- PTAB · Jan 14, 2026 · IPR2025-00632 · APJ Mitchell G Weatherly · IPR · Remand
On remand, the Board reinstituted review of all challenged claims on all grounds after finding Petitioner sufficiently explained its differing claim-construction positions.
RulingsRemand decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Id. The Director neither addressed the merits of Petitioner’s challenges nor found that our prior consideration of those merits was faulty. Accordingly, we understand that we need not reconsider our conclusion that Petitioner had demonstrated a reasonable likelihood of proving that claims 1, 2, 7–9, 11, 12, and 20–24 were unpatentable or that the merits of patentability set forth in the Petition warranted institution of inter partes review.” slip op. at 5
- BurdenDecided for petitioner
“The question before us, therefore, is whether the Petitioner’s proffered explanation that it has proposed a different claim interpretation before the Board because the District Court may decline to adopt the narrower claim interpretations it advocates there is sufficient. We find that Petitioner’s explanation is sufficient because it follows the Director’s exemplary logic. Whether a district court has already or might in the future decline to adopt constructions that a petitioner proposes in related district court litigation merely reflects the timing of when a dispute over claim interpretation will be resolved. The Director and Patent Owner both recognize that, to resolve the dispute over claim interpretation that exists here, a decision-maker must determine “a single claim construction that best captures the true meaning of the patent claim.” Remand 4; PO Remand Br. 3. Based on the record presented by the parties to date in this proceeding, no dispute exists that the disputed claim terms mean what Patent Owner says they mean in the Litigation. Accordingly, we find that, at this stage of the proceeding, it is undisputed that Patent Owner’s interpretations of the claim terms represent the “single claim construction that best captures the true meaning of the patent claim.”8 Under that claim interpretation, we” slip op. at 8
NonePatents in suitUS 11,835,421 - 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 · GrahamPatents in suitUS 12,195,773 - 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 disclosurePatents in suitUS 12,077,791 - PTAB · Nov 13, 2025 · PGR2025-00042 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 5, and 7–33, finding likely written-description and enablement failures; it found the obviousness showing insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XII. CONCLUSION Petitioner has, at this stage of the proceedings, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XIII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1, 2, 5, and 7–33 of the ’618 patent is hereby granted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 46
- Skill levelSkill level petitioner adoptedOther
“Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’618 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. 15–16. 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 petitioner constructionDecided for petitioner
“On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:2–4; see Ex. 2001 ¶¶ 48, 67 (stating a “patent’s definition controls”). Indeed, while some of the language in the definitional 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, 47:1–11. This distinction demonstrates that hyaluronidase activity is not an optional feature of a non-limiting example as Patent Owner posits, but a requirement of the “modified PH20 polypeptide” defined and claimed in the ’618 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). Moreover, Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.6 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Instituted
“Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. Ariad explains that for generic claims the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus. Id. at 1349. Ariad explains “that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. at 1350. Ariad also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. . . . But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Id. slip op. at 21
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,037,618 - PTAB · Nov 6, 2025 · PGR2025-00040 · APJ Kimberly Mcgraw · PGR · Institution
The Board instituted PGR on claims 1–9, 11–33, and 35–38 on all petition grounds, finding it more likely than not that Hassfjell-Hoff anticipates at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’437 patent is eligible for post-grant review and that it is more likely than not that at least one challenged claim of the ’437 patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of all challenged claims of the ’437 patent.” slip op. at 2
- Adverse judgmentAdverse judgmentOther
“Here, Patentee Sciencons AS filed a statutory disclaimer of claims 10 and 34 of the ’437 patent. Ex. 2001; Prelim. Resp. 43. Based on our review of Exhibit 2001 and the Office’s public records, we find that the disclaimer of claims 10 and 34 complies with the above-listed requirements of 37 C.F.R. § 1.321(a). Accordingly, we treat claims 10 and 34 as having never been part of the ’437 patent. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the original patent’ in [35 U.S.C.] § 253 to mean that the patent is treated as though the disclaimed claims never existed.”). Because post-grant review cannot be instituted based on disclaimed claims, claims 10 and 34 are outside the scope of this proceeding. 37 C.F.R. § 42.207(e) (“No post-grant review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution in view of a statutory disclaimer of all the challenged claims). Thus, we confine our analysis in this Decision to claims 1–9, 11–33, and 35– 38, the remaining challenged claims that have not been disclaimed.” slip op. at 6
- PTAB / AIA Trials › Real party in interest / privityGranted
“Sciencons AS also states that ARTBIO, Inc. is responsible for defending the ’437 patent in this proceeding and requests that ARTBIO, Inc. be included in the caption for this proceeding.2 Paper 4, 1. ARTBIO, Inc. has signed powers of attorney appointing the same practitioners that were appointed by Sciencons AS to transact all business associated with the instant post-grant review review of the ’437 patent. See Paper 3. To date, no objection has been raised to Patent Owner’s request. Given Sciencons AS’s representation that ARTBIO, Inc. is currently the exclusive licensee of the ’437 patent and is responsible for defending the ’437 patent, we grant Sciencons AS’s unopposed request that ARTBIO, Inc. be included in the caption. For convenience we refer to Sciencons AS and the purported exclusive licensee ARTBIO, Inc. collectively as “Patent Owner.” As stated supra, to the extent any party disputes ARTBIO, Inc.’s right to participate in this proceeding or to be included in the caption, the party shall request authorization to brief the issue within 10 business days of this Decision.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“nuclear chemistry, radiochemistry, or materials science, or a comparable field of study, plus approximately two to three years of professional experience with radioisotope generators, radiopharmaceutical chemistry, nuclear medicine, or other relevant industry experience” and that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Pet. 2–3 (citing Ex. 1002 ¶ 33; Ex. 1019 ¶ 27). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed definition nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposed definition of a POSITA.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 12,249,437 - PTAB · Oct 29, 2025 · IPR2025-00918 · APJ Avelyn M Ross · IPR · Institution
The Board instituted inter partes review of claims 1–11 on all asserted grounds and granted Canadian Solar’s motion for joinder in IPR2025-00007.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We instituted review of claims 1–11 of the ’104 patent in IPR2025-00007 after a review of all arguments and evidence presented by the parties, including Patent Owner’s arguments in its preliminary response. For the reasons discussed in the Institution Decision in IPR2025-00007, we determine that Petitioner demonstrates a reasonable likelihood of showing at least one claim of the ’104 patent is unpatentable. Thus, we find that the Petition warrants institution of inter partes review on all claims and grounds set forth in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Patent Owner did not file an opposition to Petitioner’s Motion for Joinder. Upon consideration of Petitioner’s arguments, we are persuaded that it is appropriate under these circumstances to join Petitioner to the proceeding in IPR2025-00007. Petitioner’s agreement to accept an “understudy” role and to not actively participate in IPR2025-00007 unless the current petitioner ceases to participate will limit any potential impact on the trial schedule and will avoid increasing the costs or complexity of the proceeding. Therefore, joinder of 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. Petitioner to IPR2025-00007 will further the goals of a just, speedy, and inexpensive resolution of Petitioner’s challenge. 37 C.F.R. § 42.1(b).” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In light of the record before us, and for purposes of this Decision, 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. We will make any final determination pertaining to the level of ordinary skill in the art, however, on the full trial record.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For purposes of this Decision, we need not expressly 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 11
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 9,722,104 - PTAB · Oct 29, 2025 · IPR2025-00917 · APJ Debra L Dennett · IPR · Institution
The Board instituted IPR on claims 1–17 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable, and granted Canadian Solar’s motion for joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We instituted review of claims 1–17 of the ’009 patent in IPR2025-00006 after a review of all arguments and evidence presented by the parties, including Patent Owner’s arguments in its preliminary response. For the reasons discussed in the Institution Decision in IPR2025-00006, we determine that Petitioner demonstrates a reasonable likelihood of showing at least one claim of the ’009 patent is unpatentable. Thus, we find that the Petition warrants institution of inter partes review on all claims and grounds set forth in the Petition.” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Patent Owner did not file an opposition to Petitioner’s Motion for Joinder. Upon consideration of Petitioner’s arguments, we are persuaded that it is appropriate under these circumstances to join Petitioner to the proceeding in IPR2025-00006. Petitioner’s agreement to accept an “understudy” role and to not 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. actively participate in IPR2025-00006 unless the current petitioner ceases to participate will limit any potential impact on the trial schedule and will avoid increasing the costs or complexity of the proceeding. Therefore, joinder of Petitioner to IPR2025-00006 will further the goals of a just, speedy, and inexpensive resolution of Petitioner’s challenge. 37 C.F.R. § 42.1(b).” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“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. 5 (citing Ex. 1003 ¶ 49). In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’009 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 ’009 patent and the prior art. We will make any final determination pertaining to the level of ordinary skill in the art, however, on the full trial record.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that “[n]o claim construction is necessary to resolve this Petition.” Pet. 25. For purposes of this Decision, we need not expressly 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 11
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 10,230,009 - PTAB · Oct 16, 2025 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 because the written-description and enablement challenges met the more-likely-than-not threshold; it found the indefiniteness and obviousness challenges insufficient.
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. See 35 U.S.C. § 324; 37 C.F.R. § 42.4(a). Considering the arguments and evidence presented, we institute a post grant review because Petitioner demonstrates “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). The following preliminary findings of fact and conclusions of law are made solely to determine whether to institute review. Any final decision will be based on the full trial record.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to [the] study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16–17 (citing Ex. 1003 ¶¶ 13, 35–36). At this stage of the proceeding and on the record before us, we apply Petitioner’s proposed POSA level, which is presently undisputed and 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 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownOther
“The definition of “modified PH20 polypeptide” in the ’345 patent permits up to 150 amino acid replacements but only “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 47:8–11. That is, the definition of “modified PH20 polypeptide” in the ’345 patent expressly requires some hyaluronidase activity. On the current record, we therefore adopt the definition for “modified PH20 polypeptide” as recited in the ’345 patent to encompass polypeptides with some hyaluronidase activity. The ’345 patent provides a specific definition of the term “hyaluronidase domain,” i.e., a “region of about 340 amino acids in length that corresponds to amino acid residues 38-374 of the precursor human PH20 sequence set forth in SEQ ID NO:6.”6 Ex. 1001, 68:19–24.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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))). Any final written decision entered in this case may include final claim constructions that differ from the preliminary understanding of the claims set forth above. Any final claim constructions will be based on the full trial record.” slip op. at 10
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham · NautilusPatents in suitUS 12,264,345 - PTAB · Oct 16, 2025 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, and 6–30 because Petitioner showed a reasonable likelihood of prevailing on written description and enablement; it did not show likely obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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, 2, and 6–30 of the ’758 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’758 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. 15–16. 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.” slip op. at 9
- 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 48:38–53 (emphasis added).” slip op. at 15
- 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)). Any final written decision entered in this case may include final claim constructions that differ from the preliminary understanding of the claims set forth above. Any final claim constructions will be based on the full trial record.” slip op. at 18
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - PTAB · Oct 16, 2025 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–15, and 17–30, finding written-description and enablement challenges likely to succeed; the obviousness challenge was not shown likely to succeed.
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, 2, 6–15, and 17–30 of the ’590 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing because Patent Owner’s proffered definition of a POSA is too restrictive. Petitioner’s proposal is sufficiently comprehensive to encompass the level of skill reflected in prior art relevant to the ’590 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. 15–16. 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.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“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 “21-42 changes, with each additional change (except at position 307) being to 1 of 19 other amino acids. But the up to 21-42 changes also can be at any of between 430 and 465 (or, in the case of the broadest claims, 474) different positions depending on which unmodified PH20 sequence is used.” Id. ¶ 120. Dr. Park calculates that “95% sequence identity [i.e., the higher percentage identity recited by the narrowest of the challenged claims] to PH201-465 means that the protein can have 23 total changes,” and that where one of those changes is one of nine choices at position 307 as required by claim 1, the number of possible PH20 polypeptides with twenty-two additional changes is “extremely large by all accounts, ranging from 1059 to 10112.” See Ex. 1004 ¶¶ 178–179. Dr. Hecht characterizes the number of possible mutations as “astronomical in size.” Ex. 1003 ¶ 125.” slip op. at 28
- 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 48:38–64 (emphasis added). Based on this express definition, the current record does not support the interpretation of Dr. Triggs-Raine that the “term ‘modified PH20 polypeptide,’ therefore, has a purely structural meaning in the context of the specification.” Ex. 2055 ¶ 68. Indeed, when reproducing the definition from this column of the ’590 patent, Dr. Triggs-Raine does not include any text after the first period, stating that “is not part of the express definition of ‘modified PH20 polypeptide’” and “merely describes an upper limit for the number of modifications possibly allowing a modified PH20 polypeptide to exhibit enzymatic activity.” Ex. 2055 ¶¶ 67, 77–78. On this record, however, we find that the entire text quoted above is part of the definition of “modified PH20 polypeptide” because it continues to detail specific elements required including a requirement that replacements in the PH20 polypeptide are permitted “so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Ex. 1001, 48:44–46; see Ex. 2001 ¶ 48 (stating a “patent’s definition controls”). Dr. Triggs-Raine recognizes the “therapeutic use of hyaluronidases” and notes that “different hyaluronidases were known to have different functions and substrates.” Ex. 2001 ¶¶ 29, 113.7 That is, Dr. Triggs-Raine recognizes hyaluronidase activity as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,060,590
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.