• 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
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentable
  PTAB · 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 mixed
  Claim construction§ 112 disclosure
  Patents in suitUS 10,993,942
• Tide International (USA), Inc. v. Upl Na Inc.Some claims unpatentable
  PTAB · Jan 4, 2022 · IPR2020-01113 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–4 are unpatentable as obvious over Misselbrook, CN ’588, and JP ’902; claims 7–12 were not shown unpatentable because the grounds did not establish motivation to add a disintegrating agent.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “relevant to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may also reflect an appropriate level of skill. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner

    “We also adopt the parties’ position that the preamble of claims 1 and 7 is not limiting beyond the term “granule.” Claims 1 and 7 each recite “[a] chemically stable dry flow, low compact, dust free soluble phosphoramidothioate granule consisting of” the set of ingredients recited in body of those claims. Ex. 1001, 7:44–45, 8:19–20. While the wherein clause describing the dimensions of “said granule” relies on “granule” in the preamble for antecedent basis, none of the other preamble language appears to be necessary to breathe life and meaning into the claim, and the claim body recites a structurally complete invention. See Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (explaining that a preamble is limiting if it is “necessary to give live, meaning, and vitality to the claim,” but “is not limiting where a patentee defines a structurally complete invention in the claim body”) (internal quotations omitted). Thus, we agree with the parties, and the district court in the related litigation, that the preamble language other than “granule” is not limiting.” slip op. at 10

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

    “Moreover, we agree that the transitional phrase “consisting of” in claims 1 and 7 creates a “very strong presumption that the claim element is ‘closed’ and therefore exclude[s] any elements, steps, or ingredients not specified in the claim.” Pet. 5; Resp. 12 (both quoting Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)). Neither party seeks to overcome that presumption, nor do we see any basis for doing so based on the record before us. Accordingly, we construe the challenged claims to be limited to granule compositions containing only those ingredients recited in the claims. There are no other terms that need to be construed to resolve the issues presented in this proceeding. Therefore, we do not construe any additional terms. See, e.g., Nidec Motor Corp. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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 11

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “demonstrating that the “general conditions” regarding the use of these ingredients in such compositions was known. In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (noting that any overlap between the claimed and disclosed ranges serves to disclose the “general conditions” of the claim). “Such overlap itself provides sufficient motivation to optimize the ranges.” Id. Moreover, we credit Mr. Geigle’s testimony that a POSITA would have understood because the concentration of acephate was increased the concentration of the other ingredients would necessarily decrease and that a POSITA would have been able optimize these amounts using standard techniques and testing. Ex. 1003 ¶¶ 85–113. Thus, Petitioner has demonstrated that these ingredient concentrations are result-effective variables that would have been obvious to optimize through routine experimentation.” slip op. at 24

  Patent outcomesUS 7,473,685 mixed
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 7,473,685
• Veeam Software Corp. v. Hybir Inc.Some claims unpatentable
  PTAB · Dec 2, 2021 · IPR2020-01038 · APJ John R Kenny · IPR · Final written decision

  Claims 30, 32, 33, 35, and 37–40 are unpatentable as obvious; claims 31, 34, and 36 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “E. Level of Skill in the Art To determine the level of an ordinarily skilled artisan, various factors” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “claim terms for construction at that stage of the proceeding, and we did not construe any claim terms expressly as none of the terms were in dispute. Inst. Dec. 22. In the briefing following institution, Patent Owner proposed a construction for the term “inventory,” see, e.g., PO Resp. 21–28, and it became clear that the parties dispute the meaning of the term. Accordingly, we address the parties’ proposed constructions for “inventory” and the arguments they present for those constructions.” slip op. at 13

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

    “As set forth above, we resolved those disputed issues in favor of Petitioner. For the portions of the preamble and limitations of claim 35 that are not recited in claim 30, we have reviewed Petitioner’s arguments and evidence for claim 35 and are persuaded that Field teaches or suggests the preamble and claim limitations. Pet. 25–28 (and the exhibits cited therein). Thus, we find that Field teaches or suggests all limitations of claim 35. Accordingly, we determine Petitioner has proven that claim 35 would have been obvious over Field.” slip op. at 55

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

    “metadata into its signature generating algorithm to create a more robust signature. Ex. 1005 ¶ 46. An ordinarily skilled artisan would have been motivated to use such an augmented signature generating algorithm in Field’s environment. Ex. 1002 ¶¶ 138–139; Ex. 1004 ¶ 40. Thus, an ordinarily skilled artisan would have modified Field’s cryptographic signature generating algorithm so it would compute a file’s signature using a file’s metadata. Ex. 1002 ¶¶ 138–139; Ex. 1004 ¶ 40. Accordingly, Field and Anderson disclose that “the cryptographic signature is also computed with the metadata.” Ex. 1002 ¶¶ 138–139; Ex. 1004 ¶ 40.” slip op. at 76

  Patent outcomesUS 8,051,043 mixed
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 8,051,043
• Veeam Software Corp. v. Hybir Inc.Some claims unpatentable
  PTAB · Dec 2, 2021 · IPR2020-01037 · APJ John R Kenny · IPR · Final written decision

  Claims 1, 2, 5, 6, 8–15, 18, 19, 21–29, and 34 are unpatentable as obvious over Field and Anderson; claims 3, 4, 7, 16, 17, and 20 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “regarding the level of ordinary skill in the art, and Petitioner does not address our preliminary finding in its Reply. Accordingly, we see no reason to disturb that finding, and, therefore, we maintain and reaffirm that one of ordinary skill in the art at the time of the invention would have had a Bachelor of Science degree in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, or an equivalent field, as well as at least three to five years of academic or industry experience in the fields of data storage, data backup, data restoration, data replication and deduplication, and/or data synchronization.” slip op. at 16

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

    “Accordingly, we find that the record does not support construing” slip op. at 32

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

    “away and (2) whether one of ordinary skill in the art would have been motivated to not transmit an inventory with multiple signatures due to a concern with backup efficiency. With respect to whether Field teaches away, Patent Owner’s argument is premised, in part, on a requirement derived from its proposed construction of “inventory”—that the claimed “inventory” must include additional data, such as filenames and directories. As discussed above, we do not agree with Patent Owner’s construction. Similar to Patent Owner’s earlier argument of a teaching away, Patent Owner fails to identify anything in Field that criticizes, discredits, or otherwise discourages one of ordinary skill in the art from creating an inventory, as properly construed. Accordingly, we do not find that Field teaches away from using or creating an inventory.” slip op. at 81

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

    “144, 202; Pet. Reply 20–21; Ex. 1024 ¶¶ 59–62. Accordingly, we determine that Petitioner has not proven that claims 3 and 16 would have been obvious over Field and Anderson. Ex. 2008 ¶¶ 129–130.” slip op. at 101

  Patent outcomesUS 8,051,043 mixed
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 8,051,043
• Liquidia Technologies, Inc. v. United Therapeutics CorporationSome claims unpatentable
  PTAB · Oct 8, 2021 · IPR2020-00770 · APJ John E Schneider · IPR · Final written decision

  Claims 1–5, 8, and 9 are unpatentable as obvious over Moriarty and Phares; claims 6 and 7 were not shown unpatentable over either asserted ground.

  RulingsFinal written decision

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

    “Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Here, we do not need to define the outer bounds of the term “pharmaceutical batch” because the parties’ dispute over this term centers on the issue of storage stability.7 Patent Owner argues “the correct construction 6 The parties use the terms “purification” and “isolation” interchangeably in the papers. We use the term “isolation” in this Decision. 7 The parties agree on the “pharmaceutical” aspect of the term. We note the ’901 patent defines “pharmaceutically acceptable” as “being useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable and includes being useful for veterinary use as well as human pharmaceutical use.” Ex. 1001, 5:27–31.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “[A]n invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office.” Graham, 383 U.S. 1, 33. “The prosecution history of a related patent can be relevant if . . . it addresses a limitation in common with the patent in suit.” Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305 (Fed. Cir. 2001); see also Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999) (“When multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation.”). Here, the Specification of the ’901 patent includes the same language “crude treprostinil salts can be stored as raw material at ambient temperature” addressed in the prosecution of the parent ’623 application. Ex. 1001, 17:5–6. More importantly, challenged claim 6 recites the same limitation “preparing a pharmaceutical product . . . after storage” the applicant expressly interpreted there. See Ex. 2028, 193. Because “the same claim limitation is at issue, prosecution disclaimer made on the same limitation in an ancestor application will attach,” the applicant’s interpretation of “storing”/“storage” during the prosecution of the ’623 application applies here. See Omega Eng’g, Inc., v. Raytek Corp., 334 F.3d 1314, 1333 (Fed. Cir. 2003). slip op. at 23

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

    “Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013). Here, step (c) of challenged claim 1 requires “contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Ex. 1001, 17:27–29 (emphasis added). The claim language itself, thus, dictates that the solution formed in step (b), and not treprostinil isolated from step (b), is the starting material for forming a salt in step (c). The Specification of the ’901 patent supports our determination. Indeed, the Specification touts that one of the advantages of the disclosed process is that “the treprostinil salts can be synthesized from the solution of treprostinil without isolation,” because “[t]he impurities carried over from intermediate steps (i.e. alkylation of triol and hydrolysis of benzindene nitrile) are removed during the carbon treatment and the salt formation step.” Ex. 1001, 17:1–11. As a result, we agree with the argument presented in the Patent Owner Response that “claim 1 requires the solution in which treprostinil is formed be used directly in the next salt-forming step without isolating treprostinil in between.” See PO Resp. 11.” slip op. at 27

  • Skill levelSkill level board ownOther

    “pharmaceutical manufacturing.” Id. at 23. We find Patent Owner’s definition of the skill level too narrow. Patent Owner relies on the declaration of Dr. Pinal, who testifies that the ’901 patent is “focused on the production of pharmaceutical compositions and products, on a commercial batch-size scale.” Ex. 2002 ¶ 91; see also id. ¶ 92 (opining that organic and medicinal chemists do not have the “requisite skill set for the large-scale manufacture” of drugs); PO Resp. 24 (arguing an ordinarily skilled artisan is aware of “problems encountered in preparing a commercial-scale pharmaceutical product”).” slip op. at 29

  Patent outcomesUS 9,604,901 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,604,901
• Netflix, Inc. / Hulu, LLC v. Divx, LLCSome claims unpatentable
  PTAB · Sep 27, 2021 · IPR2020-00648 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 16, 17, and 19 are unpatentable over Pyle and Marusi; claims 1–6, 8–10, 13, and 14 were not shown unpatentable under the asserted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we found that Petitioner’s proposal was consistent with the level of ordinary skill in the art reflected by the prior art of record and we preliminarily adopted Petitioner’s unopposed position. Inst. Dec. 8–9 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)). As neither party challenges our preliminary finding regarding the level of ordinary skill in the art, we see no reason to disturb that finding. Accordingly, we maintain and reaffirm that one of ordinary skill in the art at the time of the invention would have had “a bachelor’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with at least two years of experience in adaptive streaming and content management” or “a master’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with a specialization in adaptive streaming or content management” and that “[a] person with less education but more relevant practical experience may also meet this standard.” See Inst. Dec. 8–9 (setting forth and adopting Petitioner’s unopposed position as to the level of ordinary skill in the art) (alteration in original).” slip op. at 10

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

    “the case law makes clear that “an indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of ‘one or more’ in open-ended claims containing the transitional phrase ‘comprising’” unless an “extremely limited” exception applies. See Convolve, Inc. v. Compaq Computer Corp., 812 F.3d 1313, 1321 (Fed. Cir. 2016) (quoting KCJ Corp., 223 F.3d at 1356; Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008)). Here, claim 1 recites the transitional phrase “comprising,” meaning it is open-ended, and, therefore, the usual meaning of “a” as “one or more” would have been expected absent an extremely limited exception. In considering whether an exception applies, our review of the ’515 patent fails to indicate that the patentee intended the phrase to mean anything other than the usual meaning of “one or more.” Patent Owner asserts that “[t]he plain language of the claim clearly indicates only a single [list] is used to list multiple assets” and quotes two portions of the Specification, which state “a list of assets that satisfies criteria” and “a list of assets to which a . . . device is granted access.” PO Sur-reply 12–13 (quoting Ex. 1001, 12:60–67) (citing Ex. 1001, 2:23–34, 3:1–5, 4:21–23, 17:59–66). Although claim 1 of the ’515 patent recites “assets” in the plural, we fail to see how that conveys that the term “a” would have been understood as limited to “one.” Notably, neither party has identified any inconsistency, in the claims or other portions of the Specification (including the portions quoted and/or cited by Patent Owner), resulting from construing “a” as “one or more.” And, we find that there is no reason why the claims could not be met under the construction of “a” as “one or more.” Thus, we find that the ’515 patent does not “evince [ ] a clear intent to limit a or an to one.” See Convolve, 812 F.3d at 1321 (internal quotations omitted). Accordingly, we construe the term “a” in “a list of assets” as “one or more” such that the phrase “a list of assets” means “one or more list of assets.” Considering next the phrase “the list of assets” recited in limitation 1[e], the parties do not dispute that the use of the term “the” means that “the list of assets” refers back to the one or more list of assets retrieved in limitation 1[d] and discussed above. See PO Resp. 1–2; see generally Pet. Reply; PO Sur-reply 5. Similarly, the parties do not dispute that the phrase “the filtered list of assets,” recited in limitation 1[e], refers back to the list of assets resulting from the filtering step of limitation 1[d]. See PO Resp. 3–4; see generally Pet. Reply; PO Sur-reply 5. We agree with the parties that each of these phrases refers back to the previous instance of the recited terms.” slip op. at 15

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

    “motivated to combine these teachings for several reasons. Pet. 21. First, Petitioner contends “the combination is the use of a known technique to improve similar devices because using the capabilities of a client device to choose appropriately formatted content was a well-known technique.” Id. Petitioner asserts that “implementing Marusi’s techniques for organizing multiple representations and choosing among them based upon a client device’s capabilities would predictably function in Pyle’s system, which similarly seeks to target video content based on particular client device types and parameters.” Id. (citing Ex. 1004, 10:57–11:10; Ex. 1003 ¶ 147). Second, Petitioner argues that “detecting a client device’s capabilities based upon client device identifiers was a common and known solution to the problem of supplying information in a format usable by the client device.” Pet. 21. Petitioner contends that one of ordinary skill in the art “would have found it obvious to combine Marusi’s teachings with Pyle because it is one solution, from a finite number of known, and predictable solutions.” Id. (citing Ex. 1003 ¶ 148). Third, with respect to Marusi’s databases, Petitioner contends “[t]he combination of Marusi’s databases to manage the data in Pyle’s system uses a known technique to improve similar systems.” Pet. 21. In particular, Petitioner asserts that one of ordinary skill “would have been motivated to combine Marusi’s database teachings with Pyle because Pyle teaches storing the same content in multiple, different representations.” Id. at 21–22 (citing Ex. 1004, 9:64–10:21). Further, Petitioner argues that “[u]sing a database to store and manage multiple representations of the same data, or even to simply store voluminous data for retrieval, was an extremely well-known and common application of databases.” Id. at 22 (citing Ex. 1003 ¶ 149). Additionally, Dr. Reader opines that one of ordinary skill in the art “would have understood that the teachings of Pyle and Marusi were complementary, and therefore would have been motivated to combine Pyle with Marusi to enhance the efficiency of generating, storing, and delivering multimedia content tailored to the capabilities of particular playback devices.” Ex. 1003 ¶ 150.” slip op. at 27

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

    “Patent Owner that Petitioner and Dr. Reader fail to explain why one of ordinary skill in the art would have understood that Pyle generates a top level index file by placing a manifest file in memory for transmission to a client device. Pet. 35; see Ex. 1003 ¶ 184. “Opinions expressed without disclosing the underlying facts or data may be given little or no weight.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“Consolidated TPG”), 40–41, available at https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf (citing Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997)). Here, there is no explanation or reason given for Petitioner’s assertion or Dr. Reader’s testimony and the connection, if any, is not otherwise apparent. Further, aside from Dr. Reader’s unexplained position, Petitioner has not pointed us to any evidence of record supporting the argument that one of ordinary skill in the art would have understood that placement of a file in memory for transmission teaches generating the file as recited in limitation 1[f]. Accordingly, without any explanation whatsoever, the record is without a sufficiently supported basis upon which to make that finding, resulting in a failure of proof by Petitioner with respect to claim 1.11 10 We also note that Petitioner’s Reply does not seek to add a new argument for our consideration; rather, Petitioner’s Reply asserts, albeit incorrectly, that the argument was raised in the Petition. See Pet. Reply 15. 11 Although Petitioner’s Reply sets forth several arguments in response to other arguments raised in Patent Owner’s Response, those additional arguments do not address to this aspect of limitation 1[f]. See, e.g., Pet. c. Dependent Claims 4, 5, 8–10, and 14 Petitioner contends that the combination of Pyle and Marusi would have rendered the subject matter of claims 4, 5, 8–10, and 14 obvious to one of ordinary skill in the art. Pet. 36–41. Claims 4, 5, 8–10, and 14 depend from claim 1 and, therefore, include limitation 1[f], as discussed above. Accordingly, for the same reasons discussed with respect to claim 1, Petitioner’s analysis of these claims suffers from the same deficiency.” slip op. at 34

  Patent outcomesUS 9,998,515 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,998,515
• 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

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.