• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.Adverse judgment
  PTAB · Aug 11, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Adverse judgment

  The Board granted the joint motion for adverse judgment after Patent Owner disclaimed claims 1–3, 5–11, and 14–17, and terminated the inter partes review.

  RulingsAdverse judgment

  • Adverse judgmentAdverse judgmentGranted

    “Section 42.73 provides that “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). We agree that adverse judgment and termination are appropriate in view of the disclaimer because no challenged claim remains.” slip op. at 2

  None
  Patents in suitUS 9,546,399
• BTC Corporation v. TG Biotech Co., Ltd.No claims unpatentable
  PTAB · Nov 13, 2023 · IPR2022-00998 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 1–13 were not shown unpatentable under the asserted obviousness grounds; Patent Owner’s motion to strike Exhibit 1038 was granted.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We are not persuaded by Petitioner’s contention that we should disregard Dr. Naumovski’s testimony because she may have taken a leave of absence from work for a couple of years. The record supports that Dr. Naumovski not only meets the requirements of the person of ordinary skill in the art, but also appears to have relevant knowledge with respect to Gynostemma pentaphylum (“GP”) saponins. See Ex. 2015 (Appendix A). related field, and at least two years of experience using techniques for extraction and characterization of plant-based materials.” PO Resp. 11 (citing Ex. 2015 ¶ 74). Because there are more than 400 species of plants that contain saponins, Patent Owner disagrees that a person of ordinary skill in the art would be familiar with the structure and utility of saponins. Id. The level of skill in the art is a reference point for gauging what would have been obvious based on the reference disclosures. See Okajima, 261 F.3d at 1355. In other words, the lens of the level of ordinary skill in the art does not change a prior art’s disclosure, though it may change one’s understanding of what is disclosed. Patent Owner, however, does not explain how its definition provides a reference point that would meaningfully alter the Petition’s assertions of obviousness. For purposes of this decision, we analyze the asserted prior art with respect to the level of skill set forth by Petitioner, but there would be no difference in the outcome of this Decision if we were to apply the level of skill in the art set forth by Patent Owner. C.” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “during the full trial, we determine that Petitioner has not shown by a preponderance of the evidence that applying the methods of Kim 460 to the G. pentaphyllum starting material of Razmovski necessarily results in the damulin levels as claimed. We agree with Dr. Naumovski’s explanation that the use of an impure damulin B standard containing a double peak renders the results as shown in Exhibit 1013 unreliable. Ex. 2015 ¶¶ 141–143, 162–173; see Ex. 2007. Dr. Naumovski further explains that the use of an impure standard would require the application of a correction factor, but this correction factor would need to be reassessed as the purity of the standard decreases over time. See Ex. 2015 ¶ 166. As Dr. Naumovski explains that applying a correction factor to the linear regression would result in a shallower slope. Ex. 2015 ¶ 165 (citing 2006, 71:12–73:5; 99:2–9). “Reducing the calibration curve slope increases the amount of damulin B calculated from the experimental extracts.” Ex. 2015 ¶ 165. However, in the Experimental Report-1 the same correction factor for the damulin B standard was used to” slip op. at 41

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

    “Petitioner requests construction of the terms “an effective amount for improving or treating the metabolic syndrome,” which is found in claims 11–13, as meaning “an amount that produces any measurable amount of improvement in the metabolic syndrome” (Pet. 13–15 (citing Ex. 1003 ¶ 91)) and “[a] pharmaceutical composition for improving and treating a metabolic syndrome, comprising at least one of at least 0.7% damulin A and at least 0.5% damulin B . . . and a pharmacologically acceptable carrier or excipient,” which is found in claim 8, as meaning “a pharmaceutical composition that includes an extract with 0.7% and 0.5% of damulin A and damulin B[, respectively,] along with a carrier or excipient” (id. at 15–16 (citing Ex. 1002, 64–65, 251–52, 280; Ex. 1001, 12:15–67, Table 2)). Patent Owner argues that “constructions are not necessary.” PO Resp. 11–12. We agree with Patent Owner and determine that it is not necessary for purposes of this Decision to construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only terms” slip op. at 15

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

    “Obviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903–04 (Fed.Cir.1988)); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016) (explaining that the expectation of success issue involves a showing of “a reasonable expectation of achieving what is claimed”) (emphasis added). Here, Petitioner relies on Kim 460 to show that heating ginseng, which contains the ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, results in a teaches that ginseng with the higher Rg3 and Rg5 content is 50-fold more potent in their vasodilation studies than the non-treated samples. Razmovski teaches that G. pentaphyllum contains over 100 saponins and eight of those saponins are the same as protoparaxadiol-type ginsenosides Rb1, Rc, Rb3, Rd, F2, Rg3, malonyl-Rb1, and malonyl-Rd that are found in P. ginseng. Ex. 1007, 4. Knowing that G. pentaphyllum also contains ginsenosides Rb1, Rb2, Rc, Rd, Rg3, and Rg5, we find Petitioner’s conclusion that heating a G. pentaphyllum extract that contains these ginsenosides would similarly increase the ginsenoside levels of Rg3 and Rg5 is a reasonable inference from the cited references. Based on the teachings in Kim 460, we agree with Petitioner that it would have been reasonable to expect that the same source material, although derived from a different plant, would behave similarly to heat treatment. See Pet. 24. Because G. pentaphyllum is a less expensive starting material, we also agree with Petitioner that there is sufficient motivation to substitute G. pentaphyllum for ginseng in the methods of Kim 460. slip op. at 29

  Patent outcomesUS 8,357,786 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,357,786
• 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
• Apple Inc. v. Logantree, LPAll claims unpatentable
  PTAB · Aug 30, 2023 · IPR2022-00040 · APJ Patrick R Scanlon · IPR · Final written decision

  Claims 1–5, 8–11, 20, 25, 30–32, 36, 39–42, 45–51, 61–65, 144, and 147 are unpatentable, principally as obvious over the grounds decided.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In the Decision on Institution, we adopted Petitioner’s proposed level of ordinary skill in the art, stating it was “consistent with the evidence of record, including the asserted prior art.” Dec. Inst. 8. In proposing a different level of ordinary skill in the art, Patent Owner does not explain why its proposed skill level is more appropriate.13 PO Resp. 18. In addition, the parties’ proposed definitions are substantially similar. Accordingly, for the purposes of this Decision, we apply Petitioner’s definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 10

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

    “We determine that we need not expressly construe “movement sensor” to resolve the parties’ disputes because doing so would have no effect on the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs, 200 F.3d at 803 (Fed. Cir. 1999)). To the extent the parties raise claim construction issues in addressing the asserted grounds, we address such issues below.” slip op. at 11

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “any weight. Reply 29–30. First, Petitioner contends that the Patent Owner Response does not provide a single citation to Dr. Madisetti’s declaration, Exhibit 2005. Id. at 29. However, Patent Owner explains that the Patent Owner Response mistakenly cites to Exhibit 2001 instead of Exhibit 2005 due to a filing error and confirms that Dr. Madisetti’s declaration is persuasive. Petitioner also argues that Dr. Madisetti’s testimony in Exhibit 2005 is not based on underlying facts because, in the 60-paragraph declaration, only paragraphs 32–35 and 59 have any citations. Reply 29. Petitioner also asserts that Dr. Madisetti refused to answer questions and provide clarification during his deposition. Id. at 30 (citing Ex. 1040, 30:3–20, 52:2–14, 78:16–84:4). Patent Owner states that it served a supplemental declaration in response to Petitioner’s Objection to Evidence months before the deposition of Dr. Madisetti.14 Sur-reply 20. On this record, we decline to discount Dr. Madisetti’s testimony in its entirety as suggested by Petitioner. Instead, we consider Dr. Madisetti’s testimony, as we do all expert testimony, in accordance with governing law and Board rules. E. Ground 1: Asserted Obviousness Based on Allum, Raymond, and Conlan” slip op. at 11

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

    “We agree with Petitioner. Allum’s and Conlan’s design schemes, although different, are not mutually exclusive. Indeed, in addition to the pushbuttons, Conlan’s monitor includes a movement senor for detecting a full range of a subject’s movement and a memory in which data obtained by the monitor can be stored and later retrieved for evaluation. Ex. 1010, 2:60–63, 3:56–58, 4:47–49. As such, Conlan combines the pushbuttons for a user to tell the device about the user’s condition with a movement senor and a memory that enables the device to tell the user (or another person) about the user’s conditions (i.e., the user’s movements). Furthermore, even if Conlan did not disclose using two design schemes together, the differences in the design schemes identified by Patent Owner would not prevent one of ordinary skill in the art from considering combining the references. Rather, as Petitioner asserts, adding Conlan’s pushbuttons would allow the resulting device to gather additional data relating to a particular event, such as a feeling of dizziness, that pertains to the subject’s balance or movement. See Pet. 21–22 (citing Ex. 1010, 6:38–46; Ex. 1003 ¶¶ 78–79); see also id. at 34 (arguing that “switches 22, ‘dizziness,’ and, when depressed, the switches 22, 23 ‘cause that occurrence to be recorded in the internal memory of the monitor’”). We are persuaded that one of ordinary skill in the art would recognize such additional data to be beneficial to Allum’s diagnostic and rehabilitative tool for people prone to abnormal falling and wishing to improve movement control.” slip op. at 18

  Patent outcomesUS 6,059,576 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,059,576
• Bluebird Bio, Inc. v. Sloan Kettering Institute For Cancer ResearchInstituted
  PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution

  The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7

  • Skill levelSkill level petitioner adoptedOther

    “Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14

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

    “Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15

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

    “As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 7,541,179
• Boston Scientific Corp. And Boston Scientific Neuromodulation Corp. v. Nevro Corp.Some claims unpatentable
  PTAB · Mar 14, 2022 · IPR2020-01563 · APJ Mitchell G Weatherly · IPR · Final written decision

  Claims 1–7 and 9–21 are unpatentable as anticipated by Bradley857 and obvious over Bradley857, Bradley384, and Meadows; claim 8 was not shown unpatentable.

  RulingsFinal written decision

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

    “At the outset, we find that the plain language of clauses 1[i], 12[k], and 18[e], in isolation, requires only that the displayed image of one lead is aligned with the displayed image of the other lead without requiring any “repositioning” of previously displayed images. However, Patent Owner argues that other language recited in each independent claim requires first “establishing” the positions of the first and second leads, which necessarily means that “aligning” the images of the first and second leads refers to repositioning them on the display. Sur-reply 2–3. However, Patent Owner’s argument fails to recognize the distinction between establishing the physical “position” of the leads relative to a physical frame of reference and aligning computer-based images of those leads. For example, clauses 18[b] and 18[c] of independent claim 18 recite: “[b] establishing a first positional relationship between a location of a first signal delivery device and an anatomical feature of a patient” and “[c] establishing a second positional relationship between a location of a second signal delivery device and at least one of the location of the first signal delivery device or the anatomical feature of the patient.” Ex. 1001, 40:34–41. None of clauses 18[b] or 18[c] or the substantively identical clauses 1[d], 1[f], 12[h], 12[i]5 from the other independent claims mentions displaying an image of either lead on a computer screen. Rather, these clauses encompass establishing the spatial position of each of the first and second physical leads relative to a physical frame of reference (e.g., an anatomical feature of a patient or another lead). These limitations may be met without displaying leads on a computer screen at all. Accordingly, we reject Patent Owner’s argument that the claims first require positioning images of the leads on a display before aligning those images on the display. Rather, we find that a plain reading of “align” or” slip op. at 10

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “II. PATENT OWNER’S MOTION TO AMEND Patent Owner filed a contingent motion to amend claims. Paper 25. Patent Owner affirmatively withdrew its motion, Paper 36, after we issued Preliminary Guidance on the motion, Paper 32. Accordingly, Patent Owner’s motion to amend is moot, and we do not reach any issue presented in that motion.” slip op. at 8

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s definition of the ordinary level of skill. PO Resp. 17. For purposes of this Decision, we adopt Petitioner’s undisputed definition. We also find that Petitioner’s proposed definition is consistent with the level of skill demonstrated in the cited prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). E. CLAIMS 1–21: ANTICIPATION BY BRADLEY857” slip op. at 17

  • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner

    “which electrodes are selected for delivering therapy. Reply 10. Petitioner also responds that Bradley857’s reference to Meadows incorporates Meadows method for determining whether an electrode is “available” to the user for delivering therapy by first confirming that impedance of the electrode is within a pre-established range. Id. For example, Meadows indicates that the “number of implanted and available electrodes is typically automatically determined by impedance measurements during hardware interrogation,” Ex. 1006, 34:57–59, and that impedance of an electrode “is a general measure of the fitness of the system to perform its required function,” id. at 46:61–64. Dr. Stone, Patent Owner’s expert, agrees that Meadows’s system does not deliver therapy to an electrode if the measured impedance for that electrode is too high or too low, that is, outside a pre-established range. Ex. 1040, 82:8–87:8.” slip op. at 33

  Patent outcomesUS 10,076,665 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,076,665
• Merck Sharp & Dohme Corp. / Merck Sharp & Dohme B.V. et al. v. Microspherix LLCSome claims unpatentable
  PTAB · Jul 8, 2019 · IPR2018-00393 · APJ James A Worth · IPR · Final written decision

  Claims 1–5, 7, 8, and 10–19 are unpatentable as obvious; claims 6 and 9 were not shown unpatentable.

  RulingsFinal written decision

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

    “B. Motivation to Combine De Nijs and Schopflin The parties dispute whether a person of ordinary skill in the art would” slip op. at 21

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “that Merck failed to add a radiopaque marker to its Implanon device and that the lack of a negative impact on release rates shows unexpected success. PO Resp. 64; see also id. at 54 (“There is no dispute De Nijs does not discuss using a marker, and that Implanon did not use a marker.”). Petitioner states that the Implanon device is the commercial embodiment of Example 5 of De Nijs. Reply 5 (citing Ex. 2002, 3:15–16; Ex. 1067, 297:7–9). Example 5 of De Nijs has no polysiloxane jacket and no sealing of implant ends. Accordingly, this argument would be more relevant to claims 6 and 9 discussed below, which recite open ends or pores. Our analysis of claim 1 focuses on the broader scope of claim 1, which includes both sealed and 14 Patent Owner cited this case in its response. See PO Resp. 32. Accordingly, we do not find Petitioner’s reliance on this case at oral argument to be waived. 15 The Court in Intelligent Bio-Systems emphasized that there is a distinction between reasonable expectation of success and reason to pursue the references’ teachings. Id. at 1366–1368. According to Intelligent Bio- Systems, reasonable expectation of success only looks to “likelihood of success in combining references to meet the limitations of the claimed invention” and that, for example, appropriate cleavage conditions would have been irrelevant to the inquiry where such conditions are not required by the claim at issue. Id. at 1367. Inquiry into motivation to combine, however, considers whether a person having skill in the art would have believed that there was a reason for reaching the claimed invention in the first place. Id. at 1368; see also KSR Int’l Co., 550 U.S. at 418 (“it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does”).” slip op. at 27

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for petitioner

    “the examiner during the prosecution of the Veenstra patent. We note, however, that the claims in the prosecution of the unrelated Veenstra patent only reached allowance after incorporation of language that captured Veenstra’s unexpected results for localization of the barium sulfate as set out the specification. In other words, Merck’s other positions during the prosecution of the Veenstra patent were not successful. Because, Merck did not succeed “in persuading a court13 to accept that party’s earlier position” we do not find that estoppel applies to Petitioner in this proceeding. New Hampshire, 532 U.S. at 750–51. Accordingly, we do not agree with Patent Owner’s position that Petitioner is estopped from arguing that the addition of a marker disclosed in Schopflin to De Nijs’s implant is obvious.” slip op. at 21

  • ExcludeMotion to exclude, deniedDenied

    “First, Petitioner asserts certain exhibits and testimony should be excluded as irrelevant because they have not been discussed in any substantive paper. Paper 36, 2–4. But, as Patent Owner notes, Dr. Kiser cited the objected-to exhibits in his declarations to show his understanding of the state of the art. Paper 38, 3. Moreover, we agree with Patent Owner that the uncited portions of Dr. Kiser’s declarations include paragraphs of technical and legal background that provide context for his opinions. Id. at 5–6. We agree with Patent Owner that Dr. Kiser’s understanding of the state of the art and the exhibits supporting that understanding are relevant to the understanding of persons of ordinary skill in the art. Id. at 3–5. Accordingly, we deny Petitioner’s motion to exclude such testimony and exhibits.” slip op. at 70

  Patent outcomesUS 9,636,402 mixed
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,636,402
• St. Jude Medical, LLC v. Snyders Heart Valve LLCAll claims unpatentable
  PTAB · May 2, 2019 · IPR2018-00107 · APJ Mitchell G Weatherly · IPR · Final written decision

  Claims 1–3, 8, 9, 22, 23, 31–35, 37–39, and 45 are unpatentable, including as obvious over Bessler and Johnson; anticipation by Bessler succeeds only for claims 38, 39, and 45.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.). We find, based on our review of the record before us, that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the record, including the asserted prior art and, for the purposes of this Final Written Decision, we adopt Petitioner’s definition.” slip op. at 9

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

    “direct attachment” of the flexible valve element to the frame. Id. at 8. However, the portion of the Specification on which Patent Owner relies also describes indirectly attaching the flexible valve element to a frame by securing it to a band that is directly attached to the frame. Ex. 1001, 7:55–66. This type of indirect attachment is illustrated in Figure 3, reproduced below right. The Specification describes Figure 3 as follows: As illustrated in FIG. 3, the flexible valve element 22 is attached to the central portion 36 of the frame 20 at a position substantially centered between the anchors 34. Although the valve element 22 may be attached to the frame 20 by other means without departing from the scope of the present invention, the valve element of the preferred embodiment is attached to the frame by adhesive bonding. Further, the flexible valve element 22 is attached to the frame 20, and more particularly to the band 40, at several attachment points 56 around the frame. Id. at 7:57–66 (emphasis added). This passage indicates that the flexible valve element is attached to the frame in two ways: (1) directly by being bonded to the central portion 36 of frame 20 and (2) indirectly by being attached to band 40 at attachment points 56. The Specification later expresses a preference for bonding valve element 22 to band 40 with adhesive. Id. at 8:11–14. Interpreting “attached to” to mean “directly attached to” as suggested by Patent Owner would be inconsistent with the Specification’s broader description of how valve element 22 is attached to frame 20. We interpret claim language “in light of the specification of the patent in which it appears.” 37 C.F.R. § 42.100(b) (2018). Doing so requires us to interpret claim language in a manner that “corresponds with what and how the inventor describes his invention in the specification.” In re Smith Int’l, Inc., 871 F.3d 1375, 1383 (Fed. Cir. 2017). The inventor describes both direct and indirect methods of attaching the flexible valve element to the frame. Accordingly, we interpret “attached to” as encompassing both direct and indirect ways of attaching the flexible valve element to the frame.” slip op. at 12

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

    “Petitioner’s argument that Bessler’s valve is attached to the central part of the frame of claims 1 and 31 fails. Bessler’s valve is undeniably attached to its frame because the cuff portion of the valve is sutured to its stent. Claims 1 and 31 require the valve element to be attached to a portion of the frame located along the radial centerline. Ex. 1001, 19:19–20 (claim 1), 22:67–23:2 (claim 31). Bessler’s valves fail to meet this requirement. Bessler’s stent 32 is a hollow cylinder devoid of structure located along its centerline,3 and the “central portion of the frame” identified by Petitioner, straight sections 33, is part of walls 31 located on the radial periphery of stent 32. Id. at 5:28–43, Figure 4. Regardless of how Bessler’s valve is attached to the wall of its stent, the valve is not attached to structure “located along a centerline” as recited in claims 1 and 31. Therefore, we determine that Petitioner fails to establish by a preponderance of evidence that Bessler anticipates claims 1 and 31 or their respective dependent claims 2, 3, 8, 9, 32–35, and 37.” slip op. at 19

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

    “For all these reasons, Dr. Chronos’s assertion that incorporating Johnson’s strut-based frame and membrane into Bessler’s stent would render the combined structure too large is not supported by the objective evidence of record. Patent Owner’s argument rests upon Dr. Chronos’s testimony. Accordingly, we find Patent Owner’s argument unpersuasive. Instead, we determine that Petitioner has proven that an ordinarily skilled artisan would 5 Ex. 1009, 1:12–13. have been motivated to combine the teachings of Bessler and Johnson as alleged.” slip op. at 38

  Patent outcomesUS 6,821,297 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,821,297
• Johns Manville Corporation / Johns Manville, Inc. v. Knauf Insulation, Inc. And Knauf Insulation SPRLNo claims unpatentable
  PTAB · May 8, 2017 · IPR2016-00130 · APJ Scott A Daniels · IPR · Final written decision

  The sole claim was not shown unpatentable under the instituted § 103 and § 102 grounds because the brochures did not create the same visual impression or anticipate the claimed design.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDenied

    “The plain language of section 315(e)(1) states that the estoppel applies to grounds a petitioner “reasonably could have raised.” (Emphasis added). The statute is grammatically clear in that the verb phrase or predicate, “reasonably could have raised,” is logically tied to its subject, “petitioner.” The word “reasonably” is not a mandatory word such as, “must,” or “shall.” The word “reasonably” is a qualifier that refers to the discretion applied by a qualified searcher in conducting an adequate search. This is consistent with the legislative history of section 315: The present bill also softens the could-have-raised estoppel that is applied by inter partes review against subsequent civil litigation by adding the modifier ‘reasonably.’ It is possible that courts would have read this limitation into current law’s estoppel. Current law, however, is also amenable to the interpretation that litigants are estopped from raising any issue that it would have been physically possible to raise in the inter partes reexamination, even if only a scorched-earth search around the world would have uncovered the prior art in question. Adding the modifier ‘reasonably’ ensures that could-have-raised estoppel extends only to that prior art which a skilled searcher conducting a diligent search reasonably could have been expected to discover. 157 Cong. Rec. S1360-94 (daily ed. Mar. 8, 2011) at 1375 (stmt. of Sen. Kyl). A reasonable reading of section 315(e)(1) does not mandate estoppel of all prior art in the possession of a petitioner, or prior art which petitioner, e.g. via its employees, may have possessed or known about at some point in time. To the contrary, the prior art estopped is that which “a skilled searcher conducting a diligent search reasonably could have been expected to discover.” Id. Congress easily could have broadened the estoppel provision to extend to “any ground that the petitioner raised or [] could have raised during that inter partes review,” but it did not. See id.” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “We determine that the documents are sufficiently authenticated, first, because the marketing, company contact and product information expressly set out in the brochures, along with the witnesses’ corroborating statements, show sufficiently that Exhibits 1004 and 1005 are what they appear to be, that is, advertising brochures that were printed and produced for dissemination to Johns Manville’s customers and sales personnel for unrestricted distribution to the public. Second, we determine that the dates on the brochures are not merely “archival” dates in Mr. Mota’s files as Knauf contends. See Mot. to Exclude, 4 (citing Apple Inc. v. DSS Technology Management, Inc., IPR2015-00369, slip op. at 6 (PTAB August 12, 2015) (Paper 14)). Mr. Mota and Mr. Graves both explain that it was standard practice at Johns Manville to print these dates on the brochures to indicate a first printing of the brochure. Ex. 2019, 20:23–21:24; Ex. 2020, 39:4–40:2. This testimony is corroborated, at least circumstantially, by the documents themselves where, for example, Exhibit 1005 states “10/00 (Replaces 12/97),” where 12/97 is the date printed on Exhibit 1004 and Exhibit 1005. We agree with Knauf that hearsay is not admissible under Fed. R. Evid. 802. Mot. to Exclude, 2. However, based on the testimony of Mr. Mota and Mr. Graves, we find that the dates printed on the brochures were a common business practice at James Manville. See Ex. 2019, 20:23–21:24; Ex. 2020, 39:4–40:2. These dates, along with the testimony of Mr. Mota and Mr. Graves, are probative of the authenticity of the documents themselves and their existence and purpose at the relevant time period. Knauf has provided no persuasive evidence that either the December 1997 date or the October 2000 dates as printed on the brochures are untrustworthy, or that either Mr. Mota’s or Mr. Graves’s testimony are inconsistent with this assertion. Also, we do not consider Mr. Mota or Mr. Graves’s declarations to be hearsay, as they are not out-of-court statements. In an inter partes review, direct testimony is typically provided via affidavit, with cross-examination taken via deposition. 37 C.F.R. § 42.53(a) and see Ex. 2019, 20:23–21:24; Ex. 2020, 39:4–40:2, 44:15–20. Thus, we determine on the evidence in this proceeding that Exhibits 1004 and 1005 are properly authenticated and not inadmissible hearsay because they have been shown to be commercial product advertising publications under Fed. R. Evid. 803(17) and include customary date information that, based on the sworn testimony of Mr. Graves and Mr. Mota, was made in the regular course of business and is thus subject to the business records exception under Fed. R. Evid. 803(6).” slip op. at 18

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

    “2010, 4). For example, considering the claimed design, we observe a random swirl pattern evident in both the color and black and white images of the claimed design shown above. We find the phrase “variations in a swirl pattern” helpful to objectively describe what we observe as the relative arrangement between the “distinct hues” shown in the photograph. Moreover, both parties have advanced this term in their proposed claim constructions. Compare Pet. 17 with PO Resp. 28. Observing the design as a whole, “swirl pattern” is somewhat less than specific. We agree to an extent with Knauf’s Declarant, Professor Rake, that “swirl pattern” can aptly describe a variety of patterns. Ex. 2012 ¶ 28. Thus, to facilitate a more expressive elocution of this element, we further described the contrast imparted by the “swirl pattern” consistent with the prosecution history of the ’670 patent as having a “cloud-like appearance.” Ex. 1002, 33. Both parties have also included this term in their proposed constructions. Compare Pet. 16 with PO Resp. 28.” slip op. at 28

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “manager who has a technical or engineering background and is familiar with the insulation manufacturing process, but who does not have any specialized training in color, is a designer of ordinary skill. PO Resp. 7–10. This definition has some appeal, mainly because the claimed article of manufacture here is insulation, and it does not appear, based on the testimony of witnesses from both parties, that in the insulation manufacturing process any particular expertise in color of the insulation was generally necessary. Compare Ex. 2004, 3:15–5:7 with Ex. 2008 ¶¶ 14–16. Color, however, is an issue here in this case that involves colored insulation material, specifically because Knauf conceded during prosecution that “color is an integral part of the claimed invention.” Ex. 1002, 13. We agree that a product manager can be “a designer of ordinary skill in the art” as applied to designs because a product manager, in charge of manufacturing insulation, is knowledgeable and sufficiently trained to fabricate such products. PO Resp. 7. That a product manager without certain expertise, such as in color, may be a “designer of ordinary skill” does not explain why such a definition must necessarily exclude another person, with a skill set in color, as a designer of ordinary skill. We find this to be particularly reasonable where an unfamiliar aspect of insulation design, such as color, is a concern. Indeed, James Worden, Knauf’s declarant, confirms that a Product Manager who did not have certain experience, for example with color, would understand that “a color pigment specialist may provide an understanding of coloring various substances.” Ex. 2008 ¶¶ 15–16. Thus, while Dr. Bide’s testimony may not be particularly relevant to all aspects of insulation design, here, where color is an integral part of the design, it is reasonable to include aspects of his particular expertise within the purview of an ordinary designer. See In re Nalbandian, 661 F.2d 1214, 1216 (C.C.P.A. 1981) (“The ‘ordinary designer’ means one who brings certain background and training to the problems of developing designs in a particular field.”) We determine that the designer of ordinary skill in the art for insulation material therefore may be a product manager in the insulation manufacturing industry who has a technical (e.g. engineering) background and, on issues relating to color, may also be a person such as a pigment specialist and/or binder chemist having background and training pertaining to color in development of the insulation design.” slip op. at 40

  Patent outcomesUS D631,670 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness

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.