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  • 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
  • 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
  • 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
  • PTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision

    Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 54

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

      “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 74

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

      “E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117

    Patent outcomesUS 12,091,692 unpatentable
    § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,091,692
  • PTAB · Oct 1, 2026 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Final written decision

    Claims 1–17 are unpatentable for lack of written description, lack of enablement, and indefiniteness; the Board did not find them unpatentable as obvious.

    RulingsFinal written decision
    • Skill levelOther

      “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 7

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

      “Specification of the ’345 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’345 patent. Indeed, the definitions of “PH20” and “modified PH20 polypeptide” both require hyaluronidase activity. See Ex. 1001, 44:20–21, 49:4–7 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 47:8–11 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 61:60–67. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’345 patent. Id. at 71:16-18, 74:11–13. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 47:3–11.” slip op. at 20

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “description (see Capon, 418 F.3d at 1357–58), Patent Owner is trying to extend that to include that which is at most obvious from the prior art, as opposed to what is actually described. That is, it may have been obvious to a POSA to align PH20 sequences with other known hyaluronidase enzymes and to use the crystal structure of a different hyaluronidase (Hyal-1) in SWISS-MODEL to generate a three-dimensional structure, but none of that is described in the common disclosure itself. “[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352. While a POSA might be able to embark on their own research program to try to find suitable multiply-modified PH20 polypeptides, the four corners of the written description do not demonstrate possession of such. See id. at 1356‒57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent[s] a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 66

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

      “instances of epistasis are “rare” and an inactive PH20 polypeptide “will stay inactive . . . absent intentional ‘rescue’ mutations.” See Sur-reply 12–14. But the claims encompass far more than combinations of just two substitutions, and even Dr. Petsko concedes there are “billions” of sequences within the recited sequence space that will not properly fold. See Ex. 2070 ¶ 347; see also Ex. 1133 ¶ 237 (“While some [residues critical to protein structure] can be predicted (e.g., highly conserved positions), many others cannot without experimentation.”). Accordingly, we find Petitioner’s position more persuasive than Patent Owner’s competing position and evidence.” slip op. at 108

    Patent outcomesUS 12,264,345 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 12,264,345
  • PTAB · Sep 29, 2026 · IPR2025-01122 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–16 are unpatentable as obvious over Liao or Liao and Cheng; Rolicki is not prior art, and the challenge over Offord ’341 and Offord ’797 fails.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A. Level of Ordinary Skill in the Art Baby Jogger does not dispute Evenflo’s definition of the level of ordinary skill in the art, which is that a person of ordinary skill in the art (hereinafter, “one skilled in the art”) would have had “a bachelor’s degree in a relevant field (e.g., mechanical engineering or industrial design) and at least two years of product design experience and/or industry experience with juvenile products” and that “[m]ore education can replace product design experience, and vice versa.” Pet 8 (citing Ex. 1001 ¶¶ 31–33); PO Resp. generally. We apply that definition here, as it accords with the problems addressed in the prior art and the specification of the ’682 patent.” slip op. at 7

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

      “At the outset, we note that the claim language requires only that “the first seat and the second seat” be arranged in an inline descending configuration, not that the seat’s mounting points or other physical connections be so arranged. Ex. 1010, 17:31–33. Baby Jogger improperly reads “seats” out of the claim and substitutes the seat’s “mounting points” on the frame. A proper reading of the claim language focuses on what happens when both seats are connected to the frame, not where they are so connected. In other words, “when connected to the frame” simply emphasizes that both seats must be connected to the frame to form the inline descending configuration, as opposed to the single stroller embodiment of Figure 1, where there cannot be an inline descending configuration because only one seat is connected to the frame and the other seat is removed, i.e., not connected to the frame. That reading is supported by the specification of the ’682 patent,” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “We find that testimony persuasive, for it shows what one skilled in the art would have recognized the 2008 Provisional as necessarily disclosing. The relevant inquiry is whether the disclosure of the prior application “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis in original; citation omitted). “While a prior application need not contain precisely the same words as are found in the asserted claims, . . . the prior application must indicate to a person skilled in the art that the inventor was ‘in possession’ of the invention as later claimed.” Id. In other words, “to satisfy the written description requirement, ‘the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.’”7 Id. (quoting Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (emphasis added). “This requires that the written description actually or inherently disclose the claim element.” Id. at 1306–07. Moreover, a drawing may supply written description for the arrangement it depicts even though the text describes that arrangement in different terms. See Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317, 1319–23 (Fed. Cir. 2002).” slip op. at 16

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

      “Instead, Evenflo’s argument rests on isolating the statement—“A similar sub-frame arrangement is disclosed in [Offord ’797]”—from the remainder of the passage in which that statement appears in order to arrive at a reason to incorporate the reversibility teaching of Offord ’797. However, when that statement is read in the context of the full passage in which it appears, nowhere does that passage suggest reversibility as the reason for referencing Offord ’797. More accurately, it suggests a different reason that relates to a curved lug 108 by which sub-frame 100 rests on the stroller’s main frame 4 to carry the weight of the stroller’s two occupants— When the interface components 100 are attached to the frame assembly 4 they form a sub-frame of the frame assembly 4, and when the child-carrying units are mounted thereon, one behind the other, they are in a compact echelon formation, one of the connector sockets 106 of each component 100 being at a higher level in relation to the ground than the other connector sockets 106. The higher connector socket 106 and further connecting leg 102 are both connected to the respective opposite ends of an upper mounting piece 107. In addition, on the inner side of the lower connector sockets 106 there is a downwardly curved lug 108 which serves to rest upon a part of the basket frame 44, such that the weight of two infants is fully supported by the frame assembly 4. A similar sub-frame arrangement is disclosed in [Offord ’797]. Ex. 1051, 9:23–36 (emphasis added). That passage shows that, rather than reversibility of the sub-frame, the reference to Offord ’797 is more aptly directing the reader to the arrangement and details of a similarly curved lug structure in the stroller sub-frame of Offord ’797. Indeed, Figures 5 and 6 of Offord ’797, reproduced below, disclose just such a curved lug in the context of “corner pieces 20” having “channel 21.” Ex. 1054, 4:10–23.” slip op. at 53

    Patent outcomesUS 11,731,682 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 11,731,682
  • PTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision

    Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’652 patent.” slip op. at 58

    • Skill levelOther

      “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner

      “exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68

    Patent outcomesUS 12,049,652 unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 12,049,652
  • PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

    Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

      “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

    • BurdenNot shown unpatentable

      “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

      “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

    Patent outcomesUS 11,959,109 unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,959,109
  • PTAB · Sep 2, 2026 · PGR2025-00021 · APJ Kimberly Mcgraw · PGR · Final written decision

    Claims 1, 3–7, and 12–20 are unpatentable: the Board found the asserted Kim, Kim–Yang, Lee, and Lee–Haller obviousness grounds proved, but not Lee–Park.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(e.g., an advanced degree may substitute for professional experience).” Pet. 21 (citing Ex. 1003 ¶¶ 36–37). Petitioner further contends that a “POSITA would also have been aware of and generally knowledgeable about 3D memory’s structure, its component parts, and how it operates.” Id. Patent Owner does not dispute Petitioner’s definition of a POSITA. PO Resp. 9. Based on our review of the complete record, we adopt Petitioner’s uncontested definition of a POSITA.” slip op. at 6

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

      “The plain language of claim element [1.A] recites “wherein the first material layer is disposed over a first portion of the second material layer;” and claim element [1.B] recites “a landing pad disposed over a second portion of the second material layer.” Thus, the plain language of the claim merely recites that the first material layer is disposed over a first potion of the second material layer and the landing pad is disposed over a second portion of the second material layer. The plain language does not define what constitutes the first or second portions of the second material layer or define the first or second portions of the material layer by what is disposed above the layers. We agree with Petitioner that the term “portion” has a straightforward plain and ordinary meaning: a “part” of a larger whole. Pet. 5 (citing Ex. 1077, 406 (defining “portion” as “a part of a whole”)). The ’838 patent itself repeatedly uses the term “portion” this way. Ex. 1001, 5:40–43 (discussing both “an upper portion” and “lower portion” of a “staircase”), 5:66–6:1 (referencing “a portion of a top surface of a layer”); see also 4:39– 40, 7:15–17, 8:20–33, 8:34–65, 11:60–64, 12:38–59. Thus, we understand that the first and second portions of the second material layer are portions of (i.e., a part of the whole) second material layer. Neither the claims nor the Specification define what can constitute a first portion or a second portion of a second material layer.” slip op. at 11

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “Dr. Giapis, argues Petitioner’s proposed modification of Lee requires a POSITA to (1) start with an oxide-based insulating layer 22 as shown in Figure 5B of Lee, (2) introduce an oxidant gas into the adjacent openings, and (3) oxidize a surface that is already oxide-based to form a curved surface. PO Resp. 78–81. Patent Owner provides credible evidence supporting its argument that a POSITA would not have been motivated to make these changes to Lee, as they are technically infeasible. Id. at 79 (citing Ex. 2019 ¶¶ 191–208). Dr. Giapis credibly explains that in Park’s process, an oxygen gas would be used to oxidize the silicon nitride or polysilicon, but “introducing such an oxidant into the openings of Lee’s structure above will not promote further oxidation to the existing oxide the relevant region . . . so nothing remains to be oxidized.” Ex. 2019 ¶¶ 192–193. We credit Dr. Giapis testimony that “[i]t is not possible to further oxidize a solid oxide material with oxygen gas as in Park. That is why Park’s thermal oxidation process is performed on silicon nitride or polysilicon, which are not oxides to begin with but they can be oxidized to form silicon dioxide.” Id. ¶ 193 (citing Ex. 2028 (Plummer) at 345–350). According to Dr. Giapis, a POSITA would have understood this and not expected the combination of Lee and Park to achieve any change in shape or any rounding in Lee’s Figure 5B. Ex. 2019 ¶ 193.” slip op. at 60

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

      “Patent Owner, however, with persuasive supporting testimony from Dr. Giapis, argues Petitioner’s proposed modification of Lee requires a POSITA to (1) start with an oxide-based insulating layer 22 as shown in Figure 5B of Lee, (2) introduce an oxidant gas into the adjacent openings, and (3) oxidize a surface that is already oxide-based to form a curved surface. PO Resp. 78–81. Patent Owner provides credible evidence supporting its argument that a POSITA would not have been motivated to make these changes to Lee, as they are technically infeasible. Id. at 79 (citing Ex. 2019 ¶¶ 191–208). Dr. Giapis credibly explains that in Park’s process, an oxygen gas would be used to oxidize the silicon nitride or polysilicon, but “introducing such an oxidant into the openings of Lee’s structure above will not promote further oxidation to the existing oxide the relevant region . . . so nothing remains to be oxidized.” Ex. 2019 ¶¶ 192–193. We credit Dr. Giapis testimony that “[i]t is not possible to further oxidize a solid oxide material with oxygen gas as in Park. That is why Park’s thermal oxidation process is performed on silicon nitride or polysilicon, which are not oxides to begin with but they can be oxidized to form silicon dioxide.” Id. ¶ 193 (citing Ex. 2028 (Plummer) at 345–350). According to Dr. Giapis, a POSITA would have understood this and not expected the combination of Lee and Park to achieve any change in shape or any rounding in Lee’s Figure 5B. Ex. 2019 ¶ 193.” slip op. at 60

    Patent outcomesUS 12,010,838 unpatentable
    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 12,010,838
  • PTAB · Aug 31, 2026 · IPR2023-00199 · APJ John A Hudalla · IPR · Final written decision

    Claims 1, 4, 7, and 8 are unpatentable as obvious over Na and Kim (claim 1) and Na and Hong (claims 4, 7, and 8); other grounds were not reached.

    RulingsFinal written decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Manufacturing Resources International, Inc. (“Patent Owner” or “MRI”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). Taking into account the arguments presented by Patent Owner in the preliminary record, we determined that the information presented in the Petition established that there was a reasonable likelihood that Petitioner would prevail with respect to its unpatentability challenges. Pursuant to 35 U.S.C. § 314, we instituted this proceeding on June 20, 2023, as to all challenged claims and all grounds of unpatentability presented in the Petition. Paper 9 (“Dec. on Inst.”).” slip op. at 2

    • ExcludeMotion to exclude, deniedDenied

      “Petitioner’s Motion to Strike Petitioner moves to strike Exhibits 2055, 2056, and 2058–2061 as being improper new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Exclude Mot. 1–5. We have not relied on any of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73

    • Skill levelSkill level board ownDecided for patent owner

      “record, we adopted the following definition of the level of ordinary skill in our Decision on Institution: [A] POSITA would have had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes, associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes, associated with electronic displays. Dec. on Inst. 11. The parties’ positions have not changed since the time of institution, and we discern no reason to change the definition. Thus, we apply the same definition. We are satisfied that this definition comports with the level of skill necessary to understand and implement the teachings of the ’595 patent and the asserted prior art. Notwithstanding, we note that our analysis would not change if we adopted either party’s proposed definition in toto.” slip op. at 12

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “appear nowhere outside of the claims in the ’595 patent. This fact alone tends to undermine Patent Owner’s suggestion that the “posterior surface” must be distinct from the “rear side.” In addition, Patent Owner’s cited portions of the Specification merely refer to the “posterior surface” as being the surface opposite that on which the LEDs are mounted to which heat from the LEDs is transferred. See Ex. 1001, 4:53–55, 4:57–60. They are inconclusive as to whether the “posterior surface” must be distinct from the “rear side.” Further, Mr. Gershowitz’s testimony in support of a “distinct” construction is based on his interpretation of the words “on the” in claim 4’s recited “posterior surface on the rear side of the PCB.” Ex. 2006 ¶ 128. Specifically, he testifies that “[i]f the posterior surface was the rear side of the PCB, the claim would have said so.” Id. He does not cite any support in the Specification of the ’595 patent for his interpretation. See id. Given that his testimony amounts to speculation divorced from the context of the Specification, Mr. Gershowitz’s testimony is entitled to little weight. We also have considered Mr. Smith-Gillespie’s testimony in support of Petitioner’s contention that an ordinarily skilled artisan “would have understood that the rear outermost surface of the PCB is the recited ‘posterior surface.’” Pet. Reply 20 (citing Pet. 83; Ex. 1002 ¶ 243). He cites a passage in the Specification of the ’595 patent that states: “The PCB may comprise a metal core PCB and the posterior surface of the PCB may be metallic so that air within the constricted convection channel may cool the metallic posterior surface (and subsequently the backlight assembly) more easily and efficiently.” Ex. 1002 ¶ 243 (emphasis omitted) (quoting Ex. 1001, 4:60–65). We accord Mr. Smith-Gillespie’s testimony more weight than Mr. Gershowitz’s testimony given that Mr. Smith-Gillespie’s testimony is rooted in disclosures about metal core PCBs in the ’595 patent. It also gives some credence to the notion that the “posterior surface” and the “rear side” could be one and the same. Based on the record before us, we do not agree with Patent Owner that” slip op. at 19

    Patent outcomesUS 8,854,595 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,854,595
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