Editing MPEP 2000
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information contained therein is disclosed to the Office.</p> | information contained therein is disclosed to the Office.</p> | ||
|} | |} | ||
The amendment to 37 CFR 1.56 was proposed to | |||
address criticism concerning a perceived lack of certainty | |||
in the materiality standard. The rule as promulgated | |||
will provide greater clarity and hopefully | |||
minimize the burden of litigation on the question of | |||
inequitable conduct before the Office, while providing | |||
the Office with the information necessary for | |||
effective and efficient examination of patent applications. | |||
37 CFR 1.56 has been amended to present a | |||
clearer and more objective definition of what information | |||
the Office considers material to patentability. The | |||
rules do not define fraud or inequitable conduct which | |||
have elements both of materiality and of intent. | |||
The definition of materiality in 37 CFR 1.56 does | |||
not impose substantial new burdens on applicants, but | |||
is intended to provide the Office with the information | |||
it needs to make a proper and independent determination | |||
on patentability. It is the patent examiner who | |||
should make the determination after considering all | |||
the facts involved in the particular case. | |||
37 CFR 1.56 states that each individual associated | 37 CFR 1.56 states that each individual associated | ||
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the present application. | the present application. | ||
The term | The term “information” as used in 37 CFR 1.56means all of the kinds of information required to be | ||
disclosed and includes any information which is | disclosed and includes any information which is | ||
“material to patentability.” Materiality is defined in | |||
37 CFR 1.56(b) and discussed herein at MPEP | 37 CFR 1.56(b) and discussed herein at MPEP | ||
§ 2001.05. In addition to prior art such as patents and | § 2001.05. In addition to prior art such as patents and | ||
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uses, sales, offers to sell, derived knowledge, prior | uses, sales, offers to sell, derived knowledge, prior | ||
invention by another, inventorship conflicts, and the | invention by another, inventorship conflicts, and the | ||
like. | like. “Materiality is not limited to prior art but | ||
“Materiality is not limited to prior art but | |||
embraces any information that a reasonable examiner | embraces any information that a reasonable examiner | ||
would be substantially likely to consider important in | would be substantially likely to consider important in | ||
deciding whether to allow an application to issue as a | deciding whether to allow an application to issue as a | ||
patent.” | patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc | ||
Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, | |||
1486 (Fed. Cir. 2003) (emphasis in original) (finding | |||
article which was not prior art to be material to | |||
enablement issue). | |||
The term “information” is intended to be all encompassing, | The term “information” is intended to be all encompassing, | ||
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The rules provide for information being considered | The rules provide for information being considered | ||
after a notice of allowance is mailed and before | after a notice of allowance is mailed and before | ||
the issue fee is paid. | the issue fee is paid (37 CFR 1.97(d)) (see MPEP | ||
§ 609, paragraph B(3)). The rules also provide for an | |||
application to be withdrawn from issue | |||
(A)because one or more claims are unpatentable | |||
(37 CFR 1.313(c)(1)); | |||
(B)for express abandonment so that information | |||
may be considered in a continuing application before | |||
a patent issues (37 CFR 1.313(c)(3)); or | |||
(C) for consideration of a request for continued | |||
examination (RCE) under 37 CFR 1.114 (37 CFR | |||
1.313(a) and (c)(2)). Note that RCE practice does | |||
not | |||
apply to utility or plant applications filed before | |||
June 8, 1995 or to design applications. See MPEP | |||
§ 706.07(h). | |||
See MPEP § 1308 for additional information pertaining | |||
to withdrawal of an application from issue. | |||
In a continuation-in-part application, individuals | In a continuation-in-part application, individuals | ||
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can be met by submitting information to the Office in | can be met by submitting information to the Office in | ||
the manner prescribed by 37 CFR 1.97 and 1.98. See | the manner prescribed by 37 CFR 1.97 and 1.98. See | ||
MPEP § 609. Applicants are provided certainty as to | |||
when information will be considered, and applicants | when information will be considered, and applicants | ||
will be informed when information is not considered. | will be informed when information is not considered. | ||
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result in its being considered by the examiner may be | result in its being considered by the examiner may be | ||
held to be a violation. | held to be a violation. | ||
The Office does not anticipate any significant | |||
change in the quantity of information cited to the | |||
Office. Presumably, applicants will continue to submit | |||
information for consideration by the Office in applications | |||
rather than making and relying on their own | |||
determinations of materiality. An incentive remains to | |||
submit the information to the Office because it will | |||
result in a strengthened patent and will avoid later | |||
questions of materiality and intent to deceive. In addition, | |||
the new rules will actually facilitate the filing of | |||
information since the burden of submitting information | |||
to the Office has been reduced by eliminating, in | |||
most cases, the requirement for a concise statement of | |||
the relevance of each item of information listed in an | |||
information disclosure statement. It should also be | |||
noted that 37 CFR 1.97(h) states that the filing of an | |||
information disclosure statement shall not be considered | |||
to be an admission that the information cited in | |||
the statement is, or is considered to be, material to | |||
patentability as defined in 37 CFR 1.56. | |||
===2001.05 Materiality Under 37 CFR 1.56(b)=== | ===2001.05 Materiality Under 37 CFR 1.56(b)=== |