• 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
• 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
• 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
• Tiktok Inc. v. Ntech Properties, Inc.Some claims unpatentable
  PTAB · Jan 23, 2026 · IPR2024-01342 · APJ Terrence W Mcmillin · IPR · Final written decision

  Claims 1–4 and 6–10 are unpatentable as obvious over each asserted ground; claim 5 was not shown unpatentable because the petitions failed to establish its additional feed and time-period limitations.

  RulingsFinal written decision

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

    “1b, 1c, and 1e of claim 1 and in claims 4 and 5 of the ’753 patent. Patent Owner contends that the plain and ordinary meaning of “feed” is “one or more associated media elements.” See, e.g., PO Resp. 4. However, as discussed below, this alleged plain and ordinary meaning of feed is not supported by the claim language, the specification of the ’753 patent, or dictionary definitions of feed as contended by Patent Owner. We reject this contention and the related contentions that the cited art may be distinguished from the claims of the ’753 patent based on the recited term “feed.” Patent Owner relies on the language of claim 1 to support its” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “The parties’ definitions are similar, although we observe that Patent Owner proposes that the person of ordinary skill would have a bachelor’s degree or an equivalent or professional experience, whereas Petitioner proposes that such a person would have both a degree and experience. Neither party presents any arguments relating or referring to the level of ordinary skill in the art. Determining the level of ordinary skill in the art involves various factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). The prior art of record also reflects the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We adopt Petitioner’s assessment of the level of skill in the art. Petitioner’s assessment is supported by the testimony of Dr. Almeroth and is consistent with the ’753 patent and the asserted prior art. However, our obviousness analysis would be the same under either party’s assessment. See Ex. 2014 ¶ 17 (Patent Owner’s declarant, Dr. Goodrich, stating that “I note that my definition of a POSITA is similar to that of Dr. Almeroth” and “My opinions in this declaration would not change were I to adopt the definition of a POSITA offered by Dr. Almeroth.”).” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “16 With regard to claim 5, the Petition cites paragraphs 97 and 98 of the Almeroth Declaration (Ex. 1002). See Pet. 28–29. We have considered the cited paragraphs in the Almeroth Declatation and found that they consist of nothing more than the inadequate and conclusory contentions in the Petition preceded by, in paragraph 97, “[i]n my opinion” and “it is my opinion” and, in paragraph 98, “[i]t is also my opinion.” Ex. 1003 ¶¶ 97, 98. As related to claim 5, we accord the Almeroth Declaration little or no weight. See 37 C.F.R. § 42.65 (a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). that might become out-of-date before a user accesses access [sic] them. Ex. 1003, 11:49–58 (emphasis added). The cited passage in Whitehead mentioning “near real-time” does not support finding that Whitehead teaches or suggests the elements recited in claim 5.” slip op. at 39

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

    “Petitioner contends, “[a] POSITA would have modified Whitehead’s mixing server 130 to incorporate Marcus ’904’s algorithm (running on Marcus ’904’s receiver) for receiving, selecting, ordering, and assembling different media streams (both for content and advertising).” Pet. 33. Petitioner supports this contention by articulating the following reasons for the asserted modification of Whitehead’s mixing server 130 to incorporate Marcus ’904’s algorithm: “makes it more likely the system will identify content best suited for a particular user,” “allows for more targeted advertising and/or an opportunity to maximize revenue,” “improves Whitehead’s ability to target content and advertising to a particular user,” “would unlock new revenue sources for Whitehead,” “Marcus ’904’s content selection and concatenation algorithm improves Whitehead’s efficiency,” “[b]oth Whitehead and Marcus ’904 generate custom media programming based on a user profile,” “incorporating Marcus ’904’s teachings would not require redesigning Whitehead’s architecture and instead merely supplements Whitehead’s disclosure,” and “Petitioner’s proposed modification can be implemented entirely in software and does not require any hardware modifications. Indeed, Whitehead acknowledges that such modifications are possible. EX1003 at 19:64-20:6, 22:26-40.” Id. at 33–35 (citing Ex. 1002 (Almeroth Decl.) ¶¶ 110–115) (emphasis omitted). Based on this undisputed showing, we find that one of ordinary skill would have had a motivation to combine the teachings of Whitehead and Marcus ’904 as asserted in the Petition with a reasonable expectation of success.” slip op. at 48

  Patent outcomesUS 8,886,753 mixed
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,886,753
• Reed Semiconductor Corp. v. Monolithic Power Systems, Inc.All claims unpatentable
  PTAB · Jan 22, 2026 · IPR2024-01158 · APJ Ken B Barrett · IPR · Final written decision

  Claims 1–5, 7–15, 17, and 18 are unpatentable: claims 1–4, 9–14, 17, and 18 as anticipated by Tateishi, and claims 5, 7, 8, and 15 as obvious over Tateishi.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We discern no material difference between the parties’ definitions. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art. We note, however, that were we to adopt Patent Owner’s assessment, the outcome of this Decision would be the same.” slip op. at 13

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

    “After considering the parties’ arguments and evidence, we determine that Patent Owner has not offered persuasive evidence that a person of ordinary skill in the art reading the claims in light of the Specification would understand the plain and ordinary meaning of “control signal” to be as narrow as Patent Owner proposes. We do not construe the claims such that the “control signal” must be the exclusively controlling factor of a component, as Patent Owner urges. Petitioner’s position, on the other hand, is consistent with the evidence of record. We construe “control signal” as having its plain and ordinary meaning, namely a signal configured to control a circuit component. D. The Asserted Anticipation of Claims 1–4, 9–14, 17, and 18 by Tateishi” slip op. at 24

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

    “We determine that Petitioner has demonstrated by a preponderance of the evidence that Tateishi discloses the “control signal” recited in limitations 1B2 and 1D of independent claim 1.” slip op. at 37

  • BurdenNot shown unpatentable

    “based on the Tateishi application publication (Ex. 1007), that the Tateishi Patent (Ex. 1005) also anticipates claims 1–4, 9–14, 17, and 18. See Pet. 23–24 (“The Tateishi Patent is also prior art under (pre-AIA) §102(e)”; identifying Ground 1 as anticipation “under §102 by Tateishi and/or the Tateishi Patent”). However, we are unable to locate in the Petition or Petitioner’s Reply a discussion of or citation to the Tateishi Patent other than under the Petitioner’s heading “Identification of Challenge and Relief Requested” on pages 23 and 24 of the Petition. Cf. id. at i–x (Table of Contents identifying a section of the Petition discussing the Tateishi (Application) anticipation ground but not a section discussing a Tateishi Patent anticipation ground). Although the issued patent may be substantively identical to the published application, Petitioner does not assert that, and we decline to compare the documents to determine whether that is the case. In light of Petitioner’s silence on the alternative ground, Petitioner has not demonstrated by a preponderance of the evidence that the Tateishi Patent anticipates 1–4, 9–14, 17, and 18.” slip op. at 47

  Patent outcomesUS 9,041,377 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,041,377
• Silencerco Weapons Research, LLC v. Huxwrx Safety Co. LLCNo claims unpatentable
  PTAB · Dec 17, 2025 · IPR2024-01214 · APJ Sean P O’Hanlon · IPR · Final written decision

  Claims 2, 3, 6, 9, 12–14, 18, and 20 were not shown unpatentable; the motion to amend was granted for substitute claims 23, 26, 27, 29, 30, 32, 33, 37–40, and 42, and denied for …

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The person of ordinary skill in the art is a hypothetical person presumed to have known the relevant art at the time of the invention. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In determining the level of ordinary skill in the art, we may consider certain factors, including: “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Best Med. Int’l, Inc. v. Elekta Inc., 46 F.4th 1346, 1353 (Fed. Cir. 2022) (quoting Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007)). “The patent’s purpose can also be informative.” Id.” slip op. at 9

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

    “The ’750 patent states that “the fluid pathway can be a radially serpentine fluid pathway which causes the fluids received in the off axis chamber to flow back and forth around a radius of the off axis chamber,” also using “radially serpentine fluid pathway” to refer to this rotation around the chamber radius “while also traversing a length of the off axis chamber.” Ex. 1001, 4:34–41 (emphasis added). This is the only description of “radially” serpentine flow in the ’750 patent. Notably, the ’750 patent does not use “radially” or “serpentine” to describe a fluid pathway “which causes the fluids to spiral around the central chamber within the off axis chamber along a length of the off axis chamber,” instead referring to such a fluid pathway as a “helical fluid pathway.” Id. at 4:41–44. See CAE Screenplates, Inc. v. Heinrich Fiedler GmbH & Co. KG, 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of any evidence to the contrary, we must presume that the use of . . . different terms in the claims connotes different meanings.”); Bd. of Regents of the Univ. of Tex. Sys. v. BENQ Am. Corp., 533 F.3d 1362, 1371 (Fed. Cir. 2008) (“Different claim terms are presumed to have different meanings.”). Inst. Dec. 11–12. We explained that the flow path depicted above, which is equivalent to that of Figure 14 of the ’750 patent, “flows circumferentially about the central chamber.” Id. at 14. We maintain this interpretation. Stated differently, the depicted flow is around a longitudinal axis of the chamber. See MTA PG 6 (describing the flow path depicted above as “a back and forth flow path around a longitudinal axis of the off axis chamber; that is, a circumferentially serpentine pathway”); see also Ex. 2003 ¶ 40 (Dr. Neitzel describing the flow path depicted above as “a back and forth flow path around a longitudinal axis of the off axis chamber”). The flow is not around a radius of the chamber, which Patent Owner recognizes is required for a flow path to be radially serpentine. See PO Resp. 10 (“Patent Owner agrees with the Board’s conclusion in the [Institution Decision] that ‘radially serpentine’ as recited in the claims of the ’750 patent means a back and forth flow around a radius of the off axis chamber.” (citation modified)); PO Sur-reply 2 (agreeing that “radially serpentine” requires “a back and forth flow around a radius of the off axis chamber”).” slip op. at 14

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

    “We agree with Patent Owner that neither Petitioner nor its witness, Mr. Nixon, has explained adequately how Thurler’s disclosure of its tube e being perforated for two thirds of its length “contemplates other lengths of perforations.” See Pet. 48; Ex. 1013 ¶ 212. Such conclusory assertions fail to apprise us of why an ordinarily skilled artisan would have been motivated to modify Thurler’s device in contradiction to Thurler’s explicit disclosure. We are also not persuaded by Petitioner’s proffered reasoning for modifying Thurler’s device. First, the modification is not a matter of design choice because the perforations allow the gases generated by firing the projectile to pass into the space between tubes e and g where they partially expand. See Ex. 1015, 1:84–91. Thus, modifying the number of perforations necessarily affects the flow of gases through the device. Next, neither Petitioner nor Mr. Nixon explains adequately how reducing the amount of perforation in tube e results in an increased fluid length. See Pet. 49; Ex. 1013 ¶ 213. Rather, although less fluid may enter into tube e with Petitioner’s modification, it appears that that fluid would travel the same distance along tubes e and h as in Thurler’s unmodified device. Finally, neither Petitioner nor Mr. Nixon explains adequately how limiting the amount of gases generated by firing the projectile from entering the expansion zones of tubes g and h provides any benefit. To the contrary, limiting the amount of gases in the manner suggested by Petitioner would reduce the suppression of such gases, resulting in a less effective device. Moreover, Thurler discloses that “there is still a space of a few millimeters between [tubes] e and g which is necessary” to prevent the application of “pressure on the projectile causing the same to deviate.” Ex. 1015, 1:106–2:3. Thus, Petitioner’s modification would not result in the passage of gases occurring only at the first three of Thurler’s tubular sleeves as asserted by Petitioner. Additionally, in the Institution Decision, we explained that Petitioner did not provide adequate reasoning to support the proposed modification of Thurler’s device regarding parent claim 1 to have concentric tubes around the central tube e. See Inst. Dec. 29–31. This shortcoming, which we maintain, carries through to dependent claim 6. Accordingly, for the foregoing reasons, Petitioner has not shown, by a” slip op. at 26

  • ScopeMotion to amend granted in partGranted in part

    “We agree with Petitioner that the amendment is broadening. Petitioner’s witness testified that he “wouldn’t call a BB gun a high energy device or a high energy weapon.” Paper 33, 18:4–6. Thus, per Petitioner’s witness, use of a BB gun would not be covered by claim 22, no matter what is discharged from the BB gun. However, if high energy material is discharged from that same BB gun, that use would be covered by proposed substitute claim 43 (assuming the other claim recitations were met). See id. at 21:10–12 (Dr. Neitzel agreeing that “if something produces a high energy material, it automatically is a high energy weapon”). Thus, by deleting “high energy device” and replacing that language with “weapon,” proposed substitute claim 43 impermissibly broadens the scope of claim 22. See Sisvel Int'l S.A. v. Sierra Wireless, Inc., 81 F.4th 1231, 1241 (Fed. Cir. 2023) (“But if a substitute claim ‘is broader in any respect it is considered to be broader than the original claim even though it may be narrower in other respects.’” (citation modified) (quoting Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 1999))); see also Lectrosonics, Paper 15 at 6 (“A patent owner may not seek to broaden a challenged claim in any respect that enlarges the scope of the claims of the patent . . . . Likewise, a proposed substitute claim may not remove a feature of the claim in a manner that broadens the scope of the claims of the challenged patent.”).” slip op. at 45

  Patent outcomesUS 8,286,750 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,286,750
• MPL Brands NV, Inc. v. Buzzballz, LLCAll claims unpatentable
  PTAB · Dec 16, 2025 · IPR2024-01098 · APJ Cynthia M Hardman · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

    “Petitioner asserts that no claim term requires an express construction. See Pet. 15. We agree and find it unnecessary to construe any claim term to resolve the issues in this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 13

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

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

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

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

  Patent outcomesUS 11,738,904 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,738,904
• Straumann USA, LLC v. Smart Denture Conversions, LLCInstituted
  PTAB · Dec 10, 2025 · PGR2025-00054 · APJ Ryan H Flax · PGR · Institution

  The Board instituted PGR on claims 1–16 on all four grounds, finding at least one claim more likely than not unpatentable based on obviousness, indefiniteness, or lack of written description.

  RulingsInstitution decision

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

    “institute trial in a post-grant review. We institute a post-grant review only if the information presented in the petition filed under 35 U.S.C. § 321, if unrebutted, shows that it is more likely than not that at least one claim challenged in the petition is unpatentable. 35 U.S.C. § 324. On the existing record, we conclude that Petitioner demonstrates it is more likely than not that Petitioner would prevail in showing that at least one challenged claim of the ’781 patent is unpatentable under a presented ground. See generally Pet. Therefore, we grant institution of post-grant review. Our reasoning is discussed below.” slip op. at 2

  • PTAB / AIA Trials › Real party in interest / privityDecided for petitioner

    “STANDING Petitioner states that it certifies that: (1) the ’781 patent is available for post grant review because its earliest claimed effective filing date is October 9, 2018, and the patent issued less than nine months ago, on December 3, 2024; and (2) Petitioner is not barred or estopped from requesting a post grant review on the grounds in this petition. Pet. 5. This is sufficient. See 35 U.S.C. § 100(note)(A)–(B), § 321; 37 C.F.R. § 42.204(a). Patent Owner does not contest standing. See generally Prelim. Resp. B. REAL PARTIES-IN-INTEREST Petitioner states that “[t]he real parties-in-interest are Petitioner Straumann USA, LLC and its affiliates Institut Straumann AG and JJGC Indústria e Comércio de Materiais Dentários S.A.” Pet. 3. Patent Owner raises no objection and itself identifies “Smart Denture Conversions, LLC is the real party-in-interest.” Paper 4, 2; see generally Prelim. Resp. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At this point, we find little meaningful difference between the two proposed definitions. In fact, neither does Patent Owner’s witness, Mr. Leinsing, who states that his “opinions would not change under either definition.” Ex. 2011 ¶ 42. And, as set forth above, Patent Owner asserts that, for the sake of its present arguments, it matters not which of the two proposed definitions we use for this proceeding. Prelim. Resp. 21. Thus, at this stage, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, which, unlike Patent Owner’s, does not implicate reliance on the knowledge of people other than the individual ordinarily skilled artisan. Petitioner’s definition appears to comport with the level of skill in the art reflected in the prior art of record and the ’781 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). This issue may be further developed at trial by the parties, if desired. C.” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court thus, by default, we give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” 37 C.F.R. § 42.200(b); Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner indicates that None of the claim terms of claims 1–16 need to be construed to determine the patentability issues presented in this petition. The petition applies the ordinary meaning of the claim language as it would be understood by a POSA after reading the ’781 patent. Ex. 1002, ¶130. Petitioner will propose a construction if Patent Owner argues or the Board determines that one is required for any term. Pet. 31 (citing Ex. 1002). And, Patent Owner presents no express position on claim construction at this point. See generally Prelim. Resp. At this stage of the proceeding, we do not expressly construe any claim terms; however, this position is preliminary and we may change it based on the fully developed record at trial.8 D.” slip op. at 19

  Claim construction§ 103 obviousness§ 112 disclosurecites Graham
  Patents in suitUS 12,156,781

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.