• 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
• Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentable
  PTAB · 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 · Graham
  Patents in suitUS 10,131,682
• Samsung Electronics Co., Ltd. / Apple Inc. v. RJ Technology LLCSome claims unpatentable
  PTAB · Jan 17, 2025 · IPR2024-00597 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 2–4 and 6–18 are unpatentable as obvious over Abe and Guyomard, with claims 9–10 also obvious over Iwaizono; claims 1 and 5 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have had a Master’s degree in material science, chemical engineering, chemistry, or similar field with four years of experience designing testing, and building secondary lithium batteries.” Pet. 11 (citing Ex. 1002 ¶ 51). Petitioner further contends that a person of ordinary skill in the art would have been aware of “(1) positive electrode materials, (2) negative electrode materials, (3) separators, (4) electrolytes, (5) charge-discharge parameters, and (6) protection circuits, as well as ‘battery failure modes’ such as plating and the formation of dendrites.” Id. (citing Ex. 1002 ¶¶ 50–51). Patent Owner “does not dispute Petitioner’s level of ordinary skill.” PO Resp. 17. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the person of ordinary skill in the art as it is consistent with the disclosures of the ’641 patent and the prior art of record.” slip op. at 9

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

    “We also agree with Patent Owner that the charge cut-off voltage is not necessarily the applied voltage during charging. PO Resp. 20. Rather, depending on the charging protocol used and when in the charging cycle the voltage is applied, the applied voltage could be higher than the battery voltage. Ex. 2013; Ex. 2006 ¶ 91. For example, as discussed in more detail below with respect to the Uemura grounds, when fast charging using constant current is used and the charging rate is not slow, the applied voltage will be higher than the battery voltage when the constant current charging phase is stopped. Ex. 2006 ¶ 91; Ex. 2013. Likewise, during constant current/constant voltage charging, the applied voltage approximates the battery voltage only when the battery is nearly completely charged. Ex. 2013; Ex. 2006 ¶ 91. Thus, the applied voltage may be, but is not necessarily, the charge cut-off voltage. In view of the foregoing, we construe “charge cut-off voltage” in claims 1 and 5 as “the maximum value to which the battery is configured to be charged.” PO Resp. 18; Ex. 2008, 217:6–11; Pet. Reply 5. Contrary to Patent Owner’s arguments, however, we do not understand the phrase “configured to be charged” to necessarily represent a single voltage for the battery that is determined based on the structure and chemistry of the battery. Pet. Reply 4–5. Rather, the charge cut-off voltage is a selected potential, or voltage, of the battery or cell at the end of charging that is controlled by a circuit or device, such as a charger or control circuit within the battery. Ex. 1001, 9:50–55; Ex. 1048, 2, 7–8; Ex. 1008, 3:9–13. And, for the reasons discussed herein, the charge cut-off voltage may be, but is not necessarily, the same as the applied voltage during charging. PO Resp. 20.” slip op. at 15

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

    “charge cut-off voltage “greater than 4.2 V but less than 5.8 V” and calculating a specific or theoretic capacity “with a charge cut-off voltage limited to 4.2” (claim 1) or “with a charge cut-off voltage set at 4.2 V” (claim 5). Ex. 1001, 16:56–61, 17:6–11. Although the parties dispute the precise scope of these claim terms, the parties agree that the first use of “charge cut-off voltage” in claims 1 and 5 refers to the potential of the battery as a whole (between the cathode and the anode), and not a half-cell voltage using lithium metal as a counter electrode.10 Tr. 17:1–3 (agreeing 10 With respect to the phrase “as calculated by a theoretic capacity with a charge cut-off voltage set at 4.2 V,” the parties in fact appear to be in that the first use of “charge cut-off voltage” in claim 5 refers to a full-cell voltage); Sur-reply 5; PO Resp. 22. We need not further construe the claims to resolve the disputes between the parties. See 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) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “Given Mr. Juzkow’s unambiguous testimony that Uemura uses constant current charging that would stop when the applied voltage reached 11 The chart is reproduced from SAFT, Charging your lithium-ion batteries: 5 expert tips for a longer lifespan, (https://www.saft.com/energizing-iot/charging-your-lithium-ion-batteries-5-expert-tips-longerlifespan#:~: text=When%20the%20battery%20provides%20current,This%20restore s%20the%20battery's%20capacity). 4.3 V, as well as Dr. Yao’s persuasive testimony that Uemura’s constant charging rate is not slow, we credit the testimony of Dr. Yao that one of ordinary skill in the art would have understood that the internal voltage to which the battery of Uemura was charged is less than 4.3 V. Ex. 2006 ¶ 119. In particular, Dr. Yao persuasively testifies that one of ordinary skill in the art would have believed that the charge cut-off voltage was no more than 4.2 V, and most likely equal to “about 4 V.” Id. ¶¶ 119–122.” slip op. at 21

  Patent outcomesUS 7,749,641 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,749,641
• Samsung Electronics Co., Ltd. / Apple Inc. v. RJ Technology LLCSome claims unpatentable
  PTAB · Jan 17, 2025 · IPR2023-01183 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 2–4 and 6–18 are unpatentable as obvious over Abe and Guyomard, with claims 9 and 10 also obvious over Iwaizono; claims 1 and 5 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have had a Master’s degree in material science, chemical engineering, chemistry, or similar field with four years of experience designing testing, and building secondary lithium batteries.” Pet. 11 (citing Ex. 1002 ¶ 51). Petitioner further contends that a person of ordinary skill in the art would have been aware of “(1) positive electrode materials, (2) negative electrode materials, (3) separators, (4) electrolytes, (5) charge-discharge parameters, and (6) protection circuits, as well as ‘battery failure modes’ such as plating and the formation of dendrites.” Id. (citing Ex. 1002 ¶¶ 50–51). Patent Owner “does not dispute Petitioner’s level of ordinary skill.” PO Resp. 17. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the person of ordinary skill in the art as it is consistent with the disclosures of the ’641 patent and the prior art of record.” slip op. at 9

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

    “constructions. First, we agree with Petitioner that the ’641 patent indicates that the charge cut-off voltage selected for a particular battery need not be a fixed property of the battery or something that is set by the design and chemistry of the battery. Consistent with this conclusion, the ’641 patent discloses that a “charging device controls the charge cut-off voltage of the single lithium-ion cell within a range from 4.3 V to 5.8 V.” Ex. 1001, 9:50– 55. This strongly suggests that the charge cut-off voltage is controlled by the charger and is not necessarily an inherent property of the battery. Patent Owner contends that this is merely an unclaimed embodiment, but the relevant disclosure states that the charging device for the “present invention” may be any type of device “with the proviso that said charging device controls the charge cut-off voltage.” Id. at 9:50–53.” slip op. at 12

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

    “charge cut-off voltage “greater than 4.2 V but less than 5.8 V” and calculating a specific or theoretic capacity “with a charge cut-off voltage limited to 4.2” (claim 1) or “with a charge cut-off voltage set at 4.2 V” (claim 5). Ex. 1001, 16:56–61, 17:6–11. Although the parties dispute the precise scope of these claim terms, the parties agree that the first use of “charge cut-off voltage” in claims 1 and 5 refers to the potential of the battery as a whole (between the cathode and the anode), and not a half-cell voltage using lithium metal as a counter electrode.10 Tr. 17:1–3 (agreeing 10 With respect to the phrase “as calculated by a theoretic capacity with a charge cut-off voltage set at 4.2 V,” the parties in fact appear to be in that the first use of “charge cut-off voltage” in claim 5 refers to a full-cell voltage); Sur-reply 5; PO Resp. 22. We need not further construe the claims to resolve the disputes between the parties. See 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) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 16

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Given Mr. Juzkow’s unambiguous testimony that Uemura uses constant current charging that would stop when the applied voltage reached 11 The chart is reproduced from SAFT, Charging your lithium-ion batteries: 5 expert tips for a longer lifespan, (https://www.saft.com/energizing-iot/charging-your-lithium-ion-batteries-5-expert-tips-longerlifespan#:~: text=When%20the%20battery%20provides%20current,This%20restore s%20the%20battery's%20capacity). 4.3 V, as well as Dr. Yao’s persuasive testimony that Uemura’s constant charging rate is not slow, we credit the testimony of Dr. Yao that one of ordinary skill in the art would have understood that the internal voltage to which the battery of Uemura was charged is less than 4.3 V. Ex. 2006 ¶ 119. In particular, Dr. Yao persuasively testifies that one of ordinary skill in the art would have believed that the charge cut-off voltage was no more than 4.2 V, and most likely equal to “about 4 V.” Id. ¶¶ 119–122. Petitioner argues that because the battery of Uemura is charged “to” a maximum voltage of 4.3 V, Uemura discloses the claimed charge cut-off voltage under either Petitioner’s or Patent Owner’s construction of the term. Pet. Reply 11–12 (citing Ex. 1009 ¶ 81; Ex. 1044 ¶¶ 56–59). This argument is not persuasive because Mr. Juzkow unambiguously testified that charging in Uemura stopped when the applied voltage reached 4.3 V, and Uemura discloses that the battery was charged “at” a voltage ranging from 4.3 V to 2.0 V, not “to” such a voltage. Ex. 1009 ¶ 81; Ex. 2008, 113:2–13; Ex. 2006 ¶ 119 n.64; Sur-reply 9. In view of the foregoing, we determine that Petitioner has not demonstrated by a preponderance of the evidence that Uemura anticipates independent claims 1 and 5 of the ’641 patent.” slip op. at 21

  Patent outcomesUS 7,749,641 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,749,641
• Chongqing Yanmei Technology Co., Ltd. v. Terves, LLCSome claims unpatentable
  PTAB · Aug 27, 2024 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 19–61, 63–77, and 79 are unpatentable as anticipated by Doud; claims 78, 80, and 81 are not shown unpatentable. The contingent motion to amend is granted in part and denied in part.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art “would have at least a Ph.D. in chemistry, metallurgy, or material science or material engineering” or, in the alternative, “would have a Bachelor of Science or Master of Science degree in one of these disciplines plus experience involving the use and design of dissolvable metal alloys for use in creating tools and other downhole parts for well drilling or completion activities.” Pet. 13–14. Patent Owner does not oppose Petitioner’s contentions regarding the level of ordinary skill in the art. PO Resp. 12 n.4. Upon review of the prior art of record and the parties’ arguments, we adopt Petitioner’s unopposed definition of the ordinarily skilled artisan as it is consistent with the prior art of record.” slip op. at 7

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

    “With respect to claim 19, Petitioner proposes constructions for the terms “in situ precipitate” and “a plurality of particles of said in situ precipitate having a size of no more than 50 µm.” Pet. 11–12. With respect to claims 76–81, Petitioner proposes a construction for the term “wherein said additive material includes one or more metal materials selected from the group consisting of 0.1–35 wt. % copper, 0.1–24.5 wt. % nickel and 0.1–20 wt. % cobalt.” Id. at 13. Patent Owner contends no claims require construction for purposes of this Decision. PO Resp. 12 n.4, 17–18; Mot. 16–17. Upon review of the prior art of record, we determine that no claim terms require express construction for purposes of this Final Written 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 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “Ex. 2027, 20:25–21:5 (emphasis added). The disclosure that the “magnesium composite” of “[t]he present invention” “includes at least 50 wt% magnesium” is unambiguous and constitutes strong evidence that the inventors were not in possession of a magnesium composite with less than 50 wt. % magnesium, or additive concentrations above 50 wt. %. See SciMed Life Systems, Inc. v. Advanced Cardiovasular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (noting that a description of the “present invention” as having a particular structure “is strong evidence that the claims should not be read to encompass the opposite structure”). Consistent with this conclusion, the original claims of the ’295 application all limited the additive material in the composite to 0.05 wt %–45 wt %. Ex. 2027, 26:1– 13, 29:9–15. Likewise, in each example where copper, nickel, or cobalt additives are used in the range recited in the proposed substitute claims, the magnesium composite is “over 50 wt% magnesium,” and any claims that do not require this range of magnesium are limited to an additive range of “about 0.05 wt%–45 wt% of said mixture.”8 Ex. 2027, 6:13–7:4, 7:16–19, 8 Written description support is considered from the view point of the ordinarily skilled artisan. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Patent Owner, bearing the burden to show written description support in any priority application for which it seeks the benefit of its filing date, provides no testimony from an ordinarily skilled artisan regarding written description support in the ’295 application, or any evidence to show what such an artisan would conclude from the express disclosures of the ’295 application. Lectrosonics, Paper 15 at 7; In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (noting that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Where there is any ambiguity in the disclosures of the ’295 application, the absence of supporting testimony tends to cut against 26:2–31:2; see Ex. 1005 ¶¶ 12, 13, 18, 19, 16–21, 26, 28, claims 16–21, 26– 28. In view of the foregoing, we are not persuaded that Patent Owner has demonstrated that the inventors of the priority applications were in possession of a magnesium cast composite that included less than 50 wt. % magnesium, or greater than 50 wt. % additives. As proposed substitute claim 104 encompasses a magnesium cast composite with up to 90 wt. % additives, and therefore as little as 10 wt. % magnesium, Patent Owner has not demonstrated that the full scope of this claim finds written description support in any application prior to the ’915 application, filed on October 12, 2018.” slip op. at 17

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

    “The definiteness requirement of § 112(a) is satisfied when “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable clarity.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see 37 C.F.R. § 42.100(b) (changing the claim construction standard used to review a claim proposed in a motion to amend from the broadest reasonable construction to the “same construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b)”). Proposed substitute claim 104 generically requires “in situ precipitate” and also a specific type of in situ precipitate: “in situ galvanically-active intermetallic precipitate.” Mot. Appendix A. Although this claim would have best been clarified by Patent Owner after seeking preliminary guidance on its Motion to Amend, upon review of the written description, claims, and figures of the ’740 patent, as well as Patent Owner’s clarification in its Reply to the Opposition, we agree with Patent Owner that one of ordinary skill in the art would have understood that the “in situ galvanically-active intermetallic precipitate” is merely a more complete description of the “in situ precipitate” mentioned earlier in the sentence. Mot. Reply 4. As such, we do not find that this part of proposed substitute claim renders claim 104 indefinite.” slip op. at 22

  Patent outcomesUS 10,689,740 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Graham · Nautilus
  Patents in suitUS 10,689,740
• Samsung Electronics Co., Ltd. v. Lynk Labs, Inc.Some claims unpatentable
  PTAB · Apr 19, 2023 · IPR2021-01576 · APJ Scott Raevsky · IPR · Final written decision

  Claims 1–12 are unpatentable as obvious; claims 13–18 are not shown unpatentable because the asserted combinations fail to teach or suggest multiple LED packages connected in series.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “PO Resp. 8 (citing Ex. 2001 ¶¶ 41–42). Patent Owner argues that its definition is superior because Petitioner’s “and/or” qualifier “might be read as considering a person who has ‘related circuit design’ experience but no experience with ‘LED devices’ to be a POSITA.” Id. at 9. Patent Owner further views Petitioner’s “or a related field” phrasing as potentially including a person who has no experience with LED devices. Id. We agree with Patent Owner on both points. We agree with Patent Owner that Patent Owner’s proposal is more consistent with the problems and solutions in the ’979 patent and prior art of record. We adopt Patent Owner’s definition of the level of skill but note that had we adopted Petitioner’s level of skill, we would not have reached a different outcome here.” slip op. at 6

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

    “specification support its construction of “formed or mounted to” as encompassing indirect attachment to the substrate. Neither the plain claim language nor the specification requires the phosphor coating to be directly attached to the substrate. Limitation 1(c) recites, wherein the LED chips comprise a phosphor coating to produce a change in a color or a quality of light emitted from the LED chips, wherein the LED chips, the power connection leads, and the phosphor coating are formed or mounted to a flexible substrate that is sufficiently flexible to be formed into a cylindrical shape[.] Ex. 1001, 22:7–12 (emphasis added). The claim is inartfully written, as it requires the LEDs to comprise a phosphor coating but then separately recites that the LED chips and the phosphor coating are formed or mounted to the substrate. But Petitioner correctly explains that the plain meaning requires that “the LED chips comprise a phosphor coating” and that “the [same] phosphor coating” (included in the LED chips) is “formed or mounted to a flexible substrate.” Reply 2. In other words, the use of the term “the” before “phosphor coating” indicates reliance on the antecedent basis of “LED chips comprise a phosphor coating,” and thus the same coating of the LED chips is formed or mounted to the substrate. Logically, by including a phosphor coating with the LED chips, which are formed or mounted to the substrate, the coating of these chips is also indirectly formed or mounted to the substrate. Conversely, it would be illogical to conclude that the claim recites two phosphor coatings, one attached to the LED chips and another attached directly to the substrate, because the structure of the claim refers to a single phosphor coating of the LED chips. Even Patent Owner concedes that the claim encompasses the phosphor coating indirectly being mounted or attached to the substrate (in addition to being directly attached). PO Resp. 11 (“The ordinary English reading of the claim language does not encompass the phosphor coating only being indirectly attached to the substrate, instead, the language indicates that the coating is directly applied to the substrate.” (emphasis changed)), 13 (“the phosphor coating . . . is not merely attached to the substrate indirectly”).” slip op. at 10

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

    “After considering Patent Owner’s arguments, which we address below, we agree with Petitioner that the combination of Wojnarowski and Martin discloses this limitation and that a person of ordinary skill in the art would have been motivated to combine the references’ teachings in the manner asserted by Petitioner. Briefly, we summarize our findings, and then we address the parties’ arguments in more detail. First, we agree with Petitioner, and Patent Owner does not dispute, that Wojnarowski’s AC input voltage would have been converted to DC voltage in light of the bridge rectifier and capacitor disclosed by Wojnarowski. Pet. 25; Ex. 1002 ¶¶ 119– 20 (citing, e.g., Ex. 1005, 7:59–62, Fig. 24); PO Resp. 35–36 (acknowledging Wojnarowski discloses converting an AC input to a DC voltage). Second, we further agree with Petitioner, and Patent Owner does not dispute, that excessive current due to too few LEDs would have harmed Wojnarowski’s LEDs, and too small a current due to too many LEDs would be insufficient to power Wojnarowski’s LEDs. Pet. 26; Ex. 1002 ¶ 134; PO Resp. 48 (discussing, but not disputing, these assertions).13 Third, we agree that a POSITA would have recognized in view of Martin’s teachings and the knowledge of a skilled artisan that when configuring Wojnarowski’s device, the total forward voltage drop of the series-connected LEDs should approximately match the DC voltage output 13 Petitioner explains the relationship between voltage and current for the LEDs as follows: “the total voltage drop of the circuit would dictate the current drawn by the LED circuitry, which would have been known to be inversely proportional to the voltage.” Pet. 26 (citing Ex. 1002 ¶ 134). of Wojnarowski’s circuit. Pet. 26–27 (citing Ex. 1002 ¶¶ 132–38; Ex. 1008, Abstract (LED voltage “must be matched to the input source voltage”), ¶ 60 (“For AC or any other regularly varying input voltage, there is an additional requirement to direct drive voltage matching”)). For example, Martin teaches that “[t]he number of LEDs in the monolithic array may be selected to achieve a particular voltage drop across each device.” Ex. 1006 ¶ 22. Martin further explains, “[t]he voltage across each of the individual LEDs in the array is the line voltage divided by the number of LEDs in series,” and “[t]he number of LEDs is chosen such that the maximum voltage across each individual LED during the peak in the alternating current cycle is low enough so as not to damage the LEDs.” Id. The forward voltage drop across Martin’s 38 LEDs is about 171 V, which matches Martin’s AC input voltage peak of about 169.71 V. See id. (“At 120 RMS volts, the peak voltage will be about 180V [correction: 169.71 V],” and if the LEDs “can tolerate a maximum forward voltage of 4.5V, at least 38 LEDs connected in series are required.” (38 LEDs x 4.5 V = 171 V)); PO Resp. 41–42 (“While Martin references ‘about 180V,’ both parties agree that the correct value of the peak voltage Vp is 169.71 V.” (citing Ex. 1002 ¶ 127)). Although Martin’s LED forward voltage drop (171 V) differs slightly from the peak input voltage (169.71 V), Patent Owner conceded at the hearing that the claimed “matches” does not require an exact equivalence. Tr. 38:9–11 (“Patent Owner agrees . . . that matching has a meaning that goes beyond exact equivalence.”).14” slip op. at 22

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

    “35 U.S.C. § 311(b). PO Resp. 22–25. This statute provides that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent 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.” § 311(b) (emphasis added). Patent Owner contends that Martin is not available as prior art under 35 U.S.C. § 311(b) because it is not a patent or printed publication and is only prior art under 35 U.S.C. § 102(e). PO Resp. 22. Patent Owner argues that documents are “printed publications” as of the date they become available to the public, and Martin became public on its publication date of October 21, 2004, after the February 25, 2004 priority date of the ’979 patent. Id. at 23. Patent Owner raises a similar argument for the Soules-II reference in Ground 6. Id. at 25– 26. Petitioner responds that the AIA framework permits the use of § 102(e) prior art in IPR proceedings, unlike formerly available covered business method review (CBM) proceedings, which restricted challenges to § 102(a) prior art. Reply 29. We agree. The statute governing the formerlyavailable CBM proceeding explicitly limits challenges based on “prior art that is described by section 102(a).” AIA § 18(a)(1)(C). In contrast, § 311(b) more broadly permits challenges “on the basis of prior art consisting of patents or printed publications.” The broader language in § 311(b) implies that unlike CBMs, IPRs are not limited to challenges solely under § 102(a) prior art. The parties cite to no Federal Circuit decisions that squarely address this issue. However, the Federal Circuit has applied § 102(e) patent application publication prior art in appeals from IPR proceedings. See, e.g., Purdue Pharma L.P. v. Iancu, 767 Fed. App’x 918, 920–21, 926 (Fed. Cir. 2019) (nonprecedential) (determining that a § 102(e) patent application publication was available as prior art in an IPR). The Board has also long permitted challenges based on patent application publications under § 102(e). See, e.g., Idle Free Sys., Inc. v. Bergstrom, Inc., IPR2012-00027, Paper 14 at 27 (PTAB Jan. 31, 2013) (instituting trial over § 102(e) ground based on a patent application publication). We therefore find Patent Owner’s § 311(b) argument unpersuasive.” slip op. at 34

  Patent outcomesUS 10,652,979 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,652,979
• Syngenta Crop Protection AG v. FMC CorporationSome claims unpatentable
  PTAB · Aug 31, 2021 · PGR2020-00028 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–3, 9–13, and 21–30 are unpatentable for lack of enablement; claims 9–13 also lack written description. Petitioner did not prove anticipation or obviousness of claims 1–7 and 22–31.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider factors including the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Because Petitioner’s proposed definition is consistent with the prior art of record and the sophistication of the technology demonstrated by the record, we apply it here.5” slip op. at 10

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

    “Based on the complete record developed at trial, we determine that to resolve the disputes herein, we do not need to expressly construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for disputed terms, and only as necessary to resolve the controversy).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We find that Dr. Dayan’s testimony on these points lacks sufficient supporting analysis. In opining that the tested substituents are representative of the steric and electrostatic properties across the claimed substituents, Dr. Dayan merely compares the properties of the tested substituents to each other. See, e.g., id. ¶¶ 52–56. He does not expressly compare them to the properties of the many remaining, untested substituents within the scope of the claims. See id.; see also Reply 14 (“At best, [Dr.] Dayan testified that the positive activity . . . at each substituent” suggests that the position is involved in herbicidal activity, “not that the tested compounds were sufficient to provide any reasonable expectation of success as to the billions of structurally diverse compounds covered” by the claims.). And although Dr. Dayan acknowledges that several tested compounds showed no herbicidal activity, he does not expressly explain how he took these compounds into account in nevertheless concluding that an ordinarily skilled artisan would expect at least some activity across all claimed substituents. See, e.g., Ex. 2011 ¶¶ 54–56 (noting exceptions to herbicidal activity). As one example, Dr. Dayan acknowledges the lack of activity shown in the data for substituents larger than hydrogen at the R6 position, but does not explain the impact of that data on the remaining claimed substituents. See id. ¶ 54 (Dr. Dayan noting that activity is “not as favored by larger alkyl groups” at R6, but nevertheless concluding that “one would expect at least some herbicidal activity” across all claimed R6 substituents). In contrast, Dr. Hunt compares the size and properties of the R6 substituents that showed no activity with the size and properties of other claimed but untested R6 substituents. Ex. 1003 ¶¶ 163, 166–68; Ex. 1029 ¶¶ 37, 38. This comparison indicates that the majority of R6 substituents are larger than the tested substituents, such that the vast majority of the claimed compounds (i.e., those with compounds having R6 substituents larger than those tested), could have no herbicidal activity. Ex. 1003 ¶ 167; Ex. 1029 ¶¶ 12, 37, 38. Thus, we find that the data in the Specification regarding at least position R6 gives a person of ordinary skill in the art reason to doubt that substantially all compounds within the full scope of claim 1 of the ’202 patent would exhibit herbicidal activity. Ex. 1003 ¶ 163; Ex. 1029 ¶¶ 11, 12, 38; In re Surrey, 370 F.2d 349, 355 (CCPA 1966) (“[W]here the applicant seeks to obtain a monopoly in exchange for his disclosure of a group of compounds there should be a disclosure which gives a reasonable assurance that all, or substantially all of them are useful.”).” slip op. at 29

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “We find that the need for iterative QSAR modeling, together with the sheer number of candidate compositions that must be synthesized (each of which would take at least a week to make) for both the modeling and herbicide testing, weighs against enablement, especially in light of the limited guidance in the Specification and the general unpredictability in the art. 3. Conclusion In sum, it is undisputed that claim 1 covers at least a billion compounds. The art is unpredictable, and the Specification indicates that not all of the compounds falling within claim 1 are effective herbicides. See, e.g., Pet. 22 (listing compounds that showed no herbicidal activity). Although the level of ordinary skill in the art is relatively high and the field is mature, Petitioner establishes by a preponderance of the evidence that the ’202 patent does not provide sufficient meaningful guidance or working examples across the full scope of claim 1 to allow a person of ordinary skill in the art to determine which other compounds across the full scope of the claim have herbicidal activity without undue experimentation.” slip op. at 45

  Patent outcomesUS 10,294,202 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 10,294,202
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner.” slip op. at 13

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

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213

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.