• 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
• Runergy Alabama Inc. / Runergy USA Inc. et al. v. Trina Solar Co., Ltd.All claims unpatentable
  PTAB · Apr 15, 2026 · IPR2025-00186 · APJ Avelyn M Ross · IPR · Final written decision

  Claims 1–11 are unpatentable under § 103 over Chang and Jin; the Board found the combination disclosed the claimed isolation portion and supported the challenged claims.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art would have been someone with an advanced degree involving the disciplines of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field. Alternatively, that person would have had a bachelor’s degree in electrical engineering, applied physics, or materials science, and at least three years of experience designing, developing, or researching in the field. Pet. 4 (citing Ex. 1003 ¶ 49). Patent Owner does not address the level of ordinary skill in the art. See generally PO Resp; Sur-reply. In light of the complete trial record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’104 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’104 patent and the prior art.” slip op. at 9

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

    “C. Claim Construction We construe claim terms according to the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc); 37 C.F.R. § 42.100(b). Under Phillips, we give claim terms “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term 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.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 23. And, Patent Owner does not address claim construction. See generally PO Resp. As neither party proposes an express construction for our consideration and because we determine that an express claim construction is not necessary for us to render a decision in this matter, we do not construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 10

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “edge and offers little explanation of why the skilled artisan would apply Jin’s gap- T isolation region to both of Feldmann’s polysilicon and tunnel oxide layers. As noted above, Petitioner states that the skilled artisan would have included Jin’s gap-T isolation region in order to prevent shorting. Pet. 25. Petitioner’s reasoning is questionable—supported only by the conclusory testimony of Dr. Banerjee. Dr. Banerjee’s testimony offers no more evidentiary support than provided in the Petition. Compare Ex. 1003 ¶ 113, with Pet. 25. Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” Magnum Oil, 829 F.3d at 1380. We acknowledge Dr. Banerjee’s testimony that the combination of Jin’s gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 113 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide. Ex. 2001 ¶ 152 (referring to Ex. 2001 ¶¶ 149–151). Moreover, Dr. Peckerar testifies that “Dr. Banerjee also appears to be arguing that incorporation of impurities into the oxide will produce a MOSFET-like structure, with the contaminated oxide acting as a MOS gate leading to enhanced leakage,” but, for that to occur, “the source and drain areas would need to be of the same type.” Ex. 2001 ¶ 159. Here however, “the tunnel oxide layer is located between an n-type polysilicon layer and p-type frontside emitter layer” so “[n]o MOSFET-like structure can form because the source and drain are of different types.” Ex. 2001” slip op. at 18

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

    “base a conclusion of obviousness upon facts gleaned only through hindsight. “The invention must be viewed not after the blueprint has been drawn by the inventor, but as it would have been perceived in the state of the art that existed at the time the invention was made.” Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)). Therefore, “to establish a prima facie case of obviousness based on a combination of elements disclosed in the prior art, the [Petitioner] must articulate the basis on which it concludes that it would have been obvious to make the claimed invention.” Id. Impermissible hindsight is inferred when the specific understanding or principle within the knowledge of one of ordinary skill in the art that would motivate one (with no knowledge of the claimed invention) to make the proposed combination has not been explained. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998).” slip op. at 16

  Patent outcomesUS 9,722,104 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,722,104
• Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyNo claims unpatentable
  PTAB · Mar 23, 2026 · IPR2024-01451 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–19 were not shown unpatentable: Larson did not establish the claimed detection in a single sample volume, and the asserted obviousness combinations did not cure the deficiencies.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, “[f]or purposes of this IPR proceeding, PO does not contest Petitioner’s description of qualifications for a person of ordinary skill in the art (POSA) set forth [above].” PO Resp. 23. In view of the above, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition of a POSA for purposes of this Decision, except that we replace the phrase “at least a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection” with “around a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection.” Pet. 9 (emphasis added).13” slip op. at 14

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

    “We begin with “the context in which a term is used in the asserted claim,” which can be “highly instructive.” Phillips, 415 F.3d at 1314. In this case, claim 1 recites that the claimed assay is “capable of unambiguously detecting the presence or absence of each of said at least M analytes, in any combination of presence or absence, in a single sample volume, . . . wherein the analytes are amplified in the single sample 15 In this regard, we note that Petitioner’s claim construction position is not predicated on the collection of droplets being reconstituted into its original, pre-partition form prior to amplification; rather, the droplets remain compartmentalized from each other in the PCR thermal cycling tube. Tr. 65:21–66:9 (Petitioner’s counsel explaining that the droplets do not combine in the PCR thermal cycling tube but, rather, are “suspended in an immiscible fluid and analyzed en masse”). indicates that the first instance of single sample volume, i.e., the single sample volume in which the presence or absence of each M analytes are to be detected, is the antecedent basis for the second instance of “single sample volume,” i.e., the single sample volume in which the analytes are amplified. Thus, as the parties appear to agree, the single sample volume in which amplification takes places must be the same single sample volume in which the presence or absence of analytes are to be detected. We are not persuaded that, when accorded its plain and ordinary meaning, a single sample volume divided into a collection of droplets would be considered the “same” single sample volume prior to its partition.” slip op. at 17

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

    “With respect to the limitation, “wherein the analytes are amplified in the single sample volume,” Petitioner asserts that “Larson discloses PCR assays that amplify target polynucleotide in a single sample volume, specifically a portion of the reaction mixture that is subsequently partitioned into droplets.” Pet. 31 (emphasis added). There is no dispute that the amplification of the analytes in Larson occurs in the droplets. Larson ¶¶ 6–7 (explaining that “[d]igital PCR (dPCR) is an alternative quantitation method in which dilute sample are divided into many separate reactions” and that “[t]he template is amplified in the droplet for detection”) (emphasis added). Because the claims require that amplification of the analytes be in the same sample volume in which the at least M analytes, in any combination of presence or absence, is unambiguously detected, and because the pre-partition single sample volume is not the same single sample volume as the collection of droplets after partition under our claim construction set forth above, we find Petitioner has not shown, by a preponderance of evidence, that claims 1–10 and 13–19 are anticipated by Larson.17 Tr. 68:12–69:14 (Petitioner’s counsel” slip op. at 27

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

    “Although we agree with Petitioner that Larson contemplates scenarios in which droplets may contain more than one target molecule and does not require the exclusion of such multiple occupancy droplets in all embodiments, we are nevertheless not persuaded Petitioner has shown, based on a preponderance of evidence, that Larson renders obvious an assay capable of unambiguously detecting, in such multiple occupancy droplets, the presence or absence of each of at least M analytes, in any combination of presence or absence, when M is greater than F and F is at least 2.” slip op. at 32

  Patent outcomesUS 11,827,921 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,827,921
• Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.All claims unpatentable
  PTAB · Jan 22, 2026 · IPR2024-01093 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–16 are unpatentable: claims 1–13 and 15–16 on anticipation and obviousness grounds, and claim 14 on obviousness over Choulis.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A person of ordinary skill in the art (“POSITA”) at the time of the alleged invention of the ’164 patent would have had a Bachelor’s degree in chemistry, physics, or a comparable field of study, and at least three years of research or industrial experience with organic optoelectronic light-emitting devices. An individual with additional education could have less research or industrial experience and vice versa. Pet. 12. Patent Owner repeatedly refers to “a POSITA” without addressing the definition of that term or contesting Petitioner’s proposed definition. See Resp. 1, 2 n.1, 3, 8, 9, 15–21, 23, 26, 29, 32–33, 35, 37, 38, 40, 41, 44–49, 51–57, 61, 62 (bare references to “a POSITA”). Neither party indicates that the ultimate result on patentability would change depending on the definition selected. We adopt Petitioner’s proposed definition, which is not contested, because it is consistent with the disclosures of the asserted prior art. See Ex. 1004, (code 57); Ex. 1006, code (57); Ex. 1008, code (57); Ex. 1009, code (57) (abstracts of the references asserted in the patentability challenges).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundTerm construed board ownDecided for petitioner

    “because no information raised during the trial phase of this review changes the calculus: First and foremost, the plain terms of claim 1 include no language from which we reasonably can impose limits on the phrase “matrix material” as urged by Patent Owner. In addition, the specification includes no special definition of that phrase that supports importing Patent Owner’s proposed narrowing limitation into the claim. Furthermore, we are directed to no disclaimer of claim scope during patent prosecution that would support Patent Owner’s twice-rejected argument that the phrase “matrix material” in claim 1 excludes embedded dopants and dispersed agglomerations. And the extrinsic evidence advanced by Patent Owner during this review is ineffective to override the clear interpretation of “matrix material” that is established by the intrinsic evidence. Reply 1–7.10” slip op. at 8

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

    “We find that Petitioner establishes by a preponderance of the evidence that Choulis anticipates claim 13. We agree with Petitioner, in that regard, that Choulis explicitly teaches “using spin-coating as a method for depositing materials, which involves a simultaneous application process” as required by claim 13. Reply 16 (citing Pet. 40–41; Ex. 1044 ¶ 45).16 We 15 Petitioner raises Djobo as a background reference supporting that Choulis anticipates deposition of PVK by evaporation. Pet. 41. Patent Owner counters that Djobo, to the contrary, shows that Choulis does not teach deposition of PVK by evaporation. Resp. 48. In other words, both parties cite Djobo in connection with the ground based on anticipation by Choulis. Against that backdrop, we determine that Patent Owner waives any argument that Petitioner improperly cites Djobo as a background reference in support of the anticipation challenge, which is based on Choulis alone. Resp. 48 (nowhere asserting that the challenge is deficient on that basis). That waiver arises because no argument, in that regard, is raised in Patent Owner’s Response see Inst. Dec. 34 (“The Board shall deemed waived any issue not raised by Patent Owner in a timely response to the Petition . . . .”). 16 Patent Owner’s statement that “spin coating tends to cause phase separation” is not developed adequately on this record and, therefore, is further agree with Petitioner that Patent Owner “has not contested this point.” Resp. 48. “Therefore, there is no genuine dispute regarding the unpatentability of claim 13,” although Patent Owner raises “arguments concerning evaporation, which is a distinct process from spin-coating” relevant to the additional limitations of claim 14. Reply 16. We determine that Petitioner establishes by a preponderance of the evidence that Choulis anticipates claim 13. Patent Owner, however, has the better position on whether Choulis anticipates claim 14, which “includes the requirement of applying matrix materials via evaporation coating.” Reply 16. Petitioner seems to abandon that challenge in the Reply by raising arguments that appear, on this record, to bear exclusively on whether the subject matter of claim 14 would have been obvious over Choulis.17 Id. at 16–17. Those arguments are insufficient to counter Patent Owner’s reasons why Choulis does not anticipate the “evaporation coating” limitation of claim 14. Compare id., with Resp. 48. On this record, therefore, we determine that Petitioner does not establish by a preponderance of the evidence that Choulis anticipates claim 14. unpersuasive to persuade us “that Choulis does not have three matrix materials.” Sur-reply 15. That argument runs counter to Choulis’s explicit, intrinsic disclosures, which illustrate (Ex. 1004, Fig. 4) and describe (id. ¶ 30) an organic light emitting layer composed of three matrix materials. See Pet. 24–25 (citing Ex. 1004, Fig. 4, ¶ 30); see also Ex. 1003 ¶¶ 85–88 (persuasive declaration testimony of Dr. Holmes, cited at Pet. 24–25). 17 There is some confusion on this point, given that both parties sometimes collapse, into a single argument, whether Choulis anticipates or renders obvious claim 1. Compare Resp. 48, with Reply 16–17.” slip op. at 35

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

    “On this record, therefore, we determine that Choulis, at minimum, suggests that a person of ordinary skill in the art at the time of the invention would have recognized PMMA as a suitable alternative to PVK in Choulis’s Figure 4 embodiment, notwithstanding any differences raised by Patent Owner. Ex. 1004 ¶ 44. Patent Owner’s argument that no disclosure in Choulis suggests that an ordinarily skilled artisan “would have found it desirable to use PMMA in place of PVK in Choulis’s devices” misses the mark, where Choulis includes both PMMA and PVK in lists of materials suitable for use as host or matrix materials. Resp. 38; Ex. 1004 ¶ 44. “Our caselaw is clear. It’s not necessary to show that a combination is ‘the best option, only that it is a suitable option.’” Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021). Even if Choulis does not expressly disclose substituting PMMA for PVK in the Figure 4 embodiment, “an ordinarily skilled artisan would have found it obvious to make that substitution.” Reply 10 (citing Pet. 31 (citing Ex. 1003 ¶ 100; Ex. 1044 ¶ 23)). The suggestion for that substitution is set forth unambiguously in Choulis’s listing of both “PVK” and “PMMA” as materials suitable for use as a first “host” material in Choulis’s organic functional layer; that is, “the light emitting layer” that is “described above” in Figure 4. Ex. 1004 ¶ 44. ii. Alternative Reasoning for Replacing PVK with PMMA Patent Owner counterargues that using PPMA in place of PVK would have been understood to “upset the hole and electron balance,” as well as “affect hole-charge recombination,” and “degrade the performance of the resulting OLED system.” Resp. 37. Petitioner responds with evidence that “it would have been a routine task for” an ordinarily skilled artisan “to optimize the composition of each component within the light-emitting layer to achieve the desired charge balance.” Reply 11 (citing Ex. 1004 ¶ 24). Petitioner’s response brings to light a second reason why an ordinarily” slip op. at 40

  Patent outcomesUS 8,723,164 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,723,164
• Boe Technology Group Co., Ltd. v. 138 East LCD Advancements LimitedSome claims unpatentable
  PTAB · Dec 1, 2025 · IPR2024-00973 · APJ George R Hoskins · IPR · Final written decision

  Claims 1, 3–7, 9–13, and 15–18 are unpatentable as obvious over Reiner and over Reiner with Takahara; claims 2, 8, and 14 were not shown unpatentable.

  RulingsFinal written decision

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed

    “patentability based solely on arguments considered above in the context of claim 4. See, e.g., PO Resp. 42–43, 47–52. Therefore, Patent Owner has waived any other argument. See Inst. Dec. 44; Paper 10, 10. We adopt Petitioner’s arguments concerning these claims having been obvious over Reiner as our own in this Decision. See Pet. 40–44, 50–56, 57–70, 71; Ex. 1003 ¶¶ 134–142, 154–168, 174–221, 227. Accordingly, we conclude a preponderance of the evidence establishes these claims are unpatentable as having been obvious over Reiner.” slip op. at 83

  • Expert testimonyOther
  • Skill levelOther

  Patent outcomesUS 9,184,157 mixed
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,184,157
• Kohler Co. v. Delta Faucet Co.Some claims unpatentable
  PTAB · Oct 1, 2025 · IPR2024-00700 · APJ Jane E Inglese · IPR · Final written decision

  Claims 1, 2, and 9 are unpatentable as obvious; claims 3–8 and 10–24 were not shown unpatentable because the asserted references failed to establish limitations including the claimed light pipe features.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “For purposes of this Decision, we adopt Petitioner’s definition of a POSITA. Petitioner’s witness (Mr. Cook) qualifies as a POSITA under this definition, and, therefore, is qualified to opine from the perspective of a POSITA on technical matters included within the areas of expertise prescribed by the definition. As indicated above, Petitioner’s definition of a POSITA does not require education in the field of optics and professional experience designing or analyzing optical apparatus, unlike Patent Owner’s definition. We are aware, however, that Patent Owner’s witness (Dr. Klopp) has more extensive experience with optical systems and methods than Petitioner’s witness (Mr. Cook). Compare Ex 1003 ¶¶ 8–14, Ex. 2005, 39:21–59:17, with Ex. 2003 ¶¶ 3–20, Ex. 2004, 1–2, Ex. 1015, 10:22–13:25. Although Mr. Cook possesses excellent credentials in the field of mechanical engineering, his experience in the design and analysis of optical systems and methods is sparse and insubstantial compared to that of Dr. Klopp. Id. Due to this difference in experience levels, in instances where the witnesses express differing views on factual issues related to optical systems and methods, we will accord more weight to Dr. Klopp’s testimony than to Mr. Cook’s.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “through the light transmission portion and bottom output face 313 of light conductor 38, which teaches transmitting light in parallel with the longitudinal axis of the housing. Tseng does not disclose or teach that light is emitted through the side surface of annular protrusion 383 in a direction perpendicular to the longitudinal axis of the housing. Ex. 1004 ¶ 97. Petitioner’s assertions that this would be the case consist solely of conclusory statements, supported only by citations to Mr. Cook’s declaration. Mr. Cook, however, simply repeats Petitioner’s conclusory statements, without providing sound technical reasoning supported by objective evidence to explain and support his opinions. Ex. 2003 ¶¶ 101– 102, 105, 195–198, 202. We, therefore, accord little weight to Mr. Cook’s opinion on this particular matter because it “merely repeats, verbatim, the conclusory assertion for which it is offered to support,” and “does not cite to any additional supporting evidence or provide any technical reasoning [in] support.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). Furthermore, Mr. Cook’s opinion conflicts with that of Patent Owner’s witness, Dr. Klopp, who opines that a “POSITA would understand from Tseng’s third embodiment that light from the LED would bypass the annular protrusion 383 of outer cliff 381, while transmitting downwardly toward the output face 313.” Compare Ex. 1003 ¶¶ 174–175, 190–194, with Ex. 2003 ¶¶ 101–102, 105. As discussed above, Mr. Cook is qualified to opine from the perspective of a POSITA on technical matters included within the expertise of a person meeting Petitioner’s definition of a POSITA, which do not include optics and optical apparatus. We, therefore, credit Dr. Klopp’s opinion over that of Mr. Cook on this particular factual issue of how it is directly related to optical systems and methods about which Mr. Cook possesses limited relevant experience. See Ex. 1003 ¶¶ 6–15 (experience in communication systems and electronics); Ex. 2005, 55:16–58:19 (design experience with electronics that use indicator lights or fiber-optic communications; no professional experience with light pipes, diffusers, or plumbing fixtures). Dr. Klopp possesses substantial research and professional experience with optical methods, fiber optic light pipes, light guides, diffusers, prisms, and analysis of faucets, spray heads, and plumbing fixtures. See Ex. 2003 ¶¶ 6–10 Supra 8 (discussing weight accorded to conflicting witness testimony); see also Resp. 2–3 (arguing that “Petitioner’s expert, Mr. Cook, is a mechanical engineer with substantial professional experience in electronics for high-voltage power systems and communications, but he has limited experience with the claimed subject matter.”).” slip op. at 34

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

    “would be used to construe the claim[s] in a civil action [held] under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under that standard, claim terms generally are given their plain and ordinary meaning as would have been understood by the ordinarily skilled artisan at the time of the invention when read in the context of the specification and prosecution history. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). We construe terms in controversy only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that the claim terms do not require construction and should be afforded their plain and ordinary meaning. Pet. 13. Patent Owner contends that it applies the plain and ordinary meaning of the claim terms. Resp. 7. Taking into consideration the information presented, we determine that none of the claim terms requires express construction for purposes of resolving the dispute before us.” slip op. at 9

  • BurdenMixed

    “perpendicular to the longitudinal axis of Tseng’s housing (internal 33 and external 34 sleeves). “In an inter partes review, the burden of persuasion is on the petitioner to prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never shifts to the patentee.” In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (quoting Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)); see also Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1306 (Fed. Cir. 2017 (en banc (quoting Magnum Oil)).” slip op. at 40

  Patent outcomesUS 10,393,363 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,393,363
• Padagis US LLC v. Neurelis, Inc.Instituted
  PTAB · Sep 16, 2025 · IPR2025-00466 · APJ Timothy G Majors · IPR · Institution

  The Board instituted IPR on claims 1–27 because Petitioner showed a reasonable likelihood of prevailing on at least one claim, including claim 1 over Gwozdz and Meezan.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’786 patent’s challenged claims.1 We institute inter partes review on all challenged claims. SAS Inst. Inc. v. Iancu, 584 U.S. 357, 362–63 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “We find that Petitioner has made a threshold showing that the ’558 Provisional does not provide written description support for claim 1’s pharmaceutical solution consisting of each of the recited elements, including n-dodecyl beta-D-maltoside. It is true that “n-Dodecyl β-D-maltoside” can be found listed in the SIGMA Catalog. Ex. 1026, 316. But Dr. Donovan’s testimony helps put that listing in context. It is merely one among well over 100 ionic and non-ionic detergents listed in the cited six pages of the SIGMA Catalog. See 1026, 316–321; Ex. 1062 ¶ 50. When further considered in the context of paragraphs 150–152 of the ’558 Provisional, which generically suggest that “enhancer” compounds can be used in “some embodiments”—then introducing at least 15 classes of potential enhancers16 including “preferred” lysophospholipids and acyl carnitines—the listing of n-dodecyl beta-D-maltoside among at least 150 biological detergents in the SIGMA Catalog is even more remote. Moreover, although satisfaction of the written description requirement is not limited to what is exemplified in a priority application, none of the ’558 Provisional’s examples use any “enhancer,” much less any detergent, any alkyl glycoside, or n-dodecyl beta-D maltoside in particular. The 16 The ’558 Provisional suggests that whether “a given compound” will function as an “enhancer” in a formulation requires testing. Ex. 1008 ¶ 150 (indicating “an in vivo or good model test” may “determin[e] whether the uptake of the drug is enhanced to a clinically significant degree”). ethanol. See Ex. 1008 ¶¶ 172–174 (Examples 1 and 2). In short, we find no sufficient disclosure of “blaze marks” in the ’558 Provisional that point to the inventors’ possession of a pharmaceutical solution that includes n-dodecyl beta-D-maltoside as claimed. Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000) (analogizing an application’s generic disclosures to a forest of unmarked trees and explaining that, “to satisfy the written description requirement,” there must be “blaze marks directing the skilled artisan to that tree [within the forest that represents the claimed invention]” in the application).” slip op. at 28

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “and applying collateral estoppel to vacate a claim construction in an underlying IPR). In an IPR, “a party seeking to invoke collateral estoppel must show: ‘(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) [the party against whom collateral estoppel is being asserted] had a full and fair opportunity to litigate the issue in the first action.’” Google LLC v. Hammond Development Int’l, Inc., 54 F.4th 1377, 1381 (Fed. Cir. 2022) (quoting In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994)) (alteration in original).14 “It is [also] well established that patent claims need not be identical for collateral estoppel to apply.” Id. at 1381. Instead, “collateral estoppel requires the issues of patentability be identical.” Id. If “the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342–43 (Fed. Cir. 2013) (affirming application of collateral estoppel where claims adjudicated as obvious required a “polymeric” gel whereas similar, unadjudicated claims required a “block copolymer” gel). “Collateral estoppel also applies to common issues in actions involving different but related patents.” Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1310 (Fed. Cir. 2001), vacated on other grounds, 353 U.S. 1109 (2002).” slip op. at 22

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artReference not prior artMixed

    “We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz Provisional. Prelim. Resp. 37.20 Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the 19 Patent Owner argues this “penetration enhancers” disclosure in Gwozdz is not prior art regardless which of the disputed priority dates (March 28, 2008, or March 27, 2009) one accords to the challenged claims. Prelim. Resp. 33. 20 We also agree that collateral estoppel does not bar Patent Owner from challenging Gwozdz’s prior-art status in this case. Patent Owner’s apparent concession that Gwozdz was prior art during the 451 IPR does not equate to the issue being actually litigated. Prelim. Resp. 34–35; Ex. 1040, 14 (“Patent Owner does not contest that Gwozdz is entitled to this filing date” of the Gwozdz Provisional). Purdue, 767 F. App’x at 922 (determining “[t]he priority date for the Joshi reference . . . cannot be determined based on collateral estoppel” where patentee could have argued, but did not in fact argue, Joshi’s prior-art status in an earlier matter).” slip op. at 35

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,793,786
• Padagis US LLC v. Neurelis, Inc.Instituted
  PTAB · Sep 16, 2025 · IPR2025-00464 · APJ Annette R Reimers · IPR · Institution

  The Board instituted IPR on claims 1–22, finding a reasonable likelihood that claim 1 would have been obvious over Gwozdz and Meezan.

  RulingsInstitution decision

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

    “3. Conclusion For the reasons discussed above and based on the present record, we find that Petitioner has made an adequate threshold showing that the issues presented in this Petition are substantially the same as the issues the Board previously considered in IPR2019-00451 and that Gwozdz’s effective date is March 28, 2008. We therefore determine that Petitioner has shown that it is reasonably likely to prevail in establishing that at least claim 1 would have been obvious over Gwozdz and Meezan. IV. CONCLUSION Petitioner has shown a reasonable likelihood that it will prevail in establishing the unpatentability of at least one of the claims challenged in the Petition. We institute trial on all challenged claims under the grounds raised in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed.” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “[A POSA] would have been a pharmaceutical scientist, chemist, or biologist involved in the research and development of pharmaceutical formulations and/or delivery, and would have at least a Bachelor’s degree with at least 5 years of experience, or a Master’s, Ph.D. or Pharm.D. degree with several years of experience. In addition, a POSA would have had knowledge of benzodiazepine structure and function, and would further have knowledge and practical experience working with intranasal and transmembrane formulations, including knowledge of the physiology and anatomy of the nasal cavity, with relevant experience in developing intranasal formulations. Pet. 23; Ex. 1062 ¶ 20. Patent Owner “does not dispute” Petitioner’s POSA definition at this stage. Prelim. Resp. 16. We apply Petitioner’s proposed POSA definition for this Decision, which definition appears to be generally consistent with the cited prior art.” slip op. at 6

  • PTAB / AIA Trials › §315(e) estoppelMixed

    “As the Board’s decision in the 451 IPR explicitly found written description inadequate for the “alkyl glycoside” limitation in the ’558 Provisional, which is the same issue raised here for the ’546 patent, Petitioner has shown that issue was actually litigated and decided in the 451 IPR. Where the same issue is actually litigated and decided as part of a final adjudication in an earlier action, the test for invoking collateral estoppel in a later action is met. On this record and for the reasons above, we are persuaded that collateral estoppel bars Patent Owner from arguing the challenged claims are entitled to the priority date of the ’558 Provisional.” slip op. at 14

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

    “We agree that at least one portion of Gwozdz is not prior art. To establish that the cited disclosures in Gwozdz are prior art, Petitioner must show support for those disclosures in the Gwozdz Provisional. In re Riggs, 131 F.4th 1377, 1384 (Fed. Cir. 2025) (explaining that “the portion of the application relied on . . . as prior art must be supported by the provisional application”). Petitioner did not establish that Gwozdz’s disclosure of “penetration enhancers” finds support in the Gwozdz Provisional. Pet. 22. Conversely, Patent Owner shows that the phrase is absent in the Gwozdz 9 Patent Owner argues that as the ’546 Patent claims priority to the ’439 Application, the “penetration enhancers” disclosure in Gwozdz is not prior art because Gwozdz and the ’439 Application were filed on the same day (March 27, 2009). Prelim. Resp. 21–22. 10 Patent Owner argues that the passage in Gwozdz concerning “penetration enhancers” is relevant solely to “a pharmaceutical composition for injection,” not for intranasal administration as required by the ’546 Patent. Prelim. Resp. 22. First, as noted above, based on the record presented, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. Second, we disagree, however, that Gwozdz’s non-prior art mention of penetration enhancers is relevant solely to a pharmaceutical composition for injection as argued by Patent Owner. Gwozdz discloses that “[the] pharmaceutical compositions of the present invention” can be administered by a number of “nonlimiting” routes including intranasal administration. See Ex. 1009, 9:2–11. Provisional. Prelim. Resp. 20–21. Based on this record, we determine that Gwozdz’s mention of “penetration enhancers” is not prior art to the challenged claims. The phrase cannot, therefore, be used to establish a motivation to combine the asserted references.” slip op. at 18

  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,895,546

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.