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“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.

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

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.

In May of 2023 the U.S. Supreme Court in Amgen v. Sanofi unanimously found that claims drawn to any antibody that could 1) bind to at least two specified residues of a certain protein and 2) block the binding of the protein to a certain receptor by at least 80% were invalid for lack of enablement. In doing so, the court found patentee’s 26 specific examples and two disclosed methods for finding other examples insufficient to enable “an entire class of things defined by their function.” In Amgen the Supreme Court made it clear that claiming everything – an entire class – by only its function is not allowed unless the specification also discloses “some general quality . . . running through” the class that gives it “a peculiar fitness for the particular purpose.” The court also made it clear that only when this “general quality” is present may the specification then call for a reasonable amount of experimentation to make and use a patented invention.

The U.S. Patent and Trademark Office (USPTO) has recently issued Guidelines for assessing enablement in view of Amgen, setting forth the USPTO’s position. These Guidelines make it clear that the USPTO understands that the ruling in Amgen:

1) applies to all technologies and all types of claims, and

2) confirms that USPTO personnel should continue to use the several “factors” established in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) when assessing enablement – i.e., when assessing whether only a “reasonable” amount of experimentation (Amgen, Supreme Court) or “undue amount” of experimentation (Wands, Federal Circuit) would be required to practice the full scope of the claims.

As a reminder, the Wands factors include, but are not limited to: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make and use the invention based on the content of the disclosure.

In one sense, the USPTO has essentially said, regarding Amgen, that “there is nothing to see here.” On the other hand, however, Amgen can be seen as effectively putting an end to functional claiming in the absence of what will likely be claim-narrowing specification disclosure of “some general quality . . . running through” the functionally claimed class that gives it its “peculiar fitness for the particular purpose.” Thus, Amgen can be viewed as a “reigning in” of a claiming strategy typically used in the early and quickly developing stages of a new technology, when prior art is often unavailable to provide a moderating effect on claim scope.

Recently, the U.S. Supreme Court in Amgen Inc. v. Sanofi, 598 U.S. ___ (May 18, 2023) spoke with one voice in finding claims drawn to any antibody that could do two things – 1.) bind to at least two specified residues of the protein PCSK9 and 2.) block the binding of PCSK9 to the low density lipoprotein receptor gene by at least 80% – invalid for lack of enablement. In doing so, the court found patentee’s 26 specific examples and two disclosed methods for finding other examples insufficient to enable “an entire class of things defined by their function.”

In its analysis the court first reviewed several famous historical U.S. patent cases including the telegraph invented by Morse and the lightbulb invented by Edison that in their view established the concept that claiming everything – an entire class – that provides a certain function is not allowed unless the specification “also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose.’” Only when this general quality is present, the “specification may [then] call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.”

In reviewing Amgen’s specification the Court found that it failed to identify the required “general quality . . . running through” the claimed class of antibodies that provided their “peculiar fitness” for their claimed functions, and found Amgen’s “roadmap” and “conservative substitution” methods to be “little more than two research assignments” amounting to random trial-and-error. For these reasons, the Court found the Amgen claims to be invalid as not enabled.

The Amgen case thus provides us with good guidance for enabling broad claims generally, and especially broad, functional claims – the importance of describing a “general quality” applicable to the claimed class that gives it a “peculiar fitness” for the claimed purpose.

Only time will tell, but how this case will be applied to traditional chemical cases will be interesting to watch. Will a well-defined chemical “core” be sufficient for a Markush group potentially including 500,000 members? Maybe, with the answer probably depending at least in part on how much “detailed” core there is, and its distinctiveness. Clearly, cores described as “A-B-C” with definitions and sub-definitions for each will face an uphill battle, and probably represent one end of the chemical spectrum (the difficult end) whereas a sterol core, even with several substituents, and many choices of substituents, probably represents the other end.

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.

The USPTO is currently operating an interim process for Director review in response to the Supreme Court’s decision in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), which held that decisions rendered by the Administrative Law Judges of the Patent Trial and Appeal Board (PTAB; “Board”) regarding patent validity were not the final decisions of the agency without the ability for the Director of the USPTO to intervene. Under the interim Director review process, any party to a PTAB proceeding (e.g., inter partes review (IPR) and post-grant review (PGR) proceedings) may request review by the Director using a process similar to the current PTAB rehearing procedure.

Director Vidal has actively used the Director review process since she took office last April. In one of her recent decisions (Nested Bean, Inc. v. Big Beings Pty Ltd., IPR2020-01234, Paper 42 (February 24, 2023)), the Director decided on the issue of assessing patentability of multiple dependent claims, which was deemed to be an issue of first impression.

Nested Bean filed an IPR petition challenging claims 1-18 of a patent owned by Big Beings. Claims 1 and 2 were independent claims; claims 3-16 were multiple dependent claims depending directly or indirectly from either claim 1 or 2; and claims 17 and 18 were single directly or indirectly dependent claims of claim 1.

The Board found that claims 1, 17, and 18 were patentable but claim 2 was unpatentable. With respect to the multiple dependent claims 3-16, the Board considered them to be anticipated or rendered obvious by the prior art if either the version depending from claim 1 or the version depending from claim 2 was described by the prior art. Because the Board found that the version depending from claim 2 was unpatentable, without separately considering the patentability of the claims as dependent from claim 1, the Board concluded that claims 3-16 were also unpatentable.

Big Beings filed a request for Director review and argued that the Board should have found claims 3-16, as depending from claim 1, were patentable under pre-AIA 35 U.S.C. § 112, fifth paragraph, which was the statute governing the multiple dependent claims of the patent at issue. Director Vidal granted the request and noted that the determinations and rationale in her decision applied equally to the corresponding post-AIA version of the statute, i.e., 35 U.S.C. § 112(e).

After reviewing the language of the relevant statutes and regulations governing multiple dependent claims, Director Vidal found that the plain language of § 112, fifth paragraph, which states “[a] multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered,” clearly communicated that “a multiple dependent claim is the equivalent of several single dependent claims.” In addition to the statutory language, the Director further examined other interpretive sources, including Federal Circuit case law, the statute’s legislative history, and the current USPTO guidance and practice, and found that all these sources also supported the conclusion that a multiple dependent claim must be considered as a plurality of single dependent claims. Therefore, the Director agreed with Big Beings and held that “multiple dependent claims must be treated as multiple claims, each comprising the dependent claim and one of the claims to which it refers, and the validity (and/or unpatentability) of each of the multiple claims must be considered separately.”

Accordingly, the Director determined that the Board “erred in its analysis of multiple dependent claims 3-16 by failing to separately consider that claims 3-16 incorporate by reference the limitations of claim 1” and granted rehearing and modified the Board’s Final Written Decision.

Takeaway: By citing cases addressing alternatively recited limitations in the body of a claim as supporting its position, Nested Bean, the Petitioner, appeared to urge the Director to treat claim dependency of a multiple dependent claim in the same manner as treating alternatively recited claim features. The Director rejected this treatment. Noting that the statute is clear in specifying that a multiple dependent claim must be interpreted as several single dependent claims, the Director has clarified that the patentability of a multiple dependent claim must be separately evaluated as to each of its alternatively referenced claims.

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

Older Posts

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When to Appeal?

Declaration Anybody?

Federal Circuit Emphasizes Flexible Approach to Obviousness Determination

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

The USPTO Revisits the Determination of Obviousness

Enablement Reconsidered: USPTO Guidance in view of Amgen v. Sanofi

Big Claims, Big Trouble

Patent Eligibility of Nature-Based Products Under §101

Director Vidal Clarifies Assessment of Patentability of Multiple Dependent Claims

“Petering” Anticipation Extended to Different Physical Form

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

USPTO Further Delays Non-DOCX Fee Until June 30, 2023