• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

  On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

  RulingsRemand decision

  • RemandOther

    “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

  • BurdenNot shown unpatentable

    “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

  Patent outcomesUS 10,760,127 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 10,760,127
• CSPC Megalith Biopharmaceutical Co., Ltd. v. Lepu Biopharma Co. Ltd.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,792,370
• Gettattle, Inc. v. Afterwords, Inc.All claims unpatentable
  PTAB · Oct 5, 2026 · IPR2025-00677 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–7, 10, 13, 16, 18, and 19 are unpatentable as anticipated by Douglas and Ganesh; the revised contingent motion to amend is denied.

  RulingsFinal written decision

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

    “record before us, we conclude that Petitioner proves by a preponderance of the evidence that each challenged claim of the ’811 patent is anticipated by Douglas and by Ganesh. Accordingly, we find that claims 1–7, 10, 13, 16, 18, and 19 of the ’811 patent are unpatentable. Moreover, we find that Patent Owner’s Revised Contingent Motion to Amend adds new matter in every proposed substitute claim, and, therefore, the motion is denied.” slip op. at 80

  • 112 supportMotion to amend, deniedDenied

    “Because the RMTA does not meet the foundational statutory and regulatory requirements, we decline to reach Petitioner’s arguments as to the asserted unpatentability of the proposed substitute claims. C. CONCLUSION ON REVISED MOTION TO AMEND Because the RMTA does not meet foundational statutory and regulatory requirements for a motion to amend, it is denied.” slip op. at 80

  Patent outcomesUS 10,430,811 unpatentable
  § 102 anticipationcites Phillips
  Patents in suitUS 10,430,811
• Medivis, Inc. v. Novarad Corp.Some claims unpatentable
  PTAB · Oct 1, 2026 · IPR2023-00042 · APJ Scott Raevsky · IPR · Remand

  Claims 1–6, 11, and 20 are unpatentable as obvious over Doo and Amira; claims 12–19 were not shown unpatentable because the asserted tissue properties were not shown in Amira.

  RulingsRemand decision

  • RemandOther

    “Federal Circuit. The court issued its decision in Medivis, Inc. v. Novarad Corp., No. 2024-1794, 2026 WL 587294 (Fed. Cir. Mar. 3, 2026) (“Medivis”) (Paper 40),1 affirming-in-part, reversing-in-part, and remanding our Final Written Decision (Paper 35) for further proceedings. In its opinion, the Federal Circuit reversed our “determination of no motivation to combine Doo and Amira” and remanded for further proceedings to evaluate whether claims 1–6 and 11–20 (“the Remanded Claims”) of U.S. Patent No. 11,004,271 B2 (“the ’271 patent,” Ex. 1001) are unpatentable in view of Petitioner’s obviousness challenge over Doo and Amira. Medivis, slip op. at 9–10. We have jurisdiction under 35 U.S.C. § 6(b). We issue this Final Written Decision on Remand pursuant to 35 U.S.C. §§ 144, 318 and 37 C.F.R. § 42.73 in an inter partes review involving Medivis, Inc. (“Petitioner”) and Novarad Corp. (“Patent Owner”). For the reasons discussed below, after considering the entirety of the record in light of the Federal Circuit’s directives in Medivis, we hold that Petitioner has demonstrated, by a preponderance of the evidence, that claims 1–6, 11, and 20 are unpatentable; however, Petitioner has not demonstrated, by a preponderance of the evidence, that claims 12–19 are unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s proposed level of skill, except that we excise part of Petitioner’s definition to produce the following modified version: 4 Throughout this decision, we eliminate the parties’ italicization of reference names from quotations without noting “emphasis omitted.” 5 Doo, WO 2015/164402 A1, published October 29, 2015 (Ex. 1008). 6 Excerpt of Amira 5 User’s Guide, title through Chapter 2 (Visual Imaging 2009) (Ex. 1005). engineering, or a related field with several years of experience in the design, development, and study of augmented reality devices and . . . familiarity with conventional medical imaging data and visualization of data for medical procedures . . . . Our edit removes the alternative of “working with a team including someone with such familiarity” because one’s role in a team may be tangential to their personal experience with medical imaging. Regardless, had we adopted Petitioner’s original definition, our decision would not have changed.” slip op. at 6

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

    “We agree with Petitioner that the term “3D slices” has no apparent connection to the phrase “direct volume rendering.” Patent Owner’s argument appears to be that DVR “requires an image of the entire anatomical volume that is neither feature-specific nor segmented, [which] would seemingly require that all inner layers be displayed.” Reply 4; see Sur-reply 6–10 (not disputing Petitioner’s characterization). But, as Petitioner notes, the specification directly undermines this by teaching “display [of] a slice of the 3D data instead of a volume of the 3D data.” See Reply 4 n.2 (quoting Ex. 1001, 5:34–35). In other words, to the extent DVR would depict an image of the entire anatomical volume, displaying 3D slices “instead of a volume of the 3D data” implies the opposite of DVR. Even if “3D slices” somehow implied DVR, Patent Owner’s position is still untenable. Claim 1 does not recite “3D slices.” Instead, claim 1 recites “3D data” and “inner layers.” Ex. 1001, 18:54–65. Patent Owner fails to clarify the relationship between “slices,” “3D data,” and “layers,” and its expert even admits that slices and layers are two different things. See PO Resp. 13; Ex. 1022, 32:7–16 (agreeing that the words “slice” and “layer” are not “synonyms”), cited in Reply 4. We also agree with Petitioner that dependent claim 3 distinguishes slices and layers by reciting “slices of the projected inner layer.” Reply 4 (quoting Ex. 1001, 19:3–10). Thus, even if 3D slices somehow implied DVR, the language of claim 1 does not support limiting the claim this way.” slip op. at 12

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

    “The determination of whether a document was publicly accessible “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018). For instance, courts routinely rely on the Wayback Machine to determine when a reference was first made available to the public. Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021) (“District courts have taken judicial notice of the contents of webpages available through the Wayback Machine ‘as facts that can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.’”). We disagree with Patent Owner’s argument that “Medivis cannot rely on additional prior art”—Exhibits 1023 and 1024—“that was submitted after its Petition to carry its burden without leave from the Board.” Sur-reply 4. As Patent Owner did not file a motion to exclude these exhibits, we decline Patent Owner’s invitation to disregard them. We also find Petitioner’s Reply argument proper because it directly responds to Patent Owner’s contention that Petitioner did not prove the public accessibility of Amira. See Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F.3d, 919, 925 on issues previously raised.”). Petitioner’s Reply argument appropriately elaborates on the Petition’s contention that Amira was publicly accessible. Patent Owner also does not dispute the substance of Petitioner’s evidence. For example, Patent Owner does not address the substance of Mr. Frank-White’s declaration. We find that this evidence, including Mr. Frank- White’s declaration testimony, persuasively supports the public availability of Amira as of the date shown in the Wayback Machine URL. See Ex. 1024.” slip op. at 22

  Patent outcomesUS 11,004,271 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 11,004,271
• Evenflo Company, Inc. v. Baby Jogger II, LLCAll claims unpatentable
  PTAB · Sep 29, 2026 · IPR2025-01122 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over Liao or Liao and Cheng; Rolicki is not prior art, and the challenge over Offord ’341 and Offord ’797 fails.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. Level of Ordinary Skill in the Art Baby Jogger does not dispute Evenflo’s definition of the level of ordinary skill in the art, which is that a person of ordinary skill in the art (hereinafter, “one skilled in the art”) would have had “a bachelor’s degree in a relevant field (e.g., mechanical engineering or industrial design) and at least two years of product design experience and/or industry experience with juvenile products” and that “[m]ore education can replace product design experience, and vice versa.” Pet 8 (citing Ex. 1001 ¶¶ 31–33); PO Resp. generally. We apply that definition here, as it accords with the problems addressed in the prior art and the specification of the ’682 patent.” slip op. at 7

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

    “At the outset, we note that the claim language requires only that “the first seat and the second seat” be arranged in an inline descending configuration, not that the seat’s mounting points or other physical connections be so arranged. Ex. 1010, 17:31–33. Baby Jogger improperly reads “seats” out of the claim and substitutes the seat’s “mounting points” on the frame. A proper reading of the claim language focuses on what happens when both seats are connected to the frame, not where they are so connected. In other words, “when connected to the frame” simply emphasizes that both seats must be connected to the frame to form the inline descending configuration, as opposed to the single stroller embodiment of Figure 1, where there cannot be an inline descending configuration because only one seat is connected to the frame and the other seat is removed, i.e., not connected to the frame. That reading is supported by the specification of the ’682 patent,” slip op. at 9

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

    “We find that testimony persuasive, for it shows what one skilled in the art would have recognized the 2008 Provisional as necessarily disclosing. The relevant inquiry is whether the disclosure of the prior application “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis in original; citation omitted). “While a prior application need not contain precisely the same words as are found in the asserted claims, . . . the prior application must indicate to a person skilled in the art that the inventor was ‘in possession’ of the invention as later claimed.” Id. In other words, “to satisfy the written description requirement, ‘the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.’”7 Id. (quoting Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (emphasis added). “This requires that the written description actually or inherently disclose the claim element.” Id. at 1306–07. Moreover, a drawing may supply written description for the arrangement it depicts even though the text describes that arrangement in different terms. See Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317, 1319–23 (Fed. Cir. 2002).” slip op. at 16

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Instead, Evenflo’s argument rests on isolating the statement—“A similar sub-frame arrangement is disclosed in [Offord ’797]”—from the remainder of the passage in which that statement appears in order to arrive at a reason to incorporate the reversibility teaching of Offord ’797. However, when that statement is read in the context of the full passage in which it appears, nowhere does that passage suggest reversibility as the reason for referencing Offord ’797. More accurately, it suggests a different reason that relates to a curved lug 108 by which sub-frame 100 rests on the stroller’s main frame 4 to carry the weight of the stroller’s two occupants— When the interface components 100 are attached to the frame assembly 4 they form a sub-frame of the frame assembly 4, and when the child-carrying units are mounted thereon, one behind the other, they are in a compact echelon formation, one of the connector sockets 106 of each component 100 being at a higher level in relation to the ground than the other connector sockets 106. The higher connector socket 106 and further connecting leg 102 are both connected to the respective opposite ends of an upper mounting piece 107. In addition, on the inner side of the lower connector sockets 106 there is a downwardly curved lug 108 which serves to rest upon a part of the basket frame 44, such that the weight of two infants is fully supported by the frame assembly 4. A similar sub-frame arrangement is disclosed in [Offord ’797]. Ex. 1051, 9:23–36 (emphasis added). That passage shows that, rather than reversibility of the sub-frame, the reference to Offord ’797 is more aptly directing the reader to the arrangement and details of a similarly curved lug structure in the stroller sub-frame of Offord ’797. Indeed, Figures 5 and 6 of Offord ’797, reproduced below, disclose just such a curved lug in the context of “corner pieces 20” having “channel 21.” Ex. 1054, 4:10–23.” slip op. at 53

  Patent outcomesUS 11,731,682 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 11,731,682
• Intel Corporation v. Advanced Cluster Systems, Inc.All claims unpatentable
  PTAB · Sep 23, 2026 · IPR2025-00915 · APJ Arthur M Peslak · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–3, 5–16, and 18–30 as obvious over Menon, Trefethen, RS6000, and MPIref; claims 4 and 17 over those references plus POEref.

  RulingsFinal written decision

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

    “Ex. 1163 ¶ 37 (citing Ex. 1003 ¶ 71; Ex. 1005, 1–3). We credit Dr. Bajaj’s testimony which is unrebutted and supported by the record. We, thus, agree with Dr. Bajaj’s reasoning which is based on Menon. We further agree with Dr. Bajaj’s conclusion that Menon does not teach away from the combination with Trefethen. Id. ¶ 75. Menon’s description of building on and enhancing the teachings of Trefethen—the earlier work of the same research group at Cornell—by adding MEX routines to achieve high-performance parallel computing and extensibility for MATLAB, demonstrates a classic motivation for a POSITA to combine. RS6000 is specifically referenced in Menon-Trefethen and adds operational details of the parallel operating platform that teach a POSITA how to implement the MultiMATLAB system with a reasonable expectation of success. Considering Menon as a whole, these facts are inconsistent with Patent Owner’s teaching away arguments. For these reasons, Patent Owner’s teaching away argument is unavailing. Motivation to Combine Conclusion We have reviewed Petitioner’s evidence and contentions which we” slip op. at 42

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “For the foregoing reasons, Petitioner establishes by a preponderance” slip op. at 79

  Patent outcomesUS 11,563,621 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,563,621
• 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
• GD Energy Products, LLC v. Kerr Machine CompanyAll claims unpatentable
  PTAB · Jun 29, 2026 · PGR2025-00031 · APJ Ryan H Flax · PGR · Final written decision

  Claims 1–14 are unpatentable as obvious under each of four asserted grounds: Kerr; Aplex and Stanton; Blume, Stanton, and Wilkinson; and the sale of the Kerr Pump.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The person of ordinary skill in the art would have a minimum of a bachelor’s degree in mechanical or petrochemical engineering, or a comparable engineering discipline, and a minimum of 3-5 years of work experience in the design and/or manufacturing of reciprocating pumps and valves, including fluid ends and/or comparable high pressure fluid components, for industrial applications, including for use in the oil and gas industry. See, e.g., EX1003, ¶32.” slip op. at 12

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

    “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We decline to expressly construe any claim language. slip op. at 12

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

    “Regarding the combining of Aplex and Stanton, Petitioner asserts that the ordinarily skilled artisan would have understood that providing a packing/stuffing arrangement, as taught by Stanton, within a fluid end housing, as taught by Aplex, would improve pressure and fluid isolation compared with an arrangement where the packing was bolted to the outside of the fluid end as in Aplex unmodified. Pet. 66 (citing Ex. 1003 ¶¶ 189, 236). Patent Owner does not dispute this rationale. We find this to be a reason, with rationale underpinning, why the person of ordinary skill in the art would have combined these references with a reasonable expectation of success.” slip op. at 29

  • Adverse judgmentOther

    “The record indicates that Patent Owner has statutorily disclaimed claim 15 as of April 28, 2025. Ex. 2206.” slip op. at 8

  Patent outcomesUS 12,152,582 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 12,152,582
• Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P.Adverse judgment
  PTAB · 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

  None
  Patents in suitUS 12,290,598

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.