• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). 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 the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 13, 2026 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–15 and 17–22 are unpatentable as obvious over the specified combinations of Shapero, Delseny, and, for certain claims, Hamady or Jones.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “In the DI, we addressed Patent Owner’s arguments disputing Petitioner’s proposed definition. DI 17–18 (citing Prelim. Resp. 11–12). We stated that for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. Id. at 18. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 12. Based on the entirety of the trial record, we maintain our finding of a POSA’s skill level.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “Claim Construction In an inter partes review, we construe a claim term “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 construe any claim term expressly.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” Id.” slip op. at 29

  Patent outcomesUS 10,036,012 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,036,012
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 13, 2026 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–12 and 14–19 are unpatentable as obvious over the listed combinations; Petitioner’s motion to strike is denied.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 construe any claim term expressly.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

  Patent outcomesUS 10,876,108 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,876,108
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 12, 2026 · IPR2025-00026 · APJ Georgianna W Braden · IPR · Final written decision

  Claims 1–10 are unpatentable: claims 1–3 and 5–10 are anticipated by Porreca and obvious over Schmitt and McCloskey; claims 4 and 7 are also obvious over the listed Illumina combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “On the initial trial record, we agreed with Patent Owner that one of ordinary skill in the art would have had experience with next generation sequencing, but were not persuaded that this would only be possible in the field of molecular biology. Instead, we found that a person of ordinary skill would have had either (1) a Ph.D. in the field of chemistry, molecular biology, or biochemistry or (2) a B.S. or M.S. degree with three to five years of experience working in any of those fields. Inst. Dec. 8. We specifically found that “[t]he person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned.” Id. at 8–9. Patent Owner now submits that it does not dispute the definition of a person of ordinary skill in the art as laid out in the Institution Decision. PO Resp. 13. Reviewing the entire trial record, we maintain the same definition of a person of ordinary skill in the art and note that it is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that the skill level does not affect our analysis or our final decision.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “In the Institution Decision, the Board adopted Petitioner’s construction of the term “adaptor.” Inst. Dec. 9. Patent Owner does not dispute this construction. PO Resp. 13–14. During oral argument, Petitioner argued that claim 1 requires “an adapter to be ligated onto a target DNA, and that adapter needs to have two different sequences of DNA that are used for identification” including a “socalled identifier that's one to eight nucleotides in an indexing site.” Tr. 6:19–7:2. Patent Owner, again, did not dispute this characterization of “adaptor.” See generally Tr. Based on the entirety of the trial record, we continue to apply Petitioner’s construction of the term “adaptor,” although we note that it does not affect our analysis.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “Based on the entirety of the trial record, we do not agree with Patent Owner’s reading of either the claims or the prior art because Patent Owner takes too narrow a view of both. First, based on the plain language of Porreca, we find it uses a combination of the sequence reads of the target sequence and differentiator tag sequences to determine whether there is duplication. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. All that the claim requires is that the method identifies sequence reads with identical identifier and target sequences as duplicates. Because claim 1 contains the transition “comprising,” the claim is still satisfied if the category of identified duplicate reads contains identical labels and also contains more. Patent Owner admits that the identifier and target sequence do not have to be used simultaneously. Tr. 46:16–48:4. Instead, Patent Owner challenges whether Porreca uses the required elements in combination as recited in the challenged claims. Based on the record before us, we agree with Petitioner’s position especially in view of the open-ended nature of the claims and Patent Owner’s own admission that there is no temporal requirement for the use of target sequences and differentiator tag sequences. Specifically, we find that Porreca teaches using the combination of the target sequences and the differentiator tag sequence to determine whether particular sequence reads are unique or PCR duplicates. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. The use of both such sequences meet the claim limitations. This finding is consistent with the prosecution history of the ’357 patent and how the applicant and examiner interpreted the claims. See Ex. 1013, 69–70, 78–79. Second, we find the disclosure of Porreca sufficient to demonstrate to an ordinarily skilled artisan that “collapsing” is done by comparing target sequences and differentiator tag sequences. Porreca specifically explains that: after multiple reads have been collected for a given locus, it is possible that due to bias (e.g., caused by PCR amplification steps), a large fraction of the reads are derived from a single originating molecule. This would skew the population of target sequences observed, and would affect the outcome of the genotype call.” slip op. at 30

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “We do not agree with Patent Owner for at least two reasons. First, Patent Owner fails to address the fact that Schmitt cites to McCloskey 2007. We find that the citation of McCloskey 2007 in Schmitt indicates that the ordinarily skilled artisan would have considered the teachings of McCloskey to be highly relevant to the teachings of Schmitt and would have considered them to be both useful in the field of sequencing. See Ex. 1005 ¶ 6. Second, Patent Owner fails to explain or even identify the purported structural differences between Schmitt and McCloskey that would prevent the teachings of McCloskey from being relevant to Schmitt. In addition, we credit the testimony of Dr. Metzker that one of ordinary skill in the art would have understood the benefits of adding a barcode to target sequences and would have looked to McCloskey and the batch-stamps it teaches because both Schmitt and McCloskey are in the same field and address the same problems. See Ex. 1003 ¶¶ 110, 114. Accordingly, we find that Petitioner has demonstrated by a preponderance of the evidence that a person of ordinary skill in the art at the critical time would have had sufficient reason to combine the teachings of Schmitt and McCloskey to arrive at challenged claim 1.” slip op. at 48

  Patent outcomesUS 11,098,357 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,098,357
• Inari Agriculture, Inc. v. Corteva Agriscience LLCNo claims unpatentable
  PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

  Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

    “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

  Patent outcomesUS 8,901,378 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
  Patents in suitUS 8,901,378
• Xencor, Inc. v. Merus N.V.Instituted
  PTAB · Sep 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution

  The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the alleged invention would have at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner

    “The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,358,286
• Gene Company Pty Ltd v. The Trustees Of Columbia University In The City Of New YorkNo claims unpatentable
  PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

  • Expert testimonyPetitioner expert creditedMixed

    “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 26

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.” slip op. at 25

  Patent outcomesUS RE47,045 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
• Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Instituted
  PTAB · Jun 3, 2025 · IPR2025-00056 · APJ Ryan H Flax · IPR · Institution

  The Board instituted IPR on claims 1–30 and all three grounds, finding a reasonable likelihood that at least one claim would have been obvious over Perrett.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-” slip op. at 8

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “An inter partes review may be instituted if the information presented by a petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 19

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSA”) related to the ’061 patent would have a Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2-3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development. The 8 See infra Section II.C. 9 At this stage of the proceeding, there is no evidence of objective indicia of obviousness or non-obviousness. POSA would also have had access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects. EX1070 ¶30. Pet. 5. At this stage of the proceeding, Patent Owner neither contests Petitioner’s proposed definition of the ordinarily skilled artisan nor provides an alternative definition. See generally Prelim. Resp. For the purposes of this Decision, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the high level of skill in the art reflected in the prior art of record and the ’061 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). D.” slip op. at 20

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownNo construction neededOther

    “When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). The Specification expressly states that “[t]he terms ‘orally disintegrating tablet’, ‘orally dispersing tablet’, or ‘ODT’ refer to a solid dosage form of the present invention, which disintegrates rapidly in the oral cavity of a patient after administration, without chewing.” Ex. 1001, 5:12–15. At this stage of the proceeding, we interpret the language “orally disintegrating tablet” / “orally dispersing tablet” / “ODT” to have the meaning as expressly set forth in the Specification, as noted above. slip op. at 23

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 11,260,061
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.Instituted
  PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution

  The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

    “To accord substantial weight to evidence of secondary considerations, it “must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16

  • Skill levelSkill level board ownDecided for petitioner

    “We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 construe any claim term expressly.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 10,036,012

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.