• 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
• 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
• Cisco Systems, Inc. / Forescout Technologies, Inc. et al. v. K.Mizra LLCNo claims unpatentable
  PTAB · Sep 19, 2022 · IPR2022-00084 · APJ Minn Chung · IPR · Final written decision

  Claims 1–3, 5–13, and 15–19 were not shown unpatentable under § 103 over Gleichauf, Ovadia, and Lewis because the petitioner did not sufficiently explain why a skilled artisan would have combined Gleichauf and Lewis as …

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “Dr. Reddy additionally testifies that “URL redirection is a well-known concept in HTTP traffic” (Ex. 1003 ¶ 24) and that “[a person of ordinary skill in the art] would have been familiar with URL redirection, which was a common technique used to forcibly provide an alternative response to a client’s request for a web page” (id. at ¶ 134). During the oral hearing, Petitioner also stated, citing the Reddy Declaration, that “it was well known to redirect traffic to a separate server.” Tr. 17:8–12 (citing Ex. 1003 ¶ 134). This, however, does not provide a sufficient explanation why a person of ordinary skill in the art would have been motivated to combine Gleichauf and Lewis. This rationale and all of the other reasons for the proposed combination proffered by Petitioner establish, at most, that Gleichauf and Lewis could have been combined to meet limitations [1.8] and [1.9], rather than a person of ordinary skill in the art would have been motivated to make the proposed combination. This is insufficient. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”) (citing InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014)). We find, therefore, that Petitioner does not provide a sufficient reasoning to support obviousness of claim 1 based on the proposed combination.7 See Kinetic Concepts, 688 F.3d at 1366–67 (holding that “some kind of motivation must be shown from some source, so that the [trier of fact] can understand why a person of ordinary skill would have thought of either combining two or more references or modifying one to achieve the patented [invention]”)); InTouch Techs., 751 F.3d at 1348–49 (Fed. Cir. 2014) (“[The expert witness’s] testimony was nothing more than impermissible hindsight; she opined that all of the elements of the claims disparately existed in the prior art, but failed to provide the glue to combine these references.”).” slip op. at 36

  • Skill levelSkill level petitioner adoptedOther

    “Patent Owner does not dispute Petitioner’s articulation of the level of ordinary skill in the art. See generally PO Resp. Dr. Medvidovic, Patent Owner’s declarant, states that “[f]or the purposes of the subject IPR proceedings,” he “employ[s]” the level of ordinary skill in the art articulated by Dr. Reddy. Ex. 2009 ¶ 26. Based on the complete record, for purposes of this Decision, we adopt Petitioner’s unopposed position as to the level of ordinary skill in the art at the time of the claimed invention because Petitioner’s proposal is consistent with the level of ordinary skill in the art reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 13

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

    “The parties dispute construction of “trusted platform module” (Pet. 13–16; PO Resp. 5–6) but do not identify any issue that would turn on the construction of this term. See generally Pet.; PO Resp. Based on the complete record, for purposes of this Decision, we determine no claim terms require express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that only terms that are in controversy need to be construed, and “only to the extent necessary to resolve the controversy”); see also 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 14

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

    “Therefore, we find that Gleichauf alone provides all of the alleged benefits or advantages of the proposed combination of Gleichauf and Lewis identified by Petitioner. As discussed above, in the proposed combination of Gleichauf and Lewis, Gleichauf would be modified such that HTTP traffic from a quarantined device would not be redirected to a remediation server but instead would be redirected to a quarantine server, which serves an informational webpage to the user of the device, as taught by Lewis. Pet. 48–49; Pet. Reply 14 (citing Ex. 1005, 4:56–63, 21:1–12; Ex. 1007, 4:24– 31, 13:7–15; Pet. 48). Thus, Petitioner’s proposed combination contemplates (1) modifying Gleichauf’s network by adding a separate quarantine server, (2) modifying Gleichauf’s policy server to not redirect HTTP traffic from a quarantined device to a remediation server and to instead redirect the HTTP traffic to the quarantine server, and (3) providing a quarantine notice webpage to the user from the quarantine server, including a link to the remediation server, which the user can click on to access the remediation server. In addition, Gleichauf’s policy server would also need to be modified to not provide the notification messages to the user for HTTP traffic to avoid having both the policy server and the quarantine server provide the same or similar information displays to the user. Neither Petitioner nor Dr. Reddy explains adequately why a person of ordinary skill in the art would have been motivated to look to Lewis to introduce such significant changes to the architecture or design of Gleichauf’s network when Gleichauf alone already provides all of the alleged benefits or advantages of the proposed combination identified by Petitioner. See Pet. 26–29; Pet. Reply 14–16; Ex. 1003 ¶¶ 66–71. Thus, based on the complete record, we find that the alleged benefits or advantages of the proposed combination identified by Petitioner do not provide sufficient basis for establishing why a person of ordinary skill in the art would have been motivated to combine Gleichauf and Lewis in the manner proposed by Petitioner. See In re Anova Hearing Labs, Inc., 809 F. App’x 840, 843 (Fed. Cir. 2020) (finding that the Board’s general statements that a person of ordinary skill in the art would have combined the prior art references to address the problem of occlusion effect in hearing aids was insufficient when the Board does not explain why a person of ordinary skill in the art would have been “motivated to modify Brown, which already includes vents, to address occlusion effect”) (non-precedential); cf. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (“Because each device independently operates effectively, a person having ordinary skill in the art, who was merely seeking to create a better device to drain fluids from a wound, would have no reason to combine the features of both devices into a single device.”).” slip op. at 34

  Patent outcomesUS 8,234,705 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,234,705
• Cisco Systems, Inc. / Forescout Technologies, Inc. et al. v. K.Mizra LLCNo claims unpatentable
  PTAB · Sep 19, 2022 · IPR2022-00081 · APJ Minn Chung · IPR · Final written decision

  Claims 1–3, 5–13, and 15–19 were not shown unpatentable under § 103 because Petitioner did not sufficiently explain why a skilled artisan would combine Gleichauf and Lewis.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “person of ordinary skill in the art “would have had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of professional experience in the field of network communications, and more specifically, network security.” Pet. 10 (citing Ex. 1003 ¶ 18). Petitioner asserts that “[l]ack of professional experience can be remedied by additional education, and vice versa.” Id. (citing Ex. 1003 ¶ 18). Patent Owner does not dispute Petitioner’s articulation of the level of ordinary skill in the art. See generally PO Resp. Dr. Medvidovic, Patent Owner’s declarant, states that “[f]or the purposes of the subject IPR proceedings,” he “employ[s]” the level of ordinary skill in the art articulated by Dr. Reddy. Ex. 2009 ¶ 26. Based on the complete record, for purposes of this Decision, we adopt Petitioner’s unopposed position as to the level of ordinary skill in the art at the time of the claimed invention because Petitioner’s proposal is consistent with the level of ordinary skill in the art reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 13

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

    “The parties dispute construction of “trusted platform module” (Pet. 13–16; PO Resp. 5–6) but do not identify any issue that would turn on the construction of this term. See generally Pet.; PO Resp. Based on the complete record, for purposes of this Decision, we determine no claim terms require express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that only terms that are in controversy need to be construed, and “only to the extent necessary to resolve the controversy”); see also 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 14

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

    “Therefore, we find that Gleichauf alone provides all of the alleged benefits or advantages of the proposed combination of Gleichauf and Lewis identified by Petitioner. As discussed above, in the proposed combination of Gleichauf and Lewis, Gleichauf would be modified such that HTTP traffic from a quarantined device would not be redirected to a remediation server but instead would be redirected to a quarantine server, which serves an informational webpage to the user of the device, as taught by Lewis. Pet. 48–49; Pet. Reply 14 (citing Ex. 1005, 4:56–63, 21:1–12; Ex. 1007, 4:24– 31, 13:7–15; Pet. 48). Thus, Petitioner’s proposed combination contemplates (1) modifying Gleichauf’s network by adding a separate quarantine server, (2) modifying Gleichauf’s policy server to not redirect HTTP traffic from a quarantined device to a remediation server and to instead redirect the HTTP traffic to the quarantine server, and (3) providing a quarantine notice webpage to the user from the quarantine server, including a link to the remediation server, which the user can click on to access the remediation server. In addition, Gleichauf’s policy server would also need to be modified to not provide the notification messages to the user for HTTP traffic to avoid having both the policy server and the quarantine server provide the same or similar information displays to the user. Neither Petitioner nor Dr. Reddy explains adequately why a person of ordinary skill in the art would have been motivated to look to Lewis to introduce such significant changes to the architecture or design of Gleichauf’s network when Gleichauf alone already provides all of the alleged benefits or advantages of the proposed combination identified by Petitioner. See Pet. 26–29; Pet. Reply 14–16; Ex. 1003 ¶¶ 66–71. Thus, based on the complete record, we find that the alleged benefits or advantages of the proposed combination identified by Petitioner do not provide sufficient basis for establishing why a person of ordinary skill in the art would have been motivated to combine Gleichauf and Lewis in the manner proposed by Petitioner. See In re Anova Hearing Labs, Inc., 809 F. App’x 840, 843 (Fed. Cir. 2020) (finding that the Board’s general statements that a person of ordinary skill in the art would have combined the prior art references to address the problem of occlusion effect in hearing aids was insufficient when the Board does not explain why a person of ordinary skill in the art would have been “motivated to modify Brown, which already includes vents, to address occlusion effect”) (non-precedential); cf. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (“Because each device independently operates effectively, a person having ordinary skill in the art, who was merely seeking to create a better device to drain fluids from a wound, would have no reason to combine the features of both devices into a single device.”).” slip op. at 34

  Patent outcomesUS 8,234,705 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,234,705
• Cisco Systems, Inc. / Forescout Technologies, Inc. et al. v. K.Mizra LLCNo claims unpatentable
  PTAB · Sep 19, 2022 · IPR2021-00593 · APJ Minn Chung · IPR · Final written decision

  Claims 1–3, 5–13, and 15–19 were not shown unpatentable because Petitioner did not sufficiently explain why a skilled artisan would combine Gleichauf and Lewis as proposed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “person of ordinary skill in the art “would have had a bachelor’s degree in computer science, computer engineering, electrical engineering, or an equivalent training, and approximately two years of professional experience in the field of network communications, and more specifically, network security.” Pet. 10 (citing Ex. 1003 ¶ 18). Petitioner asserts that “[l]ack of professional experience can be remedied by additional education, and vice versa.” Id. (citing Ex. 1003 ¶ 18). Patent Owner does not dispute Petitioner’s articulation of the level of ordinary skill in the art. See generally PO Resp. Dr. Medvidovic, Patent Owner’s declarant, states that “[f]or the purposes of the subject IPR proceedings,” he “employ[s]” the level of ordinary skill in the art articulated by Dr. Reddy. Ex. 2009 ¶ 26. Based on the complete record, for purposes of this Decision, we adopt Petitioner’s unopposed position as to the level of ordinary skill in the art at the time of the claimed invention because Petitioner’s proposal is consistent with the level of ordinary skill in the art reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 13

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

    “The parties dispute construction of “trusted platform module” (Pet. 13–16; PO Resp. 5–6) but do not identify any issue that would turn on the construction of this term. See generally Pet.; PO Resp. Based on the complete record, for purposes of this Decision, we determine no claim terms require express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that only terms that are in controversy need to be construed, and “only to the extent necessary to resolve the controversy”); see also 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 14

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

    “Therefore, we find that Gleichauf alone provides all of the alleged benefits or advantages of the proposed combination of Gleichauf and Lewis identified by Petitioner. As discussed above, in the proposed combination of Gleichauf and Lewis, Gleichauf would be modified such that HTTP traffic from a quarantined device would not be redirected to a remediation server but instead would be redirected to a quarantine server, which serves an informational webpage to the user of the device, as taught by Lewis. Pet. 48–49; Pet. Reply 14 (citing Ex. 1005, 4:56–63, 21:1–12; Ex. 1007, 4:24– 31, 13:7–15; Pet. 48). Thus, Petitioner’s proposed combination contemplates (1) modifying Gleichauf’s network by adding a separate quarantine server, (2) modifying Gleichauf’s policy server to not redirect HTTP traffic from a quarantined device to a remediation server and to instead redirect the HTTP traffic to the quarantine server, and (3) providing a quarantine notice webpage to the user from the quarantine server, including a link to the remediation server, which the user can click on to access the remediation server. In addition, Gleichauf’s policy server would also need to be modified to not provide the notification messages to the user for HTTP traffic to avoid having both the policy server and the quarantine server provide the same or similar information displays to the user. Neither Petitioner nor Dr. Reddy explains adequately why a person of ordinary skill in the art would have been motivated to look to Lewis to introduce such significant changes to the architecture or design of Gleichauf’s network when Gleichauf alone already provides all of the alleged benefits or advantages of the proposed combination identified by Petitioner. See Pet. 26–29; Pet. Reply 14–16; Ex. 1003 ¶¶ 66–71. Thus, based on the complete record, we find that the alleged benefits or advantages of the proposed combination identified by Petitioner do not provide sufficient basis for establishing why a person of ordinary skill in the art would have been motivated to combine Gleichauf and Lewis in the manner proposed by Petitioner. See In re Anova Hearing Labs, Inc., 809 F. App’x 840, 843 (Fed. Cir. 2020) (finding that the Board’s general statements that a person of ordinary skill in the art would have combined the prior art references to address the problem of occlusion effect in hearing aids was insufficient when the Board does not explain why a person of ordinary skill in the art would have been “motivated to modify Brown, which already includes vents, to address occlusion effect”) (non-precedential); cf. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (“Because each device independently operates effectively, a person having ordinary skill in the art, who was merely seeking to create a better device to drain fluids from a wound, would have no reason to combine the features of both devices into a single device.”).” slip op. at 34

  Patent outcomesUS 8,234,705 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,234,705
• ROKU, Inc. v. Universal Electronics, Inc.No claims unpatentable
  PTAB · Aug 11, 2022 · IPR2021-00455 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 1–9 were not shown unpatentable over Chardon and HDMI 1.3a because the combination does not disclose data that itself identifies a controllable function.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “As Patent Owner observes, the two proposals differ “in terms of the level of experience specifically with home theater systems.” Id. at 10. Because all of the challenged claims make specific reference to a “home theater device,” Petitioner’s proposal is reasonable on the current record, and is additionally supported by the testimony of Dr. Russ. See Ex. 1003 ¶¶ 15– 19. Patent Owner notes that its expert, Dr. Turnbull, agrees with Patent Owner’s proposed articulation, but that Dr. Turnbull’s “conclusions resulting from his analysis did not change when reviewing the cited references from the perspective of the level of ordinary skill in the art as proposed by the Petition.” PO Resp. 10–11 (citing Ex. 2003, 31–41). We adopt Petitioner’s articulation of the level of ordinary skill for purposes of this Decision. We note, however, that we would reach the same ultimate conclusion were we to adopt Patent Owner’s proposal.” slip op. at 17

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

    “phrase creates a degree of ambiguity, we are mindful that “the claims themselves provide substantial guidance as to the meaning of particular claim terms” and that “the context in which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314. In this instance, the related phrasing that appears in the “automatically adding” and “causing” limitations of issued independent claim 1 is illuminating. Both of those limitations refer to “the controllable function of the controllable appliance that was identified by the data received from the controllable appliance.” Ex. 1001, 17:11–14, 17:21–24 (emphasis added). There is no question that the only antecedent for “the data” in these limitations is the “data that functions to identify a controllable function of the controllable appliance” recited in the “receiving” limitation. See id. at 17:8–9. And there is no apparent room in the language “that was identified by the data” for the introduction or consideration of such “other information” that Petitioner would like to use “in connection with” the recited “data” to identify the controllable function. See Reply 2.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “Petitioner reasons that a person of ordinary skill in the art would have combined such teachings from HDMI 1.3a with Chardon’s system because HDMI 1.3a “is a technical guide for the interoperability of the HDMI standard and how HDMI enabled devices operate,” and that “Chardon relies on HDMI capabilities to facilitate communication and monitoring-device state changes in its system.” Pet. 30–31 (citing Ex. 1005, 4:18–21; Ex. 1010, 17; Ex. 1003 ¶¶ 130–131). According to Petitioner, “[a] person of ordinary skill in the art would have therefore turned to at least one of the versions of the HDMI Specification to fill in any details in Chardon with respect to how HDMI-capable devices, such as those of Chardon and the ’486 patent operate, and would have had a reasonable expectation of success in doing so.” Id. at 31. Petitioner supports this reasoning with testimony by Dr. Russ that it is a “well-known industry practice” to rely on HDMI 1.3a as “specification of an industry standard” when “designing and building devices that implement the HDMI standard, incorporating all of the capabilities it offers.” Ex. 1003 ¶ 133. Patent Owner disputes the sufficiency of Petitioner’s showing. In” slip op. at 35

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

    “The difficulty with Petitioner’s and Dr. Russ’s position is that it is inconsistent with our adopted claim construction that the data itself identify a controllable function of the controllable appliance from which the data is received. See supra § II.C. As Patent Owner asserts, HDMI 1.3a “does not contemplate the exchange of any information that itself functions to identify a controllable function of a playback device.” PO Resp. 24 (emphasis added). All that the “Deck Status” message indicates in the example of Figure 17 is that the current status of the playback device is “Stop.” We also are not persuaded by Petitioner’s and Dr. Russ’s argument that HDMI 1.3a’s Tables 13 and 26 disclose that “Deck Info” information is returned with the “Deck Status” message, and that such “a deck status message includ[es] the features that the device can provide (e.g., play, pause, stop, etc.).” Pet. 41; Ex. 1003 ¶ 117. Reliance on such “Deck Info” information is problematic at least because it is “other information” that would be used in combination with the “Deck Status” to determine controllable functions of the controllable device, which is precluded by our adopted claim construction.” slip op. at 36

  Patent outcomesUS 10,325,486 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,325,486
• 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
• Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLCNo claims unpatentable
  PTAB · Feb 15, 2022 · IPR2020-01438 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 4 and 5 were not shown unpatentable because the evidence, including unexpected results, did not establish obviousness over the asserted prior art.

  RulingsFinal written decision

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

    “to the earliest effective filing date of June 6, 2015, the filing date of the ’063 provisional application, Allgenesis PCT thereby does not qualify as prior art against the ’820 patent. See above II.D. Accordingly, Petitioner has not met the burden of establishing that the claims are unpatentable as obvious over Allgenesis PCT. F.” slip op. at 59

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

    “the reasoning to combine the references, and the evidence of secondary considerations in the form of surprising unexpected results, we determine that Petitioner has not shown that claims 4 and 5 of the ’820 patent are unpatentable. III. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not established by a preponderance of the evidence that claims 4 and 5 of the ’820 patent are unpatentable.” slip op. at 78

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

    “equivalent for another. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). “Conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.” Hoffman-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014).” slip op. at 69

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “Ex. 1001, 11. Table 2 shows three observation days comparing 0.05% sunitinib TID with 0.05% nintedanib. On all three days, 0.05% nintedanib TID shows significant improvements over 0.05% sunitinib TID. For example, on day 12, the 0.05% nintedanib TID group had a negative value (indicating a reduction in neovascular area), while the 0.05% sunitinib TID group had a positive number (indicating a growth in neovascular area) and the difference between the two is also statistically significant with a P value of 0.016. The comparative data of measuring the reduction in neovascularization in an established animal model as shown the ’820 patent provides a sufficient nexus to the claimed method of reducing hyperemia. The data presented in Table 2 (shown above) shows that nintedanib functions unexpectedly better than sunitinib. The ’820 patent further explains that nintedanib inhibits three kinase targets, FGFR4, Lyn and Src, that are not inhibited by sunitinib, pazopanib, or other common kinases inhibitors. Ex. 1001, 12:14–17; see also id. at 11 (Table 1). In addition, “nintedanib’s potencies on FGFRl-3 are substantially higher than that of sunitinib that may also contribute to the superior efficacy of nintedanib in the cornea suture rabbit model.” Id. 12:17–20. Given these surprising and unexpected results that nintedanib has improved efficacy and a better safety profile compared to sunitinib as reported in the ’820 patent specification convinces us that on balance the weight of the evidence supports a finding that claims 4 and 5 have not been shown to be unpatentable.” slip op. at 77

  Patent outcomesUS 10,149,820 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 10,149,820
• ROKU, Inc. v. Universal Electronics, Inc.No claims unpatentable
  PTAB · Apr 13, 2021 · IPR2019-01615 · APJ Sharon Fenick · IPR · Final written decision

  Claims 1, 3, 5, and 7 were not shown unpatentable because the evidence did not establish that Chardon’s command-code database teaches the claimed listing of communication methods.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner argues that one of ordinary skill in the art would have had general knowledge of home theater systems, control of devices within the home theater systems, and remote control devices as of October 28, 2011. Further, a POSA would have had: (1) at least a bachelor’s degree in an electrical engineering, computer engineering, or equivalent coursework, and (2) at least one year of experience researching or developing structure and operating principles of common digital content reproduction and related appliances, contemporary television and home theater standards, and specifications of consumer digital reproducing devices of the time. Pet. 13. Patent Owner proposes a different standard: [A person of ordinary skill in the art] would have had a bachelor’s degree which involved software design and development coursework, for example, electrical engineering, computer engineering, computer science, cognitive science, industrial engineering, information systems, information studies, or a similar degree, and at least one year of work experience in software programming, development, or design of consumer applications. Additional education might substitute for some of the experience, and substantial experience might substitute for some of the educational background. PO Resp. 4–5 (internal citations omitted). The ’853 patent specifically relates to remote control devices, so we adopt Petitioner’s standard that includes general knowledge consistent with the field of the invention, and, additionally, is consistent with the prior art presented. See Ex. 1001, 1:63– 2:3; 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

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

    “Petitioner proposes only one claim construction, for limitation [1.4], which specifies that the first and second communication methods are “for use in controlling each of at least a first functional operation and a second functional operation of the intended target appliance.” Pet. 14–17. In our Decision on Institution, we found that no specific construction was necessary. Dec. 17. Post-institution, the parties’ arguments did not involve the construction of this term, and no express construction is necessary for us to reach our conclusion. See PO Resp. 10 (Patent Owner stating that no construction is required). We determine that no specific construction is required to resolve the controversy before us, and thus decline to construe this limitation. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 11

  • BurdenNot shown unpatentable

    “by a preponderance of the evidence that Chardon teaches or suggests a database (the “listing” of claim 1) that is “comprised of at least a first communication method and a second communication method different than the first communication method,” which methods are “used to transmit to the intended target appliance a command for controlling” a functional operation of a target appliance, as required by claim 1. We find that Petitioner has not sufficiently adduced that a database “comprised of” CEC and IR command codes would teach or suggest claim 1’s listing.” slip op. at 20

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

    “by a preponderance of the evidence that Chardon teaches or suggests a database (the “listing” of claim 1) that is “comprised of at least a first communication method and a second communication method different than the first communication method,” which methods are “used to transmit to the intended target appliance a command for controlling” a functional operation of a target appliance, as required by claim 1. We find that Petitioner has not sufficiently adduced that a database “comprised of” CEC and IR command codes would teach or suggest claim 1’s listing.” slip op. at 20

  Patent outcomesUS 9,716,853 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,716,853
• 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.