• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’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 “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 POSA 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 POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about 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 POSA 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 13

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

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. 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 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

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

    “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed

    “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

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

    “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

  Patent outcomesUS 11,318,227 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
  Patents in suitUS 11,318,227
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00248 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–3 and 5–12 are unpatentable as anticipated by Huang2; claim 4 is unpatentable as obvious over Huang2 and Kumbar. Lee grounds failed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 18– 19 (citing Ex. 1003 § II.C5). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 5–6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

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

    “A patentee “may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996)); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“[A]ny special definition given to a word must be clearly defined in the specification.”), aff'd, 517 U.S. 370 (1996); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). “[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). Among the criteria to consider in whether the patentee acted as a lexicographer to define a claim term include (a) whether the patent specification included the statement in question under a section for marks, (c) whether the sentence uses the term “refer to,” which generally “conveys an intent for [that sentence] to be definitional,” and (d) whether there are other non-limiting terms (e.g., “for example,” or “include”) that contradict a definitional intent. Alnylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (alteration in original). At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:6–7. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at issue sets out “major peaks” in quotation marks, and then uses the term “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”).” slip op. at 8

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

    “As discussed above, we agree with Patent Owner that the sentence it cites from the Specification of the ’223 patent bears sufficient hallmarks of lexicography. However, the Specification nonetheless lacks any indication that so-called “minor peaks” are a necessary component of the claimed invention. “Although it is firmly settled that an applicant may act as a 9 Figure 8B does not contain “major peaks” despite clearly depicting two “peaks higher than the average of the [three or possibly four] peaks in the result” because none of the peaks is a reflection of fiber alignment. 10 After presenting claim construction arguments based on Ayres 2008, Patent Owner confusingly states: “Finally, whether Ayres-2008 supports [Patent Owner’s] construction is irrelevant.” PO Sur-Reply 5 (emphasis added). definition that is contrary to the ordinary meaning of a claim term unless it communicates a deliberate and clear preference for this alternative definition.” Kumar v. Ovonic Battery Co., 351 F.3d 1364, 1368 (Fed. Cir. 2003). There is no indication that the patentee sought to require “minor peaks” within the scope of the claimed invention. Nor are we persuaded that a person of ordinary skill in the art would readily understand the scope of the term “major peaks” to require non-major peaks. We interpret the Specification’s statement that “‘major peaks’ herein refer to peaks higher than the average of the peaks in the result” (Ex. 1001, 13:6–7) to be teaching a person of ordinary skill in the art how to identify or discern “major peaks,” which indicate a principal axis of alignment, from any non-major peaks, which would be caused by something else. We conclude that a person of ordinary skill in the art would consider “major peaks” as used in the ’223 patent as referring to peaks that reflect the sole axis or primary axis of fiber alignment. See, e.g., id. at code (54) (“ALIGNED FIBER AND METHOD OF USE THEREOF”), code (57) (“A scaffold comprising an aligned fiber.”), 1:6–7 (“The invention relates to an aligned fiber and method of use thereof.”), 1:11–12 (“The invention relates to a scaffold comprising an aligned fiber.”), 13:16–17 (“Alignment of the fibers in the scaffold may be measured by a fast Fourier transform (FFT) analysis.”). This would certainly include peaks materially higher than the average of the peaks in the result, but it would not be limited to situations involving peaks of different heights or require so-called minor peaks. Based on the totality of the evidence before us, we do not construe the claims to require non-major peaks.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Petitioner argues that, for the aligned sample, a major peak occurs at about 90° as identified by Petitioner’s annotation (red arrow). Pet. 30–31. As support, Petitioner directs us to Huang2’s explicit description of what the peak indicates, namely that “[t]he narrow peak of the normalized intensity values in anisotropic [aligned] matrices (Figure 1C) indicated that PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 31 (alterations in original) (quoting Ex. 1005, 1794). Patent Owner disputes that the illustrated peak is a major peak solely based on the lack of any lesser peaks. See PO Resp. 13 (“[T]he height of the sole peak is identical to—not higher than—the average height of the peaks in the result.”). As discussed above, however, we do not construe “major peaks” as requiring the existence of non-major peaks. We find that the illustrated peak in the Aniso plot of the FFT analysis results (Figure 1C) is a major peak within the meaning of the claim. The evidence in support of this finding is overwhelming. First, the term “Aniso” as used in Huang2 refers to fibers “with alignment.” Ex. 1005, 1792. Huang2 describes fabricating such matrices of aligned fibers with electrospinning, the same method used to impart alignment in the ’223 patent. Id. at 1791–92. Huang2 visually confirms that the fibers in fact are aligned via scanning electron microscopy. Id. at Fig. 1B. Further, Huang2 explicitly states that the peak illustrated in the Aniso plot of the FFT analysis results (Figure 1C) is caused by the fact that the “PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 1794. This is precisely what electrospinning may yield aligned fibers and images of aligned fibers will yield FFT results with major peaks. Ex. 1001, 2:18–19, 4:46–60, 13:16–26. Additionally, Huang2 itself considers the peak illustrated in the Aniso plot of the FFT analysis to be significant, stating: “In contrast [to the Aniso plot], the lack of a significant peak for the fibers collected on a stationary surface [(i.e., without electrospinning)] demonstrated no preferred fiber orientation in the isotropic matrices” (i.e., the Iso plot). Ex. 1005, 1794. Indeed, the asserted major peak in the Aniso plot shown in Huang2’s Figure 1C is higher than any other data point on the plot. For these reasons, we find the peak to be a major peak.15 Petitioner acknowledges that Figure 1C only reports its results” slip op. at 32

  Patent outcomesUS 10,137,223 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman
  Patents in suitUS 10,137,223
• Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01452 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8, 9, 13, and 19 are unpatentable; claims 2–5, 11, 12, 17, and 18 were not shown unpatentable over Slater or Slater and Weaver.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, 12, 17, and 18 of the ’716 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 188–196. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 191– 196. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 18

  Patent outcomesUS 9,763,716 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,763,716
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01450 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8–10, 14, and 17 are unpatentable; claims 2–5, 12, and 13 were not shown unpatentable, based on anticipation by Slater and obviousness over Slater and Weaver.

  RulingsRemand decision

  • RemandMixed

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 11 of U.S. Patent No. 8,529,608 B2 (“the ’608 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6, 8–10, 12–14, and 17 (the “Remanded Claims”) are similarly unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. at 14–15. We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written Decision on Remand pursuant to 35 U.S.C. §§ 144, 318 and 37 C.F.R. § 42.73 in an inter partes review involving Stryker Corporation and Wright Medical Technology, Inc. (collectively, “Petitioner”) and OsteoMed LLC (“Patent Owner”). For the reasons discussed below, after considering the entirety of the record in light of the Federal Circuit’s directives in Stryker, we find by a preponderance of the evidence that claims 6, 8–10, 14, and 17 are unpatentable. We also conclude that Petitioner has not demonstrated, by a preponderance of the evidence, that claims 2–5, 12, and 13 are unpatentable.” slip op. at 2

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Accordingly, for the same reasons expressed by our previous decision addressing claim 8 of the ’085 patent, and the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 12, and 13 of the ’608 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 37–39; Ex. 1002 ¶¶ 161–169. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 162– 163. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 37. Patent Owner raised no separate argument regarding the patentability of claims 6 and 8, instead relying solely on its argument that Slater does not anticipate independent claim 1, on which claims 6 and 8 depend. PO Resp. 46; Reply 4 (“Patent Owner does not challenge the combination of Slater and Weaver for claims 6 and 8.”). We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 6 and 8 and find that Petitioner establishes that the combination of Slater and Weaver discloses all of the limitations of claims 6 and 8, and that one of ordinary skill in the art would have been motivated to combine Slater and Weaver for the reasons provided by Petitioner. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 37–39.” slip op. at 19

  Patent outcomesUS 8,529,608 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,529,608
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01451 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8, 9, and 13 were held unpatentable; claims 2–5, 11, and 12 were not shown unpatentable because Slater lacks the claimed central axis.

  RulingsRemand decision

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

    “addressing the ’085 patent and by the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, and 12 of the ’776 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 169–74. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 169– 74. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 17

  • RemandOther

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46, “FWD”) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 10 of U.S. Patent 9,351,776 B2 (“the ’776 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6 and 8, 9 and 11–13 (the “Remanded Claims”) are unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. 14– 15.” slip op. at 2

  Patent outcomesUS 9,351,776 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,351,776
• Preomics GmbH / Biognosys AG. v. The Brigham And Women’S Hospital, Inc.Some claims unpatentable
  PTAB · Mar 23, 2026 · IPR2024-01473 · APJ Michael A Valek · IPR · Final written decision

  Claims 1, 4, 6, 17, 22, and 25 are unpatentable as anticipated by and obvious over Cai; claims 2, 3, 7, 23, and 24 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We disagree with Patent Owner and again find Petitioner’s description of the level of ordinary skill in the art sufficient for the reasons explained in the Decision on institution. See Dec. 8–10. As explained before, the formal training required by Petitioner’s description of a POSA includes understanding of both proteins and analytical techniques for studying them. See Dec. 9. Neither Patent Owner, nor its declarant, Dr. Cimas, clearly articulates a competing POSA description at trial, but both suggest more formal training, e.g., a graduate degree, is required. See Resp. 65–66; Ex. 2023 ¶ 8 (agreeing with our observation that the educational backgrounds of the inventors and authors of Cai, Zaccaria, and Hu “suggests that a graduate degree is more typical for a POSA”) (quoting Dec. 9, n. 5). Even if we were to accept that modification, it would not change our findings herein. Nor does it suggest that Dr. Vargas, who holds a Ph.D. in chemistry from Stanford University and has substantial experience with mass spectrometry and other analytical techniques, is unqualified to testify from the perspective of one of ordinary skill in the art. See Ex. 1004 (Vargas CV). Accordingly, our findings and conclusions would be the same, even assuming the perspective of a POSA possessing the higher level of formal training and specific proteomics experience that Patent Owner suggests is appropriate here.5” slip op. at 9

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

    “Ex. 1001, 20:33–39. As Petitioner points out, the first sentence in this passage does not define the term “biological sample,” but rather the term “sample.” Id. According to that sentence, the term “sample” refers to either “a biological sample or a complex biological sample obtained from a subject.” Id. (emphasis added). Patent Owner’s argument assumes, without explanation, that the phrase “obtained from a subject” modifies both instances of “biological sample” in the first sentence. Id. But it need not be read that way. Indeed, that sentence is more naturally read to define “sample” as one of two things––either a “biological sample” or a “complex biological sample” with only the latter being “obtained from a subject.” Id. In addition, the second sentence in the passage above supports Petitioner’s view that the term “biological sample” is not limited to a sample obtained directly from a subject. It provides a broad, non-exhaustive list of “[s]uitable biological samples” that specifically includes the types of biological samples, i.e., “cell lysates,” “systemic blood,” “plasma,” assayed in Petitioner’s cited references. Ex. 1001, 20:36–39. It also lists as an example “processed tissue samples,” which would include samples that have been modified (i.e., “processed”) from the form in which they were originally obtained. Id.; see also Ex. 1001, 20:52–57 (describing tissue processing). Given this broad description, we agree with Petitioner that there is no basis in the cited intrinsic evidence for reading in the “negative limitations” Patent Owner seeks to try to distinguish the particular biological samples assayed in Cai, Hu, and Zaccaria. See Reply 3–4.” slip op. at 12

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

    “We agree with Petitioner. Step 1(a) recites forming coronas around a plurality of particles of “different particle types.” Ex. 1001, 86:53–60. Step 1(b) recites separating a “subset of the plurality of the particles comprising the coronas.” Id. at 86:61–65. As Petitioner correctly observes, as a matter of ordinary English parlance, “there is no requirement whatsoever that the ‘subset’ have all of the same characteristics as the set from which it is separated.” Reply 10. By way of analogy, consider a jar containing a plurality of coins of different coin types, e.g., nickels and dimes. One can separate out a “subset” of that plurality of coins (plural) by removing any two coins from the jar—this is true even if the two coins are both nickels or both dimes. In the same way, nothing in the ordinary meaning of the claim language requires the subset in step 1(b) to include particles with coronas representative of each of the different particle types in step 1(a). Nor has Patent Owner identified any other evidence that supports its attempt to read such a requirement into the claims. See Resp. 16, 18 (citing expert testimony that is not inconsistent with the broader, ordinary meaning of the claim language and, even if it was, would not be a proper basis for limiting the same). For these reasons, we reject Patent Owner’s interpretation of “a subset of the plurality of particles comprising the coronas” in step 1(b) as limited to a subset of each type of particle comprising the coronas formed in step 1(a).” slip op. at 15

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

    “We credit Petitioner’s showing above and agree that Cai discloses a method comprising all of the steps in claim 1. Beginning with step 1(a), Cai discloses contacting two different particle types, i.e., MWCNT and CB, with HeLa cell lysate (i.e., a biological sample) to form protein coronas around those particles. Ex. 1003 ¶¶ 199–206; Ex. 1005, Abstr. (describing MWCNT and CB as distinct “forms of carbon nanoparticles” that bind “vastly different sets of proteins”). Cai’s results show the coronas formed around the MWCNT and CB particles comprise overlapping and distinct proteins as recited in step 1(a). Ex. 1003 ¶¶ 216–222; Ex. 1005, 587 (“a small number of CB-binding proteins also bind to MWCNTs”). A subset of the proteins from the coronas on these particles is then prepared by eluting the bound proteins and analyzing them with SDS-PAGE in a MWCNT and CB “pull-down,” which reads on step 1(b). Ex. 1005, 586 (Fig. 1A–B depicting scheme for “pull-down experiment” and describing other “pull-down experiments” used with SILAC media in Fig. 3), 588 (Fig. 3). Regarding step 1(c), Cai discloses assaying the proteins in those subsets using LC-MS/MS with SILAC encoding to characterize and quantify the relative abundance of the proteins that bind to each type of particle.11 Ex. 1003 ¶¶ 225–229; Ex. 1005, 586–587 (describing “systemic characterization of carbon nanoparticle-protein corona”), 588 (Fig. 3). Cai’s results show “the relative abundance of the MWCNT-binding proteins spread over 8 orders of magnitude” and that “some of the proteins with the highest binding efficiencies” are actually “low abundance proteins” in the lysate, meaning that that Cai’s method selectively enriches such proteins for detection. Ex. 1005, 587. We credit Dr. Vargas’s testimony that these results demonstrate that Cai’s method achieves the “dynamic range” recited in step 1(c). Ex. 1003 ¶¶ 225–229.” slip op. at 23

  Patent outcomesUS 11,435,360 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,435,360
• Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentable
  PTAB · Mar 10, 2026 · IPR2024-01209 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–27 are unpatentable as obvious over the asserted combinations, principally Racz, Fitz, and Lee; both parties’ motions to exclude are dismissed as moot.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “PO Resp. 30 (citing Ex. 2006 ¶ 58). Patent Owner’s proposal is too narrow in two respects. First, it mandates certain education and experience in RF neurotomy specifically. This is too narrow as the description of the scope of the invention set forth in the ’782 patent as described above is not limited to RF neurotomy. Second, it requires the POSA to be both a physician who performs thermal ablation (RF neurotomy specifically) and an engineer with training and experience “in the design and development of devices and methods” for performing the same. Id. This is too narrow because it excludes physicians and other advanced degree holders who research and design devices and methods for performing thermal ablation but do not actually operate on patients. We adopt the Petitioner’s definition of a POSA, quoted above, as it is reflective of the level of skill in the art when viewed in light of the disclosure of the ’782 patent. Supra (quoting Pet. 11).” slip op. at 16

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

    “With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 12 (citing Ex. 1031 ¶106 (Dr. Robert D. Tucker’s11 testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 12. We likewise find no need to do so now, as neither party has proposed a construction for any claim term and none of the parties’ arguments turns on a disputed meaning of any claim language.” slip op. at 11

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “(Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Clay, 966 F.2d at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 34. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 18.” slip op. at 24

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 148 of his declaration. Ex. 1031 ¶148. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶110–117 (Racz), ¶¶118–123 (Fitz), ¶¶124–131 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶132–147). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he has “been a Professor at the University of Iowa where [he] direct[s] an active research program in radiofrequency electrosurgical procedures and instrumentation.” Ex. 1031 ¶3. He has a Ph.D. in biophysics, and he is also a medical doctor (albeit he is not Board certified as pointed out by Patent Owner19). Id. ¶2. He also has additional training and experience that is relevant, but which is not necessary, but further establishes that he is well qualified to offer the opinions set forth in his declaration. Id. ¶¶2–11. Patent Owner argues that Dr. Tucker is not qualified to testify here because “he is not Board certified” and he is “not a pain-specialist physician and has never performed a neurotomy.” PO Resp. 30. Dr. Tucker explained, however, that he is not Board certified nor does he operate on 19 See PO Resp. 30 (citing Ex. 2020, 10:19–12:20). patients because his work focuses on the development of instrumentation, not the use of it, explaining on cross-examination:” slip op. at 39

  Patent outcomesUS 10,966,782 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,966,782
• Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentable
  PTAB · Mar 6, 2026 · IPR2024-01211 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 18–47 and 53–74 are unpatentable as obvious over the asserted combinations of Racz, Fitz, Lee, and the additional references in Grounds 2–8.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 17

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 162 of his declaration. Ex. 1033 ¶162. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶124–131 (Racz), ¶¶132–137 (Fitz), ¶¶138–145 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶146–161). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he” slip op. at 39

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “35. “Although § 103 does not, by its terms, define the ‘art to which [the] subject matter [sought to be patented] pertains,’ this determination is frequently couched in terms of whether the art is analogous or not, i.e., whether the art is ‘too remote to be treated as prior art.’” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 33. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 17.” slip op. at 25

  • BurdenDecided for petitioner

    “Patent Owner does not identify any legal requirement for petitions to illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 28

  Patent outcomesUS 10,736,688 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,736,688
• Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentable
  PTAB · Mar 6, 2026 · IPR2024-01210 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–17 and 48–52 are unpatentable as obvious over the asserted combinations of prior art, principally Racz, Fitz, and Lee.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 16

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59.” slip op. at 24

  • BurdenDecided for petitioner

    “illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 26

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “a POSA would have had an apparent reason to make Racz’s modified device. Pet. 22–27. We need not address these additional arguments and evidentiary citations, however, as Petitioner has demonstrated by a preponderance of the evidence that implementing deployable filaments on the distal tip of an RF ablation device was a known technique for expanding and controlling the ablation volume. Thus, so long as there would have been a reasonable expectation of success in making Racz’s modified device (addressed infra), the combination would have been obvious. See Intel Corp., 61 F.4th at 1380 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”); Medichem, 437 F.3d at 1165 (“[A]n obviousness determination requires not only the existence of a motivation to combine elements from different prior art references, but also that a skilled artisan would have perceived a reasonable expectation of success in making the invention via that combination.”).” slip op. at 31

  Patent outcomesUS 10,736,688 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,736,688

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.