• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  PTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33

  • Expert testimonyPetitioner expert creditedOther

    “be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

  • ExcludeMotion to exclude, deniedMixed

    “A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107

  Patent outcomesUS 11,028,161 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,028,161
• Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentable
  PTAB · Sep 25, 2023 · IPR2022-00738 · APJ David Cotta · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the alternative ground.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the problems” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1001, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is limits the claim for the reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’160 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’160 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1001, 18:59–19:5. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “understand the term “adverse event” to be limited to “serious” events. Ex. 2004, 1; Ex. 1208, 1; Ex. 1209, 6; Ex. 1210, 8. The only evidence to the contrary is the testimony of Dr. Grosberg. Ex. 2037 ¶ 45. Because Dr. Grosberg’s testimony is inconsistent with the evidence he relies upon, we decline to give it substantial weight. We recognize that the Specification of the ’160 patent includes language imposing some degree of severity on the “adverse event.” Specifically, the adverse event must be significant enough to cause treatment to be “interrupted” because the event made the treatment become “intolerable by the patient.” But, we find no support in the record for imposing an additional severity requirement by effectively limiting the term “adverse event” to “serious adverse events.” Accordingly, we decline to construe the term “adverse event” to mean “a serious undesirable experience associated with the use of a treatment” as proposed by Patent Owner. PO Resp. 12. We do not find it necessary to further construe the term “adverse event” to resolve this dispute.” slip op. at 14

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “d) Conclusion regarding Sun’s disclosure of the claimed patients For the reasons discussed supra §§ II.F.1.a–c, we find that Petitioner” slip op. at 40

  Patent outcomesUS 11,028,160 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,028,160
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Some claims unpatentable
  PTAB · Jul 5, 2023 · PGR2022-00023 · APJ Robert A Pollock · PGR · Final written decision

  The Board held claims 2, 3, 5, 14, 26, 27, and 30 unpatentable for lack of written description, but did not find claims 1, 6, and 25 unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “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 and cancer biology, which would encompass the blood cancers recited by Patent Owner. 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))). We find that Dr. Gordon and Dr. Sharman are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. Ex. 1020, ¶¶ 8– 19; Ex. 2008, ¶¶ 11–24.” slip op. at 7

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “We find Dr. Sharman’s statements and deposition testimony have substantially greater credibility than Dr. Gordon’s statements and deposition testimony based on Dr. Sharman’s significantly greater relevant experience in treatment and study of hematological cancers using chemotherapeutic agents and based on Dr. Sharman’s superior recollection and more complete analysis of the record found in the ’942 patent. In particular, we found Dr. Gordon’s statement that no example “includes” every element of claim 1 factually incorrect as contradicted by at least Figure 2 of the ’942 patent where the ordinary understanding of includes to mean encompasses is used. See Ex. 1020 ¶ 131. Ebit Sys. Am., LLC v. Thales Visonix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“The PTAB [i]s entitled to weigh the credibility of the witnesses ....”).” slip op. at 16

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

    “The parties do not identify any issue relating to the preamble that needs to be addressed to resolve the sole written description challenge and the parties do not dispute that the transitional term “comprising” is “inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Georgia-Pacific Corp. v. US. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). We therefore find that there are no terms that need claim construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateWritten description inadequateMixed

    “We find that Figure 2 of the ’942 patent and the associated example provide literal and express descriptive support for claim 1 of the ’942 patent. As descriptive support for claim 1, the ’942 patent teaches treatment of leukemia or lymphoma, including chronic lymphocytic leukemia and small lymphocytic lymphoma (Ex. 1001, 16:21–22), by orally administering the Bcl-2 inhibitor GDC-0199 (Ex. 1001, 17:16) in escalating doses of 50 mg per day during a first week and 100 mg per day during a second week (Ex. 1001, Figure 2). Claim 1 of the ’942 patent, as written, does not exclude performance of the complete combination therapy shown in Figure 2. Rather, the reasonable understanding of the term “comprising” in claim 1 encompasses monotherapy with GDC-0199 alone and combination therapy with obinutuzumab. Both embodiments are described in the Specification. As Patent Owner points out, the ’942 Specification is replete with disclosures to administer GDC-0199 by itself to a patient, stating” slip op. at 16

  Patent outcomesUS 10,993,942 mixed
  Claim construction§ 112 disclosure
  Patents in suitUS 10,993,942
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Instituted
  PTAB · Apr 19, 2023 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Institution

  The Board instituted review on all challenged claims and the sole anticipation ground: claims 1–4, 8–14, and 18–26, with a reasonable likelihood of unpatentability except claim 19.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denialInstitutedDenied

    “This case differs from other situations where the Board has exercised discretion under § 314(a) to deny institution. For example, we are not presented with a later-filed petition after having considered an earlier-filed petition challenging the same patent. See, e.g., General Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19, 6–11, 15–22 (PTAB Sept. 6, 2017) (precedential)). This is the first petition filed against this patent and contains only a single ground. Also, as Petitioner asserts, and Patent Owner does not contest, the Fintiv factors are neutral or favor institution. See Pet. 61–63. Instead, Patent Owner asks us to deny institution because Petitioner” slip op. at 10

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “We have authority under 35 U.S.C. § 6 and 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” A decision to institute under § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). In addition, if the Board institutes trial, it will “institute on all grounds in the petition.” PTAB Consolidated Trial Practice Guide, 5–6 (Nov. 2019); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Having considered the arguments and evidence presented in the Petition and the Preliminary Response, for the reasons described below, we institute inter partes review.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “VIII. LEVEL OF ORDINARY SKILL IN THE ART Petitioner asserts A person of ordinary skill in the art (“POSA”) in the field of the patent between 2012 and 2021 would have held an MD with experience in clinical oncology or pharmacology; a PhD in pharmacology, pharmaceutical chemistry, cancer biology, or a related discipline; or a PharmD with experience in clinical oncology. Ex. 1020 ¶ 29. A POSA would also have practical working knowledge of oncology (Ex. 1020 ¶ 29) and experience with the design of studies necessary for drug development. This description is approximate, and additional experience could make up for less education and vice versa. Ex. 1020 ¶ 29. Pet. 15–16. Patent Owner asserts “that a POSA for purposes of the ’087 Patent would have had at least an M.D. and several years of experience treating patients with hematological malignancies (i.e., blood cancers).” Prelim. Resp. 13. Patent Owner asserts “Petitioner’s definition fails to require experience specific to hematological malignancies or blood cancers. Patent Owners’ definition of a POSA, on the other hand, accounts for the claims’ focus on lymphoma and leukemia.” Id. at 14. At this stage in the proceeding, we find that Patent Owner’s analysis more precisely establishes the level of ordinary skill in the art as it directly relates to those deciding prescribing information based on the prior art reference. See Ex. 1011, 2. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 5

  • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateNot entitled to earlier dateMixed

    “reasonable likelihood that claims 1 and 9 are not entitled benefit of priority to the ’087 or earlier priority Specifications prior to the publication of the November 2018 Venclexta label. Claim 1, for example, recites a GDC-0199 dosing regimen “compris[ing] a dose of 100 mg of GDC-0199 per day, followed by orally administering to the patient a dose of 200 mg of GDC- 0199 per day, followed by orally administering to the patient a dose of 400 mg of GDC-0199 per day.” This disclosure is not found in a single example, but must be selected from disparate parts of the Specification. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 4 (Fed Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 22

  § 102 anticipation§ 112 disclosureDiscretionary denial
  Patents in suitUS 11,110,087
• Bausch & Lomb Incorporated v. Zeavision, LLCAll claims unpatentable
  PTAB · Apr 10, 2023 · IPR2022-00089 · APJ Tina E Hulse · IPR · Final written decision

  Claims 12–14, 16–21, 23, and 24 are unpatentable: Lang anticipates some claims, and the asserted Lang-based combinations render all challenged claims obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s definition (Dec. Inst. 6–7), which Patent Owner states that it “does not contest.” PO Resp. 17. Because the parties do not dispute the level of ordinary skill in the art, we adopt Petitioner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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))). Moreover, we find that Dr. Johnson and Dr. Dorey are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art. See Ex. 1024 ¶¶ 2–11, App’x A; Ex. 2001 ¶¶ 4–14, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “Similarly, here, the Specification consistently states that the invention relates to oral formulations for protecting eye health and that the benefits of carotenoids, such as zeaxanthin and lutein, include the ability to absorb UV and blue light. See, e.g., Ex. 1001, Abstract (“Oral formulations for promoting eye health”), 4:25–31 (stating carotenoids such as zeaxanthin are “very good at absorbing ultraviolet (UV) and blue light”), 15:45–47 (“one object of this invention is to disclose multi-component orally-ingestible formulations for protecting eye health in mammals”). Like the preamble in Proveris, the preamble in claim 12 is the only reference in any of the independent claims to the allegedly inventive concept of protecting eye health from the harmful effects of blue light. Proveris, 739 F.3d at 1373. Moreover, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of claim 12 for antecedent basis for the limitation “wherein the user has macular degeneration and a lens-related disorder.” Id. at 38:21 (emphasis added). Thus, “the nutrient formulation” and “the user” in the claim body derives antecedent basis from the “nutrient formulation” and “user” that is “defined in greater detail in the preamble.” See Proveris, 739 F.3d at 1373. Accordingly, reading the patent as a whole, because the inventor clearly relied on both the preamble and the body of claim 12 to define the claimed invention, the preamble of claim 12 should be construed as limiting. See id.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would understand this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not address either of these claim terms in its Response. See generally PO Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as they are consistent with the plain and ordinary meaning of the terms. See Wellman, 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 11

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. Verisign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 13

  Patent outcomesUS 10,307,384 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,307,384
• Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentable
  PTAB · Apr 4, 2023 · IPR2021-01565 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–24 are unpatentable: claims 1–10, 12–22, and 24 as anticipated by Kaiser, and claims 1–24 as obvious under the listed grounds.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) a bachelor’s or master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

    “demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 32

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

    “activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 31–32 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 44

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

    “Although Kaiser exemplifies in detail a method involving IVC occlusion, its disclosure makes clear that the method is also applicable to the SVC. See, e.g., Ex. 1007, 6:60–64 (“the adjustable component may create a pressure gradient by . . . adjusting blood flow impedance through the superior vena cava”), 5:64–6:2 (disclosing “systems and methods may be provided to create a pressure differential” using “balloons . . . to increase a pressure drop through the . . . superior vena cava”), Claim 5 (reciting a “flow impedance device implantable within a patient’s inferior vena cava”), Claim 17 (“The method of claim 10, wherein the body lumen within which the adjustable component is positioned is . . . a superior vena cava.”), 6:31–36 (positioning pressure sensor in the superior vena cava); see also Ex. 1010, 19–22 (claims of provisional application directed to reducing blood flow through the superior vena cava); see also Pet. 29–34, 36–39; Reply 14–16; Ex. 1002 ¶¶ 152–153, 156–159, 165, 167–176 (Dr. Day’s testimony regarding the SVC positioning elements). Considering the arguments and evidence of record, including our own reading of Kaiser (see supra Section I.I.1), we find that Kaiser expressly discloses the contested element of Ground 1 relating to use of the restrictor in the SVC.” slip op. at 47

  Patent outcomesUS 10,639,460 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,639,460
• Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentable
  PTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29

  • ExcludeMotion to exclude, deniedDenied

    “As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “For the above reasons, on the full trial record we determine that” slip op. at 26

  Patent outcomesUS 10,682,414 mixed
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,682,414
• Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentable
  PTAB · Feb 7, 2023 · IPR2021-01340 · APJ David Cotta · IPR · Final written decision

  Claims 1–17 are unpatentable as obvious over Coronel and Fox because their combination teaches the claimed fault detection and process control features.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner’s proposal appears to be generally consistent with the level of skill reflected in the specification and in the cited prior art. 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, 8 163 (Fed. Cir. 1985)). And we agree with Patent Owner that “additional education can compensate for less work experience and vice versa.” Accordingly, we adopt Petitioner’s proposed definition of the POSA level with the additional clarification proposed by Patent Owner.” slip op. at 8

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

    “Petitioner does not identify any claim terms that require construction. Pet. 15. Patent Owner does not dispute Petitioner’s assertion that no claim terms require construction. PO Resp. 6. We do not find it necessary to provide an express construction for any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); 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’”).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “In view of these teachings, we agree with Petitioner and Dr. Hatalis that “[a] POSA would have recognized that applying the teachings of Fox to the system of Coronel, . . . would have promoted the desired objective of increasing process yields by combining fault detection based on multivariate analysis of tool state data with fault detection based on data received from the monitoring equipment of Coronel.” Ex. 1002 ¶ 74; Pet. 35–36. The record supports Dr. Hatalis’s testimony that “applying the methods disclosed in Fox to the system of Coronel would have been straightforward and an application of known techniques to improve a comparable system in the same way.” Ex. 1002 ¶ 75. In this regard, the 17 record supports that multivariate analysis was known and used in the art. Id. ¶ 71 (Dr. Hatalis’s testimony, citing Ex. 1013, 56–57 (article entitled “Practical issues in the deployment of a run-to-run control system in a semiconductor manufacturing facility,” (id. at 52) teaching that “FDC [fault detection and classification] can take many forms in ProcessWORKS, from traditional process monitoring techniques such as statistical process control (SPC) to advanced multivariate analysis based on trace data”)); see also Ex. 1005, 4:7–9 (“The use of the Hotelling’s T2 multivariate analysis is a statistical method well known in the prior art.”). In addition, as Dr. Hatalis explains, “because the methods described in Fox are executed using a computer, they would have been readily applied to the computer, database, and supervisor of Coronel.” Ex. 1002 ¶ 76. Further, “performing fault detection by using T2 values . . . had been previously implemented on an AME 5000 system, which is the same system referenced in Coronel,” and “Fox implements the T2 analysis with the same kind of tool used in Coronel, a plasma etcher.” Id. ¶ 78 (Dr. Hatalis’s testimony). In view of the evidence that multivariate analysis was well-known and in view of the similarities between Coronel and Fox, we agree with Petitioner that a POSA would reasonably have expected success in combining Coronel and Fox. As Dr. Hatalis explains, modifying Coronel’s method to include Fox’s multivariate analysis would have “simply involved adapting the software in the supervisor of Coronel, which already has computing capabilities and storing in its database the T2 values and UCL and LCL boundary values as taught by Fox.” Id. ¶ 83. And we find no evidence that applying Fox’s algorithms or methods to Coronel’s computer would” slip op. at 17

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Patent Owner cites the testimony of Mr. Humphrey to support that translating between the different protocols of Coronel and Fox would have brought “an additional degree complexity to the system and compromised its ability to efficiently report faults.” Ex. 2040 ¶ 70. However, the persuasiveness of Mr. Humphrey’s testimony is diminished by the absence of explanation and by the absence of citation to supporting evidence. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he 26 Board is entitled to weigh the declarations and conclude that the lack of factual corroborations warrants discounting the opinions expressed in the declarations.”); 37 C.F.R. § 42.65 (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Although Mr. Humphrey testifies that translation adds complexity, the evidence of record supports that the translation technique on which Petitioner relies was routine. Ex. 1002 ¶ 90 (Dr. Hatalis testimony that “[i]t was well-known in the art how to transmit data in ASCII format or as numeric data via the SECS II communications protocol”); Ex. 1001, 5:26–33 (explaining that translation between the communication protocol used by “equipment interface 110” and “Common Object Request Broker Architecture Interface Definition Language (COBRAIDL)” is “well known to those of ordinary skill in the art” and, thus will “not be discussed . . . to avoid unnecessarily obscuring the present invention”); see also Ex. 1018, 172 (article cited by Dr. Hatalis describing transmission of ASCII data over SECS II protocol). To the extent Mr. Humphrey’s testimony that translation adds “an additional degree complexity to the system and compromised its ability to efficiently report faults” contradicts Dr. Hatalis’s testimony, we credit Dr. Hatalis over Mr. Humphrey. Moreover, as discussed above, we credit Dr. Hatalis’s testimony that a POSA would have understood that it was necessary to translate from ASCII to SECS II in order to transmit tool state data to the supervisor for fault detection. Ex. 1002 ¶ 90. Given the evidence that the asserted translation was both necessary and routine, we find that the potential for delays that 27” slip op. at 26

  Patent outcomesUS 6,725,402 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,725,402
• Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentable
  PTAB · Feb 7, 2023 · IPR2022-00681 · APJ Miriam L Quinn · IPR · Final written decision

  Claims 1–22 of the ’248 patent and claims 1–25 and 33–53 of the ’305 patent are unpatentable as obvious over Schulze and Gupta.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “E. Level of Ordinary Skill in the Art Petitioner contends that a person having ordinary skill in the art” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “A. Whether the preamble is limiting The standard that governs the significance of the “preamble” in claim construction is set forth in Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801 (Fed. Cir. 2002). See Pet. 41. In steps, or if it is necessary to give life, meaning, and vitality to the claims. Catalina Marketing, 289 F.3d at 808. Claims 1 and 14 of the ’240 patent and claims 1, 12, 19, 33, and 44 of the ’305 patent recite preambles as follows: Claim No. Preamble Claim 1 of ’240 patent a method for scheduling in an automated manufacturing environment, comprising:” slip op. at 15

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “monitoring and assessment system that is suitable for implementing the local scheduler and related data structures disclosed in Gupta, which is implemented in software. Id. ¶ 125. The need for a scheduler that works as a local optimizer is evidenced by the recognition in Gupta’s disclosure of real-time scheduling decisions, which are advantageous for dealing with unexpected or unplanned events in a manufacturing process. Id. ¶ 121 (citing Ex. 1008, 30:19−20). Further, the local optimization scheme would have been desirable for devising scheduling strategies for specific machines, resulting in a reduction of re-engineering efforts each time a new machine is added to the process flow. Id. ¶ 119. Because Gupta focuses on a specific machine and the strategy devised for each machine, the decision-making is simplified as it focuses on optimizing each machine and not re-programming the entire process flow for the factory. Id. ¶¶ 116−118. As stated above, the enhancement of using Gupta’s local optimizer stems from the recognition that global process flow scheduling was an NP-hard program of extensive computing costs; yet, Gupta solved for it by reducing the computational costs of scheduling through optimizing local machines, rather than performing global factory calculations each time an event occurs. Id. ¶¶ 114−116; Ex. 1008, 8:48−55, 13:22−34; 13:43−48; 14:6−11. The testimony of Dr. Shanfield is persuasive and supported by the facts, and we credit it accordingly. Dr. Shanfield regarding the expectation of success is supported by the facts and we credit it accordingly. Dr. Shanfield opines that Schulze’s system is specifically designed to monitor the state of the equipment and to provide notification of events like machine operation status transitions. 1342 Shanfield Decl. ¶ 123. Gupta’s local optimization scheme is driven by events like those that Schulze captures. Id. Gupta provides additional events that are useful for Schulze’s factory, such as machine loads and unloads. Id. Thus, we agree that Schulze’s system is particularly suitable for Gupta’s local optimization scheme. And according to Dr. Shanfield, the implementation of Gupta’s scheduler (together with its database and its related data structures) would be suitable for implementation in the computer of Schulze (automated monitoring and assessment system 107) because they are both software compatible. Id. ¶¶ 124−125. Once Gupta’s scheduler is implemented in Schulze’s computer, there are no changes to the functions performed by Schulze’s semiconductor fabrication system or Gupta’s local optimization scheme. Id. ¶ 127. The implementation would require adjustments to the local scheduler program, so that it can interpret and interact with the messages generated by the equipment and MES of Schulze. Id. However, Dr. Shanfield testifies that, “[b]ased on my industry experience, such routine adjustments to the local scheduler software involve tasks like making one-time inputs identifying status flags for each equipment module being characterized, and are well within the ordinary skill of a POSA.” Id. None of these tasks would have required special techniques or extraordinary skill given the well-known components and standards used in the Schulze and Gupta implementations. Id. ¶ 128.” slip op. at 57

  Patent outcomesUS 6,968,248 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 6,968,248
• Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentable
  PTAB · Feb 7, 2023 · IPR2021-01339 · APJ David Cotta · IPR · Final written decision

  Claims 1–16, 18–26, and 28–31 are unpatentable: claims 1, 2, 6, 9–13, 18, 19, 21–23, 28, and 29 are anticipated by Brcka; the remaining challenged claims are obvious over Brcka.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposal is generally consistent with the level of skill reflected in the specification and the cited prior art. 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”) 6 Patent Owner does not present objective indicia of nonobviousness in this case. See generally, PO Resp. 9 (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). And we agree with Patent Owner that “additional education can compensate for less work experience and vice versa.” Accordingly, we adopt Petitioner’s proposed definition of the POSA level with the additional clarification proposed by Patent Owner.” slip op. at 9

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

    “Petitioner does not identify any claim terms that require construction. Pet. 18. Patent Owner does not dispute Petitioner’s assertion that no claim terms require construction. PO Resp. 16–17. We do not find it necessary to construe the claims in order to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); 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’”).” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “The implicit premise of Patent Owner’s argument is that Brcka discloses only failures and thus does not disclose “fault detection.” However, we credit the testimony of Dr. Shanfield that “[g]enerally you always need a fault to have a failure occur. So when there is a failure, a fault has occurred.” Ex. 2003, 74:6–11; see also Ex. 1003 ¶ 37 (“A fault is an abnormal tool condition, such as when a parameter strays beyond its acceptable boundary. Faults may lead to failure, which is the ‘termination of the ability of an item to perform a required function.’”) (internal citation omitted), 81 (“Machine failure, though, means that a fault condition existed requiring termination of the machine function upon the wafer.”). Thus, Brcka’s disclosure of analyzing machine failures is also, necessarily, a disclosure of a analyzing a fault. Accordingly, we find that Petitioner has established, by a preponderance of the evidence, that Brcka discloses “performing in a computer a fault detection analysis relating to processing of a workpiece.”” slip op. at 20

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

    “Petitioner cites to the embodiment depicted in Brcka’s Figure 4 as illustrating Brcka’s “fault detection analysis.” Pet. 32–33; see also Ex. 1003 ¶¶ 72–73. Figure 4 is a “flow diagram demonstrating operation of a learning system and [a] neural network model designed in accordance with at least one embodiment of [Brcka’s] invention.” Ex. 1005 ¶ 44. In step 415 of the operation disclosed in Figure 4, “a determination is made whether maintenance has been performed or a machine failure has occurred.” Id. ¶ 44, Fig. 4. If either of these things has happened, “a new reward value is calculated.” Id. In step 440, “a determination is made whether maintenance is needed.” Id. ¶ 45, Fig. 4. Thus, Brcka determines whether a failure has occurred, accounts for this determination by assigning a “reward value” (Fig. 4, step 425), and then decides whether maintenance is needed. On this record, the analysis reflected in these steps qualifies as a “fault detection analysis.” We recognize that Brcka’s fault detection analysis is used in a method that includes a predictive component. But, we do not find anything in the language of claim 1 that precludes performing the fault detection analysis as part of a predictive model. Indeed, the claim language requires only “performing . . . a fault detection analysis.” Moreover, the “fault detection” itself (i.e., Brcka’s step 415), as opposed to the analysis of the detected fault, is backward-looking, not predictive; it determines “whether . . . a machine failure has occurred.” Id. ¶ 44 (emphasis added).” slip op. at 16

  Patent outcomesUS 8,676,538 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,676,538

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.