- Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Sep 1, 2026 · IPR2023-00220 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 1–5, 7–13, and 16 are unpatentable as obvious over the asserted prior art; a separate ground was not reached because those claims were shown obvious on other grounds.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes associated with electronic displays. Dec. 7–8. The parties’ positions have not changed from those we considered in the Institution Decision, and neither party argues that the outcome of this case would differ based on our adoption of a particular level of ordinary skill in the art. Thus, we apply the same definition in this Decision. Our determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s proposed definitions, however, and we note that our conclusion would be the same under either definition.” slip op. at 8
- ExcludeMotion to exclude, deniedDenied
“new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Paper 47, 1–5. We do not rely on either of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“that Patent Owner fails to adduce evidence showing how the claimed invention satisfied the alleged need for effective outdoor cooling. See Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988) (holding that a proponent of objective evidence of long-felt need must show that “the claimed invention satisfied a long felt need”). Patent Owner states in conclusory fashion that “[d]espite the demand for outdoor displays, no one (including Samsung, despite having attempted to develop outdoor displays at least by 2005) was successful until Mr. Dunn conceived of his invention.” PO Resp. 75. Patent Owner cites no evidence for this proposition, so Patent Owner’s assertions regarding Mr. Dunn’s invention satisfying the alleged need are based on unsupported attorney argument. Accordingly, “we conclude that the nexus between the claimed invention and the purported long-felt, unmet need is too attenuated to provide a persuasive rationale for nonobviousness.” In re Karpf, 758 F. App’x 960, 965 (Fed. Cir. 2019).” slip op. at 64
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“objective indicia of nonobviousness (i.e., secondary considerations) may lead to a conclusion that the challenged claims would not have been obvious. See, e.g., Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983) (instructing that evidence of secondary considerations, when present, must always be considered in determining obviousness). Objective evidence of nonobviousness may include evidence of commercial success, licensing, copying, praise by others, long felt but unresolved need, and” slip op. at 58
Patent outcomesUS 9,173,322 unpatentable§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,173,322 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00254 · APJ Jameson Lee · IPR · Final written decision
Claims 1–3, 5–9, 11–13, 15–18, and 20 are unpatentable as obvious over Karppanen and over Yare.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. This determination of the level of ordinary skill in the art is consistent with what is reflected by the content of the applied prior art references. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). Further, our obviousness conclusions would be no different even if Patent Owner’s articulation of the level of ordinary skill in the art is adopted. B.” slip op. at 15
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Accordingly, we do not discount Mr. Smith-Gillespie’s testimony” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“1. “closed loop” The term “closed loop” is recited in each independent claim. Petitioner asserts that in the Delaware action , the district court construed “closed loop” as “gas pathway within a display housing containing gas that is essentially isolated from external air.” Pet. 11 (citing Ex. 1026, 1). Petitioner asserts that the district court’s construction is the proper construction, in light of the specification and the prosecution history of the ’740 patent. Id. at 11–12. Petitioner explains: The ’740 patent refers to the gas/air, circulating through a closed loop as the circulating gas/air and also as the “isolated gas.” (Ex. 1001, 9:64–10:3, 10:7–9, 10:56–58, 11:30–12:6 (claims reciting circulating gas/air), 3:30–[39], 3:50–52 (specification referring to gas in the closed loop as “circulating gas” and “isolated gas”), FIG. 1.) Moreover, as noted above, the Applicant distinguished the claims from the Thielemans prior art based on the argument that the closed loop must be separate from and in addition to the open loop. (Ex. [1031], pp. 44-45, 160 (Responses filed on 01/07/2019 and 08/15/2019).) The Court’s “closed loop” construction should apply here, though Applicant notes that this claim construction does not affect the applicability of the prior art in this Petition because the art teaches the separate loops. Id. at 12. Petitioner’s characterization of the prosecution history with respect to the Thielemans reference is inaccurate. Our review of the cited portions of the prosecution history reveals that the Applicants did not argue to the Examiner that the closed loop and the open loop must be isolated from each other and cannot mix. Rather, the Applicants argued that Thielemans discloses having an open loop or a closed loop, not both an open loop and a closed loop. Ex. 1031, 44–45, 160. The Applicants also argued that Thielemans’s closed loop is not “about” and is not “encircling” the electronic image assembly. Id. at 160. The cited prosecution history does not support Petitioner’s assertion. Patent Owner explains that the ITC in the related investigation” slip op. at 16
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). “[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988.” slip op. at 34
Patent outcomesUS 10,506,740 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,506,740 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00221 · APJ Jameson Lee · IPR · Final written decision
Claims 1–15 are unpatentable as obvious over Karppanen and Larson; the Board found the evidence of obviousness outweighed the evidence of nonobviousness.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. This determination of the level of ordinary skill in the art is consistent with what is reflected by the content of the applied prior art references. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (the applied prior art may reflect an appropriate level of skill). Further, our obviousness conclusions would be no different even if Patent Owner’s articulation of the level of ordinary skill in the art is adopted. B.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“1. “closed loop” The term “closed loop” is recited in each independent claim.” slip op. at 16
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“for outdoor displays, no one (including Samsung, despite having begun attempting to develop outdoor displays at least by 2005) was successful until Mr. Dunn and Mr. Hubbard conceived of their invention.” PO Resp. 65. Patent Owner cites no evidence for this proposition. Thus, Patent Owner’s assertions regarding Mr. Dunn’s and Mr. Hubbard’s invention satisfying the alleged need are based on unsupported attorney argument. Accordingly, “we conclude that the nexus between the claimed invention and the purported long-felt, unmet need is too attenuated to provide a persuasive rationale for nonobviousness.” In re Karpf, 758 F. App’x 960, 965 (Fed. Cir. 2019).” slip op. at 62
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableObjective indicia outweighedUnpatentable
“and against obviousness, and weighed the evidence accordingly. The evidence of obviousness outweighs the evidence of nonobviousness. Petitioner has shown by a preponderance of the evidence that claim 1 would have been obvious over Karppanen and Larson.” slip op. at 74
Patent outcomesUS 11,013,142 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,013,142 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Manufacturing Resources International, Inc.All claims unpatentablePTAB · Aug 31, 2026 · IPR2023-00199 · APJ John A Hudalla · IPR · Final written decision
Claims 1, 4, 7, and 8 are unpatentable as obvious over Na and Kim (claim 1) and Na and Hong (claims 4, 7, and 8); other grounds were not reached.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Manufacturing Resources International, Inc. (“Patent Owner” or “MRI”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). Taking into account the arguments presented by Patent Owner in the preliminary record, we determined that the information presented in the Petition established that there was a reasonable likelihood that Petitioner would prevail with respect to its unpatentability challenges. Pursuant to 35 U.S.C. § 314, we instituted this proceeding on June 20, 2023, as to all challenged claims and all grounds of unpatentability presented in the Petition. Paper 9 (“Dec. on Inst.”).” slip op. at 2
- ExcludeMotion to exclude, deniedDenied
“Petitioner’s Motion to Strike Petitioner moves to strike Exhibits 2055, 2056, and 2058–2061 as being improper new evidence filed by Patent Owner with its Sur-reply in contravention of 37 C.F.R. § 42.23(b). Exclude Mot. 1–5. We have not relied on any of these exhibits in rendering this Decision. Accordingly, we dismiss as moot Petitioner’s Motion to Strike.” slip op. at 73
- Skill levelSkill level board ownDecided for patent owner
“record, we adopted the following definition of the level of ordinary skill in our Decision on Institution: [A] POSITA would have had a bachelor’s degree in a pertinent discipline, such as mechanical engineering, physics, applied physics, product design, or a related field, and would also have had 2–4 years of experience working with electronic displays, including the thermal management, product design issues, and failure modes, associated with such displays, or 5–7 years of experience in the field working with electronic displays and would have developed a similar understanding of thermal management, product design issues, and failure modes, associated with electronic displays. Dec. on Inst. 11. The parties’ positions have not changed since the time of institution, and we discern no reason to change the definition. Thus, we apply the same definition. We are satisfied that this definition comports with the level of skill necessary to understand and implement the teachings of the ’595 patent and the asserted prior art. Notwithstanding, we note that our analysis would not change if we adopted either party’s proposed definition in toto.” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“appear nowhere outside of the claims in the ’595 patent. This fact alone tends to undermine Patent Owner’s suggestion that the “posterior surface” must be distinct from the “rear side.” In addition, Patent Owner’s cited portions of the Specification merely refer to the “posterior surface” as being the surface opposite that on which the LEDs are mounted to which heat from the LEDs is transferred. See Ex. 1001, 4:53–55, 4:57–60. They are inconclusive as to whether the “posterior surface” must be distinct from the “rear side.” Further, Mr. Gershowitz’s testimony in support of a “distinct” construction is based on his interpretation of the words “on the” in claim 4’s recited “posterior surface on the rear side of the PCB.” Ex. 2006 ¶ 128. Specifically, he testifies that “[i]f the posterior surface was the rear side of the PCB, the claim would have said so.” Id. He does not cite any support in the Specification of the ’595 patent for his interpretation. See id. Given that his testimony amounts to speculation divorced from the context of the Specification, Mr. Gershowitz’s testimony is entitled to little weight. We also have considered Mr. Smith-Gillespie’s testimony in support of Petitioner’s contention that an ordinarily skilled artisan “would have understood that the rear outermost surface of the PCB is the recited ‘posterior surface.’” Pet. Reply 20 (citing Pet. 83; Ex. 1002 ¶ 243). He cites a passage in the Specification of the ’595 patent that states: “The PCB may comprise a metal core PCB and the posterior surface of the PCB may be metallic so that air within the constricted convection channel may cool the metallic posterior surface (and subsequently the backlight assembly) more easily and efficiently.” Ex. 1002 ¶ 243 (emphasis omitted) (quoting Ex. 1001, 4:60–65). We accord Mr. Smith-Gillespie’s testimony more weight than Mr. Gershowitz’s testimony given that Mr. Smith-Gillespie’s testimony is rooted in disclosures about metal core PCBs in the ’595 patent. It also gives some credence to the notion that the “posterior surface” and the “rear side” could be one and the same. Based on the record before us, we do not agree with Patent Owner that” slip op. at 19
Patent outcomesUS 8,854,595 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,854,595 - Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSRPatents in suitUS 11,318,227 - Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · MarkmanPatents in suitUS 10,137,223 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Maxell, Ltd.All claims unpatentablePTAB · Apr 27, 2026 · IPR2024-00906 · APJ Frederick C Laney · IPR · Final written decision
Claims 1, 4–6, and 8–27 are unpatentable as obvious; Judge Hudalla dissented as to claim 15.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“reachable through intuitive navigation from the homepage using the descriptive titles to the reference, is sufficient to demonstrate the BT-Spec was publicly accessible. See M&K Holdings, Inc. v. Samsung Electronics Co., 985 F.3d 1376, 1381 (Fed. Cir. 2021) (“The law regarding public accessibility is not as restrictive as M&K suggests—a website’s landing page is not required to have search functionality. Instead, given the prominence of JCT-VC, the dispositive question is whether interested users of the JCT-VC website could have located Park and Zhou through reasonable diligence.”). The Bluetooth SIG website itself functioned as a well-known, organized repository that a skilled artisan would naturally consult when researching Bluetooth technology. See id. at 1382 (“The Board found that the documents in question on the meeting pages of the JCT-VC website were effectively indexed by subject matter in light of the title-search functionality and the fact that Park and Zhou featured descriptive titles. That finding supports the Board’s conclusion that Park and Zhou were publicly accessible.”).” slip op. at 39
- ExcludeMotion to exclude, deniedDenied
“IV. PATENT OWNER’S MOTION TO EXCLUDE The party moving to exclude evidence bears the burden of proof to” slip op. at 139
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“12. Conclusion Based on the complete record, we find a preponderance of the” slip op. at 115
Patent outcomesUS 11,445,241 unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,445,241 - Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Maxell, Ltd.All claims unpatentablePTAB · Apr 27, 2026 · IPR2024-00907 · APJ Frederick C Laney · IPR · Final written decision
Claims 1, 4, 5, 8–12, and 14–25 are unpatentable as obvious; the majority finds the asserted combinations persuasive despite 3GPP-Spec not qualifying as prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“accessibility. A document hosted on the official standards body website, reachable through intuitive navigation from the homepage using the descriptive titles to the reference, is sufficient to demonstrate the BT-Spec was publicly accessible. See M&K Holdings, Inc. v. Samsung Electronics Co., 985 F.3d 1376, 1381 (Fed. Cir. 2021) (“The law regarding public accessibility is not as restrictive as M&K suggests—a website’s landing page is not required to have search functionality. Instead, given the prominence of JCT-VC, the dispositive question is whether interested users of the JCT-VC website could have located Park and Zhou through reasonable diligence.”). The Bluetooth SIG website itself functioned as a well-known, organized repository that a skilled artisan would naturally consult when researching Bluetooth technology. See id. at 1382 (“The Board found that the documents in question on the meeting pages of the JCT-VC website were effectively indexed by subject matter in light of the title-search functionality and the fact that Park and Zhou featured descriptive titles. That finding supports the Board’s conclusion that Park and Zhou were publicly accessible.”).” slip op. at 40
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable
“550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” (alteration in original)). This search for answers about whether the claimed subject matter would have been obvious to a skilled artisan at the time of the invention applies “an expansive and flexible approach.” Id. at 415. Whether a patent claiming the combination of prior art elements would have been obvious is determined by whether the improvement is more than the predictable use of prior art elements according to their established functions. Id. at 417. Reaching this conclusion, however, requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination. Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention. Id.” slip op. at 14
- ExcludeMotion to exclude, deniedDenied
“IV. PATENT OWNER’S MOTION TO EXCLUDE The party moving to exclude evidence bears the burden of proof to” slip op. at 158
Patent outcomesUS 10,129,590 unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,129,590 - Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,966,782
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.