- CSPC Megalith Biopharmaceutical Co., Ltd. v. Lepu Biopharma Co. Ltd.All claims unpatentablePTAB · Oct 8, 2026 · IPR2025-00685 · APJ Ryan H Flax · IPR · Final written decision
Claims 1–23 are unpatentable as obvious over Wei and Liu, and over Leanna, Wei, and Liu.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, as at institution, we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”) (emphasis added, footnotes omitted); but see Indivior Inc. v. Dr. Reddy’s Labys., S.A., 930 F.3d 1325, 1343 (Fed. Cir. 2019) (no clear error in determination that “a person of ordinary skill . . . ‘would be on a team with an engineer or scientist . . . .’”). Consequently, we find the person of ordinary skill in the art was a person who had a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and had at least five years of experience with antibodies and antibody engineering.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that no term of the Challenged Claims requires construction to resolve the challenges in this Petition.” Pet. 32. We did not construe any terms in our Institution Decision. See DI 6–7. Patent Owner presents no express positions on claim construction. See generally Resp. For the purposes of this Decision, no terms of the challenged claims require construction. Phillips, 415 F.3d at 1312–13. D. slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“2 G. Wei et al., US 2015/0071923 Al, pub. March 12, 2015. Ex. 1005 (“Wei”). 3 J. Liu, CN 103772504 A, pub. May 7, 2014. Ex. 1007. The Liu reference is published in Simplified Chinese and Petitioner filed a certified English translation, to which we refer herein. See Ex. 1008 (“Liu”). Patent Owner does not contest the accuracy of the translation. See generally Resp. 4 M.R. Leanna & C.L. Becker, WO 2014/152199 A1, pub. Sept. 25, 2014. Ex. 1006 (“Leanna”). 5 Based on our review of each deposition transcript in view of the record as a whole, although each witness appears competent, we are left with the impression that Dr. Bournazos’s testimony is somewhat more credible than Dr. Atanackovic’s. This conclusion is based, inter alia, on each witness’s ability to recall the relevant record and respond to questions on evidentiary and technical issues.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that combining Liu’s BA03 antibody with Wei’s ADC platform would have been desirable, predictable, and routine for the ordinarily skilled artisan based on the facts that: (1) cetuximab was a wellknown and well-studied, U.S. regulatory approved, anti-EGFR antibody that would have served as a starting point for new cancer therapies; (2) humanization of therapeutic antibodies is generally desired (and “[e]very antibody can be humanized” and it is advantageous according to Patent Owner’s counsel); (3) BA03 was a well-known humanized version of cetuximab that had several known advantages over cetuximab in addition to lower immunogenicity from humanization; and (4) Wei taught a similar cetuximab-derived antibody, and a humanized cetuximab-derived antibody, each provided in an ADC with a well-known and validated off-the-shelf linker-drug platform, i.e., vc-MMAE, that exhibited a strong anti-tumor response. See, e.g., Ex. 1001, 1:57–2:32, 2:50–3:1, 5:6–53, 18:3–33, 19:26– 29; Ex. 1002 ¶¶ 14, 38, 42–43, 45–53, 56–73, 84–92, 109–117, 178–189, 202–271; Ex. 1005 ¶¶ 9–10, 229–232, 434, 437, 476, 491–506, 664–675, 685, 688, 715, 732, 1103, 1092–1141; Ex. 1008 ¶¶ 3–6, 60, 74, 141–160; Ex. 2027 ¶¶ 7–8, 38, 50, 57 (confirming our understandings regarding the claimed antibody and linker-drug payload); Ex. 2023, 173, 300; see also Resp. 1, 5–6, 23 (Patent Owner made the “choice” to use the prior-art-known BA03 antibody, and known-candidate cytotoxic payload MMAE); Hr’g Tr. 34:20–23, 36:6–38:20, 47:16–50:16 (Patent Owner’s counsel’s argument). When Liu’s BA03 antibody is provided in an ADC with a vc- MMAE or a Mc-vcPAB-MMAE platform (and used as cancer therapy as the references instruct) the invention of the challenged claims is achieved.” slip op. at 52
Patent outcomesUS 10,792,370 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,792,370 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision
Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. 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 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38
Patent outcomesUS 11,236,318 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgmentPTAB · Jun 3, 2026 · PGR2025-00086 · APJ Tawen Chang · PGR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment and terminated the PGR as to claims 1–34 after Patent Owner disclaimed all challenged claims.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“A party may request judgment against itself at any time during a proceeding,” including by “[d]isclaimer of the involved application or patent” or “[c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. §§ 42.73(b)(1)–(b)(2). Accordingly, we grant Patent Owner’s Request for Adverse Judgment and terminate the proceeding. slip op. at 2
NonePatents in suitUS 12,290,598 - Dr. Squatch, LLC v. The Procter & Gamble CompanyAll claims unpatentablePTAB · Mar 25, 2026 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the Lesniak- and Native-based grounds; the Squatch and Sturgis ground fails because Squatch was not shown to be a printed publication.
RulingsFinal written decision- BurdenDecided for patent owner
“We agree with Patent Owner that Petitioner has not shown sufficiently that Squatch is a printed publication. As described above, Petitioner relies on Squatch as a “website excerpt” placed on its site at the relevant time, but has not produced a screen shot of the website to show that it ever existed. See Ex. 1059. Petitioner provides internal documents that purport to describe what would have been on Dr. Squatch’s website at the relevant time, but falls short of establishing what was on the website for the interested consumer to view. Thus, we determine that this ground fails.” slip op. at 55
- Skill levelSkill level petitioner adoptedDecided for petitioner
“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 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications at this stage of the proceeding. PO Resp. 10. 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. See e.g., Exs. 1003, 1004.” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“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 6–7 (citing Ex. 1003, 1:39–54). For example, Lesniak’s compositions (nos. 8 and 11) that used such a secondary 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 Pet. 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.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Patent Owner asserts that the preamble of independent claims 1, 16, and 19 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 argue to the contrary. See, e.g., Pet. 19 (arguing that Lesniak discloses a deodorant stick in the form of an antiperspirant stick).” slip op. at 8
Patent outcomesUS 11,844,752 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,844,752 - Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyNo claims unpatentablePTAB · Mar 23, 2026 · IPR2024-01451 · APJ Tawen Chang · IPR · Final written decision
Claims 1–19 were not shown unpatentable: Larson did not establish the claimed detection in a single sample volume, and the asserted obviousness combinations did not cure the deficiencies.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, “[f]or purposes of this IPR proceeding, PO does not contest Petitioner’s description of qualifications for a person of ordinary skill in the art (POSA) set forth [above].” PO Resp. 23. In view of the above, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition of a POSA for purposes of this Decision, except that we replace the phrase “at least a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection” with “around a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection.” Pet. 9 (emphasis added).13” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We begin with “the context in which a term is used in the asserted claim,” which can be “highly instructive.” Phillips, 415 F.3d at 1314. In this case, claim 1 recites that the claimed assay is “capable of unambiguously detecting the presence or absence of each of said at least M analytes, in any combination of presence or absence, in a single sample volume, . . . wherein the analytes are amplified in the single sample 15 In this regard, we note that Petitioner’s claim construction position is not predicated on the collection of droplets being reconstituted into its original, pre-partition form prior to amplification; rather, the droplets remain compartmentalized from each other in the PCR thermal cycling tube. Tr. 65:21–66:9 (Petitioner’s counsel explaining that the droplets do not combine in the PCR thermal cycling tube but, rather, are “suspended in an immiscible fluid and analyzed en masse”). indicates that the first instance of single sample volume, i.e., the single sample volume in which the presence or absence of each M analytes are to be detected, is the antecedent basis for the second instance of “single sample volume,” i.e., the single sample volume in which the analytes are amplified. Thus, as the parties appear to agree, the single sample volume in which amplification takes places must be the same single sample volume in which the presence or absence of analytes are to be detected. We are not persuaded that, when accorded its plain and ordinary meaning, a single sample volume divided into a collection of droplets would be considered the “same” single sample volume prior to its partition.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“With respect to the limitation, “wherein the analytes are amplified in the single sample volume,” Petitioner asserts that “Larson discloses PCR assays that amplify target polynucleotide in a single sample volume, specifically a portion of the reaction mixture that is subsequently partitioned into droplets.” Pet. 31 (emphasis added). There is no dispute that the amplification of the analytes in Larson occurs in the droplets. Larson ¶¶ 6–7 (explaining that “[d]igital PCR (dPCR) is an alternative quantitation method in which dilute sample are divided into many separate reactions” and that “[t]he template is amplified in the droplet for detection”) (emphasis added). Because the claims require that amplification of the analytes be in the same sample volume in which the at least M analytes, in any combination of presence or absence, is unambiguously detected, and because the pre-partition single sample volume is not the same single sample volume as the collection of droplets after partition under our claim construction set forth above, we find Petitioner has not shown, by a preponderance of evidence, that claims 1–10 and 13–19 are anticipated by Larson.17 Tr. 68:12–69:14 (Petitioner’s counsel” slip op. at 27
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Although we agree with Petitioner that Larson contemplates scenarios in which droplets may contain more than one target molecule and does not require the exclusion of such multiple occupancy droplets in all embodiments, we are nevertheless not persuaded Petitioner has shown, based on a preponderance of evidence, that Larson renders obvious an assay capable of unambiguously detecting, in such multiple occupancy droplets, the presence or absence of each of at least M analytes, in any combination of presence or absence, when M is greater than F and F is at least 2.” slip op. at 32
Patent outcomesUS 11,827,921 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,827,921 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · Mar 16, 2026 · IPR2024-01378 · APJ John G New · IPR · Final written decision
Claims 1–10 are unpatentable as anticipated by Svihra or obvious over the asserted combinations; the cited non-patent references qualify as printed publications.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Legal Standards Anticipation A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). However, a reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). The “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009).” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“(citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). Of particular relevance to the case presently before us is the VidStream court’s holding that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” VidStream, 981 F.3d at 1065. Hulu addressed, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. IPR2018-01039, Paper 29 at 8. In Hulu, the Board held that, although testimonial evidence is one way to prove public accessibility, there are also various indicia of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at 18. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established. Id. at 19–20 (see Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)). Here, we find the totality of evidence supports the conclusion that Petitioner has made a sufficient showing that Svihra and Amarenco (as well as the other identified non-patent references) were printed publications, and publicly accessible, prior to the ’477 patent’s priority date. We note at the outset that Patent Owner does not allege that any contested reference is fabricated, or a counterfeit document, but only that Petitioner has not set forth sufficient facts establishing that such references were published and available. Resp. 4. Svihra bears sufficient indicia of publication to conclude it was a printed publication and publicly accessible as of 2002. Ex. 1004. First, it appears on its face to be a legitimate scientific journal article; it indicates it was included at pages 480–83 in volume 103 (No. 12) of Bratisl Lek Listy, the Bratislava Medical Journal, which was established in 1921. The article identifies that it was received for publication on May 30, 2002, and accepted for publication on December 9, 2002; and multiple means of contact for the author and publisher are provided. Id. at 480, 483. Each of these indicia supports the contention that Svihra was published and publicly available in 2002. There is no direct evidence that Svihra was publicly accessed as of this date, but the article is cited as a reference in each of Exhibits 1085–1087, which further supports that Svihra was, generally, publicly available to interested individuals of ordinary skill in the art, which further corroborates that it was a published and publicly accessible publication. Having an established publisher also creates a presumption of publication for Svihra, which has not been rebutted by Patent Owner. VidStream, 981 F.3d at 1065.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Petitioner also explains why a person of ordinary skill would have been motivated to combine the cited references, again citing specific disclosures from the references, and the supporting testimony of Dr. Wingeier. See Pet. at 27–28. Based on our review of Petitioner’s arguments and the evidence of record, we determine that Petitioner has established, by a preponderance of the evidence, that the cited references teach or suggest all of the limitations of challenged claim 1, and that Petitioner has established why a person of ordinary skill would have been motivated to combine the references, as proposed, with a reasonable expectation of success, for the reasons advocated by Petitioner with respect to Ground 2.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and the level of skill in the prior art, we adopt Petitioner’s proposed definition and additionally use the term “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 10
Patent outcomesUS 9,002,477 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,002,477 - Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentablePTAB · Mar 16, 2026 · IPR2024-01375 · APJ John G New · IPR · Final written decision
Claims 1–13 are unpatentable as obvious under § 103 over Svihra, Mann, and Ponsford, and independently over Amarenco, Mann, and Ponsford.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Ex. 1001, claim 1. In other words, to effectuate “direct” stimulation of the PTN nerve branch, a practitioner of the ’742 patent must: (1) non-invasively position an electrical stimulator relative to a portion of a patient’s body, such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; (2) passing a current through the electrical stimulator; and (3) delivering an electrical stimulus from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation. Merely “placing electrodes over branches of the PTN” cannot be said, in and of itself, to “directly” target and stimulate the branches, as Petitioner argues.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt this definition, and also use the term “skilled artisan” to refer to persons with such skill at the time the invention was filed.” slip op. at 13
- Expert testimonyPetitioner expert creditedOther
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“the evidence of record, that a person of ordinary skill in the art would have found it obvious to modify the teachings of Svihra by non-invasively stimulating a nerve branch of the PTN, e.g., the medial or lateral plantar nerves, as taught by Ponsford, to treat OAB/urinary incontinence. A skilled artisan would have understood that the fibers of a given branch of the PTN necessarily constitute a subset of the PTN fibers, stimulation of which is known to be effective in the treatment of OAB/urinary incontinence. See Ex. 1004, 480–481. Just as it was known in the art that stimulation of the much larger sacral nerve, of which the fibers of the PTN form a part, could have beneficial effects in the treatment of incontinence, and that stimulation of the PTN itself could have a similar effect (see Ex. 1084, col. 12, ll. 33–52), so, a skilled artisan could reason, might electrical stimulation of a branch of the PTN exert a similar effect. We also agree that a person of ordinary skill in the art would have been motivated to stimulate a smaller nerve branch of the PTN, rather than the entire PTN itself, so as to minimize undesirable side effects of stimulating the entire PTN, i.e., the recruitment of downstream muscular contraction, as taught by Mann. With respect as to whether a person of ordinary skill in the art would have had a reasonable expectation of success in the treatment of OAB/incontinence via stimulation of a branch of the PTN, rather than the entire PTN itself, we agree with Petitioner that a person of ordinary skill in the art, would understand from Mann that electrical stimulation of the larger, more central sacral nerve could be employed to treat OAB/urinary incontinence, and that a subset of those PTN fibers could be electrically stimulated to achieve a similar effect. See Ex. 1084, col. 12, ll. 33–52. Such a skilled artisan could similarly reason that a subset of those PTN fibers, i.e., a branch of the PTN, particularly major branches such as the plantar nerves, could also be similarly electrically stimulated to treat OAB/urinary incontinence. Although success in such an experiment would not be guaranteed, “only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness.” In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985).” slip op. at 46
Patent outcomesUS 11,224,742 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,224,742
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.