PTAB Archives - ElementIP Law

In the recent decision Laboratory Corporation of America Holdings v. Ravgen, Inc., No. 2023-1342, 2023-1345 (Fed. Cir. Jan. 6, 2025) the Federal Circuit addressed an issue that commonly arises when challenging an Examiner’s determination of obviousness: is there sufficient motivation to combine the references? 

In Ravgen the Board found themselves having to deal with references that were “neither fish nor fowl” in terms of their motivating factors; that is, references lacking clear, easily identifiable and direct statements that either encourage or discourage their combination. In affirming the Board, the Federal Circuit found that the Board had properly weighed the evidence both for and against motivation to combine and correctly found that patentee’s reasoning and evidence against combinability outweighed petitioner’s arguments in favor of combinability.

Critical to this finding was the court’s approval of the Board’s determination, made in view of the noted absence of clearly motivating statements in the references, that “the literature would have dissuaded a [person of ordinary skill in the art] from using formaldehyde or paraformaldehyde in the [Chiu] modified method.” In supporting this decision the Federal Circuit cited Arctic Cat Inc. v. Bombardier Recreational Products Inc., 876 F.3d 1350 (Fed. Cir. 2017) and noted that “[e]ven if evidence does not ‘rise to the level of teaching away,’ it is still proper for the Board to consider evidence that “suggests reasons that a skilled artisan would be discouraged from pursuing such a combination.”

Both Ravgen and Arctic Cat remind us that, in attacking an Examiner’s combination of references, the “gold standard” of a clear teaching away in one or more of the references is not always necessary, and anything in a reference that discourages its combination with another can be used to attack the Examiner’s motivation to combine.

“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.

In Ex parte Perrot-Simonetta (Appeal 2023-000358), the Patent Trial and Appeal Board (“the Board”) reversed the Examiner’s obviousness rejection based on the principle of inherency.

The claim at issue was directed to a steel part having a particular elemental composition and microstructure and exhibiting certain properties. Specifically, in addition to the specific mechanical strength, elastic limit, and breaking elongation, the claimed steel part had “a constriction at break greater than 30%.”

The Examiner rejected the claim as obvious over Gao in view of Resiak and Han. The Examiner admitted that Gao was silent towards the constriction at break value but reasoned that since Gao described steel having overlapping composition, microstructure, and other mechanical properties, one skilled in the art would have found Gao’s steel necessarily had the recited constriction at break value. The Examiner additionally cited Resiak and Han, which described steel having the recited constriction at break value and admittedly “similar” but not identical compositions, to support her inherency/obviousness position.

The Appellant argued that Resiak and Han provided evidence showing that Gao’s steel did not necessarily possess the characteristics of the claimed product, and thus rebutted, not supported, the Examiner’s allegedly prima facie case. In particular, the Appellant noted that Resiak described a steel with the recited mechanical strength and constriction at break value but not the recited breaking elongation value. The Appellant further noted the different processing parameters for steel described in Gao, Resiak, and Han and argued that the secondary references could not provide any information on the constriction at break value of Gao.

The Board agreed with the Appellant and held that the combined prior art teaching did not support the Examiner’s finding that the recited properties were necessarily present in Gao’s steel. Judge Owens further noted in his concurring opinion that the Examiner had exercised impermissible hindsight.

Takeaway: A prima facie case of either anticipation or obviousness is established when the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes. However, as shown in Perrot-Simonetta, mere overlap in composition and structure may not be sufficient to establish that the claimed and prior art products are identical or substantially identical in structure or composition.

Judges: Terry J. Owens, Catherine Q. Timm, and Lilan Ren

Two recent cases – one at the PTAB and one at the Federal Circuit – illustrate key considerations in determining whether a nature-based product is patent eligible under 35 U.S.C. §101.

In ex Parte Ronchi, the PTAB reversed an examiner’s rejection of claims as patent ineligible under §101. Independent claim 13 recited:

A powder solid composition comprising at least one phospholipid and a hydroalcoholic extract of Bergamot fruit containing flavonoids, neoeriocitrin, naringin and neohesperidin as the only extract.

The examiner found that claim 13 was directed to a “product of nature, namely naturally occurring compounds found in Bergamot fruit.” The examiner acknowledged that the recited hydroalcoholic extract was not found in nature, but argued that isolation or purification by itself “does not result in a product which is ‘markedly different’ from the naturally-occurring component.”

The appellant acknowledged that the components in claim 13 were naturally occurring, but argued that the claimed powder solid composition “is a physical form distinct from any of the naturally-occurring sources of the claimed composition.” The appellant also argued that the combination of phospholipid with the hydroalcoholic extract provided a markedly different characteristic (improved bioavailability of at least naringin and neohesperidin) compared to the extract alone.

The PTAB agreed with the appellant. Citing the Supreme Court case of Myriad, the PTAB acknowledged that “claiming a natural product that is merely separated from elements found in its natural environment, where the structure of the natural product is not otherwise altered, does not support a conclusion that the isolated product is patent eligible.” However, the PTAB noted that “the mere fact that the components of the claimed composition are all nature-based does not end the inquiry as to whether the claimed composition recites a judicial exception.” Instead, according to Myriad (and Chakrabarty) it is necessary to evaluate the claimed composition for “markedly different characteristics from any found in nature.”

In analyzing the composition of claim 13 for markedly different characteristics, the PTAB explained that it “must compare the characteristics of the claimed nature-based composition to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed nature-based product are markedly different.” The PTAB thus looked for the appropriate naturally occurring counterpart.

The PTAB did not consider Bergamot fruit itself to be an appropriate naturally occurring counterpart.[1] Instead, it considered the appropriate counterpart to be a composition containing the components recited in the extract: flavonoids, neoeriocitrin, naringin and neohesperidin. The PTAB disagreed with the examiner’s finding that Bergamot fruit extract could contain the phospholipid lecithin. Accordingly, the PTAB “determine[d] that claim 13 recites two nature-based compositions: (1) the extract having flavonoids, neoeriocitrin, naringin, and neohesperidin, and (2) the phospholipid.”

The PTAB then looked at the appellant’s comparison of the claimed composition (combining the extract and phospholipid) to the extract alone. Data in the specification showed improved bioavailability of naringin and neohesperidin when provided in the claimed composition (extract + phospholipid) compared to when provided in the extract (without the phospholipid).

These data persuaded the PTAB that the claimed composition possessed markedly different characteristics from a naturally occurring counterpart composition, and thus that the claimed composition was patent eligible under §101. Accordingly, the PTAB reversed the examiner’s rejection.

In a different recent case, ChromaDex, Inc., Trustees of Dartmouth College v. Elysium Health, Inc., the Federal Circuit found claims to a nature-based product to be ineligible under §101.

Claim 1 in ChromaDex recited:

A composition comprising isolated nicotinamide riboside [NR] in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer’s solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increased NAD+ biosynthesis upon oral administration.

The court found that claim 1 read on milk[2] as a naturally occurring product, with the only difference being that NR is not “isolated” in milk. As the PTAB did in Ronchi above, the court relied on the Supreme Court cases of Myriad and Chakrabarty in analyzing patent eligibility under §101.

The court found that “the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility. The claimed compositions remain indistinguishable from natural milk because, other than separation from some other components, the isolated NR is no different structurally or functionally from its natural counterpart in milk.”

The appellant argued that the claimed compositions were advantageous compared to milk because the isolation of NR allowed for significantly more NAD+ biosynthesis than provided by milk. However, the court found that the “claims do not require any minimum quantity of isolated NR. Nor do these claims attribute the claimed increase in NAD+ biosynthesis to the isolated NR, requiring only that the composition increase NAD+ production.” The court reasoned that “[b]ecause milk increases NAD+ biosynthesis, the claimed compositions do not possess characteristics markedly different from those found in nature.” The court concluded that “[t]he claimed compositions do not exhibit markedly different characteristics from natural milk and are, therefore, invalid for claiming a patent-ineligible product of nature.” Accordingly, the court found the claims invalid under §101.

Takeaway: Claims reciting nature-based products, i.e., products whose components are naturally occurring, face scrutiny under §101. Under the framework of Myriad and Chakrabarty, The USPTO and courts analyze these claims to determine if the claimed product possesses “markedly different characteristics” from a corresponding naturally occurring product. If such characteristics are shown (as in Ronchi) then the claims can be found patent eligible under §101. However, if such characteristics cannot be shown (as in ChromaDex) then the claims will be found patent ineligible.

[1] If it had done so, would it have found that cells in the fruit contained phospholipids in their membranes, and thus that the fruit itself contained each of the components recited in claim 13, even if not the specific phospholipids recited in dependent claim 21?

[2] Milk is a composition containing NR (but not “isolated” NR), tryptophan and nicotinamide, in admixture with a sugar (lactose). Milk is formulated for oral administration, and (through tryptophan) increases NAD+ biosynthesis upon consumption.

In the 1960s the Federal Circuit’s predecessor court, the Court of Customs and Patent Appeals (CCPA), established a “flavor” of anticipation that did not require an example – when a reference was so limited and specific in its disclosure that one of ordinary skill in the art was able to “at once envisage” the specific compound, method, etc., claimed, that claim was anticipated by the reference. On December 20, 2022, the Patent Trial and Appeal Board (PTAB) in Ex parte Mizushima (Appeal 2022-003863) extended this theory of anticipation to a secondary, academic use of an “envisioned” composition.

In Mizushima the claim was directed to a powdered coloring material comprising at least one pigment selected from three protein-based pigment candidates in combination with at least one of three chelating agents. The prior art cited described an academic study of the influence of temperature, pH, and preservatives on one of the claimed pigment candidates, all conducted in solution. Eight preservatives were used, one of which was a claimed chelating agent (citric acid), used in solution in a claimed weight ratio. In addition to the solution studies, the paper provided a microstructure analysis on dried solutions of the pigment with two of the preservatives – sugar, described as being known for stabilizing proteins, and salt.

In affirming the examiner’s rejection, the Board acknowledged that the reference failed to make a solid composition comprising the pigment and citric acid in the claimed amounts, but took the position that one of ordinary skill “would have readily recognized or inferred” such a solid composition as emanating from the described solution using citric acid given the description of dried solutions using sugar and salt.

Ex parte Mizushima thus extends traditional “Petering” anticipation, which typically arises when an examiner chooses a combination of ingredients from a limited list to provide a claimed composition, to include different physical forms of ingredient combinations described in a reference for the purpose of academic study. That is, in a typical “Petering” situation the examiner constructs the anticipatory composition for the same reason the inventors did – to cure a disease, to treat a surface, to add to gasoline, etc. Here, the only reason the authors dried two of their solutions was academic curiosity – to see how two of their preservatives coated the pigment. Would the Federal Circuit agree with the Board that academic curiosity is sufficient motivation for one of ordinary skill to “at once envisage” a new form of a described material?

Judges: Hastings, Colaianni, Kennedy

Ex parte Fox is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing the interpretation of a Markush group in a claim rejected for anticipation and obviousness.

The claim at issue was directed to “[a] cleaning solution comprising one or more solvents selected from the group consisting of acetoacetates, alcohols, glycol ethers, glycol esters, terpenes, and water…” The claim also required other components and properties.

The examiner identified a cleaning solution in the prior art which included some of the solvents listed in the claim. However, the prior art cleaning solution required a further solvent, “at least one oxyisobutyric acid ester.” The examiner asserted that, although at least one of the listed solvents must be present, the “comprising” language in the claim permitted the presence of additional solvents in the cleaning solution.

The examiner supported his position by citing MPEP 2111.03.II, which, in turn, cites In re Crish, 393 F.3d 1253 (Fed. Cir. 2004). The examiner relied on the following description of the Crish case from the MPEP:

In determining the scope of applicant’s claims directed to “a purified oligonucleotide comprising at least a portion of the nucleotide sequence of SEQ ID NO:1 wherein said portion consists of the nucleotide sequence from [521] to 2473 of SEQ ID NO:1…” the court stated that the use of “consists” in the body of the claims did not limit the open-ended “comprising” language in the claims…

The PTAB stated that a case cited in the same paragraph of the MPEP relied on by the examiner, Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, (Fed. Cir. 2016), included a fact pattern much closer to the claim on appeal. The PTAB stated that Crish was distinguishable from the claims on appeal, because Crish did not involve a Markush group of distinct alternatives from which to select.

Relying on the Multilayer case, the PTAB noted that the use of the transitional phrase “consisting of” to set off a patent claim element creates a very strong presumption that that claim element is closed and therefore excludes any elements, steps, or ingredients not specified in the claim. Thus, if a patent claim recites “a member selected from the group consisting of A, B, and C,” the member is presumed to be closed to alternative ingredients D, E, and F. In the claim on appeal, the “member” was the “solvent,” so the claim was closed to solvents other than those specifically recited in the Markush group – even though the claimed cleaning solution was open to containing other non-solvent elements.

When the claim on appeal was properly construed, the prior art was not sufficient to anticipate or render obvious the claim, because the prior art required the presence of “at least one oxyisobutyric acid ester” solvent, i.e, a solvent that was not recited in the Markush group of the claim.

Takeaway: Markush groups are frequently used to define components of composition. It is important to be intentional when drafting Markush group to control what is within and outside the scope of the claim. In thinking about a claim drafted in typical Markush format, “an X selected from the group consisting of A, B, and C,” attention is often focused on A, B, and C, which define what must be present. However, care must be taken in defining X which indicates what will be excluded from the claim. A broad X may define over the prior art but may also make design-around compositions easy to identify.

Judges: Cashion, McGee, Inglese

U.S. examiners often combine two or more references in making an obviousness rejection. Sometimes, a possible argument against obviousness is that there would not have been a reasonable expectation of success in combining the references in the way proposed by the examiner. When making such an argument, however, applicants might inadvertently raise the issue of enablement. The recent case of Ex parte During (Appeal No. 2022-000776) illustrates this situation.

Independent claim 1 in During recited:

A method of treating narcolepsy comprising administering to a patient in need thereof a pharmaceutical composition comprising 4,5,6,7-tetrahydroisoxazolo [5,4-c] pyridine-3-ol (gaboxadol) or a pharmaceutically acceptable salt thereof.

The examiner rejected claim 1 as obvious based on a combination of two references: Walsh and Abad. Walsh taught that the drug gaboxadol enhances slow wave sleep (SWS). Abad taught that certain SWS-enhancers are effective to treat narcolepsy. Combining these references, the examiner found that it would have been obvious to treat narcolepsy with gaboxadol.[1]

The applicant argued that there would not have been a reasonable expectation of success in combining the cited references to obtain the claimed methods. For example, Abad indicated that it was unclear whether SWS enhancement was the appropriate mechanism for treating narcolepsy, and that the effectiveness of any one compound was uncertain until tested. The applicant further explained that the SWS-enhancers used in Abad bound to a different receptor than gaboxadol, and therefore acted by a different mechanism.

The PTAB agreed with the applicant. It found that the cited references “merely render[] gaboxadol obvious to try in a method to treat narcolepsy.” However, “Abad does not provide specific guidance as to how gaboxadol may be used to treat narcolepsy, concluding instead that ‘[m]ore research is needed to determine the usefulness of [other potential SWS enhancers] in consolidating nocturnal sleep in narcolepsy patients.’” The PTAB cited Abad’s conclusions that “[n]arcolepsy remains a complex disease whose cure remains elusive despite our expanding knowledge about its pathophysiology” and that “[d]isease-specific therapies need further development and testing before they can be clinically relevant.”

Finding that there would not have been a reasonable expectation of success in combining Walsh and Abad to obtain the claimed methods, the PTAB reversed the obviousness rejections.

However, the PTAB issued a new ground of rejection: lack of enablement.

The PTAB noted that independent claim 1 was narrow in terms of the drug (gaboxadol or pharmaceutically acceptable salts) and disease treated (narcolepsy). However, the PTAB explained that “the Specification not only lacks any working examples regarding treatment of narcolepsy using gaboxadol, but also provides only the most generic teachings regarding, e.g., the dosage, route, and/or timing or frequency of administration.” The PTAB cited Abad’s teaching that narcolepsy is “a complex disease whose cure remains elusive despite…expanding knowledge about its pathophysiology,” and found that “a significant quantity of experimentation would have been required to carry out the claimed method.”

Thus, the same teachings from the references used by the applicant to argue against obviousness were used by the PTAB to argue against enablement. Although the PTAB reversed the obviousness rejections, it found the claims not to be enabled.

Takeaway: Applicants should be careful when addressing obviousness rejections by arguing that there would not have been a reasonable expectation of success in combining references, since such an argument might open the door to an enablement rejection. That is, if the applicant argues that the references do not provide sufficient guidance for a skilled artisan to obtain the claimed invention, the applicant should be ready to explain how a skilled artisan could practice the claimed invention based on guidance from the specification.

Judges: Fredman, Jenks, Chang

[1] The examiner also made a second obviousness rejection, over Walsh in view of Mignot, where Mignot was cited for its teaching that SWS-enhancers are effective to treat narcolepsy, similar to the teaching in Abad.

In Ex parte Langenfeld (Appeal 2021-004075), the Examiner rejected the claims as obvious over a combination of prior art references and based on the theory of design choice. The Patent Trial and Appeal Board (“Board”) reversed.

The invention at issue was directed to a method of producing rolled food products that included a step of cutting a dough sheet to form a roll sheet having a continuous pattern comprised of “an asymmetrical repeat unit.”

Wolf, the primary reference found by the Examiner, described a method of producing croissants. As admitted by the Examiner, Wolf did not disclose a cutting pattern that would produce an asymmetrical repeat unit. The Examiner then turned to Mel, which described making homemade crescent rolls. Mel disclosed cutting a circular dough into triangles and described that it was all right if the “triangles aren’t all perfect” because “[that] is something special about home cooking – it is not all perfect and rigid.” The Examiner thus concluded that “it would have been obvious to form the triangles and subsequently the rolls of Wolf as slightly asymmetrical in order to create a ‘homemade’ appearance that is special and pleasing to consumers.” The Examiner further contended that the claimed asymmetrical repeating unit shape was merely an obvious matter of design choice, alleging that the shape and symmetry of the rolls would have been obvious to adjust in the absence of a demonstration of criticality.

However, the Board found that, at best, Mel only suggested random variations, not “asymmetrical repeat units” as required by Appellant’s method. Thus, the Board agreed with Appellant that not only the resulting arrangement of Wolf as modified by Mel failed to meet the claim limitation, but Mel was “directly contrary to the Examiner’s conclusion that all the produced rolls would be the same and have the same asymmetry” in that Mel equated the homemade look to imperfection.

With respect to the Examiner’s allegation of obvious design choice, the Board noted that Appellant provided evidence showing that the asymmetrical repeating unit was significant to the invention (specifically, it was possible to retain a symmetrical outer appearance despite that each of crescent rolls had a different amount of dough at each end) and was more than one of the numerous configurations a skilled artisan would have found obvious for the purpose of forming rolled dough products. Because the prior art had no suggestion for changing the shape to any asymmetrical repeating unit shape, the Board found the evidence provided by Appellant was sufficient to prove non-obviousness. In addition, the Examiner did not adequately rebut Appellant’s evidence of significance. Therefore, the Board held that Appellant need not show the criticality of the change in shape for unexpected results and reversed the Examiner’s obviousness rejection.

Takeaway: When a claim feature cannot be found in prior art, examiners may apply the theory of “design choice” and often also request applicants to provide evidence of criticality to overcome an obviousness rejection based on design choice. Langenfeld, again, clarifies that evidence of criticality is not necessary under such circumstances if applicants provide unrebutted evidence of significance. Examples of evidence of significance include a different function associated with the claim feature, a stated problem solved by the claim feature, and improvements, advantages, and benefits of the claim feature (see also one of our previous posts here). Such evidence can be found in applicant’s specification and/or prior art or can be provided in the form of a declaration during examination.

Judges: C. Q. Timm, G. C. Best, and N. W. Wilson

In Ex parte Makarova (Appeal No. 2022-002730), the examiner rejected the claims as obvious based on a combination of references. The PTAB reversed, finding important differences between two references suggesting they should not be combined in the way proposed by the examiner.

Independent claim 1 recited:

A microfilter comprising:

a single polymer layer formed from an epoxy-based negative photo-definable dry film, wherein the single polymer layer has a flexibility to be disposed on a roll and unrolled; and

a plurality of apertures formed by exposing the single polymer layer to a UV light via an optical mask to obtain a selected shape of said apertures based on said mask, each of said apertures extending through the single polymer layer having said flexibility,

said single polymer layer having said flexibility forming a freestanding unattached microfilter structure with uniform thickness and having said flexibility.

The examiner found that the primary reference (Wolfe) described most of the limitations of claim 1. For example, Wolfe described a particulate filter with regularly spaced micropores, which comprised a single flexible polymer layer formed from a photo-definable dry film (MYLAR). The single polymer layer in Wolfe had flexibility sufficient to be disposed on a roll and unrolled, and its apertures were formed by exposing the single polymer layer to radiation via an optical mask. The single polymer layer also formed a freestanding, unattached microfilter structure with a uniform thickness.

However, the film in Wolfe was not an epoxy-based film, as recited in claim 1. The examiner turned to a secondary reference (DuPont) for this limitation.

The examiner found that DuPont described a flexible epoxy-based negative photo-definable dry film that had excellent thickness uniformity after hot roll lamination. The examiner found that it would have been obvious to substitute the film from DuPont into Wolfe’s system because both references related to microfabricated polymer membrane structures.

The applicant argued that such a substitution would not have been obvious. In particular, the applicant noted that DuPont’s film was “best suited for permanent applications where it is imaged, cured and left on devices” rather than being a freestanding unattached structure as recited in claim 1. Additionally, the excellent thickness uniformity after hot roll lamination in DuPont was premised on the film being laminated to a substrate, rather than being freestanding.

The PTAB sided with the applicant. The PTAB found that “because DuPont specifically indicates that its film is best used while laminated to an underlying substrate, a person of skill in the art would not have thought that film to be a substitute for Wolfe’s freestanding polymeric sheet.” The PTAB concluded that “the Examiner’s rationale as to why a person of skill in the art would have substituted DuPont’s film for Wolfe’s polymeric sheet is not adequately supported by the evidence of record.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Obviousness rejections often involve a primary reference describing most of the claimed elements, with a secondary reference used to fill in gaps in the primary reference. When an examiner takes the position that it would have been obvious to substitute an element from the primary reference with an element from the secondary reference, it is worth challenging that position if there is a good reason not to make such a substitution.

Judges: Housel, Best, Wilson

Older Posts

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Is Inherency Established If Overlap in Composition and Structure Is Found?

Patent Eligibility of Nature-Based Products Under §101

“Petering” Anticipation Extended to Different Physical Form

“Comprising” and “Consisting Of”? – How Closed Markush Groups Operate in Open Composition Claims

The Double-Edged Sword of Reasonable Expectation of Success and Enablement

PTAB Dismisses Examiner’s Request for Demonstration of Criticality

When a Substitution Isn’t Obvious

USPTO Withdraws Proposed Terminal Disclaimer Rule

USPTO Further Delays Non-DOCX Fee Until January 17, 2024