- 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 - Allstate Insurance Company v. Atos, LLCSome claims unpatentablePTAB · Jan 30, 2026 · IPR2021-01449 · APJ Jon M Jurgovan · IPR · Remand
Claims 3–5 are unpatentable; claims 1 and 2 are not shown unpatentable. Claims 3 and 4 are obvious over the applied grounds under the remand construction of “movement vector.”
RulingsRemand decision- RemandOther
“was incorrect, vacated the Final Written Decision as to claims 3 and 4, and remanded the case to the Board to determine the ordinary and customary meaning of “movement vector” and decide the outcome for claims 3 and 4 in accordance with that meaning. Atos, LLC v. Allstate Insurance Company, 2025 WL 1482404, at *5 (Fed. Cir. May 23, 2025); Paper 35 (“Federal Circuit Remand,” “Remand,” or “Fed. Cir. Remand”). Pursuant to the Federal Circuit’s instructions, the Board authorized the” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“considered individually and together, have well-understood, common meanings to ordinarily skilled artisans as of the invention date, reflected by the ’174 patent’s specification and other evidence of record noted above. Accordingly, we determine that the ordinary and customary meaning of “movement vector” is “a vector indicating movement of an object.” 3) “operation indicator” Petitioner” slip op. at 20
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Dr. Kanellakopoulos’s explanation that angular momentum is not inherent to an object, and its computation requires an arbitrary choice of a point of origin that has no physical meaning in the context of vehicle motion, also supports Patent Owner’s position. Id. ¶ 71 (citing Ex. 2004, 262). Accordingly, Patent Owner’s argument, that angular momentum cannot be used to detect a vehicle turning, is persuasive. Id. We also find persuasive, as Dr. Kanellakopoulos explains, that Petitioner’s argument regarding the figure on Kleppner 234 is based on misinterpretation of the vectors in that figure. Id. ¶ 67 (explaining that Kleppner 233–234 does not depict a gravity vector).” slip op. at 35
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Kleppner does not disclose a rotation vector, a person of ordinary skill would have used the knowledge of a rotation vector (because it is a term of art) alongside Kleppner’s teaching, to arrive at claim 1. See Pet. Reply 11. This argument does not satisfy Petitioner’s burden to provide articulated reasoning with some rational underpinning to support the conclusion of obviousness. See KSR, 550 U.S. at 419 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Petitioner does not explain which teaching of Kleppner a person of ordinary skill would have selected and combined with their knowledge of a rotation vector to yield the method of claim 1, or explain why a person of ordinary skill would have recognized based on Kleppner that estimating the angle between a rotation vector and gravity vector could be used to detect a vehicle turning. Nor does Petitioner respond to Patent Owner’s assertion that Kleppner provides no rationale for estimating an angle of alignment between a rotation vector and gravity vector as a way of detecting a vehicle turning. See Ex. 2001 ¶ 65.” slip op. at 35
Patent outcomesUS 9,846,174 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,846,174 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. 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)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Some claims unpatentablePTAB · Jul 10, 2023 · IPR2022-00605 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–6, 8–10, and 12–17 are unpatentable over Gravesen and Brister; claims 7, 11, and 18–28 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The person of ordinary skill in the art as of the earliest possible effective filing date (“POSITA”) would have had a Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, or a related subject, and one or more years of experience researching, developing and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a Master’s Degree, and vice versa. Pet. 14–15 (citing Ex. 1003 (Fletcher Decl.) ¶ 22). Patent Owner does not dispute Petitioner’s proposal. PO Resp. 11 n.1. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“On the full trial record, we again find that Patent Owner’s proposed narrowing is unwarranted. First, the intrinsic record does not support Patent Owner’s required “central” axis. Patent Owner argues that the Specification describes two inserter embodiments as having “rotors,” and those rotors have a central axis. PO Resp. 17–18 (citing Ex. 1001, 29:25–28, 29:55–59, Figs. 32, 45). Patent Owner, however, fails to explain why those embodiments should be understood to limit the claims. For example, in Phillips, the Federal Circuit “expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323; see also SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“[A] particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). Second, turning to the extrinsic evidence of record, Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 (Fletcher Decl.) ¶ 81 (citing Ex. 1025 (dictionary excerpts), 1). In contrast, Dr. Cima provides no evidence corroborating his evidence. The language Patent Owner quotes from the Petition comes from a “Dictionary of Mechanical Engineering.” See Pet. 38 n.9 (quoting Ex. 1024, 328). This contradicts Patent Owner’s argument that Petitioner’s proposed construction “has no basis in mechanical engineering.” PO Resp. 19. view that a rotor must rotate on a central axis. He cites a textbook indicating that “[r]otational motion needs to take place around an appropriate axis,” but he does not explain whether or why the “appropriate axis” must necessarily be a “central axis.” Ex. 2024 (Cima Decl.) ¶ 179 (quoting Ex. 2040 (Rotordynamics) 2 (emphasis added)). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).” slip op. at 11
- Strike new argumentNew argument disregardedDecided for patent owner
“Although the Petition does state that a person of ordinary skill in the art “would understand the plain and ordinary meaning of a ‘recess’ to include ‘an indentation in a line or surface (as an alcove in a room),’” the Petition does not specify what else is “include[d]” in this term, nor does it specify that the plain and ordinary meaning of “recess” includes the entire interior of a housing. The Petition also does not invoke the Specification as demonstrating that the plain and ordinary meaning of “recess” includes the entire housing.13 Pet. 64 (emphasis added). Petitioner’s belated proposal also conflicts with the language of the claims themselves. Independent claim 1 recites “a rotor disposed within the inserter housing.” Ex. 1001, 43:42. Dependent claim 7 narrows claim 1 by reciting that “the housing comprises a recess in which the rotor is received.” Id. at 44:11–12. If the interior of the inserter housing and the recess could be one and the same as Petitioner proposes, there would be no need for claim 7, because it would not further limit claim 1. See 35 U.S.C. § 112(d) (“a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed”); see also Nazomi Commc’ns, Inc. v. Arm Holdings, PLC, 403 F.3d 1364, 1370 (Fed. Cir. 2005) (“The concept of claim differentiation ‘normally means that limitations stated in dependent claims are not to be read into the independent claim from which they depend.’”) (quoting Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971–72 (Fed. Cir. 1999)). Accordingly, we decline Petitioner’s belated request to construe “recess” to include “an entire cavity of a housing or a cylinder.” 13 We acknowledge that Petitioner argued that the entire interior of Gravesen’s housing maps to the claimed “recess,” but this was in the context of comparing the prior art to the claim as construed. Indeed, Petitioner asserted that “the space within [Gravesen’s] housing is an alcove.” Pet. 64– 65 (emphasis added). In sum, Petitioner did not timely argue that the plain and ordinary meaning of the term “recess” includes an entire cavity of a housing or a cylinder. We adopt the only construction Petitioner offered and supported in the Petition. In view of the above, we construe “recess” as meaning “an indentation in a line or surface (as an alcove in a room).”” slip op. at 16
Patent outcomesUS 10,945,649 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,945,649 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentablePTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision
The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology and cancer biology, which would encompass the blood cancers recited by Patent Owner. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed
“We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16
Patent outcomesUS 10,993,942 mixedClaim construction§ 112 disclosurePatents in suitUS 10,993,942 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision
The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77
- ExcludeMotion to exclude, deniedDenied
“A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29
- Skill levelSkill level board ownOther
“Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26
- Expert testimonyPetitioner expert discountedDecided for patent owner
“With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25
Patent outcomesUS 10,766,685 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCSome claims unpatentablePTAB · Apr 24, 2023 · IPR2022-00193 · APJ John G New · IPR · Final written decision
Claims 1–8, 10–18, and 20 are unpatentable as obvious over Spenser and Spenser II; claims 9 and 19 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Spenser II provides that its cloth “has a thickness ranging from about 1 to 5 mm.” Spenser and Levi both teach a valve that has a diameter of 25 mm and 26 mm respectively when fully expanded. Accordingly, even if we were to assume a POSITA used the thinnest possible cloth in Spenser II, Petitioner’s proposed combination using the smaller Spenser 25 mm diameter (12.5 mm radius) expanded valve covered by a 1 mm cloth resulting in a 27 mm diameter (13.5 mm radius) valve…. From this we can conservatively estimate how much cloth is required for a cross-section of the proposed device (Acloth) by calculating the total area of a cross-section of the cloth-covered valve (π*(13.5 mm)2) and subtracting the area of a cross-section of just the valve (π*(12.5 mm)2). Acloth = π*(13.5 mm)2 - π*(12.5 mm)2 = 81.68 mm2 Accordingly, Petitioner’s proposed combination requires 81.68 mm2 of outer cloth in a given cross-section of the device.” slip op. at 78
- Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia no nexusDecided for petitioner
“that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16
- Expert testimonyPetitioner expert creditedDecided for petitioner
“that the claims are not obvious over Spenser and Spenser II because Petitioner fails to demonstrate that any of its proposed prior art combinations disclose or render obvious a valve with a “sealing material” that is delivered “endovascularly.” PO Resp. 11. Patent Owner also argues Petitioner fails to prove that any of its combinations disclose or render obvious a “fibrous network” “in overlapping radial alignment with native valve leaflets.” Id. at 73. Additionally, Patent Owner contends that objective indicia of non-obviousness (also called secondary considerations) support a conclusion that the challenged claims are nonobvious. Id. at 2. Finally, Patent Owner contends that the testimony of Petitioner’s expert, Dr. Buller, should be given little or no weight, because, Patent Owner argues, he has no expertise in the issues at hand. Id. at 90.” slip op. at 16
Patent outcomesUS 10,881,538 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,881,538 - Ford Motor Company v. Safe Driving Technologies LLCSome claims unpatentablePTAB · Mar 10, 2023 · IPR2021-01446 · APJ Alyssa A Finamore · IPR · Final written decision
Claims 1–4, 6, 10, 12–14, 16, 17, and 19–21 are unpatentable under §103; claim 15 was not shown unpatentable.
RulingsFinal written decision- ExcludeMotion to exclude, grantedGranted
“Our rules and Consolidated Trial Practice Guide are clear on this prohibition. And, the Consolidated Trial Practice Guide explains: “[w]here a party believes it has a basis to request relief on a ground not identified in the rules, the party should contact the Board and arrange for a conference call with the Board and opposing party to discuss the requested relief with the judge handling the proceeding.” CTPG 75. Thus, the Board identifies appropriate ways for a party to address matters that it considers to be beyond the specific procedures outlined in the rules. Merely submitting new evidence was not authorized by Board rules or guidance and Patent Owner did not seek authorization to file the new evidence. The facts warrant excluding Exhibits 2030–2032 and we grant the Motion. See CTPG 81.” slip op. at 83
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“underpinnings, why a person of ordinary skill would have been motivated to modify the prior art to achieve the claimed invention. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (“To satisfy its burden of proving obviousness, a petitioner . . . must . . . articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” (citing KSR, 550 U.S. at 418)). Nonetheless, “a disclosure that anticipates under § 102 also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (CCPA 1982)); see also Application of Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]his court has sanctioned the practice of nominally basing rejections on § 103 when, in fact, the actual ground of rejection is that the claims are anticipated by the prior art. The justification for this sanction is that a lack of novelty in the claimed subject matter, e.g., as evidenced by a complete disclosure of the invention in the prior art, is the ‘ultimate or epitome of obviousness.’” (citations and footnote omitted)).” slip op. at 14
Patent outcomesUS 9,047,170 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,047,170
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.