- Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–8 and 10–23 are unpatentable: the Board found claims 1–15 anticipated or obvious over the asserted grounds and claims 16–23 obvious over the Native combination.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 17 (citing Ex. 1002 ¶¶ 27–29). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1, 16, and 20 reciting “a deodorant stick” is limiting” as it provides antecedent basis for the recitation of “said deodorant stick being free of an aluminum salt” for each independent claim. PO Resp. 7–10. Patent Owner also points to dependent claims 6–9 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the prior art fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Reply 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that Lesniak teaches how to make stable compositions by including a secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Id. Ex. 1086 ¶ 7; see also Reply 6 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claim 1.” slip op. at 22
Patent outcomesUS 11,497,706 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,497,706 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 28, 2026 · IPR2024-01173 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7, 9–13, and 16–19 are unpatentable: claims 16–17 are anticipated by Lesniak, and the remaining challenged claims are obvious over the stated combinations.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32).” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002 ¶¶ 27–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. See generally PO Resp. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said deodorant stick being free of an aluminum salt” and “said deodorant stick” having a particular hardness range. PO Resp. 8–9. Patent Owner also points to dependent claims 5–8 as relying on the preamble reciting “a deodorant stick” as antecedent basis for claim elements. Id. at 10. We agree.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We find that the evidence of record fails to support Patent Owner’s argument that the Lesniak fails to enable a stable deodorant stick. Rather, we are persuaded by Petitioner that Lesniak sufficiently teaches compositions with the relevant ingredients and achieves stable compositions through the use of a second wax having a melting point of 73 to 90° C. Pet. Reply 8 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a second wax, namely CastorWax MP80, are disclosed as sufficiently stable. Ex. 1003, Table 2. Here, we further credit the testimony of Dr. Michniak-Kohn that secondary wax, such as castor wax, with a sufficiently high melting point. Ex. 1003, 1:39-54, 5:23-32, Table 2. Both of the compositions (nos. 8 and 11) tested by Lesniak that had such a wax passed the stability tests. Ex. 1086 ¶ 7; see also Reply 8 (“Lesniak overcame any stability issues, as it expressly discloses compositions that are ‘physically stable at high and low temperatures.’”) (citing Ex. 1003, 5:23–32). Having considered the parties’ positions and evidence of record, summarized above, we determine that Lesniak provides sufficient disclosure to enable a person of ordinary skill in the art to formulate a deodorant stick within the parameters of claims 16 and 17. e) Conclusion as to Claims 16 and 17 We agree with Petitioner that “the challenged claims recite nothing more than well-known deodorant ingredients performing their conventional functions.” Pet. Reply 2. Therefore, for the reasons discussed above, we conclude that Petitioner has proved by a preponderance of evidence that Lesniak anticipates claims 16 and 17.” slip op. at 22
Patent outcomesUS 10,905,647 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,905,647 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 26, 2026 · IPR2024-01105 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–15 are unpatentable: claims 1, 3–8, and 11–14 as anticipated by Lesniak; claims 2, 9, 10, and 15 as obvious over the respective asserted combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 27 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. PO Resp. 7– 8. We adopt and apply Petitioner’s proposed definition of a POSA, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said stick range. PO Resp. 8–10. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 27 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“disclosure to enable a person of ordinary skill in the art to formulate deodorant stick within the parameters of claim 1. d) Conclusion as to claim 1 Having considered the parties’ positions and evidence of record, summarized above, we are persuaded by Petitioner’s analysis that Lesniak discloses all elements of claim 1. We are not persuaded to Patent Owner’s arguments to the contrary. Accordingly, we determine that Lesniak anticipates claim 1.” slip op. at 20
Patent outcomesUS 10,966,915 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,966,915 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Jan 21, 2026 · IPR2024-01104 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–18 are unpatentable under § 103: claims 1–7, 9–13, and 15–18 over Lesniak, Phinney, and Bianchi ’518; claim 8 adds Lamb; claim 14 adds Bianchi ’254; and claims 1–18 are also unpatentable over the …
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claim 1 reciting “a deodorant stick” is limiting” as it provides antecedent basis for certain other claim elements, specifically, for the recitation of “said stick being free of an aluminum salt” and “said stick” having a particular hardness range. PO Resp. 8–9. We agree. Petitioner does not provide argument to the contrary. See, e.g., Pet. 30 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick). We determine that no express construction of any other claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002, ¶¶ 26–28). Patent Owner does not dispute Resp. We adopt and apply Petitioner’s proposed definition of a POSA, which is consistent with the level of skill reflected in the asserted prior art.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We have considered Patent Owner’s arguments but find, on this record, Petitioner to have the better position. In particular, we are persuaded that a POSA would have been motivated to add magnesium hydroxide to Lesniak’s compositions because Phinney teaches that: (i) zinc oxide has “low activity” as a “deodorant agent”; (ii) magnesium hydroxide is “an effective synergistic effects, hence motivating a POSA to add magnesium hydroxide to Lesniak’s zinc oxide deodorants. Ex. 1004, 1:13- 3:16, 5:61-67. Reply 10; see also PO Resp. 25–26 (arguing that a POSA would have found it obvious to add magnesium hydroxide to the composition of Lesniak because zinc oxide is not a particularly efficacious antimicrobial in deodorants when used alone, whereas magnesium hydroxide is an effective deodorant). We acknowledge that Phinney suggests mixing zinc oxide with water in order to convert zinc oxide to zinc hydroxide. See, e.g., Ex. 1004, 1:17– 19 (“It was also found that a mixture of the hydroxides of zinc and magnesium could provide long lasting protection against odour due to perspiration.”). The evidence of record, however, shows that both magnesium hydroxide and zinc oxide were known options for deodorant antimicrobials, and claim 1 does not require a minimal level of effectiveness such that the combination of magnesium hydroxide and zinc oxide would need to outperform any other combination including the mixture of zinc and magnesium hydroxides. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“Our case law does not require that a particular combination must be the preferred, or the most desirable, combination[.]”). Here, we also credit the testimony of Dr. Michniak-Kohn that “POSA would understand that the water-based vs. anhydrous distinction is not relevant, as a POSA would understand that magnesium hydroxide would still function as an antimicrobial in anhydrous compositions such as those disclosed by Lesniak.” Ex. 1086 ¶ 9 (citing Ex. 1072, 1-2, 5 (disclosing deodorants without added water and with zinc oxide and/or magnesium hydroxide)). Accordingly, we are persuaded by Petitioner that “a POSA would have been” slip op. at 22
- Obviousness (§103) › KSR rationalesMotivation foundUnpatentable
“teaches baking soda as an effective ingredient in a deodorant. Ex. 1005, 131–33. Baking soda is also known to cause irritation that may motivate some to remove it from deodorants. See Ex. 2011 ¶ 109–110. Thus, the specific set of advantages and disadvantages for using baking soda in a deodorant was known to a person of skill in the art. On this record, the inclusion or exclusion of baking soda presents no unexpected result and the evidence of record establishes that it would have been an obvious matter of design choice within the skill of the art to balance the advantages and disadvantages associated therewith. See Medichem, S. A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”); see also Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n. 8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”) In view of the above, we determine that the preponderance of the evidence supports Petitioner’s argument that claim 8 would have been obvious over the combination of Lesniak, Phinney, Bianchi ’518, and Lamb. Accordingly, we determine that claim 8 is obvious by the combination of Lesniak, Phinney, Bianchi ’518, and Lamb.” slip op. at 32
Patent outcomesUS 11,540,999 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,540,999 - Illumina Inc. v. Molecular Loop Innovations LLCAll claims unpatentablePTAB · Jan 16, 2026 · IPR2024-00965 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–6 are unpatentable: Gloor anticipates them, Parameswaran and Gloor render them obvious, and Parameswaran, Binladen, and Bentley render claim 6 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 18 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 20–23). After reviewing the record, we adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We acknowledge the ambiguous nature of the disputed claim language. On its face, it could require two or more identifier sequences together be uniquely associated with the nucleic acid of interest, as Petitioner argues; or it could require two or more identifier sequences, each individual identifier sequence must be uniquely associated with the nucleic acid of interest, as Patent Owner asserts. See Reply 2–3; Sur-reply 1–6. We, therefore, must examine the words of the claim and the specification to ascertain the scope of this limitation. The specification states that “[w]hile the pair of barcodes associated with any given template is unique, individual barcode sequences can be used with multiple templates as long as no pair is used across two different samples.” Ex. 1001, 2:50–53 (emphasis added). Elsewhere, it states that [t]he first and second identifiers are designed such that each set of identifiers is correlated to a particular sample (e.g., material obtained from a particular patient or group of patients), allowing samples to be distinguished and/or validated. The first and second identifiers may be the same or different, so long as the combination is unique with respect to the sample or sub-sample that one seeks to distinguish and/or validate. Id. at 3:15–22 (emphases added). We agree with Petitioner that the specification supports its proposed construction. See Reply 2.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Claim 5 recites “homopolymer region.” The ’200 patent specification provides an express definition for the term, stating that “the barcode sequences can be designed to have minimal or no homopolymer regions, i.e., 2 or more of the same base in a row such as AA or CCC, within the barcode sequence.” Ex. 1001, 9:6–10. Thus, we agree with Patent Owner that the term “homopolymer region” should be construed as “two or more of the same base in a row.” See PO Resp. 13 (citing Ex. 2001 ¶ 24). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any other claim term.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“A reference is considered publicly accessible if it is “made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1355 (Fed. Cir. 2018). To “determine whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents,” we “must consider all of the facts and circumstances surrounding the disclosure.” In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009); see also In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004) (explaining that a determination of whether a reference qualifies as a printed publication “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public”).” slip op. at 15
Patent outcomesUS 11,768,200 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,768,200 - PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution
The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,115,233 - Illumina Inc. v. Molecular Loop Innovations LLCNo claims unpatentablePTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24
Patent outcomesUS 11,041,852 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,041,852 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - PTAB · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,195,773 - PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted
“As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20
Claim construction§ 112 disclosurePatents in suitUS 12,077,791
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.