• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00728 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–7, 9, 10, 15–18, and 20–24 are unpatentable as obvious over Schaffer with Hartley or Eller; claims 1–3, 5, 6, 9, 15–18, and 21–24 are also obvious over Hartley and Eller.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Petitioner’s proposed POSA definition lacks specificity. That definition, if interpreted generically, could mean that a person may qualify as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2033 ¶ 61. We find that a POSA would also have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:16–54 (background of the invention). Such devices include, but are not limited to, hemostasis valves and catheters for testimony of the parties’ experts, the POSA need not have had first-hand experience designing hemostasis valves. See, e.g., Ex. 1037 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required). Further, as Dr. Zalesky testified, the POSA’s experience related to developing such devices “could be as simple as bench testing and looking at clinical data.” Id. at 74:5–75:1. Lastly, a POSA would have understood such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience or study. Ex. 2030, 24:5–21.” slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

    “above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 28

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner cites intrinsic evidence in support of its interpretation, which include claim 1’s recitation of an “active tensioning mechanism” comprising the filament and the Specification’s description of a filament that can be both “loosened” and “tightened.” PO Resp. 14–17 (citing, e.g., Ex. 1001, 9:36–37, 9:53–56 (teaching “the filament 150 is tightened” when the actuator buttons are released and “the filament 150 is loosened” when the buttons are pressed to open the valve)); see also Ex. 2025, 1288 (defining “tension” as to “tighten to a desired or appropriate degree”). These descriptions from the patent are more consistent with the view that the filament is characteristically flexible, not rigid. 10 We reached the same conclusion, based on substantially the same records, in the Institution Decision and the Final Written Decisions in the 1157, 156, and 289 IPRs. Inst. Dec. 14–18; Ex. 1042, 14–24; Ex. 1048, 16–23; Ex. 1049, 14–17 (noting the parties’ agreement at oral hearing that there was no additional argument or evidence about whether a filament requires flexibility that was not already addressed in related matters). After we construed the “filament” term to require flexibility at institution, Petitioner provided no further argument or evidence on this issue in its authorized trial briefing or at oral hearing. See generally Pet. Reply. embodiments (where the filament forms one or more loops like depicted and described in Figures 6–7) require a flexible structure. See, e.g., Ex. 2032, 15–16 (explaining that the device would not work to constrict the tubular sidewall and lumen (analogous to the elongate member defining a lumen of the claims here) if the filament forming the loop(s) was inflexible); Ex. 1001, Figs. 6–7 (filament 150, with sub-filaments 150-A and 150-B). Although flexibility of the filament in the patent’s “bight” embodiments (e.g., as shown in Figures 8 and 9) is less clear, there is a dearth of evidence from Petitioner—either intrinsic or extrinsic to the patent—showing why a POSA would have understood the bights as embracing rigid structures. See Ex. 1001, Figs. 8–9. Moreover, as admitted by Petitioner’s expert, that a filament may be made from various materials described in the patent (e.g., synthetics or metals) does not, absent more information, lead to a conclusion that a filament is “rigid.” Ex. 2030, 125:2–126:4 (testifying “the relative stiffness or rigidity is not clear from those . . . materials without knowing much more information”).” slip op. at 16

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

    “We find that Petitioner has not shown, by a preponderance of the evidence, that Schaffer anticipates claim 1 or any of the other challenged claims, each of which requires at least one “filament.” We are unpersuaded above (supra Section III.C), a filament requires flexibility, Petitioner has not demonstrated that Schaffer describes that feature in its valves. Instead, Patent Owner persuades us that Schaffer describes “rigid U-shaped actuating members—not a ‘filament.’” PO Resp. 23–24.13 We find Dr. Zalesky’s interpretation of Schaffer more credible than Mr. Thornton’s on the question of whether a POSA would have regarded Schaffer’s actuating members as being substantially rigid structures. Ex. 2033 ¶¶ 91–100 (testifying, inter alia, that a POSA would have understood from Schaffer’s disclosure about making the actuator and actuating members from machining pre-existing amounts of metals and/or plastics, and further explaining that flexible parts would deform and be difficult to machine through conventional techniques); Ex. 1005 ¶¶ 81–82. Mr. Thornton testifies that Schaffer’s disclosed manufacturing techniques for the actuator/actuating members are only examples and “a person of ordinary skill in the art could have simply purchased pre-made [and flexible] flat wire or plastic tapes or ribbons.” Ex. 1003 ¶ 79. Such testimony invokes, at best, obviousness-based reasoning. This does not establish that Schaffer alone describes a filament sufficient to anticipate the claims. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed.” slip op. at 27

  Patent outcomesUS 11,844,921 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,844,921
• Aroma360, LLC v. Air Esscentials, Inc.All claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00706 · APJ Eric C Jeschke · IPR · Final written decision

  Claims 1, 4, and 7–10 are unpatentable as obvious over Goubet and anticipated by Gao; proposed substitute claims 20 and 21 are denied as indefinite and lacking written-description support.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In the Response, Patent Owner states that it “does not dispute” the definition of one of ordinary skill in the art proposed by Petitioner, but Patent Owner “reserves the right to address [the definition] should new issues materialize.” PO Resp. 6. Patent Owner did not address this issue in the Sur-reply. As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “Network LLC, 929 F.3d 1350, 1357 (Fed. Cir. 2019). At first glance, the language of the limitation at issue—which, again, recites “the compressed air and the operative fluid mix together in said mixing chamber to form the fluid dispersion”—would seem to require the “fluid dispersion” (under the stipulated construction) to be fully formed in the “mixing chamber.” In other words, the language of the limitation alone would seem to support Patent Owner’s proposed construction for the “form the fluid dispersion” limitation. But the claim construction analysis does not end with consideration of the claim language alone. Next, we turn to the Specification. The Federal Circuit has said that the specification “is the single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Here, the discussion in the Specification of precisely the same language as in the limitation at issue strongly supports that “to form a fluid dispersion” in the limitation at issue requires only initial mixing of the compressed air and operative fluid in the mixing chamber, with further “formation” of the ”fluid dispersion” occurring downstream of the mixing chamber: More importantly, the “predetermined amount” of compressed air and the “preselected amount” of the operable fluid are initially mixed together in the mixing chamber 226 to form a fluid dispersion. The diffusion chamber 112" is further structured to facilitate the formation of a plurality of substantially uniform droplets, as defined hereinabove, in the fluid dispersion prior to discharge from the diffusion chamber 112" through discharge port 132. Ex. 1001, 10:62–11:2 (emphasis added) (discussing Figure 6), quoted, in part, at Pet. Reply 6–710; see also Ex. 1001, 5:64–6:4 (same language, except without double primes, in a discussion of Figures 1 and 2). To be sure, certain passages in the Specification could be read to indicate that a “fluid dispersion” must be fully formed in the “mixing chamber.” See, e.g., Ex. 1001, 6:11–12 (“More in particular, the suppression chamber 232 receives the fluid dispersion from the mixing chamber 226.”); see also id. at 7:22–33, 11:39–52 (both implying that a “fluid dispersion” is formed in the mixing chamber). But the passage block quoted directly above (and the similar one bridging columns 5 and 6) more directly addresses the issue at hand—i.e., the scope of “form the fluid dispersion”—by using the same” slip op. at 13

  • Expert testimonyPatent owner expert discountedMixed

    “As an initial matter, the record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration for allegedly not reviewing the parties’ claim constructions. See Pet. Reply 2 (citing Ex. 1046, 115:15–18). Contrary to Petitioner’s argument, in the cited discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1. Instead, we read Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also id. at 115:15–18 (“I don’t know if I would even apply claim construction. I applied engineering principles to a document that had been published with the patent office.”).” slip op. at 18

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

    “To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016); TriVascular, Inc. v. Samuels, 812 F.3d 1056, 1066 (Fed. Cir. 2016) (“Although the KSR test is flexible, the Board ‘must still be careful not to allow hindsight reconstruction of references . . . without any explanation as to how or why the references would be combined to produce the claimed invention.’”) (citation omitted). Based on the complete record, we agree with Patent Owner that “Petitioner’s asserted motivation boils down to the conclusory statement that given Goubet and Kaiser, ‘it was well known in the field at the time of the invention that droplets of greater uniformity result in uniform droplet evaporation.’” PO Resp. 31 (quoting Pet. 59). We agree with Patent Owner that Petitioner’s discussion of the alleged reasons to combine (Pet. 59) is insufficient to support the proposed combination here. See Magnum Oil, 829 F.3d at 1380. Specifically, we are not persuaded that Kaiser’s teachings—which relate to combustion (Ex. 1014 at 43)—would have led one of ordinary skill in the art to the proposed modifications, which would allegedly “improve the smoothness (i.e., less harsh) of the aroma generated as the oil droplets evaporate in the surrounding airspace.” See Pet. 59 (emphasis added); White Pet. Decl. ¶ 251 (same); see PO Resp. 32 (“Rather, Dr. White merely describes the ability to achieve the effect as in the claimed patent, not why a [person of ordinary skill in the art] would look to the field of electrospray injection and combustion in mesoscale power-generation systems, using high-voltage electric fields to generate charged fuel droplets for controlled combustion in catalytic micro-combustors when considering atomization for scents.”). For these reasons, we determine, in light of the complete record, that Petitioner has not shown by a preponderance of the evidence that one of ordinary skill in the art at the time of the invention would have had reason to combine Goubet and Kaiser, as proposed. slip op. at 32

  Patent outcomesUS 10,583,449 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Nautilus
  Patents in suitUS 10,583,449
• Aroma360, LLC v. Air Esscentials, Inc.All claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00705 · APJ Eric C Jeschke · IPR · Final written decision

  Claims 7–9 and 11 are unpatentable as obvious over Goubet; proposed substitute claim 21 is denied as indefinite.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In the Response, Patent Owner states that it “does not dispute” the definition of one of ordinary skill in the art proposed by Petitioner, but Patent Owner “reserves the right to address [the definition] should new issues materialize.” PO Resp. 5. Patent Owner did not address this issue in the Sur-reply. As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for patent owner

    “The record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration, as asserted in Petitioner’s overall argument. See Pet. Reply 1–2. Contrary to Petitioner’s argument, in the cited general discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1; see also Pet. Reply 2 (arguing that “Dr. Micklow’s declaration is premised on understandings of claim scope that are inconsistent with the constructions advanced by both of the parties” (emphasis added)). Instead, we read the cited portions of Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also Pet. Reply 1 (citing Ex. 1046, 112:4–12, 113:13–20, 115:15–18). Next, we turn to each of the four specific claim terms that Petitioner highlights in its further arguments.” slip op. at 12

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

    “B. Claim Construction In inter partes reviews, the Board interprets claim language using the same claim construction standard that would be used in a civil action under 35 U.S.C. § 282(b), as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms 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. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 10–11; PO Resp. 5. Based on the complete record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. 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 9

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

    “Florida Litigation a Joint Claim Construction statement that included stipulated claim constructions and disputed claim constructions for terms in the challenged patent as well as the ’449 patent and the ’918 patent. See Ex. 1018, Exhibit A (Stipulated Claim Constructions), Exhibit B (Disputed Claim Constructions). The parties stipulated to the construction of the terms “fluid dispersion” and “baffle” as recited in the challenged claim. See id., Exhibit A.10 10 When staying the Florida Litigation, the District Court cancelled the scheduled claim construction hearing. See ECF No. 67 (April 8, 2025) (granting joint motion to stay); ECF No. 68 (April 8, 2025) (cancelling the The stipulated construction of “fluid dispersion” merely restates the express definition of “fluid dispersion” from the challenged patent (although the definition is not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 3:8–20. Similarly, the stipulated construction of “baffle” essentially parrots one sentence in the challenged patent (again, not cited or discussed in the parties’ filing). Compare Ex. 1018, Exhibit A, with Ex. 1001, 7:57–59. To the extent necessary, we determine that the complete record supports the parties’ stipulated constructions of “fluid dispersion” and “baffle,” and we apply those constructions below.” slip op. at 10

  Patent outcomesUS 9,527,094 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · Nautilus
  Patents in suitUS 9,527,094
• Globus Medical, Inc. v. Spinelogik, Inc.All claims unpatentable
  PTAB · Jul 10, 2026 · IPR2025-00226 · APJ Matthew S Meyers · IPR · Final written decision

  Claims 1–5, 7, and 9 are unpatentable under §103 over Moskowitz and Steffee; the Board did not reach the Moskowitz-only ground and rejected the Hess ground.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that one of ordinary skill in the art would have had a bachelor’s or equivalent degree in mechanical engineering or a related discipline (e.g., biomedical or metals and materials engineering), and at least five years of experience consisting of (a) designing, developing, evaluating and/or using spine devices, (b) anatomy, physiology and biology of soft and calcified tissues including bone healing and fusion, and (c) biomechanical and functional loading of orthopedic implants. Pet. 17 (citing Ex. 1002 ¶ 49). Petitioner also asserts that “[m]ore education can supplement practical experience and vice versa.” Id. (citing Ex. 1002 ¶ 49). “Patent Owner does not dispute the proffered definition for a POSA.” PO Resp. 9. Based on the full record, we determine that Petitioner’s undisputed proposed level of skill is reasonable and consistent with the ’385 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art.” slip op. at 8

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

    “1. “channel” Throughout the challenged claims, “channel” appears together with “curved” in the term “curved channel.” For example, claim 1 recites “the fusion member comprising a first curved channel and a second curved channel,” “a first anchoring member configured to insert through the first curved channel,” and “second anchoring member configured to insert through the second curved channel.” Ex. 1001, 26:58–59, 26:60–61, 26:65– 66. Prior to institution, Petitioner asserted that one of ordinary skill in the art would “understand the claim term ‘channel’ to refer to a passage through which something moves or is conveyed.” Pet. 18 (citing Ex. 1002 ¶ 54). And, for purposes of our Decision on Institution, we adopted Petitioner’s proposed construction as being “consistent with the intrinsic record.” Institution Dec. 10. the ’385 [p]atent is readily understood by a POSA in context without needing explicit construction” and the plain and ordinary meaning should apply. PO Resp. 9–10. According to Patent Owner, the ’385 patent “consistently uses ‘channel’ to refer to a pathway within the fusion member through which an anchoring member traverses” and “explicitly states that channels may have different shapes and sizes and need not have a constant diameter, indicating the patentee did not intend to narrow the term beyond its common understanding.” Id. Petitioner replies noting that Patent Owner’s understanding “is substantively identical to Petitioner’s construction (‘a passage through which something moves or is conveyed’), specifically applied to an anchoring member.” Pet. Reply 6 (Pet. 18; PO Resp. 9–10). Thus, Petitioner concludes that “[t]he parties thus agree with the Board’s construction.” Id. Based on the full record, we agree with Petitioner that the parties’ positions on the meaning of the term “channel” are “substantively identical.” Because we see no difference between the parties’ position on the meaning of “channel,” we continue to adopt Petitioner’s proposed construction as it is consistent with the plain language of the claims and Specification. See Pet. 18 (citing Ex. 1001, 9:42–44, 9:53–55, 10:63–66, 11:47–63, 14:25–31, 14:65–67, 16:32–35, 22:51–57, 24:55–67) (The Specification uniformly refers to a “channel” as “a passage through which something (e.g., an anchoring member) traverses.”).” slip op. at 9

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

    “between the spinous processes in order to decompress the spinal canal, and thus, “relieve pressure on the spinal cord and nerves by increasing the area of the spinal canal.” Ex. 1006, 1:32–34, 1:50–52, 2:1–6. In contrast, the ’385 patent identifies that “the goal is to achieve solid bony fusion between the involved endplates and eliminate the symptoms caused by motion and associated degenerative and other reactive changes between these unstable vertebral segments.” Ex. 1001, 1:53–57. Thus, Hess’s disclosed implant is designed to distract and stabilize the spinous processes, not to promote solid bony fusion between adjacent vertebral bodies. Consequently, we agree with Patent Owner that “converting Hess for intervertebral fusion would require eliminating its core dynamic stabilization functionality—directly contradicting Hess’s stated design objectives.” PO Resp. 42 (citing Ex. 1006, 2:5–26, 7:43–45). We also are not persuaded that Petitioner adequately explains why a person of ordinary skill would have modified Hess’s implant in the manner proposed. Petitioner contends that only “minimal modifications” to Hess’s shell dimension and shape would be required for intervertebral use. Pet. 61–67; Ex. 1002 ¶¶ 122–128. However, simply modifying the shape and size of Hess’s shell does not, without more, support a motivation to redesign Hess’s device from a posterior interspinous implant engaging spinous processes to an interbody implant positioned between vertebral bodies and anchored into vertebral bodies. Here, Hess discloses that modifying its dimensions serves to “preserv[e] mobility and alignment.” Ex. 1006, 7:5–7. Conversely, the ’385 patent’s fusion implant serves to limit mobility between vertebrae by achieving “solid bony fusion between the fusion member and the adjacent vertebral bodies.” Ex. 1001, 24:67–25:3. spinal fusion procedures” (id. at 6:49–52), we do not find that statement, without more, to disclose or suggest reconfiguring Hess’s interspinous implant as an “a fusion member configured to position between first and second vertebral bodies,” as required by limitation [1.1]. At most, Hess’s “adjunct to” statement suggests that the interspinous implant may be used in connection with, or in support of, a fusion procedure. It does not explain how or why Hess’s implant would be redesigned for placement between two adjacent vertebral bodies, nor does it teach that Hess’s locking wings would be reoriented or adapted to anchor into vertebral bodies rather than spinous processes. On this point, Mr. Culbert states that “[t]he only changes required to modify Hess for use as an intervertebral implant would be to modify the dimensions of Hess’s shell, which was ‘dimensioned and configured for placement between the spinous processes’” (Ex. 1002 ¶ 126 (citing Ex. 1006, 7:3–4)), but Mr. Culbert does not explain how Hess’s locking wings and guide tracks would be reoriented or adapted to function as anchoring members that are inserted into adjacent vertebral bodies rather as opposed to spinous processes. Instead, Mr. Culbert simply states that “Hess’s locking wings would engage and at least partially penetrate the superior and inferior adjacent vertebrae” (emphasis added) (Ex. 1002 ¶ 135) without explaining how or why one of ordinary skill in the art would have made the modification with a reasonable expectation of success.” slip op. at 17

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “modify Hess for use as an intervertebral implant would be to modify the dimensions of Hess’s shell, which was ‘dimensioned and configured for placement between the spinous processes’” (Ex. 1002 ¶ 126 (citing Ex. 1006, 7:3–4)), but Mr. Culbert does not explain how Hess’s locking wings and guide tracks would be reoriented or adapted to function as anchoring members that are inserted into adjacent vertebral bodies rather as opposed to spinous processes. Instead, Mr. Culbert simply states that “Hess’s locking wings would engage and at least partially penetrate the superior and inferior adjacent vertebrae” (emphasis added) (Ex. 1002 ¶ 135) without explaining how or why one of ordinary skill in the art would have made the modification with a reasonable expectation of success. Hess’s disclosure that its shell may have shape variations to match adjacent bone (Ex. 1006, 7:7–13) also does not adequately explain why a person of ordinary skill would have had a reason to redesign Hess’s device for a different intervertebral environment, or why such a redesign would and “anchoring members,” i.e., locking wings. And, to the extent Hess discloses matching the shell to “the profile of the adjacent bone when deployed” (Ex. 1006, 7:11–13), Hess never suggests adapting the shell for placement between two adjacent vertebral bodies or for use as a fusion cage, it discloses that the “shell 12 is dimensioned and configured for placement between the spinous processes of symptomatic disc levels” (id. at 7:2–4). Thus, we agree with Patent Owner that the proposed modification “minimizes the structural differences and conflicting functional objectives inherent in modifying a device intended for the posterior elements of the spine for use in the anterior load-bearing column” (emphasis omitted). PO Resp. 41. For the reasons discussed above, we determine that Petitioner’s reliance on Mr. Culbert’s testimony amounts to more than just providing a motivation to modify Hess. Here, it amounts to relying on expert testimony to supply a missing limitation. As such, Petitioner’s arguments are not persuasive to demonstrate that the prior art teaches the limitations of the claim by a preponderance of the evidence. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9, 16 (PTAB Aug. 24, 2022) (precedential) (explaining that relying on expert testimony “is particularly problematic in cases where, like here, expert testimony is offered not simply to provide a motivation to combine prior-art teachings, but rather to supply a limitation missing from the prior art.”).” slip op. at 18

  Patent outcomesUS 8,460,385 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,460,385
• Globus Medical, Inc. v. Spinelogik, Inc.All claims unpatentable
  PTAB · Jul 10, 2026 · IPR2025-00225 · APJ Matthew S Meyers · IPR · Final written decision

  Claims 1–6, 11, 12, and 15–17 are unpatentable: claims 1–4, 6, 11, 12, 15, and 17 over Blain; claims 5 and 16 over Blain, Bray, and Steffee.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that one of ordinary skill in the art would have had a bachelor’s or equivalent degree in mechanical engineering or a related discipline (e.g., biomedical engineering, metals and materials engineering), and at least five years of experience with a) designing, developing, evaluating and/or using spine devices, b) anatomy, physiology and biology of soft and calcified tissues including bone healing and fusion, and c) biomechanical and functional loading of orthopedic implants. Pet. 18–19 (citing Ex. 1002 ¶¶ 77–78). Petitioner also asserts that “[m]ore education can supplement practical experience and vice versa.” Id. (citing Ex. 1002 ¶ 78). “Patent Owner does not dispute the proffered definition for a POSA.” PO Resp. 10. proposed level of skill is reasonable and consistent with the ’805 patent and the asserted prior art. Thus, for these reasons, we adopt Petitioner’s level of skill in the art.” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “Based on the full record, we determine that “housing,” as it appears in the context of the term “delivery housing” is a component that is a part of the delivery mechanism (see Ex. 1001, 11:27–31) and that simply contains and guides another component during delivery. See Ex. 1001, 13:25–27, 21:30–50. Thus, we apply the ordinary meaning of “housing,” as it appears in the context of the term “delivery housing,” and address in the context of “delivery housing,” as recited by claims 2 and 4.” slip op. at 12

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

    “understanding of plain and ordinary meaning as set forth in the litigation.” Pet. Reply 13 (citing Ex. 1022, 2 (“channel . . . [that] has a curved path”)). Thus, Petitioner concludes that the parties agree on construction of “curved channel.” Id. at 13–14.10 9 Although the parties refer to “curved” alone or to a “curved channel,” we understand the parties to be referring to a “channel of the fusion member [that] is curved,” as recited in claims 5 and 16. 10 At oral argument, the parties confirmed that there was no dispute as to the meaning of “curved channel.” See Tr. 15:12–14 (Petitioner stating that “the term “curved channel” appears consistent with the plain language of the claims and Specification. Thus, we adopt the parties’ agreed-upon construction and construe a channel that is “curved” to mean a channel following a curved trajectory.” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “We have considered Petitioner’s arguments and evidence, and Patent Owner’s counterarguments and find, on the complete trial record, that Petitioner demonstrates, by a preponderance of the evidence, that Blain discloses “a fusion member for positioning between two vertebral bodies, the fusion member having a first plurality of channels, each channel of the first plurality of channels having an opening on a same side of the fusion member,” as recited by limitation 1.1. At the outset, we find Patent Owner fails to establish that any of the alleged differences between Blain’s “apertures and the ’805 [p]atent’s internal channel geometry” relate to any particular recitation in argued limitation 1.1. Although we acknowledge that claims 5 and 16 each requires curved trajectories (see, e.g., claim 5 reciting “each channel of the fusion member is curved”), limitation 1.1 does not recite such a feature. As Petitioner correctly notes, “[n]othing in the claim requires a special ‘internal channel geometry,’ ‘shaped block,[’] ‘curved tubular channels,’ non ‘straight-through’ apertures, or ‘flexible’ anchors.” Pet. Reply 14 (footnote omitted). See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (rejecting arguments “not based on limitations appearing in the claims”). Therefore, after reviewing the arguments and evidence, we determine that Petitioner has shown by a preponderance of the evidence that Blain discloses the subject matter of limitation 1.1.” slip op. at 19

  Patent outcomesUS 9,730,805 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,730,805
• Kubota North America Corporation v. Vermeer Manufacturing CompanyAll claims unpatentable
  PTAB · Jun 30, 2026 · IPR2025-00168 · APJ Meredith C Petravick · IPR · Final written decision

  The Board held claims 31–49, 70–79, 86, and 87 unpatentable under §103 over KR996 and JP705, with Bares added for claims 70–79.

  RulingsFinal written decision

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

    “Pet. Init. CC Br. 3 (stating that “by including the term ‘generally’ in a statement, the feature (i.e., single weldment) is expressly identified as merely included in some, but not all embodiments”); PO Init. CC Br. 3 (“This language is merely exemplary, using reference numerals to refer to the embodiment’s features and qualifying ‘single weldment’ as referring ‘generally’ to specific embodiments.”). The Iowa District Court reached the same conclusion. See Ex. 1020 at 4 (holding that “‘mainframe’ will be given its plain and ordinary meaning and does not require a single weldment” (emphasis added)), cited at Pet. Init. CC Br. 2; see also 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning a term of the claim in a civil action, or a proceeding before the International Trade Commission, that is timely made of record in the inter partes review proceeding will be considered.”). Turning to the prosecution history, neither Petitioner nor Patent Owner has highlighted any specific statements that impact the scope of the term “mainframe.” And from our independent review, we do not discern any such statements. For these reasons, the intrinsic evidence as a whole supports construing “mainframe” as a primary supporting structure.” slip op. at 33

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which” slip op. at 20

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner

    “probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness.” slip op. at 55

  Patent outcomesUS 9,321,386 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,321,386
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Jun 9, 2026 · IPR2025-00289 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–15 are unpatentable: claims 1–15 under Grounds 2 and 3, and claim 10 under Ground 4; Ground 1 did not establish unpatentability.

  RulingsFinal written decision

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

    “We have construed the “filament” term in multiple related proceedings and agreed with Patent Owner that the claimed filament requires flexibility. See Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. Specifically, we determined that the evidence supports Patent Owner’s position that “a POSA would have understood the plain and ordinary meaning of the claimed ‘filament’ as a flexible length of material (e.g., one or more string(s), wire(s), tape(s)).” See, e.g., Ex. 1050, 23. We maintain that construction in this Decision for the reasons given by Patent Owner (see PO Resp. 24–32; PO Sur-reply 6–8), we disagree with Petitioner’s argument to the contrary (Pet. Reply 27–31), and we incorporate our analysis concerning the meaning of the filament term from the related proceedings identified above, which applies equally here.13 Ex. 1050 (Final Written Decision in 156 IPR); IPR2024-01157, Paper 35 (Final Written Decision) at 15–24. The parties agreed at the oral hearing that there is no additional argument or evidence 13 Although the ’005 patent is not directly related to the patents at issue in the 1157 and 156 IPRs, the ’519 Application that the ’005 patent purports to incorporate for providing all relevant disclosures about the filament term is a parent application to the challenged patents in the 1157 and 156 IPRs (see supra n.3). SightSound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1316 (Fed. Cir. 2015) (“Where multiple patents derive from the same parent application and share many common terms, we must interpret the claims consistently across all asserted patents.”) (internal quotation marks omitted). We also construed the filament term consistently in other ongoing proceedings on related patents. See, e.g., Ex. 1045 (Institution Decision in the 728 IPR), 12–18; Ex. 1046 (Institution Decision in the 989 IPR), 13–21. already addressed in those related matters. Tr. 6:13–23, 23:19–26.” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 17 (citing Ex. 1003 ¶ 35). Although Patent Owner states that it “disagrees” with Petitioner’s POSA definition, Patent Owner nevertheless applies that definition in this case. PO Resp. 32–33; see Tr. 22:23–23:5 (Patent Owner is “not disputing” Petitioner’s definition, asserting the definition “doesn’t make any difference in this case”).” slip op. at 13

  • Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed

    “We credit Dr. Zalesky’s interpretation of Schaffer on whether the POSA would have understood Schaffer as describing rigid actuating members. Dr. Zalesky testifies, for example, that a POSA would have understood from Schaffer’s disclosures about the actuating members being “machined” from metal or plastic, that such actuating members would be rigid. Ex. 2026 ¶ 101 (explaining “machining is a manufacturing process in which the desired part . . . is created using the controlled removal of bulk material” to produce a “rigid material”); Ex. 1005 ¶ 82 (“The actuating member 55 and the actuating button 261 is machined from aluminum” and “[i]n another example, the actuating member 55 and the actuating button 261 are machined from plastic”); Ex. 2026 ¶¶ 102–103 (testifying the disclosed valve assembly technique in Schaffer (Ex. 1005 ¶ 83) also indicates that “rigid” actuating members are used). Mr. Thornton opines (without citation to any persuasive supporting disclosure) that a POSA “would have understood that Schaffer’s U-shaped actuating members would have preferably been formed from a thin, flexible material.” Ex. 1003 ¶ 113. But, at deposition, Mr. Thornton conceded that machined plastics and aluminum, like disclosed in Schaffer, are rigid. Ex. 2005, 168:2–6 (“Q. And you said that plastic that would be machined would be rigid, correct? A. I think that’s a fair statement.”). Although Mr. Thornton opines that Schaffer’s actuating members would “preferably”” slip op. at 29

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

    “For the reasons above, Petitioner has not established that the claimed “filament” is disclosed in the combination of Garrison and Schaffer and, thus, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Garrison and Schaffer. Petitioner’s challenge to independent claim 10 (and the claims that depend from claim 1 and claim 10) fails for similar reasons. Each of the challenged claims requires a “filament” and, given our construction of that term and our findings above that Schaffer does not teach or suggest the claimed filament, Petitioner has not proved by a preponderance of the” slip op. at 31

  Patent outcomesUS 11,554,005 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,554,005
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Apr 7, 2026 · IPR2025-00156 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–9 are unpatentable as obvious over Schaffer combined with Hartley or Eller, with or without Garrison; anticipation by Schaffer and obviousness over Schaffer alone were not shown.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The parties propose essentially the same formal educational background for the POSA, but we agree with Patent Owner that Petitioner’s proposed POSA definition lacks some specificity concerning the POSA’s work experience. That definition, if interpreted generically, could mean that a person qualifies as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience with any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2008 ¶ 76. 10 Although unspecified in this proceeding, in the related 1157 IPR, Patent Owner stated that the field of the invention is “hemostasis valves for use during intravascular procedures.” IPR2024-01157, Paper 13 at 22. engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:24–60 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. Furthermore, as pointed out by Petitioner and consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing relevant medical devices, including hemostasis valves. Pet. Reply 28; see, e.g., Ex. 1019 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing” hemostasis valves or aspiration catheters is not necessary, but “general experience with vascular devices and procedures” is required); Ex. 2006 (Thornton Tr.), 180:13–19. As Dr. Zalesky testified, the POSA’s experience related to such devices “could be as simple as bench testing and looking at clinical data.” Ex. 1019, 74:5–75:1; see also id. at 82:3–6 (testifying a POSA need not “have specific experience with different methodologies of hemostasis”). Lastly, a POSA would have had an understanding of such devices’ design requirements as determined by the needs of the physician, patient, and procedure, which understanding may be informed by work experience and/or study. Ex. 2006, 24:5–21.” slip op. at 13

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

    “1. “aspiration catheter” Claim 1’s preamble recites “[a]n aspiration catheter.” Ex. 1001, 22:10. Petitioner contends that, as a general rule, a preamble does not limit the scope of a claim, and that the term “aspiration” here merely describes a non-limiting “intended use” of an otherwise structurally-complete invention defined by the body of the claim. Pet. 18–19. Patent Owner responds that 11 In the related 1157 IPR, Patent Owner moved to exclude Mr. Thornton’s testimony, which motion we denied. IPR2024-01157, Paper 35 at 70–72. Patent Owner filed no motion to exclude here. Owner’s arguments here.” PO Resp. 30. We need not further construe “aspiration catheter” as no dispute turns on that term’s meaning or whether it is limiting. Realtime Data, 912 F.3d at 1375 (explaining that claims need only be construed to the extent necessary to resolve matters in dispute).” slip op. at 15

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

    “That does not, however, resolve the dispute about “flexibility.” On that issue, after considering the full record developed through trial, we agree with Patent Owner that a “filament” as claimed is flexible. The claims support Patent Owner’s interpretation. Patent Owner cites the claim language, including the recitation that “the first filament [is] formed into a loop around the collapsible tubular sidewall defining a valve lumen” and that “a diameter of the valve lumen decreases in response to reducing a diameter of the loop.” As Patent Owner argues, and as we recognized at the institution stage, the claimed filament “must be flexible to constrict the valve lumen.” PO Resp. 23; Inst. Dec. 15–16; Ex. 2008 ¶ 68 (testifying that a POSA would understand this property of flexibility is essential to achieving the claimed loop formation and function). The Specification supports this understanding. Consider the “loop” embodiments as illustrated in Figures 6 or 7. Ex. 1001, Figs. 6–7. If the filament forming each depicted loop was somehow rigid, applying a force that seeks to pull the respective ends of the filament in opposing directions would not decrease the size of the loop—the loop would stay the same size and the filament would not circumferentially constrict and seal the elongate member’s lumen as described in the patent. Ex. 1001, 13:18–29.” slip op. at 18

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

    “Petitioner’s argument is unavailing. A steel beam or a plastic broom handle are longer than they are wide and yet conventionally rigid. And, specific to the subject matter here, as Mr. Thornton admits, machining the valve’s actuating members from plastic or metal, which Schaffer actually describes, would produce rigid members. Ex. 2005, 168:2–6; see also Ex. 2006, 152:8–10 (testifying a flexible aluminum wire would not be made from machining aluminum). Moreover, considering Schaffer’s cited drawings— Figure 32, in particular—does not show the actuating members changing shape or dynamically conforming to the outer surface of the seal module that those members are compressing, which, had that been shown, might indicate flexibility. Maybe the absence of any dynamic conformance of the surface of the actuating members is an unintended limitation or artifact of the drawing. Or maybe not, and what is shown is a rigid structure consistent with Schaffer’s other disclosures as already explained. We decline to find anticipation where Schaffer does not, with sufficient clarity and detail, describe a valve with a “filament” as claimed.21 Ultimately, on whether Schaffer describes rigid or flexible U-shaped actuating members, Dr. Zalesky’s interpretation of the reference is more plausible and we find greater evidentiary support for Patent Owner’s position on this issue. Notwithstanding Mr. Thornton’s testimony in his rebuttal declaration that a POSA reading Schaffer would have understood 21 Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017) (“Anticipation requires that a single reference describe the claimed invention with sufficient precision and detail to establish that the subject matter existed in the prior art.”) (emphasis added and internal quotation marks omitted). testimony on cross-examination was equivocal—he admitted “[i]t’s not clear” whether Schaffer’s U-shaped actuating members are flexible or rigid. Ex. 2006, 115:16–23 (testifying “[t]he material properties of the U-shaped actuating members are not clearly defined in the Shafer [sic] application”). Dr. Zalesky, in contrast, has consistently testified that a POSA would have understood that Schaffer describes rigid actuating members. See, e.g., Ex. 2008 ¶¶ 66–74 (citing, inter alia, Schaffer’s illustrations of the valve in operation, and the disclosed manufacturing and assembly methods as indicating that “the actuating members 55 are rigid rather than flexible”).” slip op. at 40

  Patent outcomesUS 11,697,012 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,697,012
• Imperative Care, Inc. v. Inari Medical, Inc.All claims unpatentable
  PTAB · Jan 16, 2026 · IPR2024-01157 · APJ Timothy G Majors · IPR · Final written decision

  Claims 1–9 are unpatentable: the Board found them obvious over Schaffer with Hartley or Eller, though Schaffer alone did not anticipate and Hartley with Eller did not show claims 1–3, 5, 6, and 9.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “background for the POSA, but we agree with Patent Owner that Petitioner’s proposed POSA definition lacks some specificity concerning the POSA’s work experience. That definition, if interpreted generically, could mean that a person qualifies as a POSA if they had, for example, a B.S. in mechanical engineering and only two years of experience designing any type of product in any field. That is too broad. We find that a POSA would have had the agreed-upon educational credentials—an undergraduate degree in mechanical engineering or a related engineering discipline. Ex. 1003 ¶ 35; Ex. 2008 ¶ 68. We also find that a POSA would have had 2–4 years of design or engineering experience related to products in the field of the invention, which involves endovascular devices and the surgical procedures that use such devices. Ex. 1001, 1:21–57 (background of the invention). Such devices include, but are not necessarily limited to, hemostasis valves and catheters for minimally-invasive vascular surgeries. Id. And, consistent with the testimony of the parties’ experts, the POSA need not have had firsthand experience designing hemostasis valves. See, e.g., Ex. 1015 (Zalesky Tr.), 72:11–73:7 (testifying direct experience “designing”” slip op. at 13

  • Expert testimonyPetitioner expert creditedOther

    “Schaffer’s valve to include a single flexible string or wire that replaces the two U-shaped actuating members would have been seen by the POSA as potentially advantageous—giving further reason for the POSA to have made that change. Pet. 35–36. We credit Mr. Thornton’s testimony that a POSA would have understood that Schaffer’s U-shaped actuating members may into the lumen. Ex. 1003 ¶ 81. On the other hand, a POSA would have recognized that a single flexible string or wire that is looped completely around the exterior of the seal module/lumen would provide more uniform constriction and compression around the outer diameter of some commonlyused tools and including tools with diverse shapes and sizes. Ex. 1003 ¶¶ 80–88, 93–100. We observed this same reason for modifying the art at institution and, after considering the full trial record, our view has not changed. Inst. Dec. 37 (preliminarily finding that a POSA would have considered Hartley’s string or Eller’s wire “as providing expected benefits insofar as such a filament may more precisely and uniformly constrict a lumen against inserted tools of different sizes and shapes”). Patent Owner’s expert, Dr. Zalesky, does not disagree that a flexible string or wire would have carried this advantage. Ex. 2008 ¶ 75 (testifying a “filament changes shape dynamically, allowing for better adaptability to the contours of the valve lumen as it is constricted”);21 Ex. 1015 (Zalesky Tr.), 86:19–87:4 (testifying that POSAs in 2017 would have recognized that the “cinching” effect provided by a filament would have been more effective for large-bore catheters based on “simple mechanical engineering and physics”). And, at the oral hearing, Patent Owner agreed that using Hartley’s string in Schaffer would help eliminate potential fluid gaps; but Patent Owner qualified its answer that such a benefit would allegedly only have arisen if “the highly-compliant” seal member material in Schaffer was removed,” slip op. at 53

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

    “that issue, after considering the full record developed through trial, we agree with Patent Owner that a “filament” as claimed is flexible. On balance, the evidence supports Patent Owner’s interpretation. Patent Owner cites the claim language, including the recitation that “the filament circumferentially constricts the lumen to create a seal,” which Dr. Zalesky opines a POSA would have understood as implying a flexible structure. PO Resp. 25–26; Ex. 2008 ¶¶ 71–76 (testifying, inter alia, that “[t]o ‘circumferentially constrict,’ the filament must be flexible and extend circumferentially about the lumen” such that “the filament will adapt to the shape of the lumen as the lumen is constricted and thus ‘circumferentially constrict’ the lumen as recited in Claim 1”).12 The Specification also describes the filament as being selectively “tightened” and “loosened” about the elongate member. Ex. 1001, 9:37–40, 9:55–59 (teaching “the filament 150 is tightened” when the actuator is released and “the filament 150 is loosened” when the actuator is pressed to open the valve)). Dr. Zalesky opines that a POSA would have understood the patent’s description of” slip op. at 18

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

    “challenge fails on this record whether the clearer prosecution drawings in Exhibit 1008 are considered in the analysis of anticipation by Schaffer, or not. Whether those prosecution drawings are considered “extrinsic evidence” to Schaffer (as argued by Patent Owner) or publicly-available “intrinsic evidence” with respect to Schaffer (as Petitioner argues) does not change our Decision on Ground 1. Opp. 10–11; Mot. Reply, 3–5. Patent Owner’s motion is, therefore, moot as to Ground 1.” slip op. at 72

  Patent outcomesUS 11,697,011 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,697,011
• MPL Brands NV, Inc. v. Buzzballz, LLCAll claims unpatentable
  PTAB · Dec 16, 2025 · IPR2024-01098 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–6 are unpatentable as anticipated by or obvious over Kick and as obvious over Ackermann and Kaminski, with or without Hutchinson.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(sometimes abbreviated herein as “POSITA”) would have had “(i) an associate’s or bachelor’s degree in mechanical, industrial or manufacturing engineering and (ii) at least two to three years of practical experience with designing or manufacturing mechanical products, such as food or beverage packaging. A POSITA could substitute additional education for industry experience and vice versa.” Pet. 15 (citing Ex. 1002 (Delson Decl.) ¶ 14).” slip op. at 12

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

    “Petitioner asserts that no claim term requires an express construction. See Pet. 15. We agree and find it unnecessary to construe any claim term to resolve the issues in this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 13

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

    “is no earlier than the February 25, 2020, filing date of the ’195 application. Petitioner demonstrates by a preponderance of the evidence that the volume limitations recited in independent claim 1 and dependent claims 2 and 6 lack adequate written description support in the ’934 application as filed. See Pet. 10–11. The specification, figures, and claims of the ’934 application as originally filed do not disclose any volume limitations. See Ex. 1004 (’934 prosecution history), 1–17. Instead, the volume limitations recited in the challenged claims find their first support in Figure 7, which was filed over one month after the ’934 application was filed. Compare id. at 1–17, with id. at 34–56. The addition of new matter during prosecution of a patent application is prohibited. See 35 U.S.C. § 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also 37 C.F.R. § 1.121(f); Manual of Patent Examining Procedure § 608.04. Therefore, we agree with Petitioner that “the new matter improperly added during the prosecution of the ’934 application cannot be considered part of the disclosure of the original, April 19, 2010 application and/or relied upon for claiming priority in subsequent applications.” Pet. 9.” slip op. at 20

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “obvious over Kick. Pet. 16–41. Kick published with the additional figures and disclosure the applicant submitted during prosecution of the ’934 application, and its detailed description and figures are the same as or similar to that of the ’904 patent. See id. at 16; compare Ex. 1007 (Kick), with Ex. 1001. Petitioner compares Kick to each limitation of the challenged claims. See Pet. 16–41. Based on the record before us, we find that Kick teaches or suggests each of the limitations of the challenged claims, for the reasons discussed in the Petition. See id. Accordingly, we determine that Petitioner has established by a preponderance of the evidence that Kick renders claims 1–6 of the ’904 patent unpatentable as anticipated and as obvious.” slip op. at 22

  Patent outcomesUS 11,738,904 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,738,904

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.