• 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
• 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
• Intel Corporation v. Parkervision, Inc.No claims unpatentable
  PTAB · Jan 21, 2022 · IPR2020-01302 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 1, 3, 4, 7, and 9–11 were not determined unpatentable because the asserted Larson and Larson–Butler grounds did not teach sampling.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “Neither party contends that the differences in proposals affect the outcome of this proceeding and we do not find that they do. Nonetheless, on the full record before us, we find that our identification of the level of ordinary skill in art from the Institution Decision as well as Patent Owner’s option (b) are supported by the prior art of record, the ’474 patent, and the opinions of Drs. Subramanian and Steer (which, as discussed above, recognize that additional work experience can compensate for the lack of a formal degree). Accordingly, we modify our preliminary finding to include the specifics from option (b) of Patent Owner’s proposal. Thus, we find that one of ordinary skill in the art would have at least a bachelor’s degree in electrical engineering or a related subject and two or more years of experience in the field of RF circuit design, or at least five years of work experience and training in the design and development of RF circuits and/or systems. We also find that less work experience may be compensated by a higher level of education, such as a master’s degree.” slip op. at 11

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

    “Because the parties agree that the claims remaining in the trial require “sampling” and also agree that the prior art asserted in this case does not teach “sampling” (as discussed further below), we need not construe these terms expressly to resolve the controversy before us. See Vivid Techs., 200 F.3d at 803. sampling Although claim 1 does not recite “sampling” expressly, the post- institution briefs make clear that the parties agree that claim 1 and its dependent claims require sampling. In particular, Patent Owner contends, (1) “the ’474 patent pertains to a technique called sampling, which involves the use of a ‘switch’” (PO Resp. 2); (2) “all of the challenged claims are directed to a sampling system and, in particular, an energy sampling system (also known as an energy transfer system)” (id.); and (3) “[t]he challenged claims only cover energy sampling and the use of switches” (id. at 20). In its Reply, although Petitioner disagrees with Patent Owner’s interpretation of the claims as limited to energy sampling (i.e., energy transfer systems) (Pet. Reply 3–7), Petitioner contends that based on its “subsequent analysis of [Patent Owner’s] foundational ’551 patent—one of the multiple patents which the ’474 patent incorporates by reference—[Petitioner] now agrees with [Patent Owner] that the claims cover only systems that down-convert by sampling.” Pet. Reply 2. Thus, at a minimum, the parties agree that the claims at issue in this proceeding require sampling.” slip op. at 13

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

    “Discussion As discussed above, the parties now agree that (1) the claims at issue in this proceeding require “sampling” and (2) Larson alone or in combination with Butler do not disclose “sampling” and do not otherwise render the claims unpatentable. See Pet. Reply 2 (stating Petitioner agrees that “the claims cover only systems that down-convert by sampling”), 13 (stating that Larson and Butler do not disclose “down-conversion by sampling” and therefore agreeing that “Larson and Butler do not invalidate those claims”); see Ex. 2031, 6:20–22 (Patent Owner explaining, that “as the Board is aware, both parties agree that sampling is in the claims, and the claims are not invalid in view of all the cited prior art” (capitalization altered)). As such, based on Petitioner’s explicit admissions, Petitioner has not established by a preponderance of the evidence that (1) Larson anticipates claims 1, 3, 4, and 9–11 or (2) the combination of Larson and Butler would have rendered the subject matter of claims 1, 3, 4, 7, and 9–11 obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 19

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

    “Discussion As discussed above, the parties now agree that (1) the claims at issue in this proceeding require “sampling” and (2) Larson alone or in combination with Butler do not disclose “sampling” and do not otherwise render the claims unpatentable. See Pet. Reply 2 (stating Petitioner agrees that “the claims cover only systems that down-convert by sampling”), 13 (stating that Larson and Butler do not disclose “down-conversion by sampling” and therefore agreeing that “Larson and Butler do not invalidate those claims”); see Ex. 2031, 6:20–22 (Patent Owner explaining, that “as the Board is aware, both parties agree that sampling is in the claims, and the claims are not invalid in view of all the cited prior art” (capitalization altered)). As such, based on Petitioner’s explicit admissions, Petitioner has not established by a preponderance of the evidence that (1) Larson anticipates claims 1, 3, 4, and 9–11 or (2) the combination of Larson and Butler would have rendered the subject matter of claims 1, 3, 4, 7, and 9–11 obvious to one of ordinary skill in the art at the time of the invention.” slip op. at 19

  Patent outcomesUS 7,539,474 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,539,474
• Netflix, Inc. v. Divx, LLCNo claims unpatentable
  PTAB · Aug 13, 2021 · IPR2020-00511 · APJ Bart A Gerstenblith · IPR · Final written decision

  Claims 1–3, 5, 6, 10–12, 14, and 15 were not shown unpatentable under the three § 103 grounds because the combinations did not establish the encrypted-frame limitation.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “person of ordinary skill in the art at the time of the invention would have had “a bachelor’s degree in electrical engineering, computer science, or a similar field with at least two years of experience in video encryption and cryptography or . . . a master’s degree in electrical engineering, computer science, or a similar field with a specialization in video encryption and cryptography.” Pet. 14 (citing Ex. 1003 ¶¶ 65–67). Patent Owner does not address, expressly, the level of ordinary skill in the art in its Response. See generally PO Resp. Dr. Nielson, however, applies Petitioner’s proposed level of ordinary skill in his Declaration (Ex. 2009 ¶ 34) and does not indicate that he does otherwise in his Second Declaration (see generally Ex. 2024). In our Institution Decision, we found that Petitioner’s proposal was consistent with the level of ordinary skill in the art reflected by the prior art of record and we preliminarily adopted Petitioner’s unopposed position. Inst. Dec. 10 (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978)). As neither party challenges our preliminary finding regarding the level of ordinary skill in the art, we see no reason to disturb that finding. Accordingly, we maintain and reaffirm that one of ordinary skill in the art at the time of the invention would have had “a bachelor’s degree in electrical engineering, computer science, or a similar field with at least two years of experience in video encryption and cryptography or . . . a master’s degree in electrical engineering, computer science, or a similar field with a specialization in video encryption and cryptography.” See Inst. Dec. 9–10 (finding the same).” slip op. at 11

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

    “Petitioner contends that “the challenged claims are invalid under their plain and ordinary (‘P&O’) meaning.” Pet. 15 (citing Ex. 1003 ¶ 99). In the Preliminary Response, Patent Owner raised the meaning of two claim terms—“user encryption key” and “content encryption key.” Prelim. Resp. 40–44, 46–48. In the Institution Decision, we addressed each term to the extent necessary to resolve the controversy presented, and we found, in each instance, that Petitioner’s mapping of the prior art to these limitations of the claims was sufficient on the record presented at the time. See Inst. Dec. 12– 15 (discussing the construction of the terms), 22–28 (discussing limitation 1[a], which includes “user encryption key”), 28–31 (discussing limitation 1[b], which includes “content encryption key”). In particular, on the preliminary record, we found that “Chen’s master key Kw teaches the recited ‘user encryption key’” (id. at 28) and “Chen’s work key Kw teaches the recited ‘content encryption key’” (id. at 30). In the Response, Patent Owner does not propose a construction for any claim term or contest our preliminary findings regarding limitations 1[a] and 1[b]. See generally PO Resp. Accordingly, we maintain and reaffirm our preliminary determinations regarding the meaning of the recited “user encryption key” and “content encryption key.” Dec. 12–15. Additionally, we need not construe other claim terms to resolve the present controversy before us.6” slip op. at 13

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

    “techniques, and standards in the industry regarding the same in an attempt to explain how one of ordinary skill in the art would have understood Chen at the time of the ’920 patent. As discussed herein, the weight of the evidence is very closely balanced. Fundamentally, however, it is Petitioner’s burden to establish how one of ordinary skill in the art would have understood Chen and the combined teachings of Chen and Grab-333. And, as we find herein based on the full record developed during trial, Petitioner does not establish that the combined teachings of Chen and Grab-333 would have met limitation 1[c]. Below, we walk through the parties’ arguments and evidence, starting with the Petition, and then we discuss our findings regarding Chen in light of the full trial record.” slip op. at 24

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “To begin, 37 C.F.R. § 42.23(b) specifies, in relevant part, that “[a] sur-reply may only respond to arguments raised in the corresponding reply and may not be accompanied by new evidence other than deposition transcripts of the cross-examination of any reply witness.” 37 C.F.R. § 42.23(b). The Consolidated TPG repeats the above-quoted language of the rule and also explains that [s]ur-replies should only respond to arguments made in reply briefs, comment on reply declaration testimony, or point to cross-examination testimony. As noted above, a sur-reply may address the institution decision if necessary to respond to the petitioner’s reply. This sur-reply practice essentially replaces the previous practice of filing observations on cross-examination testimony. Consolidated TPG at 73–74. Accordingly, Rule 42.23(b) provides a blanket prohibition on a patentee filing exhibits with a sur-reply, as Patent Owner has done here.” slip op. at 54

  Patent outcomesUS 9,184,920 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,184,920
• Unified Patents Inc. v. Divx, LLCNo claims unpatentable
  PTAB · Feb 8, 2021 · IPR2019-01379 · APJ Iftikhar Ahmed · IPR · Final written decision

  Claims 1 and 17 were not shown unpatentable over Kim and Huang because Petitioner did not establish an adequate motivation to combine their teachings.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Petitioner contends that a person of ordinary skill in the art “would have a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related subject, and two to three years of work experience in image and/or video processing.” Pet. 15–16 (citing Ex. 1005 ¶ 42). Patent Owner neither comments on that proposal, nor proposes an alternative level of ordinary skill in the art. See generally PO Resp. 5 The burden of showing something by a preponderance of the evidence requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence. Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993). Because Petitioner’s proposed definition is consistent with the cited prior art, we apply it for purposes of this Decision. In our view, moreover, 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 prior art itself can reflect an appropriate level of skill in the art at the time of the invention).” slip op. at 9

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

    “00052, which also involves the ’651 patent, the Board construed the term “level of detail” as “level of change of visual elements across adjacent pixels,” and that the same construction should apply here. PO Resp. 58–60 (citing IPR2020-00052, Paper 42). Petitioner does not propose a construction for that term, but argues that “the combined Kim and Huang teachings would determine the level of detail for adjacent pixels under Patent Owner’s ‘adjacent pixels’ construction.” Pet. Reply 5–11. Because our ultimate decision does not rest on the construction of that claim term, we do not construe the term in this proceeding. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); 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). As part of our obviousness analysis, we address additional claim construction arguments regarding the “determining” limitation. See infra § III.E.1.a.” slip op. at 10

  • ExcludeMotion to exclude, deniedDenied

    “We agree with Patent Owner that these exhibits represent expressions of opinion of unnamed users that Patent Owner relies on to show cotemporaneous praise existed. These exhibits are cited in the Hanson Declaration only as evidence of industry praise, i.e., to support testimony based on his personal knowledge. See Ex. 2045 ¶ 51. And although Mr. Hanson quotes statements from these exhibits in his declaration, their relevance lies in that they allegedly reflect praise for DivX’s deblocking method. For example, the statement by user “temperance”—that Petitioner objects to as being relied on for the truth of the matter asserted (Paper 46, 1– 2)—is offered to show that “[t]here was plenty of healthy debate on the boards about the quality of the new version of the codec,” and “many commenters specifically praised the deblocking.” See Ex. 2045 ¶ 46. Moreover, it is clear that these are merely opinions of online users, not factual assertions. See id. (quoting temperance: “IMHO, DivX 6 deblocking is better (for metrics and eyes) than xvid’s”) (emphasis added); see Sonos, slip op. at 7 (separating admissible expressions of opinions that constitute praise from bare factual assertions). Other statements that Petitioner objects to (Paper 46, 2) are similarly opinions of online users, not factual assertions that Patent Owner relies upon for the truth of the matter stated therein. We are therefore not persuaded that Exhibits 2018–2030 and 2032–2033 contain inadmissible hearsay.11 See Cisco Sys., Paper 41 at 50–51 (allowing exhibits cited only as evidence of industry praise); Quanergy Sys., Inc. v. Velodyne Lidar, Inc., IPR2018-00255, 2020 WL 2595492, at *2 (PTAB May 21, 2020) (citing Asetek Danmark A/S v. CMI USA, Inc., 13-CV-00457-JST, 2014 WL 12644295, at *2 (N.D. Cal. Nov. 19, 2014)).” slip op. at 55

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We agree with Patent Owner that the Petition does not detail Petitioner’s newly proposed interpretation of this claim limitation. See Pet. 29–36 (arguing only that a person of ordinary skill in the art would have recognized that Kim determines the level of detail for a region comprising an 8 x 8 block of pixels of a reconstructed video frame). On the contrary, the Petition argued: [T]he prior art cited in this Petition teaches and suggests exactly what is claimed and what allegedly distinguished the claims from Kim II: determining the level of detail of a region that includes pixels from multiple rows and multiple columns that encompass pixels immediately adjacent to at least two sides of the block boundary, and selecting a filter to apply.” Pet. 18 (emphasis added).6 Under these circumstances, we consider Petitioner’s new argument waived. See 37 C.F.R. § 42.23(b); see also Intelligent Bio-Sys., 821 F.3d at 1369 (“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ 6 Petitioner refers to a different prior art reference, U.S. Patent No. 6,983,079, cited by the examiner during the prosecution of the ’651 patent, as Kim II. the ‘evidence that supports the grounds for the challenge to each claim.’”) (citing 35 U.S.C. § 312(a)(3)).” slip op. at 23

  Patent outcomesUS 8,139,651 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 8,139,651
• Argentum Pharmaceutical LLC v. Novartis AGNo claims unpatentable
  PTAB · Oct 5, 2020 · IPR2016-01479 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1–3 were not shown unpatentable because the asserted prior-art combinations did not establish a reasonable expectation of success in treating advanced PNETs after chemotherapy failure.

  RulingsFinal written decision

  • Skill levelOther

    “demonstrate by a preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time of the invention to a person having ordinary skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations.10 See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The level of ordinary skill in the art may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundDecided for patent owner

    “Judged by the correct standard, the evidence leaves little doubt that a person of ordinary skill in the art would have been motivated to pursue everolimus as a potential treatment option for advanced PNETs after failure of cytotoxic chemotherapy. Novartis does not seriously contend otherwise, focusing its arguments instead on whether the motivation to pursue everolimus was greater than the motivation to pursue other possible treatments. Not only does Öberg 2004 discusses rapamycin as an “interesting new compound” that suggests clinical trials with rapamycin in combination with cytotoxic chemotherapy, it specifically provides a treatment algorithm that shows rapamycin among the potential “experimental therapies” following failure of cytotoxic chemotherapy. Ex. 1027, 60, Fig 1. And O’Donnell specifically demonstrates that administration of everolimus to human cancer patients was safe. Ex. 1029, 200. We credit Dr. Ratain’s testimony that by 2005, there was a “significant body” of data on the administration of everolimus to humans, but no reported clinical data on rapamycin. Ex. 1003 ¶ 135. Given the difference in information on everolimus and rapamycin, we find that the skilled artisan would have been motivated to pursue everolimus as an alternative to the rapamycin disclosed in Öberg 2004. Even if a person of ordinary skill would have had reason to pursue everolimus, however, our inquiry does not end there. Argentum must also prove that the skilled artisan “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). That “expectation of success need only be reasonable, not absolute.” Id. at 1364. “Whether an ordinarily skilled artisan would have reasonably expected success . . . is measured as of the date of the invention.” Amgen Inc. v. F. Hoffman–La Roche Ltd., 580 F.3d 1340, 1362 (Fed. Cir. 2009).” slip op. at 15

  • Obviousness (§103) › Analogous artNot shown unpatentableDecided for patent owner

    “the only prior art clinical trial of everolimus presented to us, was a Phase I trial designed to test dosages, not efficacy. Ex. 1029, 803. While Öberg 2004 does disclose the promise of rapamycin, we agree with the District Court that at the time of the invention the mTOR pathway was insufficiently understood, such that a person of ordinary skill in the art would not have reasonably expected rapamycin’s “promise,” as reported in Öberg 2004, to translate to everolimus. Ex. 1027, 60. And in regard to Boulay 2004, Novartis argues that the record lacks sufficient evidence to support Argentum’s contention that the CA20948 rat pancreatic tumor model described therein was applicable to the treatment of PNETs. Ex. 1005, 253. On this point, again we agree with the District Court. District Court Decision, 287 F. Supp. 3d at 526 (“I find that Defendant has failed to establish by clear and convincing evidence that CA20948 is a PNET model.”). Upon evaluating the full record before us, we find that the CA20948 tumor model line originated from a pancreatic adenocarcinoma, which is distinct from a neuroendocrine tumor (NET). Ex. 2038, 197–99; Ex. 2041 ¶¶ 132–134. We credit and rely on Dr. Kulke’s testimony that pancreatic adenocarcinomas and PNETs were known to differ in their origin, incidence, clinical behavior, molecular genetics, and responses to pharmacotherapies. Ex. 2041 ¶¶ 57, 135–136. Argentum does not dispute the distinction between CA20948 and PNETs, but instead argues that tests performed on CA20948 would nevertheless be understood to be applicable to PNETs. Reply 17–18. Argentum’s primary support for this argument derives from the De Jong reference, which discloses the use of the CA20948 pancreatic tumor line in a study of the treatment of neuroendocrine tumors. Ex. 1010, Abstract. As based treatment of tumors using radioactive somatostatin-analogues. PO Resp. 33; Ex.1010, 356–58. Both neuroendocrine tumors and CA20948 express somatostatin receptors; it is this commonality that made CA20948 useful as a model for NETs in De Jong’s study of radiation treatment. Ex. 2041 ¶¶ 139, 141. But just because some features of a cell line make it useful in studies of tumors where those features are relevant, it does not necessarily follow that the cell line is relevant to all studies of those tumors. See Tr. 14:15–25. As Dr. Kulke credibly explains, the person of ordinary skill in the art would not have understood from the De Jong radiation treatment study that CA20948 could be used as a model for NETs in a pharmacotherapy study. Ex. 2041 ¶ 143–146. For these reasons, we agree with the District Court that Argentum has not proven CA20948 to be a PNET model; nor is there reason to believe that a person of ordinary skill in the art would have considered CA20948 to be applicable to studying the treatment of PNETs with mTOR inhibitors, much less such treatment after the failure of cytotoxic chemotherapy.” slip op. at 18

  • ExcludeMotion to exclude, deniedMixed

    “We agree. If Argentum had submitted only certain portions of Dr. Kulke’s testimony into the record before us, Novartis would be entitled to rely on FRE 106 to request that the Board admit other portions of his testimony that, in fairness, should be considered. But that is not what Novartis requests here; nor could it, given that Exhibits 1070, 1095, and 1119 were already admitted in their entirety. And in any event, Novartis’ request would not have been proper as part of a motion to exclude. Upon reviewing the Motion, it is clear that Novartis is using its FRE 106 arguments as a vehicle for introducing additional citations to, and discussion of, Dr. Kulke’s testimony that were not introduced in the multiple other opportunities for merits briefing that Novartis had during this trial. For this” slip op. at 28

  Patent outcomesUS 9,006,224 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,006,224
• Becton, Dickinson And Company v. Baxter Corporation EnglewoodNo claims unpatentable
  PTAB · Apr 29, 2020 · IPR2019-00119 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–13 and 22 were not shown unpatentable because the asserted obviousness combinations failed to establish required claim elements.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “The parties agree that a person of ordinary skill in the art as of the relevant date would have several years of experience with remote pharmacy work supervision and verification systems and a familiarity with basic pharmacy processes and have been aware of relevant regulations. Pet. 10– 11; PO Resp. 6 (referencing Inst. Dec. 9). As noted by Petitioner, the Board 10 previously applied this definition in an inter partes review of the Alexander reference asserted here. Pet. 10–11 (referencing IPR2015-00883, Paper 29 at 43). As the parties’ undisputed proposed definition is consistent with the cited prior art, we adopt it consistent with our Institution Decision. 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, 163–164 (Fed. Cir. 1985)).” slip op. at 10

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

    “We address below the two claim terms provisionally construed in our Institution Decision, as well as element [8j], subsequently raised by the parties. No other terms require express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy and only to the extent necessary to resolve the controversy.”).” slip op. at 12

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

    “Whereas the plain language of element [8j] mandates that each step “must be verified before the operator can continue,” the parties initially appear to disagree about who––or what––is responsible for the verification. Patent Owner contends that element [8j] embodies the concept of a “hard stop,” wherein “the system will not allow the operator to proceed to the next step until the prior step has been verified.” PO Resp. 24; Sur-reply 1. To 14 the extent Patent Owner uses the term “hard stop” as a short hand for the words of element [8j], we agree with this portion of its construction.8 As we further understand Patent Owner’s position, however, verification that a step is properly completed requires input from a remote pharmacist overseeing the operator. See PO Resp. 27 (distinguishing Alexander as not requiring “the remote pharmacist must verify each and every step before the operator is allowed to proceed”). But reading claim 8 (directed to a system) to require a method step performed by a pharmacist would appear to “combine . . . two separate statutory classes of invention.” See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). Moreover, claim 8 makes no mention of a pharmacist and Patent Owner fails to explain adequately why we should import such a limitation from the Specification into the claim. Accordingly, we decline to apply Patent Owner’s construction of element [8j] to the extent it requires input from a remote pharmacist. We, nevertheless, note that in the Sur-reply, Patent Owner indicates that element [8j] may be satisfied where “the workstation . . . captur[es] the image and scan[s] the barcode in order to verify the step has been performed.” Sur-reply 6 (emphasis added).” slip op. at 14

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

    “issuance of Alexander would evidence prior invention under § 102(g)(2), our governing statute provides that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C § 311(b). Although Alexander is a printed publication, Petitioner does not seek to use it as such under § 102(g)(2) but, instead, as evidence of prior invention, which is not a legitimate basis for challenge in inter partes review.10 For the above reasons, and as set forth at pages 15–17 of our Institution Decision, Alexander is not available as prior art in this proceeding under 35 U.S.C § 102(g)(2).” slip op. at 22

  Patent outcomesUS 8,554,579 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,554,579
• Intel Corporation v. VLSI Technology LLCNo claims unpatentable
  PTAB · Feb 26, 2020 · IPR2018-01661 · APJ Lynne E Pettigrew · IPR · Final written decision

  Claims 1–5, 15, and 16 were not shown unpatentable because the asserted combinations failed to establish the claimed power gain and power loss relationship used to determine whether to power down.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “B. Level of Ordinary Skill in the Art Relying on the testimony of Dr. Raghunathan, Petitioner proposes that a person of ordinary skill in the art at the time of the alleged invention of the ’014 patent “would have had at least an M.S. degree in computer science, computer engineering, or electrical engineering (or equivalent experience), and would have three years of experience with computer hardware and software power management design techniques.” Pet. 24 (citing Ex. 1102 ¶¶ 57–58). In our Institution Decision, we adopted Petitioner’s proposal with a modification to the level of education based on Patent Owner’s proposal in its Preliminary Response. Inst. Dec. 7 (citing Prelim. Resp. 5). Specifically, we determined that “a person of ordinary skill in the art would have had at least a B.S. degree in computer science, computer engineering, or electrical engineering (or equivalent experience) and three years of experience with computer hardware and software power management design techniques.” Id. Neither party argues during trial that our definition of the level of ordinary skill in the art was incorrect. See PO Resp. 2–3. See generally Pet. Reply. Because our preliminary determination is consistent with the level of ordinary skill in the art reflected by the prior art of record, we maintain and reaffirm that a person of ordinary skill in the art would have had at least a B.S. degree in computer science, computer engineering, or electrical engineering (or equivalent experience) and three years of experience with computer hardware and software power management design techniques.” slip op. at 8

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

    “We need only construe claim terms that are in controversy, 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) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In this proceeding, neither party proposes a formal construction for any term. See Pet. 23; PO Resp. 3. We find it unnecessary to construe expressly any claim terms to resolve the controversy before us.” slip op. at 9

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

    “Weighing the parties’ arguments and evidence on the complete record now before us, we find Petitioner has not shown that a person of ordinary skill in the art would have understood Takahashi’s “predetermined value” to be an estimated power gain. Patent Owner, with the support of Dr. Wolfe’s credible testimony, persuasively argues that Takahashi’s “predetermined value” is a previous value of the cache-miss rate. Petitioner, on the other hand, does not point to anything in Takahashi that describes the “predetermined value” as an estimated power gain, nor does Petitioner cite any testimony from Dr. Raghunathan in support of its position other than a portion of his declaration that is substantially the same as the discussion in the Petition. See Pet. 33–34 (citing Ex. 1102 ¶ 80); see also Ex. 1102 ¶¶ 72– 80 (testimony substantially the same as pages 29–34 of the Petition). Without any suggestion in Takahashi that the “predetermined value” relates to an estimated power gain, Takahashi’s stated goal of reducing power consumption is not sufficient to show that Takahashi’s “predetermined value” is representative of an estimated power gain. For these reasons, we find that Petitioner has not established that Takahashi teaches or suggests an estimated power gain or determining whether to power down a portion of a device component in response to a relationship between an estimated power gain and an estimated power loss, as recited in independent claim 1. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over the teachings of Takahashi.” slip op. at 19

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

    “We focus on one argument we find particularly persuasive—that Hu does not teach using the L2Access:leak ratio to “determin[e] whether to power down” a cache or a portion of a cache, as required by claim 1, even if the L2Access:leak ratio can be considered a relationship between an estimated power gain and an estimated power loss. See PO Resp. 24; PO Sur-reply 16–18. In its Reply, Petitioner alleges that “Hu explicitly discloses using the L2Access:leak ratio to determine when to power down the L1 cache.” Pet. Reply 16 (emphasis added) (citing Ex. 1102 ¶¶ 97–98). Petitioner, however, does not support this proposition by quoting or citing specific language in Hu, relying only on Dr. Raghunathan’s declaration, which provides substantially the same discussion as the Petition. Compare Ex. 1102 ¶¶ 97–98, with Pet. 39–40. We agree with Patent Owner that the portion of Hu cited in the Petition and Dr. Raghunathan’s declaration does not teach using the L2Access:leak ratio to determine whether to power down the L1 cache, as Petitioner contends. See PO Sur-reply 16–18; Pet. 39–41; Ex. 1102 ¶¶ 97– 99. Rather, Hu discloses determining values of the normalized cache leakage energy for different decay intervals at four values of the L2Access:leak ratio—5, 10, 20, and 100. Ex. 1104, 175–76; see PO Sur-reply 17. Hu uses these assumed values of the L2Access:leak ratio as inputs to generate simulation data, not to determine whether to power down a cache or portion of a cache. Ex. 1104, 175, see PO Resp. 24; PO Sur-Reply 15–16. Petitioner argues that Hu teaches that the higher the L2Access:leak ratio, the longer the system should wait before powering down the cache. Pet. 39–41; Pet. Reply 16–17. Hu, however, does not expressly compare the effect of different L2Access:leak ratios other than to state that when the L2Access:leak ratio is 100, a small decay interval is detrimental to performance and power. Ex. 1104, 175. As Patent Owner correctly asserts, Hu does not describe using the L2Access:leak ratio to determine an appropriate decay interval, nor does Hu describe using the L2Access:leak ratio to determine whether to power down a portion of a cache. See PO Sur-Reply 17–18.” slip op. at 24

  Patent outcomesUS 8,020,014 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,020,014
• Neptune Generics, LLC v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · Feb 10, 2020 · IPR2018-01494 · APJ David Cotta · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under any asserted § 103 ground because the evidence did not establish the claimed serum-level testing and dose adjustment would have been obvious.

  RulingsFinal written decision

  • BurdenDecided for patent owner

    “In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner has not met this burden here because the Petition does not clearly articulate why an optimization rationale would have led the skilled artisan to “adjust[] the daily dose of the patient to achieve mifepristone blood levels greater than 1300 ng/mL.” slip op. at 14

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner contends that the person of ordinary skill in the art (“POSA”) would have: either a Pharm. D. or a Ph.D. in organic chemistry, pharmacy, pharmacology, or a related discipline; or a Bachelor’s or Master’s degree in organic chemistry or a related field with at least four years of experience relating to the study of pharmacokinetics or dosing of drugs, their detection and quantification, or their metabolism. Pet. 12. Patent Owner does not challenge Petitioner’s definition. Accordingly, we accept Petitioner’s definition, which is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 9

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

    “Although the parties propose constructions for several claim terms (Pet. 12–15; PO Resp. 17–18), we determine that no explicit construction of any claim term is necessary to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 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))); 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’”).” slip op. at 10

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

    “Finally, Petitioner asserts that it would have been obvious that “the daily dosing of the patient could be adjusted to optimize mifepristone blood level, whatever level that might be.” Pet. 30. This argument is not persuasive for several reasons. First, Petitioner must do more than show that the ordinary artisan could have done what was claimed. Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness 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.”).” slip op. at 15

  Patent outcomesUS 8,921,348 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,921,348

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.