• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  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
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Oct 2, 2023 · IPR2022-00794 · APJ Daniel J Galligan · IPR · Final written decision

  Claims 1, 2, and 6–8 were not shown unpatentable because the prior art combinations did not establish the claimed messaging through the server system.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Tr. 78:6–10. Patent Owner responded “I don’t think it makes any difference for this panel’s determination.” Tr. 78:13–14. We agree and determine that the differences in the level of skill offered by the parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems.” See Inst. Dec. 10. We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ289 Patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art).” slip op. at 9

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

    “1. media player Patent Owner contends that, based on the “intrinsic record . . . an ordinary artisan would have understood the ordinary and customary meaning of ‘media player’ in the ’289 patent refers to application software and does not encompass hardware devices.” PO Resp. 14 (citing Ex. 2022 ¶¶ 92–93). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player.’” Pet. Reply 1. Rather, Petitioner states the media players relied upon in the Petition are all application software. Pet. Reply 1–2. Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 24–27)—are application software. The third ‘media player’ is likewise not a hardware device.” Pet. Reply 2 (alteration in original). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Muthukumarasamy “controls delivery of selected media content and selects and controls the media devices that deliver the selected media content according to a media type of the selected media content.” Because Muthukumarasamy teaches that the media device displays media content from various disparate sources depending on the media type and media source, a [person of ordinary skill in the art] would have understood the media device loads an appropriate media player depending on the media type and source. Pet. 23–24 (citing Ex. 1008 ¶ 47; Ex. 1005 ¶¶ 66–67). Petitioner, however, proffers insufficient evidence or argument that the content choices described in paragraph 47 of Muthukumarasamy would have led an ordinarily skilled artisan to understand a media player is obtained and loaded in the content presentation device. Rather, Dr. Bederson makes conclusory statements without providing evidence to support the assertions (Ex. 1005 ¶¶ 66–67).” slip op. at 33

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “Muthukumarasamy discussed above. In particular, Petitioner has not explained how Hayward teaches receiving the one or more messages in a system server. Rather, Petitioner relies on Hayward to teach “identify a particular media player for playing content from the file,” and “identify a location of the particular media player.” Pet. 41–45. More specifically, Petitioner contends that a person of ordinary skill in the art “would have been motivated by and found it obvious from Hayward to implement the DBCS (e.g., the RCIBS) to facilitate control of internet content presented at the content presentation device using any number of media players through embedded media player pages, as described in Hayward.” Pet. 65. However, to the extent Petitioner’s assertions rely on “implement[ing] the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the content presentation device” (Pet. Reply 22), we determine Petitioner has not shown the combined process of Muthukumarasamy and Hayward would include the required messages being received by the server (e.g., zHub/zNode), as opposed to directly by the RCIBS as discussed above. Additionally, Petitioner has not shown, for the zHub/zNode process, that Hayward cures the deficiencies of Muthukumarasamy as set forth above. Accordingly, Petitioner has not shown that the combination of Muthukumarasamy and Hayward teaches “receiving, in a server system, one or more messages from a personal computing device . . . wherein the one or more messages, . . . identify a particular media player for playing content from the file wherein the media player is a computer application operable to present content and control presentation of the content,” as recited in claim 1 and commensurately recited in independent claim 6. Additionally, because claim 2 depends from claim 1 and claims 7 and 8 depend from claim 6, we conclude that Petitioner has not established by a preponderance of evidence that the subject matter of claims 2, 7, and 8 would have been obvious over the combination of Muthukumarasamy and Hayward.” slip op. at 37

  Patent outcomesUS 8,904,289 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,904,289
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Sep 27, 2023 · IPR2022-00795 · APJ Debra K Stephens · IPR · Final written decision

  Claims 1, 2, and 5–9 were not shown unpatentable over Muthukumarasamy alone or with Hayward because the claimed signals identifying a media player were not shown to pass through the asserted server system.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “(Tr. 78:6–10). Patent Owner responded: “I don’t think it makes any difference for this panel’s determination” (Tr. 78:13–14). We agree and determine that the differences in the level of skill offered by the Parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems” (see Inst. Dec. 10). We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ251 Patent and the prior art of record (cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art)).” slip op. at 11

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

    “1. Media player Patent Owner contends, based on the “intrinsic record . . . an ordinary artisan would have understood the ordinary and customary meaning of ‘media player’ in the ’251 Patent refers to application software and does not encompass hardware devices” (PO Resp. 13 (citing Ex. 2022 ¶¶ 81–92, 95)). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player’” (Pet. Reply 1). Rather, Petitioner states the media players relied upon in the Petition are all software (Pet. Reply 1–2). Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 23–26)—are application software. The third ‘media player’ is likewise not a hardware device” (Pet. Reply 1–2). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 12

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

    “2. Additional Terms In light of the record and our findings, reasonings, and conclusions discussed below, we determine that no other terms or phrases in the claims require express construction (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 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “We determine that Hayward does not cure the deficiencies of Muthukumarasamy discussed supra. In particular, Petitioner has not explained how Hayward teaches receiving the one or more signals in a system server. Rather, Petitioner relies on Hayward to teach “identify a particular media player for playing the video content” (Pet. 38–41). More specifically, Petitioner contends “a [person of ordinary skill in the art] would have been motivated by and found it obvious from Hayward to implement the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the display device using any number of media players through embedded media player pages, as described in Hayward” (Pet. 15, 40 (citing Ex. 1005 ¶¶ 60, 102)). However, to the extent Petitioner’s assertions rely on “implement[ing] the DBCS (e.g., the RCIBS) to facilitate presentation of internet content at the display device . . .” (Pet. Reply 22 (emphasis omitted)), we determine Petitioner has not shown the combined process of Muthukumarasamy and Hayward would include the required signals being received by the server (e.g., zHub/zNode), as opposed to directly by the RCIBS as discussed above. Additionally, Petitioner has not shown, for the zHub/zNode process, that Hayward cures the deficiencies of Muthukumarasamy as set forth above.” slip op. at 39

  Patent outcomesUS 8,356,251 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,356,251
• Google LLC v. Touchstream Technologies, Inc.No claims unpatentable
  PTAB · Sep 27, 2023 · IPR2022-00793 · APJ Debra K Stephens · IPR · Final written decision

  Claims 1–5, 8, 11, 12, 14, 15, 27, and 28 were not shown unpatentable as obvious over Muthukumarasamy alone or with Hayward.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “(Tr. 78:6–10). Patent Owner responded: “I don’t think it makes any difference for this panel’s determination” (Tr. 78:13–14). We agree and determine that the differences in the level of skill offered by the Parties are not so significant as to warrant any changes to the definition set forth in the Decision to Institute. Therefore, we maintain our determination that an ordinarily skilled artisan would have had “a bachelor’s degree in electrical engineering or computer science (or equivalent experience) and two years of experience designing or implementing interactive systems with networked media or media playback systems” (see Inst. Dec. 10). We determine this level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ʼ528 Patent and the prior art of record (cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect an appropriate level of skill in the art)).” slip op. at 10

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

    “‘media player’ in the ’528 patent refers to application software and does not encompass hardware devices” (PO Resp. 16 (citing Ex. 2022 ¶¶ 83–91, 94)). Petitioner asserts that it “has not alleged any hardware device is a ‘media player’” and thus, “the Board need not resolve whether ‘hardware devices’ are encompassed by ‘media player’” (Pet. Reply 1). Rather, Petitioner states the media players relied upon in the Petition are all application software (Pet. Reply 1–2). Petitioner specifically states, “Petitioner has identified three ‘media players’ in the prior art. Two of these—Muthukumarasamy’s ‘Video Player[s]’ and Hayward’s ‘media players’ (Petition, 21–24)—are application software. The third ‘media player’ is likewise not a hardware device” (Pet. Reply 1–2). Thus, the parties agree that the term “media player” refers to software and not to a hardware device, and we apply this interpretation in our patentability analysis.” slip op. at 12

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

    “2. Additional Terms In light of the record and our findings, reasonings, and conclusions discussed below, we determine that no other terms or phrases in the claims require express construction (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 12

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

    “We are not persuaded. Even if the zHub and the zNode would be used to control the volume on the TV on which the streamed content is displayed, this device cooperation does not show the particular messaging recited in the claim. More specifically, even under Petitioner’s scenario that the “Volume Up” command flows from the IED (“personal computing device”) through the zHub/zNode (“server system”) to the TV (“content presentation device”), this command does not “identify a particular media player for playing content from the file.” Petitioner has not shown any messages in Muthukumarasamy that “identify a particular media player for playing content from the file” and flow from the IED through the zHub/zNode to the content presentation device. Thus, Petitioner’s assertions about devices working together fall short of proving by preponderant evidence that Muthukumarasamy discloses the particular messaging contents and path recited in claim 1.” slip op. at 30

  Patent outcomesUS 8,782,528 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,782,528
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Platinum Optics Technology Inc. v. Viavi Solutions Inc.No claims unpatentable
  PTAB · Oct 3, 2022 · IPR2021-00631 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 1–3, 5–8, 10–12, 14, 16–21, and 23 were not shown unpatentable because the asserted combinations did not establish the claimed hydrogenated silicon properties.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Supported by Mr. Willey’s testimony, Petitioner proposes that a person of ordinary skill in the art would have had “a Bachelor’s degree or equivalent in physics, or in a related science or engineering field, along with at least 5 years of experience in optical coating design and the manufacturing of optical filters, including various deposition techniques.” Pet. 13 (citing Ex. 1002 ¶¶ 66–68). According to Petitioner, “[a]dditional education (e.g., a Master’s degree with exposure to coating design and manufacturing) may substitute for some industrial experience in optical thin film design, and more industrial experience can substitute for a different educational background. Id. (citing Ex. 1002 ¶ 66). Patent Owner neither directly addresses Petitioner’s proposal nor provides its own proposal. See Tr. 35:15–18 (Patent Owner confirming for the record that it has not proposed a different level of ordinary skill than Petitioner’s proposal). Petitioner’s proposal is reasonable and consistent with the prior art presented. 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). We accordingly adopt Petitioner’s proposal.” slip op. at 11

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “Based on the statements Dr. Clemens made under oath in his Declaration, we find that he qualifies as a person having at least ordinary skill in the art according to our adopted definition. The questions Petitioner raises about Dr. Clemens’s qualifications were insufficiently explored on cross-examination to impeach that testimony. With respect to Petitioner’s further complaint that Dr. Clemens “did not review all the evidence in rendering his opinions, did not select the materials he reviewed, and did no independent research on the question of enablement,” we agree with Patent Owner that Petitioner cites no authority for the propositions that expert witnesses must review all exhibits or perform independent research. Sur-reply 27. Indeed, we do not find it particularly unusual for an expert witness to focus his analysis and opinions on specific issues identified by counsel, and Dr. Clemens properly discloses the underlying facts and data upon which his opinions are based. See 37 C.F.R. § 42.65(a). We thus accord due weight to Dr. Clemens’s testimony.” slip op. at 15

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

    “Petitioner contends that “the claims do not need an express construction to resolve the issues presented in this proceeding” but nevertheless “provides its proposed interpretations of two terms [namely, ‘center wavelength’ and ‘passband’] to clarify how Petitioner is applying the prior art to the claims.” Pet. 13. Patent Owner does not directly address Petitioner’s proposed constructions for these terms, and appears generally to treat the terms in a manner consistent with Petitioner’s proposals. We conclude that no express claim construction is necessary for any claim term. See Nidec Motor Corp. v. 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 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “One difficulty with Petitioner’s position is that it treats the refractive index and extinction coefficient as independent variables in its argument. But the prior art is clear that the adjusting the hydrogen content of Si:H to achieve a desired extinction coefficient necessarily affects the refractive index—and, as we discuss above, that such adjustments do so in a direction counterproductive to the combination of parameters the inventors sought. And we agree with Patent Owner that the refractive index and extinction coefficient “are not parameters subject to simple adjustment, but properties resulting from the parameters of the fabrication process.” PO Resp. 52 (citing Ex. 2001 ¶¶ 121–122; Ex. 1016, Figs. 2–3). At the Oral Hearing, Petitioner conceded that Patent Owner’s characterization is accurate when considering the hydrogenated silicon material. See Tr. 65:7– 12. When Petitioner refers to the refractive index and extinction coefficient as result-effective variables, Petitioner means that those parameters are variables that can affect the properties of the claimed optical filter. See id. at 64:6–65:12. As we note above, Petitioner’s argument thus presumes that the refractive index and extinction coefficient can be independently adjusted to achieve desired filter properties—but the asserted prior art teaches against such independence because the known method of adjusting the hydrogen content of Si:H not only affects both the refractive index and extinction coefficient, but does so in a manner counterproductive to the inventors’ objective.” slip op. at 35

  Patent outcomesUS 9,354,369 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,354,369
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. 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 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• DISH Network L.L.C. / DISH Technologies L.L.C. et al. v. Sound View Innovations, LLCNo claims unpatentable
  PTAB · Feb 8, 2022 · IPR2020-01276 · APJ John A Hudalla · IPR · Final written decision

  The Board held claims 1–3, 5–7, 13–15, 18, 20, 21, 24, 25, 27, and 29 not unpatentable over either asserted obviousness combination.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “After institution, neither party put forth arguments related to the level of ordinary skill. We discern no reason to change the level of ordinary skill in the art applied in this Final Written Decision. Thus, a person of ordinary skill in the art would have had either (1) a Bachelor of Science in Electrical Engineering, Computer Engineering, Computer Science, or a related field, as well as three to four years of experience in implementing protocols and/or equipment for streaming multimedia data; or (2) a Master’s degree in Electrical Engineering, or an equivalent field, as well as two years of experience in implementing protocols and/or equipment for streaming multimedia data. We are satisfied that this definition comports with the level of skill necessary to understand and implement the teachings of the ’796 patent and the asserted prior art.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “independent claims 1, 15, 20, and 27 are limiting. Dec. on Inst. 10–11. Petitioner does not take an express position on whether the preambles of the challenged claims are limiting. See Pet. 21 (stating that Geagan teaches the preamble “to the extent it is limiting”). Patent Owner supports our preliminary determination that the preambles are limiting. PO Resp. 37–41. Given this posture, we discern no reason to change our initial determination that the preambles are limiting. Thus, even though the disposition of this case does not turn on any particular limitation in the preamble, we maintain our determination that the preambles of claims 1, 15, 20, and 27 are limiting to the extent they color our analysis of Petitioner’s rationale for combining various prior art references.” slip op. at 9

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

    “We determine that no terms require explicit construction.2 See, e.g., Nidec Motor Corp. v. 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 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “Petitioner attempts to decouple these central control aspects from the functionality of sliding windows. In particular, Petitioner argues that “[t]he majority of the functionality for implementing the sliding window buffers is found in Vishlitzky’s stream servers themselves” and that Patent Owner has not established “that the controller servers of Vishlitzky exercise control over the playout history, the buffers, or sliding window functionality of Vishlitzky’s stream servers.” Pet. Reply 8–9. Yet Petitioner expressly relies on Vishlitzky’s admission control program, which runs on controller servers 28, 29, to teach the “determining” step of claim 1. Pet. 35–36, 40–41; Pet. Reply 21–22. Petitioner has not explained how the admission control program’s centralized function of choosing an appropriate stream server to service a request (see Ex. 1010, 7:62–8:3) would be implemented in the stream servers themselves. In addition, Petitioner’s analogy between Vishlitzky’s controller servers and the memory controllers used with Geagan’s proxy (Pet. 63; Pet. Reply 9) does not detail how and whether Petitioner proposes to modify Vishlitzky’s centralized controller functions such that they might be compatible with “the distributed nature of Geagan’s proxy approach,” as Petitioner characterizes it. Pet. Reply 10. At the oral hearing, Petitioner also suggested that a controller within a single proxy from Geagan could allocate incoming requests to multiple of Vishlitzky’s stream servers within that same proxy. Tr. 55:1–57:21; see also PO Sur-reply 23–24 (discussing this potential argument). In other words, Petitioner seemed to suggest that multiple stream servers from Vishlitzky’s stream server architecture in Figure 16, along with controller servers from Figure 2, could be replicated in each of Geagan’s proxies. Yet Petitioner disavows such a mapping in its Reply: “[T]he Petition does not propose that a POSITA would have bodily incorporated the entirety of Vishlitzky’s hardware control structure when implementing Geagan’s system using Vishlitzky’s ‘sliding window’ to store cached streaming content.” Pet. Reply 6. Nor was this the combination described in the Petition. Instead, Petitioner proposed “to implement the buffer of Geagan as a ‘pre-configured playout history (PH) buffer’ . . . because Vishlitzky teaches that it is advantageous to pre-configure a playout buffer.” Pet. 34; see also id. at 62–63 (“[A] POSITA would have had a reasonable expectation of success in implementing details of the ATM-based stream server of Vishlitzky in Geagan’s proxy . . . .”). Petitioner further characterizes this as “[t]he buffer of Geagan’s proxy, as implemented as a pre-configured PH buffer per Vishlitzky.” Pet. 39. And, importantly, Petitioner cites the creation of another proxy device in Geagan for teaching the recited “non pre-configured PH buffer”: “Geagan in view of Vishlitzky discloses ‘servicing the first request from a non pre-configured PH buffer,’ such as by live-streaming content using a buffer at the proxy device that is created at the time of the request for an unpopular live stream.” Pet. 42 (emphasis added). Finally, even if Petitioner’s papers had proposed a combination where Vishlitzky’s entire stream server and controller architecture is incorporated in each of Geagan’s proxies, Petitioner has failed to articulate reasons with some rational underpinning why an ordinarily skilled artisan would have made this combination. Thus, we are not persuaded by Petitioner’s arguments. At the very least, Petitioner has not explained where Vishlitzky’s controller servers would be disposed in the combined system and how they” slip op. at 28

  Patent outcomesUS 6,757,796 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,757,796
• DISH Network L.L.C. / DISH Technologies L.L.C. et al. v. Sound View Innovations, LLCNo claims unpatentable
  PTAB · Jan 18, 2022 · IPR2020-01041 · APJ Debra K Stephens · IPR · Final written decision

  DISH failed to prove claim 13 unpatentable as obvious over either Durand and Bennett or Goyal and Bennett.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We regard Petitioner’s formulation of the level of skill as consistent with the prior art before us (see Okajima 261 F.3d 1355). Based on the present record, including the disclosure in the ’456 Patent, we apply Petitioner’s definition of the level of ordinary skill in the art. We determine Petitioner’s asserted level of skill comports with the qualifications a person would have needed to understand and implement the teachings of the ’456 Patent and the prior art of record (cf. Okajima, 261 F.3d at 1355 (the prior art itself may reflect an appropriate level of skill in the art)). As we determine the four instances of “at least” in Petitioner’s formulation introduce ambiguity, we remove these terms from our definition. Accordingly, we determine an ordinarily skilled artisan would have a Bachelor of Science in one of Electrical Engineering, Computer Engineering, Computer Science, or a related field, as well as three to four years of experience in implementing resource reservations for UNIX-based computing systems, or a Master’s degree in Electrical Engineering, or an equivalent field, as well as two years of experience in implementing resource reservations for UNIX-based computing systems.” slip op. at 7

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

    “We determine that it is not necessary to provide an express interpretation of any terms of claim 13 (Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review)).” slip op. at 9

  • BurdenNot shown unpatentable

    “However, Petitioner has not set forth with specificity where Bennett teaches the request uses the one or more object references. Indeed, Petitioner has not explained how these two teachings of Bennett disclose the recited limitations with sufficient specificity or how one of ordinary skill in the art would modify Durand with these teachings of Bennett to achieve the recited limitations. Accordingly, Petitioner has not established that the combination of Durand and Bennet teaches the subject matter of claim 13. Therefore, based on the entire trial record, we determine Petitioner has not established by a preponderance of the evidence that the subject matter of claim 13 would have been obvious over Durand and Bennet under 35 U.S.C. § 103.” slip op. at 19

  • Strike new argumentNew argument disregardedDecided for patent owner

    “In its Reply, as noted by Patent Owner (PO Sur-reply 11), Petitioner offers a new theory, pointing to a different system call of Goyal (Pet. Reply 19–20 (citing Ex. 1090 ¶ 144 (citing Ex. 1002 ¶ 352–354))). Petitioner contends this new argument is to address Patent Owner’s alleged contention that “‘quality of service’ must already be ‘provided’ at the same time when the correspondence to the ‘reference to an object’ is created (Pet. Reply 19 (citing Ex. 1090 ¶ 141)). Thus, in Dr. Negus’ Reply Declaration, Dr. Negus asserts Goyal teaches the recited “quality of service guarantees that correspond to a reference to an object” relying on the “int hsfq_move (int from, int to, .....)” which “is used to move a thread from one leaf node to another”1 (Ex. 1090 ¶ 144). Petitioner’s alleged reliance on the hsfq_move (int from, int to, …….) system call instead of the int hsfq_mknod (char *name, int parent, int weight, int flag, scheduler_id side) system call represents a change in Petitioner’s unpatentability contentions that is presented for the first time in Petitioner’s Reply (see Pet. Reply 19–20). We acknowledge that the Petition mentions a “move” function: “Additionally, system calls are used to remove, move, and administer nodes in the scheduling structure. Goyal also discloses several additional functions to manage the scheduling structure, including removing, moving, and administering nodes.” (Pet. 61 (citing Ex. 1002 ¶¶ 350–352 (citing Ex. 1007 § 4))). But the cited portion of Dr. Negus’ Declaration simply states that there are other system calls, including “int hsfq_parse(char *name, int hint),” “int hsfq_rmnod(int id, int 1 We note Dr. Negus refers to the system call as “int hsfq_move” (see e.g., Ex. 1002 ¶¶ 144, 352) although Goyal discloses the system call as “hsfq_move” (Ex. 1007 § 4). We consider Dr. Negus’ naming to refer to the same system call as disclosed in Goyal. mode),” and “int hsfq_admin(int node, int cmd, void *args)” and the system call “‘int hsfq_move(int from, int to, .....)’ which ‘is used to move a thread from one leaf node to another’” (Ex. 1002 ¶ 352; see also id. ¶ 144 (repeating the same information as paragraph 352)). Additionally, these teachings of Goyal are discussed in conjunction with the limitation “utilizing an application programming interface . . . to establish one or more quality of service guarantees” (id. ¶¶ 356, 359). Thus, Dr. Negus’ initial Declaration does not elaborate on the move function, and the Petition does not rely on the “hsfq_move” system call to teach the limitations of claim 13. Petitioner asserts that this argument in reply is to address “Patent Owner’s new claim construction position” (Pet. Reply 19). We disagree. As outlined above, the Petition does not identify where an object reference is “used in the request,” as specifically recited in claim 13. Petitioner’s new reply argument, therefore, attempts to fill in a gap in Petitioner’s unpatentability contentions from the Petition that was pointed out by Patent Owner. Under the circumstances here, we do not consider this a permissible reply argument (see Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), available at https://www.uspto.gov/sites/ default/files/documents/tpgnov.pdf (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.”)). Thus, we do not consider Petitioner’s newly presented contentions.” slip op. at 26

  Patent outcomesUS 6,725,456 not shown unpatentable
  Claim constructioncites Phillips · KSR · Graham
  Patents in suitUS 6,725,456
• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision

  Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19

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

    “In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18

  Patent outcomesUS 10,195,214 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214

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.