• Lenovo (United States) Inc. / Motorola Mobility LLC v. Theta IP, LLCNo claims unpatentable
  PTAB · Oct 16, 2024 · IPR2023-00697 · APJ Barbara A Benoit · IPR · Final written decision

  Claims 1, 3, 4, and 8 were not proven unpatentable: Rauhala does not disclose the required simultaneous signal-strength determinations, and Masaaki does not cure the deficiency for claim 4.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Following institution, Patent Owner maintained the same level of ordinary skill proposed in its preliminary response and did not address our discussion of the level of ordinary skill in the art in the Institution Decision. PO Resp. 24–25; see also Prelim. Resp. 24. For the reasons discussed in the Institution Decision, we adopt and apply for this Decision the level of ordinary skill articulated by Petitioner and used previously in our Institution Decision. See Dec. 8–10. In light of our review of the complete record, we find that this formulation is consistent with the ’825 patent, the prior art of record, and is supported by the testimony of Dr. Baker. See Ex. 1002 ¶¶ 27– 31. Our decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 12

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

    “We agree with Patent Owner that the desired signal and interferer signal must be received at the same time. The plain language of the claim requires the wireless transceiver to “receiv[e] a wireless signal having a desired signal and an interferer signal,” the determining of a signal strength of the interferer signal and the determining of a signal strength of the desired signal must be performed at the same time; otherwise, the determinations of signal strengths would not be of the same wireless signal. The specification supports this understanding. “When a receiver is actively receiving a desired signal, each block in the signal path has at its input the desired signal as well as noise and possibly interfering signals.” Ex. 1001, 5:20–22; see also id. at 5:31–33 (“FIGS. 2A and 2B illustrate examples of desired signals, interferers, and noise that may be received by one of the various circuits in a” slip op. at 21

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

    “We agree with Patent Owner that Rauhala does not state that the signal strengths are measured simultaneously or at the same time. Indeed, as discussed above, Rauhala indicates unequivocally in the same paragraph the opposite—that detector DET provides to control unit 42 “an indication about either the receive channel signal strength RSS or the strength of any signal on the reception band.” Ex. 1004 ¶ 17. Rauhala describes that “control unit 42 provides two one-bit control signals cA and cM” based on indications received from detector DET. Id. Importantly, Rauhala indicates that “at the same time as” describes how the control unit 42 uses the received inputs RSS and RSSn shown in Figure 4, which are described earlier in paragraph 17 as indications of either RSS or RSSn from detector DET. Id. (“Signal cA is 0 when signal RSS is greater than S4 and signal RSSn is at the 11 Dr. Baker’s reply declaration correctly quotes Rauhala paragraph 17 but cites to paragraph 18. We deem this harmless error. same time smaller than Sn. . . . Signal cM is 1 when signal RSS is not greater than S4 and signal RSSn is at the same time at least Sn. Otherwise, signal cM is 0.”). The burden remains on Petitioner to demonstrate by a preponderance of the evidence that Rauhala discloses the disputed limitations as arranged or combined in the claim. Petitioner does not persuasively reconcile these “either/or” statements regarding the functioning of detector DET with the “at the same time as” statements regarding control signals output by control unit 42 in paragraph 17. We do not find persuasive Petitioner counsel’s position expressed at the hearing that Rauhala’s “either/or” statements are “simply an imprecise description” (Tr. 16:22–24). We do not see a lack of precision in Rauhala’s “either/or” statements.” slip op. at 30

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “When asked at his deposition to explain Rauhala’s use of the word “or” regarding the functioning of detector DET, Dr. Baker asserted that “[detectors] can be designed to determine RSS or RSSn.” Ex. 2016, 85:5– 12. We find Dr. Baker’s testimony that “it’s reasonable that if you can design . . . the detector to detect one or the other, you can also design it to detect both” to be without factual support. Id. at 85:13–16. He points to no textbook or other independent evidence to support that would have led one of ordinary skill to design such a detector or to support that one of ordinary skill would have understood Rauhala’s detector to be so designed. Furthermore, Dr. Baker recognizes that “Rauhala doesn’t teach the details of what’s in the detector.” Id. at 91:6–7. We give little weight to Dr. Baker’s unsupported testimony that one could design a detector to detect both RSS and RSSn from the same wireless signal. See 37 C.F.R. 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); see also Xerox Corp. v. Bytemark, Inc., No. IPR2022-00624, 2022 WL 3648989, at *6 (PTAB 2022) (precedential) (Director affirming because “the cited declaration testimony is conclusory and unsupported, adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight”).” slip op. at 31

  Patent outcomesUS 10,129,825 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,129,825
• Lenovo (United States) Inc. / Motorola Mobility LLC v. Theta IP, LLCNo claims unpatentable
  PTAB · Oct 16, 2024 · IPR2023-00698 · APJ Thomas L Giannetti · IPR · Final written decision

  Claims 7–11, 13, and 19–21 were not shown unpatentable because Rauhala does not disclose simultaneous desired and interferer signal-strength determinations, defeating anticipation and the obviousness combination.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The two proposals are materially similar in the education requirement, but differ marginally in professional experience required (three versus five years). See supra. While we were persuaded, on the preliminary record, that both Petitioner’s and Patent Owner’s proposals were consistent with the problems and solutions in the ’202 patent and the prior art of record, on balance, we determined that Petitioner’s proposal was a better reflection of the level of skill in the prior art, and we therefore adopted it for our Institution Decision. See Institution Dec. 12–13. For this Decision, we adopt the description of the person of ordinary skill articulated by Petitioner and used previously in our Institution Decision. In light of our review of the complete record, we find that this formulation is consistent with the ’202 patent, the prior art of record, and is supported by the testimony of Dr. Baker. See Baker I Decl. ¶¶ 28–32. Our Decision would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 12

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “85:13–16. He admits that “Rauhala doesn’t teach the details of what’s in the detector.” Id. at 91:6–7. He points to no textbook or other independent evidence that would have led a person of ordinary skill to design such a detector. Our Trial Practice Guide cautions against crediting such unsupported testimony: The Board has broad discretion to assign weight to be accorded expert testimony. Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010). However, the testimony must be based on sufficient facts and data. Fed. R. Evid. 702(b). “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Patent Trial and Appeal Board Consolidated Trial Practice Guide 35 (Nov. 2019).7 We therefore give Dr, Baker’s unsupported testimony on this issue little weight.” slip op. at 24

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

    “We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017). Having considered the positions of the parties, we find that for the purpose of this decision, we do not need to construe these terms to resolve a dispute.” slip op. at 9

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

    “requirement.” Pet. Reply 5. We do not agree with Petitioner. We find that the language of the claims supports Patent Owner’s argument that the desired signal and the interferer signal are received together. As discussed infra, claim limitations 7.7 and 7.8 recite determining a signal strength of the interferer signal and determining a signal strength of the desired signal. These determinations must be performed at the same time; otherwise, the determinations of signal strengths would not be of the same wireless signal. See Larson II Decl. ¶ 70; Baker II Decl. ¶¶ 48–49 (explaining that consideration of signal strengths detected at the same time would be “essential”). The specification of the ’202 patent further supports this finding: “When a receiver is actively receiving a desired signal, each block in the signal path has at its input the desired signal as well as noise and possibly interfering signals.” Ex. 1001, 5:22–24; see also Figs. 2A, 2B (showing interferer signals and desired signals together).” slip op. at 17

  Patent outcomesUS 10,524,202 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 10,524,202
• 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
• 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
• 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
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCNo claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00146 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, and 5 were not shown unpatentable because Nakamura did not disclose the claimed spacer, and Petitioner did not establish a basis to modify it.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “level of skill in the art than that proposed by Petitioner. PO Resp. 11‒12. In particular, Patent Owner disagrees with Petitioner’s requirement for an advanced degree in mechanical engineering or a closely related field as it would, for example, exclude both the named inventors of the ’679 patent as well as “a large majority of active workers in the field at the time of the invention.” Id. at 12 (citing Ex. 2002 ¶ 80). Rather, Patent Owner contends that the person of ordinary skill in the art at the time of the invention would have a Bachelor of Science degree in engineering and at least 3 years of experience working or studying in the field of heat pipes; or an equivalent level of education, training, and work experience. Id. at 11 (citing Ex. 2002 ¶¶ 77‒79). Dr. Pokharna comports with the qualifications a person would have needed to understand and implement the teachings of the ’679 patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). Moreover, Petitioner concedes that this dispute as to the appropriate level of skill in the art “is immaterial because the challenged claims are invalid under both sides’ definitions.” Reply 1 n.2. We agree with Petitioner that the outcome of this proceeding is not dependent on our application of one party’s definition as compared to the other. Nonetheless, because Petitioner’s and Dr. Pokharna’s definition better reflects the level of ordinary skill in the art, we adopt and apply it here. C.” slip op. at 10

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

    “extending between and contacting said first and second plates,” claim 1 separately recites “a depression formed in said first plate,” which projects into said vapor chamber and is bonded to said second plate. PO Resp. 25–26 (emphasis added) (citing Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (“Where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”)); see Ex. 2002 ¶ 114. Whereas claim 1 requires that a spacer contact both the first and second plates, it makes clear (as do claims 4 and 6) that a depression formed in a first plate is bonded to only the opposing plate. See Ex. 1001, claim 7 (reciting that a “depression formed in said second plate . . . is in contact with an inner surface of said first plate”). We, thus, infer from the structure of the recited in claim 1 are distinct components with distinct properties. In particular, the claimed “spacer . . . extending between and contacting said first and second plates” is a distinct element between and in contact with two plates, whereas the claimed “depression” is a part of one plate that contacts, or is bonded to, an opposing plate.” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “whether a reference is a printed publication. Suffolk Techs., LLC v. AOL Inc., 752 F.3d 1358, 1364 (Fed. Cir. 2014). The determination of whether a given reference qualifies as a prior art “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding its disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). The key inquiry is whether the reference was made “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989); see In re Wyer, 655 F.2d 221, 226 (CCPA 1981). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citation omitted). Bruckelmyer and Wyer specifically addressed the public accessibility of laid open patent applications.” slip op. at 24

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

    “The relevant language of independent claim 1 is not merely “spacer” but “spacer. . . extending between and contacting said first and second plates,” which we construe as referring to a “structure separate from and in 16 Petitioner also addresses obviousness under the construction of “spacer” that Patent Owner proposed before the district court but that we do not adopt here. See id. at 36–41; section II(C)(2), n.7, above. 17 Petitioner and its expert also reference Nakamura’s Figures 5 and 6, which show embossed depressions in only one plate. Pet. 39–40; Ex. 1002 ¶ 64. Nonetheless, we agree with Patent Owner that “Petitioner’s grounds are based on the concavities 9 described and illustrated with respect to Figure 4 of Nakamura,” and Petitioner’s passing reference to the alternative embodiment of Nakamura’s Figures 5 and 6 does not substantially affect our analysis, which focuses on the embodiment of Figure 4. See PO Resp. 46 (citing Inst. Dec. 15–18). clearance between the plates.” See section II(C)(2), above. Applying this panel’s construction, we agree with Patent Owner that Petitioner has neither shown how Nakamura discloses this limitation, nor identified any rationale or motivation to modify Nakamura to provide a “spacer. . . extending between and contacting said first and second plates,” as recited in claim 1. See PO Resp. 46–47. As discussed above, Petitioner seeks to satisfy this limitation by pointing to the “H-shaped structure” defined by concavities pressed into opposing plates of the heat pipe illustrated in Nakamura’s Figure 4. But as Patent Owner points out, “these concavities are integral with the portions of the container in which they are formed, and a concavity cannot be said to contact the same plate in which it is formed without rendering the term ‘contacting’ in claim 1 meaningless.” Id. (citing Ex. 2002 ¶¶ 116, 145).” slip op. at 35

  Patent outcomesUS 7,100,679 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,100,679
• 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
• Apple Inc. / HTC Corporation et al. v. Invt Spe LLCNo claims unpatentable
  PTAB · Mar 25, 2020 · IPR2018-01473 · APJ Thu A Dang · IPR · Final written decision

  Claims 1–3, 5–9, and 11 were not shown unpatentable under § 103 over Keskitalo and Lindell because Petitioner did not adequately explain why a skilled artisan would combine their teachings.

  RulingsFinal written decision

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “Petitioner contends that “[c]laim 1 includes limitations in means-plus[-]function format, which creates a rebuttable presumption that the [Applicant] intended to invoke 35 U.S.C. § 112, ¶ 6.”3 Pet. 7; see also Altiris Inc. v. Symantec Corp., 318 F.3d 1363, 1375 (Fed. Cir. 2003). In the Decision on Institution, we addressed Petitioner’s proposed constructions of the means-plus-function terms (Pet. 10–12), and we determined that Petitioner has set forth proposed structures that support these limitations. Dec. on Inst. 8–12; see 37 C.F.R. § 42.104(b)(3) (2018).” slip op. at 9

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

    “As for the other claim limitations of independent claims 1, 6, and 7, and claims 2, 3, 5, 8, 9 and 11 depending therefrom, neither party has proposed a construction of any other term. See Pet. 6–7; PO Resp. 12–13. We determine that we need not further construe expressly any other claim terms to resolve the arguments before us. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (explaining that only claim 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. to an inter partes review).” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). In that regard, Petitioner’s expert, Andrew C. Singer, Ph.D., testifies that a POSITA at the time of the invention would have been a person having a Bachelor’s degree in electrical engineering or the equivalent plus three years of experience working with digital communication systems or in network engineering or a Master’s degree in electrical engineering with an emphasis on communication systems or the equivalent plus one year of experience working with digital communication systems or in network engineering. Pet. 4–5; Ex. 1003 ¶ 35. Patent Owner does not dispute Dr. Singer’s assessment of the level of ordinary skill in the art. See generally PO Resp. We adopt and apply Dr. Singer’s assessment of the level of ordinary skill in the art, which is consistent with the level of ordinary skill reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (holding that absent evidence to the contrary, “the prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art).” slip op. at 15

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

    “position of Patent Owner. In particular, we are unpersuaded by Petitioner’s contention that it would have been obvious to modify Keskitalo such that its predetermined thresholds for transmission power are average transmission power values in accordance with the teachings of Lindell. Pet. 26. That is, we are not persuaded that Petitioner has demonstrated by the preponderance of the evidence that it would have been obvious to have used Lindell’s average transmission power values as Keskitalo’s predetermined thresholds for transmission power. See Harmonic, 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) as requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”); Magnum Oil Tools, 829 F.3d at 1380 (holding that Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements”).” slip op. at 24

  Patent outcomesUS 6,611,676 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,611,676
• 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.