- PTAB · Dec 12, 2025 · IPR2025-00763 · APJ Christopher L Ogden · IPR · Institution
The Board instituted IPR of claims 1–10 on all asserted grounds, finding a reasonable likelihood that Zeira alone or Zeira with Yi renders at least one challenged claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute an inter partes review when “the information presented in the petition . . . and any response . . . 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); see also 37 C.F.R. § 42.108(c). Applying that standard, we institute an inter partes review of all the challenged claims of the ’838 patent based on all grounds set forth in the Petition for the reasons explained below. This is a preliminary decision, and we will base our final written decision on the full trial record.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“had “a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and at least two years of practical experience with design or development of telecommunication and/or wireless communications systems, or the equivalent.” Pet. 10 (citing Ex. 1003 ¶ 21). Patent Owner does not contest this at this stage. See Prelim. Resp. Petitioner’s proposed level of ordinary skill appears to be consistent with the problems addressed in the ’838 patent. See Ex. 1001, 1:30–2:48. Therefore, we adopt it for this decision.” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
“person of ordinary skill in the art would have understood that Zeira’s RRC message includes MAC timer information. Zeira explicitly discloses that the calculated duration information is transmitted to the WTRU. Ex. 1005 ¶ 74. Zeira also discloses that information to “[c]onfigure the MAC layer” is transmitted to the WTRU in the form of an RRC message. Id. ¶ 423. Further, the duration is calculated while considering the amount of time that the MAC layer would need to transmit the current buffered data. Id. ¶ 76. Given these disclosures, we find sufficiently credible Dr. Lo’s testimony that a person of ordinary skill in the art would have understood Zeira to disclose that the RRC message received by the WTRU includes MAC timer information, and that the extent it does not, it would have been a predictable variation, at the time of the claimed invention, to implement a timer relating to the duration of network resources at the MAC layer as Yi teaches. Ex. 1003 ¶¶ 74–87, 107–113.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“person of ordinary skill in the art would have understood that Zeira’s RRC message includes MAC timer information. Zeira explicitly discloses that the calculated duration information is transmitted to the WTRU. Ex. 1005 ¶ 74. Zeira also discloses that information to “[c]onfigure the MAC layer” is transmitted to the WTRU in the form of an RRC message. Id. ¶ 423. Further, the duration is calculated while considering the amount of time that the MAC layer would need to transmit the current buffered data. Id. ¶ 76. Given these disclosures, we find sufficiently credible Dr. Lo’s testimony that a person of ordinary skill in the art would have understood Zeira to disclose that the RRC message received by the WTRU includes MAC timer information, and that the extent it does not, it would have been a predictable variation, at the time of the claimed invention, to implement a timer relating to the duration of network resources at the MAC layer as Yi teaches. Ex. 1003 ¶¶ 74–87, 107–113.” slip op. at 16
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,212,838 - PTAB · Dec 9, 2025 · IPR2025-00756 · APJ Thu A Dang · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 11, and 12 on three §103 grounds, finding a reasonable likelihood of unpatentability over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION Because we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing at least one of the challenged claims is unpatentable, we institute inter partes review as to all challenged claims and grounds presented in the Petition. At this stage of the proceeding, we have not made a final determination as to the patentability of any of these challenged claims. ORDER For the reasons given, it is ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is instituted as to claims 1, 2, 5–8, 11, and 12 of the ’803 patent to determine whether: 1) claims 1, 5–7, 11, and 12 are unpatentable under 35 U.S.C. § 103 as obvious over TS 36.300, TS 36.321, and TS 36.331; 2) claims 1, 2, 5–8, 11, and 12 are unpatentable under 35 U.S.C. § 103 as obvious over Ericsson and TS 25.331; and 3) claims 5, 6, 11, and 12 are unpatentable under 35 U.S.C. § 103 as obvious over Ericsson, TS 25.331, and Sebire; and” slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“ordinary meaning, “primary” and “non-primary” cells are all cells that the WTRU is connected to (PO Resp. 16), the plain language in claim 1, and similarly in claim 7, does not require a “primary” node or “non-primary” cell to have a connection to the WTRU. See Ex. 1001, 10:38−56; 11:11–26. We find unavailing Patent Owner’s contention that the claims require that the WTRU “be connected to more than one cell,” wherein cells that are “associated with a wireless network node,” but are not connected to the WTRU “at the same time” cannot be “primary” or “non-primary” cells. PO Resp. 16. In the ’803 patent, nothing in the Specification clearly limits “primary” and “non-primary” cells as Patent Owner proposes. Prelim. Resp. 16. Patent Owner points to the Specification of the ’803 patent to show that, for softer handover, the WTRU is connected “with more than one cell [] which are controlled by the same Node-B,” and “[o]ne of the[se] cells 808 may be designated as a primary cell 808a, while other cells are designated as a non-primary cells 808b.” Id. (alterations in original) (citing Ex. 1001, 8:44–46, 9:4–6, Figs. 8A–B). However, this portion of the Specification (describing a softer handover embodiment in which a cell “may be designated” as a primary while other as non-primary) does not provide a clear definition to warrant interpreting the “primary” and “non-primary” cells as requiring “connection” to the WTRU “at the same time.” Id. That is, nothing in the Specification clearly precludes “primary” and “non-primary” cells from being “source” and “target” cell, as Patent Owner contends. PO Resp. 16. and the Specification, we determine that the terms “primary” and “non-primary” recited in claims 1 and 7 are not limited to cells connected to a WRTU at the same time. We determine no further explicit construction of this term is necessary to resolve the controversy. See Vivid Techs., 200 F.3d at 803.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“f) Motivation to combine Ericsson and TS 25.331 Petitioner contends that a “POSITA would have been motivated to combine Ericsson and TS 25.331 because they are directed to similar technologies and a skilled artisan would have understood the benefits of combining these two references,” and “would have understood that there was a high likelihood of success in making the combination.” Pet. 34 (citing Ex. 1003 ¶¶ 156–157). In particular, the references “are both reasonably pertinent to the problem faced by the inventor, namely protocols for handover in a telecommunications system.” Id. (citing Ex. 1003 ¶ 158). According to Petitioner, the combination “involves the predictable use of interchangeable prior art elements according to their established functions” more than routine engineering.” Id. at 37 (citing Ex. 1003 ¶ 174). At this stage of the proceeding, Patent Owner does not present arguments in the Preliminary Response addressing the specific merits of Petitioner’s contentions with respect to the motivation to combine Ericsson and TS 25.331. See generally Prelim. Resp. 15–18. We find availing Petitioner’s contention that Ericsson and TS25.331 are “directed to similar technologies,” and that a “skilled artisan would have understood the benefits of combining these two references.” Pet. 34. On this preliminary record, we are persuaded that Petitioner has made a sufficient showing that a POSITA would have had a reason to combine the teachings of Ericsson and TS 25.331.” slip op. at 20
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Dr. Kakaes, contends that a person of ordinary skill in the art (POSITA) “would have had a B.S. in Electrical Engineering or a related field with at least three years of experience designing, developing, and/or testing telecommunication systems,” and “would also have familiarity with the wireless standards and well-known protocols for accessing wireless networks existing at the relevant time,” wherein “[m]ore education may supplement practical experience or vice versa.” Pet. 12–13. At this stage in the proceeding, Patent Owner does not contest Petitioner’s proposal or offer an alternative. On this record, we are persuaded that Petitioner’s proposal is consistent with the technology described in the Specification and the cited prior art. For purposes of this Decision, we adopt Petitioner’s proposed level of skill.” slip op. at 10
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,764,803 - 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 · IPR2025-00820 · APJ Neil T Powell · IPR · Institution
The Board instituted IPR on claims 1–11 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Tadros, Porter, Kalili, and Texin 990R.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition and the Preliminary Response shows “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). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1–11 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 17–18 (citing Ex. 1007 ¶¶ 13–15). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See generally Prelim. Resp. At this stage of the proceeding and on the present record, we adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’090 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Additionally, only terms that are in controversy need to be construed, and these need be construed only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 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)). Both parties indicate that no claim terms need to be expressly construed. Pet. 29–30; Prelim. Resp. 5. Consistent with that, we determine that we need not construe any claim terms expressly in order to resolve the parties’ dispute regarding whether Petitioner has demonstrated a reasonable likelihood of prevailing.” slip op. at 8
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Weighing the parties’ arguments and evidence, we find Petitioner’s arguments and evidence sufficient at this stage to demonstrate a reasonable likelihood of prevailing. Pet. 8–17, 30–49. For example, regarding whether of Porter’s disclosure to the problem faced by inventor of the ’090 patent. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164. The ’090 patent illustrates that its inventor faced the problem of selecting desirable materials for an aligner, including selecting a desirable material for an aligner’s hard layer. Ex. 1001, 5:44–59. Petitioner and Dr. Osswald provide significant evidence and reasoning tending to show that Porter’s discussion of Tritan logically would have commended itself to the attention of an inventor facing the problem of selecting an aligner hard layer. Pet. 8 (citing Ex. 1007 ¶¶ 98–108, 125–127, 144–164). For example, Dr. Osswald explains that “because Tritan copolyesters are BPA-free, Rafih specifically discloses Tritan EX401 as an exemplary material” for its oral appliance. Id. ¶ 99 (citing Ex. 1104, 5:4–64, claims 2, 9, 10). In view of this, Dr. Osswald testifies that “Rafih would inform a [person of ordinary skill in the art] that Porter’s guidance regarding replacing polycarbonate with Tritan applies to dental appliances.” Ex. 1007 ¶ 146. At this stage, weighing Petitioner’s evidence against Patent Owner’s contrary attorney argument that Porter focuses on dishware, we determine Petitioner has shown sufficiently that Porter is analogous art. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164; Prelim. Resp. 1, 9–10, 18–21.” slip op. at 11
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 11,648,090 - PTAB · Nov 6, 2025 · IPR2025-00821 · APJ Neil T Powell · IPR · Institution
The Board instituted review of claims 1–23, 25, and 26 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over Tadros, Porter, Kalili, and Texin 990R.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition and the Preliminary Response shows “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). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1–23, 25, and 26 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 17 (citing Ex. 1007 ¶¶ 13–15). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See generally Prelim. Resp. At this stage of the proceeding and on the present record, we adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’090 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Additionally, only terms that are in controversy need to be construed, and these need be construed only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party indicates that we need to construe expressly any claim terms. Pet. 27–28; Prelim. Resp. 5. Consistent with that, we determine that we need not construe any claim terms expressly in order to resolve the parties’ dispute regarding whether Petitioner has demonstrated a reasonable likelihood of prevailing.” slip op. at 8
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“arguments and evidence sufficient at this stage to demonstrate a reasonable likelihood of prevailing. Pet. 8–17, 53–71. For example, regarding whether Porter is analogous art, Petitioner sufficiently shows reasonable pertinence of Porter’s disclosure to the problem faced by inventor of the ’091 patent. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 146–165. The ’091 patent illustrates that its inventor faced the problem of selecting desirable materials for an aligner, including selecting a desirable material for an aligner’s hard layer. Ex. 1001, 5:44–59. Petitioner and Dr. Osswald provide significant evidence and reasoning tending to show that Porter’s discussion of Tritan logically would have commended itself to the attention of an inventor facing the problem of selecting an aligner hard layer. Pet. 8 (citing Ex. 1007 “because Tritan copolyesters are BPA-free, Rafih specifically discloses Tritan EX401 as an exemplary material” for its oral appliance. Id. ¶ 99 (citing Ex. 1104, 5:4–64, claims 2, 9, 10). In view of this, Dr. Osswald testifies that “Rafih would inform a [person of ordinary skill in the art] that Porter’s guidance regarding replacing polycarbonate with Tritan applies to dental appliances.” Ex. 1007 ¶ 147. At this stage, weighing Petitioner’s evidence against Patent Owner’s countervailing attorney argument that Porter focuses on dishware, we determine Petitioner has shown sufficiently that Porter is analogous art. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 146–165; Prelim. Resp. 1–2, 9–10, 34–36.” slip op. at 13
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 11,648,091 - PTAB · Nov 6, 2025 · IPR2025-00819 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims based on both obviousness grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18–19 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 28–38 (claim 1), 38–51. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 34–36 (citing Ex. 1007 ¶¶ 31, 39–42, 147–151, 174–176). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard.” slip op. at 14
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,154,384 - PTAB · Nov 6, 2025 · IPR2025-00818 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims 1–22 based on all three asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the briefing and cited evidence of record, we institute inter partes review because we find that Petitioner establishes a reasonable likelihood that it will prevail with respect to at least one of the claims challenged in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time the invention was made. See Graham, 383 U.S. at 17–18. Petitioner proposes that a person of ordinary skill in the art (sometimes referred to herein as a “POSITA”) would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that no terms require construction, but that “Petitioner applies the prior art consistent with Patent Owner’s assertions in its Infringement Contentions (EX1014, 6-20.).” Pet. 26. Patent Owner does not propose any express claim constructions. Prelim. Resp. 5. Nor does Patent Owner allege that any of Petitioner’s claim interpretations contradict Petitioner’s position in the related district court litigation. Id. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 27–36 (claim 1), 36–46. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 32–35 (citing Ex. 1007 ¶¶ 31, 39–41, 57–87, 146–150, 171–172). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard. We also disagree with Patent Owner’s arguments about “adhesive lamination” using “tie layers” at this point in the proceeding. Prelim. Resp. 15–18. On this record, we are persuaded that Petitioner has adequately supported its arguments that one of ordinary skill in the art would have been motivated to use adhesive lamination to achieve the proposed combination. See, e.g., Pet. 33–35; Ex. 1007 ¶¶ 39–42, 120, 45, 51, 116, 120. Petitioner relies on Kalili as disclosing a hard layer suitable for combination with Tadros’s soft layers (Pet. 32), and more particularly, doing so in the context of a laminated multilayer aligner (Reply 4). To create the laminated multilayer aligner proposed, Petitioner’s suggested use of a particular type of well-known lamination, i.e. adhesive lamination, is sufficiently developed and supported in the Petition. Pet. 32–35. Here, Patent Owner recognizes that Kalili teaches lamination, but suggests that it does not specifically teach using adhesive lamination. Prelim. Sur-reply 5. We note, however, that the parties have identified limited types of known lamination for aligners: coextrusion, extrusion lamination, and adhesive lamination. Prelim Sur-reply 4; Pet. 14–15 n.3, 33. In KSR, the Supreme Court explained that when “there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR, 550 U.S. at 421. “If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” Id. Having reviewed Petitioner’s proffered arguments as to Tadros, Kalili, and Texin 990R, including motivation to combine the references asserted in this ground, with a reasonable expectation of success, we are persuaded on this record that Petitioner has met its burden for institution with respect to Ground 1.” slip op. at 14
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 10,973,613 - 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
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.