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  • PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

    Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

      “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

      “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,140,841
  • PTAB · Feb 7, 2025 · IPR2024-01257 · APJ Timothy G Majors · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable, chiefly because Garrison did not disclose the claimed negative-pressure arrangement.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Based on the record here and for the reasons discussed below, we find that Petitioner has not demonstrated a reasonable likelihood that it will prevail in establishing that any of the challenged claims are unpatentable. We, therefore, do not institute inter partes review.” slip op. at 2

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

      “We need only construe the claims to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Patent Owner neither disputes Petitioner’s proffered construction nor disputes Petitioner’s contention that Hartley teaches a “filament” as claimed. See, e.g., Pet. 41–43; Prelim. Resp. 17. We need not expressly construe the term “filament” or any other term for this Decision.” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner proposes that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 20 (citing Ex. 1003 ¶¶ 35–36). Patent Owner contends that Petitioner’s proposal is “insufficient,” yet Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s proposed definition. Prelim. Resp. 17. We apply Petitioner’s proposed POSA level for the purposes of this Decision, which level does not appear to be inconsistent with the prior art of record.” slip op. at 11

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

      “On this record, we agree with Patent Owner that Petitioner has not shown sufficiently that Garrison describes the subject matter of claim 1’s system with the subject matter being arranged as recited in the claim. Prelim. Resp. 44–62. Patent Owner argues, for example, that Petitioner “fails to identify any embodiment of Garrison that discloses . . . an aspiration system including an aspiration pump in which negative pressure is generated in a first chamber and a second chamber when a valve is closed.” Id. at 45. Patent Owner cites, inter alia, Petitioner’s identification of “an aspiration pump that is positioned upstream of a receptacle such that the pump delivers fluid (e.g., blood) to the receptacle via positive pressure and thus cannot generate negative pressure in the receptacle”—the alleged “first chamber” identified by Petitioner. Id. at 45–46 (emphasis added). Patent Owner persuasively supports its counterarguments with the teachings of Garrison and the testimony of Mr. Brown. See, e.g., Ex. 1006, Figs. 32–36; Ex. 2001 ¶¶ 64–76. We discuss in further detail below. whenever Garrison discloses a pump in the embodiments identified by Petitioner—whether a peristaltic pump as shown in Figures 32–34, a centrifugal pump, or the pump device 3250 shown in Figure 36—the pump is positioned to draw fluid through an inlet and expel the fluid out of an outlet via positive pressure to a downstream delivery location such as a receptacle or blood return line. Such a pump would not and could not generate negative pressure in the downstream delivery location (the receptacle the Petition alleges is the first chamber) for multiple reasons—and therefore would not generate negative pressure in any “first chamber” identified by Petitioner. Prelim. Resp. 46. We agree with Patent Owner.” slip op. at 22

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,744,691
  • PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution

    The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”1 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

      “Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
    Patents in suitUS 11,395,838
  • PTAB · Jul 28, 2023 · IPR2023-00503 · APJ Cynthia M Hardman · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that any of claims 1–14 would have been obvious under the asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

      “review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and cited evidence, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we do not institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “understanding of a person of ordinary skill in the art (sometimes referred to herein as a “POSITA”) as of November 16, 2018. See supra n.1. Petitioner contends that [a] POSITA with respect to the ’962 Patent would have had a Ph.D. in a relevant field of organic chemistry or biochemistry, with several years of research experience gained during those studies or afterwards in organic synthesis, including chiral synthesis, and the use of enzymes in reactions. Winkler ¶ 51. A POSITA could also include a person with a lesser academic degree, but with several years’ experience sufficient to develop equivalent experience in synthetic organic chemistry, such as in pharmaceutical applications or in the chiral synthesis of compounds with biological activity. Pet. 13 (citing Ex. 1002 (Winkler Decl.) ¶¶ 51–52). Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 5–6. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 7

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

      “Having reviewed the arguments and evidence of record (including the claim construction order in the Texas Case), we determine that no construction of any claim term is needed to decide whether to institute this Petition. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

    • Expert testimonyPetitioner expert discountedOther

      “Petitioner’s only support for its assertion that a person of ordinary skill in the art would have modified Divi’s process to “avoid[] a resolution step” is a citation to an identical, conclusory statement by Dr. Winkler. See Pet. 14, 21; Ex. 1002 (Winkler Decl.) ¶¶ 94, 119–20. We agree with Patent Owner that Dr. Winkler’s testimony is entitled to little or no weight, because it does not disclose the underlying facts or data on which the opinion is based. See 37 C.F.R. § 42.65(a); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”). Obviousness arguments “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). On this record, Petitioner and Dr. Winkler fail to adequately explain why a person of ordinary skill in the art would have wanted to modify Divi’s process to “avoid[] a resolution step,” or why converting Divi’s process to an enantioselective synthesis would have “improve[d] the reaction,” particularly in view of Divi’s teaching that “enantioselective synthesis is too expensive on an industrial scale.” Ex. 1003 (Divi), 2:8–11; see also id. at 1:64–2:4 (discussing expense of chiral intermediates and catalysts and their lack of suitability for industrial production).” slip op. at 19

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,913,962
  • PTAB · Nov 14, 2022 · IPR2022-00873 · APJ David Cotta · IPR · Institution

    The Board denied institution because Apple did not show a reasonable likelihood that claims 1–15 were unpatentable over the asserted obviousness grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–15 of the ’444 patent.” slip op. at 2

    • BurdenDecided for patent owner

      “In sum, the Petition asserts that the claimed “converter assembly” is present in Libbus as part of the “wireless communication circuitry,” but the evidence cited in support does not persuade us that Petitioner is reasonably likely to prevail in establishing that: 1) that Libbus fairly suggests that its wireless communication circuitry includes a converter assembly, 2) that a converter assembly is inherently present in Libbus’s wireless communication circuitry, or 3) that the POSA would have at once envisaged that Libbus’s wireless communication circuitry includes a converter assembly. In reaching this conclusion, we give Dr. Fletcher’s testimony diminished weight because he does not provide or explain the underlying facts or data on which his opinion is based and because his assertion that the converter assembly includes a processor appears contrary to Libbus’s disclosure of where the processor is located. F. Ground 2 In Ground 2, Petitioner asserts that claims 12 and 14 would have been obvious over the combination of Libbus and Batkin. Pet 48–56. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly.” Id. Petitioner does not introduce any additional evidence in connection with Ground 2 bearing on the “converter assembly” limitation. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly.” G. Ground 3 In Ground 3, Petitioner asserts that claims 5 and 13 would have been obvious over the combination of Libbus, Faarbaek, and Vyshedskiy. Pet 56–64. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly” (for claims 5 and 13) and on Faarbaek as disclosing a “credit card form factor” (for claim 5). Id. Petitioner does not introduce any additional evidence in connection with Ground 3 bearing on the “converter assembly” or “credit card form factor” limitations. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly” or that Faarbaek discloses a “credit card form factor.” H. Ground 4 In Ground 4, Petitioner asserts that claim 13 would have been obvious over the combination of Libbus, Batkin, and Vyshedskiy. Pet 64–65. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly.” Id. Petitioner does not introduce any additional evidence in connection with Ground 4 bearing on the “converter assembly” limitation. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly.” I. Ground 5 In Ground 5, Petitioner asserts that claims 7 and 15 would have been obvious over the combination of Libbus, Faarbaek, and the Headset Profile. Pet. 65–68. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly” (for claims 7 and 15) and on Faarbaek as disclosing a “credit card form factor” (for claim 7). Id. Petitioner does not introduce any additional evidence in connection with Ground 5 bearing on” slip op. at 23

    • Expert testimonyPetitioner expert discountedOther

      “Petitioner also cites the testimony of Dr. Fletcher to support its position that the POSA would have “understood” Libbus’s wireless communication circuitry to include a converter assembly. Pet. 24 (citing Ex. 1003 ¶ 84). As an initial matter, Dr. Fletcher’s testimony that a POSA would understand Libbus’s wireless communications circuitry to include a converter is not well explained, nor is it supported by evidence beyond Dr. Fletcher’s assertion that it is so. Dr. Fletcher merely parrots the statement in the Petition that a POSA “would have understood the wireless communication circuitry to include a converter assembly and a transmitter because the wireless communication circuitry is connected to the electrocardiogram circuitry, modulates an ECG signal, and wirelessly transmits the ECG signal to another device.” Ex. 1003 ¶ 84. And Dr. Fletcher’s evidentiary support is the same unpersuasive evidence cited in the Petition—paragraphs 48 and 59 of Libbus. Id. We give Dr. Fletcher’s testimony some weight, but that weight is substantially diminished by the absence of persuasive explanation and supporting evidence. See Rohm & Haas Co. v. Brotech Crop., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (“Nothing in the rules or in our jurisprudence requires the fact finder to credit the unsupported assertions of an expert witness.”); see also 37 C.F.R. § 42.65 (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”).” slip op. at 18

    • Skill levelSkill level petitioner adoptedOther

      “Pet. 6. According to Petitioner, a “greater amount of education . . . with a focus on designing wearable devices and/or sensors for measuring physiological signals . . . would also qualify for the hypothetical person of ordinary skill in the art in lieu of fewer years of multidisciplinary work experience.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA. See generally Prelim. Resp. Petitioner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’444 patent. Accordingly, for purposes of this Decision, we accept Petitioner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,342,444
  • PTAB · Sep 6, 2022 · IPR2022-00611 · APJ Lynne H Browne · IPR · Institution

    Institution was denied for claims 1–10 because the petition did not show a reasonable likelihood that any asserted obviousness combination rendered the claims unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “compressed by squeezing water from the tissue. Ex. 1010 ¶ 37. Scott states that “if the tissue is fixed during or immediately after the compression, it will retain its reduced thickness even if re-introduced into an aqueous solution.” Id. Scott then states that “the tissue will not significantly rehydrate because it has been crosslinked and is no longer as porous as the fresh tissue.” Id. Petitioner does not convince us that tissue that is “not significantly rehydrated” and less porous than fresh tissue is necessarily the same as “dry” tissue in accordance with the definition of “dry” adopted in Section II B above. For this reason, we agree with Patent Owner that Scott does not disclose or suggest “a dry valve directly sutured to the stent member” as required by claims 1 and 6. Ex. 1001, 14:11, 14:37. The Petition does not rely on Chen to cure this deficiency in Scott.” slip op. at 16

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

      “On the record before us, we agree with Patent Owner that in the context of the claimed invention a “dry” valve is one made of tissue from which water and other liquids are removed. This understanding is consistent with Petitioner’s initial position that a person of ordinary skill in the art “would have understood that the plain and ordinary meaning of ‘dry’ is ‘free or relatively free from water or liquid.’” Pet. 37 (citing Ex. 1003 ¶ 86 (citing Ex. 1033, 696)). We do not agree with Petitioner’s second position that a person of ordinary skill in the art “would have understood that the term ‘dry’ as that term is used in the ’945 Patent claims to describe a heart valve is where the tissue is substantially free from water” because neither the Petition nor Petitioner’s expert, Mr. Scott, cite any authority in support of this position or provide a reasoned explanation as to why this would be so. Pet. 37; Ex. 1003 ¶ 87. For purposes of this decision, we adopt Patent Owner’s definition of “dry” as “free or relatively free from water or liquid.” Prelim. Resp. 12 (citing Pet. 37).” slip op. at 11

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

      “Patent Owner also proposes claim construction for “to decrease the molecular distance of collagen fibers” and “dry valve has been subjected to light and mechanical compression to decrease the molecular distance of collagen fibers.” Prelim. Resp. 12–16. Construction of these terms, however, is not required in order to resolve the controversy before us. Accordingly, we do not construe this claim language at this time.” slip op. at 11

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

      “Patent Owner contends that Scott does not disclose a dry valve subjected to light to decrease the molecular distance of the collagen fibers. Prelim. Resp. 32. Patent Owner contends further that Petitioner does not even allege that Scott or any other reference teaches subjecting tissue to light to decrease the molecular distance of collagen fibers. See id. at 35. On the record before us, we agree with Patent Owner that Petitioner does not adequately explain why a person of ordinary skill in the art would subject Scott’s dry valve to light to decrease the molecular distance of the collagen fibers. Scott describes the use of compression to decrease the molecular distance of the collagen fibers. Petitioner does not explain how subjecting the compressed tissue to light would further decrease the molecular distance of the collagen fibers as required by claims 1 and 6. Indeed, Petitioner merely asserts that such treatment was known and that is would decrease manufacturing time. Pet. 48–49. For this reason, we agree with Patent Owner that Scott does not disclose or suggest a dry valve “wherein the treated mammalian pericardium tissue forming the dry valve has been subjected to light and mechanical compression to decrease the molecular distance of collagen fibers.” as required by claims 1 and 6. Ex. 1001, 14:15–18, 14:42–45. The Petition does not rely on Chen to cure this deficiency in Scott.” slip op. at 17

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 10,390,945
  • PTAB · Jul 27, 2022 · IPR2022-00637 · APJ Cynthia M Hardman · IPR · Institution

    The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that claims 1–25 were obvious over either asserted combination.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “III. Conclusion After considering the evidence and arguments of record, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to any claim challenged in the Petition.10 Accordingly, we do not institute an inter partes review. IV. Order In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to all challenged claims, and no trial is instituted.” slip op. at 24

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

      “Regarding a motivation to replace Gravesen’s lever with Yodfat’s cylindrical rotor, Petitioner argues that (1) “[t]he ’440 patent does not describe any benefit conferred by the claimed cylindrical rotor shape,” and (2) cylindrical rotors and levers were “similar solution[s]” for translating a torsion spring’s rotation to linear movement of an inserter. Pet. 96, 99; Ex. 1035 ¶¶ 219, 233, 234. On this record, Petitioner’s contentions amount to little more than a statement that cylindrical rotors were known in the prior art. As stated in KSR, however, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co., 550 U.S. at 418. Rather, Petitioner must demonstrate that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. While it may have been technically feasible for a person of ordinary skill in the art to substitute Yodfat’s cylindrical rotor for Gravesen’s lever to achieve linear movement, “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Standing alone, Petitioner’s allegation of interchangeability of a cylindrical rotor and a lever to effect linear movement of an inserter is insufficient to provide a reason to combine. Petitioner also contends that a person of ordinary skill in the art “would have recognized the utility of a cylindrically shaped rotor for positioning Gravesen’s driving spring 215 to provide both insertion force and at least some retraction force.” Pet. 96 (citing Ex. 1008 ¶ 124; Ex. 1004 ¶ 8). In Petitioner’s obviousness combination, however, separate driving springs effect insertion and retraction. See, e.g., id. at 52–53 (arguing that rotation of lever 211 operates to insert the needle), 46 (arguing that torsion spring 215 rotates lever 211), 58–59 (arguing that retraction spring 22 operates to retract the needle).8 Indeed, Petitioner contends that separating the operation of the insertion and retraction springs advantageously reduces the weight of the retraction apparatus, and thus the pain experienced by the subject. See id. at 24, 59; Ex. 1035 ¶¶ 57, 114. Thus, on this record, Petitioner’s proffered motivation to use Yodfat’s cylindrical rotor to drive a spring for “both insertion force and at least some retraction” (Pet. 96) conflicts with the two-spring embodiment of Gravesen that is the basis for Petitioner’s obviousness argument. See Prelim. Resp. 58; Ex. 2001 ¶ 117.” slip op. at 18

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

      “and does not offer any express claim constructions. Pet. 17. Patent Owner also does not offer any express claim constructions, but disputes Petitioner’s understanding of the terms “rotor” and “recess.” Prelim. Resp. 21–22, 49, 51–53. For purposes of institution, we conclude that we need only address the term “recess.” We do so below in the context of analyzing Petitioner’s obviousness challenge based on Gravesen and Brister. See supra Section II.C.4; see also Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

    Claim construction§ 103 obviousnesscites Graham
    Patents in suitUS 11,013,440

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.