- PTAB · Sep 9, 2025 · IPR2025-00440 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claim 21 on both asserted § 103 grounds, finding a reasonable likelihood that claim 21 is obvious over Mizumura with the ’498 PCT and over Mizumura with McClymont.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claim of the ’318 patent is unpatentable. Accordingly, we institute an inter partes review of the challenged claim on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Nevertheless, we determine that the contrary evidence Petitioner has cited suffices to establish a reasonable likelihood of success at this preliminary stage of the proceeding. In this regard, we also note Dr. Jain’s testimony — currently unrebutted — that an ordinarily skilled artisan would have known, based on Tokunaga’s sequence comparisons of Factor C proteins, that “certain sequence differences between [Limulus polyphemus] and Tachypleus tridentatus were non-conservative (i.e., potentially giving rise to changes in function in terms of enzymatic activity of Factor C).” Ex. 1002 ¶ 94 (citing Ex. 1022, 157). We likewise note Dr. Jain’s testimony that such artisan would have recognized Tokunaga’s conclusion, regarding “immunological and biochemical properties” of Factor C proteins of the two different horseshoe crab species, to be “based on only gross biophysical-biochemical properties” that are not “granular enough” to predict functional properties such as residual activity in presence of specific ions. Ex. 1002 ¶ 100.” slip op. at 22
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledOther
“submitted in a different proceeding and in a different forum, and our rules contemplate objections to admissibility only after institution. See 37 C.F.R. § 42.64(b)(1) (“Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial.”); also compare Fed. R. Evid. 801(c) (defining hearsay as a statement, not made at the current trial or hearing, “offer[ed] in evidence to prove the truth of the matter asserted”), with Fed. R. Evid. 801(d)(2) (excluding from hearsay statement offered against an opposing party where statement was made by “a person whom the party authorized to make a statement on the subject” or by a “party’s agent or employee on a matter within the scope of that relationship and while it existed”). Nevertheless, as discussed above, Petitioner has provided contrary evidence, including statements from Patent Owner’s patent application, suggesting that, “due to the various differences and diversity of biomolecules depending on the genus and species of the horseshoe crab,” it had not been possible “to accurately determine the full-length sequence structure, expression, and function of [Limulus] proteins and genes using conventional methods” more than 20 years after complete gene and amino sequences from two Tachypleus horseshoe crab species had been reported. Pet. 35 (citing, e.g., Ex. 1005 ¶¶ 12–17). Thus, even if we were to take the Frohman Declaration into account, we find that Petitioner has established a reasonable likelihood 28 of success that the ’767 application disclosures did not enable an ordinarily skilled artisan to make and use the invention of the challenged claim without undue experimentation. Furthermore, assuming that the disclosures in ’767 application would have enabled an ordinarily skilled artisan to express recombinant Limulus polyphemus Factor C protein in HEK293, we find Petitioner has established, sufficient for purposes of institution, that the disclosures do not enable an ordinarily skilled artisan to make such a protein exhibiting the “full scope” of the claimed residual activity, without undue experimentation. Patent Owner cites to disclosures in the ’767 application that (1) describe how to produce recombinant Factor C in HEK293 cells and measure residual activity, (2) suggest “Factor C expressed in mammalian cells can have low susceptibility to activity inhibition by ions,” and (3) provide examples where residual activity met the required minimum. Prelim. Resp. 26–27, 32–34. Nevertheless, whether an ordinarily skilled artisan would have been able to make, based on these disclosures and without undue experimentation, a recombinant Factor C protein having residual activity encompassed by claim 21 but higher — even significantly higher — than that achieved in the example, is a fact intensive issue that would benefit from further development during trial.15 See, e.g., In re” slip op. at 28
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’767 application does not provide adequate written description support for claim 21 of the ’318 patent and that, accordingly, Mizumura, the ’498 PCT, and McClymont qualify as prior art to the challenged claim.” slip op. at 19
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,236,318 - PTAB · Jul 16, 2025 · PGR2025-00012 · APJ Debra L Dennett · PGR · Institution
Instituted PGR on claims 1–3 based on five grounds; the Board found each ground met the institution threshold on the preliminary record.
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). A post-grant review may also be instituted when “the petition raises a novel or unsettled legal question that is important to other patents or patent applications.” See id. § 324(b). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the 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 of the ’201 patent.” slip op. at 2
- Skill levelSkill level board ownOther
“At this stage of the proceedings, neither Petitioner’s nor Patent Owner’s proffered definitions of the level of skill appear appropriate. Petitioner’s proposal requires as little as a bachelor’s degree in organic chemistry and two years of experience as a laboratory technician working on development of molecules with targeted biological activity, and an ambiguous “understanding” of certain processes. Patent Owner’s proposal, other the other hand, requires multiple years of both formal training and actual, practical experience in highly specialized fields that involve detection of optical or radiolabeled compounds and use of molecular imaging techniques such as PET and SPECT. For the purposes of this decision, on the record at this time, we find that a POSA would have had a Ph.D. in chemistry, biochemistry, or a comparable field or an M.D., and at least four years of experience in chemical synthesis of compounds that may be used to target biologically-significant tissues. This definition 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). The parties will have the opportunity to cross-examine Dr. Martin and Dr. VanBrocklin in this proceeding to develop a full record for us to determine the weight that each expert’s testimony should be given. We invite the parties to further brief the definition of a POSA here, and whether we should discount either experts’ testimony due to lack of qualifications.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“c) Analysis On the present record, we find that “low molecular weight” is not limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration all concerns metabolomics and metabolites, and we find no reason that even a vague definition of metabolites applies to the claimed compounds. See Ex. 1002, ¶ 102. Moreover, the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’201 patent fall outside of Patent Owner’s proposed definition is persuasive (see id., ¶ 103), as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts’” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically form about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) The Pomper reference (Ex. 1006) also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 2002, ¶ 60; Ex. 1006, ¶ 12. The table giving the molecular weight of a “selection of compounds disclosed by Pomper” (see Ex. 2002, ¶ 62) is not persuasive in defining “low molecular weight,” as it does not explain how those included were “selected” and does not include molecular weights for all of the examples.7 In addition, Patent Owner’s definition does not appear to apply to all claimed compounds.8 7 At least one of the examples (SRV73) not included in the table appears to have a molecular weight well over “about 1,500 Daltons.” 8 See, e.g., claim 113 of Ex. 1006. Patent Owner’s arguments distinguishing “low molecular weight” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“The ’201 patent defines “alkyl” as “a straight (i.e., unbranched) or branched chain, acyclic or cyclic hydrocarbon group, or combination thereof” “ that has “the number of carbon atoms designated (i.e., C1–C10 means one to ten carbons, including 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 carbons)” and “[i]n particular embodiments, the term ‘alkyl’ refers to C1-20 inclusive, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 carbons” “unless otherwise stated.” Ex. 1001, 39:44–58. Although substituents at the R1x position in the claims are limited to “C1-6alkyl,” those at position R3x are not. Ex. 1001, Certif. Corr. Patent Owner’s representation that “Jansen I provides ‘the following definitions’ stating that ‘alkyls groups of this invention comprise from 1 to 6 carbon atoms’” is inaccurate. See Prelim. Resp. 19. In fact, Jansen I states: The term “alkyl” by itself or as part of another substituent refers to a fully saturated hydrocarbon of Formula CxH2x+1 wherein x is a number greater than or equal to 1. Generally, alkyl groups of this invention comprise from 1 to 6 carbon atoms. Alkyl groups may be linear or branched and may be substituted as indicated herein. When a subscript is used herein following a carbon atom, the subscript refers to the number of carbon atoms that the named group may contain. Ex. 1007, 22:16–23 (emphasis added). Neither the ’201 patent nor its incorporation by reference of Jansen I would have conveyed to a POSA that the “(CO)alkyl” of the substituent in the R3x position in the claims is intended to comprise from one to six carbon atoms or is limited to any particular length and size. “(C(O)alkyl,” having no number of carbon atoms designated, means” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,938,201 - PTAB · Jun 6, 2025 · IPR2025-00140 · APJ James A Worth · IPR · Institution
The Board instituted IPR of claims 1–18 on all petitioned challenges, finding a reasonable likelihood that at least claim 1 is obvious over Nakajima and the knowledge of a person of ordinary skill.
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 filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of claims 1–18 of the ’250 patent is unpatentable, and we institute an inter partes review of claims 1–18 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) would have had an undergraduate degree in mechanical engineering or equivalent coursework, and a year or more of experience in designing, prototyping, and/or manufacturing fluid containers or similar products. Pet. 15 (citing Ex. 1002 ¶ 25). Petitioner asserts that more work experience may substitute for a lower level of education, and vice versa. Id. Patent Owner admittedly sets forth “a similar, though slightly different, level of ordinary skill”: a bachelor’s degree in mechanical experience with liquid-containing devices, with more work experience substituting for less education and vice versa. Prelim. Resp. 28 (citing Ex. 2001 ¶ 50). Patent Owner discerns no material difference between the definitions provided by the parties for purposes of the Board’s decision on whether to institute this proceeding. Id. For purposes of this decision, we adopt Petitioner’s proposed level of skill as being consistent with the prior art, although our conclusion on whether to institute would be unchanged under either definition.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“For purposes of this decision on institution, we adopt the proffered dictionary definition of “mouthpiece” as “a part (as of an instrument) that goes in the mouth or to which the mouth is applied” (see Ex. 2005), and we construe this as an intended use of this component of the apparatus, because this definition is consistent with the plain and ordinary meaning of the term which is a compound of “mouth” and “piece” and also because this definition is consistent with the Specification. For example, the Specification describes the use of the mouthpiece as follows: “In use, the mouthpiece is adapted to be configured to the dispensing configuration by a user placing the mouthpiece in the user’s mouth and biting upon or otherwise compressing the appropriate portions of sidewalls 92 of the mouthpiece.” Ex. 1001, 8:45–49. We note that, although the Specification refers to bite-actuation of the mouthpiece, for example in the field of the disclosure and certain embodiments (e.g., Ex. 1001, 1:25–27), the independent claims do not require bite-actuation. The Specification identifies the mouthpiece as item 72 (which is depicted, for example, in Figure 25, reproduced supra). Ex. 1001, 3:7‒8. 7 Exhibit 2005 appears to be from an online Merriam-Webster dictionary accessed March 13, 2025. Ex. 2005, 4. At this time, there is no argument in the preliminary record that this definition would have been different before the critical date of the patent.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although the construction of this limitation may be helpful in deciding the issues of unpatentability, we determine that the construction of this term would benefit from further briefing during the trial phase of this proceeding, and we invite the parties to continue to brief this issue. Therefore, we do not provide a preliminary construction of the term at this time.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,851,250 - PTAB · Apr 21, 2025 · IPR2024-01504 · APJ James A Worth · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 7, 9, and 10 on all petitioned grounds, finding a reasonable likelihood that claim 1 is obvious over Iafrate and Kivioja.
RulingsInstitution decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 21–22. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. Instead, for purposes of this Decision, we find a person of ordinary skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“1. “indexing site” Petitioner argues that the ’357 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 23 (citing Ex. 1004, 4:40–44). Patent Owner does not disagree other than to argue that no claim requires construction. The ’357 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. provide a definition for “indexing site,” and we construe the term in accordance therewith.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“3. “identifying sequence reads with identical identifier and target sequences as duplicates” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary the term “duplicates” means that the sequences are identical. We observe that the ’357 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1004, 4:12–15. The claim does not use the exact wording as the Specification.4” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“4. “comprising” The parties may address the meaning of the transitional phrase “comprising” and whether the prior art meets the claim if the prior art discloses a method of identifying as duplicates those sequence reads with identical labels and target fragments and, in addition also identifies other sequence reads as duplicates, including sequence reads with some mutations resulting from PCR or SBS error. See Ex. 1079 ¶ 117. On this preliminary record, we construe “comprising” as an open-ended transition that is not limited to the listed steps. See Vivid Techs., Inc., 200 F.3d at 811.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,098,357 - PTAB · Apr 21, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Institution
Instituted IPR of claims 1–3, 5–11, and 14–17 on all petitioned grounds; the Board found a reasonable likelihood that at least claim 1 was obvious over Iafrate and Kivioja.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the record at this stage of the proceeding, we determine that Petitioner has made an adequate showing on claim 1’s preamble language.9 Kivioja discloses that “with the UMI method one can reproducibly detect the number of molecules after different numbers of PCR cycles without normalization.” Ex. 1012, 2–3. Dr. Sims opines that a person of ordinary skill would have understood that Kivioja’s method teaches a method of detecting and removing duplicate sequencing reads, i.e., that Kivioja’s method of counting unique sequences necessarily identifies duplicate reads. See Ex. 1079 ¶ 260. 8 We recognize that the burden remains with Petitioner to prove unpatentability of the challenged claims. See 35 U.S.C. § 316(e). 9 We do not need to decide for purpose of institution whether the preamble is limiting.” slip op. at 20
- Skill levelSkill level patent owner adoptedDecided for patent owner
“On this preliminary record, we agree with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 23. However, we disagree with Patent Owner that a POSA only need to “have had experience with DNA sequencing methods” (Prelim. Resp. 8) because an artisan with experience with only pre-NGS sequencing methods would not qualify as a person of ordinary skill. skill would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill is consistent with the skill level reflected in the disclosures of the ’399 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“1. “indexing site” Petitioner argues that the ’399 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 24 (citing Ex. 1003, 4:34–38). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. Ex. 1003, 4:34–38. We understand this passage of the ’399 patent to provide a definition for “indexing site,” and we construe the term in accordance therewith. 2. “indexing primer binding site” Petitioner argues that the ’399 patent defines “indexing primer binding site” as the binding site for a primer used to read the indexing site/sample index, specifically, “a nucleotide sequence for binding a primer for an indexing site.” Pet. 24 (citing Ex. 1003, 4:33–34). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An indexing primer binding site is a nucleotide sequence for binding a primer for an indexing site.” Ex. 1003, definition for “indexing primer binding site,” and we construe the term in accordance therewith. 3. “identifier site” Petitioner argues that the ’399 patent defines “identifier site” as a molecular tag attached to fragments prior to amplification, specifically, “a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Pet. 25 (citing Ex. 1003, 4:43-45). Petitioner argues that an “identifier site” “can be designed as a set of sequences, or it can be semi-random, or it can be completely random.” Id. (citing Ex. 1003, 4:49–51). Petitioner argues that an “identifier site” can also “be a fixed length, or it can be a variable length.” Id. (citing Ex. 1003, 4:51–54). Patent Owner does not disagree other than to argue that no claim term requires construction. The ’399 patent states: “An identifier site is a nucleic acid sequence that comprises random bases and is used to identify duplicate sequencing reads.” Ex. 1003, 4:43–45. We understand this passage of the ’399 patent to provide a definition for “identifier site,” and we construe the term in accordance therewith. 4. “target sequence primer binding site” Petitioner argues that the ’399 patent defines “target sequence primer binding site” as a binding site for a primer used to read the fragment sequence, specifically, a “nucleotide sequence for binding a primer for a target sequence.” Pet. 25 (citing Ex. 1003, 4:62–65). Petitioner also argues that the ’399 patent expressly discloses that this site can be a standard Illumina sequence compatible with an Illumina primer for an SBS reaction to read the DNA fragment. Id. (citing Ex. 1003, 16:48–51 & SEQ ID No. 3). requires construction. The ’399 patent states: “A target sequence primer binding site nucleotide sequence for binding a primer for a target sequence.” Ex. 1003, 4:62–63. The ’399 patent appears to have a typographical error at this juncture in the Specification because the quoted text is missing a verb (e.g., “is”) and is therefore an incomplete sentence. Based on the context of the surrounding parts of the Specification, we infer that the ’399 patent intended to define “target sequence primer binding site” as a “nucleotide sequence for binding a primer for a target sequence.”” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“5. “identifying a duplicate sequencing read as the sequencing read comprising the same identifier site and nucleic acid fragment as another sequencing read in the population of sequencing reads” Although the parties do not request construction of this limitation, we note that the parties may wish to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary to resolve a dispute). For example, the parties may wish to address whether the “same identifier and nucleic acid fragment” means that the sequences are identical. We observe that the ’399 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1003, 4:8–11. The claim does not use the exact wording as the Specification.5” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 9,546,399 - Painteq, LLC v. Orthocision, Inc.InstitutedPTAB · Jul 12, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–23 based on all petition grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the current record, we determine that the Petition demonstrates “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). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a medical or an engineering degree and would have had experience with surgical instruments and implants used for spinal joint fusion, including [sacroiliac (“SI”)] joint fusion.” Pet. 7 (citing Ex. 1002 ¶ 15). At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this Decision. slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. At this stage of the proceeding and for purposes of instituting trial, we determine that there are no terms that require express construction. See” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, based on the current record, we find that the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 9
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,083,511 - Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCInstitutedPTAB · Jun 13, 2023 · IPR2023-00173 · APJ Arthur M Peslak · IPR · Institution
The Board instituted review of claims 1–6 on the asserted obviousness grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“whether to institute an inter partes review under 35 U.S.C. § 314(a). See also 37 C.F.R § 42.4(a) (2021) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not explicitly construe the term “vehicle floor tray” or any other claim term for the purposes of this decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368 (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)). However, we offer the following reasons for not adopting Patent Owner’s proposed construction. Claim 1 recites the term “vehicle floor tray” but does not recite any specific structural details of the tray. Ex. 1001, 19:42–60. Thus, nothing in the claim language suggests the structural aspects of a vehicle floor tray included in Patent Owner’s proposed construction.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, industrial design, or a closely related field, or equivalent formal training, education, or practical experience in a field relating to product design, CAD, or manufacturing.” Pet. 13 (citing Ex. 1003 ¶¶ 27–28). Petitioner further contends that the person of ordinary skill in the art “would also have a minimum of three to five years of experience in plastics engineering, CAD, manufacturing, plastic product design, or a related industry,” but that “a higher level of training or practical experience might make up for less education, and vice-versa.” Id. Patent Owner does not, at this stage of the proceeding, dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 12. For the purposes of this Decision, we apply Petitioner’s proposed level of skill in the art because it appears consistent with the problems addressed in the ’917 patent and the prior art.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In his testimony concerning background prior art, Mr. Perreault relies on two prior art patents that disclose “floor mats” described similarly to Patent Owner’s description of a “vehicle floor tray.” See Ex. 1003 ¶¶ 29–30 (citing Ex. 1013 (“Bailey”); Ex. 1015 (“Tyler”)). Bailey describes a “floor mat” that is “molded or otherwise preformed into a tray-like shape which conforms to the contour of a portion of the carpeted automobile floor. The mat is dimensioned and configured to nest within and abut against the sides of a carpeted floor well of the vehicle.” Ex. 1013, 2:37–42, Fig. 6. Tyler describes “contoured vehicle floor mats” that “mate[] with the vehicle floorboard to hold the mat in place.” Ex. 1013, code (57), 1:52–54. Based on these exhibits, we find that Mr. Perreault’s testimony is not conclusory and not based on an improper definition of floor tray. Based on the present record and after considering Patent Owner’s contentions, Petitioner sufficiently establishes that Stanesic discloses the subject matter of the preamble. In particular, Stanesic discloses “a tray-like central area” and “the raised wall 22 has two walls that rise about one to about two inches from the base 15” (Ex. 1005, 2:61–62), which sufficiently supports Petitioner’s contention that Stanesic discloses, or at least suggests, a vehicle floor tray.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,138,917 - Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCInstitutedPTAB · Jun 13, 2023 · IPR2023-00172 · APJ Arthur M Peslak · IPR · Institution
The Board instituted inter partes review of claims 1–6 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim would be unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“whether to institute an inter partes review under 35 U.S.C. § 314(a). See also 37 C.F.R § 42.4(a) (2021) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“and Cicotte, the dispute for the first prong of the Advanced Bionics framework revolves around whether Rothkop is cumulative of Exhibits 2001, 2002, 2003, and 2004 cited in an IDS considered by the Examiner. Petitioner does not dispute that Cicotte is cumulative of Exhibit 2005 or 2006. See Prel. Reply. For the purposes of the § 325(d) analysis, we will assume, without deciding, that Rothkop is cumulative of at least one of the references Patent Owner relies on, i.e., Exhibits 2001, 2002, 2003, and 2004. We, thus, assume, without deciding, that the first prong of the Advanced Bionics framework is satisfied and move to the second prong. 4. Advanced Bionics Framework, Prong Two: Has Petitioner Demonstrated that the Office Erred in a Manner Material to the Patentability of the Challenged Claims? The ’655 patent issued from an application filed on August 6, 2014.” slip op. at 45
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the following reasons, we do not adopt Patent Owner’s proposed construction. Claim 1 recites a “vehicle floor tray” but does not recite any specific structural details of the tray. Ex. 1001, 19:46–2:2. Thus, nothing in the claim language suggests the aspects of a vehicle floor tray included in Patent Owner’s proposed construction. Patent Owner does not direct us to an explicit lexicographic definition of the term “vehicle floor tray” in the Specification of the ’655 patent. Rather, Patent Owner relies on descriptions of aspects of the embodiment disclosed in Figure 1 of the ’655 patent. For example, the ’655 patent generally describes that “[f]loor trays have sidewalls.” Ex. 1001, 1:58. The ’655 patent states that in an “aspect” of the invention, “a vehicle floor tray has a central panel for the placement on the floor of a vehicle foot well, and at least first and second upstanding panels.” Id. at 5:28–30. In column 7, the ’655 patent describes that “[d]isposed around the central or floor panel 102 are a series of upstanding side panels, which will vary in number and configuration from one vehicle model to the next.” Id. at 7:47–49 (emphasis added). These portions of the Specification suggest that the term “vehicle floor tray” should not be limited to any particular number of side panels or any particular configuration such as the side panels are joined to the floor panel and each other. In the Summary of the Invention, the ’655 patent discloses “a vehicle” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“For the following reasons, Patent Owner’s contentions are unavailing based on the present record. First, as discussed above, Patent Owner’s attempt to draw a distinction between floor trays and floor mats is unavailing based on the present record and undercut by its own exhibits describing Patent Owner’s vehicle floor trays as “mats.” See Ex. 2010; Ex. 2012; Ex. 2013; Ex. 2014. Second, as discussed above, the fact that Petitioner has not shown that someone previously scanned a vehicle footwell is unavailing because this challenge is based on obviousness, not anticipation. Third, the sentence in Rothkop that Patent Owner contends discloses a kind of scanner, not what is to be scanned, is “[t]he data input device may comprise a scanner 12 for scanning a physical part such as an existing seat, frame, or vehicle.” Ex. 1006, 4:61– 63. Based on the present record, we do not agree that this sentence discloses a type of scanner. Fourth, Patent Owner’s arguments concerning the claimed invention creating a new product versus reverse engineering an existing product in Rothkop raises potential fact questions that are best resolved at trial based on a fully developed record. Petitioner provides numerous reasons why a person of ordinary skill in the art would have been motivated to combine Stanesic, Rothkop, and Cicotte in such a manner that teaches or suggests all limitations of claim 1. Pet. 29–34. Petitioner sufficiently supports this reasoning with the testimony of Mr. Perreault that he supports with reference to Stanesic, Rothkop, Cicotte, and other references showing the background art. Ex. 1003 ¶¶ 147–157. Further, Patent Owner does not dispute Petitioner’s conclusion that the combination of Stanesic, Rothkop, and Cicotte “would be nothing more than applying known techniques . . . to a known method of producing a custom-fit vehicle floor tray . . . that is ready for improvement, yielding the predictable result of generating a custom-fit floor tray.” Compare Pet. 33, with Prelim. Resp. Based on the present record and after considering all of Patent” slip op. at 32
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,899,655 - PTAB · Apr 24, 2023 · IPR2023-00074 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 11, and 15 on all asserted grounds, finding a reasonable likelihood that claims 1, 2, 5–7, and 11 are obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on our review of the record, we find that Petitioner has not shown persuasively that the Examiner did not consider the same or substantially the same art that Petitioner relies upon for its obviousness challenges. Petitioner’s grounds primarily rely on three different “May” references, only one of which the Examiner considered during prosecution, i.e., the May Article. The additional primary references relied upon by Petitioner are the May Thesis, which provides a more detailed disclosure than the May Article, and the May Abstract, which provides less detail than the May Article, in terms of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9 vector. Those differences are only material with respect to whether each reference discloses the fragments as recited in independent claim 1, or renders those fragments obvious. As discussed in Section II.D.2., however, we determine that the May Thesis is not prior art. 11 The ’221 application claims priority to provisional application no. 60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29, 2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852 provisional application”), filed on July 2, 2001, referred to, collectively, as “the provisional applications,” “the provisionals” and “the Provisionals.” Article, but in less detail, the May Abstract may be considered cumulative to the May Article. Because the May Thesis provides more explicit details regarding the fragments disclosed in the May Article, it may not be considered to be cumulative to the May Article. However, as discussed in Section II.D.2., we determine that the May Thesis is not prior art. When considering the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the May Article or Patent Owner distinguishes the May Article, we note that Patent Owner alleged during prosecution and here that the May Article is not prior art for a number of reasons, including that it is the work of the inventors and that it was published one year or less before the priority date asserted by Patent Owner for the challenged claims. We note also that Petitioner contends that the challenged claims are not entitled to the priority date asserted by Patent Owner, and recognized by the Examiner. Based on the foregoing, we conclude that substantially the same prior art that Petitioner relies upon was previously presented to the Examiner during prosecution. The first part of the § 325(d) framework is, therefore, met. Accordingly, we turn to the second part of the § 325(d) and determine whether error by the Office has been shown. See Advanced Bionics at 8.” slip op. at 10
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 18–19 (citing Ex. 1002 ¶¶ 14– 15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Based on our consideration of the arguments and evidence presented at this stage of the proceeding, we determine, for purposes of this Decision, that claims 1, 2, 5–7, and 11 of the ’061 patent are not entitled to receive benefit of the filing date for either the ’861 provisional application or the ’852 provisional application. In particular, we find persuasive Petitioner’s arguments that the provisional applications do not satisfy the written description requirements of 35 U.S.C. § 112 for those claims. Independent claim 1 recites, in part, “a recombinant lentiviral vector which comprises a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 11:57–67. Independent claim 11 recites, in part, “a recombinant lentiviral vector comprising a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 12:64–13:7. Based upon our review, we agree with Petitioner that these limitations are not adequately described in the provisional applications. The ’061 patent Specification (and the ’221 Application) describe the term “functional globin gene” as: that does not produce a hemoglobinopathy phenotype, and which is effective to provide therapeutic benefits to an individual with a defective globin gene. The functional globin gene may encode a wild-type globin appropriate for a mammalian individual to be treated, or it may be a mutant form of globin, preferably one which provides for superior properties, for example superior oxygen transport properties. . . . Suitably, the globin may encode α-globin, β-globin, or γ-globin. Ex. 1001, 2:44–55 (emphasis added); see also Ex. 1032, 3:24–4:3 (same). Based on this description, we agree with Petitioner that the ’061 patent claims cover a recombinant vector comprising a nucleic acid encoding a “functional globin” genus that includes wild-type globin and mutant forms of globin, wherein the globin may encode different globin types, i.e., α-, β-, or γ-globin. Patent Owner does not identify, nor do we see, any portion of the provisional applications describing the genus of functional globin. Rather, as Petitioner demonstrates, the provisional applications describe one species of that genus, i.e., the wild-type human β-globin. Pet. 14–18. The provisionals do not describe the “functional globin” genus. Indeed, as Petitioner correctly asserts, during the ’061 patent prosecution, Applicants/Patent Owner, relied on a description of “functional globin,” quoted above, that does not appear and has not counterpart in the provisional applications. Compare Ex. 1001, 2:44–55 and Ex. 1032, 3:24–4:3 with Ex. 1034 and Ex. 1035.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,058,061 - PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,541,179
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.