About that Conclusory Rejection… Show Me the Evidence
- October 10, 2018
- Posted by: Stephanie Amoroso, Ph.D.
- Category: Blog
Responding to Conclusory and Unsupported Allegations by USPTO Examiners
The USPTO examiners frequently make factual assertions about the technical subject matter under examination to support rejections—primarily under 35 U.S.C. §§ 103, 112 and 101. But these assertions frequently lack sound reasoning, or evidentiary support for any alleged rationale. Almost as frequently, rebuttal evidence applicants submit is dismissed in an equally conclusory manner. When this happens, applicants should respond by reminding the examiners that these factual assertions or rebuttals must be both articulated with some reasoning and supported by evidence where applicable.
While it is true that the USPTO is unable to perform experiments challenging or substantiating an applicant’s or prior art data, respectively, any technical or scientific theories or mechanisms the examiners rely on to render a claim obvious must nonetheless be supported by evidence in the scientific literature. The Federal Circuit’s predecessor court stated that “[w]hen the PTO seeks to rely upon a chemical theory, in establishing a prima facie case of obviousness, it must provide evidentiary support for the existence and meaning of that theory.” In re Grose, 592 F.2d 1161, 1165, 1167-68 (CCPA 1979). In Grose, the examiner and the Board found that the claimed zeolite had an identical crystal structure as a prior art zeolite based on an allegedly de minimus difference in X-ray diffraction data. The USPTO reasoned that just as a known structural relationship between chemical isomers can supply a prima facie case of obviousness, so could a close x-ray diffraction pattern for crystals. Id. at 1165. The court found the USPTO’s reasoning deficient because the USPTO did not proffer evidence of any chemical theory supporting its analogy of the claimed crystal structures to chemical isomers. Id. at 1168. That said, the court was compelled to affirm the rejection because the applicant declined to submit evidence that the differences in X-ray diffraction data were significant to a person of ordinary skill. Id. at 1167.
More recently, the Federal Circuit reversed an obviousness rejection based on the USPTO’s conclusory allegations of “routine optimization” for obviousness, holding that “[a]bsent some additional reasoning, the Board’s finding that a skilled artisan would have arrived at the claimed invention through routine optimization is insufficient to support a conclusion of obviousness.” In re Stepan Co., 868 F.3d 1342, 1346 (Fed. Cir. 2017). At issue was the examiner’s contention that it would be a routine optimization to select a surfactant (for an herbicide formulation) that would achieve the claimed “cloud point” of at least 70°C, where the prior art disclosed use of surfactants with cloud points above 60°C. The court found that “missing from the Board’s analysis is an explanation as to why it would have been routine optimization” to select and adjust the claimed surfactants to achieve the claimed cloud point. Id. The court further held that the applicant does not have the burden to show the criticality of a claim limitation in the absence of evidence that a person of ordinary skill would have a reason optimize the prior art in the way the examiner asserted. Id. at 1345.
The message from the courts is that examiners must articulate precise reasoning, supported by evidence, to support a prima facie case of obviousness where they are relying on a scientific theory to support obviousness, and when asserting motivations to modify the prior art. Conclusory allegations of “routine optimization” or references to use of “common sense” cannot be used as a substitute for reasoned analysis and evidence.
Likewise, after an applicant responds to a prima facie rejection with factual data or evidence, the USPTO cannot continue to ignore or dismiss such evidence or rebuttal arguments in a cursory manner. MPEP § 1302.14 and the Federal Circuit instructs examiners to consider all evidence and provide more than conclusory reasons why such evidence is insufficient to overcome a rejection:
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.
Although an examiner can be unpersuaded by evidence presented by an applicant, the evidence must be given proper consideration. The Board has reversed examiners who have been “largely dismissive” of evidence. In Ex parte Malone, the Examiner deemed a declaration insufficient to overcome the obviousness rejections because it purportedly stated only conclusions as to why a person of ordinary skill would not understand the prior art reference to disclose a claimed feature. The Board chastised the Examiner for a “largely dismissive” response to the applicant’s declaration (which contained detailed facts) and reversed the obviousness rejection “since the Examiner did not properly consider the submitted evidence” or explain in detail why it was deficient. And in Ex parte Rapp, the applicant submitted a declaration as evidence of long-felt need and commercial success for a food product. The Examiner acknowledged that the appellant had presented rebuttal evidence, but stated: “However, the claimed composition and process has been shown and would have been obvious to make such a product as shown above.” The PTAB reversed the obviousness rejection, characterizing the examiner’s response to the declaration as “largely dismissive.”
Not only must factual evidence be considered, examiners must articulately rebut any facts in the declaration to properly maintain the rejection. In re Alton, 76 F.3d 1168, 1174 (Fed. Cir. 1996). In Alton, the examiner failed to rebut factual evidence in a declaration which explained why one of ordinary skill in the art would have recognized that Alton had possession of the invention:
First, by concluding that the Wall declaration addressed an issue of law instead of an issue of fact, and second, by failing to articulate adequate reasons to rebut the Wall declaration, the examiner and Board failed to consider the totality of the record for the purpose of issuing a final rejection and thus erred as a matter of law.
Further, in Grose and Stepan, supra, the courts also found that the USPTO improperly failed to appropriately consider applicants’ evidence. The Board in Grose disregarded evidence that the prior art disclosed no method of making the zeolite, which the applicant cited to show that claimed zeolite was obvious. Grose, 592 F.2d at 1168. In Stepan, the Federal Circuit chastised the Board for ignoring applicant’s evidence that the closest prior art examples did not achieve the claimed cloud point and weighted against any reasonable expectation of success of obtaining a formulation with the claimed cloud point. Stepan, 868 F.3d at 1347.
Requiring examiners to proffer evidence supporting or in response to factual issues can also be a tool to respond to patent eligibility rejections under § 101. Just as the Federal Circuit recently held that factual evidence as to whether a limitation is “routine or conventional” must be considered in the step 2B eligibility analysis (Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir 2018)), applicants should also ask examiners for factual evidence supporting that the claimed subject matter is, in fact, a product of nature to begin with, at step 2A.