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  • PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

    Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

      “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

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

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

    Patent outcomesUS 8,901,378 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 8,901,378
  • PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

    The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “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, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. 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))).” slip op. at 7

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

      “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” 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 5

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

      “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

    Patent outcomesUS 11,110,087 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,110,087
  • PTAB · Apr 7, 2020 · IPR2019-00026 · APJ Charles J Boudreau · IPR · Final written decision

    Claims 1, 15, and 41 were not shown unpatentable: Abadi did not identify suspicious code in its annotations, and the Abadi and Gryaznov combination did not cure that deficiency.

    RulingsFinal written decision
    • Skill levelOther

      “differences between the claimed subject matter and the prior art are “such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations, including (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; 2 Abadi et al., U.S. Patent No. 6,253,370 B1, issued June 26, 2001 (filed Dec. 1, 1997) (Ex. 1008, “Abadi”). 3 Dmitry O. Gryaznov, Scanners of the Year 2000: Heuristics, Virus Bull. Conf. 225 (Sept. 1995) (Ex. 1009, 2–11, “Gryaznov”). (3) the level of skill in the art; and (4) when in evidence, objective evidence of nonobviousness, i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). “To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). We analyze the asserted grounds with the principles stated above in mind.” slip op. at 7

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

      “Having considered the parties’ arguments, we see no reason to disturb their agreed construction of “Downloadable” as “an executable application program, which is downloaded from a source computer and run on the destination computer,” with which the parties state their express agreement. We clarify in Section II.D.2. below that we agree with Patent Owner that the executable application program that is to be run on the destination computer must be the same executable application program that is downloaded from the source computer within the agreed construction. Sur-reply 1–2. This interpretation is not a question of the construction of the term “Downloadable” itself, but rather flows from the express language of the challenged claims, in which “the Downloadable” that is “ma[de] . . . available to web clients” in the final step of each of independent claims 1 and 41 has its antecedent basis in the first claim step, “receiving . . . a Downloadable.” Likewise, the antecedent in claim 15 for “the Downloadable” that is made available to web clients is the Downloadable in which suspicious code is identified by the content inspection engine. We also agree with Patent Owner that the claimed “linking” of a DSP “to the Downloadable” does not compel a different understanding because we are not persuaded that the linking contemplated in the ’844 patent requires modification of the code of the Downloadable itself. Sur-reply 2–3.” slip op. at 12

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

      “Having considered the full record developed during trial, we agree with Patent Owner that the replacement of the word “profile” with “information” does not add any clarity to the meaning of this phrase and that the proper construction of “Downloadable security profile that identifies suspicious code in [the received / a] Downloadable” in the context of the ’844 patent is “profile that must at least include, but is not necessarily limited only to, an identification of hostile, potentially hostile, undesirable, or potentially undesirable code in the corresponding Downloadable.” PO Resp. 7–8. Regardless, we do not discern that the difference between the parties’ positions with respect to these phrases is dispositive of any issues in this proceeding.” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “generate an ID for the Downloadable.” PO Resp. 21 (emphasis added) (quoting Ex. 2015, 15), 23 (emphasis added) (citing Ex. 2015, 20). Based on Patent Owner’s arguments, we are not persuaded that the ’639 provisional demonstrates possession by the inventors of linking a DSP to the Downloadable “before a web server makes the Downloadable available to web clients.” Rather, by the time that the DSP has been linked to the Downloadable (e.g., by code scanner 325, in Patent Owner’s mapping), we understand that the Downloadable has already been received—and hence “made available”—by the web server. Notably, this conclusion does not depend on where the “linking” occurs—particularly, whether it may occur at a network gateway, a focus of the parties’ claim construction arguments (see, e.g., Pet. 25–27; PO Resp. 10–12; Section II.B.5, supra)—but instead on when it occurs relative to the Downloadable being made available to clients. Further, having considered the alleged Appendix to the ’639 provisional (Ex. 2015, 37–45), including portions cited by Dr. Butler in related litigation (see Ex. 2047), we are not persuaded that anything in the Appendix demonstrates possession of linking “before a web server makes the Downloadable available to web clients.” In conclusion, therefore, we are not persuaded that the inventors were in possession of the subject matter of the challenged claims at any time prior to the December 22, 1997, filing date of the ’648 application.” slip op. at 35

    Patent outcomesUS 6,154,844 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 6,154,844

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.