- PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 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). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00317 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–23 are unpatentable: claims 1–7 and 10–23 as anticipated by Forshew, and claims 1–23 and 1–9 and 11–23 as obvious over Forshew with Wagle and Wagle with Chan, respectively.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner has not subsequently challenged the above definition. See Ex. 2031 ¶ 48 (Dr. Furneaux applying the above definition). For the reasons set forth in our Institution Decision, and because Petitioner’s proposed level is commensurate with the level of skill reflected in the prior art of record, we apply the same definition here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). C. Claim Construction” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“adopt Petitioner’s proposed definition of “capture probes” as encompassing at least, “PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” See DI 18–24. For the reasons set forth in our Institution Decision, and as further addressed below, we apply that definition here—albeit with a minor modification in wording. In particular, we credit Patent Owner’s argument that the phrase “PCR primer capture probe” is not a recognized term of art and its use in our construction “would improperly inject ambiguity into the claim.” POR 58– 59 (citing, e.g., Ex. 2018, 166:10–169:1, 171:16–175:2; Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004)). Although we recognize Petitioner’s use of “PCR primer capture probe” as a shorthand for its position that, as read in light of the Specification, PCR primers are a species of, and/or indistinguishable from, the genus of capture probes, Patent Owner’s point is well taken. Accordingly, we clarify the meaning of “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). We do not view this modification as altering the substance of our provisional construction or the analysis in our Institution Decision.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“Ex2112, slide 5 for the ‘plurality of capture probes’ limitation of step 1(a),” Petitioner contends that its “bare reference to ‘pullout’” suggests at most, “that by May 2012, Mr. West contemplated that a particular type of capture probe would be among many other ‘lab solutions’ for addressing accuracy.” Reply 7–8; see Ex. 1225 ¶¶ 123–126. In this respect we note Mr. West’s testimony that he understood “pullout” in Slide 5, as a reference to Agilent SureSelect biotinylated probe system. See Ex. 1222, 83:8–85:22, 88:7–16. We, nevertheless, find persuasive Dr. Quackenbush’s testimony that “a POSA reviewing Slide 5 in light of the overall record on conception would have insufficient information to determine how, specifically, Personalis intended to use the ‘Pullout,’ other than that their purpose was to provide a laboratory solution to improve the accuracy of 2012 sequencing technology in some way.” Ex. 1225 ¶ 125. Considering the evidence of record, we credit Dr. Quackenbush’s testimony that a person of ordinary skill in the art reading Personalis’ conception exhibits, including Exhibit 2112, “would have found, at most, an incipient research project for improving the accuracy of sequencing technology that would involve the use of an undefined combination of various conventional techniques.” Ex. 1225 ¶ 128. In addition to Dr. Quackenbush’s testimony as to claim steps involving capture probes (elements 1(a)–1(c)), we further find persuasive his testimony that Patent Owner provides no corroboration of the conception of steps 1(d)–1(f), which require assaying samples obtained from the same individual obtained at different time points. See id. ¶¶ 120–121, 126–127; Reply 9–10; Sur-Reply 6–8 (citing, e.g., Ex. 2032 ¶¶ 91–134; Ex. 2109; Ex. 2112; Ex. 2036). In sum, we find that Personalis’ exhibits and related testimony do not evidence sufficient conception of the invention set forth in the challenged claims. See, e.g., Ex. 1225 ¶¶ 120–128 (Dr. Quackenbush’s testimony about missing aspects of the claims in Patent Owner’s proofs, such that the “completed thought” is not shown).15 Considering the above, we find that Patent Owner has not satisfied the burden of establishing that its claimed invention is entitled to a priority date that precedes either of the respective publication dates of Forshew and Chan. Accordingly, Forshew and Chan qualify as prior art to the ’033 patent.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In Section II.C. above, we construe “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). Accordingly, in disclosing the use of PCR primers, Forshew discloses “capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification. See Pet. 29–33 (citing Ex. 1020 ¶¶ 117–122; Ex. 1030, 2–3). Forshew further satisfies the “plurality of capture probes” “COSMIC: mining complete cancer genomes in the Catalogue of Somatic Mutations in Cancer,” 39 NAR D945-950 (2011)). limitation in disclosing the use of PCR primers for the detection and monitoring of cancer-associated alleles. See, e.g, id.; Ex. 1020, 3 (“We designed 48 primer pairs to amplify 5995 bases of genomic sequence covering coding regions (exons and exon junctions) of TP53 and PTEN, and selected regions in EGFR, BRAF, KRAS, and PIK3CA (table S1) by overlapping short amplicons (Fig. 1A).”). For the reasons set forth above, Petitioner has sufficiently shown that Forshew discloses “capture probes” and “a plurality of capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification.” slip op. at 36
Patent outcomesUS 11,408,033 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,408,033 - Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentablePTAB · Jun 12, 2024 · IPR2023-00224 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over Leary, Chan, and Liao; the Board also found claims 1–11 and 13–19 unpatentable over Leary.
RulingsFinal written decision- Skill levelDecided for petitioner
“B. Level of Ordinary Skill in the Art” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“7. Objective Indicia of Non-Obviousness Objective indicia of non-obviousness may include long-felt but unsolved need, failure of others, unexpected results, commercial success, copying, licensing, industry praise, and expert skepticism. Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1379 (Fed. Cir. 2012). “[O]bjective indicia ‘may often be the most probative and cogent evidence of nonobviousness in the record,’” and “help turn back the clock and place the claims in the context that led to their invention.” Id. at 1378. Evidence of objective indicia of non-obviousness “must always when present be considered en route to a determination of obviousness.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012); see also Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc). Such evidence, however, does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1372 (Fed. Cir. 2007). (“Here, the record establishes such a strong case of obviousness that Pfizer’s alleged unexpectedly superior results are ultimately insufficient.”)” slip op. at 53
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. Rather, “any 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.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826 (CCPA 1968). Moreover, a precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. KSR, 550 U.S. at 418. Rather, “any 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.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotations and citations omitted).” slip op. at 9
Patent outcomesUS 11,384,394 unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,384,394 - PTAB · May 31, 2024 · IPR2024-00255 · APJ Patrick R Scanlon · IPR · Institution
The Board instituted IPR of claims 1–4 and 6–11 on both asserted obviousness grounds, finding a reasonable likelihood that Petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“that, because judgments have been entered in the district court actions, there is finality as that relates to Fintiv issues. In a similar instance, where a district court’s § 101 determination was appealed to the Federal Circuit, the Director determined that the Board had the authority to institute an inter partes review and a Fintiv analysis should be performed. See Volvo Penta of the Americas, LLC v. Brunswick Corp., IPR2022-01366, Paper 15 at 1–8 (PTAB May 2, 2023). The Director has additionally distinguished a Fintiv analysis under similar circumstances to those here, where “the district court’s judgment of invalidity under 35 U.S.C. § 101, i.e., a statutory ground that could not have been raised before the Board, does not raise concerns of inefficient duplication of efforts or potentially inconsistent results between the Board and the district court.” AviaGames, Inc., Paper 14 at 3. Further, the Director determined that, “the challenged claims have not yet been cancelled and remain in force until the opportunity to appeal has been exhausted,” noting that “[b]y the time an appeal will have concluded, Petitioner will be barred under 35 U.S.C. § 315(b) from bringing a new challenge in an IPR petition.” Id. at 3–4. Fintiv states that “a district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and discern that the § 101 issues addressed in the Federal Circuit appeal would duplicate the anticipation and obviousness issues addressed here. Accordingly, given the limited § 101 issues on appeal, we do not discern there are any concerns about duplication of efforts. Moreover, because of the uncertainty of the timing of any remand from the Federal Circuit to the district court to address any anticipation or obviousness issues, the present circumstances with a pending appeal effectively act as a stay on the assessment of invalidity issues.9” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail with respect to at least one challenged claim. Accordingly, we institute an inter partes review of the challenged claims on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of ordinary skill in the art. Pet. 7 n.2 (citing Ex. 1003 ¶¶ 8, 10, 26). Dr. Sundaresan testifies that a person having ordinary skill in the art “had at least a Bachelor’s degree in electrical engineering, computer science, or a similar discipline, and at least two years of experience in the field working with . . . navigation and/or geolocation systems,” and “[s]uperior education could compensate for a deficiency in work experience, and vice-versa.” Ex. 1003 ¶ 8. For the purposes of its Preliminary Response, Patent Owner does not dispute Petitioner’s definition of the level of ordinary skill in the art. Prelim. Resp. 32. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’104 patent and the prior art. See” slip op. at 7
- Prior constructionPrior construction adoptedDecided for petitioner
“For purposes of this Decision, we adopt the district court’s construction of “grid point” as “a point associated with representative calibration data for an area.” See Ex. 1054, 18–20. This construction is consistent with the claim language and the specification of the ’104 patent and is further supported by the reasoning provided by the district court’s claim construction order. See id. We do not discern a need to construe explicitly any other claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 7,561,104 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five asserted 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
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - PTAB · May 10, 2024 · IPR2024-00259 · APJ Sheila F Mcshane · IPR · Institution
The Board instituted inter partes review of claims 1, 7, 9, 32, 38, and 40 on the asserted obviousness ground over Bhattacharya and Yost.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“that because judgements have been entered in the district court actions, this suggests finality. In a similar instance in Volvo, where a district court’s § 101 determination was appealed to the Federal Circuit, the Director determined that the Board had the authority to institute an inter partes review and a Fintiv analysis should be performed. See Volvo Penta of the Americas, LLC v. Brunswick Corp., IPR2022-01366, Paper 15 at 1–8 (PTAB May 2, 2023). The Director has additionally distinguished the Fintiv analysis in AviaGames under similar circumstances to those here, where “the district court’s judgment of invalidity under 35 U.S.C. § 101, i.e., a statutory ground that could not have been raised before the Board, does not raise concerns of inefficient duplication of efforts or potentially inconsistent results between the Board and the district court.” AviaGames, IPR2022- 00530, Paper 14 at 3 (PTAB Mar. 2, 2023) (Decision on Director Review). Further, the Director determined that “the challenged claims have not yet been cancelled and remain in force until the opportunity to appeal has been exhausted,” noting that “[b]y the time an appeal will have concluded, Petitioner will be barred under 35 U.S.C. § 315(b) from bringing a new challenge in an IPR petition.” Id. at 3–4. Fintiv states that “a district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts.” Fintiv at 6. In view of the circumstances, we do not discern that the § 101 issues addressed in the Federal Circuit appeal duplicate the obviousness issues addressed here. The timing of the progress of the appeal and any potential remand to the district court is uncertain. Accordingly, given the limited § 101 issues on appeal, we do not discern there are any concerns about duplication of efforts. Moreover, because of the uncertainty of the timing of any remand from the Federal Circuit to the district court to address any obviousness issues, the present circumstances with a pending appeal effectively act as a stay on the assessment of invalidity issues.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“viii. Conclusion Accordingly, we are persuaded that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing that claim 1 is rendered obvious by Bhattacharya and Yost.” slip op. at 32
- Skill levelSkill level petitioner adoptedOther
“IV. ANALYSIS A. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art: would have had at least a Bachelor’s degree in electrical engineering, computer science, or a similar discipline, and at least two years of experience in the field working with working with navigation and/or geolocation systems. Pet. 6–7 (citing Ex. 1003 ¶ 8). Petitioner also contends that additional education could compensate for less work experience and vice versa. Id. at 7. For the purposes of the Preliminary Response, Patent Owner adopts Petitioner’s asserted level of ordinary skill in the art. Prelim. Resp. 26. For the purposes of this Decision, we adopt the assessment offered by Petitioner, except for the inclusion of “at least,” as it is consistent with the ’753 patent and the prior art before us. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Prior constructionPrior construction adoptedOther
“patent and district court issued claim constructions for some terms that were disputed. Ex. 1020; Ex. 1025. Petitioner uses the district court’s construction or the agreed-upon construction for the terms “calibration data,” “calibration points,” “grid point,” “network measurement report,” and the order of the “providing,” “generating,” “evaluating,” and “selecting” steps of claim 1. Pet. 7–9 (citing Ex. 1020; Ex. 1025). Petitioner proposes that all terms should be interpreted consistent with the Phillips standard. Id. at 7. Patent Owner “does not dispute Petitioner’s statement on claim construction for the purposes of this Preliminary Response” and “reserves the right to present arguments on the constructions should the Petition be instituted.” Prelim. Resp. 26. For the purposes of this Decision, we will use the district court’s claim constructions and those agreed-upon by the parties in the litigations, where the adoption of those constructions have been agreed to by the parties at this juncture in this proceeding. We determine that we need not expressly construe any other claim terms at this juncture. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,406,753 - PTAB · May 10, 2024 · IPR2024-00032 · APJ Brian D Range · IPR · Institution
The Board instituted IPR on claims 1–5, 9, 11, 12, 14–16, 18–22, 25, 27, 29, 31, 32, and 35 on all asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–5, 9, 11, 12, 14–16, 18–22, 25, 27, 29, 31, 32, and 35 of the ’494 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts.” Fintiv at 6. In view of the circumstances, we do not discern that the § 101 issues addressed in the Federal Circuit appeal would duplicate the anticipation and obviousness issues addressed here. Accordingly, given the limited § 101 issues on appeal, we do not discern there are any concerns about duplication of efforts. Moreover, because of the uncertainty of the timing of any remand to the district court to address any anticipation or obviousness issues, the present circumstances with a pending appeal effectively act as a stay on the assessment of invalidity issues.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“an IDS in the ’494 patent, we agree with Patent Owner that the record shows that Bhattacharya and Spain10 were listed on an IDS during prosecution of the parent ’358 patent, which the ’494 patent Examiner was required to consider. Prelim. Resp. 5 (citing MPEP 609.02). As such, we determine that Bhattacharya and Spain were presented previously to the Office. See Prelim. Resp. 9; Advanced Bionics at 7–8. We also agree with Patent Owner that the addition of Meunier does not substantially impact our § 325(d) analysis because of the Petition’s limited reliance on this reference. For these reasons, we determine that the first prong of Advanced Bionics is met and turn to the second prong.” slip op. at 23
- Skill levelSkill level petitioner adoptedOther
“would have at least a Bachelor’s degree in electrical engineering, computer science, or a similar discipline, and at least two years of experience in the field working with working with navigation and/or geolocation systems. 1003 ¶ 8; Pet. 6, n.2. According to Petitioner, “[s]uperior education could compensate for a deficiency in work experience, and vice-versa.” Ex. 1003 ¶ 8. Patent Owner does not dispute the level of ordinary skill in the art. Prelim Resp. 43. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’494 patent specification and the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,786,494 - PTAB · May 10, 2024 · IPR2024-00031 · APJ Patrick R Scanlon · IPR · Institution
The Board instituted IPR of claims 15–20, 24, 26, and 27 on all asserted grounds, finding a reasonable likelihood of success on anticipation and obviousness.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“time it was made, 35 U.S.C. § 103 requires us to resolve the level of ordinary skill in the pertinent art at the time of the invention. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention. In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Factors that may be considered in determining the level of ordinary skill in the art include, but are not limited to, the types of problems encountered in the art, the sophistication of the technology, and educational level of active workers in the field. Id. In a given case, one or more factors may predominate. Id.” slip op. at 6
- Prior constructionPrior construction adoptedDecided for petitioner
“district-court-type standard, as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“district-court-type standard, as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Fintiv states that “a district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts.” Fintiv at 6. In view of the circumstances, we do not discern that the § 101 issues addressed in the Federal Circuit appeal would duplicate the anticipation and obviousness issues addressed here. Accordingly, given the limited § 101 issues on appeal, we do not discern there are any concerns about duplication of efforts. Moreover, because of the uncertainty of the timing of any remand from the Federal Circuit to the district court to address any anticipation or obviousness issues, the present circumstances with a pending appeal effectively act as a stay on the assessment of invalidity issues.7” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 8,400,358 - PTAB · May 9, 2024 · IPR2024-00158 · APJ William V Saindon · IPR · Institution
The Board instituted review of claims 1–4, 7–14, 16, 17, 21, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Pham and Wu, and granted joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion for Claim 1 Having reviewed the Petition and Preliminary Response, we determine that Petitioner has a reasonable likelihood of success in showing that the subject matter of claim 1 would have been obvious in view of Pham and Wu. E. Conclusion on the Merits of the Petition We have found that the Petition warrants institution based on Petitioner’s showings for claim 1. We have reviewed Patent Owner’s arguments about the other grounds, but they largely rely on the earlier unpersuasive arguments for claim 1. On whole, we determine that Petitioner has shown that the Petition warrants institution.” slip op. at 18
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“FURTHER ORDERED that the Motion for Joinder with IPR2023- 00703 is granted, and Palo Alto Networks, Inc. and Fortinet, Inc. are joined as a party in IPR2023-00703;” slip op. at 27
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the related district court matters identified above. Opp. Mot. Join 4–12. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”). Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo at 3. Because Petitioner has offered a stipulation like in Sotera, i.e., to “not pursue in the copending district court litigation the specific ground asserted in the petition, or any other ground that was raised or could have been reasonably raised in an IPR (i.e., grounds that could have been raised under §§ 102 or 103 on the basis of prior art patent or printed publications)” (Reply Mot. Join 4–5), we do not discretionarily deny institution under Fintiv.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“factor one necessarily outweighs the other General Plastic factors.”) (Director Review). Patent Owner focuses its analysis on factor 5 and proposed factor 8. Id. at 13–15. As to factor 5, which looks for an explanation of the time between petition filing, we determine that Petitioner sufficiently explained the time between Cisco’s petition and its own when it noted that it merely filed its petition and request for joinder when the statute permitted it. Reply Mot. Join 6 (citing 37 C.F.R. § 42.122(b)). In particular, the statute requires the earlier petition to be instituted before joining a party. 35 U.S.C. § 315(c) (requiring joinder to be to instituted proceedings). Thus, the time elapsed between filings is motivated by the statutory and regulatory procedures. See also 37 C.F.R. § 42.122(b) (requiring the joinder motion to be filed “no later than one month after the institution date of any inter partes review for which joinder is requested”). As to proposed factor 8, we agree with Petitioner that the present situation does not apply. Reply Mot. Join. 6–7; see also Shenzhen, IPR2018-00761, Paper 15, 18–19 (Saindon, concurring) (“There are legitimate reasons why a petition may be filed after [a decision on institution)].”). Proposed factor 8 analyzes situations where a second petitioner strategically waits to file its petition to see what happens to an earlier filed petition. Shenzhen, IPR2018-00898, Paper 9 at 7. If both of the petitioners were sued at or around the same time, but one waits until the other goes first, it can lead to an inference that the delay in filing a different petition was to gain an unfair advantage. Id. at 14 (looking with disfavor on a wait-and-see strategy to use the first petition as a “test case”). That is not the case here, where the second petition is a copycat petition. The Petition here cannot be said to have been filed second in order to glean knowledge from the first petition because it is the same petition. Thus, we do not see this Petition as being a strategic attempt to use Cisco’s petition as a “test case,” and do not consider factor 8 to weigh toward denial. Finally, reviewing factor 6, we do not find that granting Petitioner’s motion to join would cause an undue burden on the Board. Petitioner is serving as an “understudy” and thus, from our perspective, Petitioner’s presence does not change the existing Cisco IPR. Patent Owner argues that if Cisco were to settle then Petitioner would continue the proceeding. Opp. Mot. Join. 15. We do not see this as an undue burden in this situation. Petitioner’s Motion for Joinder serves to lessen our burden (as well as Patent Owner’s) compared to the scenario of it filing its own unique petition. We do not see the present case as similar to the Apple case, in which a copycat joinder petition was denied. See Apple, IPR2020-00854, Paper 9. That case, in our view, turned on the fact that the petitioner had already filed a petition that was denied on the merits. See id. at 4 (“In effect, it would be as if [the petitioner] had brought the second challenge to the patent in the first instance,” and labeling this a “serial attack.”). The situation here is not analogous to the Apple case because this is Petitioner’s only petition against the ’436 patent. The Petition is not a “serial attack” on the ’436 patent, it is merely Petitioner’s statutorily required vehicle to join as a party to an existing petition. Accordingly, we do not find factor 6 to weigh towards denial. Reviewing the General Plastic factors as a whole, including proposed factor 8, we find no factors to weigh toward denial and decline to exercise our discretion to deny institution.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,566,612 - PTAB · May 9, 2024 · IPR2024-00099 · APJ William V Saindon · IPR · Institution
The Board instituted review of claims 1–4, 7–14, 16, 17, 21, and 22 on all asserted grounds and granted joinder to IPR2023-00673.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314(b) and 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “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 provided below, we determine that Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’436 patent is unpatentable, we institute an inter partes review. 37 C.F.R. § 42.108(a) (2023).” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“compressed, or use security protocols, then the packets transit the packet engine. Pet. 41–42 (citing Ex. 1004 ¶¶ 49, 51, 53). Patent Owner argues that only the SA parameter association task in Pham may be offloaded. Prelim. Resp. 26–27 (citing Ex. 1004 ¶¶ 38, 51). Patent Owner’s argument here implies that the filtering function remains at the ingress processor and that some packets will be filtered and never reach the packet engine. See id. (citing, e.g., Ex. 1004 ¶ 38); Ex. 1004 ¶ 38 (“In the preferred embodiments of the present invention, the ingress processors 30, 34 are tasked with filtering and routing functions . . . .”). The statement Patent Owner relies on is not in the same section as the one Petitioner relies on. In other words, it does not appear on this record that we can limit the disclosure of paragraph 51 based on the statements in paragraph 38. On this record, we are not persuaded that only the SA parameter association task can be offloaded. As Pham notes, tasks can be moved between processors to perform load balancing. Ex. 1004 ¶ 54. We see no disclosure that prevents certain tasks from being load balanced or otherwise tasked to the security processor.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“find them persuasive on this record. Id. at 32–33. At a high level, Patent Owner’s arguments are that Petitioner’s modification to Pham would “increase[] complexity and resources.” Id. at 33. On this record, this argument is unpersuasive because even if the addition of Wu’s intrusion detection system was somehow more complex, the reason to combine it is to gain certain beneficial features. See, e.g., Pet. 30–31. Patent Owner’s arguments do not show that the alleged increase in complexity would somehow dissuade a person of ordinary skill in the art from including these beneficial features. See, e.g., Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016) (“[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (alteration in original); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”).” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the related district court matters identified above. Opp. Mot. Join 4–12. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”). Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo at 3. Because Petitioner has offered a stipulation like in Sotera, i.e., to “not pursue in the copending district court litigation the specific ground asserted in the petition, or any other ground that was raised or could have been reasonably raised in an IPR (i.e., grounds that could have been raised under §§ 102 or 103 on the basis of prior art patent or printed publications)” (Reply Mot. Join 4–5), we do not discretionarily deny institution under Fintiv.” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,685,436
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.