• Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution denied
  PTAB · Aug 8, 2024 · IPR2024-00520 · APJ John G New · IPR · Institution

  The Board denied institution because Dexcom did not show a reasonable likelihood that claims 5–7 were unpatentable under either Stafford–Raymond ground.

  RulingsInstitution decision

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

    “Burden of Proof “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”)). Therefore, in an inter partes review, the burden of proof is on the Petitioner to show that the challenged claims are unpatentable; that burden never shifts to the patentee. See 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (citing Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)). At the institution stage, Petitioner must show a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 14

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

    “We do not find these arguments persuasive. It may be so that Turner teaches that its recesses 77 receive rotation-restricting protrusions 71, which “extend[] into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” Ex. 1011 ¶ 69. And, it may also be so that Turner teaches this assembly as an advantage in that it prevents rotation of body 20. Id. However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its” slip op. at 32

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

    “In each of the ’335 Specification, Stafford, Raymond, and Turner, the OBU is universally depicted as having a circular perimeter oriented around a longitudinal axis, and possessing either a cylindrical shape (’335 patent, Stafford, Raymond) or a roughly domed shape, with a circular, circumferential collar. See, e.g., Ex. 1001, Figs. 8, 17, 52, 54; Ex. 1009, Figs 3A–C, 4A; Ex. 1010, Figs. 14–16, Ex. 1011, Figs. 2A–B, 5G, 7A-B, 9, 11, 13A–B, 14, 15, 19, 20, 21, 25, 29, 30, 37, 38. Moreover, in each description of the location of recesses 3766 in the ’335 Specification, the recesses are described as being located “on the side walls” of the OBU. See Ex. 1001, col. 44, ll. 8–12; col. 45, ll. 61–64. Given the circular perimeter of all of these embodiments of the disclosures of the ’335 Specification, the teachings of Petitioner’s cited references, the dictionary definition of “periphery” as being “the perimeter of a circle or other closed curve,” and the ordinary meaning that the terms would have had to a skilled artisan at the time of the invention, in view of the ’335 Specification and file history” (Phillips, 415 F.3d at 1312–13), we conclude that a person of ordinary skill in the art would understand that the “plurality of recesses disposed on a periphery of the on body electronics unit housing” would be located “on the circumference of the on-body housing,” as we concluded in the ’01396 IPR Decision. See Dec. 48; see also Ex. 1001, col. 44, ll. 9–14 (stating that “gripping arms 3762 [of medical device carrier 3730] are provided with engagement boss 3764 which are configured to engage with corresponding recesses 3766 provided on the side walls of the on body housing 322”).” slip op. at 38

  • Strike new argumentNew argument disregardedDecided for patent owner

    “However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its 12 The Petition makes a design choice argument with respect to the teachings of Raymond on Ground 1, contending that “it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing—one to engage the protrusions on each of the two arms taught by Raymond.” Pet. 38. However, Petitioner adduced no prior art teaching or evidence of record of “spaced-apart plural recesses on the housing” that Reply Brief if that argument could first have been raised in its Petition. 37 C.F.R. § 42.23(b); see also L’Oréal USA, Inc. v. Univ. of Massachusetts, 2018 WL 4278992, *5 n.4 (PTAB Sept. 7, 2018); Matterport, Inc. v. Appliance Comp. III, Inc., 2021 WL 6340164, *9–10 (PTAB Nov. 19, 2021).” slip op. at 32

  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,266,335
• Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution denied
  PTAB · Apr 16, 2024 · IPR2023-01397 · APJ John G New · IPR · Institution

  The Board denied institution on all grounds because Dexcom did not show a reasonable likelihood that claims 1–4, 8, 9, and 11–27 were unpatentable.

  RulingsInstitution decision

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

    “We do not find Petitioner’s argument persuasive. Figure 29 is a “cross-sectional view,… of the insertion device” disclosed by Raymond. Ex. 1110 ¶ 55. Another view of base 122 is depicted in Raymond’s Figure 18, a detail of which is reproduced below: Detail of Figure 18 of Raymond showing base 122 As depicted in Figure 18, base 122 of Raymond’s device comprises a circular disk, with an annular ring on the proximal side. This view is consistent with the cross-sectional view of base 122 in Raymond’s Figure 29, reproduced below: Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict” slip op. at 29

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

    “Detail of Raymond’s Figure 29 depicting a cross-sectional view of base 122 The annular ring of base 122, as depicted in Raymond’s Figures 18 and 29 thus comprises, at most, a single recess encircling base 122 beneath the annular ring at the periphery of the base. As such, it neither teaches nor suggests “a plurality of recesses disposed on a periphery of the on-body electronics unit housing, wherein the plurality of recesses comprises a first recess in a spaced relation to a second recess,” as required by challenged claim 1 of the ’335 patent. Petitioner’s argument that Figures 20 and 30 of Raymond depict plural recesses in Raymond’s base 122 is based upon a false premise. See Pet. 37–38. The depiction of base 122 in these Figures is entirely consistent with the depiction of base 122 in Raymond’s Figure 18 as having an annular ring with a single recess situated beneath its rim. With respect to Petitioner’s argument that it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing (see Pet. 38), neither Petitioner nor its Declarant, Dr. Fletcher, adduces any evidence beyond that conclusory statement. Id. at 38 (citing Ex. 1103 ¶ 70; Ex. 1110, Figs. 18, 25–27); Ex. 1003, 77. Petitioner makes no persuasive argument as to why a skilled artisan would substitute multiple recesses for a single annular ring, which seemingly serves the purpose of allowing base 122 to be held in position by base-retaining arms 1226. To the contrary, substituting multiple recesses in base 122 to engage retaining arms 1226, and ensuring that each retaining arm 1226 suitably engages each recess, would seem only to add needless complexity to the design, without producing a substantial benefit or improvement.” slip op. at 30

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

    “Turner’s rotation-resisting recesses 77 are not located on the periphery of its body 20. Instead, they are disclosed as being located upon the upper surface of body 20, between its central axis and its edge, and are configured to receive rotation-resisting protrusions 71 of insertion device 70. This placement of rotation-resisting recesses 77 is depicted in Figure 9 of Turner, which is reproduced again below: Figure 9 of Turner is a perspective, exploded view of its fluid delivery system including body 20 and rotation-restricting recesses 77 We therefore find that Turner does not teach or suggest the limitation of challenged claim 1 (and all claims by their dependency) reciting “an on body electronics unit housing comprising a plurality of recesses disposed on a periphery of the on body electronics unit housing.” We further conclude that Petitioner provides no persuasive reason why a person of ordinary skill in the art would have been motivated to alter the location of Turner’s rotation-resisting recesses 77 from the upper surface to the circumferential periphery of body 20, because Turner and the ’335 patent teach that their respective recesses serve different functions. Turner teaches that:” slip op. at 47

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

    “Because we deny institution of inter partes review on the merits, we need not reach the parties’ arguments with respect to whether we should exercise our discretion and deny institution of inter partes review under Section 325(d). As we conclude in Sections IV.B.2.d and IV.C.2.c above, Petitioner has failed to meet its burden of showing a reasonable likelihood of demonstrating at trial that the challenged claims are unpatentable over the combination of Thomas and Raymond, or of Thomas, Raymond, and Turner. That remains true even if, arguendo, the Examiner materially erred in concluding that Thomas is not prior art to the ’335 patent, an issue upon 13 Thomas et al. (US 2010/0198034 A1, August 5, 2010) (“Thomas ’034”), Ex. 2101. 14 The publication date of the Thomas reference that is a basis of Grounds 1 and 2 in this inter partes review is August 12, 2010, one week after the publication of Thomas ’034. which we express no view. We consequently deny as moot Patent Owner’s request that we exercise our discretion under Section 325(d).” slip op. at 51

  § 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 11,266,335
• Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution denied
  PTAB · Apr 16, 2024 · IPR2023-01396 · APJ John G New · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood that claims 1–4, 8, 9, and 11–27 were unpatentable.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the 1 The other Petition seeking inter partes review of challenged claims 1–4, 8, 9, and 11–27 of the ’335 patent is in Dexcom, Inc. v. Abbott Diabetes Care Inc., IPR2023-01397 (filed October 6, 2023). 2 Available at: https://www.uspto.gov/TrialPracticeGuideConsolidated. petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Patent Owner’s Preliminary Response, the Explanation, the Explanation Response, and the evidence of record as presently developed, we determine that the evidence presented fails to demonstrate a reasonable likelihood that Petitioner would ultimately prevail at trial in establishing the unpatentability of the challenged claims of the ’335 patent. We consequently deny institution of inter partes review.” slip op. at 2

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

    “We further conclude that Petitioner provides no persuasive reason why a person of ordinary skill in the art would have been motivated to alter the location of Turner’s rotation-resisting recesses 77 from the upper surface of body 20 to the periphery of body 20, because Turner and the ’335 patent teach that their respective recesses serve different functions. Turner teaches that: Body 20 and insertion device 70 may be configured such that insertion device 70 cannot rotate with respect to body 20 when fully inserted in body 20. One manner of achieving this configuration comprises providing hub 74 with rotation-restricting protrusions 71, which extend in a downstream or downward direction from the main portion of insertion device hub 74, and by providing cap element 24 of body 20 with rotation-restricting recesses 77. When insertion device 70 is fully inserted in body 20, as shown in FIG. 3, at least a portion of each protrusion 71 extends into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” slip op. at 49

  § 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,266,335
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Feb 22, 2024 · IPR2023-01325 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, and 4–6 were unpatentable under any asserted obviousness ground.

  RulingsInstitution decision

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

    “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 reasons discussed below, we do not institute review of claims 1, 4, and 4–6 of the ’033 patent.” slip op. at 2

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

    “concerning the ’834 patent, the intrinsic evidence is minimally helpful in revealing an affirmative meaning for the claims’ “spacing(s)” terms. IPR2023-01151, Paper 12, 39–41. The Specification does not use the term “spacings” in relation to the positioning of adjacent fibers; the drawings might be helpful, but neither party proposes a specific construction that is reliant on them. And, portions of the prosecution record are arguably confounding. For example, the applicant distinguished claimed “spacings” from “tightly knitted fibers.” Ex. 2140, 1001 (suggesting a more “loosely defined fiber structure” may be covered); see also Ex. 1002, 29–30 (asserting the claimed design has “a lesser [fiber] density construction” compared to Walther). This begs the question, at what point does a cloth of “tightly knitted fibers” convert to a cloth having a “loosely defined” fiber structure that would come within the scope of the claimed “spacings?” The record does not answer. Applicant’s suggestion during prosecution that the claimed spacings between fibers are “intentionally placed” about the frame and not simply “the spacing that may be inherent” in fibrous cloths is also unavailing on this record in clearly defining the metes and bounds of the term. Ex. 1002, 28–29. Whether the alleged absence of “objective boundaries” for the term “spacings” supports a conclusion that the claims are invalid as indefinite would be a question for the court. Paper 11, 5 (arguing There is insufficient technical detail available to determine whether the SAPIEN 3 Ultra does or does not include “spacings” as claimed and we take no position on whether such device infringes any claim of the ’033 patent. that a conclusion that the claims are indefinite is “outside the Board’s [IPR] jurisdiction”).12 Notwithstanding the lack of any express claim construction for the “spacings” term from either party, claim 1 of the ’033 patent requires something more than just “spacings.” Claim 1 requires “spacings extending through a thickness of the sealing assembly that allow fluid to pass therethrough when the prosthetic heart valve assembly is in an undeployed state.” Ex. 1001, 22:11–15 (emphasis added). In other words, the spacings must allow fluid to pass through the sealing assembly’s thickness when the valve is undeployed. For reasons discussed below, we are not persuaded on this record that Petitioner is reasonably likely to prevail in showing that this limitation is met—particularly the fluid-passing element—in the proposed combinations of Spenser or Levi with Spenser II.” slip op. at 31

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

    “We, thus, find Dr. Brecker’s testimony more credible that “[i]t would, accordingly, be counterintuitive for a [POSA] to look to a device designed to occlude a blood vessel when designing a TAVR.” Id. ¶¶ 119–120 (testifying “[n]o [POSA] would look to this [occluder] design when considering a TAVR valve and . . . would further have concerns about the pro-thrombotic potential of the arrangement of fibers in Chuter”). Where a proposed combination would run counter to the primary reference’s stated purpose, the POSA would not generally be motivated to make that combination. Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069–70 (Fed. Cir. 2018).” slip op. at 43

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner

    “Grounds 1 and 2 is based on the combination of either Levi and Spenser II, or Spenser and Spenser II. Yet Petitioner purports to modify Spenser II’s compressible material, or supplant it with something else, based on “porous” fabrics allegedly known elsewhere in the art, which art is not identified in the Petition itself as part of any asserted combination. Pet. 49. To see what specific modifications or combinations Petitioner might be suggesting, requires we look to three paragraphs of Dr. Buller’s Declaration, cited but not discussed by Petitioner, where eight additional references are mentioned. Ex. 1003 ¶¶ 157–159 (identifying Exs. 1106–1112, and 1129). This format is an improper incorporation-by-reference of argument and evidence that, had Petitioner wanted to pursue some other combination of asserted art beyond Levi, Spenser, and Spenser II, needed to be set forth explicitly in the Petition. 37 C.F.R. § 42.6(a)(3). Moreover, it leaves the record unclear and forces Patent Owner, the Board, and the public to guess at what combination(s) are, in fact, being urged. We also find that Petitioner’s position reveals a hindsight bias insofar as it suggests, with the aim of arriving at the claimed subject matter, removing Spenser II’s “sufficiently dense” and fluid impermeable compressible material (Ex. 2128 ¶ 222) in favor of some other sufficiently “porous” and fluid permeable material. Hindsight is further evidenced because Spenser II’s cited material is already described as being compressible and adapted to allow coagulation and tissue ingrowth—factors cited by Patent Owner as allegedly motivating a change to some other material. Ex. 1011 ¶ 145. Altogether, we find unpersuasive Petitioner’s position based on unspecified combinations of unasserted prior art to achieve benefits that Spenser II’s existing compressible material already provides.” slip op. at 36

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,491,033
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Feb 7, 2024 · IPR2023-01232 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution because Petitioner had not shown a reasonable likelihood that claims 11–13 were unpatentable on any asserted obviousness ground.

  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 reasons discussed below, we do not institute review of claims 11–13 of the ’310 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 50). Patent Owner does not expressly contest Petitioner’s proposed definition or offer an alternative. See generally Prelim. Resp. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 14

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

    “construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Petitioner contends that “[n]o terms of the ’310 patent require construction to resolve the patentability issues herein.” Pet. 19. Also, Petitioner contends, its “grounds are based on [Patent Owner’s] allegations that the ’310 patent covers Petitioner’s SAPIEN 3 Ultra valve and the scope of the claims asserted by [Patent Owner] in litigation.” Id. (citing Ex. 1122 (Complaint); Ex. 1123 (Infringement Contentions), 2, 262–476).11 Patent Owner does not propose any express claim construction. Instead, Patent Owner contends that the claims should be interpreted according to their ordinary and customary meaning. See, e.g., Prelim. Resp. 18–19, 35–36 (asserting that Petitioner’s mapping of the claims is, in respects, contrary to the “plain language” of the claims). 11 Petitioner identifies a claim construction order in related litigation where the district court construed an “outer frame” as a “self-expanding frame.” Pet. 19 (citing Ex. 1140, 17). We need not further construe the “outer frame” term here because Petitioner contends, without dispute, that the prior art discloses self-expanding frames. Id. at 19–20, 26. Moreover, Patent Owner states that it has disclaimed those claims reciting the term “outer frame” to reduce the number of issues before the Board. Prelim. Resp. 75. about the scope of the claims, we address those arguments below in our discussion of the mapping of claims to the asserted prior art.” slip op. at 15

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

    “We are unpersuaded. The language of claim 11 states the “sealing material is attached to the frame,” but also that it is the plurality of outwardly-extending “fibers” that maintain “contact with the frame along the height of the sealing material” whether the valve assembly is compressed or expanded. Supra Section II(D). Thus, according to this plain language, Petitioner must demonstrate that Spenser II’s identified fibers contact with the frame in its modification of Spenser or Levi—not just that some portion of Spenser II’s compressible material be attached to and contact the frame. On this record, we agree with Patent Owner that Petitioner’s contrary interpretation is “at-odds with the plain language of the claims.” Prelim. Resp. 18, 35. The cited excerpt from the prosecution history does not support Petitioner’s position that the “in contact” limitation is met if the sealing material—but not necessarily the fibers—contacts the frame. Petitioner cites an assertion by applicant during prosecution that modifying Levi’s valve so that the “sealing material” is in contact with the frame would not show that the claimed subject matter is obvious. Pet. 44 (citing Ex. 1002, 147–148). In its more complete context, however, applicant’s prosecution argument was made in furtherance of applicant’s repeated assertion that replacing Levi’s loosely-fit, “billowing” skirt with a tightly-held and bulky sleeve would change Levi’s principle of operation and make it too large and Resp. 35–36 (arguing applicant’s position is also “consistent” with claims’ plain language because, if Levi’s billowing skirt included outwardly-extending fibers, such fibers could not contact the frame along the skirt’s height when it billows out from the frame).15 Applicant’s argument does not rise to a concession that the “fibers in contact with the frame” limitation can be met so long as the sealing material contacts the frame. At best for Petitioner, the relevant prosecution history could be characterized as ambiguous; it does not justify rewriting claim 11’s plain language. See, e.g., Ex. 1002, 127–128 (earlier version of proposed amendment to application claim 31, reciting “the sealing material is in contact with the outer frame”), 138–139 (later version of the proposed and as-entered amendment, expressly changing the language to require “the plurality of fibers is in contact with the outer frame”).” slip op. at 28

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,389,310
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution denied
  PTAB · Jan 9, 2024 · IPR2023-01151 · APJ Timothy G Majors · IPR · Institution

  The Board denied institution on all asserted grounds because Petitioner did not show a reasonable likelihood that any challenged, undisclaimed claim was unpatentable.

  RulingsInstitution decision

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

    “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 reasons discussed below, we do not institute review of claims 2, 9, 17, and 18 of the ’834 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 49). Patent Owner does not expressly contest Petitioner’s proposed definition. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 16

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “during prosecution. Pet. 18, 99. According to Petitioner, Spenser II never describes its compressible material as including “tightly knitted fibers” and a POSA would, instead, have understood Spenser II’s compressible material as comprising “loose, porous materials.” Pet. 18, 99. We agree with Petitioner that the phrases “tightly knitted” and “tightly knitted fibers” do not appear in Spenser II. At the same time, neither does Spenser II describe its compressible material as being “loose” and “porous.” Notably, in prior proceedings before the Board, Petitioner’s declarant Dr. Buller testified that Spenser II’s compressible material “includes a plurality of PET fibers on the inward-facing surface of the compressible material” (i.e., the “base layer” and alleged “second plurality” of fibers here; Paper 9, 5), that is “sufficiently dense to prevent blood from leaking through the cloth/fabric.” Ex. 2128 ¶ 222; see also Ex. 2122, 20:2–22:18 (testifying that “nonporous” as used in the Specification means “that fluid would not pass through it” and such fluid includes “all components of blood”). We find that Dr. Buller’s description of Spenser II as having a dense, blood impermeable base layer is, on balance, more consistent with applicant’s characterization of Spenser II as having an arrangement of “tightly-knitted fibers”—even if some imagined or microscopic spaces between fibers might still exist in a base layer. Ex. 2128 ¶ 222; see also Ex. 2002 (Brecker testimony) ¶¶ 42–45 (testifying, inter alia, that the description of a “tight fitted outer seal is . . . consistent with Spenser II’s Figure 22” and “knitted” is consistent with Buller’s testimony describing Spenser II’s compressible material as “velour-like woven or knitted” PET (citing Ex. 1003 ¶ 162; Ex. 2134 ¶ 56). We are, thus, unpersuaded on this record that applicant mischaracterized Spenser II.” slip op. at 38

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

    “Altogether, the parties’ alleged “plain meaning” yet otherwise undefined interpretation of the “spacing” limitations leaves the Board with insufficient clarity about what the claimed “spacing” means in the affirmative. Paper 9, 3 (arguing “plain meaning”); Paper 11, 3 (arguing applicant’s arguments are in “full harmony with the plain meaning”). The intrinsic evidence is minimally helpful: the Specification does not use the term “spacing” in relation to the positioning of adjacent fibers; the drawings might be helpful but neither party proposes a specific construction that is reliant on them.15 The prosecution history provides clues, but portions of the prosecution record are arguably confounding. The applicant distinguished 15 For example, Dr. Brecker, in support of Patent Owner’s argument, identifies several of the patent drawings and testifies that, “as is particularly clear in Figure 13 (but also present elsewhere), there are gaps and spaces between the fibers that extend to the frame” and then proceeds to testify that prior art, like Spenser II’s compressible material, “bears no resemblance” to the “exemplary” spacings identified in prosecution. See, e.g., Ex. 2002 ¶¶ 42–43. Dr. Brecker’s articulation of a “spacing” does not seem to add anything meaningful beyond the language of the claim as written. And, simply comparing the patent drawings to the prior art drawings presumes a sort of “know-it when you see it” interpretation—it is not an affirmative construction for a “spacing” as claimed. the claimed “spacings” from “tightly knitted fibers.” Ex. 1002, 1001. At what point, however, does a cloth of “tightly knitted fibers” qualify as more “loosely defined” and come within the scope of the claimed “spacing?”16 Id. The applicant also described the “spacing” in semi-functional terms based on “advantages” provided by the claim feature. See, e.g., id. (asserting, e.g., that the spacing permits “expansion and contraction” with “lesser rigidity”); see also id. at 1133, 1140 (asserting, e.g., “reduce[d] restrictions” and avoidance of “restrained valve foreshortening” with the then-claimed “openings”). It is not, however, evident where the Specification supports such “advantages”—no citations were given in prosecution. And, in prosecution of related applications, applicant argued, for example, that “[w]hile all fibers have some degree of being spaced-apart, the construction from Applicant’s claimed invention clearly requires some level more spacing.” Ex. 1149, 13–14 (assertion differences over “Dehdashtian” (alias to Spenser II)) (emphasis added). On this record, what would suffice as “some level more spacing” is unclear. Id.” slip op. at 39

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,337,834
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.

  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) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. 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)). C. Claim Construction” slip op. at 11

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

    “We interpret a claim “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(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 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))). D. Overview of Asserted References” slip op. at 12

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,129,343
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution

  Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. 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 14

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

    “The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 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))).” slip op. at 15

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

    “For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2

  • BurdenNot shown unpatentable

    “Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,536,122
• Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because claims 1–4 had been statutorily disclaimed.

  RulingsInstitution decision

  • Adverse judgmentAdverse judgmentDenied

    “Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2

  None
  Patents in suitUS 10,406,226
• Guardant Health, Inc. v. University Of WashingtonInstitution denied
  PTAB · Jan 31, 2023 · IPR2022-01388 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution of review of claims 1–27, exercising § 314(a) discretion under General Plastic because the follow-on petition used lessons from earlier petitions and had weak merits.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticInstitution denied

    “to study a patent owner’s preliminary response to, or the Board’s institution decision on, a prior petition, such that the petitioner would have been in a position to gain a benefit from having that information before filing another petition. General Plastic, Paper 19 at 17. Under this analysis, we disfavor a follow-on petition that “us[es] our decisions as a roadmap.” Id. Petitioner filed this third Petition on August 10, 2022, after Patent Owner filed its Preliminary Responses in the ’449 and ’450 IPRs on May 6, 2022, and after we issued our decisions denying the petitions in those cases on August 1, 2022. 6 Craig et al., Identification of Genetic Variants Using Bar-Coded Multiplexed Sequencing, 5 NATURE METHODS 887–93 (2008) (Ex. 1036, “Craig”). 7 Shiroguchi et al., Digital RNA Sequencing Minimizes Sequence Dependent Bias and Amplification Noise with Optimized Single-Molecule Barcodes, 109 PROC. NATL. ACAD. SCI. 1347–52 (2012) (Ex. 1010, “Shiroguchi”). Petitioner nevertheless argues that we should institute review of this third Petition because “the Board never reached the merits of patentability under the prior petition[s],” and Petitioner “derived few if any benefits” from seeing Patent Owner’s preliminary responses and our decisions denying institution in those cases. Pet. 62. We disagree. Below, to explain that this third Petition indeed uses our prior decisions as a roadmap, we: (1) summarize Kinde’s teachings; (2) summarize the parties’ arguments and our decision denying institution in the ’450 IPR; and (3) discuss Petitioner’s arguments in this third Petition.” slip op. at 12

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

    “Petitioner that this factor favors institution, it would not outweigh considerations under the other six factors, all of which favor denying institution. This is so especially in view of the weak merits, as discussed below. H. The Merits of This Third Petition Are Weak In this third Petition, Petitioner relies on an alleged “Craig Variation” of Kinde’s method. See, e.g., Pet. 10, 26, 35–36. According to Petitioner, “all claims encompass the obvious variation of Kinde’s method utilizing barcoded adapters (i.e., the Craig Variation).” Id. at 26. Patent Owner contends the so-called Craig Variation is “imaginary.” Prelim. Resp. 7. Putting aside that issue, we found in at least three related IPR proceedings that Petitioner did not explain sufficiently why an ordinarily skilled artisan would have introduced Craig’s adapters, which comprises exogenous barcodes, to Kinde’s endogenous method. See IPR2022-00816, Paper 16, 13–15; IPR2022-00935, Paper 11, 32–35; IPR2022-01159, Paper 17, 10–14. In the current Petition, Petitioner relies on substantially the same arguments regarding modifying Kinde’s endogenous UIDs with Craig’s adaptors. In other words, the merits of this third Petition are weak. In sum, the weakness in the merits of this third Petition further favors denying institution.” slip op. at 25

  Discretionary denial
  Patents in suitUS 10,689,699

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.