• 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
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco LimitedAll claims unpatentable
  PTAB · Jul 30, 2026 · IPR2025-00560 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–29 are unpatentable under each asserted obviousness ground, including Chang and Fang, because Petitioner proved unpatentability by a preponderance of the evidence.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Additionally, we note that Patent Owner did not cross-examine Mr. Ryan Bauer, who provided a detailed, 169-page expert report providing, on behalf of Petitioner, his opinions about the issues in this proceeding. See Exhibit 1003. Mr. Bauer’s testimonial evidence in this proceeding remains unrebutted.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. Based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.” slip op. at 17

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

    “Petitioner asserts that the Examiner construed the term “self- contained, in-bra wearable device” to mean “complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 8 (citing Ex. 1005, 2290).14 According to Petitioner, “[Patent Owner] did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner contends that all other terms “should receive their plain and ordinary meaning.” Id. We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 17

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

    “(3) 1[a][1] a diaphragm configured to prevent milk from reaching an air pump by forming a seal around its outer edge; Petitioner relies on Fang for the disclosure of a diaphragm, as stated in this clause. Pet. 25–26. Petitioner asserts the proposed combination of elements suggest a breast pump device that would have used a diaphragm pump including first and second diaphragm housing components and an elastic diaphragm, “in accordance with Fang’s suggestions.” Id. at 25. As also asserted by Petitioner, Fang discloses that flexible diaphragm 7 (i.e., a membrane) is configured to prevent milk from reaching the pump. Id. at 26 (citing Ex. 1009 ¶ 19 (“The elastic diaphragm 7 is used to prevent milk from flowing into the air pump main unit 8.”). Mr. Bauer testifies: The flexible diaphragm [diaphragm 7 in Fang] forms a watertight and airtight seal around its outer edge. In doing so, the diaphragm prevents the passage of milk from reaching the air pump and facilitates generation of negative pressure during operation. Fang also explains that the elastic diaphragm 7 deforms away from the nipple tunnel when a vacuum is created on a pumping chamber, which then creates negative air pressure in the nipple tunnel when a vacuum is created on a pumping chamber.” slip op. at 28

  Patent outcomesUS 11,813,381 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,813,381
• Luxottica Of America, Inc. v. E-Vision Smart Optics, Inc.Adverse judgment
  PTAB · Jun 29, 2026 · IPR2025-01512 · APJ Arthur M Peslak · IPR · Adverse judgment

  The Board granted Patent Owner’s request for adverse judgment, cancelled claims 1–27, and terminated the proceeding.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “A party may request entry of adverse judgment against itself at any time during an inter partes review proceeding. See 37 C.F.R. § 42.73(b). Under these circumstances, entry of judgment adverse to the Patent Owner is appropriate as to claims 1–27 of the ’612 patent. Consequently, we grant Patent Owner's request for adverse judgment.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
  None
  Patents in suitUS 11,971,612
• 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
• Albany International Corp. v. Voith Patent GmbHInstituted
  PTAB · Dec 12, 2025 · IPR2025-01116 · APJ Christopher M Kaiser · IPR · Institution

  The Board instituted IPR of claims 1–15 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over Sudre, Lee, and Penven.

  RulingsInstitution decision

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

    “determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). Inter partes review may not be instituted unless “the information presented in the petition filed under [35 U.S.C.] section 311 and any response filed under [35 U.S.C.] section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(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.” 37 C.F.R. § 42.108(a) (2023). In other words, a decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute . . . on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019)1 (“CTPG”); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had at least (1) a Bachelor’s Degree (or higher) in material science, materials engineering, mechanical engineering, textile engineering, or a related field, and (2) a minimum of two years of working experience in textiles engineering, fibers and textiles manufacturing, or a related field.” Pet. 4 (citing Ex. 1003 ¶¶ 21–22). Petitioner also argues that “[a]dditional education could substitute for professional experience, and vice versa.” Id. On the present record, Patent Owner does not contest Petitioner’s proposed level of ordinary skill. Prelim. Resp. 25–26. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’566 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “Both parties argue that no claim terms require express construction at this stage of the proceeding. Pet. 3; Prelim. Resp. 26. On the present record, we agree. 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))). To the extent the parties’ arguments regarding unpatentability do address claim construction issues, we address these issues below.” slip op. at 10

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

    “articulated a reason why a person of ordinary skill in the art would have combined the teachings of Sudre, Lee, and Penven. Prelim. Resp. 60–63. In particular, Patent Owner argues that a person of ordinary skill in the art “would not have been motivated to look into Penven to modify the teachings of Lee because Lee and Penven disclose substantially different structures.” Id. at 60–61. This argument does not address Petitioner’s proposed reason to combine, which looks to Lee and Penven each to modify Sudre, not to Penven to modify Lee. See Pet. 79–81. In addition, “[c]ombining the teachings of references does not involve an ability to combine their specific structures.” In re Nievelt, 482 F.2d 965, 968 (CCPA 1973). In other words, “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . . Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425–26 (CCPA 1981). Petitioner provides “some articulated reasoning with some rational underpinning” to combine the teachings of Sudre with those of Lee and Penven. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In particular, Petitioner directs us to Sudre’s teaching of “a method for manufacturing PMC,” to Sudre’s lack of teaching of “specific parameters, such as warp thread size and spacing” to satisfy the “particular requirements” of its fabric. Pet. 79 (citing Ex. 1003 ¶¶ 248–250; Ex. 1004, 1:2–5, 6:14–17). As Petitioner points out, id. at 79–80, Lee and Penven provided yarn diameters and loop diameters that were conventional, and there is evidence of record that a person of ordinary skill in the art would have used these conventional diameters in constructing Sudre’s paper machine clothing. Ex. 1003 ¶¶ 258–261, 263–266; Ex. 1006, 3:64–66.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,261,566
• 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
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Nov 19, 2025 · PGR2025-00053 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–3 and 5–15, finding written-description and enablement challenges more likely than not to succeed, but not the obviousness challenge.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 5– 15 of the ’773 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’773 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Pet. 7. We have adjusted the claims challenged to only those that remain in effect following Patent Owner’s disclaimer. See Ex. 2003. 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”; Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 Biochemistry 6911–6920 (2007) (Ex. 1006). Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 16–17. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 8

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

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:8–22 (emphasis added). On this record, however, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:13–15. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:8–22. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’773 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional).” slip op. at 13

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

    “We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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 14

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,195,773
• Merck Sharp & Dohme LLC v. Halozyme, Inc.Instituted
  PTAB · Nov 19, 2025 · PGR2025-00050 · APJ Susan L C Mitchell · PGR · Institution

  The Board instituted PGR on claims 1–3 and 6–10 because Petitioner showed they were more likely than not to lack written-description support and enablement.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition and the cited evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of claims 1–3 and 6– 10 of the ’791 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’791 patent. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in analysis of protein structure, Petitioner is asserting that knowledge of proteins generally is sufficient to understand the types of problems encountered in the art and the prior art solutions to those problems, and the ordinary artisan need not have expertise specifically in hyaluronidases. See Pet. 20. Petitioner requires that the POSA would be able to apply key scientific concepts (e.g., biochemistry, recombinant biology, sequence analysis and protein modeling) to enzymes such as hyaluronidases. See id. At this stage of the proceeding and on the record before us now, we apply Petitioner’s proposed POSA level, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 9

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

    “refers to a PH20 polypeptide that contains at least one amino acid modification, such as at least one amino acid replacement as described herein, in its sequence of amino acids compared to a reference unmodified PH20 polypeptide. A modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity. Typically, a modified PH20 polypeptide contains 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 amino acid replacements. It is understood that a modified PH20 polypeptide also can include any one or more other modifications, in addition to at least one amino acid replacement as described herein. Id. at 47:4–18 (emphasis added). On this record, we find that the definition of “modified PH20 polypeptide” permits amino acid replacements in the PH20 polypeptide but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. Indeed, while some of the language in the above paragraph is permissive in nature, i.e.., describing the number of amino acid replacements a modified PH20 polypeptide “can have” or “[t]ypically . . . contains” or the other modifications the polypeptide “can include,” the phrase “so long as” is not. See Ex. 1001, 47:4–18. This distinction demonstrates that hyaluronidase activity is not an optional feature, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’791 patent. See Alynylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (explaining that the “contrast” between “non-limiting terms” and more definitive statements may indicate that the latter is definitional). Thus, the evidence of record shows the ’791 patent recognizes a broad understanding of a “modified PH20 polypeptide” as encompassing PH20 sequences from a variety of different mammalian species, with or without precursor or signal sequences, with or without post-translational modifications, and with up to 150 amino acid replacements. The express definition of “modified PH20 polypeptide” in the ’791 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:9–11. That is, the provided definition of “modified PH20 polypeptide” in the ’791 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’791 patent to encompass polypeptides with some hyaluronidase activity. We determine that we need not expressly construe any other claim terms for the purpose of deciding whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e 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 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted

    “As we noted, on the current record claim 1 is reasonably interpreted to encompass PH20 polypeptides with some hyaluronidase activity. But even if we were to find that immunization using PH20 polypeptide as a contraceptive antigen serves to satisfy the utility requirement for the instant claims, there is a similar concern as to whether modified PH20 polypeptides with significant differences from the native protein as encompassed by claim 1 would maintain the antigenic determinants necessary to function as contraceptives. See Ex. 1003 ¶ 122. That the modified PH20 polypeptides would be homogenous in function is contradicted both by evidence in the ’791 patent itself and by Dr. Hecht and Dr. Parker. The ’791 patent discloses synthesis of 6,753 single amino acid mutations in residues 1‒447 of SEQ ID NO: 3. See Ex. 1001, 199:15–200:34. The ’791 patent teaches that just under 10% of these mutations, i.e. over 600, “exhibit activity that is increased compared to wildtype.” Id. at 233:1–2. Appendix A of Dr. Hecht’s Declaration shows 3,380 of these mutations were inactive, or 57.13%. See Ex. 1003, Appendix A-1, 171. Thus, the ’791 patent evidences that even when only a single mutation is made in the PH20 polypeptide, that single mutation is more likely than not to alter the structure in such a way as to inactivate the hyaluronidase activity found in the native PH20 polypeptide. On this record, Dr. Hecht persuasively demonstrates that when the full scope of claim 1 is addressed, which includes not just single mutations in the PH20 polypeptide, but also multiple mutations, there is no expectation of structural homogeneity, stating that “[i]ntroducing multiple amino acid changes simultaneously . . . could prevent the folding of sequences into secondary structures and structural motifs and can destabilize those structures if they do form.” Ex. 1003 ¶ 59. Dr. Hecht notes that claim 1 allows “up to 21 changes, with each additional change (except at position 309) being to any of 19 alternative amino acids. But the up to 21 changes also can be at any of 433 different positions.” Id. ¶ 129. Dr. Park calculates that the number of distinct polypeptides that meet the claimed criteria “is extremely large by all accounts, ranging from 1049 to 1060 distinct polypeptides.” See Ex. 1004 ¶ 161. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 134.” slip op. at 20

  Claim construction§ 112 disclosure
  Patents in suitUS 12,077,791

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.