• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  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
• 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
• Tesla, Inc. v. Intellectual Ventures II LLCNo claims unpatentable
  PTAB · Aug 20, 2026 · IPR2025-00343 · APJ Scott A Daniels · IPR · Final written decision

  Claims 1–6 and 8–13 were not shown unpatentable because Petitioner did not establish a reason to combine Bucknell’s multiplexing techniques with Eckert.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “Patent Owner does not expressly dispute Petitioner’s definition of a person of ordinary skill in the art. See generally PO Resp. On this record, Petitioner’s proposed level of ordinary skill in the art is not disputed and is consistent with our review and understanding of the technology and descriptions in the ’138 patent and the asserted prior art references. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we rely on Petitioner’s proposed level of ordinary skill in the art.” slip op. at 12

  • Prior constructionPrior construction adoptedDecided for petitioner

    “1. a subset of radio bearers Petitioner points out that in IPR2022-01127 the Board “preliminarily determined that a subset of the plurality of radio bearers” means “less than all of the plurality of radio bearers.” Pet 12 (citing Ex. 1019, 18–19). Petitioner explains that, in the present proceeding, it has applied “the prior art in accordance with that construction; however, in view of the asserted grounds, no claim term requires express construction to find the Challenged Claims unpatentable.” Id. (citing Nidec 868 F.3d 1017). Patent Owner neither disputes the prior construction of “a subset of radio bearers,” nor offers additional constructions. See generally PO Resp. To the extent necessary, and in accordance with our prior determination, we construe “a subset of the plurality of radio bearers” to mean “less than all of the plurality of radio bearers.”” slip op. at 13

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

    “bears pointing out that the specification of the ’138 patent appears to explain what “a single allocation” means: If there are multiple QoS requirements within a single 3GPP PDP context, a single physical allocation of radio resources may be made to the UE. In this manner, a single PDP context implies a single CCTrCh. This single physical allocation of radio resources provided to a UE is shared amongst a number of services, in proportion to their respective QoS requirements, for example in proportion to the signalled weight values (Stier). Ex. 1001, 9:36–43 (emphasis added). Petitioner’s expert, Dr. Ding, explains that the “abbreviation CCTrCh was understood in the art to refer to a transport channel known as the Coded Composite Transport Channel.” Ex. 1003 ¶ 88. Dr. Ding testifies that Eckert teaches selecting data for uplink within a determined TTI and scheduling the uplink transmission on a transport channel, E-DCH, where scheduling of the E-DCH in a UE is controlled by a base station. Eckert, [0012] (“[A] new dedicated transport channel called Enhanced Dedicated Channel (E-DCH) has been introduced for this purpose. The fundamental characteristics of this new transport channel include . . . scheduling controlled by the base station, also called NodeB in UMTS…” Id. ¶ 90. In addition to Eckert disclosing a single transport channel E-DCH, Petitioner argues that Eckert discloses using a “finite quantum of physical resources” where “[t]he ’138 patent disclosure parallels Eckert, with both the E-DCH and CCTrCH transport channels relating to a UMTS uplink, employing spreading codes in code division multiple access (CDMA), and Reply 6 (citing Ex. 1005, ¶¶ 3, 8, 15, 23; Ex. 1071 ¶¶ 17–20; Ex. 1011 ¶¶ 6, 51). We do not need to specifically interpret this claim phrase because there is no actual dispute as to the meaning of the claim language itself and because, ultimately, the construction of this phrase plays no part in our Decision.” slip op. at 15

  • BurdenNot shown unpatentable

    “D. Ground 1: Claims 1–4 and 8–11 – Alleged Obviousness over Eckert in view of Bucknell and Lohr-1 On the complete record now before us, Petitioner has not established a preponderance of evidence that claims 1–4 and 8–11 would have been obvious over Eckert, Bucknell, and Lohr-1. For the reasons explained below we determine that Petitioner has failed to show why a person of ordinary skill in the art would have modified Eckert in view of Bucknell in the manner claimed. We focus our analysis below on claim 1, and more specifically on those limitations for which the combination of Eckert and Bucknell is asserted. 1. Limitations [1.0]–[1.2] and the combination of Eckert and Bucknell The combination of Eckert and Bucknell is essential to each of Petitioner’s asserted grounds in this proceeding. Pet. 13. At the outset, we address this issue because our determination that Petitioner has failed to show why a person of ordinary skill in the art would have combined Eckert and Bucknell is dispositive as to all grounds.” slip op. at 20

  Patent outcomesUS 10,292,138 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,292,138
• 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
• Globus Medical, Inc. v. Spinelogik, Inc.All claims unpatentable
  PTAB · Jul 10, 2026 · IPR2025-00226 · APJ Matthew S Meyers · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

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

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

  Patent outcomesUS 9,730,805 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,730,805
• 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.