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  • PTAB · Sep 29, 2025 · IPR2021-00580 · APJ Monica S Ullagaddi · IPR · Remand

    On remand, the Board held claims 1–10 not shown unpatentable under the Sachs anticipation and obviousness grounds because Sachs did not disclose the required timer stopping, and the new theories were not considered.

    RulingsRemand decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Whether Mr. Bates is a Person of Ordinary Skill in the Art In the Final Written Decision, we adopted Petitioner’s definition because “there does not appear to be a dispute that needs to be resolved.” FWD 8. Here, where Mr. Bates’ qualifications are challenged, we have reviewed the complete record including the parties’ arguments on remand and we find that Mr. Bates does not meet the requirements for a person of ordinary skill in the art according to Petitioner’s definition for level of ordinary skill in the art, which we adopted (see FWD 8). Notably, the panel adopted Petitioner’s definition of the level of ordinary skill in the Institution Decision (Paper 16, 8), and neither party challenged that determination during the trial, although Patent Owner did offer its own definition (PO Resp. 9). Mr. Bates has one degree: “a bachelor’s degree in Business Management.” Ex. 2001 ¶ 7. A degree in Business Management is not “a degree in electrical engineering or a similar discipline.” Pet. 35 (emphasis added). Accordingly, we disregard the testimony of Mr. Bates in rendering our findings and conclusions in this Decision. We note that, even if we did consider Mr. Bates’s testimony, the findings and conclusions rendered in this Decision would not change.” slip op. at 12

    • Expert testimonyPatent owner expert discountedDecided for petitioner

      “cover for his lack of education.” Pet. Remand Br. 4. Patent Owner disagrees and argues, inter alia, that “Mr. Bates was a pioneer in the cellular telecommunications field with more than five decades of practical and teaching experience.” PO Remand Resp. 5 (citing Ex. 2001 ¶¶ 8–23) (emphasis omitted); see id. at 3–4, 6. Whether Mr. Bates is a Person of Ordinary Skill in the Art In the Final Written Decision, we adopted Petitioner’s definition because “there does not appear to be a dispute that needs to be resolved.” FWD 8. Here, where Mr. Bates’ qualifications are challenged, we have reviewed the complete record including the parties’ arguments on remand and we find that Mr. Bates does not meet the requirements for a person of ordinary skill in the art according to Petitioner’s definition for level of ordinary skill in the art, which we adopted (see FWD 8). Notably, the panel adopted Petitioner’s definition of the level of ordinary skill in the Institution Decision (Paper 16, 8), and neither party challenged that determination during the trial, although Patent Owner did offer its own definition (PO Resp. 9). Mr. Bates has one degree: “a bachelor’s degree in Business Management.” Ex. 2001 ¶ 7. A degree in Business Management is not “a degree in electrical engineering or a similar discipline.” Pet. 35 (emphasis added). Accordingly, we disregard the testimony of Mr. Bates in rendering our findings and conclusions in this Decision. We note that, even if we did consider Mr. Bates’s testimony, the findings and conclusions rendered in this Decision would not change.” slip op. at 12

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “C. Claim Construction The Federal Circuit determined that “the plain and unambiguous language of claim 1 requires that a method, to come within the claim, must perform both limitations 1[c] and 1[d] where their preconditions apply.” Sierra Wireless, 130 F.4th at 1022. We interpret the claims and analyze Petitioner’s unpatentability arguments under the Federal Circuit’s determination.” slip op. at 13

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Petitioner was on notice, when Patent Owner’s Response was filed at the latest, that claim 1 could be construed as unconditionally requiring both limitations 1[c] and 1[d]. Indeed, Petitioner contended that it had shown both limitations “in single references.” Pet. Reply 5. Petitioner now seeks to shift its unpatentability contentions for limitation 1[c] from Figure 5 of Sachs to Figures 6 and 7. Petitioner’s new reliance on Figures 6 and 7 of Sachs is “a meaningfully distinct contention” from its position in both the Petition and the Reply. See Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359, 1367 (Fed. Cir. 2015). We therefore find that Petitioner impermissibly presents new theories of unpatentability on remand. 3. Independent Claim 1 We decline to address Petitioner’s new theories of unpatentability proposed on remand concerning Sachs’s Figure 7. See Pet. Remand Br. 15– 20. Although Petitioner cites pages 59–61 of the Petition as discussing Figure 7 of Sachs (see Pet. Remand Br. 15), the cited discussion concerns dependent claims 5 and 10, not independent claims 1 and 8.” slip op. at 17

    Patent outcomesUS 7,869,396 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,869,396
  • PTAB · Apr 30, 2025 · IPR2024-00114 · APJ Jon M Jurgovan · IPR · Final written decision

    Claims 1–8 were not shown unpatentable because DiPerna964 and Strack do not teach or suggest the panic button readying itself to perform the claimed functions.

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

      “After review of the ’404 patent’s description, we find no disclosure that pressing the panic button together with another button causes the panic button to ready itself to perform functions (1) and (2) as recited in limitation 1[d]. The closest descriptions we find to limitation 1[d] are that the safety switch readies the panic button to contact 911 (Ex. 1001, 6:59–62), that the panic button may be activated by pressing the panic button with another button (id., 3:59–67, and that the panic button may start a speech recognition process that can trigger the device (id., 7:61–62). Consequently, claim 1 is itself the best source for determining what the claim language means. We determine that the ordinary and customary meaning of the “ready itself” feature of claim 1 is that the panic button “prepares itself to be triggered to perform the panic button functions (1) and (2).” Since the intrinsic evidence is sufficiently clear to discern the meaning of the “ready itself” limitation, we do not resort to extrinsic evidence. See Phillips, 415 F.3d at 1317 (explaining that extrinsic evidence is less significant than intrinsic evidence); Seabed Geosolutions (US) Inc. v. Magseis FF LLC, 8 F.4th 1285, 1287 (Fed. Cir. 2021) (Court of Appeals gives primacy to intrinsic evidence and resorts to extrinsic evidence only if consistent with intrinsic evidence); Sequoia Tech., LLC v. Dell, Inc., 66 F.4th 1317, 1324 (Fed. Cir. 2023) (Court of Appeals stating that its “decision rests solely on the intrinsic evidence”).” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

      “Thus, the ’353 application describes that moving the safety switch into position readies the panic button to contact 911, which is not the same as the panic button being activated to ready itself to perform functions (1) and (2) required by claim 1 of the ’404 patent. Patent Owner’s reliance on disclosures elsewhere in the ’353 application is unavailing. PO Resp. 5–8 (citing Ex. 1006, 15, 17, 19–21, 23, 25); PO Sur-Reply 2–3 (citing Ex. 1006, 15, 17, 19–20, 24–25)). For example, while the ’353 application does mention voice activation with a codeword and activation by depressing of the panic button together with another button (see, e.g., Ex. 1006, 17, 21, 24–25), it does not mention that depressing the panic button together with another button causes the panic button to ready itself to perform recited functions (1) and (2). The application explains that “[t]he [panic] button can send a signal to a controller inside the device to activate [the code word activation] process” and “[t]he [panic] button can start the speech recognition process in one embodiment, to trigger the device.” Ex. 1006, 25. But that describes readying the device for activation by the code word, not readying the button to perform the recited functions. The ’353 application also mentions the word “ready” in relation to using a self-defense mechanism such as pepper spray, which does not appear to be related the readying of the panic button recited in claim 1. Ex. 1006, 15, 19–20. Petitioner has thus met its burden to demonstrate that claims 1–8 of the ’404 patent lack written description support for a panic button adapted to “ready itself” to perform the recited functions because the limitation is not present in the ’353 application to which the ’404 patent claims priority.3 Pet. 8–10. The burden of production thus shifted to Patent Owner to demonstrate that the ’353 application has written description support for limitation 1[d], which it has not done on this record. PO Resp. 5–8; PO Sur-Reply 2–3.” slip op. at 15

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

      “DiPerna964 discloses a separate “safety” switch that readies the panic button to contact 911 upon being pressed (Ex. 1028 ¶ 41), but there is no mention of pressing the panic button together with another button to cause the panic button to “ready itself” to perform panic button functions (1) dialing a public or private network for an emergency purpose and (2) activating the transmitting unit, as limitations 1[d] and 1[e] require. DiPerna964 mentions pressing two buttons together to activate the panic button (see, e.g., Ex. 1028 ¶¶ 17, 23–25, 27), but not to “ready itself” to perform recited functions (1) and (2). Petitioner relies on Strack’s triggering the collection of audio, video, and location data for transmission to a remote location as equivalent to a panic button readying itself to, when activated, perform the panic button functions (1) dialing a public or private network for an emergency purpose and (2) activating the transmitting unit. Pet. 15–17 (citing Ex. 1002 ¶¶ 76–88). We do not agree with Petitioner’s contention because Petitioner fails to explain how Strack’s button press that collects and then transmits audio, video, and location data would ready the panic button to perform recited functions (1) and (2). It appears that Strack’s button press readies the device, not the button, to perform the functions. As neither DiPerna964 nor Strack nor their combination teach or suggest limitations 1[d] and 1[e], we determine it is unnecessary to proceed further with the obviousness analysis. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014) (citing Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1164 (Fed.Cir.2006) (stating that we consider motivation to combine and reasonable expectation of success only “if all the elements of an invention are found in a combination of prior art references”)).” slip op. at 21

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not dispute Petitioner’s proposed level of skill in the art, which appears consistent with the educational level, technology, problems and solutions identified in the ’404 patent and prior art references asserted by Petitioner. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). Accordingly, we apply Petitioner’s proposed level in this Decision.” slip op. at 18

    Patent outcomesUS 11,265,404 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,265,404
  • PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

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

      “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

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

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

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

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

    Patent outcomesUS 11,110,087 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,110,087
  • PTAB · Oct 26, 2023 · IPR2022-00730 · APJ Iftikhar Ahmed · IPR · Final written decision

    Claims 22, 23, 30, 32, and 33 were not shown unpatentable because Pakzad did not disclose the claimed combined macro and femto timing information, and the obviousness grounds did not address that limitation.

    RulingsFinal written decision
    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “information from all three types of sources together or at the same time. Patent Owner argues that “a [person of ordinary skill in the art] would understand that this passage in Pakzad ‘any one of several sources’ confirms that Pakzad only uses a single signal source at a time.” PO Resp. 34 (citing Ex. 2002 ¶ 69). Dr. Chrissan testifies that he understands this disclosure to mean that “Pakzad teaches a single signal source at a time, not more than one.” Ex. 2002 ¶ 70 (emphasis added). We find Patent Owner’s interpretation, supported by Dr. Chrissan’s testimony, to be a reasonable reading of Pakzad’s disclosure. Dr. Chrissan further testifies that “Pakzad’s invention is about using both a course [sic] routing graph and fine routing graph to make computation of a motion model (e.g., a particle filter) more efficient,” and “Pakzad was not directed to leveraging a heterogenous network by incorporating both macro and femto cells concurrently.” Id. ¶ 68. We agree with Dr. Chrissan’s explanation for the lack of clear disclosure in Pakzad about which measurements Pakzad uses with its particle filter.” slip op. at 25

    • 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 been someone with at least (1) a bachelor’s degree in electrical engineering, computer engineering/science, or a related scientific field, and (2) either (a) a master’s degree in electrical engineering, computer engineering/science, or a related filed, or (b) two or more years of work or research experience in wireless networking and/or computing.” Pet. 21 (citing Ex. 1009 ¶ 23). Patent Owner does not dispute Petitioner’s definition for a person of ordinary skill in the art, but adds that the person of ordinary skill in the art “may alternatively have additional years of practical and relevant work or research experience as substitution for less or different technical education, and vice versa.” See PO Resp. 17. We determine that the level of ordinary skill proposed by Petitioner is consistent with the ’819 patent and the asserted prior art. See 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). We adopt Petitioner’s proposed level in deciding the patentability of the challenged claims.” slip op. at 9

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

      “claim 30 should be construed “to refer to the previously recited ‘femto base station timing information,’ ‘macro base station timing information,’ and ‘femto base station position information.’” PO Resp. 18. Patent Owner argues that its proposed construction is “based on at least three aspects of the intrinsic record: (1) the claim language itself; (2) guidance from the specification defining the disputed term; and (3) illustrative embodiments confirming the meaning of the disputed term.” Id. (citing Ex. 2002 ¶ 47). Specifically, Patent Owner contends that “the specification describes two embodiments that further confirm to a [person of ordinary skill in the art] that ‘the base station information’ consists of the [three types of information previously] recited.” Id. at 19–23 (citing Ex. 1001, 19:29–33, 20:50–54, Figs. 8, 9; Ex. 2002 ¶¶ 47–55).” slip op. at 10

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

      “More importantly, anticipation requires that the four corners of a single, prior art document describe every element of the claimed invention, and we are not persuaded that Pakzad describes the combinational use of the two different types of timing information as claimed. See Xerox Corp. v. 3Com Corp., 458 F.3d 1310, 1322 (Fed. Cir. 2006) (citing Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000)). The Federal Circuit has made it clear that “it is not enough that the prior art reference discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole, or that it includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Net MoneyIN, 545 F.3d at 1371 (citation omitted) (emphasis added). In Net MoneyIN, although a prior art reference described two protocols, which when taken together, disclosed “all five links arranged or combined in the same way as claimed,” the Federal Circuit determined that the reference did not anticipate the claim. See id. Rather, the Federal” slip op. at 28

    Patent outcomesUS 8,958,819 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Enfish · Phillips · KSR · Graham
    Patents in suitUS 8,958,819
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
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