USPTO Archives - ElementIP Law

“If you give me six lines written by the hand of the most honest of men, I will find something in them which will hang him.”

― Cardinal Richelieu (1585-1642)

On April 29, 2024, the Patent Trial and Appeal Board in Ex parte Wang (Appeal 2023-003255) affirmed an examiner’s single reference obviousness rejection of a claim to a process for stabilizing a protein against thermal inactivation:

A process for stabilizing a protein against thermal inactivation, comprising: binding a protein to the surface of a solid substrate; the protein bound to the surface by a linker moiety between an active group of the protein and said substrate, wherein the linker comprises a bond formed from one or more active groups selected from the group consisting of alcohol, thiol, carboxylic acid, anhydride, epoxy, and ester, and wherein said bond of the protein to the solid substrate stabilizes the protein against thermal inactivation.

This claim was finally rejected over Minier, characterized by the Examiner as disclosing a protein bound to a solid surface via “an alcohol linker active group bound to [a] metal substrate through a glutaraldehyde active group,” and thereby being inherently stabilized against thermal inactivation.

Appellants made two arguments. First, Appellants argued that surface bonding through a glutaraldehyde group was not included in or suggestive of the requirements of Claim 1. Second, they challenged the inherency finding.

With regard to the first argument, Appellants, in their Pre-Appeal Brief filed in direct response to the final rejection, characterized Claim 1 as reciting “[a] protein bound to the surface [of a solid substrate] by a linker moiety between an active group of the protein and said substrate, wherein the linker comprises a bond formed from [an] alcohol, thiol, carboxylic acid, anhydride, epoxy, and ester.” Then, in their Appeal Brief, Appellants characterized Claim 1 as reciting “[a] process for stabilizing a protein against thermal inactivation comprising binding a protein to the surface of a substrate; … by a linker moiety …. formed from one or more active groups selected from the group consisting of alcohol, thiol, carboxylic acid, anhydride, epoxy, and ester.” In both instances, Appellant argued that the reference’s use of a glutaraldehyde active group failed to disclose bonding a protein to a surface using one of their claimed linker moiety’s active groups. As for their second argument – inherent stabilization – Appellants argued that the reference nowhere discussed or recognized any thermal stabilization of the bound protein.

The Board was having none of it. Characterizing both issues as ones that “resolve based on a proper interpretation of claim 1” the Board walked Appellants through their surface/linker/active group claim language, demonstrating that in Claim 1 the linker’s active group need not be directly bound to the surface in the claim, just located “between” the protein and the surface. And with regard to thermal stability, the Board pointed to Appellants’ specification, which described thermal stability as a property necessarily flowing from the bond. Rejection Affirmed.

What went wrong? Well, Appellant was apprised of the Office’s interpretation of their claim language after the first rejection. Rather than discuss the case with the Examiner and come to agreement as to how to distinguish their clearly different invention from the applied art they barreled ahead with the same claim language, insisting that the Office see things their way. And when the Office didn’t, rather than seek reconsideration from the Examiner, Appellant filed a multi-issue Pre-Appeal Brief that simply upheld the rejection and provided no useful feedback. Full Appeal (with Oral Hearing) followed, after which the Board provided Appellant with the same answer the Examiner had given them two and a half years earlier: your invention is different, but your claims encompass the prior art.

The moral of the story? Differences aren’t important unless they are reflected in the claims. Listen to what the Examiner is saying – they look at the claims differently than you do. Sometimes, they are right. Oftentimes, simple amendments can address the issue, as here.

On April 17, 2024, the Patent Trial and Appeal Board in Ex parte Sanada (Appeal 2023-002165) affirmed an examiner’s single-reference obviousness rejection of a claim to a magnetic material comprising magnetic particles and an intercalated phase and requiring an angle of orientation between the magnetic particles and the plane of the material to be 10° or less.

In attacking the prima facie case, Appellant argued that the applied reference did not suggest the claimed combination of particularities concerning each of the magnetic particles, the intercalated phase, and the angle of orientation, and urged that the data in the specification demonstrated “unexpectedly favorable strength and magnetic properties for their inventive Examples in contrast to Comparative Examples.”

Appellant’s first argument was dismissed by the Board in view of the reference’s disclosure of overlapping ranges for each limitation, citing In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) (“A prima facie case of obviousness arises when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). In dismissing the second argument – that data in the specification demonstrated unexpected results – the Board reviewed the specification and found it lacking:

Here, Appellant’s unexpected results are not supported by factual evidence. The Specification’s description of Figures 11–13 and Tables 1 and 2 does not describe the inventive Examples as demonstrating results that are unexpected. For instance, paragraphs 110–112 of the Specification do not describe the results shown in Figures 11–13 as unexpected and paragraph 166 merely states that results provided in Table 2 are “excellent” and “remarkable effects are obtained.” Therefore, Appellant’s assertions that the results are unexpected are supported only by attorney argument and conclusory statements in the Specification, which are insufficient.

and in a final blow noted that Appellant had not addressed whether the asserted unexpected results provided a comparison with the closest prior art. Rejection affirmed.

What could Appellant have done differently? They could have filed a Declaration supporting their contentions and providing the (apparently available) data in the form of evidence sufficient to overcome the rejection. As noted in In re Soni, 54 F.3d 746 (Fed. Cir.1995), cited by the Board in this appeal, “when an applicant demonstrates substantially improved results, as Soni did here, and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary (emphasis in original).” Because it is unusual for a patent specification to describe data as unexpected, the filing of a Declaration providing this statement and explaining the importance of the results can oftentimes mean the difference between allowance and rejection.

Recently we reviewed the USPTO’s published Examiner guidance concerning “the flexible approach to determining obviousness that is required by KSR Int’l Co. v. Teleflex Inc. (KSR)” in which the Office instructed Examiners to avoid any type of formalistic or formulaic approach when providing a reason to modify the prior art in favor of relying on any possible source that “may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious.” Unfortunately for applicants, this advice seems to have accurately captured the current sensibility of the Federal Circuit which, in Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024), recently openly admonished a District Court for using a “degree of rigidity” in its obviousness analysis that was foreclosed by KSR and, perhaps most devastatingly, for “ask[ing] the wrong questions about important aspects of the obviousness inquiry.”

In particular, and among the district court’s several identified errors, the Federal Circuit in Janssen found that the district court analyzed the prior art without giving the needed weight to the perspective of a person of ordinary skill in the art (POSA) who is “capable of deducing what references fairly suggest or employing ordinary creativity.” And instead of considering the prior art in context or in combination, the Federal Circuit criticized the district court’s consideration of each reference one-by-one, “identifying each difference or dissimilarity between an individual reference and the claims, but not fully assessing the teachings in toto” thereby yielding a “siloed and inflexible approach” that left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s understanding of, or motivation to modify, the primary references at issue.” This approach, in the view of the Federal Circuit, inflated the significance of “minor variations between the prior art and the claims,” leading to the district court’s erroneous conclusion of nonobviousness.

Given the general decorum typically surrounding court opinions, this level of direct and unfettered criticism can mean only one thing – that at least for the foreseeable future the USPTO guidelines got it right insofar as the Federal Circuit is concerned. As the Federal Circuit, citing KSR, emphasized in this case, “[a]ssessing obviousness is based on an ‘expansive and flexible approach’ that ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ’.” Applicant beware.

On February 27, 2024, the USPTO published “updated guidance to provide a review of the flexible approach to determining obviousness that is required by KSR Int’l Co. v. Teleflex Inc. (KSR).” While these guidelines are “a matter of internal Office management” and do not constitute new rules or new law, going forward they can be expected to significantly influence how Examiners determine obviousness on a day-to-day basis.

Although the stated purpose of the guidelines refers to the 2007 KSR case, the updated guidance first emphasizes that the factual inquiries set forth in the much earlier Supreme Court decision in Graham v. John Deere (1966) continue to control the obviousness determination within the Office: the scope and content of the prior art; the differences between the prior art and the claims at issue; and the level of ordinary skill. Against this background, the obviousness or nonobviousness of the subject matter is determined in light of any so-called secondary considerations such as unexpected results, commercial success, long felt but unsolved needs, failure of others, etc. It is upon this established “Graham framework” that the Office then addresses the ways in which KSR and its Federal Circuit progeny influence this framework.

Here, the guidelines make it very clear that the Office views KSR and its progeny as mandating flexibility in the determination of obviousness, in two respects: “first with regard to the proper understanding of the scope of the prior art, and second with regard to appropriate reasons to modify the prior art.” As concerns the proper (i.e., flexible) understanding of the prior art, the guidelines emphasize that a person of ordinary skill is “a person of ordinary creativity, not an automaton” who has “common sense, which may be used to glean suggestions from the prior art that go beyond the primary purpose for which that prior art was produced” and to make “reasonable inferences” and “be able to fit the teachings of multiple patents together like pieces of a puzzle.” With regard to a flexible approach in providing a reason to modify the prior art the guidelines disavow any type of formalistic or formulaic approach, such as the teaching, suggestion, and motivation (TSM) test, in favor of any possible source that “may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious” including market forces, design incentives, the interrelated teachings of multiple patents, any need or problem known in the field of endeavor at the time of invention and addressed by the patent, and the background knowledge, creativity, and common sense of the person of ordinary skill.

Finally, and in summing up, the guidelines note the requirement that the Examiner provide a “clear articulation of the reason(s) why the claimed invention would have been obvious,” warning that “common sense—whether to supply a motivation to combine or a missing limitation—cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references” and emphasizing that all relevant evidence, including objective indicia of nonobviousness, must be considered in making the obviousness determination.

On balance, these guidelines do not substantially change what we currently see from Examiners in the chemical arts, so why publish them now? Are we about to see an even more “flexible” approach to obviousness? We think (hope) not. Instead, we believe that these guidelines have been published to make the determination of obviousness more consistent throughout the various technical areas of the Office, including the mechanical and electrical arts where, in our limited experience, the amendments and rebuttal arguments necessary to overcome obviousness rejections are perhaps not as significant, or as convincing, as those necessary for success in the chemical arts.

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