- PTAB · Sep 8, 2025 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–15, and 17–30 based on written-description and enablement challenges; it found the obviousness challenge insufficient at this stage.
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, Preliminary Response, Reply, Sur-Reply, 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 ’520 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 ’520 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 be an expert 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. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided 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). 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 ’520 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 this text 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, 48:44–47; see Ex. 2055 ¶ 67 (stating a “patent’s definition controls”). And Dr. Triggs-Raine states “the modified PH20 polypeptides have multiple credible uses, including ‘therapeutic uses of modified PH20 polypeptides that have the ability to degrade hyaluronan.’” Ex. 2055 ¶ 115.7 That is, Dr. Triggs-Raine recognizes hyaluronidase as the primary utility for the modified PH20 polypeptides recited in claim 1.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateInstituted
“Thus, the ’520 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 “21-42 changes, with each additional change (except at position 324) 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 to PH201-465 means that the protein can have 23 total changes,” and that where one of those changes is one of five choices at position 324 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” slip op. at 27
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - PTAB · Jul 11, 2025 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1, 2, 6–14, and 16–29, finding the written-description and enablement challenges met the institution threshold; the obviousness challenge did not.
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, Preliminary Response, Reply, Sur-Reply, 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, 6–14, and 16–29 of the ’035 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 ’035 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 be an expert 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 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided 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
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateInstituted
“On the current record, the evidence shows it is more likely than not that the claims of the ’035 patent fail to satisfy the written description requirement because they “recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad, 598 F.3d at 1353. Accordingly, on the current record, we find that Petitioner has demonstrated that it is more likely than not that the ’035 patent does not comply with the written description requirement. Similarly, the current record does not appear to provide evidence of possession of the full scope of the claims of the ’035 patent in the ’731 application or any of the subsequent divisional or continuation applications leading to the ’035 patent that claim priority to the ’731 application (which appear to all have similar specifications) for the reasons given above.10 Therefore, the ’035 patent might not receive the benefit of priority to the earlier filed applications, and based on this preliminary determination, is eligible for post-grant review” slip op. at 30
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,123,035 - PTAB · Jul 10, 2025 · IPR2025-00175 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board instituted review of claims 1–17 on all asserted grounds, finding a reasonable likelihood of unpatentability on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review is authorized by statute 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 (2018); see also 37 C.F.R. § 42.4 (2023). For the reasons discussed below, we determine that Petitioner establishes a reasonable likelihood of prevailing with respect to the patentability of at least one claim of the ’562 patent. Accordingly, we institute an inter partes review of claims 1–17 of the ’562 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA”) would have had “at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design,” and “[a]dditional education could substitute for professional experience and vice versa.” Pet. 6 (citing Ex. 1002 ¶¶ 80–” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Neither party proposes any explicit construction of any term. See Pet. 7 (“For the purposes of this IPR, the plain meaning of each term can be applied.”). We do not expressly construe any term for purposes of this Decision.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“On this record, we are persuaded that Petitioner adequately establishes that Usui discloses all of the limitations of claim 1. Usui discloses that aluminum or aluminum alloy layer 15 is in electrical contact with titanium underlayer 13, and titanium nitride layer 14 is located “intermediate the [titanium underlayer] 13 and the aluminum or aluminum alloy layer 15” to prevent “reaction between the aluminum layer 15 and underlayer 13.” Ex. 1004, 3:27–29, 3:38–41, 3:58–63. Usui further discloses that “a capping layer is provided above layer 15,” and that “[p]referred capping layers are titanium nitride and combinations of as layer 18 of a group IVA metal, preferably titanium with a titanium nitride layer 19.” Id. at 3:67–4:6. Usui teaches that titanium nitride layer 19 is about 150 to 800 Å thick, and that the thickness of titanium underlayer 13 is between about 90 to 110 Å. Id. at 3:31–33, 4:6–8. Usui also teaches that the interconnect metallurgy structures described therein “exhibit[] enhanced electromigration characteristics” and “are especially useful for forming electrical connections or wiring such as between active and/or passive devices of an integrated circuit structure.” Id. at 1:8–14. Usui’s description of a plurality of metal layers (layers 13–18) and a capping layer formed over the plurality of metal layers (layer 19), along with its description of the structure’s usefulness for forming electrical connections in an integrated circuit structure, is sufficient, on this record, to establish that Usui discloses “an electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. Usui’s teaching that the capping layer is a refractory metal nitride (titanium nitride) that has a thickness (150–800 Å) greater than the bottommost layer of the plurality of metal layers (layer 13, 90–110 Å), sufficiently establishes, on this record, that Usui discloses the “said capping layer consisting only of a refractory metal nitride, said refractory metal nitride forming a top of said electrical contact and having a thickness greater than that of a bottommost layer of said plurality of metal layers” limitation of claim 1.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,686,562 - PTAB · Jul 9, 2025 · IPR2025-00094 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR on claims 1–16 and all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Bonn and Mizuta.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this preliminary stage, we determine whether the information presented shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been unpatentable over the proposed prior art. We analyze the asserted grounds with the above-noted principles in mind.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design.” Pet. 5 (citing Ex. 1003 ¶¶ 67–69). Petitioner also argues that “[a]dditional education could substitute for professional experience and vice versa.” Id. On the present record, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. Prelim. Resp. 1–52. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears to be consistent with the ’003 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We apply the same claim-construction standard used in the federal courts—in other words, the claim-construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b), which is articulated in Phillips. See 37 C.F.R. § 42.100(b). Under the Phillips standard, the “words of a claim ‘are generally given their ordinary and customary meaning,’” which “is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips, 415 F.3d at 1312–13. Neither party proposes construing any claim terms. Pet. 6; Prelim. Resp. 1–52. On the present record, we agree. As discussed below, we are able to determine whether to institute inter partes review of the ’003 patent without expressly construing any terms. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Patent Owner argues that Petitioner does not show sufficiently that a person of ordinary skill in the art would have had a reason to modify Bonn to remove local oscillator 55. Prelim. Resp. 13–15. We disagree. Petitioner argues that, “[i]n addition to using Figure 7’s ‘dual gate FET structure in high frequency signal mixing’ applications . . . , Bonn discloses using this dual gate FET in ‘other applications such as high frequency signal amplification.’” Pet. 22 (quoting Ex. 1006, 11:26–37). Indeed, Bonn does suggest using its structure for signal amplification. Ex. 1006, 11:26–37 (“the dual gate FET structure of the present invention can be tailored to provide superior performance . . . in . . . other applications such as high frequency signal amplification”). On the present record, this appears to have provided the motivation for a person of ordinary skill in the art to use Bonn for amplification instead of for signal mixing. Petitioner relies on the testimony of Dr. Bernstein to show the modifications that a person of ordinary skill in the art would have considered necessary in order to convert Bonn’s structure for signal-amplification use. Pet. 23–25 (citing Ex. 1003 ¶¶ 98–109). In particular, Petitioner cites Dr. Bernstein’s testimony that a person of ordinary skill in the art “would have found it obvious to remove Figure 1’s LO (local oscillator) port 55 and its associated impedance matching components because the LO signal is no longer being mixed.” Ex. 1003 ¶ 98; see Pet. 23. Dr. Bernstein supports this testimony with citations to Bonn and with reasoning regarding why a person of ordinary skill in the art would have made this modification. Ex. 1003 ¶ 98 (citing Ex. 1006, 1:20–23, 3:19–21, 3:30–41). Accordingly, on the present record, we are persuaded that Petitioner has shown sufficiently that a person of ordinary skill in the art would have had reason to modify Bonn’s structure to remove the connection between a local oscillator and the gate of the second transistor. Finally, Patent Owner argues that Petitioner’s proposed modification would have rendered Bonn inoperable for its intended purpose because the modification would eliminate the ability of Bonn’s structure to conduct high frequency signal mixing. Prelim. Resp. 26–27. As Patent Owner notes, one purpose of Bonn is to mix high-frequency signals. Ex. 1006, 11:33–36. But Bonn itself teaches using its structure for “other applications,” including “high frequency signal amplification.” Id. at 11:33–37. Thus, on the present record, we are persuaded that Petitioner’s proposed modification does not render Bonn inoperable for its intended purpose so much as it acknowledges the modifications necessary to convert Bonn from one of its intended purposes to another. Thus, Petitioner has shown sufficiently for the purpose of the present Decision that a person of ordinary skill in the art would have had reason to combine Bonn and Mizuta and that the combination of Bonn and Mizuta teaches or suggests the disputed limitation of claim 1. We encourage the parties to develop the arguments and the record surrounding this issue further during the trial.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,264,003 - PTAB · Jun 18, 2025 · IPR2025-00321 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–7, 9, 16, and 17, finding a reasonable likelihood that claim 1 is anticipated by Boyer.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“approximately two weeks before the statutory deadline for a final written decision, but the most recent median time-to-trial statistics for Judge Gilstrap in the Eastern District of Texas indicate that the actual trial date will likely be in July 2026, which is later than the statutory deadline to issue a final written decision in this proceeding in mid-June 2026. See Ex. 2001, 7 (median time from filing to trial of 23.2 months); Prelim. Resp. 10. Thus, we find this factor is neutral or weighs slightly against discretionary denial.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“At this preliminary stage, we determine whether the information presented shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been unpatentable over the proposed prior art. We analyze the asserted grounds with the above-noted principles in mind.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art “would have had (1) at least a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a related field, and (2) at least two years of research or industry experience in 3D printing or materials used for 3D printing.” Pet. 5 (citing Ex. 1003 ¶¶ 14–16). Petitioner also argues that “[a]dditional experience could substitute for a formal degree or formal training (and vice versa).” Id. Patent Owner proposes a slightly different level of skill, arguing that a person of ordinary skill in the art “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 24. Neither party explains why the outcome of this case would be affected by the adoption of any of the proffered definitions of a person of ordinary skill in the art. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears to be consistent with the ’713 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“We note that, as discussed below, we are able to determine whether to institute inter partes review of the ’713 patent without expressly construing the term “from multiple print heads or deposition lines.” See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). As for Patent Owner’s argument that Petitioner has failed to carry its burden to identify how the claims are to be construed, we disagree on the present record. Although Petitioner does not provide a preferred construction for the single term it proposes requires construction, Petitioner does identify which of its two alternative constructions applies to each of its asserted grounds of unpatentability. Pet. 6 (“Under the first construction, [the obviousness grounds] are applicable, and [the anticipation ground] would be excluded from the claim scope. Under the alternative construction, all of [the asserted grounds] are applicable.”). In our view, this approach does not fail to satisfy Petitioner’s burden under 37 U.S.C. § 42.104(b)(3).” slip op. at 17
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 9,421,713 - PTAB · Jun 18, 2025 · IPR2025-00311 · APJ Christopher M Kaiser · IPR · Institution
The Board instituted IPR of claims 1, 3–11, and 17–22 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on claim 1 over Mazumder and Mori.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on Petitioner’s first stipulation filed on December 18, 2024.15 Prelim. Resp. 13–15. Patent Owner does not address Petitioner’s updated second stipulation filed on April 8, 2025. This updated second stipulation mitigates any concerns of duplicative efforts between the district court and the Board, as well as concerns of any potentially conflicting decisions. See Sand at 12. We therefore find that this factor weighs against exercising discretion to deny institution. See id., n.5. 5. Whether Petitioner and the Defendant in the Parallel Proceeding are the Same Party Whereas Petitioner does not address factor 5, Patent Owner argues that the parties to this proceeding are both in the related district court litigation. Pet. 98–99; Prelim. Resp. 15. While it is common in IPR proceedings for the petitioner and patent owner to also be parties in a related district court proceeding, this factor weighs slightly in favor of discretionary denial. Fintiv, Paper 11 at 13–14.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“c) Conclusion Regarding Claim 1 Based on the current record, we determine that there is a reasonable likelihood that Petitioner will prevail in demonstrating that claim 1 is unpatentable as obvious over the combination of Mazumder and Mori. Accordingly, we institute inter partes review with respect to all claims and all grounds asserted in the Petition. 5. Claims 3, 5–7, 9, 10, and 19–22 Because Petitioner demonstrates a reasonable likelihood of success in proving that at least one claim of the ’324 patent is unpatentable, we institute on all grounds and all claims raised in the Petition. See 37 C.F.R. § 42.108(a). Therefore, at this stage of the proceeding, it is not necessary for us to provide an assessment of every challenge raised by Petitioner, especially, as in this case, when Patent Owner does not separately argue those claims. See Prelim. Resp. 28–46. Those challenges, in our view, are best left for trial after full development of the record.” slip op. at 27
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). For a reference to be analogous art, it must be “either in the field of the applicant's endeavor or [be] reasonably pertinent to the problem with which the inventor was concerned.” In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006) (citing In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992)). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor's endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor's attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Mazumder because “the presentation of both image types would have beneficially aided the remote user to more easily visually compare the actual image and virtual image to quickly identify any defects or problems with the fabrication process.” Pet. 23–24 (citing Ex. 1003 ¶ 113). Patent Owner argues that “it is hindsight to use ‘the invention to define the problem the invention solves.’” Prelim. Resp. 43 (quoting Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377 (Fed. Cir. 2012); citing AT&T Services Inc. et. al. v. Innovative Sonic Ltd., IPR2024-001143 (PTAB Feb. 11, 2025)). According to Patent Owner, because neither Mazumder nor Mori teaches visual comparison of image types, the idea to improve the Mazumder-Mori combination by simultaneously displaying different image types and thus permitting visual comparison must be driven by hindsight. Id. at 44–45. But Petitioner cites evidence other than the ’324 patent to support the person of ordinary skill in the art having a desire to visually compare the different images presented in the Mazumder-Mori combination. Pet. 23–24 (citing Ex. 1003 ¶ 113). Specifically, Dr. Wolfe testifies that “the presentation of the actual images captured by the camera and the virtual images simultaneously within the user interface would have beneficially aided the remote user to more easily visually compare the actual image and virtual image to quickly identify any defects or problems with the fabrication process” and that a person of ordinary skill in the art would have recognized this. Ex. 1003 ¶ 113. Thus, Petitioner has shown sufficiently for the purpose of the present decision that Mori teaches or suggests the disputed limitation of claim 1. We encourage the parties to develop the arguments and the record surrounding this issue further during the trial.” slip op. at 26
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,562,324 - PTAB · Jun 11, 2025 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Institution
The Board instituted PGR on claims 1–4, 7–19, and 22; it found written-description and enablement challenges likely to succeed, but the obviousness ground insufficient.
RulingsInstitution decision- 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 ’298 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 be an expert in hyaluronidases. See Pet. 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. Moreover, Patent Owner fails to persuasively explain why Petitioner’s definition that includes a person with expertise in other enzymes is insufficient. Even if we were to apply Patent Owner’s POSA definition, it is not clear on the record before us that Petitioner’s experts lack relevant expertise or qualifications of at least a POSA. Patent Owner will have the chance to cross-examine Dr. Hecht and Dr. Park in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. Patent Owner will have further opportunity on a full record to assert that we should discount either experts’ testimony due to lack of appropriate qualifications. 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 petitioner
“posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 44:59–62. The ’298 patent provides an express definition of the term “modified PH20 polypeptide” which 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 47:15–30 (emphasis added).” slip op. at 14
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Under the second step of the Advanced Bionics framework, we must determine whether Petitioner has demonstrated Examiner error in a manner material to the patentability of the challenged claims. Advanced Bionics, at 10. Becton, Dickinson Factors (c), (e), and (f) inform our analysis at this step. Id. at 8.” slip op. at 21
- 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, Preliminary Response, Reply, Sur-Reply, 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 1–4, 7–19, and 22 of the ’298 patent, and therefore, we grant post-grant review for the reasons articulated below.” slip op. at 2
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - PTAB · Jun 2, 2025 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Institution
Instituted PGR on claims 1–4 and 8–21 because the Board found a more-likely-than-not showing of written description and enablement failures; the obviousness ground did not meet that threshold.
RulingsInstitution decision- 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 prior art relevant to the ’600 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 be an expert in hyaluronidases. See Pet. 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.” 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 48:38–53 (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. 2001 ¶ 68.4 Indeed, when reproducing the definition from this column of the ’600 patent, Dr. Triggs-Raine does not include any text after the first period, but the ’600 patent text 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. On this” slip op. at 13
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“on the ’429 patent, and there is no evidence of record that the Examiner meaningfully considered the relevant disclosures of the ’429 patent. We find unpersuasive Patent Owner’s reliance on the Examiner’s issuance of an office action with a written description rejection over a different issue that also included some double patenting rejections. As to Becton, Dickinson Factor (e), “whether Petitioner has pointed out sufficiently how the [E]xaminer erred in its evaluation of the asserted prior art,” Petitioner provides persuasive evidence of Examiner error. See Pet. 36–39 (citing Ex. 1009, 21–27). We agree with Petitioner that the Examiner overlooked the written description requirement with regard to claim 1. As discussed below, we find that, on the current record, the evidence sufficiently shows that it is more likely than not that the claims fail to comply with the written description requirement. See Section X. We, thus, find that the Examiner erred by either overlooking, or failing to appreciate, the factual underpinning necessary to support a written description for the breadth of an enormous genus claim such as claim 1 of the ’600 patent.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XIII. CONCLUSION Petitioner has, at this stage, 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. XIV. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 and 8–21 of the ’600 patent is hereby instituted 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 60
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,952,600 - PTAB · Apr 25, 2025 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR of claims 1–9 on all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Chee.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial.” slip op. at 13
- BurdenDecided for petitioner
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“tags,” and “locus of origin” need be addressed at this stage of the proceeding. We determine that no express construction of “consensus base call” is necessary to determine whether to institute inter partes review. 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))). 1. “Set of [Unique] Differentiator Tags” Petitioner asserts that both “set of differentiator tags” as used in claim 1 and “set of unique differentiator tags” as used in claim 9 should be given the same construction—“set of prepared tags where each tag includes a unique sequence as compared to the other tags.” See Pet. 16 (citing Ex. 1005 ¶ 89; Ex. 1001, 28:25–29, 28:53–57). Petitioner further asserts that “[t]hese unique differentiator tags are associated with target nucleic acids so that each nucleic acid is uniquely identifiable.” Pet. 16. Petitioner also points to the prosecution history of the ’730 patent in which Petitioner asserts the Patent Owner argued and the Board acknowledged that each differentiator tag is unique. Id. at 16–17. Petitioner concludes that “[a]n interpretation of ‘differentiator tags’ to include non-unique tags is not possible, and if it were, Applicant disclaimed any interpretation that would allow non-unique tags.” Id. at 17.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Having considered the parties’ positions and evidence of record, summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claim 1 challenged in Ground I. Petitioner provides sufficient support on the record before us to provide a reasonable likelihood of succeeding in showing that claim 1 is anticipated by Chee.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730 - PTAB · Apr 11, 2025 · IPR2024-01498 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–19, finding a reasonable likelihood of unpatentability on multiple obviousness grounds, while declining institution under Ground 9 at the preliminary merits stage.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition 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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–19 of the ’752 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we determine that Petitioner has established a reasonable likelihood of prevailing in showing that claims 1 and 4–14 are obvious over the combination of Native and Bianchi ’254. In particular, we are persuaded by Petitioner that the combination of Native and Bianchi ’254 discloses a deodorant stick comprising each element of claims 1 and 4–14. Pet. 41–50. We also find that Petitioner has shown sufficiently on the record before us that a person of ordinary skill in the art would have had a reasonable expectation of success to implement Bianchi ’254’s hardness range in Native’s formula. Here, we credit Dr. Michniak-Kohn’s testimony that a person of ordinary skill in the art would have understood how to adjust hardness using the structurants in a deodorant composition. Ex. 1002 ¶ 41, 191–192.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“biased testimony from an employee” and the Petition therefore lacks sufficient evidence to establish the images provided in the Squatch declaration as containing prior art printed publication material. Id. at 27–28 (citing Finnigan Corp. v. ITC, 180 F.3d 1354, 1366 (Fed. Cir. 1999) (“[T]he law has long looked with disfavor upon invalidating patents on the basis of mere testimonial evidence absent other evidence that corroborates that testimony.”); Nobel Biocare Services AG v. Instradent USA, Inc., 903 F.3d 1365, 1377-78 (Fed. Cir. 2018) (“corroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.”). 3. Discussion Having considered the parties’ positions and evidence of record, summarized above, we find Patent Owner to have, at this stage of the proceeding, the better position.. Accordingly, we determine that there is insufficient evidence to indicate a reasonable likelihood that Petitioner will prevail in establishing that that claims 15–19 would have been obvious over the combination of Squatch and Sturgis for the reasons set forth in the Preliminary Response and summarized above. However, we will make our final determination on these issues on the full record developed during this proceeding. See Hulu LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, 11 (PTAB Dec. 20, 2019) (precedential) (“To prevail in a final written decision in an inter partes review, the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.”).” slip op. at 30
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“35 U.S.C. § 325(d). Prelim. Resp. 29–38. In determining whether to deny institution under § 325(d), we use the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 32
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,844,752
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.