716 Affidavits or Declarations Traversing Rejections, 37 CFR 1.132
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When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section.
716.01 Generally Applicable Criteria
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The following criteria are applicable to all evidence traversing rejections submitted by applicants, including affidavits or declarations submitted under 37 CFR 1.132:
(A) Timeliness.
Evidence traversing rejections must be timely or seasonably filed to be entered and entitled to consideration.
Affidavits and declarations submitted under 37 CFR 1.132 and other evidence traversing rejections are considered timely if submitted:
- prior to a final rejection,
- before appeal in an application not having a final rejection,
- after final rejection , but before or on the same date of filing an appeal, upon a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented; or
- after the prosecution is closed (e.g., after a final rejection, after appeal, or after allowance) if applicant files the affidavit or other evidence with a request for continued examination (RCE) in a utility or plant application filed on or after June 8, 1995; or a continued prosecution application (CPA) in a design application.
(B) Consideration of evidence.
Evidence traversing rejections, when timely presented, must be considered by the examiner whenever present.
- All entered affidavits, declarations, and other evidence traversing rejections are acknowledged and commented upon by the examiner in the next succeeding action.
- The extent of the commentary depends on the action taken by the examiner.
- Where an examiner holds that the evidence is sufficient to overcome the prima facie case, the comments should be consistent with the guidelines for statements of reasons for allowance.
Where the evidence is insufficient to overcome the rejection, the examiner must specifically explain why the evidence is insufficient. General statements such as “the declaration lacks technical validity” or “the evidence is not commensurate with the scope of the claims” without an explanation supporting such findings are insufficient.
716.01(a) Objective Evidence of Nonobviousness
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OBJECTIVE EVIDENCE MUST BE CONSIDERED WHEN TIMELY PRESENT
- The Court of Appeals for the Federal Circuit stated that “evidence rising out of the so-called ‘secondary considerations’ must always when present be considered en route to a determination of obviousness.”
- Such evidence might give light to circumstances surrounding the origin of the subject matter sought to be patented.
- As indicia of obviousness or unobviousness, such evidence may have relevancy.
Examiners must consider comparative data in the specification which is intended to illustrate the claimed invention in reaching a conclusion with regard to the obviousness of the claims.
- However, where a prima facie case of obviousness is established, the failure to provide rebuttal evidence is dispositive.
716.01(b) Nexus Requirement and Evidence of Nonobviousness
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TO BE OF PROBATIVE VALUE, ANY SECONDARY EVIDENCE MUST BE RELATED TO THE CLAIMED INVENTION (NEXUS REQUIRED)
To be given substantial weight in the determination of obviousness or nonobviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations.
- The term “nexus” designates a factually and legally sufficient connection between the objective evidence of nonobviousness and the claimed invention so that the evidence is of probative value in the determination of nonobviousness.
716.01(c) Probative Value of Objective Evidence
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I. TO BE OF PROBATIVE VALUE, ANY OBJECTIVE EVIDENCE SHOULD BE SUPPORTED BY ACTUAL PROOF
Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
II. ATTORNEY ARGUMENTS CANNOT TAKE THE PLACE OF EVIDENCE
The arguments of counsel cannot take the place of evidence in the record.
Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
III. OPINION EVIDENCE
Although factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive.
- Expert opinion that an application meets the requirements of 35 U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight.
In assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion.
- Although an affidavit or declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application.
An affidavit of an applicant as to the advantages of his or her claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone.
716.01(d) Weighing Objective Evidence
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IN MAKING A FINAL DETERMINATION OF PATENTABILITY, EVIDENCE SUPPORTING PATENTABILITY MUST BE WEIGHED AGAINST EVIDENCE SUPPORTING PRIMA FACIE CASE
When an applicant timely submits evidence traversing a rejection, the examiner must reconsider the patentability of the claimed invention.
- The ultimate determination of patentability must be based on consideration of the entire record, by a preponderance of evidence, with due consideration to the persuasiveness of any arguments and any secondary evidence.
The submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself.
Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of a prima facie case was reached, not against the conclusion itself.
- In other words, each piece of rebuttal evidence should not be evaluated for its ability to knockdown the prima facie case.
- All of the competent rebuttal evidence taken as a whole should be weighed against the evidence supporting the prima facie case.
Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness.
- If, after evaluating the evidence, the examiner is still not convinced that the claimed invention is patentable, the next Office action should include a statement to that effect and identify the reason(s) (e.g., evidence of commercial success not convincing, the commercial success not related to the technology, etc.).
716.02 Allegations of Unexpected Results
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716.02(a) Evidence Must Show Unexpected Results
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I. GREATER THAN EXPECTED RESULTS ARE EVIDENCE OF NONOBVIOUSNESS
“A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.”
A greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected.
- Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage.
II. SUPERIORITY OF A PROPERTY SHARED WITH THE PRIOR ART IS EVIDENCE OF NONOBVIOUSNESS
Evidence of unobvious or unexpected advantageous properties, such as superiority in a property the claimed compound shares with the prior art, can rebut prima facie obviousness.
- “Evidence that a compound is unexpectedly superior in one of a spectrum of common properties . . . can be enough to rebut a prima facie case of obviousness.”
- No set number of examples of superiority is required.
III. PRESENCE OF AN UNEXPECTED PROPERTY IS EVIDENCE OF NONOBVIOUSNESS
Presence of a property not possessed by the prior art is evidence of nonobviousness
IV. ABSENCE OF AN EXPECTED PROPERTY IS EVIDENCE OF NONOBVIOUSNESS
Absence of property which a claimed invention would have been expected to possess based on the teachings of the prior art is evidence of unobviousness.
716.02(b) Burden on Applicant
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I. BURDEN ON APPLICANT TO ESTABLISH RESULTS ARE UNEXPECTED AND SIGNIFICANT
The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.”
II. APPLICANTS HAVE BURDEN OF EXPLAINING PROFFERED DATA
“[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness.”
III. DIRECT AND INDIRECT COMPARATIVE TESTS ARE PROBATIVE OF NONOBVIOUSNESS
Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims.
- The patentability of an intermediate may be established by unexpected properties of an end product “when one of ordinary skill in the art would reasonably ascribe to a claimed intermediate the ‘contributing cause’ for such an unexpectedly superior activity or property.”
716.02(c) Weighing Evidence of Expected and Unexpected Results
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I. EVIDENCE OF UNEXPECTED AND EXPECTED PROPERTIES MUST BE WEIGHED
Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention.
- Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness.
II. EXPECTED BENEFICIAL RESULTS ARE EVIDENCE OF OBVIOUSNESS
“Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.”
716.02(d) Unexpected Results Commensurate in Scope With Claimed Invention
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Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.”
- In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.
I. NONOBVIOUSNESS OF A GENUS OR CLAIMED RANGE MAY BE SUPPORTED BY DATA SHOWING UNEXPECTED RESULTS OF A SPECIES OR NARROWER RANGE UNDER CERTAIN CIRCUMSTANCES
The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof.
II. DEMONSTRATING CRITICALITY OF A CLAIMED RANGE
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
716.02(e) Comparison With Closest Prior Art
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An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.
- “A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference.”
I. THE CLAIMED INVENTION MAY BE COMPARED WITH PRIOR ART THAT IS CLOSER THAN THAT APPLIED BY THE EXAMINER
Applicants may compare the claimed invention with prior art that is more closely related to the invention than the prior art relied upon by the examiner.
II. COMPARISONS WHEN THERE ARE TWO EQUALLY CLOSE PRIOR ART REFERENCES
Showing unexpected results over one of two equally close prior art references will not rebut prima facie obviousness unless the teachings of the prior art references are sufficiently similar to each other that the testing of one showing unexpected results would provide the same information as to the other.
III. THE CLAIMED INVENTION MAY BE COMPARED WITH THE CLOSEST SUBJECT MATTER THAT EXISTS IN THE PRIOR ART
Although evidence of unexpected results must compare the claimed invention with the closest prior art, applicant is not required to compare the claimed invention with subject matter that does not exist in the prior art.
716.02(f) Advantages Disclosed or Inherent
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716.02(g) Declaration or Affidavit Form
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716.03 Commercial Success
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I. NEXUS BETWEEN CLAIMED INVENTION AND EVIDENCE OF COMMERCIAL SUCCESS REQUIRED
An applicant who is asserting commercial success to support its contention of nonobviousness bears the burden of proof of establishing a nexus between the claimed invention and evidence of commercial success.
- The term “nexus” designates a factually and legally sufficient connection between the evidence of commercial success and the claimed invention so that the evidence is of probative value in the determination of nonobviousness.
II. COMMERCIAL SUCCESS ABROAD IS RELEVANT
Commercial success abroad, as well as in the United States, is relevant in resolving the issue of nonobviousness.
716.03(a) Commercial Success Commensurate in Scope With Claimed Invention
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716.03(b) Commercial Success Derived From Claimed Invention
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I. COMMERCIAL SUCCESS MUST BE DERIVED FROM THE CLAIMED INVENTION
In considering evidence of commercial success, care should be taken to determine that the commercial success alleged is directly derived from the invention claimed, in a marketplace where the consumer is free to choose on the basis of objective principles, and that such success is not the result of heavy promotion or advertising, shift in advertising, consumption by purchasers normally tied to applicant or assignee, or other business events extraneous to the merits of the claimed invention, etc.
- In ex parte proceedings before the Patent and Trademark Office, an applicant must show that the claimed features were responsible for the commercial success of an article if the evidence of nonobviousness is to be accorded substantial weight.
II. COMMERCIAL SUCCESS MUST FLOW FROM THE FUNCTIONS AND ADVANTAGES DISCLOSED OR INHERENT IN THE SPECIFICATION DESCRIPTION
To be pertinent to the issue of nonobviousness, the commercial success of devices falling within the claims of the patent must flow from the functions and advantages disclosed or inherent in the description in the specification.
- Furthermore, the success of an embodiment within the claims may not be attributable to improvements or modifications made by others.
III. IN DESIGN CASES, ESTABLISHMENT OF NEXUS IS ESPECIALLY DIFFICULT
Establishing a nexus between commercial success and the claimed invention is especially difficult in design cases.
- Evidence of commercial success must be clearly attributable to the design to be of probative value, and not to brand name recognition, improved performance, or some other factor.
IV. SALES FIGURES MUST BE ADEQUATELY DEFINED
Gross sales figures do not show commercial success absent evidence as to market share, or as to the time period during which the product was sold, or as to what sales would normally be expected in the market.
716.04 Long-Felt Need and Failure of Others
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I. THE CLAIMED INVENTION MUST SATISFY A LONG-FELT NEED WHICH WAS RECOGNIZED, PERSISTENT, AND NOT SOLVED BY OTHERS
Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution.
The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors:
- First, the need must have been a persistent one that was recognized by those of ordinary skill in the art.
- Second, the long-felt need must not have been satisfied by another before the invention by applicant.
- Third, the invention must in fact satisfy the long-felt need.
II. LONG-FELT NEED IS MEASURED FROM THE DATE A PROBLEM IS IDENTIFIED AND EFFORTS ARE MADE TO SOLVE IT
Long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references.
III. OTHER FACTORS CONTRIBUTING TO THE PRESENCE OF A LONG-FELT NEED MUST BE CONSIDERED
The failure to solve a long-felt need may be due to factors such as lack of interest or lack of appreciation of an invention’s potential or marketability rather than want of technical know-how.
716.05 Skepticism of Experts
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716.06 Copying
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716.07 Inoperability of References
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716.09 Sufficiency of Disclosure
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716.10 Attribution Affidavit or Declaration to Overcome Rejection Under Pre-AIA 35 U.S.C. 102 or 103
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This MPEP section is not applicable to applications subject to the first inventor to file provisions of the AIA unless being relied upon to overcome a rejection under pre-AIA 35 U.S.C. 102(g).
When subject matter, in a patent application filed jointly by S and another, is claimed in a later application filed by S, the joint patent or joint patent application publication is a valid reference available as prior art under pre-AIA 35 U.S.C. 102(a), (e), or (f) unless overcome by affidavit or declaration under 37 CFR 1.131(a) showing prior invention or an unequivocal declaration by S under 37 CFR 1.132 that he or she conceived or invented the subject matter disclosed in the patent or published application. Disclaimer by the other patentee or other applicant of the published application should not be required but, if submitted, may be accepted by the examiner.
An affidavit or declaration under 37 CFR 1.131(a) cannot be used to overcome a rejection based on a U.S. patent or U.S. patent application publication naming another inventor which claims interfering subject matter.
Where there is a published article identifying the authorship or a patent or an application publication identifying the inventorship that discloses subject matter being claimed in an application undergoing examination, the designation of authorship or inventorship does not raise a presumption of inventorship with respect to the subject matter disclosed in the article or with respect to the subject matter disclosed but not claimed in the patent or published application so as to justify a rejection under pre-AIA 35 U.S.C. 102(f).
- An uncontradicted “unequivocal statement” from the applicant regarding the subject matter disclosed in an article, patent, or published application will be accepted as establishing inventorship.
A successful 37 CFR 1.132 affidavit or declaration establishing derivation by the author, patentee, or applicant of the published application of a first reference does not enable an applicant to step into the shoes of that author, patentee, or applicant of the published application in regard to its date of publication so as to defeat a later second reference.
The following examples demonstrate the application of an attribution affidavit or declaration.
Example 1
During the search the examiner finds a reference fully describing the claimed invention. The applicant is the author or patentee and it was published or patented less than one year prior to the filing date of the application. The reference cannot be used against applicant since it does not satisfy the 1-year time requirement of pre-AIA 35 U.S.C. 102(b).
Example 2
Same facts as above, but the author or patentee is an entity different from applicant. Since the entities are different, the reference is prior art under pre-AIA 35 U.S.C. 102(a) or (e).
In the situation described in Example 2, an affidavit under 37 CFR 1.132 may be submitted to show that the relevant portions of the reference originated with or were obtained from applicant. Thus the affidavit attempts to convert the fact situation from that described in Example 2 to the situation described in Example 1.
