• Dental Recycling North America, Inc. v. Solmetex, LLCInstitution denied
  PTAB · Mar 19, 2024 · PGR2023-00055 · APJ Michael A Valek · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable under the asserted grounds.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized 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.” 35 U.S.C. § 324; 37 C.F.R. § 42.4. Upon considering the present record, we determine that Petitioner has not satisfied its burden to show that it is more likely than not that any of the challenged claims are unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the testimony of its declarant, Petitioner contends a person of ordinary skill (“POSA”) “would have been an individual with at least a bachelor’s degree in mechanical engineering, or at least 3 years of experience designing or manufacturing vacuums, filters, medical devices, or the related components.” Pet. 22 (citing Ex. 1003 ¶¶ 94–95). Patent Owner does not respond to Petitioner’s contention in its Preliminary Response, but asks its declarant to apply Petitioner’s proposed level of skill in the art in his analysis. See Ex. 2001 ¶ 86. 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. C. Claim Construction” slip op. at 11

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

    “Petitioner contends that “[a]ll terms of the ’175 patent should be given their plain and ordinary meaning as understood by a POSA,” but does not propose any express claim construction for consideration. See Pet. 22–23. Petitioner further asserts that the preambles of the independent claims are limiting. Id. at 23–25. Patent Owner argues “that claim construction is not necessary at this time,” but urges that “in the event the Board determines that claim construction is necessary, Petitioner’s proposal to construe the preambles of the independent claims as limiting should be rejected.” Prelim. Resp. 65. We need not determine whether the preambles of the independent claims are limiting to reach the outcome in this decision. Accordingly, no express claim construction is necessary here. 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.”). D. Grounds 1–4 and Petitioner’s Related Priority Challenge” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot shown unpatentable

    “Based on the record before us, Patent Owner has the better position. It is well settled that the original drawings may themselves be sufficient to provide description for later-filed claims. Vas-Cath, 935 F.2d at 1565 (holding that “drawings alone may provide a ‘written description’ of an invention as required by § 112”). That is the case here with respect to the original figures submitted with the Great-Grandparent application. We agree with Patent Owner and Dr. Garris that original Figures 4A–B and 5B show a flange or “radially protruding structure” configured as in the challenged claims. Ex. 2001 ¶¶ 106–113. Moreover, the original description in the Great-Grandparent application describes “removable retaining pins 13” that “ensure the recycling container,” i.e., container 12 in Figures 4A–B, “does not detach from the air-water separation tank 5 when there is no vacuum in the system.” Ex. 1002, 213 (¶ 92). Based on this description and the depiction of retaining pin 13 in the original Figure 2, a POSA would have understood that the pins engage with the radially protruding structure to hold the container in place as recited in the challenged claims. Ex. 2001 ¶ 114. Petitioner’s argument that the original figures do not depict the radially protruding structure and retaining pins working together to hold the container in place is unpersuasive. Patent Owner has sufficiently demonstrated that a POSA would have understood how the structures in original Figures 2 and 4A interact based on a side-by-side comparison of the same. See Pet. 38–43; Ex. 2001 ¶ 114. Indeed, the applicants made a similar comparison during prosecution, which proved persuasive to the Examiner. Ex. 1002, 87, 98. The Petition provides no reason to doubt that a POSA would understand the original figures and description just as Patent Owner contends. Moreover, contrary to Petitioner’s arguments, the fact that the specification and drawings were amended does not mean that Patent Owner had to add new matter to overcome the Examiner’s rejections. See Pet. 16– 17. In this case, the amendments to the specification during prosecution of the ’175 patent made the operation of the retaining pin and radially protruding structure, as shown by the original figures, even clearer. But that does not mean that the original description was inadequate.” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 11,660,175
• Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution denied
  PTAB · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.

  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.” 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 claim 1 is unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 10

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

    “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. § 42.200. 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 be understood by a person of ordinary skill in the art, 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)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11

  • BurdenNot shown unpatentable

    “In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20

  Claim construction§ 102 anticipation§ 112 disclosurecites KSR
  Patents in suitUS 11,642,361
• Life Spine, Inc. v. Globus Medical, Inc.Institution denied
  PTAB · Jun 12, 2023 · IPR2022-01603 · APJ Michael A Valek · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–17 were unpatentable on any asserted obviousness ground.

  RulingsInstitution decision

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

    “In an inter partes review, “the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time the invention was made. See Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (“POSITA”): would have had at least a Bachelor’s Degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. EX1002, ¶59. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields. Id. Superior education could compensate for a deficiency in work experience, and vice-versa. Id Pet. 10. Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 9–10.” slip op. at 11

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

    “Petitioner contends “that the Board need not specially construe any terms of the Challenged Claims to institute IPR because they are shown to be obvious regardless of construction.” Pet. 10. Patent Owner argues that “[t]he Board does not need to construe any terms or phrases in the Challenged Claims to resolve the parties’ disputes at the preliminary response stage—Patentee’s arguments herein do not require adopting any express constructions.” Prelim. Resp. 9 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). For purposes of this Decision, and given that neither party seeks any express claim construction, we determine that no express claim construction is necessary. 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.”). To the extent our consideration of Petitioner’s grounds touches on any implicit issues of claim construction, those are addressed in our analysis of Petitioner’s grounds below.” slip op. at 12

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

    “would have been obvious to one of ordinary skill in the art to modify Miller to have non-parallel endplate surfaces in the device’s collapsed configuration based on the teachings in Olmos. See Pet. 53–55, 61–63. The only reasoning Petitioner articulates for modifying Miller is that the modification would “predictably provide the ability to accommodate lordosis,” and a “POSITA would have understood that these benefits are desirable for certain applications.” Id. at 63 (citing Ex. 1002 ¶¶ 61–71, 418– 420). However, Miller discloses that its implant already accommodates lordosis by varying the height of the wedges. See Ex. 1010 ¶ 43 (“The height differentiation [between the wedges] results in a restoration of lordosis as the device is being expanded.”). Petitioner has not articulated sufficient reasoning to explain why a POSITA would modify Miller to address a concern that Miller already addresses via a different mechanism. Neither Petitioner, nor Mr. Drewry, explains any additional functionality or other benefit that such a modification might provide that would not already have been present in Miller’s device. See Pet. 63 (stating only that “[a] POSITA would have understood that these benefits are desirable for certain applications”). On this record, Petitioner’s vague and conclusory reference to “benefits,” in the absence of any identification of an actual purported benefit—other than the lordosis-accommodating benefit already provided by Miller’s implant—is not sufficient reasoning to support the asserted combination of references. See TQ Delta, LLC v. CISCO Sys., Inc., 942 F.3d 1352, 1359 (Fed. Cir. 2019) (quoting KSR, 550 U.S. at 418) (Obviousness “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.”). Moreover, our reviewing court has long cautioned that “[c]are must be taken to avoid hindsight reasoning to avoid hindsight reconstruction by using ‘the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.’” In re NTP, Inc., 654 F.3d 1279, 1299 (Fed. Cir. 2011) (quoting Grain Processing Corp. v. Am. Maize-Prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988)). Here, the cited references teach distinct approaches with a similar result, i.e., when the device is in its elongated configuration the bone-contacting surfaces are at an angle to each other sufficient to accommodate lordosis. Given that both approaches accomplish the same result, the current record does not reveal a reason for making the multiple modifications Petitioner proposes in its combination other than a desire to arrive at device with all of the elements recited in claim 1. Thus, absent improper hindsight, Petitioner has not sufficiently explained why a POSITA would have been led to modify Miller in the manner argued in the Petition. For these reasons, Petitioner has not established a reasonable likelihood of prevailing on its assertion that independent claim 1, and therefore claims 2, 3, 9, 11, and 12 as well, would have been obvious over Miller and Olmos.” slip op. at 40

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,402,739
• Absolute Dental Services, Inc. v. Watson Guide IP, LLCInstitution denied
  PTAB · May 4, 2023 · IPR2023-00177 · APJ James A Tartal · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable under the asserted grounds.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2021). An inter partes review may not be instituted “unless . . . the information presented in 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.” 35 U.S.C. § 314(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that the decision whether to institute inter partes review requires “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2

  • 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). Petitioner contends a person of ordinary skill in the art “would at least have had a doctoral degree in dentistry and at least three to four years of experience working with guided dental surgery for installing dental implants and prosthesis.” Pet. 11 (citing Ex. 1005 ¶ 21). Patent Owner does not dispute the level of ordinary skill identified by Petitioner. See generally Prelim. Resp. We find that the ’016 patent and the cited prior art references reflect a level of skill at the time of the claimed invention that is consistent with the level of skill proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this Decision, we adopt Petitioner’s proposed definition for a person of ordinary skill in the art.” slip op. at 11

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

    “Petitioner proposes no express claim constructions and states that the “Petition can be decided without claim construction.” Pet. 12. Patent Owner also proposes no express claim constructions and states that “the Board need not construe any of the limitations of the ’016 [patent] claims to deny institution.” Prelim. Resp. 11. We agree that it is not otherwise necessary to address the express interpretation of any claim term for purposes of this Decision. See 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 12

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

    “The surface Petitioner identifies with its annotation is the top of “a rod of circular cross-section.” See Ex. 1004 ¶ 24. Petitioner offers no additional explanation in the Petition to show why one of ordinary skill in the art would have understood the rounded surface of Zerhat’s rod, illustrated in Figure 11, to disclose a “horizontal surface,” as required by claim 6. Looking to the portions of the testimony of Dr. Yaste cited by Petitioner for this limitation, we find that testimony unconvincing. According to Dr. Yaste, “Zerhat describes that the fixation base has ‘a plane substantially parallel to the plane of the jaw,’” and from a person of ordinary skill in the art’s “perspective, ‘parallel to the plane of the jaw’ and ‘horizontal’ are synonymous in the context of the fixation base and mounting.” Ex. 1005 ¶ 124. From this, Dr. Yaste concludes that “Figure 11 of Zerhat shows rail (10) as having a horizontal surface, i.e., surface portion perpendicular to its front and rear surfaces.” Id. On its face, however, Figure 11 shows no such thing, because, as Patent Owner notes, the only disclosure of Zerhat Petitioner directs us to “is in reality, and indisputably, the top view of a curved surface,” corresponding to a rod of circular cross section shown in Figure 11 as rail 10. See Prelim. Resp. 25. Thus, the issue is not whether the fixation base of Zerhat lies in a plane substantially parallel to the plane of the jaw, as Dr. Yaste discusses, but whether Petitioner has shown how Zerhat discloses a fixation base with a “horizontal surface,” as required by claim 6. Because Figure 11 of Zerhat, the only disclosure of Zerhat relied upon by Petitioner for this limitation, illustrates rail 10 as circular rod, Petitioner fails to show how Zerhat discloses a fixation base with a “horizontal surface,” as required by claim 6. Accordingly, we conclude Petitioner has not demonstrated a reasonable likelihood of success in showing that claim 6 is anticipated by Zerhat.” slip op. at 15

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,173,016
• Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution denied
  PTAB · Jan 4, 2023 · IPR2022-01103 · APJ Michael A Valek · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable on the asserted obviousness grounds.

  RulingsInstitution decision

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

    “Considering the arguments and evidence of record, we determine that the Petition does not demonstrate “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we do not institute an inter partes review.” slip op. at 2

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

    “14 Because we deny the Petition on the merits, we do not reach Patent Owner’s argument for discretionary denial under 35 U.S.C. § 325(d). Prelim. Resp. 23–39.” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time of the invention. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Petitioner contends that as of September 15, 2011 (see supra n.1), a person of ordinary skill in the art (sometimes referred to herein as a “skilled artisan”) “had the equivalent of a graduate degree in pharmaceutics or a related field, and knowledge and experience making oral-dosage formulations. This individual could work with other specialists including, e.g., an M.D., clinical pharmacologist, and medicinal chemist.” Pet. 10–11 (citing Buckton Decl. ¶¶ 81–84). For the purposes of the Preliminary Response, Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 42. 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 6

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

    “Petitioner asserts that the claims do not require any construction, but also states that a person of ordinary skill in the art would have understood the term “inert low moisture carrier,” which appears in claim 1, to include Avicel PH112. Pet. 12. For purposes of the Preliminary Response, Patent Owner “does not challenge the claim construction positions set forth in the Petition.” Prelim. Resp. 41. For purposes of this Decision, we determine that no claim terms need to be construed. 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 7

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 9,616,097
• Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution denied
  PTAB · Jan 4, 2023 · IPR2022-01105 · APJ Cynthia M Hardman · IPR · Institution

  The Board denied institution because Mylan did not show a reasonable likelihood that any challenged claim was unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “On this record Petitioner has not shown a reasonable likelihood of establishing that at least one of the challenged claims is unpatentable as obvious over Shailubhai, Remington, and Mihranyan. We focus our analysis on claim 1’s recitation of “an inert low moisture carrier.”” slip op. at 11

  • BurdenDenied

    “On this record, we find that Petitioner’s reliance on Lai is insufficient to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 13

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

    “to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 13

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Dr. Buckton’s testimony does not provide the missing explanation. He merely repeats the Petition’s statement that Lai teaches “peptides in particularly are generally subject to degradation from moisture during storage,” without explaining how Lai supports that conclusion. Buckton Decl. ¶ 104; see also id. ¶ 144. Dr. Buckton also cites Aulton, but again fails to indicate exactly what in Aulton indicates that peptides generally, much less plecanatide specifically, are moisture-sensitive. Id. ¶ 144. Indeed, the cited page of Aulton does not mention peptides at all. See Ex. 1029 (Aulton), 9. On this record, Dr. Buckton’s testimony lacks sufficient explanation and is not persuasive to support Petitioner’s burden for institution. 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.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (noting that Board has discretion to accord little weight to expert’s “broad conclusory statements that it determined were unsupported by corroborating references”).” slip op. at 16

  Claim construction§ 103 obviousnessDiscretionary denialcites Graham
  Patents in suitUS 9,925,231
• Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution denied
  PTAB · Jan 4, 2023 · IPR2022-01104 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–16 were unpatentable on any asserted obviousness ground.

  RulingsInstitution decision

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

    “To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that claims 1–16 of the ’024 patent are unpatentable. B. Real Parties-in-Interest” slip op. at 2

  • BurdenDenied

    “to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 15

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

    “On this record, we find that Petitioner’s reliance on Lai is insufficient to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 15

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

    “12 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 13 Because we deny the Petition on the merits, we do not reach Patent Owner’s argument for discretionary denial under 35 U.S.C. § 325(d). Prelim. Resp. 23–40.” slip op. at 22

  Claim construction§ 103 obviousnessDiscretionary denialcites Graham
  Patents in suitUS 9,919,024
• Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution denied
  PTAB · Jan 4, 2023 · IPR2022-01102 · APJ Sheridan K Snedden · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–16 were unpatentable on any asserted obviousness ground.

  RulingsInstitution decision

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

    “moisture (which Petitioner does not address), coupled with Petitioner’s unexplained, superficial citation to Lai, Petitioner does not sufficiently demonstrate for purposes of institution that a skilled artisan would have understood plecanatide to be a moisture-sensitive material such that they would have been motivated to formulate it with a low-moisture MCC carrier. See, e.g., Novartis Pharm. Corp. v. Watson Labs., Inc., 611 F. App’x 988, 995–96 (Fed. Cir. 2015) (affirming finding of no motivation to add an antioxidant to a formulation where the prior art did not unambiguously identify the subject drug as susceptible to oxidative degradation). A petition must include “a detailed explanation of the significance of the evidence.” 37 C.F.R. § 42.22(a)(2) (emphasis added); see also 35 U.S.C. § 312(a)(3) (petition must identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”) (emphasis added). Here, the Petition fails to sufficiently explain how Lai supports Petitioner’s assertion that “[p]eptides were generally understood to be susceptible to water-induced degradation,” particularly given the equivocal and sometimes contrary teachings in Lai that the Petition ignores. Pet. 17. Dr. Buckton’s testimony does not provide the missing explanation. He merely repeats the Petition’s statement that Lai teaches “peptides in particular are generally subject to degradation from moisture during storage,” without explaining how Lai supports that conclusion. Buckton Decl. ¶ 104; see also id. ¶ 144. Dr. Buckton also cites Aulton, but again fails to indicate exactly what in Aulton indicates that peptides generally, much less plecanatide specifically, are moisture-sensitive. Id. ¶ 144. Indeed, the cited page of Aulton does not mention peptides at all. See Ex. 1029 (Aulton), 9. On this record, Dr. Buckton’s testimony lacks sufficient explanation and is not persuasive to support Petitioner’s burden for institution. 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.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (noting that Board has discretion to accord little weight to expert’s “broad conclusory statements that it determined were unsupported by corroborating references”). For at least the reasons discussed above, on this record we are not persuaded that Petitioner has shown a reasonable likelihood of establishing that claim 1 is unpatentable as obvious over Shailubhai, Camilleri, Remington, and Mihranyan. Dependent claims 2, 4–6, 8–9, and 11–16 incorporate all of the limitations of independent claims 1 and 3. Petitioner’s arguments and evidence for these dependent claims do not remedy the deficiencies discussed above for claims 1 and 3. See Pet. 36–43. Accordingly, Petitioner has not demonstrated a reasonable likelihood of prevailing on Ground 1. F. Ground 3: Alleged Obviousness over 2009 Abstract and Doelker” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot reached

    “On this record, we find that Petitioner’s reliance on Lai is insufficient to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 15

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Dr. Buckton’s testimony does not provide the missing explanation. He merely repeats the Petition’s statement that Lai teaches “peptides in particular are generally subject to degradation from moisture during storage,” without explaining how Lai supports that conclusion. Buckton Decl. ¶ 104; see also id. ¶ 144. Dr. Buckton also cites Aulton, but again fails to indicate exactly what in Aulton indicates that peptides generally, much less plecanatide specifically, are moisture-sensitive. Id. ¶ 144. Indeed, the cited page of Aulton does not mention peptides at all. See Ex. 1029 (Aulton), 9. On this record, Dr. Buckton’s testimony lacks sufficient explanation and is not persuasive to support Petitioner’s burden for institution. 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.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (noting that Board has discretion to accord little weight to expert’s “broad conclusory statements that it determined were unsupported by corroborating references”).” slip op. at 18

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

    “Petitioner asserts that the claims do not require any construction, but also states that a person of ordinary skill in the art would have understood the term “inert low moisture carrier,” which appears in claim 1, to include Avicel PH112. Pet. 13. Patent Owner “does not challenge the claim construction positions set forth in the Petition.” See generally Prelim. Resp. For purposes of this Decision, we determine that we need not construe any claim term. 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)). C. Obviousness: Legal Standard” slip op. at 7

  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 9,610,321
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01115 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving the challenged claims obvious, including the claimed tagging efficiency.

  RulingsInstitution decision

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

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, 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.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 7

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

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claim 1. Pet. 18–19. Petitioner asserts that a “POSA [person of ordinary skill in the art] would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. at 19 (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s construction. Prelim. Resp. 32–33. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See 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 8

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

    “40–60% tagging efficiency, Petitioner fails to sufficiently explain why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer the adaptor.” Ex. 1009 ¶ 38.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,801,063
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01116 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that the claims were obvious over the asserted prior art.

  RulingsInstitution decision

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

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, 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 decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6

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

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See 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 7

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

    “40–60% tagging efficiency, Petitioner fails to explain sufficiently why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi-degenerate bases) in the adaptor.” Ex. 1009 ¶ 38. Moreover, as Patent Owner notes, Petitioner is silent as to how the references’ different starting sample sizes affect tagging efficiency. Prelim. Resp. 37–38. According to the KAPA data sheet submitted by Petitioner, “[t]he proportion of fragmented DNA that is successfully converted to adapter-ligated molecules decreases as input is reduced.” Ex. 1015, 4. The KAPA data sheet states that “[w]hen starting library construction (end repair) with >100 ng fragmented DNA, 15–40% of input DNA is typically recovered as adapter-ligated molecules, whereas the recovery typically ranges from 0.5 to 15% for libraries constructed from 100 pg–100 ng DNA.”” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,889,858

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.