for the IPEA to establish the international preliminary examination report (IPER). Accordingly, a 1-month time limit should be set by the examiner in situations when a 2-month time limit would risk delaying the date of establishment of the IPER beyond:

(A)28 months from the priority date; or

(B)8 months from the date of payment of the handling fee referred to in PCT Rule 57.1 and the preliminary examination fee referred to in PCT Rule 58.1(a); or

(C)8 months from the date of receipt by the IPEA of the translation furnished under PCT Rule 55.2.

As a general rule, a 1-month time limit for reply to the written opinion should be set by the examiner if the written opinion (Form PCT/IPEA/408) has not been completed by the examiner within 24 months following the application’s “priority date” as defined in PCT Article 2.

The United States rules pertaining to international preliminary examination of international applications do not provide for any extension of time to reply to a first written opinion. See 37 CFR 1.484(d) and MPEP § 1878.02.

X.AUTHORIZED OFFICER

Every written opinion must be signed by an examiner having at least partial signatory authority.

The first document prepared by the examiner in most international applications during the international preliminary examination proceedings will be the written opinion. Normally only in those international applications where all the formal matters are proper and the claims are directed to inventions which have novelty, inventive step and industrial applicability will an international preliminary examination report be established without a written opinion having been issued first.

1878.01(a)Prior Art for Purposes of the Written Opinion and the International Preliminary Examination Report [R-2]

PCT Article 33.

The International Preliminary Examination


(6)The international preliminary examination shall take into consideration all the documents cited in the international search report. It may take into consideration any additional documents considered to be relevant in the particular case.



PCT Rule 64.

Prior Art for International Preliminary Examination

64.1.Prior Art

(a)For the purposes of Article 33(2) and (3), everything made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations) shall be considered prior art provided that such making available occurred prior to the relevant date.

(b)For the purposes of paragraph (a), the relevant date will be:

(i)subject to item (ii), the international filing date of the international application under international preliminary examination;

(ii)where the international application under international preliminary examination validly claims the priority of an earlier application, the filing date of such earlier application.

64.2.Non-Written Disclosures

In cases where the making available to the public occurred by means of an oral disclosure, use, exhibition or other non-written means (“non-written disclosure”) before the relevant date as defined in Rule 64.1(b) and the date of such non-written disclosure is indicated in a written disclosure which has been made available to the public on a date which is the same as, or later than, the relevant date, the non-written disclosure shall not be considered part of the prior art for the purposes of Article 33(2) and (3). Nevertheless, the international preliminary examination report shall call attention to such non-written disclosure in the manner provided for in Rule 70.9.

64.3.Certain Published Documents

In cases where any application or any patent which would constitute prior art for the purposes of Article 33(2) and (3) had it been published prior to the relevant date referred to in Rule 64.1was published on a date which is the same as, or later than, the relevant date but was filed earlier than the relevant date or claimed the priority of an earlier application which had been filed prior to the relevant date, such published application or patent shall not be considered part of the prior art for the purposes of Article 33(2) and (3). Nevertheless, the international preliminary examination report shall call attention to such application or patent in the manner provided for in Rule 70.10.

The above provisions apply mutatis mutandis to the written opinion of the International Searching Authority. See PCT Rule 43bis.1(b).

The relevant date for the purpose of considering prior art is defined in PCT Rule 64.1(b) as the international filing date or, where the international application contains a valid claim for priority, that date of priority.

When a potentially relevant document has been published between a claimed priority date of the application and its international filing date, the examiner is required to consider whether the claimed priority date is valid for the purposes of determining the “relevant date” of the claims in the international application. Note that if there is time left for the applicant to perfect, correct or add a priority claim but there is insufficient time for the examiner to make a proper determination as to whether the priority claim is valid, due to the need to issue a timely written opinion by the International Searching Authority, the “relevant date” for the purposes of the written opinion will be based on the claimed priority date. See Chapter 11 of the International Search and Preliminary Examination Guidelines, which may be obtained from WIPO’s website (www.wipo.int/pct/en/texts/ gdlines.htm). In cases where any application or any patent which would constitute prior art for the purpose of international preliminary examination as to novelty and inventive step (nonobviousness) was published on or after the relevant date of the international application under consideration but was filed earlier than the relevant date or claimed the priority of an earlier application which was filed prior to the relevant date, the published application or patent is not to be considered part of the prior art for the purpose of international preliminary examination as to novelty and inventive step. Nevertheless, these documents are to be listed on Form PCT/IPEA/409 under the heading “CERTAIN PUBLISHED DOCUMENTS”.

In determining whether there is inventive step, account should be taken of what the applicant acknowledges in his/her description as known. Such acknowledged prior art should be regarded as correct and used during preliminary examination where appropriate.

For oral or nonwritten disclosure, see PCT Rules 64.2 and 70.9.

1878.01(a)(1)Novelty for Purposes of the Written Opinion and the International Preliminary Examination Report [R-2]

Novelty is defined in PCT Article 33(2).



PCT Article 33.

The International Preliminary Examination


(2)For the purposes of the international preliminary examination, a claimed invention shall be considered novel if it is not anticipated by the prior art as defined in the Regulations.


The above provisions apply mutatis mutandis to the written opinion of the International Searching Authority. See PCT Rule 43bis.1(b).

1878.01(a)(2)Inventive Step for Purposes of the Written Opinion and the International Preliminary Examination Report [R-2]

Inventive step is defined in PCT Article 33(3).

PCT Article 33.

The International Preliminary Examination


(3)For purposes of the international preliminary examination, a claimed invention shall be considered to involve an inventive step if, having regard to the prior art as defined in the Regulations, it is not, at the prescribed relevant date, obvious to a person skilled in the art.


PCT Rule 65.

Inventive Step or Non-Obviousness

65.1.Approach to Prior Art

For the purposes of Article 33(3), the international preliminary examination shall take into consideration the relation of any particular claim to the prior art as a whole. It shall take into consideration the claim’s relation not only to individual documents or parts thereof taken separately but also its relation to combinations of such documents or parts of documents, where such combinations are obvious to a person skilled in the art.

65.2.Relevant Date

For the purposes of Article 33(3), the relevant date for the consideration of inventive step (non-obviousness) is the date prescribed in Rule 64.1.

The above provisions apply mutatis mutandis to the written opinion of the International Searching Authority. See PCT Rule 43bis.1(b).

1878.01(a)(3)Industrial Applicability for Purposes of the Written Opinion and the International Preliminary Examina- tion Report [R-2]

Industrial applicability is defined in PCT Article 33(4).

PCT Article 33.

The International Preliminary Examination


(4)For the purposes of the international preliminary examination, a claimed invention shall be considered industrially applicable if, according to its nature, it can be made or used (in the technological sense) in any kind of industry. “Industry” shall be understood in its broadest sense, as in the Paris Convention for the Protection of Industrial Property.


The above provisions apply mutatis mutandis to the written opinion of the International Searching Authority. See PCT Rule 43bis.1(b).

1878.02Reply to the Written Opinion of the ISA or IPEA [R-3]

PCT Article 34.

Procedure Before the International Preliminary Examining Authority


(2)(d) The applicant may respond to the written opinion.


PCT Rule 66.

Procedure before the International Preliminary Examining Authority


66.3.Formal Response to the International Preliminary Examining Authority

(a)The applicant may respond to the invitation referred to in Rule 66.2(c) of the International Preliminary Examining Authority by making amendments or - if he disagrees with the opinion of that Authority - by submitting arguments, as the case may be, or do both.

(b)Any response shall be submitted directly to the International Preliminary Examining Authority.




66.5.Amendment

Any change, other than the rectification of obvious errors, in the claims, the description, or the drawings, including cancellation of claims, omission of passages in the description, or omission of certain drawings, shall be considered an amendment.

66.6.Informal Communications with the Applicant

The International Preliminary Examining Authority may, at any time, communicate informally, over the telephone, in writing, or through personal interviews, with the applicant. The said Authority shall, at its discretion, decide whether it wishes to grant more than one personal interview if so requested by the applicant, or whether it wishes to reply to any informal written communication from the applicant.


66.8.Form of Amendments

(a)Subject to paragraph (b), the applicant shall be required to submit a replacement sheet for every sheet of the international application which, on account of an amendment, differs from the sheet previously filed. The letter accompanying the replacement sheets shall draw attention to the differences between the replaced sheets and the replacement sheets and shall preferably also explain the reasons for the amendment.

(b)Where the amendment consists in the deletion of passages or in minor alterations or additions, the replacement sheet referred to in paragraph (a) may be a copy of the relevant sheet of the international application containing the alterations or additions, provided that the clarity and direct reproducibility of that sheet are not adversely affected. To the extent that any amendment results in the cancellation of an entire sheet, that amendment shall be communicated in a letter which shall preferably also explain the reasons for the amendment.

66.9.Language of Amendments

(a)Subject to paragraphs (b) and (c), if the international application has been filed in a language other than the language in which it is published, any amendment, as well as any letter referred to in Rule 66.8, shall be submitted in the language of publication.

(b)If the international preliminary examination is carried out, pursuant to rule 55.2, on the basis of a translation of the international application, any amendment, as well as any letter referred to in paragraph (a), shall be submitted in the language of that translation.

(c)Subject to Rule 55.3, if an amendment or letter is not submitted in a language as required under paragraph (a) or (b), the International Preliminary Examining Authority shall, if practicable, having regard to the time limit for establishing the international preliminary examination report, invite the applicant to furnish the amendment or letter in the required language within a time limit which shall be reasonable under the circumstances.

(d)If the applicant fails to comply, within the time limit under paragraph (c), with the invitation to furnish an amendment in the required language, the amendment shall not be taken into account for the purposes of the international preliminary examination. If the applicant fails to comply, within the time limit under paragraph (c), with the invitation to furnish a letter referred to in paragraph (a) in the required language, the amendment concerned need not be taken into account for the purposes of the international preliminary examination.

37 CFR 1.485. Amendments by applicant during international preliminary examination.

(a)The applicant may make amendments at the time of filing the Demand. The applicant may also make amendments within the time limit set by the International Preliminary Examining Authority for reply to any notification under § 1.484(b) or to any written opinion. Any such amendments must:

(1)Be made by submitting a replacement sheet in compliance with PCT Rules 10 and 11.1 to 11.13 for every sheet of the application which differs from the sheet it replaces unless an entire sheet is cancelled; and

(2)Include a description of how the replacement sheet differs from the replaced sheet. Amendments that do not comply with PCT Rules 10 and 11.1 to 11.13 may not be entered

(b)If an amendment cancels an entire sheet of the international application, that amendment shall be communicated in a letter.

All amendments in reply to a written opinion must be received within the time limit set for reply in order to be assured of consideration in the international preliminary examination report. Amendments filed at or before expiration of the period for reply will be considered. Since the examiner will begin to draw up the final report rather promptly after the time period expires, amendments filed after expiration of the reply period may not be considered. However, as indicated in MPEP § 1871, there may be situations where it is advisable, to the extent possible, to take such amendments or arguments into account, for example, where the international preliminary examination report has not yet been completed and it is readily apparent to the examiner that consideration of the late-filed response would result in the issuance of a favorable report. In view of the short time period for completion of preliminary examination, applicants are strongly encouraged to file any amendments promptly. 37 CFR 1.484(d) does not allow for extensions of time to reply to a written opinion. The policy of not allowing extensions of time is to ensure that the USPTO can meet its treaty deadline for transmission of the final report.

Any change, other than the rectification of obvious errors in the claims, the description, or the drawings, including the cancellation of claims, omission of passages in the description or omission of certain drawings will be considered an amendment (PCT Rule



66.5). The Patent and Trademark Office when acting as the International Preliminary Examining Authority will not accept any non-English applications or amendments.

Any amendments to the claims, the description, and the drawings in reply to a written opinion must (1) be made by submitting a replacement sheet for every sheet of the application which differs from the sheet it replaces unless an entire sheet is cancelled and (2) include a description of how the replacement sheet differs from the replaced sheet in accordance with PCT Rule 66.8.

In the particular case where the amendment cancels claims, passages in the description or certain drawings resulting in the cancellation of an entire sheet, the amendment must be submitted in the form of a letter cancelling the sheet (PCT Rule 66.8(a)).

Replacement sheets must be in typed form.

Any paper submitted by the applicant, if not in the form of a letter, must be accompanied by a letter signed by the applicant or agent (PCT Rule 92.1). The letter must draw attention to the differences between the replaced sheet and the replacement sheet.

The examiner should make sure that amendments filed in accordance with the PCT, which are necessary to correct any deficiencies notified to the applicant, do not go beyond the disclosure of the international application as filed, thus violating PCT Article 34(2)(b). In other words, no amendment should contain matter that cannot be substantiated by the application as originally filed. In a situation where new matter is introduced by amendment in reply to a written opinion, the international preliminary examination report will be established as if the amendment had not been made, and the report should so indicate. It shall also indicate the reasons why the amendment goes beyond the disclosure (PCT Rule 70.2(c)). Although new matter which appears on a replacement sheet will be disregarded for the purpose of establishing the report, the remainder of the replacement sheet, including any amendments which do not constitute new matter, will be taken into consideration for the purpose of establishing the report.

INTERVIEWS

The examiner or applicant may, after the filing of a demand and during the time limit for reply to the written opinion, request a telephone or personal interview. Only one interview is a matter of right, whether by telephone or in person. Additional interviews may be authorized by the examiner in a particular international application where such additional interview may be helpful to advance the international preliminary examination procedure.

All interviews of substance must be made of record by using PCT/IPEA/428 Notice on Informal Communication with the Applicant.

When an interview is arranged, whether by telephone or in writing, and whether by the examiner or by the applicant, the matters for discussion should be stated.

The records of interviews or telephone conversations should indicate, where appropriate, whether a reply is due from the applicant or agent or whether the examiner wishes to issue an additional written opinion or establish the international preliminary examination report.

If the applicant desires to reply to the written opinion, such reply must be filed within the time limit set for reply in order to assure consideration. No extensions to the time limit will be considered or granted. If no timely reply is received from the applicant, the international preliminary examination report will be established by the examiner, treating each claim substantially as it was treated in the written opinion. Replies to the written opinion which are not filed within the time limit set but which reach the examiner before the examiner takes up the application for preparation of the final report may be considered. Thus, only timely replies can be assured of consideration.

The applicant may reply to the invitation referred to in Rule 66.2(c) by making amendments or, if the applicant disagrees with the opinion of the authority, by submitting arguments, as the case may be, or both (PCT Rule 66.3).

If applicant does not reply to the written opinion, the international preliminary examination report will be prepared in time for forwarding to the International Division in finished form by 27 months from the priority date.



1879Preparation of the International Preliminary Examination Report[R-3]

PCT Article 35.

The International Preliminary Examination Report

(1)The international preliminary examination report shall be established within the prescribed time limit and in the prescribed form.

(2)The international preliminary examination report shall not contain any statement on the question whether the claimed invention is or seems to be patentable or unpatentable according to any national law. It shall state, subject to the provisions of paragraph (3), in relation to each claim, whether the claim appears to satisfy the criteria of novelty, inventive step (non-obviousness), and industrial applicability, as defined for the purposes of the international preliminary examination in Article 33(1) to (4). The statement shall be accompanied by the citation of the documents believed to support the stated conclusion with such explanations as the circumstances of the case may require. The statement shall also be accompanied by such other observation as the Regulations provide for.

(3)(a)If, at the time of establishing the international preliminary examination report, the International Preliminary Examining Authority considers that any of the situations referred to in Article 34(4)(a) exists, that report shall state this opinion and the reasons therefor. It shall not contain any statement as provided in paragraph (2).

(b)If a situation under Article 34(4)(b) is found to exist, the international preliminary examination report shall, in relation to the claims in question, contain the statement as provided in subparagraph (a), whereas, in relation to the other claims, it shall contain the statement as provided in paragraph (2).

PCT Administrative Instruction Section 604.

Guidelines for Explanations Contained in the International Preliminary Examination Report

(a)Explanations under Rule 70.8 shall clearly point out to which of the three criteria of novelty, inventive step (non-obviousness) and industrial applicability referred to in Article 35(2), taken separately, any cited document is applicable and shall clearly describe, with reference to the cited documents, the reasons supporting the conclusion that any of the said criteria is or is not satisfied.

(b)Explanations under Article 35(2) shall be concise and preferably in the form of short sentences.

The international preliminary examination report is established on Form PCT/IPEA/409.

The international preliminary examination report must be established within:

For applications having an international filing date on or after January 1, 2004:

(A)28 months from the priority date; or

(B)6 months from the time provided under PCT Rule 69.1 for the start of international preliminary examination; or

(C)6 months from the date of receipt by the IPEA of the translation furnished under PCT Rule 55.2whichever expires last, as provided in PCT Rule 69.2.

For applications having an international filing date before January 1, 2004:

(A)28 months from the priority date; or

(B)8 months from the date of payment of the fees referred to in PCT Rules 57.1 and 58.1(a); or

(C)8 months from the date of receipt by the International Preliminary Examining Authority of the translation furnished under PCT Rule 55.2, whichever expires last, as provided in PCT Rule 69.2.

To meet the 28-month date for establishing the report, Office practice is to complete internal processing by 27 months from the priority date in order to provide adequate time for reviewing, final processing and mailing. Thus, under normal circumstances, the applicant receives the report, at the latest, 2 months before national processing at the elected Offices may start. This ensures that he/she has time to consider whether, and in which elected Offices, he/she wants to enter the national stage and to take the necessary action.

The international preliminary examination report contains, among other things, a statement (in the form of simple “yes” or “no”), in relation to each claim which has been examined, on whether the claim appears to satisfy the criteria of novelty, inventive step (non-obviousness) and industrial applicability. The statement is, where appropriate, accompanied by the citation of relevant documents together with concise explanations pointing out the criteria to which the cited documents are applicable and giving reasons for the International Preliminary Examining Authority’s conclusions. Where applicable, the report also includes remarks relating to the question of unity of invention.

The international preliminary examination report identifies the basis on which it is established, that is, whether, and if so, which amendments have been taken into account. Replacement sheets containing amendments under PCT Article 19 and/or Article 34which have been taken into account are attached as



“annexes” to the international preliminary examination report. Amendments under PCT Article 19 which have been considered as reversed by an amendment under PCT Article 34 are not annexed to the report; neither are the letters which accompany replacement sheets.

Superseded amendments are not normally included. However, if a first replacement sheet is acceptable and a second replacement sheet for the same numbered sheet contains subject matter that goes beyond the original disclosure of the application as filed, the second replacement sheet supersedes the first replacement sheet, but both the first and second replacement sheets shall be attached to the international preliminary examination report. In this case, the superseded replacement sheets are to be marked as provided in Administrative Instructions Section 602. The international preliminary examination report may not express a view on the patentability of the invention. PCT Article 35(2) expressly states that “the international preliminary examination report shall not contain any statement on the question whether the claimed invention is or seems to be patentable or unpatentable according to any national law.”


I. CLASSIFICATION OF SUBJECT MATTER

The classification of the subject matter shall be either (1) that given by the International Searching Authority under PCT Rule 43.3, if the examiner agrees with such classification, or (2) shall be that which the examiner considers to be correct, if the examiner does not agree with that classification. Both the International Patent Classification (IPC) and the U.S. classification should be given. This classification is placed on the first sheet of the report.


II. BOX NO. I. BASIS OF REPORT

When completing Box I, item 1, of Form PCT/ IPEA/409, the examiner must indicate whether or not the report has been established on the basis of the international application in the language in which it was filed. If a translation was furnished for the purpose of the search, the publication or the examination, this must be indicated. The international preliminary examination report will be established on the basis of any amendments, rectifications, priority and/or unity of invention holdings and shall answer the questions concerning novelty, inventive step, and industrial applicability for each of the claims under examination.

In completing Form PCT/IPEA/409, the examiner should first indicate any amendments and/or rectifications of obvious errors taken into account in establishing the international preliminary examination report. The amendments and/or rectifications should be indicated by references to the dates on which the amendments and/or rectifications were filed.

For the purpose of completing Box I, item 1, substitute and/or rectified sheets of the specification and drawings filed during Chapter I proceedings are considered to be originally filed pages/sheets and should be listed as originally filed pages/sheets. Only those amendments or rectifications to the specification and drawings filed on the date of Demand or after the filing of a Demand should be listed as later filed pages/ sheets.

Substitute and/or rectified sheets of claims filed during the Chapter I proceedings are also considered to be originally filed claims and should be listed as originally filed claims. However, amended sheets of claims filed under Article 19 in response to the international search report are to be indicated as claims as amended under Article 19. Applicant’s submission of a timely amendment to the claims alleged to be under Article 19 is accepted under Article 34 (not Article 19) unless the International Bureau has indicated the amendments were accepted under Article 19. Only those amendments, or rectifications to the claims filed on the date of Demand or after the filing of a Demand should be listed as later filed claims.

Amendments and/or rectifications filed but not taken into account in the establishment of the report (e.g., an amendment not taken into account because the amendment went beyond the disclosure of the international application as filed or a rectification that is not considered to be merely a correction of an obvious error) are then indicated separately. The replacement sheets (but not replacement sheets superseded by later replacement sheets) or letters cancelling sheets under PCT Rule 66.8(a) are included as an annex to the report.

With respect to Box I, item 3, the examiner must indicate whether any amendments have resulted in the



cancellation of pages of the description, claims, drawings, sequence listings or any tables related to sequence listings.

With respect to Box 1, item 4, the examiner must indicate whether any amendments to the description, claims, drawings, sequence listings or any tables related to sequence listing that are annexed to the report, have been treated as if they had not been made because they go beyond the disclosure as filed.

The final report package when sent to the International Application Processing Division for mailing must include copies of all amendments and rectifications entered and any cover letters to those amendments.


III. BOX NO. II. PRIORITY

Box II of Form PCT/IPEA/409 is to inform applicant of non-establishment of a request for priority. If the report is established as if the priority claim contained in the Request of the international application had not been made, it shall so indicate. This will occur in the event that the applicant has failed to comply with the invitation to furnish either

(A)a copy of the earlier application whose priority is claimed, or

(B)a translation of the earlier application, or

(C)where the priority claim is found invalid, e.g., the claimed priority date is more than one year prior to the international filing date (PCT Rule 17) or all claims are directed to inventions which were not described and enabled by the earlier application (PCT Rule 64.1), or

(D)where the priority claim has been withdrawn.


IV. BOX NO. III. NON-ESTABLISHMENT OF OPINION WITH REGARD TO NOVELTY, INVENTIVE STEP OR INDUSTRIAL APPLICABILITY

Indications that a report has not been established on the questions of novelty, inventive step or industrial applicability, either as to some claims or as to all claims, are given in Item III on the Report. The examiner must specify that the report has not been established because:

(A)the application relates to subject matter which does not require international preliminary examination;

(B)the description, claims or drawings are so unclear that no meaningful opinion could be formed;

(C)the claims are so inadequately supported by the description that no meaningful opinion could be formed.

Where the report has not been established in relation to certain claims only, the claims affected must be specified.

If the nucleotide and/or amino acid sequence listing, and/or tables related thereto, do not comply with the standard in Annex C of the Administrative Instructions, the examiner must indicate the reason for non-compliance.


V. BOX NO. IV. LACK OF UNITY OF INVENTION

If the applicant has paid additional fees or has restricted the claims in response to an invitation to do so or if the applicant has failed to respond to the invitation to pay additional fees or restrict the claims, the international preliminary examination report shall so indicate. The examiner should indicate whether:

(A)the claims have been restricted;

(B)additional fees have been paid without protest;

(C)additional fees have been paid by the applicant under protest;

(D)the applicant has neither restricted the claims nor paid additional fees;

(E)the examiner was of the opinion that the international application did not comply with the requirement of unity of invention but decided not to issue an invitation to restrict the claims or pay additional fees.

In addition, if the examiner is examining less than all the claims, the examiner must indicate which parts of the international application were, and which parts were not, the subject of international preliminary examination.

In the case where additional fees were paid under protest, the text of the protest, together with the decision thereon, must be annexed to the report by International Application Processing Division IPEA personnel if the applicant has so requested.



Where an indication has been given under item (E) above, the examiner must also specify the reasons for which the international application was not considered as complying with the requirement of unity of invention.


VI. BOX NO. V. REASONED STATEMENT UNDER ARTICLE 35(2) WITH REGARD TO NOVELTY, INVENTIVE STEP, AND INDUSTRIAL APPLICABILITY; AND CITATIONS AND EXPLANATIONS SUPPORTING SUCH STATEMENT

The examiner must indicate whether each claim appears to satisfy the criteria of novelty, inventive step (nonobviousness), and industrial applicability. The determination or statement should be made on each of the three criteria taken separately. The determination as to any criteria should be negative if the criteria as to the particular claim is not satisfied. The examiner should always cite documents believed to support any negative determination as to novelty and inventive step. Any negative holding as to lack of industrial applicability must be fully explained. See the furthur discussion in MPEP § 1845.01 relating to Box No. V of Form PCT/ISA/237. The citation of documents should be in accordance with Administrative Instructions Sections 503 and 611. The procedure is the same as the procedure for search report citations. Explanations should clearly indicate, with reference to the cited documents, the reasons supporting the conclusions that any of the said criteria is or is not satisfied, unless the statement is positive and the reason for citing any document is easy to understand when consulting the document. If only certain passages of the cited documents are relevant, the examiner should identify them, for example, by indicating the page, column, or the lines where such passages appear. Preferably, a reasoned statement should be provided in all instances.


VII. BOX NO. VI. CERTAIN DOCUMENTS CITED

If the examiner has discovered, or the international search report has cited, a relevant document which refers to a nonwritten disclosure, and the document was only published on or after the relevant date of the international application, the examiner must indicate on the international preliminary examination report:

(A)the date on which the document was made available to the public;

(B)the date on which the non-written public disclosure occurred.

The examiner should also identify any published application or patent and should provide for each such published application or patent the following indications:

(A)its date of publication;

(B)its filing date, and its claimed priority date (if any).

The Report may also indicate that, in the opinion of the International Preliminary Examining Authority, the priority date of the document cited has not been validly claimed (PCT Rule 70.10).

Guidelines explaining to the examiner the manner of indicating certain special categories of documents as well as the manner of indicating the claims to which the documents cited in such report are relevant are set forth in Administrative Instructions Sections 507(c), (d), and (e) and 508.


VIII. BOX NO. VII. CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION

If, in the opinion of the examiner, defects existing in the form or contents of the international application have not been suitably solved at the prescribed time limit for establishing the international preliminary examination report, the examiner may include this opinion in the report, and if included, must also indicate the reasons therefor. See the further discussion in MPEP § 1845.01 relating to Box No. VII of Form PCT/ISA/237.


IX. BOX NO. VIII. CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION

If, in the opinion of the examiner, the clarity of claims, the description, and the drawings, or the question as to whether the claims are fully supported by the description have not been suitably solved at the prescribed time limit for establishing the international



preliminary examination report, the examiner may include this opinion in the report, and if included, must also indicate the reasons therefor. See the further discussion in MPEP § 1845.01 relating to Box No. VIII of Form PCT/ISA/237.

X.FINALIZATION OF THE INTERNATIONAL PRELIMINARY EXAMINATION REPORT

The date on which the report was completed and the name and mailing address of the International Preliminary Examining Authority are indicated on the cover sheet (Form PCT/IPEA/416) of the international preliminary examination report. This information is generated automatically by the OACS software when preparing the report. In addition, the date on which the demand for international preliminary examination was submitted and the name of the authorized officer responsible for the report must be indicated. Pursuant to Administrative Instructions Section 612, an “authorized officer” is the person who actually performed the examination work and prepared the international preliminary examination report or another person who was responsible for supervising the examination. Thus, an examiner need not have signatory authority in order to be named as an authorized officer on the examination report. However, the “file copy” of the international preliminary examination report must be signed by a primary examiner.




Form PCT/IPEA/409. International Preliminary Examination ReportForm PCT/IPEA/409. International Preliminary Examination Report




Form PCT/IPEA/409 (Box I)Form PCT/IPEA/409 (Box I)




Form PCT/IPEA/409 (Box II)Form PCT/IPEA/409 (Box II)




Form PCT/IPEA/409 (Box III)Form PCT/IPEA/409 (Box III)




Form PCT/IPEA/409 (Box IV)Form PCT/IPEA/409 (Box IV)




Form PCT/IPEA/409 (Box V)Form PCT/IPEA/409 (Box V)




Form PCT/IPEA/409 (Supplemental Box)Form PCT/IPEA/409 (Supplemental Box)





1879.01Time Limit for Preparing Report in International Applications Having an International Filing Date On or After January 1, 2004 [R-5]

[Note: The regulations under the PCT were changed effective January 1, 2004 and corresponding changes were made to Title 37 of the Code of Federal Regulations. See January 2004 Revision of Patent Cooperation Treaty Application Procedure, 68 FR 59881 (Oct. 20, 2003), 1276 O.G. 6 (Nov. 11, 2003). The discussion of the procedures in effect for applications filed prior to January 1, 2004 has been moved from this section to MPEP § 1879.01(a).]

PCT Rule 69.

Start of and Time Limit for International Preliminary Examination

69.1.Start of International Preliminary Examination

(a)Subject to paragraphs (b) to (e), the International Preliminary Examining Authority shall start the international preliminary examination when it is in possession of all of the following:

(i)the demand;

(ii)the amount due (in full) for the handling fee and the preliminary examination fee, including where applicable, the late payment fee under Rule 58bis.2; and

(iii)either the international search report or the declaration by the International Searching Authority under Article 17(2)(a) that no international search report will be established, and the written opinion established under Rule 43bis.1;

provided that the International Preliminary Examining Authority shall not start the international preliminary examination before the expiration of the applicable time limit under Rule 54bis.1(a) unless the applicant expressly requests an earlier start.

(b)If the national Office or intergovernmental organization that acts as International Searching Authority also acts as International Preliminary Examining Authority, the international preliminary examination may, if that national Office or intergovernmental organization so wishes and subject to paragraphs (d) and (e), start at the same time as the international search.

(b-bis) Where, in accordance with paragraph (b), the national Office or intergovernmental organization that acts as both International Searching Authority and International Preliminary Examining Authority wishes to start the international preliminary examination at the same time as the international search and considers that all of the conditions referred to in Article 34(2)(c)(i) to (iii) are fulfilled, that national Office or intergovernmental organization need not, in its capacity as International Searching Authority, establish a written opinion under Rule 43bis.1

(c)Where the statement concerning amendments contains an indication that amendments under Article 19 are to be taken into account (Rule 53.9(a)(i)), the International Preliminary Examining Authority shall not start the international preliminary examination before it has received a copy of the amendments concerned.

(d)Where the statement concerning amendments contains an indication that the start of the international preliminary examination is to be postponed (Rule 53.9(b)), the International Preliminary Examining Authority shall not start the international preliminary examination before whichever of the following occurs first:

(i)it has received a copy of any amendments made under Article 19;

(ii)it has received a notice from the applicant that he does not wish to make amendments under Article 19; or

(iii)the expiration of the applicable time limit under Rule 46.1.

(e)Where the statement concerning amendments contains an indication that amendments under Article 34 are submitted with the demand (Rule 53.9(c)) but no such amendments are, in fact, submitted, the International Preliminary Examining Authority shall not start the international preliminary examination before it has received the amendments or before the time limit fixed in the invitation referred to in Rule 60.1(g) has expired, whichever occurs first.

69.2.Time Limit for International Preliminary Examination

The time limit for establishing the international preliminary examination report shall be whichever of the following periods expires last:

(i)28 months from the priority date; or

(ii)six months from the time provided under Rule 69.1 for the start of the international preliminary examination; or

(iii)six months from the date of receipt by the International Preliminary Examining Authority of the translation furnished under Rule 55.2.

PCT Rule 69.2 was amended as reproduced above for applications having an international filing date on or after January 1, 2004. The time limit for preparing the international preliminary examination report is 28 months from the priority date, or 6 months from the time provided under PCT Rule 69.1 for the start of the international preliminary examination, or 6 months from the date of receipt by the International Preliminary Examining Authority of the translation furnished under PCT Rule 55.2, whichever expires first. This time limit is 27 months internally to ensure sufficient time to process, review and mail the report in sufficient time to reach the International Bureau by 28 months from the earliest priority date.



1879.01(a) Time Limit for Preparing Report in International Application Having an International Filing Date Before January 1, 2004 [R-2]

[Note: For international applications filed on or after January 1, 2004, see MPEP § 1879.01.]

Former

PCT Rule 69.

Start of and Time Limit for International Preliminary Examination(as amended July 1, 1998)

69.1.Start of International Preliminary Examination

(a)Subject to paragraphs (b) to (e), the International Preliminary Examining Authority shall start the international preliminary examination when it is in possession both of the demand and of either the international search report or a notice of the declaration by the International Searching Authority under Article 17(2)(a) that no international search report will be established.

(b)If the competent International Preliminary Examining Authority is part of the same national Office or intergovernmental organization as the competent International Searching Authority, the international preliminary examination may, if the International Preliminary Examining Authority so wishes and subject to paragraph (d), start at the same time as the international search.

(c)Where the statement concerning amendments contains an indication that amendments under Article 19 are to be taken into account (Rule 53.9(a)(i)), the International Preliminary Examining Authority shall not start the international preliminary examination before it has received a copy of the amendments concerned

(d)Where the statement concerning amendments contains an indication that the start of the international preliminary examination is to be postponed (Rule 53.9(b)), the International Preliminary Examining Authority shall not start the international preliminary examination before

(i)it has received a copy of any amendments made under Article 19,

(ii)it has received a notice from the applicant that he does not wish to make amendments under Article 19, or

(iii)the expiration of 20 months from the priority date, whichever occurs first.

(e)Where the statement concerning amendments contains an indication that amendments under Article 34 are submitted with the demand (Rule 53.9(c)) but no such amendments are, in fact, submitted, the International Preliminary Examining Authority shall not start the international preliminary examination before it has received the amendments or before the time limit fixed in the invitation referred to in Rule 60.1(g) has expired, whichever occurs first.

69.2.Time Limit for International Preliminary Examination

The time limit for establishing the international preliminary examination report shall be:

(i)28 months from the priority date, or

(ii)eight months from the date of payment of the fees referred to in Rules 57.1 and 58.1(a), or

(iii)eight months from the date of receipt by the International Preliminary Examining Authority of the translation furnished under Rule 55.2, whichever expires last.

For international applications having an international filing date before January 1, 2004, the period for preparing the IPER is set forth in former PCT Rule 69.2 (as amended July 1, 1998). The time limit for preparing the international preliminary examination report is 28 months from the priority date, or 8 months from the date of payment of the fees referred to in PCT Rules 57.1 and 58.1(a), or 8 months from the date of receipt by the International Preliminary Examining Authority of the translation furnished under PCT Rule 55.2, whichever expires first. This time limit is 27 months internally to ensure sufficient time to process, review and mail the report in sufficient time to reach the International Bureau by 28 months from the earliest priority date.

1879.02Transmittal of the International Preliminary Examination Report

PCT Article 36.

Transmittal, Translation, and Communication of the International Preliminary Examination Report

(1)The international preliminary examination report, together with the prescribed annexes, shall be transmitted to the applicant and to the International Bureau.


PCT Rule 71.

Transmittal of the International Preliminary Examination Report

71.1.Recipients

The International Preliminary Examining Authority shall, on the same day, transmit one copy of the international preliminary examination report and its annexes, if any, to the International Bureau, and one copy to the applicant.

71.2.Copies of Cited Documents

(a)The request under Article 36(4) may be presented any time during seven years from the international filing date of the international application to which the report relates.



(b)The International Preliminary Examining Authority may require that the party (applicant or elected Office) presenting the request pay to it the cost of preparing and mailing the copies. The level of the cost of preparing copies shall be provided for in the agreements referred to in Article 32(2) between the International Preliminary Examining Authorities and the International Bureau.

(c)[Deleted]

(d)Any International Preliminary Examining Authority may perform the obligations referred to in paragraphs (a) and (b) through another agency responsible to it.

The international preliminary examination report is transmitted to the International Bureau using a transmittal Form PCT/IPEA/416. Every effort is made to ensure that the transmittal is effected in sufficient time to reach the International Bureau before the expiration of the time limit set in PCT Rule 69.2.

AUTHORIZED OFFICER

Form PCT/IPEA/416 must be signed by a primary examiner.

1879.03Translations [R-2]


PCT Article 36.

Transmittal, Translation, and Communication of the International Preliminary Examination Report


(2)(a)The international preliminary examination report and its annexes shall be translated into the prescribed languages.

(b)Any translation of the said report shall be prepared by or under the responsibility of the International Bureau, whereas any translation of the said annexes shall be prepared by the applicant.



PCT Rule 70.

International Preliminary Report on Patentability by the International Preliminary Examining Authority (International Preliminary Examination Report)


70.17 Languages of the Report and the Annexes

The report and any annex shall be in the language in which the international application to which they relate is published, or, if the international preliminary examination is carried out, pursuant to Rule 55.2, on the basis of a translation of the international application, in the language of that translation.

PCT Rule 72.

Translation of the International Preliminary Examination Report and of the Written Opinion of the International Searching Authority

72.1.Languages

(a)Any elected State may require that the international preliminary examination report, established in any language other than the official language, or one of the official languages, of its national Office, be translated into English.

(b)Any such requirement shall be notified to the International Bureau, which shall promptly publish it in the Gazette.

72.2.Copy of Translation for the Applicant

The International Bureau shall transmit a copy of the translation referred to in Rule 72.1(a) of the international preliminary examination report to the applicant at the same time as it communicates such translation to the interested elected Office or Offices.


72.2bis. Translation of the Written Opinion of the International Searching Authority Established Under Rule 43bis.1

In the case referred to in Rule 73.2(b)(ii), the written opinion established by the International Searching Authority under Rule 43bis.1 shall, upon request of the elected Office concerned, be translated into English by or under the responsibility of the International Bureau. The International Bureau shall transmit a copy of the translation to the elected Office concerned within two months from the date of receipt of the request for translation, and shall at the same time transmit a copy to the applicant.

72.3.Observations on the Translation

The applicant may make written observations as to the correctness of the translation of the international preliminary examination report or of the written opinion established by the International Searching Authority under Rule 43bis.1 and shall send a copy of the observations to each of the interested elected Offices and to the International Bureau.

The written opinion established by the International Searching Authority and the international preliminary examination report and any annexes are established in Chinese, English, French, German, Japanese, Russian or Spanish, if the international application was filed in one of those languages or translated into one of those languages. See PCT Rules 48.3(b), 55.2 and 70.17. Each elected State may require that the written opinion and/or the report, if it is not in (one of) the official language(s) of its national Office, be translated into English. See PCT Rule 72.1(a). In that case, the translation of the body of the written opinion and/or report is prepared by the International Bureau, which transmits copies to the applicant and to each interested elected Office. If any elected



Office requires a translation of annexes to the report, the preparation and furnishing of that translation is the responsibility of the applicant. See PCT Article 36(2)(b).

The U.S. requires the final report and the annexes thereto to be in English. Translation of the annexes for national stage purposes is required pursuant to 35 U.S.C. 371(c)(5) and 37 CFR 1.495(e). Failure to timely provide such translation results in cancellation of the annexes.

1879.04Confidential Nature of the Report [R-3]

PCT Article 38.

Confidential Nature of the International Preliminary Examination

(1)Neither the International Bureau nor the International Preliminary Examining Authority shall, unless requested or authorized by the applicant, allow access within the meaning, and with the proviso, of Article 30(4) to the file of the international preliminary examination by any person or authority at any time, except by the elected Offices once the international preliminary examination report has been established.

(2)Subject to the provisions of paragraph (1) and Articles 36(1) and (3) and 37(3)(b), neither the International Bureau nor the International Preliminary Examining Authority shall, unless requested or authorized by the applicant, give information on the issuance or non-issuance of an international preliminary examination report and on the withdrawal or non-withdrawal of the demand or of any election.

PCT Rule 44ter.

Confidential Nature of Written Opinion, Report, Translation and Observations

(a)The International Bureau and the International Searching Authority shall not, unless requested or authorized by the applicant, allow access by any person or authority before the expiration of 30 months from the priority date:

(i)to the written opinion established under Rule 43bis.1, to any translation thereof prepared under Rule 44bis.3(d) or to any written observations on such translation sent by the applicant under Rule 44bis.4;

(ii)if a report is issued under Rule 44bis.1, to that report, to any translation of it prepared under Rule 44bis.3(b) or to any written observations on that translation sent by the applicant under Rule 44bis.4.

(b)For the purposes of paragraph (a), the term “access” covers any means by which third parties may acquire cognizance, including individual communication and general publication.

37 CFR 1.11. Files open to the public.

(a)The specification, drawings, and all papers relating to the file of an abandoned published application, except if a redacted copy of the application was used for the patent application publication, a patent, or a statutory invention registration are open to inspection by the public, and copies may be obtained upon the payment of the fee set forth in § 1.19(b)(2). See § 2.27 for trademark files.


37 CFR 1.14. Patent applications preserved in confidence.


(g)International applications. (1) Copies of international application files for international applications which designate the U.S. and which have been published in accordance with PCT Article 21(2), or copies of a document in such application files, will be furnished in accordance with PCT Articles 30 and 38 and PCT Rules 94.2 and 94.3, upon written request including a showing that the publication of the application has occurred and that the U.S. was designated, and upon payment of the appropriate fee (see § 1.19(b)), if:

(i)With respect to the Home Copy (the copy of the international application kept by the Office in its capacity as the Receiving Office, see PCT Article 12(1)), the international application was filed with the U.S. Receiving Office;

(ii)With respect to the Search Copy (the copy of an international application kept by the Office in its capacity as the International Searching Authority, see PCT Article 12(1)), the U.S. acted as the International Searching Authority, except for the written opinion of the International Searching Authority which shall not be available until the expiration of thirty months from the priority date; or

(iii)With respect to the Examination Copy (the copy of an international application kept by the Office in its capacity as the International Preliminary Examining Authority), the United States acted as the International Preliminary Examining Authority, an International Preliminary Examination Report has issued, and the United States was elected.

(2)A copy of an English language translation of a publication of an international application which has been filed in the United States Patent and Trademark Office pursuant to 35 U.S.C. 154(d)(4) will be furnished upon written request including a showing that the publication of the application in accordance with PCT Article 21(2) has occurred and that the U.S. was designated, and upon payment of the appropriate fee (§ 1.19(b)(4)).

(3)Access to international application files for international applications which designate the U.S. and which have been published in accordance with PCT Article 21(2), or copies of a document in such application files, will be permitted in accordance with PCT Articles 30 and 38 and PCT Rules 44ter.1, 94.2and 94.3, upon written request including a showing that the publication of the application has occurred and that the U.S. was designated.

(4)In accordance with PCT Article 30, copies of an international application-as-filed under paragraph (a) of this section will not be provided prior to the international publication of the application pursuant to PCT Article 21(2).



(5)Access to international application files under paragraphs (a)(1)(i) through (a)(1)(vi) and (g)(3) of this section will not be permitted with respect to the Examination Copy in accordance with PCT Article 38.

(h)Access or copies in other circumstances. The Office, either sua sponte or on petition, may also provide access or copies of all or part of an application if necessary to carry out an Act of Congress or if warranted by other special circumstances. Any petition by a member of the public seeking access to, or copies of, all or part of any pending or abandoned application preserved in confidence pursuant to paragraph (a) of this section, or any related papers, must include:


(1)The fee set forth in § 1.17(g); and

(2)A showing that access to the application is necessary to carry out an Act of Congress or that special circumstances exist which warrant petitioner being granted access to all or part of the application.

For a discussion of the availability of copies of documents from international application files and/or access to international application files, see MPEP § 110.

1880Withdrawal of Demand or Election [R-2]

PCT Article 37.

Withdrawal of Demand or Election

(1)The applicant may withdraw any or all elections.

(2)If the election of all elected States is withdrawn, the demand shall be considered withdrawn.

(3)(a) Any withdrawal shall be notified to the International Bureau.

(b)The elected Office concerned and the International Preliminary Examining Authority concerned shall be notified accordingly by the International Bureau.

(4)(a) Subject to the provisions of subparagraph (b), withdrawal of the demand or of the election of a Contracting State shall, unless the national law of that State provides otherwise, be considered to be withdrawal of the international application as far as that State is concerned.

(b)Withdrawal of the demand or of the election shall not be considered to be withdrawal of the international application if such withdrawal is effected prior to the expiration of the applicable time limit under Article 22; however, any Contracting State may provide in its national law that the aforesaid shall apply only if its national Office has received, within the said time limit, a copy of the international application, together with a translation (as prescribed), and the national fee.

PCT Rule 90bis.

Withdrawals


90bis.4.Withdrawal of the Demand, or of Elections

(a)The applicant may withdraw the demand or any or all elections at any time prior to the expiration of 30 months from the priority date.

(b)Withdrawal shall be effective upon receipt of a notice addressed by the applicant to the International Bureau.

(c)If the notice of withdrawal is submitted by the applicant to the International Preliminary Examining Authority, that Authority shall mark the date of receipt on the notice and transmit it promptly to the International Bureau. The notice shall be considered to have been submitted to the International Bureau on the date marked.


PCT Administrative Instruction Section 606.

Cancellation of Elections


(a)The International Preliminary Examining Authority shall cancel ex officio:

(i)the election of any State which is not a designated State;

(ii)the election of any State not bound by Chapter II of the Treaty.

(b)The International Preliminary Examining Authority shall enclose that election within square brackets, shall draw a line between the square brackets while still leaving the election legible and shall enter, in the margin, the words “CANCELLED EX OFFICIO BY IPEA” or their equivalent in the language of the demand, and shall notify the applicant accordingly.

Any withdrawal of the demand or any election must be sent to the International Bureau or to the International Preliminary Examining Authority. Withdrawal, if timely, is effective upon receipt by the International Bureau or the International Preliminary Examining Authority. Pursuant to PCT Rule 90bis.5, the withdrawal must be signed by all of the applicants, except as provided in PCT Rule 90bis.5(b) in the case where an applicant/inventor for the United States could not be found or reached after diligent effort and the withdrawal is signed by at least one applicant. Pursuant to PCT Rules 90.4(e) and 90.5(d), the requirement for a separate power of attorney or a copy of the general power of attorney shall not be waived in cases of withdrawal.



1881Receipt of Notice of Election and Preliminary Examination Report by the United States Patent and Trademark Office [R-2]

PCT Rule 61.

Notification of the Demand and Elections


61.2.Notification to the Elected Offices

(a)The notification provided for in Article 31(7) shall be effected by the International Bureau.


(b)The notification shall indicate the number and filing date of the international application, the name of the applicant, the filing date of the application whose priority is claimed (where priority is claimed) and the date of receipt by the International Preliminary Examining Authority of the demand.

(c)The notification shall be sent to the elected Office together with the communication provided for in Article 20. Elections effected after such communication shall be notified promptly after they have been made.


(d)Where the applicant makes an express request to an elected Office under Article 40(2) prior to the international publication of the international application, the International Bureau shall, upon request of the applicant or the elected Office, promptly effect the communication provided for in Article 20 to that Office.

61.3.Information for the Applicant

The International Bureau shall inform the applicant in writing of the notification referred to in Rule 61.2 and of the elected Offices notified under Article 31(7).


All notices of election are received by the Office of PCT Operations from the International Bureau. The Office of PCT Operations prepares the appropriate records of the election and places the paper in storage with the communicated copy of the international application until the national stage is entered. The international preliminary examination report received by the USPTO will also be included in the national stage file. The international preliminary examination report is communicated to the elected Offices by the International Bureau.


1893National Stage (U.S. National Application Filed Under 35 U.S.C. 371) [R-5]

37 CFR 1.9. Definitions.

(a)(1)A national application as used in this chapter means a U.S. application for patent which was either filed in the Office under 35 U.S.C. 111, or which entered the national stage from an international application after compliance with 35 U.S.C. 371.

(2)A provisional application as used in this chapter means a U.S. national application for patent filed in the Office under 35 U.S.C. 111(b).

(3)A nonprovisional application as used in this chapter means a U.S. national application for patent which was either filed in the Office under 35 U.S.C. 111(a), or which entered the national stage from an international application after compliance with 35 U.S.C. 371.


Thus, there are three types of U.S. national applications: a national stage application under the PCT (an application which entered the national stage in the U.S. from an international application after compliance with 35 U.S.C. 371), a regular domestic national application filed under 35 U.S.C. 111(a), and a provisional application filed under 35 U.S.C. 111(b).

An applicant who uses the Patent Cooperation Treaty gains the benefit of:

(A)a delay in the time when papers must be submitted to the national offices;

(B)an international search (to judge the level of the relevant prior art) and, for international applications filed on or after January 1, 2004, a written opinion on the question of whether the claimed invention appears to be novel, to involve an inventive step (to be non-obvious), and to be industrially applicable before having to expend resources for filing fees, translations and other costs;

(C)a delay in the expenditure of fees;

(D)additional time for research;

(E)additional time to evaluate financial, marketing, commercial and other considerations; and

(F)the option of obtaining international preliminary examination.

The time delay is, however, the benefit most often recognized as primary. Ultimately, applicant might choose to submit the national stage application. The national stage is unique compared to a domestic national application in that



(A)it is submitted later (i.e., normally 30 months from a claimed priority date as compared to 12 months for a domestic application claiming priority).

(B)the status of the prior art is generally known before the national stage begins and this is not necessarily so in a domestic national application.

(C)if the filing of an international application is to be taken into account in determining the patentability or validity of any application for patent or granted patent, then special provisions apply. See MPEP § 1895.01, subsection (E) and MPEP § 1896.

IDENTIFICATION OF THE NATIONAL STAGE APPLICATION

Once an international application entering the U.S. national phase (“national stage application”) has been accorded a U.S. application number (the two digit series code followed by a six digit serial number), that number should be used whenever papers or other communications are directed to the USPTO regarding the national stage application. See 37 CFR 1.5 (a). The national stage application is tracked through the Patent Application Locating and Monitoring (PALM) system by the eight digit U.S. application number. Therefore, processing is expedited if the U.S. application number is indicated. The international application number, international filing date, and the national stage entry date under 35 U.S.C. 371 (if such has been accorded) should also be included, as such would also be helpful for identification purposes and can be used to cross-check a possibly erroneous U.S. application number.

1893.01Commencement and Entry [R-3]


35 U.S.C. 371. National stage: Commencement.

(a)Receipt from the International Bureau of copies of international applications with any amendments to the claims, international search reports, and international preliminary examination reports including any annexes thereto may be required in the case of international applications designating or electing the United States.

(b)Subject to subsection (f) of this section, the national stage shall commence with the expiration of the applicable time limit under article 22 (1) or (2), or under article 39 (1)(a) of the treaty.

(c)The applicant shall file in the Patent and Trademark Office —

(1)the national fee provided in section 41(a) of this title;

(2)a copy of the international application, unless not required under subsection (a) of this section or already communicated by the International Bureau, and a translation into the English language of the international application, if it was filed in another language;

(3)amendments, if any, to the claims in the international application, made under article 19 of the treaty, unless such amendments have been communicated to the Patent and Trademark Office by the International Bureau, and a translation into the English language if such amendments were made in another language;

(4)an oath or declaration of the inventor (or other person authorized under chapter 11 of this title) complying with the requirements of section 115 of this title and with regulations prescribed for oaths or declarations of applicants;

(5)a translation into the English language of any annexes to the international preliminary examination report, if such annexes were made in another language.

(d)The requirement with respect to the national fee referred to in subsection (c)(1), the translation referred to in subsection (c)(2), and the oath or declaration referred to in subsection (c)(4) of this section shall be complied with by the date of the commencement of the national stage or by such later time as may be fixed by the Director. The copy of the international application referred to in subsection (c)(2) shall be submitted by the date of the commencement of the national stage. Failure to comply with these requirements shall be regarded as abandonment of the application by the parties thereof, unless it be shown to the satisfaction of the Director that such failure to comply was unavoidable. The payment of a surcharge may be required as a condition of accepting the national fee referred to in subsection (c)(1) or the oath or declaration referred to in subsection (c)(4) of this section if these requirements are not met by the date of the commencement of the national stage. The requirements of subsection (c)(3) of this section shall be complied with by the date of the commencement of the national stage, and failure to do so shall be regarded as a cancellation of the amendments to the claims in the international application made under article 19 of the treaty. The requirement of subsection (c)(5) shall be complied with at such time as may be fixed by the Director and failure to do so shall be regarded as cancellation of the amendments made under article 34 (2)(b) of the treaty.

(e)After an international application has entered the national stage, no patent may be granted or refused thereon before the expiration of the applicable time limit under article 28 or article 41 of the treaty, except with the express consent of the applicant. The applicant may present amendments to the specification, claims, and drawings of the application after the national stage has commenced.

(f)At the express request of the applicant, the national stage of processing may be commenced at any time at which the application is in order for such purpose and the applicable requirements of subsection (c) of this section have been complied with.



37 CFR 1.491. National stage commencement and entry.

(a)Subject to 35 U.S.C. 371(f), the national stage shall commence with the expiration of the applicable time limit under PCT Article 22(1) or (2), or under PCT Article 39(1)(a).

(b)An international application enters the national stage when the applicant has filed the documents and fees required by 35 U.S.C. 371(c) within the period set in § 1.495.

Subject to 35 U.S.C. 371(f), commencement of the national stage occurs upon expiration of the applicable time limitunder PCT Article 22(1) or (2), or under PCT Article 39(1)(a). See 35 U.S.C. 371(b) and 37 CFR 1.491(a). PCT Articles 22(1), 22(2), and 39(1)(a) provide for a time limit of not later than the expiration of 30 months from the priority date. Thus, in the absence of an express request for early processing of an international application under 35 U.S.C. 371(f) and compliance with the conditions provided therein, the U.S. national stage will commence upon expiration of 30 months from the priority date of the international application. Pursuant to 35 U.S.C. 371(f), the national stage may commence earlier than 30 months from the priority date, provided applicant makes an express request for early processing and has complied with the applicable requirements under 35 U.S.C. 371(c).

Entry into the national stage occurs upon completion of certain acts, as stated in 37 CFR 1.491(b).

1893.01(a)Entry via the U.S. Designated or Elected Office [R-3]

PCT Article 2.

Definitions


(xiii)“designated Office” means the national Office of or acting for the State designated by the applicant under Chapter I of this Treaty;

(xiv)“elected Office” means the national Office of or acting for the State elected by the applicant under Chapter II of this Treaty;


37 CFR 1.414. The United States Patent and Trademark Office as a Designated Office or Elected Office.

(a)The United States Patent and Trademark Office will act as a Designated Office or Elected Office for international applications in which the United States of America has been designated or elected as a State in which patent protection is desired.

(b)The United States Patent and Trademark Office, when acting as a Designated Office or Elected Office during international processing will be identified by the full title “United States Designated Office” or by the abbreviation “DO/US” or by the full title “United States Elected Office” or by the abbreviation “EO/ US.”

(c)The major functions of the United States Designated Office or Elected Office in respect to international applications in which the United States of America has been designated or elected, include:

(1)Receiving various notifications throughout the international stage and

(2)Accepting for national stage examination international applications which satisfy the requirements of 35 U.S.C. 371.

An international application designating the U.S. will enter the national stage via the U.S. Designated Office unless a Demand electing the U.S. is filed under PCT Article 31 whereupon entry will be via the U.S. Elected Office. The procedure for entry is as prescribed in 37 CFR 1.495.

37 CFR 1.495. Entering the national stage in the United States of America.

(a)The applicant in an international application must fulfill the requirements of 35 U.S.C. 371 within the time periods set forth in paragraphs (b) and (c) of this section in order to prevent the abandonment of the international application as to the United States of America. The thirty-month time period set forth in paragraphs (b), (c), (d), (e) and (h) of this section may not be extended. International applications for which those requirements are timely fulfilled will enter the national stage and obtain an examination as to the patentability of the invention in the United States of America.

(b)To avoid abandonment of the application, the applicant shall furnish to the United States Patent and Trademark Office not later than the expiration of thirty months from the priority date:

(1)A copy of the international application, unless it has been previously communicated by the International Bureau or unless it was originally filed in the United States Patent and Trademark Office; and

(2)The basic national fee (see § 1.492(a)).


(c)(1) If applicant complies with paragraph (b) of this section before expiration of thirty months from the priority date, the Office will notify the applicant if he or she has omitted any of:

(i)A translation of the international application, as filed, into the English language, if it was originally filed in another language and if any English language translation of the publication of the international application previously submitted under 35 U.S.C. 154(d) (§ 1.417) is not also a translation of the international application as filed (35 U.S.C. 371(c)(2));

(ii)The oath or declaration of the inventor (35 U.S.C. 371(c)(4) and § 1.497), if a declaration of inventorship in compliance with § 1.497 has not been previously submitted in the international application under PCT Rule 4.17(iv) within the time limits provided for in PCT Rule 26ter.1;



(iii)The search fee set forth in § 1.492(b);

(iv)The examination fee set forth in § 1.492(c); and

(v)Any application size fee required by § 1.492(j);

(2)A notice under paragraph (c)(1) of this section will set a time period within which applicant must provide any omitted translation, oath or declaration of the inventor, search fee set forth in § 1.492(b), examination fee set forth in § 1.492(c), and any application size fee required by § 1.492(j) in order to avoid abandonment of the application.

(3)The payment of the processing fee set forth in § 1.492(i) is required for acceptance of an English translation later than the expiration of thirty months after the priority date. The payment of the surcharge set forth in § 1.492(h) is required for acceptance of any of the search fee, the examination fee, or the oath or declaration of the inventor after the date of the commencement of the national stage (§ 1.491(a)).

(4)A “Sequence Listing” need not be translated if the “Sequence Listing” complies with PCT Rule 12.1(d) and the description complies with PCT Rule 5.2(b).

(d)A copy of any amendments to the claims made under PCT Article 19, and a translation of those amendments into English, if they were made in another language, must be furnished not later than the expiration of thirty months from the priority date. Amendments under PCT Article 19 which are not received by the expiration of thirty months from the priority date will be considered to be canceled.

(e)A translation into English of any annexes to an international preliminary examination report (if applicable), if the annexes were made in another language, must be furnished not later than the expiration of thirty months from the priority date. Translations of the annexes which are not received by the expiration of thirty months from the priority date may be submitted within any period set pursuant to paragraph (c) of this section accompanied by the processing fee set forth in § 1.492(f). Annexes for which translations are not timely received will be considered canceled.

(f)Verification of the translation of the international application or any other document pertaining to an international application may be required where it is considered necessary, if the international application or other document was filed in a language other than English.

(g)The documents and fees submitted under paragraphs (b) and (c) of this section must be clearly identified as a submission to enter the national stage under 35 U.S.C. 371. Otherwise, the submission will be considered as being made under 35 U.S.C. 111(a).

(h)An international application becomes abandoned as to the United States thirty months from the priority date if the requirements of paragraph (b) of this section have not been complied with within thirty months from the priority date. If the requirements of paragraph (b) of this section are complied with within thirty months from the priority date but either of any required translation of the international application as filed or the oath or declaration are not timely filed, an international application will become abandoned as to the United States upon expiration of the time period set pursuant to paragraph (c) of this section.

1893.01(a)(1)Submissions Required by 30 Months from the Priority Date [R-5]

To begin entry into the national stage, applicant is required to comply with 37 CFR 1.495(b) within 30 months from the priority date. Thus, applicant must pay the basic national fee on or before 30 months from the priority date and be sure that a copy of the international application has been received by the U.S. Designated or Elected Office prior to expiration of 30 months from the priority date. Where the international application was filed with the United States Receiving Office as the competent receiving Office, the copy of the international application referred to in 37 CFR 1.495(b) is not required.

Facsimile transmission is not acceptable for submission of the basic national fee and/or the copy of the international application. See 37 CFR 1.6(d). Likewise, the certificate of mailing procedures of 37 CFR 1.8 do not apply to the filing of the copy of the international application and payment of the basic national fee. See 37 CFR 1.8(a)(2)(i)(F). Applicants may file these items using the Express Mail mailing procedures set forth in 37 CFR 1.10. In addition, applicants may now file national stage submissions online using the EFS-Web system. Further information regarding EFS-Web is available at http:// www.uspto.gov/ebc/efs_help.html.

Applicants cannot pay the basic national fee with a surcharge after the 30 month deadline. Failure to pay the basic national fee within 30 months from the priority date will result in abandonment of the application. The time for payment of the basic fee is not extendable.

Similarly, the copy of the international application required under 37 CFR 1.495(b) must be provided within 30 months from the priority date to avoid abandonment. A copy of the international application is provided to the U.S. Designated or Elected Office by the International Bureau (the copy is ordinarily communicated to the Office on the day of publication of the international application at about 18 months from the priority date). The International Bureau also mails a confirmation (Form PCT/IB/308) to applicant upon which applicant can rely that the copy has been provided. This confirmation constitutes conclusive



evidence of transmission of the international application. See PCT Rule 47.1(c).

If the basic national fee has been paid and the copy of the international application (if required) has been received by expiration of 30 months from the priority date, but the required oath or declaration, translation, search fee (37 CFR 1.492(b)), examination fee (37 CFR 1.492(c)), or application size fee (37 CFR 1.492(j)) has not been filed prior to commencement of the national stage (see MPEP § 1893.01), the Office will send applicant a notice identifying any deficiency and provide a period of time to correct the deficiency as set forth in 37 CFR 1.495(c). The time period usually set is 2 months from the date of the notification by the Office or 32 months from the priority date, whichever is later. This period may be extended for up to 5 additional months pursuant to the provisions of 37 CFR 1.136(a). Failure to timely file the proper reply to the notification will result in abandonment of the national stage application. The processing fee set forth in 37 CFR 1.492(i) will be required for acceptance of an English translation of the international application later than the expiration of thirty months after the priority date, and the surcharge fee set forth in 37 CFR 1.492(h) will be required for acceptance of any of the search fee, examination fee, or oath or declaration of the inventor after the date of commencement. 37 CFR 1.495(c)(3).

For further information regarding the oath or declaration required under 35 U.S.C. 371(c)(4) and 37 CFR 1.497 for entry into the U.S. national phase, see MPEP § 1893.01(e).

For further information regarding the translation required under 35 U.S.C. 371(c)(2) and 37 CFR 1.495(c), see MPEP § 1893.01(d).

1893.01(a)(2)Article 19 Amendment (Filed With the International Bureau) [R-3]

The claims of an international application may be amended under PCT Article 19 after issuance of the search report. The description and drawings may not be amended under PCT Article 19. The amendment is forwarded to the U.S. Designated Office by the International Bureau for inclusion in the U.S. national stage application. Article 19 amendments which were made in English will be entered by substituting each page of amendment for the corresponding English language page of claims of the international application. If the Article 19 amendments were made in a language other than English, applicant must provide an English translation for the U.S. national stage application. The Article 19 amendment(s) and the English translation of the amendment(s) must be received by the Office by the date of commencement of the national stage (see MPEP § 1893.01). Otherwise, the amendment(s) will be considered to be canceled, 35 U.S.C. 371(d). If such canceled amendments are desired, they must be offered under 37 CFR 1.121 as a preliminary amendment or a responsive amendment under 37 CFR 1.111.

Applicants entering the national stage in the U.S. are encouraged to submit an amendment in accordance with 37 CFR 1.121 rather than an English translation of an Article 19 amendment. Sometimes when an Article 19 amendment is translated into English, it cannot be entered. That is, each page of an Article 19amendment must be entered by substituting a page of amendment for the corresponding page of claims of the international application. After translation of a page, the translated page may no longer correspond to a page of the claims of the international application such that the amendment is capable of entry by substituting the page of English translation (of the amendment) for the corresponding page of claims of the international application without leaving an inconsistency. Where applicant chooses to submit an English translation of the Article 19 amendment, applicant should check to be sure that the English translation can be entered by substituting the pages of translation for corresponding pages of the claims of the international application without leaving an inconsistency. If entry of the page of translation causes inconsistencies in the claims of the international application the translation will not be entered. For example, if the translation of the originally filed application has a page which begins with claim 1 and ends with a first part of claim 2 with the remainder of claim 2 on the next page then translation of the Article 19 amendment to only claim 1 must include a substitute page or pages beginning with the changes to claim 1 and ending with the last of the exact same first part of claim 2. This enables the original translated first page of claims to be replaced by the translation of the amendment without changing the subsequent unamended



page(s). Alternatively, applicant may submit a preliminary amendment in accordance with 37 CFR 1.121.

1893.01(a)(3)Article 34 Amendments (Filed with the International Preliminary Examining Authority) [R-3]

Amendments to the international application that were properly made under PCT Article 34 during the international preliminary examination phase (i.e., Chapter II) will be annexed by the International Preliminary Examining Authority to the international preliminary examination report (IPER) and communicated to the elected Offices. See PCT Article 36, PCT Rule 70.16, and MPEP § 1893.03(e). If these annexes are in English, they will normally be entered into the U.S. national stage application by the Office absent a clear instruction by the applicant that the annexes are not to be entered. However, if entry of the replacement sheets will result in an obvious inconsistency in the description, claims or drawings of the international application, then the annexes will not be entered. If the annexes are in a foreign language, a proper translation of the annexes must be furnished to the Office not later than the expiration of 30 months from the priority date, unless a period has been set pursuant to 37 CFR 1.495(c) to furnish an oath or declaration, English translation of the international application, search fee (37 CFR 1.492(b)), examination fee (37 CFR 1.492(c)), or application size fee (37 CFR 1.492(j)), in which case the translations of the annexes, accompanied by the processing fee set forth in 37 CFR 1.492(f), may be submitted within the period set pursuant to 37 CFR 1.495(c). See 37 CFR 1.495(e). Annexes for which translations are not timely received will be considered canceled. Amendments made under PCT Article 34 to the international application after commencement and entry into the U.S. national phase (see MPEP § 1893.01) will not be considered in a U.S. national stage application. However, applicants may still amend the U.S. national stage application by way of a preliminary amendment submitted in accordance with 37 CFR 1.115 and 37 CFR 1.121.

Where an English translation of the annexes is provided, the translation must be such that the translation of the originally filed application can be changed by replacing the originally filed application page(s) (of translation) with substitute page(s) of translation of the annex. Thus, applicant should check to be sure that the English translation can be entered by substituting the pages of translation for corresponding pages of the claims of the international application without leaving an inconsistency. If entry of the page of translation causes inconsistencies in the specification or claims of the international application the translation will not be entered. Non-entry of the annexes will be indicated on the “NOTICE OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495” (Form PCT/DO/ EO/903). For example, if the translation of the originally filed application has a page which begins with claim 1 and ends with a first part of claim 2 with the remainder of claim 2 on the next page then translation of the annex to only claim 1 must include a substitute page or pages beginning with the changes to claim 1 and ending with the last of the exact same first part of claim 2. This enables the original translated first page of claims to be replaced by the translation of the annex without changing the subsequent unamended page(s). Alternatively applicant may submit a preliminary amendment in accordance with 37 CFR 1.121. The fact that an amendment made to the international application during the international phase was entered in the national stage application does not necessarily mean that the amendment is proper. Specifically, amendments are not permitted to introduce “new matter” into the application. See PCT Article 34(2)(b). Where it is determined that such amendments introduce new matter into the application, then the examiner should proceed as in the case of regular U.S. national applications filed under 35 U.S.C. 111(a) by requiring removal of the new matter and making any necessary rejections to the claims. See MPEP § 608.04 and § 2163.06.

1893.01(c)Fees [R-3]

Because the national stage fees are subject to change, applicants and examiners should always consult the Official Gazette for the current fee listing.

Fees under 37 CFR 1.16 relate to national applications under 35 U.S.C. 111(a), and not to international



applications entering the national stage under 35 U.S.C. 371. National stage fees are specifically provided for in 37 CFR 1.492. However, an authorization to charge fees under 37 CFR 1.16 in an international application entering the national stage under 35 U.S.C. 371 will be treated as an authorization to charge fees under 37 CFR 1.492. See 37 CFR 1.25(b). Accordingly, applications will not be held abandoned if an authorization to charge fees under 37 CFR 1.16has been provided instead of an authorization to charge fees under 37 CFR 1.492.

A preliminary amendment accompanying the initial national stage submission under 35 U.S.C. 371 that cancels claims and/or eliminates multiple dependent claims will be effective to reduce the number of claims to be considered in calculating extra claim fees required under 37 CFR 1.492(d)-(e) and/or eliminate the multiple dependent claim fee required under 37 CFR 1.492(f). A subsequently filed amendment canceling claims and/or eliminating multiple dependent claims will not entitle applicant to a refund of fees previously paid. See MPEP § 607 and § 608.

The processing fee set forth in 37 CFR 1.492(i) will be required for acceptance of an English translation of the international application later than the expiration of thirty months after the priority date, and the surcharge fee set forth in 37 CFR 1.492(h) will be required for acceptance of any of the search fee, examination fee, or oath or declaration of the inventor after the date of commencement. 37 CFR 1.495(c)(3).

1893.01(d)Translation [R-5]

Applicants entering the national stage in the U.S. are required to file an English translation of the international application if the international application was filed in another language and was not published under PCT Article 21(2) in English. 35 U.S.C. 371(c)(2) and 37 CFR 1.495(c). A “Sequence Listing” need not be translated if the “Sequence Listing” complies with PCT Rule 12.1(d) and the description complies with PCT Rule 5.2(b). See 37 CFR 1.495(c). The translation must be a translation of the international application as filed or with any changes which have been properly accepted under PCT Rule 26 or any rectifications which have been properly accepted under PCT Rule 91. A translation of less than all of the international application (e.g., a translation that fails to include a translation of text contained in the drawings or a translation that includes a translation of claims amended under PCT Article 19 or 34 but does not include a translation of the original claims) is unacceptable. In addition, a translation that includes modifications other than changes that have been properly accepted under PCT Rule 26 or 91 (e.g., a translation that includes headings that were not present in the international application as originally filed) is unacceptable. A translation of words contained in the drawings must be furnished either in the form of new drawings or in the form of a copy of the original drawings with the translation pasted on the original text matter. See PCT Rule 49.5(d).

Amendments, even those considered to be minor or to not include new matter, may not be incorporated into the translation. If an amendment to the international application as filed is desired for the national stage, it may be submitted in accordance with 37 CFR 1.121. An amendment filed under 37 CFR 1.121should be submitted within 3 months after completion of the 35 U.S.C. 371(c) requirements for entry into the national stage. See 37 CFR 1.115(b)(3)(iii). If applicant has timely paid the basic national fee and submitted the copy of the international application but the translation is missing or is defective, a Notification of Missing Requirements (PCT/DO/EO/905) will be sent to applicant setting a period to correct any missing or defective requirements. The time period is 32 months from the priority date or 2 months from the date of the notice, whichever expires later. The time period may be extended for up to five additional months as provided in 37 CFR 1.136(a). A processing fee is required for accepting a translation after 30 months from the priority date. See 37 CFR 1.492(i).

Pursuant to PCT Rule 48.3(c), if the international application is published in a language other than English, the publication shall include an English translation of the title of the invention, the abstract, and any text matter pertaining to the figure or figures accompanying the abstract. The translations shall be prepared under the responsibility of the International Bureau.

A translation of the international application as filed and identified as provided in 37 CFR 1.417 submitted for the purpose of obtaining provisional rights pursuant to 35 U.S.C. 154(d)(4) can be relied on to



fulfill the translation requirement under 35 U.S.C. 371(c)(2) in a national stage application.

1893.01(e)Oath/Declaration [R-3]

37 CFR 1.497. Oath or declaration under 35 U.S.C. 371(c)(4).

(a)When an applicant of an international application desires to enter the national stage under 35 U.S.C. 371 pursuant to §1.495, and a declaration in compliance with this section has not been previously submitted in the international application under PCT Rule 4.17(iv) within the time limits provided for in PCT Rule 26ter.1, he or she must file an oath or declaration that:

(1)Is executed in accordance with either §§ 1.66 or 1.68;

(2)Identifies the specification to which it is directed;

(3)Identifies each inventor and the country of citizenship of each inventor; and

(4)States that the person making the oath or declaration believes the named inventor or inventors to be the original and first inventor or inventors of the subject matter which is claimed and for which a patent is sought.

(b)(1) The oath or declaration must be made by all of the actual inventors except as provided for in §§ 1.42, 1.43 or 1.47.

(2)If the person making the oath or declaration or any supplemental oath or declaration is not the inventor (§§ 1.42, 1.43, or §1.47), the oath or declaration shall state the relationship of the person to the inventor, and, upon information and belief, the facts which the inventor would have been required to state. If the person signing the oath or declaration is the legal representative of a deceased inventor, the oath or declaration shall also state that the person is a legal representative and the citizenship, residence and mailing address of the legal representative.

(c)Subject to paragraph (f) of this section, if the oath or declaration meets the requirements of paragraphs (a) and (b) of this section, the oath or declaration will be accepted as complying with 35 U.S.C. 371(c)(4) and § 1.495(c). However, if the oath or declaration does not also meet the requirements of § 1.63, a supplemental oath or declaration in compliance with § 1.63 or an application data sheet will be required in accordance with § 1.67.

(d)If the oath or declaration filed pursuant to 35 U.S.C. 371(c)(4) and this section names an inventive entity different from the inventive entity set forth in the international application, or if a change to the inventive entity has been effected under PCT Rule 92bis subsequent to the execution of any oath or declaration which was filed in the application under PCT Rule 4.17(iv) or this section and the inventive entity thus changed is different from the inventive entity identified in any such oath or declaration, applicant must submit:

(1)A statement from each person being added as an inventor and from each person being deleted as an inventor that any error in inventorship in the international application occurred without deceptive intention on his or her part;

(2)The processing fee set forth in § 1.17(i); and

(3)If an assignment has been executed by any of the original named inventors, the written consent of the assignee (see §3.73(b) of this chapter); and

(4)Any new oath or declaration required by paragraph (f) of this section.

(e)The Office may require such other information as may be deemed appropriate under the particular circumstances surrounding the correction of inventorship.

(f)A new oath or declaration in accordance with this section must be filed to satisfy 35 U.S.C. 371(c)(4) if the declaration was filed under PCT Rule 4.17(iv), and:

(1)There was a change in the international filing date pursuant to PCT Rule 20.2 after the declaration was executed; or

(2)A change in the inventive entity was effected under PCT Rule 92bis after the declaration was executed and no declaration which sets forth and is executed by the inventive entity as so changed has been filed in the application.

(g)If a priority claim has been corrected or added pursuant to PCT Rule 26bis during the international stage after the declaration of inventorship was executed in the international application under PCT Rule 4.17(iv), applicant will be required to submit either a new oath or declaration or an application data sheet as set forth in § 1.76 correctly identifying the application upon which priority is claimed.

Applicants entering the national stage in the U.S. are required to file an oath or declaration of the inventor in accordance with 37 CFR 1.497(a) and (b). If the basic national fee and copy of the international application has been received by the expiration of 30 months from the priority date, but the required oath or declaration has not been filed, the Office will send applicant a Notification of Missing Requirements (Form PCT/DO/EO/905) setting a time period to correct any missing or defective requirements and to submit the surcharge fee required under 37 CFR 1.492(h) unless previously paid. The time period is 32 months from the priority date or 2 months from the date of the notice, whichever expires later. The time period may be extended for up to five additional months as provided in 37 CFR 1.136(a). Failure to timely file the required oath or declaration will result in abandonment of the application.

An oath or declaration satisfying the requirements of 37 CFR 1.497(a)-(b) will be sufficient for the purposes of entering the U.S. national phase. However, if the oath or declaration fails to also comply with the additional requirements for oaths and declarations set forth in 37 CFR 1.63, applicants will need to submit a supplemental oath or declaration, or an application data sheet where permitted under 37 CFR 1.63(c), to correct the deficiency. See 37 CFR 1.497(c).



In general, the requirement for an oath or declaration in compliance with 37 CFR 1.497(a)-(b) will have been previously satisfied if a declaration in compliance with PCT Rule 4.17(iv) and executed by all the inventors was submitted within the time limits provided in PCT Rule 26ter.1 in the international phase. However, if the inventorship was changed in the international application under PCT Rule 92bissuch that the inventorship identified in the PCT Rule 4.17(iv) declaration no longer corresponds to that of the international application (see 37 CFR 1.41(a)(4)), then a new oath or declaration in accordance with 37 CFR 1.497(a)-(b) will be required to enter the national stage. See 37 CFR 1.497(f)(2). Similarly, a new oath or declaration in compliance with 37 CFR 1.497(a)-(b) is required where the PCT Rule 4.17(iv) declaration was executed prior to a change in the international filing date pursuant to PCT Rule 20.2. See 37 CFR 1.497(f)(1). In addition, where a priority claim has been corrected or added pursuant to PCT Rule 26bis after execution of the PCT Rule 4.17(iv) declaration, then a supplemental oath or declaration, or an application data sheet, identifying the correct priority claim will be required. See 37 CFR 1.497(g).

CORRECTION OF INVENTORSHIP

The inventorship of an international application entering the national stage under 35 U.S.C. 371 is that inventorship set forth in the international application, which includes any changes effected under PCT Rule 92bis. See 37 CFR 1.41(a)(4). Accordingly, an oath or declaration that names an inventive entity different than that set forth in the international application will not be accepted for purposes of entering the U.S. national phase unless the requirements under 37 CFR 1.497(d) are satisfied. These requirements include: (A) a statement from each person being added as an inventor and from each person being deleted as an inventor that any error in inventorship in the international application occurred without deceptive intention on his or her part; (B) the processing fee set forth in 37 CFR 1.17(i); and (C) the written consent of the assignee if an assignment has been executed by any of the original named inventors (see 37 CFR 3.73(b)).

If an inventor refuses to execute the oath or declaration or cannot be found or reached after diligent effort, applicant must file an oath or declaration and a petition in accordance with 37 CFR 1.47. See 37 CFR 1.497(b) and MPEP § 409.03. Similarly, where an inventor is deceased or legally incapacitated, an oath or declaration in accordance with the provisions of 37 CFR 1.42 or 1.43 must be provided. See 37 CFR 1.497(b) and MPEP § 409.01 and § 409.02.

Where there has been no change of inventorship but the name of an inventor indicated in the international application during the international phase has changed such that the inventor’s name is different from the corresponding name indicated in an oath or declaration submitted under 37 CFR 1.497, for example, on account of marriage, then a petition under 37 CFR 1.182 will be required to accept the oath or declaration with the changed name. See MPEP § 605.04(c). However, where the discrepancy between the name of the inventor indicated in the international application during the international phase and the name of the inventor as it appears in the oath or declaration submitted under 37 CFR 1.497 is the result of a typographical or transliteration error, then a petition under 37 CFR 1.182 will not be required. In such case, the Office should simply be notified of the error. Similarly, a typographical or transliteration error in the name of an inventor identified in a previously submitted oath or declaration may be corrected by simply notifying the Office of the error. A new oath or declaration is not required to correct such error. See MPEP § 201.03 and § 605.04(g).

1893.02Abandonment [R-5]

If the requirements for the submission of the basic national fee and a copy of the international application (if necessary) prior to the expiration of 30 months from the priority date are not satisfied, then the international application becomes abandoned as to the United States at thirty months from the priority date. 37 CFR 1.495(h). If the requirements under 37 CFR 1.495(b) are timely met, but the requirements under 37 CFR 1.495(c) for an English translation of the international application, oath/declaration, search fee, examination fee and application size fee are not met within a time period set in a notice provided by the Office, then the application will become abandoned upon expiration of the time period set in the notice. See 37 CFR 1.495(c)(2) and 1.495(h).

Examiners and applicants should be aware that sometimes papers filed for the national stage are deficient and abandonment results. For example, if the fee



submitted does not include at least the amount of the basic national fee that is due, the application becomes abandoned.

Applicant may file a petition to revive an abandoned application in accordance with the provisions of 37 CFR 1.137. See MPEP § 711.03(c). For applicant’s convenience, applicant may use either Form PTO/SB/61PCT (unavoidably abandoned application) or Form PTO/SB/64PCT (unintentionally abandoned application), as appropriate, for this purpose. These forms are available online at http://www.uspto.gov/ web/forms/index.html#patent.

1893.03Prosecution of U.S. National Stage Applications Before the Examiner [R-5]

37 CFR 1.496. Examination of international applications in the national stage.

(a)International applications which have complied with the requirements of 35 U.S.C. 371(c) will be taken up for action based on the date on which such requirements were met. However, unless an express request for early processing has been filed under 35 U.S.C. 371(f), no action may be taken prior to one month after entry into the national stage.

(b)National stage applications having paid therein the search fee as set forth in § 1.492(b)(1) and the examination fee as set forth in § 1.492(c)(1) may be amended subsequent to the date of entry into the national stage only to the extent necessary to eliminate objections as to form or to cancel rejected claims. Such national stage applications will be advanced out of turn for examination.

An international application which enters the national stage will be forwarded to the appropriate Technology Center (TC) for examination in turn based on the 35 U.S.C. 371(c) date of the application. If an international preliminary examination report (IPER) prepared by the United States International Preliminary Examining Authority or a written opinion on the international application prepared by the United States International Searching Authority states that the criteria of novelty, inventive step (non-obviousness), and industrial applicability, as defined in PCT Article 33(1)-(4) have been satisfied for all of the claims presented in the application entering the national stage, the national stage search fee is reduced and the national stage examination fee is reduced. See 37 CFR 1.492(b)(1) and 37 CFR 1.492(c)(1). Such applications may be amended only to the extent necessary to eliminate objections as to form or cancel rejected claims, and they will be advanced out of turn for examination. See MPEP § 708 for a discussion of the order of examination of applications by examiners.

Once the national stage application has been taken up by the examiner, prosecution proceeds in the same manner as for a domestic application with the exceptions that:

(A)the international filing date (or, if appropriate, the priority date) is the date to keep in mind when searching the prior art; and

(B)unity of invention proceeds as under 37 CFR 1.475.


1893.03(a)How To Identify That an Application Is a U.S. National Stage Application [R-5]

Applicant’s initially deposited application must be clearly identified as a submission to enter the national stage under 35 U.S.C. 371. See 37 CFR 1.495(g). Otherwise, unless the submission is clearly identified as a submission pursuant to 35 U.S.C. 154(d)(4) for the purpose of obtaining provisional rights, the application will be treated as an application filed under 35 U.S.C. 111(a). See 37 CFR 1.417.

That is, if applicant wishes the application to be treated as a filing under 35 U.S.C. 111(a), applicant’s originally filed application papers need indicate simply that the papers are for a new U.S. patent application. If, however, applicant is submitting papers for entry into the national stage of a PCT application, or to establish an effective date for provisional rights resulting from the filing of a PCT application under 35 U.S.C. 154(d), applicant must so state. Applicants seeking to enter the national stage are advised to use transmittal Form PTO-1390, as this form clearly indicates that the submission is under 35 U.S.C. 371. Examination of the original application papers occurs in either the Office of Initial Patent Examination or in the National Stage Processing Division of the Office of PCT Operations where it is determined whether applicant has asked that the papers be treated as a submission to enter the national stage under 35 U.S.C. 371. If the application is accepted for entry into the national stage, the National Stage Processing Division will mail Form PCT/DO/EO/903 indicating



acceptance of the application as a national stage submission under 35 U.S.C. 371. PALM records will indicate that the application is a national stage entry of the PCT application (e.g., under “Continuity Data”). Initially, the examiner should check the application file for the presence of Form PCT/DO/EO/903 and review the PALM Bib-data sheet for an indication that the application is a national stage entry (371) of the PCT application.

If neither of these indications are present the application may, in the absence of evidence to the contrary (there is an indication in the originally filed application papers that processing as a national stage is desired), be treated as a filing under 35 U.S.C. 111(a). Thus, if both indications are present, the application should be treated as a submission under 35 U.S.C. 371. The examiner is advised to consult the Office of PCT Legal Administration if he or she has any question as to whether the application should be treated under 35 U.S.C. 111(a) or 371.

In accordance with the notice at 1077 O.G. 13 (14 April 1987), if the applicant files a U.S. national application and clearly identifies in the accompanying oath or declaration the specification to which it is directed by referring to a particular international application by PCT Application Number and International Filing Date and that he or she is executing the declaration as, and seeking a U.S. Patent as, the inventor of the invention described in the identified international application, then the application will be accepted as submitted under 35 U.S.C. 371. Merely claiming priority of an international (PCT) application in an oath or declaration will not serve to indicate a submission under 35 U.S.C. 371. Also, if there are any conflicting instructions as to whether the filing is under 35 U.S.C. 111(a) or 35 U.S.C. 371, the application will be accepted as filed under 35 U.S.C. 111(a). A conflicting instruction will be present, for example, where applicant includes in the initial submission under 35 U.S.C. 371, a “Utility Patent Application Transmittal” (Form PTO/SB/05) or includes a benefit claim under 35 U.S.C. 120 to the international application. Applications that have been processed under 35 U.S.C. 371 and later found by the examiner to contain conflicting instructions should be forwarded to the Office of PCT Legal Administration for resolution.




Form PCT Filed Under 35 USC 371Form PCT Filed Under 35 USC 371




Form PCT/DO/DO/903. Notification Of Acceptance Of Application Under 35 U.s.c. 371 And 37 Cfr 1.494 Or 1.495Form PCT/DO/DO/903. Notification Of Acceptance Of Application Under 35 U.s.c. 371 And 37 Cfr 1.494 Or 1.495




1893.03(b)The Filing Date of a U.S. National Stage Application [R-5]

An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that

An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office except as otherwise provided in section 102(e) of this title.

Similarly, PCT Article 11(3) provides that

...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.

37 CFR 1.496(a), first sentence, reads “International applications which have complied with the requirements of 35 U.S.C. 371(c) will be taken up for action based on the date on which such requirements were met.” Thus, when the file wrapper label or PALM bib-data sheet and filing receipt are printed, the information is read from the PALM data base and the information printed in the filing date box is the date of receipt of 35 U.S.C. 371(c)(1), (c)(2) and (c)(4) requirements rather than the actual international filing date.

The NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495 (Form PCT/DO/EO/903), a copy of which is reproduced in MPEP § 1893.03(a), indicates the date of receipt of the 35 U.S.C. 371(c)(1), (c)(2), and (c)(4) requirements, and it also indicates the date of completion of all 35 U.S.C. 371 requirements, which is further explained below. Filing receipts are mailed concurrently with the mailing of the Form PCT/DO/EO/903.

The “Application Filing Date” field formerly displayed in PAIR was changed to “Filing or 371(c) Date” to clearly indicate that for international applications that enter the national stage under 35 U.S.C. 371, the information displayed in this field is the date of receipt of the 35 U.S.C. 371(c)(1), (c)(2) and (c)(4) requirements. Applicants are quite often confused as to the true filing date and will ask for corrected filing receipts thinking that the information thereon is wrong. This explanation should offer some clarity. For most legal purposes, the filing date is the PCT international filing date. Exceptions to this general rule include the following:

(A)Availability as a prior art reference under former 35 U.S.C. 102(e) (prior to the amendment by the American Inventors Protection Act of 1999 (AIPA) (Pub. L. 106-113, 113 Stat. 1501 (1999)). If a U.S. patent issued from an international application filed prior to November 29, 2000, the international application was not considered to have been filed in the United States for prior art purposes under 35 U.S.C. 102(e) and PCT Article 64(4)(a) until the date the application fulfilled the requirements of 35 U.S.C. 371(c) (1), (2), and (4).

(B)Availability as a prior art reference under 35 U.S.C. 102(e) as amended by the AIPA, and further amended by the Intellectual Property and High Technology Technical Amendments Act of 2002 (Pub. L. 107-273, 116 Stat. 1758 (2002)). If an international application was filed on or after November 29, 2000, but did not designate the U.S. or was not published in English under PCT Article 21(2), the international filing date is not treated as a U.S. filing date for prior art purposes under 35 U.S.C. 102(e). See MPEP § 706.02(a) and § 2136.03.

(C)Patent term adjustment under 35 U.S.C. 154(b)(1)(B) and 37 CFR 1.702(b) when the USPTO has failed to issue a patent within three years of the “actual filing date” of an application. In this situation, the “actual filing date” is the date the national stage commenced under 35 U.S.C. 371(b) or (f). See MPEP § 2730.

The “Date of Completion of all 35 U.S.C. 371Requirements” included on the NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495 (Form PCT/DO/ EO/903) is relevant for purposes of patent term adjustment under 35 U.S.C. 154(b)(1)(A)(i)(II) and 37 CFR 1.702(a)(1) when the USPTO has failed to mail at least one of a notification under 35 U.S.C. 132or a notice of allowance under 35 U.S.C. 151 not later than fourteen months after the date on which the



requirements under 35 U.S.C. 371 were fulfilled. This date is the latest of:

(A)the date of submission of the basic national fee;

(B)the date of submission or communication of the copy of the international application;

(C)the date of submission of the translation of the international application if the international application is not in the English language;

(D)the date of submission of an oath or declaration of the inventor in compliance with 35 U.S.C. 371(c)(4) (see 37 CFR 1.497(c) for an explanation of when an oath or declaration will be accepted as complying with 35 U.S.C. 371(c)(4));

(E)the earlier of 30 months from the priority date or the date of request for early processing under 35 U.S.C. 371(f) if requested prior to 30 months from the priority date (Form PCT/DO/EO/903 will indicate the date early processing was requested);

(F)if a request for early processing has not been requested prior to 30 months from the priority date, the date of submission of any translation of the annexes to the international preliminary examination report if the translation of the annexes are filed within the time period set in a Notification of Missing Requirements (Form PCT/DO/EO/905) requiring either an English translation of the international application or an oath or declaration; and

(G)the date of submission of any surcharge for submitting the oath or declaration later than 30 months from the priority date.

1893.03(c)The Priority Date, Priority Claim, and Priority Papers for a U.S. National Stage Application [R-5]

A U.S. national stage application may be entitled to: (A) a right of priority under 35 U.S.C. 119(a) and 365(b) based on a prior foreign application or international application designating at least one country other than the United States; and (B) the benefit of an earlier filed U.S. national application or international application designating the United States pursuant to 35 U.S.C. 119(e) or 35 U.S.C. 120 and 365(c).

I.RIGHT OF PRIORITY UNDER 35 U.S.C. 119(a) and 365(b)

Pursuant to 35 U.S.C. 365(b) a U.S. national stage application shall be entitled to a right of priority based on a prior foreign application or international application designating at least one country other than the United States in accordance with the conditions and requirements of 35 U.S.C. 119(a) and the treaty and the PCT regulations. See in particular PCT Article 8and PCT Rules 4.10 and 26bis. To obtain priority in the U.S. national stage application to such applications, the priority must have been timely claimed in the international stage of the international application. See 37 CFR 1.55(a)(1)(ii). If priority was properly claimed in the international stage of the international application, the claim for priority is acknowledged and the national stage application file is checked to see if the file contains a copy of the certified copy of the priority document submitted to the International Bureau.

If the priority claim in the national stage application is to an application, the priority of which was not claimed in the international stage of the international application, the claim for priority must be denied for failing to meet the requirements of the Patent Cooperation Treaty, specifically PCT Rule 4.10.

For a comparison with 35 U.S.C. 119(a)-(d) priority claims in a national application filed under 35 U.S.C. 111(a), see MPEP § 1895.01.

II.THE CERTIFIED COPY

The requirement in PCT Rule 17 for a certified copy of the foreign priority application is normally fulfilled by applicant providing a certified copy to the receiving Office or to the International Bureau or by applicant requesting the receiving Office to prepare and transmit the priority document to the International Bureau if the receiving Office issued the priority document. Pursuant to PCT Rule 17.1(a)-(b), applicant must submit the certified copy, or request the receiving Office to prepare and transmit the certified copy, within 16 months from the priority date. Where applicant has complied with PCT Rule 17, the International Bureau will stamp the face of the certified copy to indicate compliance with the rule and the date the document was received by the International Bureau. The International Bureau will then forward a copy of the stamped certified priority document to each



Designated Office that has requested such document. The U.S. Patent and Trademark Office, as a Designated Office, will normally request the International Bureau to furnish the copy of the certified priority document upon receipt of applicant’s submission under 35 U.S.C. 371 to enter the U.S. national phase. The copy from the International Bureau is placed in the U.S. national stage file. The copy of the stamped priority document sent to the U.S. Patent and Trademark Office from the International Bureau is acceptable to establish that applicant has filed a certified copy of the priority document. The examiner should acknowledge in the next Office action that the copy of the certified copy of the foreign priority document has been received in the national stage application from the International Bureau. Note the example of an acceptable priority document with the stamp (box) in the upper right hand section indicating receipt by the International Bureau (WIPO) on 30 December 2002 and the stamped indication “PRIORITY DOCUMENT SUBMITTED OR TRANSMITTED IN COMPLIANCE WITH RULE 17.1(a) OR (b).”



PCT/AU02/01658




If the International Bureau is unable to forward a copy of the certified priority document to the U.S. Patent and Trademark Office because applicant failed to comply with PCT Rule 17(a)-(b), then applicant will have to provide a certified copy of the priority document during the national stage to fulfill the requirement of 37 CFR 1.55(a)(2).

III. BENEFIT CLAIM UNDER 35 U.S.C. 119(e), OR 120 AND 365(c)

A national stage application may include a benefit claim under 35 U.S.C. 119(e), or 120 and 365(c) to a prior U.S. national application or under 35 U.S.C. 120 and 365(c) to a prior international application designating the U.S. The conditions for according benefit under 35 U.S.C. 120 are as described in MPEP § 201.07, § 201.08, and § 201.11 and are similar regardless of whether the U.S. national application is a national stage application submitted under 35 U.S.C. 371 or a national application filed under 35 U.S.C. 111(a).

The conditions for according benefit under 35 U.S.C. 119(e) are also similar for national stage applications and applications filed under 35 U.S.C. 111(a), and the conditions are described in MPEP § 201.11.

In order for a national stage application (of international application “X”) to obtain benefit under 35 U.S.C. 119(e) of a prior U.S. provisional application, the national stage application must comply with the requirements set forth in 37 CFR 1.78(a)(4) through 37 CFR 1.78(a)(6). Public Law 106-113 amended 35 U.S.C. 119(e) to eliminate the copendency requirement for a nonprovisional application claiming benefit of a provisional application. 35 U.S.C. 119(e)(2) as amended became effective on November 29, 1999 and applies to provisional applications filed on or after June 8, 1995. 37 CFR 1.78(a)(4) requires that the prior provisional application must be entitled to a filing date as set forth in 37 CFR 1.53(c), and the basic filing fee set forth in 37 CFR 1.16(d) must be paid on the provisional application within the time period set forth in 37 CFR 1.53(g). Additionally, the provisional application must name as an inventor at least one inventor named in the later filed international application “X” and disclose the named inventor’s invention claimed in at least one claim of the national stage application in the manner provided by the first paragraph of 35 U.S.C. 112. The national stage application must contain a reference to the provisional application (either in an application data sheet (37 CFR 1.76) or in the first sentence(s) of the specification), identifying it as a provisional application, and including the provisional application number (series code and serial number). The required reference to the earlier provisional application must be submitted within the time period provided by 37 CFR 1.78(a)(5)(ii). This time period is not extendable. However, if the entire delay, between the date the claim was due under 37 CFR 1.78(a)(5)(ii) and the date the claim was filed, was unintentional, a petition under 37 CFR 1.78(a)(6) may be filed to accept the delayed claim. If the provisional application was filed in a language other than English, an English-language translation of the non-English language provisional application and a statement that the translation is accurate will be required. See MPEP § 201.11, subsection VI. If the translation and statement that the translation is accurate were not filed in the provisional application or in the later-filed national stage application before November 25, 2005, applicant will be notified and given a period of time within which to file an English-language translation and a statement that the translation is accurate in the provisional application, and a reply in the national stage application that the translation and statement were filed in the provisional application. Failure to timely reply to such a notice will result in abandonment of the national stage application. See 37 CFR 1.78(a)(5)(iv).

In order for a national stage application (of international application “X”) to obtain benefit under 35 U.S.C. 120 and 365(c) of a prior filed copending nonprovisional application or prior filed copending international application designating the United States of America, the national stage application must comply with the requirements set forth in 37 CFR 1.78(a)(1) through 37 CFR 1.78(a)(3). The prior nonprovisional application or international application must name as an inventor at least one inventor named in the later filed international application “X” and disclose the named inventor’s invention claimed in at least one claim of the national stage application in the manner provided by the first paragraph of 35 U.S.C. 112. The national stage application must contain a reference to the prior nonprovisional or international



application (either in an application data sheet (37 CFR 1.76) or in the first sentence(s) of the specification), identifying it by application number (series code and serial number) or international application number and international filing date and indicating the relationship of the applications. The required reference to the earlier filed application must be submitted within the later of four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f) or sixteen months from the filing date of the prior-filed application. This time period is not extendable and failure to timely submit the required reference to the earlier application will be considered a waiver of any benefit under 35 U.S.C. 120, 121, or 365(c) to such prior-filed application. See 37 CFR 1.78(a)(2)(ii). However, if the entire delay, between the date the claim was due under 37 CFR 1.78(a)(2)(ii) and the date the claim was filed, was unintentional, a petition under 37 CFR 1.78(a)(3) may be filed to accept the delayed claim.

A prior filed nonprovisional application is copending with the national stage application if the prior U.S. national application was pending on the international filing date of the national stage application.

A prior international application designating the United States of America is copending with the national stage application if the prior international application was not abandoned or withdrawn on the international filing date of international application “X.”

Note: a national stage application submitted under 35 U.S.C. 371 may not claim benefit of the filing date of the international application of which it is the national stage since its filing date is the date of filing of that international application. See also MPEP § 1893.03(b). Stated differently, since the international application is not an earlier application (it has the same filing date as the national stage), a benefit claim under 35 U.S.C. 120 in the national stage to the international application is inappropriate and may result in the submission being treated as an application filed under 35 U.S.C. 111(a). See MPEP § 1893.03(a). Accordingly, it is not necessary for the applicant to amend the first sentence(s) of the specification to reference the international application number that was used to identify the application during international processing of the application by the international authorities prior to commencement of the national stage.

For a comparison with 35 U.S.C. 120 benefit claims in a national application filed under 35 U.S.C. 111(a), see MPEP § 1895.

1893.03(d)Unity of Invention [R-3]

37 CFR 1.499. Unity of invention during the national stage

If the examiner finds that a national stage application lacks unity of invention under § 1.475, the examiner may in an Office action require the applicant in the response to that action to elect the invention to which the claims shall be restricted. Such requirement may be made before any action on the merits but may be made at any time before the final action at the discretion of the examiner. Review of any such requirement is provided under §§ 1.143 and 1.144.

PCT Rule 13 was amended effective July 1, 1992. 37 CFR 1.475 was amended effective May 1, 1993 to correspond to PCT Rule 13.

Examiners are reminded that unity of invention (not restriction) practice is applicable in international applications (both Chapter I and II) and in national stage applications submitted under 35 U.S.C. 371. Restriction practice continues to apply to U.S. national applications filed under 35 U.S.C. 111(a), even if the application filed under 35 U.S.C. 111(a) claims benefit under 35 U.S.C. 120 and 365(c) to an earlier international application designating the United States or to an earlier U.S. national stage application submitted under 35 U.S.C. 371.

When making a lack of unity of invention requirement, the examiner must (1) list the different groups of claims and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group.

The principles of unity of invention are used to determine the types of claimed subject matter and the combinations of claims to different categories of invention that are permitted to be included in a single international or national stage patent application. See MPEP § 1850 for a detailed discussion of Unity of Invention. The basic principle is that an application should relate to only one invention or, if there is more than one invention, that applicant would have a right to include in a single application only those inventions which are so linked as to form a single general inventive concept.



A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. For example, a corresponding technical feature is exemplified by a key defined by certain claimed structural characteristics which correspond to the claimed features of a lock to be used with the claimed key. Note also the examples contained in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from WIPO’s web site (www.wipo.int/pct/en/texts/ gdlines.htm).

A process is “specially adapted” for the manufacture of a product if the claimed process inherently produces the claimed product with the technical relationship being present between the claimed process and the claimed product. The expression “specially adapted” does not imply that the product could not also be manufactured by a different process.

An apparatus or means is specifically designed for carrying out the process when the apparatus or means is suitable for carrying out the process with the technical relationship being present between the claimed apparatus or means and the claimed process. The expression specifically designed does not imply that the apparatus or means could not be used for carrying out another process, nor does it imply that the process could not be carried out using an alternative apparatus or means.

Note: the determination regarding unity of invention is made without regard to whether a group of inventions is claimed in separate claims or as alternatives within a single claim. The basic criteria for unity of invention are the same, regardless of the manner in which applicant chooses to draft a claim or claims.

If an examiner (1) determines that the claims lack unity of invention and (2) requires election of a single invention, when all of the claims drawn to the elected invention are allowable (i.e., meet the requirements of 35 U.S.C. 101, 102, 103 and 112), the nonelected invention(s) should be considered for rejoinder. Any nonelected product claim that requires all the limitations of an allowable product claim, and any nonelected process claim that requires all the limitations of an allowable process claim, should be rejoined. See MPEP § 821.04 and § 821.04(a). Any nonelected processes of making and/or using an allowable product should be considered for rejoinder following the practice set forth in MPEP § 821.04(b).

FORM PARAGRAPHS FOR LACK OF UNITY IN NATIONAL STAGE APPLICATIONS

¶ 18.19 National Stage Restriction in 35 U.S.C. 371Applications

Restriction is required under 35 U.S.C. 121 and 372.

This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.

In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.

Examiner Note:

1.This form paragraph is to be used when making a restriction requirement in an application filed under the provisions of 35 U.S.C. 371.

2.This form paragraph is to be followed by form paragraphs 18.06 through 18.06.02, as appropriate, and by form paragraph 18.07.

¶ 18.20 National Stage Election of Species in 35 U.S.C. 371 Applications

This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.

The species are as follows:

[1]

Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.

Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise include all the limitations of an allowed generic claim as provided by 37 CFR 1.141. If claims are added after the election, applicant must indicate which are readable upon the elected species. MPEP § 809.02(a).

Examiner Note:

1.This form paragraph is to be used when making an election of species requirement in an application filed under the provisions of 35 U.S.C. 371.

2.In bracket 1, list each species by Fig. No. or embodiment.



3.This form paragraph is to be followed by form paragraphs 18.17 and 18.18.

¶ 18.21 National Stage Election by Original Presentation in 35 U.S.C. 371 Applications

Newly submitted claim [1] directed to an invention that lacks unity with the invention originally claimed for the following reasons: [2]

Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim [3] withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.

1893.03(e)Documents Received from the International Bureau and Placed in a U.S. National Stage Application File [R-5]

The national stage application includes documents forwarded by the International Bureau and submissions from applicant. Some of the documents from the International Bureau are identified in this section with a brief note as to their importance to the national stage application. The examiner should review each such document and the important aspect indicated.

I. THE PUBLICATION OF THE INTERNATIONAL APPLICATION

The publication of the international application includes

(A)a cover page with the applicant/inventor data, the application data (application number, filing date, etc.) and the Abstract (and, if appropriate, a figure of drawing),

(B)the description, claims and drawing parts of the international application, and

(C)the search report (Form PCT/ISA/210), if available.

The cover page is important as a source of the correct application data, most importantly the filing date and priority date accorded to the international application. If the international application is published in English, the Office will use the description, claims, abstract and drawings as published in the pamphlet for the U.S. national stage application under 35 U.S.C. 371. The description, claims and drawing parts of the international application reflect the application subject matter on the international filing date and are important for comparison with any amendments to check for new matter. The search report reflects the International Searching Authority’s opinion regarding the prior art.

The abstract is reproduced on the cover page of the publication, even though it appears on a separate sheet of the international application in accordance with PCT Rule 11.4(a). The requirement of 37 CFR 1.52(b) that the abstract “commence on a separate physical sheet or electronic page” does not apply to the copy of the published international application communicated to the designated Offices by the International Bureau under PCT Article 20. Accordingly, it is improper for the examiner of the U.S. national stage application to require the applicant to provide an abstract commencing on a separate sheet if the abstract does not appear on a separate sheet in the publication of the international application. Unless the abstract is properly amended under the U.S. rules during national stage processing, the abstract that appears on the cover page of the published international application will be the abstract published by the USPTO under 35 U.S.C. 122(b) and in any U.S. patent issuing from the application.


II. THE INTERNATIONAL PRELIMINARY EXAMINATION REPORT AND THE INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY (CHAPTER I AND II)

When an international preliminary examination is performed by an International Preliminary Examining Authority (IPEA), an international preliminary examination report (IPER) is prepared on Form PCT/IPEA/ 409 by the IPEA and sent to the elected Offices. This report reflects the IPEA’s non-binding opinion regarding novelty, inventive step and industrial applicability. For international applications filed on or after January 1, 2004, the IPER bears the title “International Preliminary Report on Patentability (Chapter II of the Patent Cooperation Treaty)”.

If the applicant did not timely file a demand for international preliminary examination with the IPEA, and the international application has a filing date on



or after January 1, 2004, then an “International Preliminary Report on Patentability (Chapter I of the Patent Cooperation Treaty)” reflecting the International Searching Authority’s (ISA’s) non-binding opinion regarding novelty, inventive step and industrial applicability is sent to the designated Offices.

The examiner may adopt any portion or all of the report on patentability of the IPEA or ISA upon consideration in the national stage so long as it is consistent with U.S. practice. The first Office action on the merits should indicate the report on patentability of the IPEA or ISA has been considered by the examiner. The indication may be a mere acknowledgement.

The IPER may include annexes, i.e., amendments to the international application that were made during the international phase. See MPEP § 1893.01(a)(3). These annexes will be placed in the U.S. national stage application file. Consequently, if the international application has been extensively amended during the international stage, there may be a number of different copies of the description, claims and drawings present in the national stage application file. The IPER may be consulted in Box No. I “Basis of the report” to determine what pages the report was based upon. Using the IPER as a roadmap of what happened during Chapter II examination will help determine which version should be examined.

Original sheets, substitute sheets, and rectified sheets included as part of the application examined under Chapter II are listed in the IPER as pages “originally filed/furnished.” Replacement sheets showing amendments made under PCT Article 19 or 34 and considered during Chapter II are also listed. See MPEP § 1879. If the IPER was established in a language other than English, the International Bureau will translate the IPER into English. However, the International Bureau will not translate the annexes to the IPER into English. Unless proper and timely translations are furnished by the applicant, foreign language annexes will be considered canceled. See MPEP § 1893.01(a)(3). All replacement sheets in the international application are marked with the international application number and the date of receipt in the upper right-hand corner. Replacement sheets that contain changes in format only and are accepted by the receiving Office are marked as “SUBSTITUTE SHEET” at the bottom of the page. Replacement sheets that contain a rectification of an obvious error and are accepted by either the ISA or the IPEA are marked as “RECTIFIED SHEET” at the bottom of the page. Additionally, replacement sheets to the claims submitted to the International Bureau as Article 19Amendments will be marked as “AMENDED SHEET (Article 19)” at the bottom of the page. Furthermore, replacement sheets to the description, claims and drawings submitted to the IPEA as Article 34 Amendments will be marked as “AMENDED SHEET” at the bottom of the page. The IPER will indicate in “Box No. I Basis of the Report” that replacement sheets submitted under either PCT Article 19 or 34 have been considered and will indicate the date they were received and the replacement sheets will be annexed to the IPER. The NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371AND 37 CFR 1.495 (Form PCT/DO/EO/903) should also be consulted, as it will indicate if the annexes or their translation have not been entered. A sample copy of the form has been reproduced at the end of MPEP § 1893.03(a). Additionally, if the annexes have been entered, the National Stage Processing Division of the Office of PCT Operations will write in pencil on any original sheet(s) or translations thereof that were replaced, “Replaced by Article 34 Amendment” and on the amended sheet(s) or translations thereof,” Article 34.”


III. THE PRIORITY DOCUMENT

See the discussion in MPEP § 1893.03(c).


IV. NOTIFICATION OF WITHDRAWAL

If the national stage application papers include an indication that the international application or US designation has been withdrawn, then the application should be brought to the attention of the Office of PCT Legal Administration to determine whether the withdrawal occurred prior to completion of the requirements under 35 U.S.C. 371(c). If the withdrawal occurred prior to completion of the requirements under 35 U.S.C. 371(c), then entry into the U.S. national stage is prohibited. See 35 U.S.C. 366. The indication of withdrawal may appear on a Notification of Withdrawal (PCT/IB/307 or PCT/RO/136), a Notification that International Application Considered to



Be Withdrawn (Form PCT/RO/117), or other notification.


1893.03(e)(1)Title of the Invention [R-5]

In the absence of an application data sheet (37 CFR 1.76) or preliminary amendment changing the title, the Office will use the title of the invention that appears on the first page of the description of the published international application (if published under PCT Article 21 in English) or the title that appears on the first page of the description of the English translation of the international application (if not published under PCT Article 21 in English) in preparing the official filing receipt. If the title does not appear on the first page of the description, and an application data sheet or preliminary amendment changing the title has not been furnished, then the title will be taken from the cover page of the published international application. If applicant furnishes an application data sheet or preliminary amendment changing the title, the Office will use the title as indicated in such document in preparing the official filing receipt. If applicant submits both an application data sheet and a preliminary amendment, the later filed document will govern. See 37 CFR 1.76(d)(1). An application data sheet will govern over a concurrently filed preliminary amendment. See 37 CFR 1.76(d)(2).

1893.03(f)Drawings and PCT Rule 11 [R-2]

The drawings for the national stage application must comply with PCT Rule 11. The copy of the drawings provided by the International Bureau has already been checked and should be in compliance with PCT Rule 11. Accordingly, the drawing provided by the International Bureau (see MPEP § 1893.03(e)) should be acceptable. The USPTO may not impose requirements beyond those imposed by the Patent Cooperation Treaty (e.g., PCT Rule 11). However, the examiner does have the authority to require new drawings if the drawings were published without meeting all requirements under the PCT for drawings.

1893.03(g)Information Disclosure Statement in a National Stage Application [R-3]

An extensive discussion of Information Disclosure Statement practice is to be found in MPEP § 609. Although not specifically stated therein, the duty to disclose information material to patentability as defined in 37 CFR 1.56 is placed on individuals associated with the filing and prosecution of a national stage application in the same manner as for a domestic national application. The averment with respect to the duty under 37 CFR 1.56 required under 37 CFR 1.63(b)(3) in an oath or declaration is applicable to oaths and declarations filed in U.S. national stage applications. See 37 CFR 1.497(c).

When an international application is filed under the Patent Cooperation Treaty (PCT), prior art documents may be cited by the examiner in the international search report and/or the international preliminary examination report. It is desirable for the U.S. examiner to consider the documents cited in the international application when examining the U.S. national stage application or when examining an application filed under 35 U.S.C. 111(a) which claims the benefit of the international application under 35 U.S.C. 365(a) or (c).


When all the requirements for a national stage application have been completed, applicant is notified (Form PCT/DO/EO/903) of the acceptance of the application under 35 U.S.C. 371, including an itemized list of the items received. The itemized list includes an indication of whether a copy of the international search report and copies of the references cited therein are present in the national stage file. The examiner will consider the documents cited in the international search report, without any further action by applicant under 37 CFR 1.97 and 1.98, when both the international search report and copies of the documents are indicated to be present in the national stage file. The examiner will note the consideration in the first Office action. There is no requirement that the examiners list the documents on a PTO-892 form. See form paragraphs 6.53, 6.54, and 6.55 (reproduced in MPEP § 609.03). Otherwise, applicant must follow the procedure set forth in 37 CFR 1.97 and 1.98



in order to ensure that the examiner considers the documents cited in the international search report.

This practice applies only to documents cited in the international search report relative to a national stage application filed under 35 U.S.C. 371. It does not apply to documents cited in an international preliminary examination report that are not cited in the search report. It does not apply to applications filed under 35 U.S.C. 111(a) claiming the benefit of an international application filing date.

1895A Continuation, Divisional, or Continuation- in-Part Application of a PCT Application Designating the United States [R-2]

It is possible to file a U.S. national application under 35 U.S.C. 111(a) during the pendency (prior to the abandonment) of an international application which designates the United States without completing the requirements for entering the national stage under 35 U.S.C. 371(c). The ability to take such action is based on provisions of the United States patent law. 35 U.S.C. 363 provides that “[a]n international application designating the United States shall have the effect, from its international filing date under article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office....” 35 U.S.C. 371(d) indicates that failure to timely comply with the requirements of 35 U.S.C. 371(c) “shall be regarded as abandonment... by the parties thereof....” It is therefore clear that an international application which designates the United States has the effect of a pending U.S. application from the international application filing date until its abandonment as to the United States. The first sentence of 35 U.S.C. 365(c) specifically provides that “[i]n accordance with the conditions and requirements of section 120 of this title,... a national application shall be entitled to the benefit of the filing date of a prior international application designating the United States.” The condition of 35 U.S.C. 120 relating to the time of filing requires the later application to be filed before the patenting or abandonment of or termination of proceedings on the first application. The filing of continuations of an international (PCT) application designating the U.S. was used primarily in instances where there was difficulty in obtaining a signed oath or declaration by the expiration of the time for entry into the national stage. Because these continuation applications historically resulted from a need to bypass the requirements of 35 U.S.C. 371, they became known as “bypass” applications. Since applicants are now notified of missing or defective oaths or declarations and/or translations, and are given a time period to respond which is extendable under 37 CFR 1.136(a), the use of this practice with respect to continuation applications has diminished.

Continuation-in-part applications are generally filed in instances where applicants seek to add matter to the disclosure which is not supported by the disclosure of the international application as originally filed, as new matter may not be added to a U.S. national stage application. See 37 CFR 1.121(f).

1895.01Handling of and Considerations in the Handling of Continuations, Divisions, and Continuations-In- Part of PCT Applications [R-5]

Rather than submitting national stage application papers under 35 U.S.C. 371, a continuing application (i.e., continuation, C-I-P, or division) under 35 U.S.C. 111(a) of the international (PCT) application may be filed. Pursuant to 35 U.S.C. 365(c), a regular national application filed under 35 U.S.C. 111(a) and 37 CFR 1.53(b) (not under 37 CFR 1.53(d)) may claim benefit of the filing date of an international application which designates the United States.

A typical time line involving a continuing application filed during the pendency of an international application is illustrated as follows:

Timeline

To obtain benefit under 35 U.S.C. 120 and 365(c) of a prior international application designating the U.S., the continuing application must:



(A)include a specific reference to the prior international application (either in the application data sheet (37 CFR 1.76) or in the first sentence(s) of the specification),

(B)be copending with the prior international application, and

(C)have at least one inventor in common with the prior international application.

With regard to (A), the specific reference to the international application required under 35 U.S.C. 120 and 365(c) must either be contained in the first sentence(s) of the specification following the title or included in an application data sheet. 37 CFR 1.78(a)(2)(iii). The specific reference must identify the parent international application by international application number and international filing date and indicate the relationship of the applications (i.e., continuation, continuation-in-part, or division). See 37 CFR 1.78(a)(2)(i)) and MPEP § 201.11. An example of an appropriate first sentence of the specification is, for example, “This is a continuation of International Application PCT/EP2004/000000, with an international filing date of January 5, 2004, now abandoned.” The required reference must be submitted within the time period provided by 37 CFR 1.78(a)(5)(ii). This time period is not extendable. A certified copy of the international application (and an English translation) of the international application may be required by the examiner to perfect the claim for benefit under 35 U.S.C. 120 and 365(c) if the international application did not originate in the United States and such is necessary, for example, where an intervening reference is found and applied in a rejection of one or more claims. If the international application was published by the International Bureau pursuant to PCT Article 21, then a certified copy would not normally be necessary.

If benefit under 35 U.S.C. 119(e), 120 and 365(c) is also being claimed to an earlier filed national application (or international application designating the U.S.) via an intermediate international application designating the U.S., the examiner must examine the intermediate international application to see if it contains a proper reference to the earlier application. The reference will usually be included on the cover page of the published international application and/or may appear in the first sentence(s) of the description of the published application. A lack of a proper reference in the published international application does not necessarily mean that a proper reference is not contained in the second international application. Accordingly, the examiner may need to inspect the Home Copy of the international application (if the USPTO was the receiving Office) to determine whether the requirements under 37 CFR 1.78(a) have been satisfied. For example, the Home Copy file may contain a proper reference in a separate paper or a decision granting a petition to accept a late benefit claim may be present in the application file. See MPEP § 201.11(a).

With regard to (B), a U.S. national application is considered copending with a prior international application designating the U.S. if the international application was pending on the filing date of the U.S. national application. Generally, except in cases where the international application has been withdrawn (either generally or as to the United States), an international application becomes abandoned as to the United States upon expiration of 30 months from the priority date (i.e., the priority date claimed in the international application or, if no priority is claimed, the international filing date) unless a proper submission under 35 U.S.C. 371 to enter the U.S. national phase is filed prior to the expiration of this 30-month period. See MPEP § 1893.01(a)(1) and § 1893.02. However, if the international application is one where the 20-month period from the priority date expired before April 1, 2002, then it was necessary to file a demand electing the United States prior to the expiration of 19 months from the priority date in order to extend the international phase to 30 months from the priority date. If such a demand was not timely filed, then under former 37 CFR 1.494, such an international application became abandoned at the expiration of 20 months from the priority date unless a proper submission under 35 U.S.C. 371 to enter the U.S. national phase was made prior to the expiration of 20 months from the priority date. Accordingly, if the international application is not subject to the filing of a demand in order to delay entry into the U.S. national phase to 30 months from the priority date, then a national application filed prior to the expiration of this 30 month period will be copending with the international application unless the international application was withdrawn, either generally or as to the United States, prior to the filing of the national application. To determine whether the application was withdrawn,



the examiner must either review the Home Copy of the international application file (if the USPTO was the receiving Office), or require applicant to certify that the international application was not withdrawn or considered to be withdrawn, either generally or as to the United States, prior to the filing date of the national application claiming benefit under 35 U.S.C. 120 and 365(c) to such international application. In order to expedite examination, applicant should certify at the time of filing a national application claiming benefit under 35 U.S.C. 120 and 365(c) to an international application that the international application has not been withdrawn. If the national application claiming benefit to the international application was filed after the expiration of this 30-month period, then there will be no copendency in the absence of a timely and proper submission to enter the U.S. national phase under 35 U.S.C. 371. The existence of a national stage application may be checked through PALM and the records of the national stage application should be consulted to verify copendency. Additionally, if the 20-month period from the priority date of the international application expired before April 1, 2002 and the national application claiming benefit under 35 U.S.C. 120 and 365(c) was filed later than 20 months from the priority date of the international application, the applicant may be required to submit proof of the filing of a demand electing the United States within 19 months from the priority date. This proof may be in the form of a copy of the “Notification of Receipt of Demand by Competent International Preliminary Examining Authority” (Form PCT/ IPEA/402) showing the demand was received prior to the expiration of 19 months from the priority date, and a copy of the “Notification Concerning Elected Offices Notified of Their Election” (Form PCT/IB/ 332) showing the election of the United States. If the parent international application was not copending (i.e., abandoned or withdrawn), benefit under 35 U.S.C. 120 is not possible.

With regard to (C), inventors will normally be identified on the cover page of the published international application. In addition, such information is indicated in the PCT Gazette, which is available in electronic form from WIPO’s web site (www.wipo.int/pct/en/index.html).

PRIORITY CLAIMS UNDER 35 U.S.C. 119(a)-(d)

A claim for foreign priority under 35 U.S.C. 119(a)-(d) must be made in the continuing application in order to obtain the benefit of the filing date of the prior filed foreign application. This is true regardless of whether such a claim was made in the parent international application. A foreign priority claim is proper in the continuing application if the foreign application was filed within 12 months prior to the filing of the continuing application or within 12 months prior to the international filing date of the parent international application. In addition, the required claim must be made within the time period set forth in 37 CFR 1.55(a)(1). This time period is not extendable. See MPEP § 201.14. A certified copy of any foreign priority document must be provided by the applicant unless the parent international application has entered the national stage under 35 U.S.C. 371 and the national stage application contains a photocopy of the priority document from the International Bureau. See MPEP § 1893.03(c). In such case, the applicant, in the continuing application, may state that the priority document is contained in the national stage application.

For a discussion of U.S. national applications filed under 35 U.S.C. 111(a) having foreign priority claims under 35 U.S.C. 119(a)-(d) and 365(a) to a prior international application designating at least one country other than the United States, see MPEP § 201.13(b).

1896The Differences Between a National Application Filed Under 35 U.S.C. 111(a) and a National Stage Application Submitted Under 35 U.S.C. 371 [R-5]

The following section describes the differences between a U.S. national application filed under 35 U.S.C. 111(a), including those claiming benefit of a PCT application under 35 U.S.C. 120 (a continuation, division, or a continuation-in-part of a PCT application), and a U.S. national stage application(submitted under 35 U.S.C. 371).



Chart of Some Common Differences National Applications (filed under 35 U.S.C. 111(a))

National Stage Applications (submitted under 35 U.S.C. 371)

Filing Date

Deposit date in USPTO of specification, claim and any necessary drawing

International filing date of PCT application

Date application was “filed in the United States” for prior art purposes under 35 U.S.C. 102(e)

See MPEP § 706.02(f)(1)

See MPEP §§ 706.02(f)(1), 1857.01, and 1895.01

35 U.S.C. 119(a)-(d) Priority Requirement

Claim & certified copy provided by applicant

Copy of certified copy provided by WIPO, claim by applicant

Unity of Invention

U.S. restriction practice

Unity of invention practice under 37 CFR 1.499

Filing Fees

37 CFR 1.16

37 CFR 1.492

Reference to Application in Declaration

Attached application, U.S. Application No., etc.

Same as in a 35 U.S.C. 111(a) filing or may refer to the international application

Copendency with International Application

Applicant provides proof

Not an issue



The differences between a national application filed under 35 U.S.C. 111(a) and a national application submitted under 35 U.S.C. 371 are often subtle, but the differences are important.

I.FILING DATE

The filing date of a 35 U.S.C. 111(a) application is the date when the USPTO receives a specification as prescribed by 35 U.S.C. 112 containing a description and at least one claim, and any required drawings. See 37 CFR 1.53(b).

The filing date of a PCT international application is the date applicant satisfies Article 11 requirements, i.e., includes a description, a claim, names at least one applicant who is a resident or national of a PCT Contracting State, filed in the prescribed language, and designates at least one Contracting State. See MPEP § 1810. By virtue of 35 U.S.C. 363, the U.S. filing date of an international application that designates the United States is, for most legal purposes, the international filing date. See MPEP § 1893.03(b).

II.EFFECTIVE DATE AS A REFERENCE

A reference under 35 U.S.C. 102(e) must be a U.S. patent, a U.S. application publication (35 U.S.C. 122(b)), or a WIPO publication of an international application under PCT Article 21(2).

References That Did Not Result From, Nor Claimed Benefit of, an International Application

The 35 U.S.C. 102(e) date of a reference that did not result from, nor claimed the benefit of, an international application is its earliest effective U.S. filing date, taking into consideration any proper priority or benefit claims to prior U.S. applications under 35 U.S.C. 119(e) or 120 if the prior application(s) properly support(s) the subject matter used to make the rejection. See MPEP § 706.02(a).

References That Resulted From, or Claimed Benefit of, an International Application

If a reference resulted from, or claimed the benefit of, an international application, the following must be determined:

(A)If the international application meets the following three conditions:



(1)an international filing date on or after November 29, 2000;

(2)designated the United States; and

(3)published under PCT Article 21(2) in English,

the international filing date is a U.S. filing date for prior art purposes under 35 U.S.C. 102(e). If such an international application properly claims benefit to an earlier-filed U.S. or international application, or priority to an earlier-filed U.S. provisional application, apply the reference under 35 U.S.C. 102(e) as of the earlier filing date, assuming all the conditions of 35 U.S.C. 102(e), 119(e), 120, or 365(c) are met. Note, where the earlier application is an international application, the earlier international application must satisfy the same three conditions (i.e., filed on or after November 29, 2000, designated the U.S., and had been published in English under PCT Article 21(2)) for the earlier international filing date to be a U.S. filing date for prior art purposes under 35 U.S.C. 102(e).

(B)If the international application was filed on or after November 29, 2000, but did not designate the United States or was not published in English under PCT Article 21(2), do not treat the international filing date as a U.S. filing date for prior art purposed under 35 U.S.C. 102(e). In this situation, do not apply under 35 U.S.C. 102(e) the reference as of its international filing date, its date of completion of the 35 U.S.C. 371(c)(1), (2) and (4) requirements, or any earlier filing date to which such an international application claims benefit or priority. The reference may be applied under 35 U.S.C. 102(a) or (b) as of its publication date, or 35 U.S.C. 102(e) as of any later U.S. filing date of an application that properly claimed the benefit of the international application (if applicable).

(C)If the international application has an international filing date prior to November 29, 2000, apply the reference under the provisions of 35 U.S.C. 102and 374, prior to the AIPA amendments:

(1)For U.S. patents, apply the reference under 35 U.S.C. 102(e) as of the earlier of the date of completion of the requirements of 35 U.S.C. 371(c)(1), (2) and (4) or the filing date of the later-filed U.S. application that claimed the benefit of the international application;

(2)For U.S. application publications and WIPO publications directly resulting from international applications under PCT Article 21(2), never apply these references under 35 U.S.C. 102(e). These references may be applied as of their publication dates under 35 U.S.C. 102(a) or (b);

(3)For U.S. application publications of applications that claim the benefit under 35 U.S.C. 120 or 365(c) of an international application filed prior to November 29, 2000, apply the reference under 35 U.S.C. 102(e) as of the actual filing date of the later-filed U.S. application that claimed the benefit of the international application.

Examiners should be aware that although a publication of, or a U.S. patent issued from, an international application may not have a 35 U.S.C. 102(e) date at all, or may have a 35 U.S.C. 102(e) date that is after the effective filing date of the application being examined (so it is not “prior art”, the corresponding WIPO publication of an international application may have an earlier 35 U.S.C. 102(a) or (b) date.

III.35 U.S.C. 119(a)-(d) AND 365(b) PRIORITY REQUIREMENTS

The certified copy of the foreign priority application must be provided to the Office by applicant in a U.S. national application filed under 35 U.S.C. 111(a). Where applicant filed an international application claiming priority to an earlier filed national application, the certified copy of the priority application may be provided to the International Bureau by applicant during the international stage. The International Bureau (WIPO) then sends a copy of the certified copy of the priority application to each designated office for inclusion in the national stage application. A U.S. national stage application filed under 35 U.S.C. 371 will have a photocopy of the priority document with the first page stamped by the International Bureau to indicate that it is a priority document received by WIPO and the date of such receipt. Such a photocopy is acceptable in a U.S. national stage application to establish that applicant has filed a certified copy of the priority document. If the photocopy is missing from the national stage application file, either the document has been misplaced or it was not provided due to a defect in priority during the international stage. If the priority claim was not in accordance with PCT Rule 4.10 or the priority document was not provided in accordance with PCT Rule 17, the photocopy of the priority document will not



have been provided by the International Bureau. If a copy of the foreign priority document is not in the national stage application file but applicant asserts that a certified copy of the priority document was timely furnished under PCT Rule 17 in the international phase, then the examiner should consult with a Special Program Examiner in his or her Technology Center or a PCT Special Program Examiner.

IV.UNITY OF INVENTION

U.S. national applications filed under 35 U.S.C. 111(a) are subject to restriction practice in accordance with 37 CFR 1.141-1.146. See MPEP § 803. U.S. national stage applications (which entered the national stage from international applications after compliance with 35 U.S.C. 371) are subject to unity of invention practice in accordance with 37 CFR 1.475 and 1.499 (effective May 1, 1993).

V.FILING FEES

U.S. national applications filed under 35 U.S.C. 111(a) are subject to the national application filing fees set forth at 37 CFR 1.16. Submissions to enter the U.S. national stage under 35 U.S.C. 371 are subject to the national stage fees prescribed at 37 CFR 1.492.

VI.REFERENCE TO APPLICATION IN DECLARATION

Applicant’s oath or declaration is required to identify the specification to which it is directed (37 CFR 1.63(b)(1)). The specification may be identified in a U.S. national application filed under 35 U.S.C. 111(a) by reference to an attached specification or by reference to the application number and filing date of a specification previously filed in the Office. MPEP § 601.01(a) gives the minimum requirements for identification of the specification. Submissions to enter the U.S. national stage under 35 U.S.C. 371 may identify the specification (in the oath or declaration) in the same manner as applications filed under 35 U.S.C. 111(a) or may identify the specification by reference to the application number and filing date of the international application.

← MPEP 1845 ↑ MPEP 1800