- Illumina Inc. v. Molecular Loop Innovations LLCAll claims unpatentablePTAB · Jan 16, 2026 · IPR2024-00965 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–6 are unpatentable: Gloor anticipates them, Parameswaran and Gloor render them obvious, and Parameswaran, Binladen, and Bentley render claim 6 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 18 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 20–23). After reviewing the record, we adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We acknowledge the ambiguous nature of the disputed claim language. On its face, it could require two or more identifier sequences together be uniquely associated with the nucleic acid of interest, as Petitioner argues; or it could require two or more identifier sequences, each individual identifier sequence must be uniquely associated with the nucleic acid of interest, as Patent Owner asserts. See Reply 2–3; Sur-reply 1–6. We, therefore, must examine the words of the claim and the specification to ascertain the scope of this limitation. The specification states that “[w]hile the pair of barcodes associated with any given template is unique, individual barcode sequences can be used with multiple templates as long as no pair is used across two different samples.” Ex. 1001, 2:50–53 (emphasis added). Elsewhere, it states that [t]he first and second identifiers are designed such that each set of identifiers is correlated to a particular sample (e.g., material obtained from a particular patient or group of patients), allowing samples to be distinguished and/or validated. The first and second identifiers may be the same or different, so long as the combination is unique with respect to the sample or sub-sample that one seeks to distinguish and/or validate. Id. at 3:15–22 (emphases added). We agree with Petitioner that the specification supports its proposed construction. See Reply 2.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Claim 5 recites “homopolymer region.” The ’200 patent specification provides an express definition for the term, stating that “the barcode sequences can be designed to have minimal or no homopolymer regions, i.e., 2 or more of the same base in a row such as AA or CCC, within the barcode sequence.” Ex. 1001, 9:6–10. Thus, we agree with Patent Owner that the term “homopolymer region” should be construed as “two or more of the same base in a row.” See PO Resp. 13 (citing Ex. 2001 ¶ 24). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any other claim term.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“A reference is considered publicly accessible if it is “made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1355 (Fed. Cir. 2018). To “determine whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents,” we “must consider all of the facts and circumstances surrounding the disclosure.” In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009); see also In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004) (explaining that a determination of whether a reference qualifies as a printed publication “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public”).” slip op. at 15
Patent outcomesUS 11,768,200 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,768,200 - Illumina Inc. v. Molecular Loop Innovations LLCNo claims unpatentablePTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision
Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24
Patent outcomesUS 11,041,852 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,041,852 - Caption Health, Inc v. University Of British ColumbiaInstitution deniedPTAB · Dec 19, 2025 · IPR2025-01066 · APJ Mary C Hoffman · IPR · Institution
Institution was denied because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable, including failure to show the claimed image-receiving quality-assessment neural network.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted “unless . . . 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.” Based on the current record and for the reasons explained below, Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one of the challenged claims of the ’591 patent. Thus, we do not institute this inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Because Petitioner’s formulation is supported by declaratory testimony and appears consistent with the level of skill reflected in the asserted prior art and the ’591 patent, and because Patent Owner does not provide any supporting evidence, we adopt Petitioner’s formulation of the level of ordinary skill in the art. See Ex. 1002 ¶¶ 31–33. Our decision would be the same regardless of the differences between Petitioner’s and Patent Owner’s formulations.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not propose any express claim construction. Pet. 11– 12; Prelim Resp. 17. We also determine that no express claim construction is necessary for our Decision, apart from that discussed in our below analysis. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only terms in controversy must be construed “and only to the extent necessary to resolve the controversy”) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Petitioner also fails to provide sufficient rationale and a reasonable expectation of success in combining Krishnan and Lee to arrive at a quality assessment neural network configured to receive an image. See Pet. 34–37. For example, the Petition lacks an explanation of why a POSITA would have been motivated to modify Krishnan’s quality assessment neural network to be configured to receive an image, instead of extracted features, in view of Lee’s image-receiving category classifying neural network. Id. Without such further explanation, Petitioner’s challenge falls short. Petitioner’s argument that neural networks for image quality assessment were “well-known” is not persuasive—it does not address the particular scope of limitation 1i, which also requires that the neural network is configured to receive images. Pet. 35 (citing Ex. 1002 ¶¶ 47–51, 118; Exs. 1017, 1023, 1024, 1026). Petitioner’s argument that combining Krishnan and Lee “would merely amount to applying known work from the field . . . to yield predictable results” is not persuasive because the Petition ties this reasoning to modifying Krishnan with Lee’s view-category-specific assessment parameters, not modifying Krishnan’s quality assessment neural network to receive images instead of extracted features. Id. at 37 (citing Ex. 1002 ¶ 126). Lastly, we note Petitioner’s expert’s discussion regarding neural networks for image quality assessments. Ex. 1002 ¶¶ 43–53 (citing Exs. 1010, 1015, 1016, 1017, 1018, 1023, 1024, 1026). However, the Petition does not explain how this evidence demonstrates that the proposed combination teaches or suggests a quality assessment neural network configured to receive images, or that such would have been obvious in the context of the claimed invention. See Pet. 32–37.” slip op. at 19
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,129,591 - 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 - Nokia Of America Corporation / AT&T Services, Inc. v. Iarnach Technologies LimitedSome claims unpatentablePTAB · Dec 10, 2025 · IPR2024-00899 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–3, 5, 10, 11, and 14 are unpatentable as obvious; claims 4, 12, 13, and 15 were not shown unpatentable under the asserted § 103 grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(citing Ex. 1003 ¶ 22). Patent Owner does not contest this proposed level of ordinary skill. PO Resp. 5. Also, neither party argues that the precise level of ordinary skill would be dispositive in this proceeding. We adopt Petitioner’s proposed level of ordinary skill because it is undisputed, supported by testimonial evidence, and consistent with the asserted prior art and the types of problems and solutions in the ’892 patent. See, e.g., Ex. 1001, 1:19–2:8.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We agree with Petitioner. The evidence of record, including the ’892 patent and its prosecution history,9 indicates that the ordinary and customary meaning of “transitioning . . . from . . . to” encompasses both direct and indirect transitions. Looking first to the claim language itself, the word “directly” appears in claims 1, 6, and 10, but not claim 14, presumptively suggesting that claim 14 was intended to more broadly capture systems with either direct or indirect transitions. See CAE Screenplates Inc. v. Heinrich Fiedler GmbH, 224 F.3d 1308, 1317 (Fed. Cir. 2000) (“In the absence of any evidence to the contrary, we must presume that the use of . . . different terms in the claims connotes different meanings.”). Holding otherwise would fail to give any effect to the word “direct” as it appears in claims 1, 6, and 10. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions methodologies that render phrases in claims superfluous).” slip op. at 12
- Expert testimonyPetitioner expert creditedOther
“predictable and well-motivated variation of G.987.3, at the time of the claimed invention, to include a direct transition between the ONU’s two low-power states. See KSR v. Teleflex, 550 U.S. at 417 (“When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, . . . . If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”). We credit Dr. Sergienko’s testimony that a person of ordinary skill in the art would have been motivated to reduce power consumption and would have looked to ways of modifying G.987.3 to further that design goal. See Ex. 1003 ¶ 70; see also Ex. 1007, 97 (“For a variety of reasons, it is desirable to reduce the power consumed by an ONU as much as possible . . . .”). We also credit Dr. Sergienko’s testimony that there were only a small number of ways to modify the state transitions in G.987.3’s ONU, and that it would have been obvious to consider those possibilities. Ex. 1003 ¶ 70. Patent Owner does not contest this. Dr. Litvin concedes, for Patent Owner, that “there is no conceivable way the [ITU] did not consider the proposed transition” between the ONU’s two low-power states when drafting G.987.3, although he contends the standards body prohibited such direct transitions as “a conscious and reasoned design choice.” Ex. 2007 ¶ 108; see also id. ¶ 109 (opining that there were only four possible choices for transitions in the ONU, and the ITU “undoubtedly considered all of them, including the direct transition from . . . Listen and . . . Asleep”); PO Resp 24 (conceding that “G.987 explicitly considered the very direct transitions that Petitioner say would be used”). We also find persuasive Petitioner’s additional or alternative argument that Röger would have motivated modifying G.987.3 by allowing the ONU, while in sleep mode, to periodically turn on its receiver and check for messages from the OLT, which would have been direct transitions between “first” and “second” states as recited in claim 1. Pet. 20–22 & n.4; Ex. 1003 ¶¶ 82–84. The evidence suggests that modifying G.987 as Petitioner proposes would have been within the abilities of a person of the ordinary skill in the art at the time of the claimed invention—either to add a direct transition between Listen and Asleep states or to allow the ONU, while in its sleep (both transmitter and receiver off) mode, to periodically turn on its receiver temporarily to listen for polling messages from the OLT, as Röger teaches. Pet. 11–12, 14–15, 19; Ex. 1003 ¶¶ 70, 74. We also agree with Petitioner that there would have been motivation” slip op. at 26
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find persuasive Petitioner’s arguments that it would have been a predictable and well-motivated variation of G.987.3, at the time of the claimed invention, to include a direct transition between the ONU’s two low-power states. See KSR v. Teleflex, 550 U.S. at 417 (“When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, . . . . If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”). We credit Dr. Sergienko’s testimony that a person of ordinary skill in the art would have been motivated to reduce power consumption and would have looked to ways of modifying G.987.3 to further that design goal. See Ex. 1003 ¶ 70; see also Ex. 1007, 97 (“For a variety of reasons, it is desirable to reduce the power consumed by an ONU as much as possible . . . .”). We also credit Dr. Sergienko’s testimony that there were only a small number of ways to modify the state transitions in G.987.3’s ONU, and that it would have been obvious to consider those possibilities. Ex. 1003 ¶ 70. Patent Owner does not contest this. Dr. Litvin concedes, for Patent Owner, that “there is no conceivable way the [ITU] did not consider the proposed transition” between the ONU’s two low-power states when drafting G.987.3, although he contends the standards body prohibited such direct transitions as “a conscious and reasoned design choice.” Ex. 2007 ¶ 108; see also id. ¶ 109 (opining that there were only four possible choices for transitions in the ONU, and the ITU “undoubtedly considered all of them, including the direct transition from . . . Listen and . . . Asleep”); PO Resp 24 (conceding that “G.987 explicitly considered the very direct transitions that Petitioner say would be used”). We also find persuasive Petitioner’s additional or alternative argument that Röger would have motivated modifying G.987.3 by allowing the ONU, while in sleep mode, to periodically turn on its receiver and check for messages from the OLT, which would have been direct transitions between “first” and “second” states as recited in claim 1. Pet. 20–22 & n.4; Ex. 1003 ¶¶ 82–84. The evidence suggests that modifying G.987 as Petitioner proposes would have been within the abilities of a person of the ordinary skill in the art at the time of the claimed invention—either to add a direct transition between Listen and Asleep states or to allow the ONU, while in its sleep (both transmitter and receiver off) mode, to periodically turn on its receiver temporarily to listen for polling messages from the OLT, as Röger teaches. Pet. 11–12, 14–15, 19; Ex. 1003 ¶¶ 70, 74.” slip op. at 26
Patent outcomesUS 9,806,892 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,806,892 - PTAB · Dec 10, 2025 · IPR2025-01069 · APJ Daniel J Galligan · IPR · Institution
The Board instituted IPR on claims 1–14 and all asserted grounds, finding a reasonable likelihood of prevailing based on Bharadwaj alone and Bharadwaj with Yu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute review. Paper 11. The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless the information presented in the Petition and the Preliminary Response shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons explained below, we institute an inter partes review of all challenged claims on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Patent Owner contends that a person of ordinary skill in the art need not be defined as of the critical date, we disagree. Under Section 103, we must determine “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains” (emphasis added). “Obviousness is determined from the vantage point of a hypothetical person having ordinary skill in the art to which the patent pertains.” In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). Thus, we define the hypothetical person of ordinary skill in the art as of a time before the effective filing date. To the extent Patent Owner’s argument is that, to testify from the perspective of a person of ordinary skill in the art, one need not have been a person of ordinary skill in the art as of the critical date, we agree. Although one must at least possess ordinary skill in the art to testify from the perspective of a person of ordinary skill, [a]n expert need not have acquired that skill level prior to the time of the invention to be able to testify from the vantage point of a person of ordinary skill in the art. Rather, an expert can acquire the necessary skill level later and develop an understanding of what a person of ordinary skill knew at the time of the invention. Osseo Imaging, LLC v. Planmeca USA Inc., 116 F.4th 1335, 1341 (Fed. Cir. 2024). the uncontested assessment offered by Petitioner, which appears consistent with the ’077 patent and the asserted prior art, except that we delete the qualifier “at least” to eliminate vagueness as to the amount of experience.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“C. Claim Construction The parties agree that no claim terms require express construction. Pet. 10; Prelim. Resp. 2–4. Patent Owner, however, notes that, in related district court litigation, Petitioner has asserted that some claims terms are indefinite. Patent Owner argues that the Petition should be denied because Petitioner has taken inconsistent claim construction positions between the district court and the Board. Paper 14 at 1–3 (citing Tesla, Inc. v. Intellectual Ventures II LLC, IPR2025-00340, Paper 18 at 4 (PTAB Nov. 5, 2025) (informative); Revvo Techs., Inc. v. Cerebrum Sensor Techs., Inc., IPR2025-00632, Paper 20 at 4–5 (PTAB Nov. 3, 2025) (precedential)). Petitioner responds that, in the related district court litigation, the parties have narrowed the claim construction disputes and that Petitioner accords the plain and ordinary meaning to claim terms and no longer asserts that any claim term of the ’077 patent is indefinite. Paper 15 (citing, inter alia, Ex. 1126 (Defendants’ Responsive Claim Construction Brief)). The evidence supports Petitioner’s position because, in the related district court litigation, the defendants agree with the plaintiff (Patent Owner) that certain phrases in the ’077 patent claims should be given their “[p]lain and ordinary meaning” and are “not indefinite.” Ex. 1126, 6 (native page 1). Thus, the record does not show inconsistent claim construction positions that warrant denial under PTAB precedent. See Revvo, Paper 20 at 5 (addressing a situation in which a petitioner advances “different claim construction positions” in district court and at the PTAB). 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 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“We agree with Patent Owner that Bharadwaj includes subject matter that is not in Bharadwaj-Prov59, namely the change from adding the value Resp. 20; Ex. 1007 ¶ 51 (adding m); Ex. 1006 ¶ 50 (subtracting m); Prelim. Resp. 20. Petitioner, however, points out this change in the Petition and acknowledges that it is after the identified critical date of August 20, 2015. See Pet. 28. Thus, we do not understand Petitioner to be relying on Bharadwaj’s disclosure of subtracting m to determine length, as disclosed in the publication of the non-provisional application, as a prior art disclosure. We understand Petitioner to be relying on disclosures in Bharadwaj-Prov059 for prior art teachings for its obviousness contentions. Patent Owner does not appear to dispute that Bharadwaj-Prov59’s disclosures are prior art, arguing instead that it is improper to rely “on matters in Bharadwaj beyond ‘incorporation by reference’ of the Bharadwaj-Prov59.” See Prelim. Resp. 20–21. On this record, we determine that Bharadwaj-Prov59’s disclosures are prior art as of its June 2, 2015, filing date by virtue of its incorporation by reference into Bharadwaj, a published US patent application. Ex. 1006 ¶ 1; see Pet. 12–13.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,313,077 - 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 - Salvacion USA, Inc. v. Trutek CorpAll claims unpatentablePTAB · Dec 2, 2025 · IPR2024-00711 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–3 and 8 are unpatentable as anticipated by Chen, Baker, Wahi ’005, and, for claims 1, 2, and 8, Rolf; the Board also finds them obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision, we adopted Petitioner’s definition of a person of ordinary skill in the art (“POSITA”) as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Based on our consideration of the full record, we maintain our determination that a POSITA at the time the application for the ’802 patent was filed “would have had at least an undergraduate degree in pharmacy, chemistry, biochemistry, biomedical engineering or a closely related field, such that the POSITA generally understand[s] pharmaceutical formulation.” Pet. 12. Additionally, we agree with Petitioner that “[a] POSITA would be familiar with the chemical ingredients in the [’802] Patent, biocidic agents, and cationic agents, have knowledge of airborne particles including viruses and bacteria, and understand electrostatic fields, electrostatic attraction and repulsion, adhesion and cohesion.” Id. (citing Ex. 1002 ¶¶ 38–39).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“of independent claims 1, 2, and 8 as limiting. Inst. Dec. 7–8. The parties do not dispute our construction of the preambles of claims 1, 2, and 8 as limiting. See generally PO Resp.; Pet. Reply 2–4. After consideration of the full trial record, we maintain our construction of the preamble of claims 1, 2, and 8 as limiting for the reasons set forth in our Institution Decision. Id. Briefly, the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body are used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“After consideration of the full trial record, we maintain our construction. From our perspective, the claims themselves support this construction as the claims expand upon the term “electrostatically inhibiting” with specific means for achieving such inhibition. Specifically, claims 1 and 2 recite electrostatically attracting the particulate matter, holding the matter in place, and inactivating the matter. Additionally, the Specification supports our construction as it describes the use of “an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless.” Ex. 1001, 3:36–40; PO Resp. 10 n.6.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“We adopt the parties’ construction of “adequate impermeability” that has been accepted in the related district court litigation: “Adequate impermeability” refers to the “thin film holding harmful particles in place and inhibiting them from penetrating the thin film and contacting the skin or tissue of an individual’s nasal passages. This is done by varying the concentration of ingredients . . .[,] thereby adjusting the adhesion and cohesion of the thin film.” Pet. Reply 3 (quoting Ex. 1010, 17). Furthermore, as stated in our Institution Decision, along with that term, the claim language explains that the thin film is meant to stick to the skin or tissue and to hold the particulate matter in place. Inst. Dec. 9–10. The claim language also explains that the cohesion of the formulation is adjusted to provide adequate impermeability to the thin film. Thus, it is reasonable to consider the recited impermeability is a function of the cohesive properties of the thin film, and that such impermeability refers to a property of the thin film, i.e., inhibiting the penetration or passage of matter through it onto the skin or tissue at the application site.” slip op. at 10
Patent outcomesUS 8,163,802 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - 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
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.