|← MPEP 2143||↑ MPEP 2100||MPEP 2145 →|
- 1 2144 Sources of Rationale Supporting a Rejection Under 35 U.S.C. 103
- 1.1 RATIONALE MAY BE IN A REFERENCE, OR REASONED FROM COMMON KNOWLEDGE IN THE ART, SCIENTIFIC PRINCIPLES, ART-RECOGNIZED EQUIVALENTS, OR LEGAL PRECEDENT
- 1.2 THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR COMBINING REFERENCES
- 1.3 LEGAL PRECEDENT CAN PROVIDE THE RATIONALE SUPPORTING OBVIOUSNESS ONLY IF THE FACTS IN THE CASE ARE SUFFICIENTLY SIMILAR TO THOSE IN THE APPLICATION
- 1.4 RATIONALE DIFFERENT FROM APPLICANT'S IS PERMISSIBLE
- 1.5 2144.01 Implicit Disclosure
- 1.6 2144.02 Reliance on Scientific Theory
- 1.7 2144.03 Reliance on Common Knowledge in the Art or "Well Known" Prior Art
- 1.8 2144.04 Legal Precedent as Source of Supporting Rationale
- 1.8.1 I. AESTHETIC DESIGN CHANGES
- 1.8.2 II. ELIMINATION OF A STEP OR AN ELEMENT AND ITS FUNCTION
- 1.8.3 III. AUTOMATING A MANUAL ACTIVITY
- 1.8.4 IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS
- 1.8.5 V. MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS
- 1.8.6 VI. REVERSAL, DUPLICATION, OR REARRANGEMENT OF PARTS
- 1.9 2144.05 Obviousness of Ranges
- 1.10 2144.06 Art Recognized Equivalence for the Same Purpose
- 1.11 2144.07 Art Recognized Suitability for an Intended Purpose
- 1.12 2144.08 Obviousness of Species When Prior Art Teaches Genus
- 1.12.1 I. GUIDELINES FOR THE EXAMINATION OF CLAIMS DIRECTED TO SPECIES OF CHEMICAL COMPOSITIONS BASED UPON A SINGLE PRIOR ART REFERENCE
- 1.12.2 II. DETERMINE WHETHER THE CLAIMED SPECIES OR SUBGENUS WOULD HAVE BEEN OBVIOUS TO ONE OF ORDINARY SKILL IN THE PERTINENT ART AT THE TIME THE INVENTION WAS MADE
- 1.12.3 III.RECONSIDER ALL EVIDENCE AND CLEARLY COMMUNICATE FINDINGS AND CONCLUSIONS
- 1.13 2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers)
- 1.13.1 REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
- 1.13.2 HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
- 1.13.3 PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT CONTROLLING
- 1.13.4 PRESENCE OR ABSENCE OF PRIOR ART SUGGESTION OF METHOD OF MAKING A CLAIMED COMPOUND MAY BE RELEVANT IN DETERMINING PRIMA FACIE OBVIOUSNESS
- 1.13.5 PRESUMPTION OF OBVIOUSNESS BASED ON STRUCTURAL SIMILARITY IS OVERCOME WHERE THERE IS NO REASONABLE EXPECTATION OF SIMILAR PROPERTIES
- 1.13.6 IF PRIOR ART COMPOUNDS HAVE NO UTILITY, OR UTILITY ONLY AS INTERMEDIATES, CLAIMED STRUCTURALLY SIMILAR COMPOUNDS MAY NOT BE PRIMA FACIE OBVIOUS OVER THE PRIOR ART
- 1.13.7 PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF SUPERIOR OR UNEXPECTED RESULTS
RATIONALE MAY BE IN A REFERENCE, OR REASONED FROM COMMON KNOWLEDGE IN THE ART, SCIENTIFIC PRINCIPLES, ART-RECOGNIZED EQUIVALENTS, OR LEGAL PRECEDENT
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR COMBINING REFERENCES
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
LEGAL PRECEDENT CAN PROVIDE THE RATIONALE SUPPORTING OBVIOUSNESS ONLY IF THE FACTS IN THE CASE ARE SUFFICIENTLY SIMILAR TO THOSE IN THE APPLICATION
The examiner must apply the law consistently to each application after considering all the relevant facts. If the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court.
RATIONALE DIFFERENT FROM APPLICANT'S IS PERMISSIBLE
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”)
In In re Linter the claimed invention was a laundry composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering phosphate, and brightener in specified proportions. The claims were rejected over the combination of a primary reference which taught all the claim limitations except for the presence of sugar, and secondary references which taught the addition of sugar as a filler or weighting agent in compositions containing cationic fabric softeners. Appellant argued that in the claimed invention, the sugar is responsible for the compatibility of the cationic softener with the other detergent components. The court sustained the rejection, stating “The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references.” 173 USPQ at 562.
See MPEP § 2145, paragraph II for case law pertaining to the presence of additional advantages or latent properties not recognized in the prior art.
2144.01 Implicit Disclosure
“[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968) (A process for catalytically producing carbon disulfide by reacting sulfur vapor and methane in the presence of charcoal at a temperature of “about 750-830°C” was found to be met by a reference which expressly taught the same process at 700°C because the reference recognized the possibility of using temperatures greater than 750°C.).
2144.02 Reliance on Scientific Theory
The rationale to support a rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle. However, when an examiner relies on a scientific theory, evidentiary support for the existence and meaning of that theory must be provided. Although the theoretical mechanism of an invention may be explained by logic and sound scientific reasoning, this fact does not support an obviousness determination unless logic and scientific reasoning would have led one of ordinary skill in the art to make the claimed invention.
2144.03 Reliance on Common Knowledge in the Art or "Well Known" Prior Art
In limited circumstances, it is appropriate for an examiner to take official notice of facts not in the record or to rely on “common knowledge” in making a rejection, however such rejections should be judiciously applied.
PROCEDURE FOR RELYING ON COMMON KNOWLEDGE OR TAKING OFFICIAL NOTICE
The standard of review applied to findings of fact is the "substantial evidence" standard under the Administrative Procedure Act (APA). See MPEP § 1216.01.
The following guidance is provided in order to assist the examiners in determining when it is appropriate to take official notice of facts without supporting documentary evidence or to rely on common knowledge in the art in making a rejection, and if such official notice is taken, what evidence is necessary to support the examiner’s conclusion of common knowledge in the art.
A. Determine When It Is Appropriate To Take Official Notice Without Documentary Evidence To Support The Examiner's Conclusion
Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known.
For example, it might not be unreasonable to take official notice of the fact that it is desirable to make something faster, cheaper, better, or stronger without the specific support of documentary evidence.
It is never appropriate to rely solely on “common knowledge” in the art without evidentiary support in the record, as the principal evidence upon which a rejection was based. An assessment of basic knowledge and common sense that is not based on any evidence in the record lacks substantial evidence support.
- In re Ahlert, 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA 1970)
- In re Fox, 471 F.2d 1405, 1407, 176 USPQ 340, 341 (CCPA 1973)
- In re Grose, 592 F.2d 1161, 1167-68, 201 USPQ 57, 63 (CCPA 1979)
- In re Zurko, 258 F.3d 1379, 1385, 59 USPQ2d 1693, 1697 (Fed. Cir. 2001)
B. If Official Notice Is Taken of a Fact, Unsupported by Documentary Evidence, the Technical Line Of Reasoning Underlying a Decision To Take Such Notice Must Be Clear and Unmistakable
Ordinarily, there must be some form of evidence in the record to support an assertion of common knowledge.
In certain older cases, official notice has been taken of a fact that is asserted to be “common knowledge” without specific reliance on documentary evidence where the fact noticed was readily verifiable, such as when other references of record supported the noticed fact, or where there was nothing of record to contradict it. If such notice is taken, the basis for such reasoning must be set forth explicitly. The examiner must provide specific factual findings predicated on sound technical and scientific reasoning to support his or her conclusion of common knowledge.
C. If Applicant Challenges a Factual Assertion as Not Properly Officially Noticed or not Properly Based Upon Common Knowledge, the Examiner Must Support the Finding With Adequate Evidence
To adequately traverse such a finding, an applicant must specifically point out the supposed errors in the examiner's action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. If applicant adequately traverses the examiner’s assertion of official notice, the examiner must provide documentary evidence in the next Office action if the rejection is to be maintained.
If the examiner is relying on personal knowledge to support the finding of what is known in the art, the examiner must provide an affidavit or declaration setting forth specific factual statements and explanation to support the finding. See 37 CFR 1.104(d)(2).
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate.
D. Determine Whether the Next Office Action Should Be Made Final
If the examiner adds a reference in the next Office action after applicant’s rebuttal, and the newly added reference is added only as directly corresponding evidence to support the prior common knowledge finding, and it does not result in a new issue or constitute a new ground of rejection, the Office action may be made final. If no amendments are made to the claims, the examiner must not rely on any other teachings in the reference if the rejection is made final. If the newly cited reference is added for reasons other than to support the prior common knowledge statement and a new ground of rejection is introduced by the examiner that is not necessitated by applicant’s amendment of the claims, the rejection may not be made final. See MPEP § 706.07(a).
Any rejection based on assertions that a fact is well- known or is common knowledge in the art without documentary evidence to support the examiner’s conclusion should be judiciously applied. Furthermore, as noted by the court in Ahlert, any facts so noticed should be of notorious character and serve only to “fill in the gaps” in an insubstantial manner which might exist in the evidentiary showing made by the examiner to support a particular ground for rejection. It is never appropriate to rely solely on common knowledge in the art without evidentiary support in the record as the principal evidence upon which a rejection was based. See Zurko, 258 F.3d at 1386, 59 USPQ2d at 1697; Ahlert, 424 F.2d at 1092, 165 USPQ 421.
2144.04 Legal Precedent as Source of Supporting Rationale
As discussed in MPEP § 2144, if the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court. Examples directed to various common practices which the court has held normally require only ordinary skill in the art and hence are considered routine expedients are discussed below. If the applicant has demonstrated the criticality of a specific limitation, it would not be appropriate to rely solely on case law as the rationale to support an obviousness rejection.
I. AESTHETIC DESIGN CHANGES
In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (Claim was directed to an advertising display device comprising a bottle and a hollow member in the shape of a human figure from the waist up which was adapted to fit over and cover the neck of the bottle, wherein the hollow member and the bottle together give the impression of a human body. Appellant argued that certain limitations in the upper part of the body, including the arrangement of the arms, were not taught by the prior art. The court found that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art.). But see In re Dembiczak, 175 F.3d 994, 50 USPQ2d 1614 (Fed. Cir. 1999) (The claims of a utility application, drawn to a generally round, orange plastic trash bag with a jack-o-lantern face, were rejected under 35 U.S.C. 103. However, the court reversed the rejection for lack of motivation to combine conventional trash bags with a reference showing a jack-o-lantern face on an orange paper bag stuffed with newspapers.); Ex parte Hilton, 148 USPQ 356 (Bd. App. 1965) (Claims were directed to fried potato chips with a specified moisture and fat content, whereas the prior art was directed to french fries having a higher moisture content. While recognizing that in some cases the particular shape of a product is of no patentable significance, the Board held in this case the shape (chips) is important because it results in a product which is distinct from the reference product (french fries).).
II. ELIMINATION OF A STEP OR AN ELEMENT AND ITS FUNCTION
A. Omission of an Element and Its Function Is Obvious If the Function of the Element Is Not Desired
Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient).
B. Omission of an Element with Retention of the Element's Function Is an Indicia of Unobviousness
Note that the omission of an element and retentionof its function is an indicia of unobviousness. In reEdge, 359 F.2d 896, 149 USPQ 556 (CCPA 1966) (Claims at issue were directed to a printed sheet having a thin layer of erasable metal bonded directly to the sheet wherein said thin layer obscured the original print until removal by erasure. The prior art disclosed a similar printed sheet which further comprised an intermediate transparent and erasure-proof protecting layer which prevented erasure of the printing when the top layer was erased. The claims were found unobvious over the prior art because the although the transparent layer of the prior art was eliminated, the function of the transparent layer was retained since appellant’s metal layer could be erased without erasing the printed indicia.).
III. AUTOMATING A MANUAL ACTIVITY
In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined “old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed.” The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.).
IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS
A. Changes in Size/Proportion
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
B. Changes in Shape
In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
C. Changes in Sequence of Adding Ingredients
Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facieobvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
V. MAKING PORTABLE, INTEGRAL, SEPARABLE, ADJUSTABLE, OR CONTINUOUS
A. Making Portable
In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952) (Fact that a claimed device is portable or movable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results.).
B. Making Integral
In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form “a single integral and gaplessly continuous piece.” Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).
C. Making Separable
In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is “press fitted” and therefore not manually removable. The court held that “if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.”).
D. Making Adjustable
In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954) (Claims were directed to a handle for a fishing rod wherein the handle has a longitudinally adjustable finger hook, and the hand grip of the handle connects with the body portion by means of a universal joint. The court held that adjustability, where needed, is not a patentable advance, and because there was an art- recognized need for adjustment in a fishing rod, the substitution of a universal joint for the single pivot of the prior art would have been obvious.).
E. Making Continuous
In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to a method of producing a cementitious structure wherein a stable air foam is introduced into a slurry of cementitious material differed from the prior art only in requiring the addition of the foam to be continuous. The court held the claimed continuous operation would have been obvious in light of the batch process of the prior art.).
VI. REVERSAL, DUPLICATION, OR REARRANGEMENT OF PARTS
A. Reversal of Parts
In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious expedient.).
B. Duplication of Parts
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
C. Rearrangement of Parts
In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). However, “The mere fact that a worker in the art could rearrange the parts of the reference device to meet the terms of the claims on appeal is not by itself sufficient to support a finding of obviousness. The prior art must provide a motivation or reason for the worker in the art, without the benefit of appellant’s specification, to make the necessary changes in the reference device.” Ex parte Chicago Rawhide Mfg. Co., 223 USPQ 351, 353 (Bd. Pat. App. & Inter. 1984).
VII. PURIFYING AN OLD PRODUCT
Pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are unobvious over the prior art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989).
Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. In re Cofer, 354 F.2d 664, 148 USPQ 268 (CCPA 1966) (Claims to the free- flowing crystalline form of a compound were held unobvious over references disclosing the viscous liquid form of the same compound because the prior art of record did not suggest the claimed compound in crystalline form or how to obtain such crystals.).
See also Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987) (Claims to interleukin 2 (a protein with a molecular weight of over 12,000) purified to homogeneity were held unpatentable over references which recognized the desirability of purifying interleukin 2 to homogeneity in a view of a reference which taught a method of purifying proteins having molecular weights in excess of 12,000 to homogeneity wherein the prior art method was similar to the method disclosed by appellant for purifying interleukin 2.).
Compare Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (Claims were directed to human nerve growth factor b-NGF free from other proteins of human origin, and the specification disclosed making the claimed factor through the use of recombinant DNA technology. The claims were rejected as prima facie obvious in view of two references disclosing b-NGF isolated from human placental tissue. The Board applied case law pertinent to product-by-process claims, reasoning that the prior art factor appeared to differ from the claimed factor only in the method of obtaining the factor. The Board held that the burden of persuasion was on appellant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The Board further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.).
2144.05 Obviousness of Ranges
See MPEP § 2131.03 for case law pertaining to rejections based on the anticipation of ranges under 35 U.S.C. 102 and 35 U.S.C. 102/103.
I. OVERLAP OF RANGES
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima faciecase of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).
“[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005)(claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus. Id. See also In re Baird, 16 F.3d 380, 29 USPQ2d 1550 (Fed. Cir. 1994); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); MPEP § 2144.08.
A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The patent claim at issue was directed to a weight plate having 3 elongated openings that served as handles for transporting the weight plate. Multiple prior art patents each disclosed weight plates having 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 USPQ2d at 1226. The court stated that the claimed weight plate having 3 elongated openings fell within the “range” of the prior art and was thus presumed obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The court further stated that the “range” disclosed in multiple prior art patents is “a distinction without a difference” from previous range cases which involved a range disclosed in a single patent since the “prior art suggested that a larger number of elongated grips in the weight plates was beneficial… thus plainly suggesting that one skilled in the art look to the range appearing in the prior art.” Id.
II. OPTIMIZATION OF RANGES
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
B. Only Result-Effective Variables Can Be Optimized
A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) (The claimed wastewater treatment device had a tank volume to contractor area of 0.12 gal./sq. ft. The prior art did not recognize that treatment capacity is a function of the tank volume to contractor ratio, and therefore the parameter optimized was not recognized in the art to be a result- effective variable.). See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (prior art suggested proportional balancing to achieve desired results in the formation of an alloy).
III. REBUTTAL OF PRIMA FACIE CASE OF OBVIOUSNESS
Applicants can rebut a prima facie case of obviousness based on overlapping ranges by showing the criticality of the claimed range. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g) for a discussion of criticality and unexpected results.
A prima facie case of obviousness may also be rebutted by showing that the art, in any material respect, teaches away from the claimed invention. In re Geisler, 116 F.3d 1465, 1471, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997) (Applicant argued that the prior art taught away from use of a protective layer for a reflective article having a thickness within the claimed range of “50 to 100 Angstroms.” Specifically, a patent to Zehender, which was relied upon to reject applicant’s claim, included a statement that the thickness of the protective layer “should be not less than about [100 Angstroms].” The court held that the patent did not teach away from the claimed invention. “Zehender suggests that there are benefits to be derived from keeping the protective layer as thin as possible, consistent with achieving adequate protection. A thinner coating reduces light absorption and minimizes manufacturing time and expense. Thus, while Zehender expresses a preference for a thicker protective layer of 200-300 Angstroms, at the same time it provides the motivation for one of ordinary skill in the art to focus on thickness levels at the bottom of Zehender’s ‘suitable’ range- about 100 Angstroms- and to explore thickness levels below that range. The statement in Zehender that ‘[i]n general, the thickness of the protective layer should be not less than about [100 Angstroms]’ falls far short of the kind of teaching that would discourage one of skill in the art from fabricating a protective layer of 100 Angstroms or less. [W]e are therefore ‘not convinced that there was a sufficient teaching away in the art to overcome [the] strong case of obviousness’ made out by Zehender.”). See MPEP § 2145, paragraph X.D., for a discussion of “teaching away” references.
Applicant can rebut a presumption of obviousness based on a claimed invention that falls within a prior art range by showing “(1) [t]hat the prior art taught away from the claimed invention...or (2) that there are new and unexpected results relative to the prior art.” Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The court found that patentee offered neither evidence of teaching away of the prior art nor new and unexpected results of the claimed invention drawn to a weight plate having 3 elongated handle openings. 392 F.3d at 1323, 73 USPQ2d at 1229. The court then turned to considering substantial evidence of pertinent secondary factors such as commercial success, satisfaction of a long-felt need, and copying by others may also support patentability. Id. Nevertheless, the court found that Iron Grip failed to show evidence of commercial success, copying by others, or satisfaction of a long felt need for the following reasons: (A) Iron Grip’s licensing of its patent to three competitors was insufficient to show nexus between the “merits of the invention and the licenses,” and thus did not establish secondary consideration of commercial success; (B) in response to Iron Grip’s argument that the competitor’s production of a three- hole plate is evidence of copying, the court stated that “[n]ot every competing product that falls within the scope of a patent is evidence of copying” since “[o]therwise every infringement suit would automatically confirm the nonobviousness of the patent;” and (C) although Iron Grip offered as evidence that the absence of the three-grip plate on the market prior to its patent showed that the invention was nonobviousness, the court stated that “[a]bsent a showing of a long-felt need or the failure of others, the mere passage of time without the claimed invention is not evidence of nonobviousness.” 392 F.3d at 1324-25, 73 USPQ2d at 1229-30.
2144.06 Art Recognized Equivalence for the Same Purpose
COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive.... Appellant argues... hindsight reconstruction or at best,... ‘obvious to try’.... We agree with appellant.”).
SUBSTITUTING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) (The mere fact that components are claimed as members of a Markush group cannot be relied upon to establish the equivalency of these components. However, an applicant’s expressed recognition of an art-recognized or obvious equivalent may be used to refute an argument that such equivalency does not exist.); In re Scott, 323 F.2d 1016, 139 USPQ 297 (CCPA 1963) (Claims were drawn to a hollow fiberglass shaft for archery and a process for the production thereof where the shaft differed from the prior art in the use of a paper tube as the core of the shaft as compared with the light wood or hardened foamed resin core of the prior art. The Board found the claimed invention would have been obvious, reasoning that the prior art foam core is the functional and mechanical equivalent of the claimed paper core. The court reversed, holding that components which are functionally or mechanically equivalent are not necessarily obvious in view of one another, and in this case, the use of a light wood or hardened foam resin core does not fairly suggest the use of a paper core.); Smithv. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. “This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor.” 209 USPQ at 759.).
An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
2144.07 Art Recognized Suitability for an Intended Purpose
The selection of a known material based on its suitability for its intended use supported a prima facieobviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.).
See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988) (Claimed agricultural bagging machine, which differed from a prior art machine only in that the brake means were hydraulically operated rather than mechanically operated, was held to be obvious over the prior art machine in view of references which disclosed hydraulic brakes for performing the same function, albeit in a different environment.).
2144.08 Obviousness of Species When Prior Art Teaches Genus
I. GUIDELINES FOR THE EXAMINATION OF CLAIMS DIRECTED TO SPECIES OF CHEMICAL COMPOSITIONS BASED UPON A SINGLE PRIOR ART REFERENCE
These “Genus-Species Guidelines” are to assist Office personnel in the examination of applications which contain claims to species or a subgenus of chemical compositions for compliance with 35 U.S.C. 103 based upon a single prior art reference which discloses a genus encompassing the claimed species or subgenus but does not expressly disclose the particular claimed species or subgenus. Office personnel should attempt to find additional prior art to show that the differences between the prior art primary reference and the claimed invention as a whole would have been obvious. Where such additional prior art is not found, Office personnel should follow these guidelines to determine whether a single reference 35 U.S.C. 103 rejection would be appropriate. The guidelines are based on the Office’s current understanding of the law and are believed to be fully consistent with binding precedent of the Supreme Court, the Federal Circuit, and the Federal Circuit’s predecessor courts.
The analysis of the guidelines begins at the point during examination after a single prior art reference is found disclosing a genus encompassing the claimed species or subgenus. Before reaching this point, Office personnel should follow appropriate antecedent examination procedures. Accordingly, Office personnel should first analyze the claims as a whole in light of and consistent with the written description, considering all claim limitations. When evaluating the scope of a claim, every limitation in the claim must be considered. See, e.g., In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995). However, the claimed invention may not be dissected into discrete elements to be analyzed in isolation, but must be considered as a whole. See, e.g., W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548, 220 USPQ 303, 309 (Fed. Cir. 1983); Jones v. Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir. 1983) (“treating the advantage as the invention disregards the statutory requirement that the invention be viewed ‘as a whole’”). Next, Office personnel should conduct a thorough search of the prior art and identify all relevant references. Both claimed and unclaimed aspects of the invention should be searched if there is a reasonable expectation that the unclaimed aspects may be later claimed. If the most relevant prior art consists of a single prior art reference disclosing a genus encompassing the claimed species or subgenus, Office personnel should follow the guidelines set forth herein.
These guidelines do not constitute substantive rulemaking and hence do not have the force and effect of law. Rather, they are to assist Office personnel in analyzing claimed subject matter for compliance with substantive law. Thus, rejections must be based upon the substantive law, and it is these rejections which are appealable, not any failure by Office personnel to follow these guidelines.
Office personnel are to rely on these guidelines in the event of any inconsistent treatment of issues between these guidelines and any earlier provided guidance from the Office.
II. DETERMINE WHETHER THE CLAIMED SPECIES OR SUBGENUS WOULD HAVE BEEN OBVIOUS TO ONE OF ORDINARY SKILL IN THE PERTINENT ART AT THE TIME THE INVENTION WAS MADE
The patentability of a claim to a specific compound or subgenus embraced by a prior art genus should be analyzed no differently than any other claim for purposes of 35 U.S.C. 103. “The section 103 requirement of unobviousness is no different in chemical cases than with respect to other categories of patentable inventions.” In re Papesch, 315 F.2d 381, 385, 137 USPQ 43, 47 (CCPA 1963). A determination of patentability under 35 U.S.C. 103 should be made upon the facts of the particular case in view of the totality of the circumstances. See, e.g., In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (in banc). Use of per se rules by Office personnel is improper for determining whether claimed subject matter would have been obvious under 35 U.S.C. 103. See, e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir. 1996); In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995); In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). The fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) (“The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious.”); In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (Federal Circuit has “decline[d] to extract from Merck[& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule that... regardless of how broad, a disclosure of a chemical genus renders obvious any species that happens to fall within it.”). See also In re Deuel, 51 F.3d 1552, 1559, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995).
A proper obviousness analysis involves a three-step process. First, Office personnel should establish a prima facie case of unpatentability considering the factors set out by the Supreme Court in Graham v. John Deere. See, e.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993) (“The PTO bears the burden of establishing a case of prima facieobviousness.”); In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966), requires that to make out a case of obviousness, one must:
(A) determine the scope and contents of the prior art;
(B) ascertain the differences between the prior art and the claims in issue;
(C) determine the level of skill in the pertinent art; and
(D) evaluate any evidence of secondary considerations.
If a prima facie case is established, the burden shifts to applicant to come forward with rebuttal evidence or argument to overcome the prima facie case.
If a prima facie case is established, the burden shifts to applicant to come forward with rebuttal evidence or argument to overcome the prima facie case. See, e.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531; Rijckaert, 9 F.3d at 1532, 28 USPQ2d at 1956; Oetiker, 977 F.2d at 1445, 24 USPQ2d at 1444. Finally, Office personnel should evaluate the totality of the facts and all of the evidence to determine whether they still support a conclusion that the claimed invention would have been obvious to one of ordinary skill in the art at the time the invention was made. Id.
A. Establishing a Prima Facie Case of Obviousness
To establish a prima facie case of obviousness in a genus-species chemical composition situation, as in any other 35 U.S.C. 103 case, it is essential that Office personnel find some motivation or suggestion to make the claimed invention in light of the prior art teachings. See, e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666 (Fed. Cir. 1996) (“[T]he mere possibility that one of the esters or the active methylene group-containing compounds... could be modified or replaced such that its use would lead to the specific sulfoalkylated resin recited in claim 8 does not make the process recited in claim 8 obvious ‘unless the prior art suggested the desirability of [such a] modification’ or replacement.”) (quoting In re Gordon, 733 F.2d 900, 902, 221 USPQ 1125, 1127 (Fed. Cir. 1984)); In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991) (“[A] proper analysis under § 103 requires, inter alia, consideration of... whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process.”). In order to find such motivation or suggestion there should be a reasonable likelihood that the claimed invention would have the properties disclosed by the prior art teachings. The prior art disclosure may be express, implicit, or inherent. Regardless of the type of disclosure, the prior art must provide some motivation to one of ordinary skill in the art to make the claimed invention in order to support a conclusion of obviousness. See, e.g., Vaeck, 947 F.2d at 493, 20 USPQ2d at 1442 (A proper obviousness analysis requires consideration of “whether the prior art would also have revealed that in so making or carrying out [the claimed invention], those of ordinary skill would have a reasonable expectation of success.”); In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988) (“The consistent criterion for determination of obviousness is whether the prior art would have suggested to one of ordinary skill in the art that this process should be carried out and would have a reasonable likelihood of success, viewed in the light of the prior art.”); Hodosh v. Block Drug Co., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed. Cir. 1986). These disclosed findings should be made with a complete understanding of the first three “Graham factors.” When evidence of secondary considerations such as unexpected results is initially before the Office, for example in the specification, that evidence should be considered in deciding whether there is a prima faciecase of obviousness. The determination as to whether a prima facie case exists should be made on the full record before the Office at the time of the determination. Thus, Office personnel should:
(A)determine the “scope and content of the prior art”;
(B)ascertain the “differences between the prior art and the claims at issue”; and
(C)determine “the level of ordinary skill in the pertinent art.”
1. Determine the Scope and Content of the Prior Art
As an initial matter, Office personnel should determine the scope and content of the relevant prior art. Each reference must qualify as prior art under 35 U.S.C. 102 (e.g., Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597 (Fed. Cir. 1987) (“Before answering Graham’s ‘content’ inquiry, it must be known whether a patent or publication is in the prior art under 35 U.S.C. § 102.”)) and should be in the field of applicant’s endeavor, or be reasonably pertinent to the particular problem with which the inventor was concerned. In re Oetiker, 977 F.2d 1443, 1447, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). Accord, e.g., In re Clay, 966 F.2d 656, 658- 59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992).
In the case of a prior art reference disclosing a genus, Office personnel should make findings as to:
(A) the structure of the disclosed prior art genus and that of any expressly described species or subgenus within the genus;
(B) any physical or chemical properties and utilities disclosed for the genus, as well as any suggested limitations on the usefulness of the genus, and any problems alleged to be addressed by the genus;
(C) the predictability of the technology; and
(D) the number of species encompassed by the genus taking into consideration all of the variables possible.
2. Ascertain the Differences Between the Closest Disclosed Prior Art Species or Subgenus of Record and the Claimed Species or Subgenus
Once the structure of the disclosed prior art genus and that of any expressly described species or subgenus within the genus are identified, Office personnel should compare it to the claimed species or subgenus to determine the differences. Through this comparison, the closest disclosed species or subgenus in the prior art reference should be identified and compared to that claimed. Office personnel should make explicit findings on the similarities and differences between the closest disclosed prior art species or subgenus of record and the claimed species or subgenus including findings relating to similarity of structure, chemical properties and utilities. In Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1537, 218 USPQ 871, 877 (Fed. Cir. 1983), the Court noted that “the question under 35 U.S.C. § 103 is not whether the differences [between the claimed invention and the prior art] would have been obvious” but “whether the claimed invention as a whole would have been obvious.” (emphasis in original).
3. Determine the Level of Skill in the Art
Office personnel should evaluate the prior art from the standpoint of the hypothetical person having ordinary skill in the art at the time the claimed invention was made. See, Ryko Mfg. Co. v. Nu-Star Inc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057 (Fed. Cir. 1991) (“The importance of resolving the level of ordinary skill in the art lies in the necessity of maintaining objectivity in the obviousness inquiry.”); Uniroyal Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1050, 5 USPQ2d 1434, 1438 (Fed. Cir. 1988) (evidence must be viewed from position of ordinary skill, not of an expert). In most cases, the only facts of record pertaining to the level of skill in the art will be found within the prior art reference. However, any additional evidence presented by applicant should be evaluated.
4. Determine Whether One of Ordinary Skill in the Art Would Have Been Motivated To Select the Claimed Species or Subgenus
In light of the findings made relating to the three Graham factors, Office personnel should determine whether one of ordinary skill in the relevant art would have been motivated to make the claimed invention as a whole, i.e., to select the claimed species or subgenus from the disclosed prior art genus. See, e.g., Ochiai, 71 F.3d at 1569-70, 37 USPQ2d at 1131; Deuel, 51 F.3d at 1557, 34 USPQ2d at 1214 (“[A] prima facie case of unpatentability requires that the teachings of the prior art suggest the claimed compounds to a person of ordinary skill in the art.” (emphasis in original)); Jones, 958 F.2d at 351, 21 USPQ2d at 1943-44 (Fed. Cir. 1992); Dillon, 919 F.2d at 692, 16 USPQ2d at 1901; In re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1984) (“The prior art must provide one of ordinary skill in the art the motivation to make the proposed molecular modifications needed to arrive at the claimed compound.”). See also In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1311 (Fed. Cir. 1996) (discussing motivation to combine). To address this key issue, Office personnel should consider all relevant prior art teachings, focusing on the following, where present.
(a) Consider the Size of the Genus
Consider the size of the prior art genus, bearing in mind that size alone cannot support an obviousness rejection. See, e.g., Baird, 16 F.3d at 383, 29 USPQ2d at 1552 (observing that “it is not the mere number of compounds in this limited class which is significant here but, rather, the total circumstances involved”). There is no absolute correlation between the size of the prior art genus and a conclusion of obviousness. Id. Thus, the mere fact that a prior art genus contains a small number of members does not create a per serule of obviousness. Some motivation to select the claimed species or subgenus must be taught by the prior art. See, e.g., Deuel, 51 F.3d at 1558-59, 34 USPQ2d at 1215 (“No particular one of these DNAs can be obvious unless there is something in the prior art to lead to the particular DNA and indicate that it should be prepared.”); Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552; Bell, 991 F.2d at 784, 26 USPQ2d at 1531 (“Absent anything in the cited prior art suggesting which of the 1036 possible sequences suggested by Rinderknecht corresponds to the IGF gene, the PTO has not met its burden of establishing that the prior art would have suggested the claimed sequences.”). However, a genus may be so small that, when considered in light of the totality of the circumstances, it would anticipate the claimed species or subgenus. For example, it has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original). More specifically, the court in Petering stated:
A simple calculation will show that, excluding isomerism within certain of the R groups, the limited class we find in Karrer contains only 20 compounds. However, we wish to point out that it is not the mere number of compounds in this limited class which is significant here but, rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus. With these circumstances in mind, it is our opinion that Karrer has described to those with ordinary skill in this art each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name. Id. (emphasis in original). Accord In re Schaumann, 572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA 1978) (prior art genus encompassing claimed species which disclosed preference for lower alkyl secondary amines and properties possessed by the claimed compound constituted description of claimed compound for purposes of 35 U.S.C. 102(b)). C.f., In re Ruschig, 343 F.2d 965, 974, 145 USPQ 274, 282 (CCPA 1965) (Rejection of claimed compound in light of prior art genus based on Petering is not appropriate where the prior art does not disclose a small recognizable class of compounds with common properties.).
(b) Consider the Express Teachings
If the prior art reference expressly teaches a particular reason to select the claimed species or subgenus, Office personnel should point out the express disclosure which would have motivated one of ordinary skill in the art to select the claimed invention. An express teaching may be based on a statement in the prior art reference such as an art recognized equivalence. For example, see Merck & Co. v. Biocraft Labs., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989) (holding claims directed to diuretic compositions comprising a specific mixture of amiloride and hydrochlorothiazide were obvious over a prior art reference expressly teaching that amiloride was a pyrazinoylguanidine which could be coadministered with potassium excreting diuretic agents, including hydrochlorothiazide which was a named example, to produce a diuretic with desirable sodium and potassium eliminating properties). See also, In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1312 (Fed. Cir. 1996) (holding there is sufficient motivation to combine teachings of prior art to achieve claimed invention where one reference specifically refers to the other).
(c) Consider the Teachings of Structural Similarity
Consider any teachings of a “typical,” “preferred,” or “optimum” species or subgenus within the disclosed genus. If such a species or subgenus is structurally similar to that claimed, its disclosure may motivate one of ordinary skill in the art to choose the claimed species or subgenus from the genus, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214 (“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”). The utility of such properties will normally provide some motivation to make the claimed species or subgenus. Id.
In making an obviousness determination, Office personnel should consider the number of variables which must be selected or modified, and the nature and significance of the differences between the prior art and the claimed invention. See, e.g., In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (reversing obviousness rejection of novel dicamba salt with acyclic structure over broad prior art genus encompassing claimed salt, where disclosed examples of genus were dissimilar in structure, lacking an ether linkage or being cyclic); In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425 (CCPA 1971) (the difference from the particularly preferred subgenus of the prior art was a hydroxyl group, a difference conceded by applicant “to be of little importance”). In the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (“the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.” Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989)). The effect of a conservative substitution on protein function depends on the nature of the substitution and its location in the chain. Although at some locations a conservative substitution may be benign, in some proteins only one amino acid is allowed at a given position. For example, the gain or loss of even one methyl group can destabilize the structure if close packing is required in the interior of domains. James Darnell et al., Molecular Cell Biology 51 (2d ed. 1990).
The closer the physical and chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). Cf. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure of dissimilar species can provide teaching away).
Similarly, consider any teaching or suggestion in the reference of a preferred species or subgenus that is significantly different in structure from the claimed species or subgenus. Such a teaching may weigh against selecting the claimed species or subgenus and thus against a determination of obviousness. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (reversing obviousness rejection of species in view of large size of genus and disclosed “optimum” species which differed greatly from and were more complex than the claimed species); Jones, 958 F.2d at 350, 21 USPQ2d at 1943 (reversing obviousness rejection of novel dicamba salt with acyclic structure over broad prior art genus encompassing claimed salt, where disclosed examples of genus were dissimilar in structure, lacking an ether linkage or being cyclic). For example, teachings of preferred species of a complex nature within a disclosed genus may motivate an artisan of ordinary skill to make similar complex species and thus teach away from making simple species within the genus. Baird, 16 F.3d at 382, 29 USPQ2d at 1552. See also Jones, 958 F.2d at 350, 21 USPQ2d at 1943 (disclosed salts of genus held not sufficiently similar in structure to render claimed species prima facieobvious).
Concepts used to analyze the structural similarity of chemical compounds in other types of chemical cases are equally useful in analyzing genus-species cases. For example, a claimed tetra-orthoester fuel composition was held to be obvious in light of a prior art tri- orthoester fuel composition based on their structural and chemical similarity and similar use as fuel additives. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1900- 02. Likewise, claims to amitriptyline used as an antidepressant were held obvious in light of the structural similarity to imipramine, a known antidepressant prior art compound, where both compounds were tricyclic dibenzo compounds and differed structurally only in the replacement of the unsaturated carbon atom in the center ring of amitriptyline with a nitrogen atom in imipramine. In re Merck & Co., 800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986). Other structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093-95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. Id.
(d) Consider the Teachings of Similar Properties or Uses
Consider the properties and utilities of the structurally similar prior art species or subgenus. It is the properties and utilities that provide real world motivation for a person of ordinary skill to make species structurally similar to those in the prior art. Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971). Conversely, lack of any known useful properties weighs against a finding of motivation to make or select a species or subgenus. In re Albrecht, 514 F.2d 1389, 1392, 1395-96, 185 USPQ 585, 587, 590 (CCPA 1975) (The prior art compound so irritated the skin that it could not be regarded as useful for the disclosed anesthetic purpose, and therefore a person skilled in the art would not have been motivated to make related compounds.); Stemniski, 444 F.2d at 586, 170 USPQ at 348 (close structural similarity alone is not sufficient to create a prima facie case of obviousness when the reference compounds lack utility, and thus there is no motivation to make related compounds.). However, the prior art need not disclose a newly discovered property in order for there to be a prima facie case of obviousness. Dillon, 919 F.2d at 697, 16 USPQ2d at 1904-05 (and cases cited therein). If the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species, e.g., id. For example, based on a finding that a tri-orthoester and a tetra-orthoester behave similarly in certain chemical reactions, it has been held that one of ordinary skill in the relevant art would have been motivated to select either structure. 919 F.2d at 692, 16 USPQ2d at 1900-01. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
(e) Consider the Predictability of the Technology
Consider the predictability of the technology. See, e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d at 1901- 05; In re Grabiak, 769 F.2d 729, 732-33, 226 USPQ 870, 872 (Fed. Cir. 1985). If the technology is unpredictable, it is less likely that structurally similar species will render a claimed species obvious because it may not be reasonable to infer that they would share similar properties. See, e.g., In re May, 574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA 1978) (prima facieobviousness of claimed analgesic compound based on structurally similar prior art isomer was rebutted with evidence demonstrating that analgesia and addiction properties could not be reliably predicted on the basis of chemical structure); In re Schechter, 205 F.2d 185, 191, 98 USPQ 144, 150 (CCPA 1953) (unpredictability in the insecticide field, with homologs, isomers and analogs of known effective insecticides having proven ineffective as insecticides, was considered as a factor weighing against a conclusion of obviousness of the claimed compounds). However, obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
(f) Consider Any Other Teaching To Support the Selection of the Species or Subgenus
The categories of relevant teachings enumerated above are those most frequently encountered in a genus-species case, but they are not exclusive. Office personnel should consider the totality of the evidence in each case. In unusual cases, there may be other relevant teachings sufficient to support the selection of the species or subgenus and, therefore, a conclusion of obviousness.
5. Make Express Fact-Findings and Determine Whether They Support a Prima Facie Case of Obviousness
Based on the evidence as a whole (In re Bell, 991 F.2d 781,784, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1057 (Fed. Cir. 1990)), Office personnel should make express fact-findings relating to the Graham factors, focusing primarily on the prior art teachings discussed above. The fact-findings should specifically articulate what teachings or suggestions in the prior art would have motivated one of ordinary skill in the art to select the claimed species or subgenus. Kulling, 897 F.2d at 1149, 14 USPQ2d at 1058; Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1579 n.42, 1 USQP2d 1593, 1606 n.42 (Fed. Cir. 1987). Thereafter, it should be determined whether these findings, considered as a whole, support a prima facie case that the claimed invention would have been obvious to one of ordinary skill in the relevant art at the time the invention was made.
B. Determining Whether Rebuttal Evidence Is Sufficient To Overcome the Prima Facie Case of Obviousness
If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., Dillon, 919 F.2d at 692, 16 USPQ2d at 1901. Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789- 90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139- 40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
Office personnel should consider all rebuttal arguments and evidence presented by applicants. See, e.g., In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995) (error not to consider evidence presented in the specification). C.f., In re Alton, 76 F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996) (error not to consider factual evidence submitted to counter a 35 U.S.C. 112 rejection); In re Beattie, 974 F.2d 1309, 1313, 24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992) (Office personnel should consider declarations from those skilled in the art praising the claimed invention and opining that the art teaches away from the invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788 (“[Rebuttal evidence] may relate to any of the Graham factors including the so-called secondary considerations.”). Rebuttal evidence may include evidence of “secondary considerations,” such as “commercial success, long felt but unsolved needs, [and] failure of others.” Graham v. John Deere Co., 383 U.S. at 17, 148 USPQ at 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692- 93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness). Rebuttal evidence may include evidence that the claimed invention was copied by others. See, e.g., In re GPAC, 57 F.3d 1573, 1580, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Hybritech Inc. v. Monoclonal Antibodies, 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir. 1986). It may also include evidence of the state of the art, the level of skill in the art, and the beliefs of those skilled in the art. See, e.g., In re Oelrich, 579 F.2d 86, 91-92, 198 USPQ 210, 214 (CCPA 1978) (Expert opinions regarding the level of skill in the art were probative of the Nonobviousness of the claimed invention.); Piasecki, 745 F.2d at 1471, 1473-74, 223 USPQ at 790 (Evidence of nontechnological nature is pertinent to the conclusion of obviousness. The declarations of those skilled in the art regarding the need for the invention and its reception by the art were improperly discounted by the Board.); Beattie, 974 F.2d at 1313, 24 USPQ2d at 1042-43 (Seven declarations provided by music teachers opining that the art teaches away from the claimed invention must be considered, but were not probative because they did not contain facts and did not deal with the specific prior art that was the subject of the rejection.). For example, rebuttal evidence may include a showing that the prior art fails to disclose or render obvious a method for making the compound, which would preclude a conclusion of obviousness of the compound. A conclusion of obviousness requires that the reference(s) relied upon be enabling in that it put the public in possession of the claimed invention. The court in In re Hoeksema, 399 F.2d 269, 274, 158 USPQ 596, 601 (CCPA 1968), stated:
Thus, upon careful reconsideration it is our view that if the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public. [footnote omitted.] In this context, we say that the absence of a known or obvious process for making the claimed compounds overcomes a presumption that the compounds are obvious, based on close relationships between their structures and those of prior art compounds.
The Hoeksema court further noted that once a prima facie case of obviousness is made by the PTO through citation of references, the burden is on the applicant to produce contrary evidence establishing that the reference being relied on would not enable a skilled artisan to produce the different compounds claimed. Id. at 274-75, 158 USPQ at 601. See also Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666, 667 (Fed. Cir. 1985) (citing Hoeksema for the proposition above); In re Grose, 592 F.2d 1161, 1168, 201 USPQ 57, 63-64 (CCPA 1979) (“One of the assumptions underlying a prima facie obviousness rejection based upon a structural relationship between compounds, such as adjacent homologs, is that a method disclosed for producing one would provide those skilled in the art with a method for producing the other... Failure of the prior art to disclose or render obvious a method for making any composition of matter, whether a compound or a mixture of compounds like a zeolite, precludes a conclusion that the composition would have been obvious.”).
Consideration of rebuttal evidence and arguments requires Office personnel to weigh the proffered evidence and arguments. Office personnel should avoid giving evidence no weight, except in rare circumstances. Id. See also In re Alton, 76 F.3d 1168, 1174- 75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996). However, to be entitled to substantial weight, the applicant should establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention. The Federal Circuit has acknowledged that applicant bears the burden of establishing nexus, stating:
In the ex parte process of examining a patent application, however, the PTO lacks the means or resources to gather evidence which supports or refutes the applicant’s assertion that the sales constitute commercial success. C.f. Ex parte Remark, 15 USPQ2d 1498, 1503 ([BPAI] 1990) (evidentiary routine of shifting burdens in civil proceedings inappropriate in ex parte prosecution proceedings because examiner has no available means for adducing evidence). Consequently, the PTO must rely upon the applicant to provide hard evidence of commercial success.
In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996). See also GPAC, 57 F.3d at 1580, 35 USPQ2d at 1121; In re Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir. 1994) (Evidence of commercial success of articles not covered by the claims subject to the 35 U.S.C. 103 rejection was not probative of nonobviousness.). Additionally, the evidence must be reasonably commensurate in scope with the claimed invention. See, e.g., In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990); In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d 746, 34 USPQ2d 1684 (Fed. Cir. 1995) does not change this analysis. In Soni, the Court declined to consider the Office’s argument that the evidence of nonobviousness was not commensurate in scope with the claim because it had not been raised by the examiner (54 F.3d at 751, 34 USPQ2d at 1688).
When considering whether proffered evidence is commensurate in scope with the claimed invention, Office personnel should not require the applicant to show unexpected results over the entire range of properties possessed by a chemical compound or composition. See, e.g., In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987). Evidence that the compound or composition possesses superior and unexpected properties in one of a spectrum of common properties can be sufficient to rebut a prima faciecase of obviousness. Id.
For example, a showing of unexpected results for a single member of a claimed subgenus, or a narrow portion of a claimed range would be sufficient to rebut a prima facie case of obviousness if a skilled artisan “could ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof.” In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Evidence of the unobviousness of a broad range can be proven by a narrower range when one skilled in the art could ascertain a trend that would allow him to reasonably extend the probative value thereof.). But see, Grasselli, 713 F.2d at 743, 218 USPQ at 778 (evidence of superior properties for sodium containing composition insufficient to establish the non-obviousness of broad claims for a catalyst with “an alkali metal” where it was well known in the catalyst art that different alkali metals were not interchangeable and applicant had shown unexpected results only for sodium containing materials); In re Greenfield, 571 F.2d 1185, 1189, 197 USPQ 227, 230 (CCPA 1978) (evidence of superior properties in one species insufficient to establish the nonobviousness of a subgenus containing hundreds of compounds); In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972) (one test not sufficient where there was no adequate basis for concluding the other claimed compounds would behave the same way). However, an exemplary showing may be sufficient to establish a reasonable correlation between the showing and the entire scope of the claim, when viewed by a skilled artisan. See, e.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439; Clemens, 622 F.2d at 1036, 206 USPQ at 296. On the other hand, evidence of an unexpected property may not be sufficient regardless of the scope of the showing. Usually, a showing of unexpected results is sufficient to overcome a prima facie case of obviousness. See, e.g., In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975). However, where the claims are not limited to a particular use, and where the prior art provides other motivation to select a particular species or subgenus, a showing of a new use may not be sufficient to confer patentability. See Dillon, 919 F.2d at 692, 16 USPQ2d at 1900-01. Accordingly, each case should be evaluated individually based on the totality of the circumstances.
Office personnel should not evaluate rebuttal evidence for its “knockdown” value against the prima facie case, Piasecki, 745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it as not compelling or insufficient. If the evidence is deemed insufficient to rebut the prima facie case of obviousness, Office personnel should specifically set forth the facts and reasoning that justify this conclusion.
III.RECONSIDER ALL EVIDENCE AND CLEARLY COMMUNICATE FINDINGS AND CONCLUSIONS
A determination under 35 U.S.C. 103 should rest on all the evidence and should not be influenced by any earlier conclusion. See, e.g., Piasecki, 745 F.2d at 1472-73, 223 USPQ at 788; In re Eli Lilly & Co., 902 F.2d 943, 945, 14 USPQ2d 1741, 1743 (Fed. Cir. 1990). Thus, once the applicant has presented rebuttal evidence, Office personnel should reconsider any initial obviousness determination in view of the entire record. See, e.g., Piasecki, 745 F.2d at 1472, 223 USPQ at 788; Eli Lilly, 902 F.2d at 945, 14 USPQ2d at 1743. All the proposed rejections and their bases should be reviewed to confirm their correctness. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the Office’s findings and conclusions, articulating how the conclusions are supported by the findings.
Where applicable, the findings should clearly articulate which portions of the reference support any rejection. Explicit findings on motivation or suggestion to select the claimed invention should also be articulated in order to support a 35 U.S.C. 103 ground of rejection. Dillon, 919 F.2d at 693, 16 USPQ2d at 1901; In re Mills, 916 F.2d 680, 683, 16 USPQ2d 1430, 1433 (Fed. Cir. 1990). Conclusory statements of similarity or motivation, without any articulated rationale or evidentiary support, do not constitute sufficient factual findings.
2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers)
REJECTION BASED ON CLOSE STRUCTURAL SIMILARITY IS FOUNDED ON THE EXPECTATION THAT COMPOUNDS SIMILAR IN STRUCTURE WILL HAVE SIMILAR PROPERTIES
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, paragraph II.A.4.(c).
HOMOLOGY AND ISOMERISM ARE FACTS WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
Isomers having the same empirical formula but different structures are not necessarily considered equivalent by chemists skilled in the art and therefore are not necessarily suggestive of each other. Ex parteMowry, 91 USPQ 219 (Bd. App. 1950) (claimed cyclohexylstyrene not prima facie obvious over prior art isohexylstyrene). Similarly, homologs which are far removed from adjacent homologs may not be expected to have similar properties. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960) (prior art disclosure of C8 to C12 alkyl sulfates was not sufficient to render prima facie obvious claimed C1 alkyl sulfate).
Homology and isomerism involve close structural similarity which must be considered with all other relevant facts in determining the issue of obviousness. In re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967). Homology should not be automatically equated with prima facie obviousness because the claimed invention and the prior art must each be viewed “as a whole.” In re Langer, 465 F.2d 896, 175 USPQ 169 (CCPA 1972) (Claims to a polymerization process using a sterically hindered amine were held unobvious over a similar prior art process because the prior art disclosed a large number of unhindered amines and only one sterically hindered amine (which differed from a claimed amine by 3 carbon atoms), and therefore the reference as a whole did not apprise the ordinary artisan of the significance of hindered amines as a class.).
PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT CONTROLLING
Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.).
See also In re Mayne, 104 F.3d 1339, 41 USPQ2d 1451 (Fed. Cir. 1997) (claimed protein was held to be obvious in light of structural similarities to the prior art, including known structural similarity of Ile and Lev); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating depression would have been expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement) (see MPEP § 2144.08, paragraph II.A.4(c) for a more detailed discussion of the facts in the Mayne and Merck cases); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (The tri-orthoester fuel compositions of the prior art and the claimed tetra-orthoester fuel compositions would have been expected to have similar properties based on close structural and chemical similarity between the orthoesters and the fact that both the prior art and applicant used the orthoesters as fuel additives.) (See MPEP § 2144 for a more detailed discussion of the facts in the Dillon case.).
Compare In re Grabiak, 769 F.2d 729, 226 USPQ 871 (Fed. Cir. 1985) (substitution of a thioester group for an ester group in an herbicidal safener compound was not suggested by the prior art); In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993) (The established relationship between a nucleic acid and the protein it encodes in the genetic code does not render a gene prima facie obvious over its corresponding protein in the same way that closely related structures in chemistry may create a prima facie case because there are a vast number of nucleotide sequences that might encode for a specific protein as a result of degeneracy in the genetic code (i.e., the fact that most amino acids are specified by more than one nucleotide sequence or codon).); In re Deuel, 51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) (“A prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein.” The existence of a general method of gene cloning in the prior art is not sufficient, without more, to render obvious a particular cDNA molecule.).
PRESENCE OR ABSENCE OF PRIOR ART SUGGESTION OF METHOD OF MAKING A CLAIMED COMPOUND MAY BE RELEVANT IN DETERMINING PRIMA FACIE OBVIOUSNESS
“[T]he presence—or absence—of a suitably operative, obvious process for making a composition of matter may have an ultimate bearing on whether that composition is obvious—or nonobvious—under 35 U.S.C. 103.” In re Maloney, 411 F.2d 1321, 1323, 162 USPQ 98, 100 (CCPA 1969).
“[I]f the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public. In this context, we say that the absence of a known or obvious process for making the claimed compounds overcomes a presumption that the compounds are obvious, based on the close relationships between their structures and those of prior art compounds.” In re Hoeksema, 399 F.2d 269, 274- 75, 158 USPQ 597, 601 (CCPA 1968).
See In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) for a general discussion of circumstances under which the prior art suggests methods for making novel compounds which are of close structural similarity to compounds known in the prior art. In the biotechnology arts, the existence of a general method of gene cloning in the prior art is not sufficient, without more, to render obvious a particular cDNA molecule. In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995) (“[T]he existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.”); In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993). However, it may be proper to apply “methodology in rejecting product claims under 35 U.S.C. 103, depending on the particular facts of the case, the manner and context in which methodology applies, and the overall logic of the rejection.” Ex parte Goldgaber, 41 USPQ2d 1172, 1176 (Bd. Pat. App. & Inter. 1996).
PRESUMPTION OF OBVIOUSNESS BASED ON STRUCTURAL SIMILARITY IS OVERCOME WHERE THERE IS NO REASONABLE EXPECTATION OF SIMILAR PROPERTIES
The presumption of obviousness based on a reference disclosing structurally similar compounds may be overcome where there is evidence showing there is no reasonable expectation of similar properties in structurally similar compounds. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (appellant produced sufficient evidence to establish a substantial degree of unpredictability in the pertinent art area, and thereby rebutted the presumption that structurally similar compounds have similar properties); In reSchechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953). See also Ex parte Blattner, 2 USPQ2d 2047 (Bd. Pat. App. & Inter. 1987) (Claims directed to compounds containing a 7-membered ring were rejected as prima facie obvious over a reference which taught 5- and 6- membered ring homologs of the claimed compounds. The Board reversed the rejection because the prior art taught that the compounds containing a 5-membered ring possessed the opposite utility of the compounds containing the 6-membered ring, undermining the examiner’s asserted prima facie case arising from an expectation of similar results in the claimed compounds which contain a 7-membered ring.).
IF PRIOR ART COMPOUNDS HAVE NO UTILITY, OR UTILITY ONLY AS INTERMEDIATES, CLAIMED STRUCTURALLY SIMILAR COMPOUNDS MAY NOT BE PRIMA FACIE OBVIOUS OVER THE PRIOR ART
If the prior art does not teach any specific or significant utility for the disclosed compounds, then the prior art is not sufficient to render structurally similar claims prima facie obvious because there is no motivation for one of ordinary skill in the art to make the reference compounds, much less any structurally related compounds. In re Stemniski, 444 F.2d 581, 170 USPQ 343 (CCPA 1971).
Where structurally similar “prior art compounds ‘cannot be regarded as useful’ for the sole use disclosed [by the reference],... a person having ordinary skill in the art would lack the ‘necessary impetus’ to make the claimed compounds.” In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975) (prior art reference studied the local anesthetic activity of various compounds, and taught that compounds structurally similar to those claimed were irritating to human skin and therefore “cannot be regarded as useful anesthetics.” 514 F.2d at 1393, 185 USPQ at 587).
Similarly, if the prior art merely discloses compounds as intermediates in the production of a final product, one of ordinary skill in the art would not have been motivated to stop the reference synthesis and investigate the intermediate compounds with an expectation of arriving at claimed compounds which have different uses. In re Lalu, 747 F.2d 703, 223 USPQ 1257 (Fed. Cir. 1984).
PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF SUPERIOR OR UNEXPECTED RESULTS
A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (Affidavit evidence which showed that claimed triethylated compounds possessed anti-inflammatory activity whereas prior art trimethylated compounds did not was sufficient to overcome obviousness rejection based on the homologous relationship between the prior art and claimed compounds.); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-fold improvement of activity over the prior art held sufficient to rebut prima facie obviousness based on close structural similarity).
However, a claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. It is the differences in fact in their respective properties which are determinative of nonobviousness. If the prior art compound does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, applicant’s recognition of the benefit is not in itself sufficient to distinguish the claimed compound from the prior art. In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991).
See MPEP § 716.02 - § 716.02(g) for a discussion of evidence alleging unexpectedly advantageous or superior results.
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