- Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyInstitution deniedPTAB · Jan 29, 2025 · IPR2024-01178 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Bio-Rad did not show a reasonable likelihood of proving any challenged claim unpatentable, as relied-upon Saxonov disclosures were not shown to qualify as prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314. Upon considering the parties’ arguments and evidence, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of the challenged claims.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“benefit of its provisional application’s filing date for pre-AIA 35 U.S.C. § 102(e) prior art purposes when two conditions are met: (1) the provisional provides sufficient support for at least one claim in the reference patent or published patent application; and (2) the provisional application provide sufficient support for the subject matter relied upon for prior art purposes in the reference patent or application. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1377, 1381–82 (Fed. Cir. 2015); MPEP §§ 2136 (I), 2136.03 (III), 2136 (Examples 2, 4, 7); see, e.g., Google LLC v. Ikorongo Tech, LLC, IPR 2021-00058, Paper 14 at 10–12 (PTAB May 10, 2021). The burden of production is on the Petitioner to show in its Petition that the asserted references qualify as prior art. See Dynamic Drinkware, 800 F.3d at 1380 (explaining that a petitioner bears the initial burden of production to establish that the asserted references qualify as prior art).” slip op. at 18
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“Each of the remaining grounds asserted in the Petition relies on Saxonov to reach a number of limitations of independent claim 1 and the challenged dependent claims. Because Petitioner has not shown that all of the relied-upon portions of Saxonov are prior art to the ’170 patent, we determine that Petitioner has failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’170 patent in any of the remaining grounds.” slip op. at 24
- PTAB / AIA Trials › Discretionary denialNot reached
“Because we deny institution upon consideration of the merits of Petitioner’s challenges, Patent Owner’s argument that we should exercise our discretion under 35 U.S.C. § 314(a) to deny institution is moot.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,770,170 - Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyInstitution deniedPTAB · Jan 29, 2025 · IPR2024-01177 · APJ Erica A Franklin · IPR · Institution
Institution was denied for claims 1–9 because Bio-Rad did not show a reasonable likelihood of unpatentability on any ground relying on Saxonov, which was not established as prior art.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage in the proceeding, Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 26. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’051 patent and the cited art, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner has identified certain claim terms for which it has proposed constructions in a parallel proceeding. Pet. 27–29. Petitioner notes that it has that “[o]ther terms, as used herein, are consistent with Patent Owner’s arguments and positions in the parallel proceeding,” without identifying those terms. Id. at 28. Patent Owner requests that the Board adopt Patent Owner’s proposed constructions from the parallel proceeding for certain claim terms. PO Prelim. Resp. 26–27. Neither party provides a discussion for their proposed constructions. In any event, for purposes of this Decision, we determine there is no need to expressly construe any claim term, as the parties appear to agree to the ordinary and customary meaning of the identified terms.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“benefit of its provisional application’s filing date for pre-AIA 35 U.S.C. § 102(e) prior art purposes when two conditions are met: (1) the provisional provides sufficient support for at least one claim in the reference patent or published patent application; and (2) the provisional application provides sufficient support for the subject matter relied upon for prior art purposes in the reference patent or application. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1377, 1381–82 (Fed. Cir. 2015); MPEP §§ 2136 (I), 2136.03 (III), 2136 (Examples 2, 4, 7); see, e.g., Google LLC v. Ikorongo Tech, LLC, IPR2021-00058, Paper 14 at 10–12 (PTAB May 10, 2021). The burden of production is on the Petitioner to show in its Petition that the asserted references qualify as prior art. See Dynamic Drinkware, 800 F.3d at 1380 (explaining that a petitioner bears the initial burden of production to establish that the asserted references qualify as prior art).” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“explains how each of the relied-upon disclosures in Saxonov Figures 9 and 10, and Saxonov paragraphs 17, 18, 37, 76, and 79, which are not present in the ’013 provisional, are supported by the ’013 provisional, we determine that Petitioner has not shown that those cited portions of Saxonov are entitled to the priority date of the ’013 provisional. Accordingly, on this record, we determine that those relied-upon portions of Saxonov do not qualify as prior art to the ’051 patent.” slip op. at 24
Claim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 10,068,051 - PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution
The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.… Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSRPatents in suitUS 11,844,943 - PTAB · Jan 27, 2025 · IPR2024-00965 · APJ Zhenyu Yang · IPR · Institution
Instituted review of claims 1–6 on all asserted grounds because Petitioner showed a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedInstituted
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 20; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for purposes of institution, Petitioner has met its burden to show a reasonable likelihood that Gloor was publicly accessible before the priority date of the ’200 patent. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“institution under § 325(d). Prelim. Resp. 21–29. Under 35 U.S.C. § 325(d), in determining whether to institute an inter partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 11
§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,768,200 - PTAB · Jan 27, 2025 · IPR2024-01197 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims, 1–40, and all petitioned grounds after finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not proposed a definition of a person of ordinary skill in the art in its Preliminary Response. On the current record, for purposes of this Decision, we apply Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’729 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We note, however, that the open-ended language “at least” and “or more” expands the range of experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s formulation.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner bears the burden of stating “[h]ow the challenged claim is to be construed.” 37 C.F.R. § 42.104(b)(3). However, only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . 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))). Based on the preliminary record, we find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. Any final written decision entered in this case may include express” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Conclusion as to Ground 1 Based on the foregoing discussion, and having considered the arguments and evidence presented by Petitioner, including the presently unrebutted testimony of Dr. Parr, we are persuaded Petitioner has shown a reasonable likelihood of prevailing with respect to Ground 1 sufficient for purposes of institution. E. Other Asserted Grounds of Unpatentability Having determined that Petitioner meets the threshold showing necessary to support institution of review based on the ground that asserts obviousness over Dohil in view of the knowledge of a POSA, we decline to address whether any other ground asserted in the Petition also supports institution. See Pet. 15–16 (grounds chart); see also SAS, 138 S. Ct. at 1359–60 (requiring the Board’s final written decision to address every claim the petitioner presents for review); Patent Trial and Appeal Board Consolidated Trial Practice Guide7 (“Trial Practice Guide”) (Nov. 2019) 11 (“The Board will not institute on fewer than all claims or all challenges in a petition.”); PGS Geophysical, 891 F.3d at 1359–1360. We emphasize our determination in this Decision is not a final determination on the construction of any claim term or the patentability of any challenged claim and, thus, leaves undecided any factual issues necessary to determine whether sufficient evidence supports Petitioner’s contentions by a preponderance of the evidence in the final written decision.” slip op. at 23
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“additional evidence and facts presented in the Petition warrant reconsideration of prior art or arguments,” we agree with Petitioner that the Examiner materially erred because the Examiner did not have the benefit of the teachings of the FDA Guidance, which Petitioner relies on in Grounds 1 (Dohil) and 3 (Dohil and Venkatesh) as representative of the knowledge of a POSA with regard to orally disintegrating tablets. See, e.g., Pet. 23.” slip op. at 36
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,771,729 - PTAB · Jan 27, 2025 · IPR2024-00964 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–8 based on both asserted obviousness grounds: Parameswaran with Gloor and Parameswaran with Bentley.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on the ground raised in the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We agree with Patent Owner that testimony from a “custodian with any personal knowledge of arXiv.org or its regular practices” would have strengthened Petitioner’s argument that Gloor is prior art. See Prelim. Resp. 27; see also, e.g., Murray & Poole Enters. LTD v. Institut De Cardiologie De Montreal, IPR2023-01064, Paper 49 (PTAB Jan. 14, 2025) (considering testimony regarding the internet archive service known as the Wayback Machine (https://web.archive.org/) in determining public accessibility). At the institution stage, however, Petitioner needs to show that Gloor qualifies as prior art by “a reasonable likelihood” standard. See Hulu, LLC, v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential) (“[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.”). We find that, for the purposes of institution, with Dr. Gloor’s declaration and the supporting exhibits attached therein, Petitioner has met this burden. To prevail in this inter partes review, Petitioner must meet the preponderance of the evidence standard. See 35 U.S.C. § 316(e). Thus, we encourage the parties to fully develop the record during trial to facilitate the ultimate resolution of this issue.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“detailed analysis to support its argument that the combination of Parameswaran and Gloor teaches or suggests each limitation of claim 1. Pet. 23–36. Petitioner also contends that an ordinarily skilled artisan would have been motivated combine the teachings of the two references and would have had a reasonable expectation of success in doing so. Id. at 36–45. Patent Owner counters that the combination does not teach or suggest two limitations, namely the amplifying and discarding steps of the method. Prelim. Resp. 18–24. Patent Owner also challenges Gloor’s prior art status. Id. at 24–28. Based on the current record, we find Petitioner’s argument with respect to the amplifying and discarding steps more persuasive. With respect to the remaining limitations, we find persuasive Petitioner’s analysis on the prior art’s teachings. We also find persuasive Petitioner’s analysis on the motivation to combine and reasonable expectation of success. For the purposes of institution, we adopt those analyses as our own. We address Patent Owner’s counterarguments below.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“cross-over events (id. at 18–21). Based on the current record, we find Petitioner’s argument more persuasive. Petitioner relies on the combination of Parameswaran and Gloor as teaching the amplifying step. See Pet. 31–33. As such, Patent Owner cannot show non-obviousness “by attacking references individually.” In re Keller, 642 F.2d 413, 426 (CCPA 1981). Patent Owner argues that “because Parameswaran used pyrosequencing on the surface of beads in a Roche 454 sequencer, it does not disclose the formation of clusters.” Prelim. Resp. 21 (citing Pet. 31). Petitioner, however, relies on Gloor for teaching “amplifying said nucleic acid templates on a surface of a flow cell thereby to form clusters.” Pet. 31–32. Patent Owner does not challenge this reliance. See generally Prelim. Resp. Patent Owner contends that Petitioner “equat[es] the claimed chimeric sequences with ‘mismatched’ or ‘misassigned’ sequences containing an ‘unexpected’ pair of forward and reverse barcode motifs identified in Parameswaran.” Prelim. Resp. 18–19. But, according to Patent Owner, “Petitioner does not point to any disclosure in Parameswaran identifying these “mismatched” motifs as chimeric sequences—as opposed to mere sequencing or sample handling error—nor does Petitioner cite any disclosure in Parameswaran regarding such sequences resulting from cross-over events.” Id. at 19. We find Patent Owner’s characterization of Petitioner’s argument inaccurate. As we understand it, Petitioner does not “equat[e]” the claimed chimeric sequences with “mismatched” sequences in Parameswaran. Instead, as Patent Owner acknowledges, “Petitioner argues that ‘sequences with mismatched barcode motifs’ in Parameswaran ‘include chimeric sequences resulting from cross-over events.’” Id. (quoting Pet. 32) (emphasis added).” slip op. at 14
§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,041,852 - PTAB · Jan 13, 2025 · IPR2024-01156 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all grounds, finding it more likely than not that the claims are unpatentable.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On the current record, there is no controversy over the meaning of any of the claim terms and neither party identifies a claim construction that would impact our analysis. We therefore find that, at this stage of the proceeding, there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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
- Skill levelSkill level petitioner adoptedDecided for petitioner
“VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts (without opposition): A person of ordinary skill in the art (“POSA”) at the time of invention would have a working knowledge of microbiology and would have been involved in developing testing methodologies for analysis of samples such as food products (“validation methodologies”). The POSA would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies. The POSA would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The motivation-to-combine analysis is a flexible one. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed,” [but the] “analysis ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’” Intel Corp. v. PACT XXP Schweiz AG, 61 F.4th 1373, 1379–80 (Fed. Cir. 2023) (quoting KSR, 550 U.S. at 418, 420 (emphasis added)). “[I]f there’s a known technique to address a known problem using ‘prior art elements according to their established functions,’ then there is a motivation to combine,” because KSR explains that “if a technique has been used to improve one device [or method], and a person of ordinary skill in the art would recognize that it would improve similar devices [or methods] in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1380 (quoting KSR, 550 U.S. at 417; and Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 797 (Fed. Cir. 2021)). If addressing a known problem, the prior art combination need not be “the best option, only . . . a suitable option.” Id. (quoting Intel, 21 F.4th at 800 (emphasis original)).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,845,486 - PTAB · Jan 13, 2025 · IPR2024-00186 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review on all challenged claims and all 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
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “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.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Office (“USPTO”) issued a Memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings With Parallel District Court Litigation” (“Memorandum”)11, which states, among other things, that “the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have 11 Available at www.uspto.gov/sites/default/files/documents/interim_proc_ discretionary_denials_aia_parallel_district_court_litigation_memo_2022 0621_.pdf. reasonably been raised before the PTAB.” Memorandum 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). By email dated November 25, 2024, Petitioner requested leave to file a Reply to Patent Owner’s Preliminary Response to address, inter alia, its proposed submission of a Sotera stipulation. Ex. 3001. We denied Petitioner’s request for briefing, but granted its request to submit the stipulation. Id. The Sotera stipulation avers that “if IPR Nos. IPR2024- 00183, IPR2024-00185, and IPR2024-00186 are instituted, National Beef will not pursue in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat’ / Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023), any ground National Beef raised or reasonably could have raised in the aforementioned IPRs,” and that the stipulation “binds National Beef in the related district court proceeding, Inst. for Envtl. Health, Inc. v. Nat'l Beef Packing Co., LLC, No. 1:23-cv-00826 (D. Del. Aug. 1, 2023).” Ex. 1064. Applying the guidance provided in the Memorandum, we decline to exercise our discretion to deny institution in this proceeding under Fintiv because Petitioner submitted a Sotera stipulation.” slip op. at 20
- BurdenInstituted
“Thus, Petitioner has accounted for each step/element of independent claims 1 and 37 as taught by the combination of ICMSF and Gombas, and has also provided a reason why, with rational underpinnings, the prior art would have been combined and modified, with a reasonable expectation of success. On the current record, including Patent Owner’s arguments that we considered and are addressed in detail below, Petitioner’s evidence for this ground is sufficient to provide a reasonable likelihood of success in demonstrating unpatentability of at least one claim.” slip op. at 31
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. We also agree with Patent Owner that the ’771 patent provides definitions that guide the understanding of the term “lots” including: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of products of a production process, etc.), where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g., proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1003, 5:43‒54. The ’771 patent similarly provides definitions for “product portion,” “test lot sample,” and “composite lot-unit” that provide significant guidance and clarity as to the meaning of these terms. Ex. 1003, 5:60‒6:4, 6:12‒29, 7:49‒63. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). We decline to expressly interpret this term at this time.” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,637,771 - PTAB · Jan 13, 2025 · IPR2024-00185 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–7, 11, 12, 14–20, 22–24, 26, and 29–36 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION After considering the evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’143 Patent is unpatentable. In particular, because Petitioner has demonstrated a reasonable likelihood that at least one claim is rendered obvious by the asserted combinations of ICMSF, Hughes, and Price, we institute inter partes review on all grounds set forth in the Petition. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim or the construction of any claim term. Thus, our view with regard to any conclusion reached in the foregoing could change upon consideration of Patent Owner’s merits response and completion of the record.” slip op. at 54
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction may impact our decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)). We also agree with Patent Owner that the ’143 patent provides definitions that guide the understanding of the term “lots” including teaching: The term “test lot” or “reportable lot” as used herein to refer to an assemblage of one or more specimens of a medium or process (e.g. assemblage of specimens of air, water, solids or of product of a production process, etc.) where such assemblage can be sampled by taking portions of the one or more specimens thereof, and where the one or more specimens of the assemblage are operationally linked in a manner (e.g. proximity, time, process step, etc.) whereby information derived about sampled portions is operationally applicable to all specimens of the assemblage, and thus to the test lot. In particular instances, portions are synonymous with specimens. Ex. 1002, 5:34–45. The Specification similarly provides definitions for “product portion,” “test lot sample,” and “single-unit production lot” that provide significant guidance and clarity as to the meaning of these terms. Id. at 5:52–63, 6:2–20.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“validation” as used herein with respect to production lots refers to determining that a particular sample tests negative using the detection assay. Where a modular composite sample tests negative, all single-unit production lot samples comprising the composite sample are validated along with the respective single-unit production lots, which are thus cleared for release. Where a modular composite sample tests positive, individual single unit production lots may nonetheless yet be validated if particular respective single-unit production lot samples test negative. Ex.1002, 7:15–24 (emphasis added). The above text expressly equates “validation” to a determination that “a particular sample tests negative.” The initial definitional sentence makes no mention of “cleared for release” as necessary for “validation.” The subsequent sentence refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and, even then, the “cleared for release” language indicates a separate step that may happen after the samples are “validated.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“On the current record, we are not persuaded that Petitioner has insufficiently articulated a motivation to combine or modify the asserted references. With respect to Ground 1, for example, Petitioner contends that one of ordinary skill in the art would have been motivated to modify ICMSF based on Gombas under the teaching-suggestion-motivation test so portions of the enriched, retained samples are further tested after a positive test of a composite sample by the same protocol, with a reasonable expectation of success for efficient validation. See § XII-A-1-h supra; Dickson ¶¶ 417-19. Pet. 53–54. Petitioner further argues that ordinarily skilled artisan would have sought to improve[] ICMSF with the similar methods of Gombas to yield efficient validation, which is a predictable result. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In this combination, a POSA would have simply substituted steps of ICMSF, as described above, with those of Gombas so portions of the enrichment cultures are retained and are further tested after a positive test of a composite sample by the same protocol for predictably efficient validation. MPEP § 2143(I)(B); Dickson ¶ 420. Id. at 53. As such, the Petition provides specific reasons to combine ICMSF and Gombas that are consistent with the flexible test recited in KSR, including the benefit of efficient validation of the test and that the combination is a simple substitution of steps. As KSR notes, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 US at 417. Here, Petitioner has made its reasons to combine explicit. See Pet. 53–” slip op. at 47
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,822,143 - PTAB · Jan 13, 2025 · IPR2024-00183 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–6, 10, 11, 13–20, 22, 23, and 26–33 because the asserted combinations of ICMSF, Hughes, and Price showed a reasonable likelihood that at least one claim was obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“314. 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.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); 37 C.F.R. § 42.108(a). After considering the evidence and arguments presented in the Petition, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’584 patent is unpatentable. Accordingly, we institute an inter partes review as to the challenged claims of the ’584 patent on the grounds of unpatentability set forth in the Petition. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention (POSA/POSITA), “would most likely have an advanced degree in microbiology, food science, or animal science and at least two years of work experience but may alternatively have a bachelor’s degree in those areas and at least four years of experience with validation methodologies.” Pet. 11. (citing Ex. 1041 ¶¶ 22–24). Petitioner further contends that a person of ordinary skill in the art would have had “a working knowledge of microbiology,” “would have been involved in developing sampling and testing methodologies for analysis of food products (“validation methodologies”),” and “would have been familiar with relevant scientific literature and industry regulations, directives, and guidelines relating to validation methodologies.” Id.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the term “lots” does not require construction because on the current record, there is no controversy over the meaning of the term, and neither Petitioner nor Patent Owner identify any way that claim construction impacts the decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“This definition requires that a “validation” determines that “a particular sample tests negative.” The initial definition sentence makes no mention of “cleared for release” as necessary for “validation.” Rather, the definition only refers to “cleared for release” in the more limited situation where a particular composite sample “tests negative all single-unit production lot samples,” and even then, the “cleared for release” is a separate step that occurs after the samples are “validated.”” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 7,534,584
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.