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  • PTAB · Jul 9, 2024 · IPR2023-00407 · APJ Robert J Silverman · IPR · Final written decision

    Claim 1 is unpatentable as anticipated by Stanziale ’771; the Board did not reach the alternative grounds.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “As an initial matter, the recited expression “mounted to” is broad. The Federal Circuit has explained that words in a claim “will ordinarily be given their full meaning,” without imposing narrowing modifications on the claim language. Johnson Worldwide, 175 F.3d at 989, see also Virginia Panel, 133 F.3d at 865–66. As to whether the “mounted to” connection may be an indirect connection, the parties agree that an indirect connection is permitted — a view that is amply supported by the intrinsic record, as discussed above. With regard to the types of movement that may occur between a “string guide” and a corresponding “limb,” the intrinsic record shows that that various types of movements (including no movement at all) are characterized as “mounted to.” Slight variations of “mounted to,” occurring in the intrinsic record, are helpful in understanding the claim language — particularly because the ’015 patent itself uses such a variant (“mounted . . . on”) to describe the very connection (between a “string guide” and a “limb”) that is elsewhere, and in claim 1, is described as “mounted to.” See Ex. 1001, 5:23–26.” slip op. at 22

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “Patent Owner’ sole argument — i.e., that Stanziale ’771 fails to teach the “mounted to” limitation — is based upon its construction of the “mounted to” limitation, which permits the “string guide” to be rotatable relative the corresponding “limb,” but permits no other type of relative motion. See PO Resp. 4, 13–14. As discussed above, we do not accept Patent Owner’s construction of the “mounted to” limitation. In Stanziale ’771, first and second pulleys 145, 146, and interconnecting pivot 147 (all three of which Petitioner maps to claim 1’s “string guide[s]”) are pivotally connected to a number of intermediate members (e.g., lever arms or pushing arms 32, connecting elements 27, and constraining member 29) which are, in turn, pivotally connected to elastic members 10 (which Petitioner maps to claim 1’s “limb[s]”). See Pet. 41–42 (citing Ex. 1012 7:9–17, 8:26–8:13, 11:8–9, 14:18–15:22, 16:24–25, 16:29, 17:2, 17:15–17, 17:24–27, 19:12–30, 20:32–21:16, Figs. 1–7; Ex. 1016 ¶¶ 177–179); see also Ex. 1012 11:3–7, 11:34–12:4, 12:10–17, 16:29–18:3, 18:22–19:30, Figs. 8, 9, 10a, 10b. Therefore, Stanziale ’771, in Petitioner’s mapping, teaches the “string guide[s]” connected indirectly to the “limb[s].” Per the construction of the “mounted to” limitation employed herein (“connected to, either directly or indirectly”), Petitioner establishes, by a preponderance of the evidence, that Stanziale ’771 teaches the “string guide[s]” “mounted to” the “limb[s],” as recited in claim 1 of the ’015 patent. Contrary to Patent Owner’s concerns (see Paper 47, 1), the indirect connection between Stanziale ’771’s “string guide[s]” and “limb[s]” is not “unbounded.” Rather, the connection disclosed by Stanziale ’771 is the type of indirect connection supported by the intrinsic record. See supra § II.B. Patent Owner’s contention that “a POSA would be disinclined to rely on [Stanziale ’771] as a reference for the improved crossbow design disclosed in Claim 1” is not persuasive. See PO Resp. 38 (citing Ex. 2029 ¶ 46). The test for anticipation is whether a prior art reference discloses each and every element recited in the claim, not whether one of ordinary skill in the art would have been inclined to rely on the reference. See Net MoneyIN, Inc., 545 F.3d at 1369.” slip op. at 32

    • ExcludeMotion to exclude, deniedMixed

      “Motions to exclude evidence are authorized under 35 C.F.R. § 42.64. Rule 42.64(b)(1) states: “Once a trial has been instituted, any objection [to evidence] must be filed within five business days of service of evidence to which the objection is directed.” Further, “[t]he objection must identify the grounds for the objection with sufficient particularity to allow correction in the form of supplemental evidence.” 35 C.F.R. § 42.64(b)(1). “A motion to exclude evidence must be filed to preserve any objection.” 35 C.F.R. § 42.64(c).” slip op. at 40

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “In the present proceeding, Petitioner proposed — and Patent Owner does not dispute (see PO Resp. 3) — the following definition of a person of ordinary skill in the art: A hypothetical POSA to which the ’015 Patent pertains would be a technical person who has at least some experience working in the field of archery, reviewing crossbows or engineering related to bows and/or crossbows, and is generally familiar with prior art crossbows. (Ex. 1016 ¶17.) Such a person would likely have at least a bachelor’s degree in mechanical engineering or, alternatively, would have several years of experience in the field of archery or engineering related to bows and/or crossbows. (Id.) Pet. 28. As discussed above, we adopt Petitioner’s description of a person of ordinary skill for the purposes of this Decision. See supra § II.A. Petitioner alleges various deficiencies in Mr. Teater’s background, education, and knowledge. Paper 39, 4–8. Nevertheless, Mr. Teater satisfies the definition, of a person of ordinary skill in the art, that Petitioner advanced. Specifically, Mr. Teater has reviewed crossbows for 14 years, encompassing the relevant priority date for the ’015 patent, during which time he wrote evaluations of various bows and crossbows, developed and published testing standards for crossbows, and served on the Archery Trade Association’s technical committee for standards and guidelines. Paper 41, 4 (citing Ex. 2029 ¶¶ 3, 4, 7). Accordingly, Mr. Teater satisfies Petitioner’s definition of “a technical person who has at least some experience working in the field of archery, reviewing crossbows or engineering related to bows and/or crossbows, and is generally familiar with prior art crossbows.” Pet. 28. Petitioner emphasizes that Mr. Teater “does not have a degree in mechanical engineering.” Paper 39, 4 (citing Ex. 2034, 1; Ex. 1034, 43:20–44:5). However, no degree of any kind is mandatory for satisfying Petitioner’s definition of a person of ordinary skill in the art. Indeed, Petitioner’s definition states that “[s]uch a person would likely have at least a bachelor’s degree in mechanical engineering or, alternatively, would have several years of experience in the field of archery or engineering related to bows and/or crossbows.” Pet. 28 (emphasis added). There is no dispute that Mr. Teater meets this standard. Petitioner raises various other issues that form no part of the definition that Petitioner advanced — for example, whether Mr. Teater has taught courses related to crossbows, whether he is named as an inventor on a” slip op. at 36

    Patent outcomesUS 9,354,015 unpatentable
    Claim construction§ 102 anticipationcites Phillips
    Patents in suitUS 9,354,015
  • PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

    Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

      “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

    Patent outcomesUS 11,278,505 unpatentable
    Claim construction§ 112 disclosurecites Phillips
    Patents in suitUS 11,278,505
  • 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 · Graham
    Patents in suitUS 11,591,393
  • PTAB · 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 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,408,033
  • 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 · Graham
    Patents in suitUS 11,584,968
  • 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 · Graham
    Patents 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 Graham
    Patents in suitUS 8,400,358
  • PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

    The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” 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 5

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

      “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

    Patent outcomesUS 11,110,087 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,110,087
  • PTAB · Apr 11, 2024 · IPR2022-01528 · APJ Neil T Powell · IPR · Final written decision

    Claims 15–19 are unpatentable: the Board found claims 15–16 anticipated or obvious and claims 17–19 obvious; it did not reach the Yong-Xavier-Cason ground for claim 17.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We find that the ’435 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected by those sources is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Accordingly, for purposes of this Decision, we adopt Petitioner’s asserted level of ordinary skill in the art.” slip op. at 12

    • Expert testimonyDecided for patent owner

      “technologies, [and he admits] that his only retail technology experience is limited to MBA case studies from the early 1990s.” Pet. Reply 3 (citing Ex. 1022, 15:20–22, 16:3–7, 17:22–23; Ex. 2010). Based on this, Petitioner advances that we “should afford little weight to Dr. Williams’ testimony.” Id. Patent Owner counters that we should afford full weight to Dr. Williams’s testimony. PO Sur-reply 2. Patent Owner contends that Dr. Williams meets Petitioner’s definition of a person of ordinary skill in the art. Id. According to Patent Owner, “Dr. Williams surpasses the education requirement” and meets the experience requirements. Id. at 3. Addressing Petitioner’s concerns about retail technology experience, Patent Owner asserts that “Dr. Williams testified that his MBA curriculum contained coursework that included study of POS systems, particularly though case studies.” Id. (citing Ex. 2009 ¶ 3; Ex. 1022 16:3–7). “This is precisely the ‘more education’ in the [person of ordinary skill in the art] definition that can ‘supplement practical experience,’” Patent Owner argues. Id. (citing Pet. 12). Patent Owner persuades us that Petitioner’s concerns regarding Dr. Williams’s retail technology and knowledge and experience are not a basis for affording less weight to Dr. Williams’s testimony.” slip op. at 13

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “Contrary to Patent Owner’s argument, the ’435 patent’s Specification supports Petitioner’s position. As Petitioner argues, the Specification’s disclosure that “[u]ser identification information may include a username, a password, [or] both a username and password” conveys that “a username, a password, [or] both a username and password” is a short, non-exhaustive list of user identification information according to the ’435 patent. Ex. 1001, 6:2–4 (emphasis added). This comports with the plain meaning of “user identification information,” which seemingly would refer to information that identifies a user. Consistent with this, the claim language does not convey any meaning of “user identification information” other than its plain meaning. See, e.g., id. at 24:7–9. Accordingly, we do not adopt Patent Owner’s suggestion that limitation 16a’s “user identification information” requires a username, a password, or both. PO Resp. 72; PO Sur-reply 30. Instead, we conclude that “user identification information” encompasses information that identifies a user.” slip op. at 16

    • BurdenPetitioner expert creditedUnpatentable

      “Weighing all of the parties’ arguments and evidence, we find Petitioner has shown that Fletchall discloses performing all of limitations 15h–15j’s actions by the same server, specifically payment server 130. For example, Petitioner persuades us that Fletchall discloses payment server 130 performing the actions of limitations 15h and 15i: “retrieving . . . payment information to complete the transaction” and “completing . . . the transaction based on the payment information.” Ex. 1001, 23:43–24:2; Pet. 24–26 (citing Ex. 1008, 4:35–49, 11:3–12, 12:42–45, 13:9–14, 13:45–47; Ex. 1002 ¶¶ 199–204, 206–208, 210; Ex. 1001, 10:59–11:3, Fig. 2B). Petitioner’s evidence also shows that Fletchall discloses limitation 15j’s “transmitting . . . a confirmation receipt to the mobile phone in response to completion of payment for the transaction” by payment server 130 on its own. Ex. 1001, 24:3–5; Pet. 26–27 (citing Ex. 1008, 9:26–32, 11:57–61; Ex. 1002 ¶¶ 213–214). For example, Petitioner cites Fletchall’s disclosure of at least one embodiment in which “the electronic receipt is generated by the payment server (130) and provided to the transaction module (106b) of the mobile POS application (106).” Ex. 1008, 9:26–29; Pet. 27. Thus, Petitioner demonstrates that Fletchall discloses performing all of limitations 15h–15j by payment server 130. This showing is not diminished by Patent Owner’s observation that the Petition mentions Fletchall’s product database 121 when discussing limitation 15j. PO Sur-reply 27 n.12 (citing Pet. 26–27). In the passages Petitioner cites, Fletchall contains multiple, alternative disclosures about creating and sending a receipt. Ex. 1008, 9:26–32, 11:57–61; Pet. 27. For example, Fletchall contains (1) a disclosure that a receipt can be generated and transmitted by payment server 130 on its own (Ex. 1008, 9:26–29) and (2) an alternate disclosure that “[t]he electronic receipt may be generated by the product database (121) in cooperation with the payment server (130) and provided to the transaction module 106(b) of the mobile POS application (106)” (id. at 9:29–32). As Dr. Shamos notes, Fletchall also discloses that “[t]he electronic receipt may be generated by the payment server.” Ex. 1008, 11:19–20; Ex. 1002 ¶ 213. Immediately following this disclosure, Fletchall describes handling the electronic receipt by payment server 130 and product database 121 working in cooperation as an alternative to handling the electronic receipt by payment server 130 on its own: The electronic receipt may be generated by the payment server, by the product database in cooperation with the payment server and/or by a mobile application installed on the mobile device directly. Once generated, the electronic receipt may be sent to the mobile device to be stored in a memory or in a storage device of the mobile device. Ex. 1008, 11:19–25 (emphasis added). Petitioner’s reliance on Fletchall’s disclosure of handling the electronic receipt by payment server 130 on its own supports Petitioner’s case, regardless of Fletchall’s alternate disclosure of handling the electronic receipt by payment server 130 in cooperation with product database 121.” slip op. at 28

    Patent outcomesUS 10,803,435 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,803,435
  • PTAB · Apr 10, 2024 · IPR2022-01564 · APJ Patrick R Scanlon · IPR · Final written decision

    Claims 1–14 are unpatentable as anticipated by Keith; the Board did not reach the alternative obviousness ground over Hanson and Keith.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “claims of the later-filed application must be supported by the written description in the parent ‘in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.’” Anascape, Ltd. v. Nintendo of Am. Inc., 601 F.3d 1333, 1335 (Fed. Cir. 2010) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)). “[T]he hallmark of written description is disclosure,” and the test “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” of that application. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)). “[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. But, “[i]t is not sufficient for purposes of the written description requirement of [35 U.S.C.] § 112 that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood, 107 F.3d at 1572.” slip op. at 33

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. Inc., v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). Moreover, “[b]ecause the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Whether a reference anticipates is assessed from the perspective of an ordinarily skilled artisan. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“‘[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching’ that every claim element was disclosed in that single reference.”). slip op. at 13

    • BurdenFwd all claims unpatentableDecided for petitioner

      “preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R. § 42.1(d) (2022). “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) (2012) (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 the 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 12

    Patent outcomesUS 10,803,435 unpatentable
    § 102 anticipation§ 112 disclosurecites KSR · Graham
    Patents in suitUS 10,803,435

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.