• CQV Co., Ltd. v. Merck Patent GmbHNo claims unpatentable
  PTAB · Oct 14, 2025 · PGR2021-00054 · APJ Kristina M Kalan · PGR · Remand

  Claims 1–22 were not shown unpatentable because Sample C was not proven publicly available as prior art, and the original decision found the remaining grounds insufficient.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “We agree with Patent Owner that Petitioner’s evidence in Kuntz (Ex. 1026), the Annual Report (Ex. 1028), Masuko (Ex. 1029), and Pfaff (Ex. 1034) is insufficient to show that Xirallic® Sample C was available to the public before the effective filing date of the ’861 patent. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26. Kuntz, the Annual Report, Masuko, and Pfaff may support a finding that the Xirallic® line of products was available to the public, but these documents do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public. We also agree with Patent Owner that the Technical Data Sheets (Exs. 1005–1010), Certificates of Analysis (Exs. 1011–1017), and Material Safety Data Sheet (Ex. 1025) are insufficient to show that Xirallic® Sample C was available to the public. Petitioner has not asserted, nor do we find, that any of these documents refer to or describe the lot of Xirallic® from which Sample C was taken. See Final Dec. 26–27. Regardless of how the Technical Data Sheets were used in the Opposition against the European counterpart of the ’861 patent (Exs. 1040, 1041) and during the prosecution of the application from which the ’861 patent issued (Ex. 1003, 102–104), the Technical Data Sheets do not refer to or describe the lot of Xirallic® from which Sample C was taken. Moreover, as noted by Patent Owner, the Technical Data Sheets (Exs. 1005–1010) indicate that they are “preliminary” and Petitioner has not provided any evidence that the Technical Data Sheets were ever issued to the public, as opposed to just issued internally. See PO Resp. 18–19. We also find persuasive Patent Owner’s argument that the Technical Data Sheets are preliminary because other, later-dated technical data sheets (Exs. 2012, 2013) lack the “preliminary” label and list characteristics that are different from those in Exhibits 1005–1010. See PO Resp. 19 (comparing, e.g., Ex. 1009 and Ex. 2013; Ex. 1005 and Ex. 2012). The Technical Data Sheets may support a finding that the Xirallic® products they describe existed as of the dates on the documents, but they do not support a finding that the lot of Xirallic® from which Sample C was taken was available to the public.” slip op. at 20

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedOther

    “witnesses. See Elbit Systems of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (citing Trs. of Columbia Univ. v. Illumina, Inc., 620 F. App’x 916, 922 (Fed. Cir. 2015); Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982)). We have reviewed the witness testimony in the record and, more particularly, Mr. Choi’s deposition answers regarding Petitioner’s purchase of the lot of Xirallic® from which Sample C came. We find that Mr. Choi’s responses cast doubt on the credibility of his declaration testimony, namely with regard to the public availability of Sample C. Mr. Choi represented that he was involved in the purchase of the lot of Xirallic® from which Sample C was taken. Ex. 2011, 48:1–23. Mr. Choi stated that he instructed Petitioner’s marketing team manager to buy the sample from a distributor of Patent Owner’s products located in Europe. Id. at 48:24–49:4. Mr. Choi stated that he has evidence of the transaction, but refused to reveal the name of the company from which Petitioner purportedly purchased the lot of Xirallic® (id. at 49:5–50:3) and refused to produce an email in his possession that would corroborate his testimony regarding Petitioner’s acquisition of the product (id. at 50:8–16, 51:10–23). Mr. Choi represented that he does not remember how much Petitioner paid for Sample B. Id. at 56:4–5. Mr. Choi admitted that the entity from which Petitioner acquired the lot of Xirallic® from which Sample C was taken is “not currently a Merck distributor” (Ex. 2011, 50:4–7) and was not “a Merck distributor at the time” that “samples B and C were purchased” (id. at 51:25–52:2). According to Mr. Choi, the company is a “former distributor” of Patent Owner’s products. Id. at 52:3–6. Mr. Choi did not know, according to his testimony, when that unnamed entity first obtained the lot of Xirallic® (id. at 52:7–10) and he stated that he did not have personal knowledge of how the entity obtained the lot of Xirallic® (id. at 52:12–19). Instead, Mr. Choi assumed the entity was “able to obtain the sample through the routine course or process” the entity uses “to take samples or get samples.” Id. at 52:12–19. Mr. Choi believed the sample of Xirallic® from which Sample C was taken was sealed when Petitioner received it because samples from dealers are sealed, and he remembered observing that the package was from a dealer. Id. at 52:24– 54:25. However, Mr. Choi admitted that he did not obtain a technical data sheet or certificate of analysis for the lot of Xirallic® from which Samples B and C were taken. Id. at 59:6–11. Mr. Choi also answered questions regarding Petitioner’s purchase of Samples D and H. Ex. 2011, 62:20–66:8, 67:7–9, 73:12–13, 73:17–22. Similar to his testimony regarding Samples B and C, Mr. Choi admitted withholding an email regarding the purchase of the lot of Xirallic® from which Sample D was taken. Id. at 62:20–63:9. Mr. Choi also admitted that he did not know how Akzo USA or Axalta obtained the Xirallic® the companies sold to him, and admitted that Akzo USA was not a distributor of Patent Owner’s products at the time Petitioner purchased the product. Id. at 63:10–66:8, 73:17–22. Mr. Choi also admitted that Petitioner did not pay Akzo USA for the lot of Xirallic® from which Sample D was taken, and did not pay Axalta for the lot of Xirallic® from which Sample H was taken. Id. at 67:7–9, 73:12–13. Although Petitioner presents declaration testimony from Mr. Choi representing that he purchased the lot of Xirallic® from which Samples B and C were taken in October 2011 (Ex. 1004 ¶ 16), Mr. Choi’s declaration testimony lacks corroborating evidence, and his deposition testimony does not support that the product was available to the public, as we found in our Final Written Decision. See Final Dec. 27–28. Notably, Petitioner produced corroborating evidence for Mr. Choi’s acquisition of Samples A, H, and I. See Ex. 1004 ¶¶ 13 (citing Ex. 1047), 18 (citing Exs. 1024, 1025). However, Mr. Choi withheld similar evidence for the Xirallic® lots from which Samples B, C, and D were taken. See Ex. 2011, 50:8–16, 51:10–23, 62:20– 63:9; Final Dec. 28. As Patent Owner argues, there is “no information to determine when a contract was established, that there was consideration for the exchange, that the product was available to be delivered when the alleged transaction took place, or even when the product was delivered. Choi has no memory of what was paid for the product.” Sur-Reply 24–25; see also PO Resp. 13–14; PO Br. Rem. 2–4.” slip op. at 34

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Based on the evidence discussed above, we are not persuaded that Petitioner has shown by a preponderance of the evidence that Sample C was available to the public. Regardless of whether a company avoids wasting shelf life of its products (Ex. 1004 ¶¶ 15–16), there is no persuasive evidence in the record showing that the lot of Xirallic® from which Sample C was taken was released from quality control and then made available to the public by Patent Owner. Mr. Choi’s testimony shows that Petitioner obtained the lot of Xirallic® from which Sample C was taken in an atypical manner (i.e., not from Patent Owner or one of Patent Owner’s current distributors) (Ex. 2011, 49:5–50:7, 50:8–16, 51:10–23, 51:25–52:6, 52:12– 19), and there is no evidence in the record to show that the lot of Xirallic® was intended for sale, rather than for experimental use only or for some other restricted use. Accordingly, we determine Petitioner has not demonstrated by a preponderance of the evidence that Sample C qualifies as prior art against the ’861 patent, and we determine that Petitioner has not shown by a preponderance of the evidence that the ’861 patent is unpatentable over the grounds relying on Sample C.” slip op. at 38

  Patent outcomesUS 10,647,861 not shown unpatentable
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 10,647,861
• Innoscience (Zhuhai) Technology Company, Ltd. / Innoscience America, Inc. v. Efficient Power Conversion CorporationNo claims unpatentable
  PTAB · Mar 25, 2025 · IPR2023-01382 · APJ Kimberly Mcgraw · IPR · Final written decision

  Claims 1–3 were not shown unpatentable under any of five § 103 grounds because Petitioner failed to establish sufficient motivation to modify or combine the prior art.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “A petition must identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3) Here, Petitioner merely provides general assertions about multiple references, without clearly identifying how, or why a POSITA would have been motivated, to modify the processes disclosed in those references to arrive at the claimed invention. Thus, the Petition does not state with particularity that Saxler’s particular technique for etching is to be used instead of Beach’s etching step when substituting Beach’s self-aligned process for Saxler’s two mask process. Nor does the Petitioner provide a sufficient reason, absent hindsight, why a POSITA would have been motivated to combine the references to result in a process that forms Saxler’s Modified Figure 1A. Thus, for these additional reasons, Petitioner has not shown by a preponderance of the evidence that claim 1 would have been obvious over Saxler, Beach, and Shenoy.” slip op. at 34

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Both parties agree that the differences between the definitions do not impact the analysis. Resp. 11; Reply 2. In light of the record before us, and for purposes of this Decision, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’347 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand and implement the teachings of the ’347 patent and the prior art. We also note that our Decision would be the same under either parties’ definition.” slip op. at 13

  • Expert testimonyOther

    “Petitioner’s expert, Dr. Shealy states that he understands paragraph 52 to mean that it is “fair game to pull the recess out of any of those figures [Figures 1A through 6].” Ex. 2004, 39:12–21. Dr. Shealy, however, also clarifies that “[a]s I said before, I think you could take all the embodiments and bring in which ones you want, depending on what you’re trying to accomplish.” Ex. 2004, 40:24–41:1. During the hearing, Petitioner admitted that Dr. Shealy’s “statement to modify the reference depending on what you're trying to accomplish” means that “a POSITA may modify with reason to do so. A POSITA would have removed Saxler’s recess to obtain the benefits of enhancement-mode.” Tr. 19:19–25. Again, the Petition does not provide a reason why a POSITA would have removed Saxler’s gate recess.” slip op. at 28

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “remove the recess in Saxler Figure 1A to arrive at the allegedly enhancement mode transistor of Modified Figure 1A. Contrary to Petitioner’s assertions in its Reply and at the hearing, the Petition makes no argument that a POSITA would have removed the recess from Saxler Figure 1A to realize the benefits of an enhancement mode transistor. See Reply 4–5; Pet. 24–68. Rather, the Petition merely asserts that a POSITA would have understood that the gate recess of Figure 1A is optional without providing any persuasive reason why a POSITA would have removed the gate recess but retained the sloped sidewalls of Figure 1A. Pet. 25, 40, 45. For example, Petitioner asserts that Saxler’s gate contact may be “recessed or non-recessed” and that when the gate recess shown in Figure 1A is not utilized, Saxler would have the structure of Saxler Modified Figure 1A. Pet. 25 (citing Ex. 1003 ¶ 81; Ex. 1007 ¶ 52, 66); see also Pet. 40, 45 (citing Ex. 1007 ¶ 52). Neither of these paragraphs provide sufficient motivation to a POSITA to remove the gate recess from Saxler Figure 1A. Saxler paragraph 52 states: Exemplary devices according to some embodiments of the present invention are schematically illustrated in FIGS. 1A through 6. Thus, while embodiments of the present invention are described herein with reference to a recessed gate structure or a non-recessed gate structure, other embodiments of the present invention may include or not include a gate recess. Accordingly, embodiments of the present invention should not be construed as limited to the particular exemplary embodiments described herein but may include any suitable structure having a cap layer and/or passivation layer as described herein. Ex. 1007 ¶ 52. Petitioner’s expert, Dr. Shealy states that he understands paragraph 52 to mean that it is “fair game to pull the recess out of any of those figures [Figures 1A through 6].” Ex. 2004, 39:12–21. Dr. Shealy, however, also clarifies that “[a]s I said before, I think you could take all the embodiments and bring in which ones you want, depending on what you’re trying to accomplish.” Ex. 2004, 40:24–41:1. During the hearing, Petitioner admitted that Dr. Shealy’s “statement to modify the reference depending on what you're trying to accomplish” means that “a POSITA may modify with reason to do so. A POSITA would have removed Saxler’s recess to obtain the benefits of enhancement-mode.” Tr. 19:19–25. Again, the Petition does not provide a reason why a POSITA would have removed Saxler’s gate recess.” slip op. at 28

  Patent outcomesUS 9,748,347 not shown unpatentable
  § 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,748,347
• Innoscience (Zhuhai) Technology Company, Ltd. / Innoscience America, Inc. v. Efficient Power Conversion CorporationNo claims unpatentable
  PTAB · Mar 18, 2025 · IPR2023-01383 · APJ Kimberly Mcgraw · IPR · Final written decision

  Claims 1–5 were not shown unpatentable because Petitioner did not sufficiently establish a reason to modify the asserted prior art.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We disagree with Petitioner’s argument because it fails to address Dr. Schubert’s academic and other experience with GaN transistors. Dr. Schubert is currently a tenured full professor in the Department of Electrical Computer, and Systems Engineering at Rensselaer Polytechnic Institute and was previously a tenured full professor in the Department of Electrical and Computer Engineering at Boston University. Ex. 2001, 129. Additionally, Dr. Schubert was the director of Boston University’s Semiconductor Devices Research Laboratory. Ex. 2001, 129. Dr. Schubert persuasively explains that his general expertise is in the field of electrical engineering and applied physics, including semiconductors, processing, and devices and his specific expertise is in the field of semiconductor materials (such as GaN), semiconductor devices, semiconductor integrated circuits, ohmic contacts, Schottky contacts, HEMTs, and optoelectronic devices such as light-emitting diodes (LEDs). Ex. 2001 ¶ 11, App’x A pp.129–137. His experience includes “the design, growth, fabrication, and testing of semiconductor devices as well as the employment of these devices in a variety of applications” and he is “familiar with both the design of such transistors [HEMTs] and the manufacturing processes used for FETs. Ex. 2001 ¶ 11, App’x A, pp. 129–137. He is an author or co-author of numerous text books and articles, and co-inventor of numerous patents, including those dealing with HEMT transistors and GaN devices. Ex. 2001 ¶ 13, App’x A, pp. 129–137. Petitioner fails to present any persuasive argument or evidence that Dr. Schubert’s extensive education and experience regarding GaN transistors is insufficient or lacking such that his testimony should be given little weight. Finally, we disagree with Petitioner’s additional argument that that its expert’s testimony (Dr. Shealy) should be given more weight than Patent Owner’s expert’s testimony (Dr. Schubert) because “[u]nlike Dr. Schubert, Dr. Shealy is one of the pioneer scientists in the field of GaN transistors.” Reply 34 (stating that Dr. Shealy’s research lab built the first GaN HEMT device on silicon in 1999 and citing Ex. 2002, 87:19–238). Obviousness is determined through the lens of a “person of ordinary skill in the art,” not through the lens of a person with extraordinary skill or a pioneer in the field. Given Dr. Schubert’s extensive relevant education and experience, Petitioner does not persuasively explain why Dr. Shealy’s testimony on any specific topic, or his testimony in general, should be given more weight than Dr. Schubert’s.” slip op. at 16

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”). Graham, , 383 U.S. at 17–18. Petitioner argued that a person of ordinary skill in the art would have had a “at least a four-year degree in electrical engineering, chemical engineering, physics, or material science or a closely related field and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies. Additional education could substitute for professional experience and vice versa.” Pet. 11 (citing Ex 1003 ¶ 69). Patent Owner did not dispute this proposed definition prior to institution. See generally Prelim. Resp. In our Decision on Institution, we adopted Petitioner’s proposal. After institution, Patent Owner asserted a slightly different definition of a POSITA, namely someone who “would have possessed at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” Resp. 17. Relevant graduate education could substitute for the professional work experience. Id. Upon review of the full record, we see no reason to modify, and we thus maintain, the definition of a POSITA applied in our Decision on Institution. We also determine that our decision would be the same under either of the parties’ proposed definitions.” slip op. at 14

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “During the proceeding, the parties also dispute the proper construction of “etching away the doped GaN layer, except a portion of the doped GaN layer beneath the gate contact” as recited in step [1e4] and provided briefing on this issue. Papers 35, 36, 37, 38. Because, as explained below, our determination rests upon Petitioner’s failure to show a sufficient reason to modify the asserted art, which is not dependent upon any particular claim construction, we need not, and do not, address these claim construction issues. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy).” slip op. at 13

  • ExcludeDenied

    “III. PETITIONER’S MOTION TO EXCLUDE EXHIBIT 2008 Petitioner filed a Motion to Exclude (Paper 25, “Mot.”) Exhibit 2008, which is a hearing transcript from the parallel ITC investigation. Mot. 1. Because we do not rely upon Exhibit 2008 in our Decision, we dismiss Petitioner’s motion as moot.” slip op. at 47

  Patent outcomesUS 8,404,508 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,404,508
• Intel Corporation v. Besang Inc.No claims unpatentable
  PTAB · Dec 11, 2024 · IPR2023-00991 · APJ Jon B Tornquist · IPR · Final written decision

  The Board held claims 1 and 13–17 not unpatentable, finding the asserted obviousness grounds deficient in claim limitations or motivation to combine.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The parties proposed definitions differ in that Petitioner would permit a degree in “materials science” and require three years, as opposed to two years, of relevant experience. Compare Pet. 9 with PO Resp. 14. On this record, we adopt Patent Owner’s proposed definition, as it is more consistent with the prior art of record and the disclosures of the ’702 patent. We note, however, that neither party contends that the outcome of this case depends on the slight differences in the proposed definitions of a person of ordinary skill in the art.” slip op. at 9

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

    “1996) (“It is well-settled that, in interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history.”). Upon review of the parties’ arguments and the intrinsic record, we agree with Petitioner that the ’702 patent does not support a construction of “stackable add-on layer” that encompasses memory cells formed by sequential deposition on a substrate without being formed and then added to a separately formed substrate. Pet. 11–12. First, the plain language of the claim does not require merely a “layer” having a plurality of vertically oriented semiconductor memory cells, but rather “a stackable add-on layer” having a plurality of vertically oriented semiconductor memory cells; that plurality is bonded to the dielectric layer. Ex. 1001, 12:29–32. A construction that gives meaning to all words of the claim is preferred. Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is preferred over one that does not do so.”).” slip op. at 12

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “As discussed above, we do not understand a “stackable add-on layer” to include memory cells that are formed by sequential deposition on or above a substrate without being added to a separately formed substrate. It is undisputed, and indeed it is Petitioner’s assertion, that Lee’s memory devices are formed by sequential deposition. Pet. 16, 29 n.11, 51 (“In Lee, each level 3104 is deposited on the underlying level of array 3101.”). Therefore, Petitioner has not shown that Lee discloses every limitation of independent claim 13 under our claim construction. Thus, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious in view of Lee. 3. Analysis: Claims 14–17 Claims 14–17 each depend, directly or indirectly, from claim 13. Petitioner’s arguments with respect to these claims do not remedy the deficiencies noted above with respect to claim 13. Pet. 31–41. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 14–17 would have been obvious over Lee.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “We agree with Patent Owner that Petitioner has not demonstrated that Aspar would improve Lee, would solve a problem in Lee, and that Petitioner is proposing to use Aspar in a way that is not disclosed in the reference. PO Resp. 49–50 (citing Ex. 2029 ¶¶ 153–162); Tr. 57:24–58:12; Pet. 61; KSR, 550 U.S. at 417 (asking whether a technique “would improve similar devices in the same way”), 420 (asking whether there was a known problem in the art), 421 (asking whether one of ordinary skill in the art had reason to “pursue the known options”); Intel, 61 F.4th at 1381 (explaining that obviousness may be demonstrated by showing that there was a known problem in the art (“cache coherency in multiprocessor systems”) and that a person of ordinary skill in the art would recognize that that the prior art solution to this problem (“global segmented secondary cache”) would improve the system of another prior art reference). Petitioner does not persuasively show that there was any known problem in the art with respect to Lee or its monolithic method of constructing memory arrays. Nor does Petitioner provide persuasive argument or evidence that Aspar’s wafer bonding would improve Lee’s memory device.10 For example, Petitioner states in a conclusory fashion that Aspar would address the known problem of “fabricating 3D structures,” but does not explain what those problems were or why Lee fails to solve them. Pet. 61. Dr. Sechen’s testimony merely parrots the Petition, providing no further analysis or explanation of what problem might exist in Lee when fabricating its 3D structures. Ex. 1003 ¶ 212. The Petition notes that Aspar transfers “thin layers of very good thickness homogeneity and with a high crystalline quality,” but the Petition never asserts that Lee’s direct deposition method fails to provide these same or similar qualities. Pet. 60–61.” slip op. at 27

  Patent outcomesUS 7,378,702 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,378,702
• Micron Technology, Inc. / Micron Semiconductor Products, Inc. et al. v. Besang Inc.No claims unpatentable
  PTAB · Nov 13, 2024 · IPR2023-00900 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 13–17 were not shown unpatentable: Lee-based grounds fail on the stackable add-on layer limitation, and Watanabe-based grounds fail on nonvolatile memory, enablement, or motivation to combine.

  RulingsFinal written decision

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

    “meaning in the art. See Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed. Cir. 2004) (stating that, absent an accepted meaning in the art, “we construe a claim term only as broadly as provided for by the patent itself”). Thus, we must attempt to discern the meaning of this term from the claim language itself and from the remainder of the intrinsic record. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“It is well-settled that, in interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history.”). Upon review of the parties’ arguments and the intrinsic record, we agree with Petitioner that the ’702 patent does not support a construction of “stackable add-on layer” that encompasses memory cells formed by sequential deposition on a substrate without being formed and then added to a separately formed substrate.” slip op. at 10

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “As discussed above, we construe “stackable add-on layer” to not include memory cells that are formed by sequential deposition on or above a substrate without being added to a separately formed substrate. It is undisputed, and indeed it is Petitioner’s assertion, that Lee’s memory devices are formed by sequential deposition. See Pet. 52 (asserting that in Lee “the layers of the array are directly deposited on the layers of each underlying level, and the array is deposited on the interlayer insulating layer formed over a substrate”); see also id. at 70 (“Lee discloses forming vertical memory devices through layer-by-layer sequential deposition on the substrate . . . .”). Therefore, Petitioner does not show that Lee discloses every limitation of independent claim 13 under our claim construction. Thus, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious in view of Lee. 3. Claims 14 and 15 Claims 14 and 15 depend from claim 13. Ex. 1001, 12:35–42. Petitioner’s arguments for these claims do not remedy the deficiencies noted above with respect to independent claim 13. Pet. 54–59. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 14 and 15 would have been obvious in view of Lee alone. E. Claims 16 and 17 over Lee and Endoh Petitioner contends the subject matter of claims 16 and 17 would have been obvious over the combined disclosures of Lee and Endoh. Pet. 59–69. Petitioner’s arguments with respect to these claims, however, do not remedy the deficiencies noted above with respect to Lee and its monolithic, sequentially deposited memory array. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claims 16 and 17 would have been obvious over Lee and Endoh.” slip op. at 18

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “combined Lee and Watanabe to achieve improved integration density. Pet. 71. Petitioner concedes, however, that the benefits of Lee’s design related to 3-D integration and improved integration density would be obtained if Lee’s memory structures are formed using either Lee’s monolithic construction method or Watanabe’s alternative stacking method. Pet. Reply 13–14 (citing Ex. 1041 ¶ 34). Thus, we are not persuaded that improved integration density provides a sufficient rationale for Petitioner’s combination of Lee’s memory device and Watanabe’s stacking method. Petitioner argues that Watanabe’s stacking method “improves the accuracy of the wiring” because the wiring is made “for each planar member.” Pet. 72 (citing Ex. 1005, 6:1–3). Watanabe also states that its disclosed methods provide “a low interconnection wire resistance.” Ex. 1005, 6:20–23. Petitioner does not, however, explain sufficiently how Watanabe’s stacking method would improve Lee’s device. For example, Petitioner does not address whether the alleged wiring benefit already existed in Lee’s monolithic array or explain how this benefit would also apply to Lee’s particular memory array, which differs in construction and elements from Watanabe’s device. This diminishes Petitioner’s benefits-based motivation to combine arguments. In general, a petitioner need not demonstrate that a particular alternate method would improve a prior art device in order to show a motivation to combine. Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380–81 (Fed. Cir. 2023); see Pet. Reply 20 (citing Intel). But here, Petitioner affirmatively invokes improvement of Lee’s device as a reason for the combination, and we must evaluate Petitioner’s contention. Moreover, any relative lack of improvement or benefits must be weighed against any problems the alternative method would introduce. See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 795–96 (Fed. Cir. 2021) (noting that simultaneous advantages and disadvantages to a proposed combination must be analyzed to determine whether the disadvantages “outweighed any reason to combine”). Here, as discussed above in more detail with respect to the ground based on Watanabe, the evidence shows that one of ordinary skill in the art would have expected Watanabe’s bonding temperature of 900– 1000° C to damage the electronic devices in an underlying substrate. Ex. 2029 ¶¶ 75–76; Ex. 2028, 123:13–124:7; Ex. 2027, 715. The expected damage to Lee’s device, when balanced against the limited evidence of a benefit to the combination,7 outweighs the reason to combine Lee and Watanabe set forth in the Petition. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that claim 13 would have been obvious over Lee and Watanabe. 2. Analysis – Claims 14 and 15 Claims 14 and 15 both depend directly from independent claim 13. Ex. 1001, 12:35–42. Petitioner’s arguments with respect to claims 14 and 15 do not remedy the deficiencies noted above with respect to independent claim 13. Pet. 73. Accordingly, Petitioner does not demonstrate by a preponderance of the evidence that these claims would have been obvious over Lee and Watanabe.” slip op. at 40

  • Expert testimonyPatent owner expert creditedOther

    “We credit the testimony of Dr. Przybylski that one of ordinary skill in the art would have understood that Watanabe’s stacked structure would be severely impacted if bonded at a temperature above 900° C, as disclosed in Watanabe. Ex. 2029 ¶¶ 76–77. Dr. Przybylski’s opinion is supported by Dr. Lee’s testimony (Ex. 2028, 123:13–124:7, 125:6–126:7), as well as Watanabe (Ex. 1005, 6:6–14) and Batude (Ex. 2027, 715). As further discussed below, we find that Petitioner has not rebutted Patent Owner’s showing of nonenablement, and Patent Owner has carried its burden to demonstrate that Watanabe was not enabled for bonding temperatures of 900–1000° C, as of the 2004 filing date of the ’702 patent.” slip op. at 32

  Patent outcomesUS 7,378,702 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,378,702
• Candela Corporation v. Nikolai TankovichNo claims unpatentable
  PTAB · Jun 5, 2024 · IPR2023-00234 · APJ Sheridan K Snedden · IPR · Final written decision

  The Board held claims 1–28 not shown unpatentable because the asserted combinations did not establish simultaneous delivery of overlapping and non-overlapping laser beams.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 19; Ex. 1002 ¶ 77. Patent Owner does not dispute this proposed level of skill, but offers that a “POSA may have alternatively held a degree in electrical engineering.” PO Resp. 10; Ex. 4–10, 13, 15–17. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record, and also consider Patent Owner’s additional proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed patent owner constructionDecided for patent owner

    “In this case, the Specification is devoted to the teaching simultaneous delivery of multiple laser beams. The Specification begins by stating that “[t]here are no lasers or laser handpieces on the market today that can simultaneously deliver two or more wavelengths of laser energy in spacial, fractional form.” Ex. 1001, 1:12–14. The Specification explains that “laser treatment usually requires different modalities of energy in order [to] successfully treat the pathologies to which they are applied,” but that “the sequential application of multiple wavelengths of laser energy compromises the treatment.” Id. at 1:16–25. The Specification then continues to explain various problems associated with the sequential application of multiple wavelengths. Id. at 1:25–52. The Specification concludes its introduction as follows: What is needed in the art therefore is an effective laser therapy system that can simultaneously deliver multiple wavelengths of laser energy through the use of a single laser unit without producing interference between the wavelengths within the treated tissue.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “summarized above, we find Patent Owner to have the better position. In particular, we agree with Patent Owner that the combination of Hsia and Black fail to teach or suggest simultaneously delivering non-overlapping beams. The combination also fails to teach or suggest producing beam patterns that include both overlapping and non-overlapping beams. PO Resp. 34. To begin, while we recognize that Hsia discloses overlapping and non-overlapping treatment patterns, those patterns are achieved by the sequential delivery of laser beams as a user physically moves a single handpiece that delivers a single beam across the skin of a patient. Ex. 1004 ¶ 68, Figs. 8 and 9; Ex. 2001 ¶¶ 73–74. Black does not cure that deficiency as Black does not disclose treatment with non-overlapping beams. Ex. 2001 ¶ 99. Black discloses using a “refractive optics, mirror-based optical delivery device” for the simultaneous delivery of multiple overlapping laser beams. Ex. 1006 ¶¶ 12– 13. The beams align on an optical path and, using different laser beam parameters, deliver treatment at various depths within a combined beam path. Id. ¶¶ 54, 58–59. Thus, while Black may be characterized as creating overlapping beams, we do not find sufficient support for a finding that Black teaches or suggests creating non-overlapping beams for simultaneous delivery, and the claims require both. We also do not find sufficient support for Petitioner’s claim that a POSA would have found it obvious to combine Black and Hsia to simultaneously produce both overlapping beams and nonoverlapping beams, based on the disclosures in these references. See, e.g.,” slip op. at 31

  • BurdenFwd all claims patentableNot shown unpatentable

    “Claims Claims Not 35 U.S.C. § Reference(s)/ Claims Shown Shown Basis Unpatentable Unpatentable 1–28 103 Hsia, Black 1–28 Hsia, Black, 23 103 23 Negus Hsia, Black, 27, 28 103 27, 28 Altshuler Altshuler, 1–28 103 1–28 Black Altshuler, 23 103 23 Black, Negus Overall Outcome 1–28 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–28 of the ’481 patent are unpatentable; and” slip op. at 41

  Patent outcomesUS 10,675,481 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,675,481
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.No claims unpatentable
  PTAB · Jan 26, 2024 · IPR2022-01400 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–29 were not shown unpatentable over the asserted obviousness grounds because the prior-art combinations did not teach key limitations of claims 1, 17, and 29.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Having considered these arguments on the full trial record, we find Patent Owner has the better position because Petitioner’s showing that element 1(b) is taught by Schmitt is unpersuasive. We begin with Patent Owner’s argument concerning the distinction between the cfDNA molecules and the duplex tag comprising the molecular barcode found in the text of claim 1. Element 1(a) recites “a population of cell-free deoxyribonucleic acid (cfDNA) molecules.” Ex. 1001, 61:7–9. Element 1(b) recites “tagging a plurality of the cfDNA molecules in the population” of element 1(a) “with duplex tags comprising molecular barcodes to produce tagged parent polynucleotides . . . wherein the duplex tags are attached to both ends of a added). We agree with Patent Owner and credit the testimony of its declarant that this claim language distinguishes the duplex tags from the ends of the cfDNA molecule to which they are attached. Resp. 8; Ex. 2015 ¶¶ 38–39, 60, 61. That is, the duplex tag is not part of the cfDNA molecule itself, but rather is “attached to both the ends” of that molecule by “tagging” it as recited in element 1(b). We also agree with Patent Owner that given this distinction, claim 1 does not encompass Schmitt’s hybrid embodiment. Resp. 18–20. As Petitioner notes, “[i]n Schmitt’s hybrid-tag embodiment, the strands are grouped based on the combination of the short n-mer barcode and the end of the target DNA.” Pet. 11; see Resp. 17 (“[T]he combination of the endogenous shear sequence and exogenous 3-mer sequence together provide the SMI used for grouping and matching in Schmitt’s DCS process.”). Petitioner and its declarant illustrate the grouping in Schmitt’s hybrid embodiment with the following diagram. Pet. 12; Ex. 1002 ¶¶ 96–98. Petitioner’s diagram shows the PCR products produced from sequencing a “Target DNA” molecule that has been tagged with 3-mers X and Y according to Schmitt’s hybrid embodiment. See Ex. 1002 ¶ 98 (describing diagram). A portion of the endogenous sequence of the DNA molecule labeled L and R is used in combination with the 3-mer sequence to group the resulting strands into two families labeled the “X+L→R+Y Family” and the “R+Y→X+L Family.” Ex. 1002 ¶ 98; Ex. 2015 ¶ 62 (explaining that Petitioner’s diagram shows that “the relied upon hybrid SMI sequences of Schmitt include sequence from the sample DNA molecule not contained in the adapter or the duplex tags”). SMIs, differently label the strands and therefore are the recited “duplex tags.” See Pet. 27–28 (“duplex tags comprise both the fragment DNA end sequences and a shorter n-mer tag”) (emphasis added) (internal quotations omitted). However, we credit Dr. Quackenbush’s testimony that end sequences L and R are not “attached to both ends” of the cfDNA molecule by “tagging” it as recited in element 1(b). See Ex. 2015 ¶ 59–62 (explaining that Schmitt’s hybrid SMI sequences include a portion of the sample DNA molecule, which is “not contained in adapter molecules or duplex tags that are attached to the DNA molecules”). Rather, end sequences L and R are the pre-existing, endogenous ends of that molecule. Id. Thus, Petitioner’s theory of unpatentability does not account for the distinction the claim language draws between the cfDNA molecule and the duplex tags. Petitioner’s argument that the ’306 patent defines “duplex tag” as a” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “That is, although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner has not sufficiently explained why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, the Petition does not address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi degenerate bases) in the adaptor.” Ex. 1083 ¶ 30. sticky-end adapter-DNA litigation to be even more efficient than Meyer’s blunt-end adapter-DNA ligation” is also unpersuasive. See Pet. 60–61. The KAPA data sheet discloses sticky-end adapter DNA ligation, but KAPA teaches that only 0.5 to 15% tagging efficiency is expected when the starting sample is 100 pg–100 ng of “high quality DNA.” Ex. 1015, 4. Thus, the KAPA data suggests that the use of sticky-end adapters, such as what Schmitt discloses, does not in and of itself teach or suggest the tagging efficiency limitations. Moreover, the record shows that tagging efficiency depends on a variety of other factors, including the quality of the input DNA. The KAPA data sheet states that tagging efficiency “can be significantly lower for DNA of lower quality.” Ex. 1015, 4. Fisher also explains that “the efficiency of adaptor ligation varies between samples, probably because of variation in input DNA quality.” Ex. 1031, 5–6. Petitioner’s argument that the DNA the KAPA data sheet refers to as “lower quality” is “from formalin-fixed, paraffin-embedded (‘FFPE’) samples (well known for having chemically damaged DNA)” is unavailing. See Reply 25–26 (citing Ex. 1098 ¶¶ 96–98). First, neither Petitioner, nor its declarant, address the similar teaching in Fisher. Second, even if the specific type of lower quality DNA in the KAPA data sheet is different, the salient point, i.e., that tagging efficiency depends on DNA quality, remains unrebutted. This is significant because Petitioner does not sufficiently address how the quality of the cfDNA of Narayan compares to the quality of the genomic DNA samples of Meyer and Schmitt or how that would affect the expected tagging efficiency. Petitioner’s assertion that “significant quantities of cfDNA could be isolated from blood samples” (see Reply 26), fact that a significant quantity of cfDNA could be obtained does not show that the quality of that DNA is similar such that a POSA using such would have expected to achieve a tagging efficiency similar to that in Meyer.” slip op. at 40

  • Strike new argumentNew argument disregardedDenied

    “We are not persuaded. First, this is an inappropriate new argument. The Petition presents a different mapping, alleging that the “duplex tag” comprises both the endogenous end sequence of the cfDNA molecule and the 3-mer barcode of Schmitt’s hybrid tag embodiment. Pet. 27 (“the duplex tags comprise both the fragment DNA end sequences and ‘a shorter n-mer tag’ to serve as ‘unique molecular identifiers’”) (quoting Ex. 1083 ¶ 30, Ex. 1002 ¶¶ 162–163); see also Tr. 62:13–63:19 (Petitioner’s counsel noting he was unaware of any explicit statement in the Petition that Schmitt’s duplex tag comprised just the 3-mer without the end sequence). Nor did Petitioner regarding element 1(b). See Reply 8–10. Rather, consistent with the mapping in the Petition, the Reply identifies “Schmitt’s hybrid tags,” i.e., the combination of the endogenous end sequence and the n-mer, as the duplex tags in element 1(b). See Reply 8 (urging that “duplex tags” are “tags that differently label the complementary strands,” which “is precisely what Schmitt’s hybrid tags do”). Because this argument was not previously presented, Patent Owner has not been afforded a sufficient opportunity to address it. Thus, Petitioner’s new argument excluding the end sequences in Schmitt’s hybrid tag embodiment from the alleged “duplex tags comprising molecular barcodes” has been waived. Second, even if we were to consider it on the merits, Petitioner’s new mapping for element 1(b) is inconsistent with Petitioner’s allegations for element 1(e). Element 1(e) recites “reducing or tracking redundancy” in sequence reads “using at least sequencing information from the molecular barcodes of the duplex tags to determine distinct cfDNA molecules.” Ex. 1001, 61:26–30. For these limitations, the Petition points to Schmitt’s grouping of reads into families based on their SMI and asserts that Schmitt determines distinct cfDNA molecules based on “the complementary nature of the SMI on the two strands of the duplex.” See Pet. 30–32 (internal quotations omitted). Thus, like Petition’s mapping for element 1(b), Petitioner’s allegations for element 1(e) rely on a duplex tag that includes both the 3-mer and the end sequence of the cfDNA molecule. Petitioner has not sufficiently explained, much less shown by a preponderance of the evidence, that Schmitt teaches or suggests the limitations in element 1(e) based on its new mapping of the 3-mer alone as duplex tags.” slip op. at 25

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Motion to exclude, deniedDenied

    “We do not rely on any of these exhibits in rendering our decision on Petitioner’s grounds. Therefore, we dismiss as moot Petitioner’s motion to exclude Exhibits 1069, 1074, 1078, 1079, and 1085–1088.” slip op. at 46

  Patent outcomesUS 11,149,306 not shown unpatentable
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,149,306
• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 10, 2023 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–30 were not proven unpatentable because Petitioner failed to establish a reason to combine the Travers references with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that a person of ordinary skill in the art by March 20, 2012 would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields. Pet. 11 (citing Ex. 1002 ¶¶ 46–47). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 5 (citing Ex. 2014 ¶¶ 28–30). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner

    “Patent Owner argues that, in a few instances, the ’127 patent discloses “sequence reads” as corresponding to “multiple and distinct sequencing reactions.” Id. (citing Ex. 1001, 4:12–18, 4:45–49, 9:5–9, 9:11–12). Those disclosures, however, relate to “only one method for making the invention and do[] not automatically lead to finding a clear disavowal of claim scope.” Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 797 (Fed. Cir. 2019). Patent Owner does not point to, and we cannot find, any intrinsic evidence that would limit “sequence reads” as Patent Owner contends. Patent Owner also relies on Travers as extrinsic evidence that supports its argument. PO Resp. 9. Specifically, Patent Owner contends that Travers “refers to the sense and antisense target DNA sequences as subreads, which are distinct from the ‘raw read sequence’ or ‘raw read’ that comprises all of the subreads physically linked together.” Id. (citing Ex. 1021, 2). Patent Owner, however, ignores that Travers ’075 refers to the sequence of a sense or antisense strand as a “sequence read,” and not a subread. See Ex. 1018 ¶ 61. As a result, we find insufficient evidence to support Patent Owner’s proposed construction of “sequence read” as requiring “multiple and distinct sequencing reactions.”7 Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Based on the complete record, we see no need to expressly address any other claim term.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “We are not persuaded by Petitioner’s arguments. First, the prior art references Petitioner relies on relate to sequencing SMRTbell templates; specifically, they teach two polymerase binding sites in the two hairpin adapters per SMRTbell molecule, one on each end of the target molecule. See Ex. 1021, Fig. 1. They do not speak to concatemers with multiple polymerase binding sites interspersed along the molecule. Second, as explained above, a two-round RCR already generates three polymerase binding sites. See Ex. 2014 ¶ 178. Thus, even if we were to agree with Petitioner that the optimal stoichiometric ratio for SMRTbell templates applies to RCR produced concatemers, the polymerase to concatemer template ratio is at least three, i.e., 50% higher than the number Petitioner points to.11 See Reply 16 (citing Ex. 1035, 34). 11 The product of one round of RCR replication has only two polymerase binding sites. But, with only one copy of A and A each, it would not satisfy Third, and most importantly, the prior art does not support Petitioner’s arguments. The SMRT sequencing “approach is based on eavesdropping on a single DNA polymerase molecule working in a continuous, processive manner.” Ex. 2021, 1 (“Within each [ZMW] chamber, a single DNA polymerase molecule is attached to the bottom surface.”). Indeed, in SMRT sequencing, polymerase molecules are randomly distributed among the ZMWs, leading to a Poisson distribution of occupancy. At optimal loading, the distribution is 36.8% empty ZMWs, 36.8% with just one polymerase, and 26.4% with two or more. In this experiment, ~35% of the ZMWs produced traces indicative of single DNA polymerase occupancy, of which 82% produced full-length reads.” slip op. at 33

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

    “3. Summary In sum, Petitioner has not met its burden to show that an ordinarily skilled artisan would have had a reason to sequence RCR replicated concatemers on PacBio’s sequencing platform with a reasonable expectation of success. Thus, Petitioner has not shown the Travers references render the claims 1–10, 12, and 15–28 obvious.12 F. Other Grounds Claim 11 depends from claim 1. Petitioner asserts that claim 11 would have been obvious over the combination of Travers ’075, Travers 2010, and NEB Expressions. Pet. 58–60. 12 The parties dispute whether there are objective indicia to support a conclusion of nonobviousness. PO Resp. 68–74; Reply 23–27; Sur-reply 27–29. We do not address this issue because we determine Petitioner has not met its burden in showing the reason to combine/modify the Travers references or the reasonable expectation of success.” slip op. at 45

  Patent outcomesUS 10,760,127 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,760,127
• Mylan Pharmaceuticals, Inc. / MSN Laboratories Private Ltd et al. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Sep 8, 2023 · IPR2023-00016 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–6 were not shown unpatentable: the unexpected results supporting claim 1 outweighed the evidence of obviousness, and the other grounds depended on that unestablished premise.

  RulingsFinal written decision

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Peterson, Petitioner” slip op. at 8

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

    “C. Claim Construction Petitioner asserts that “[t]he claim terms do not require construction to apply the grounds.” Pet. 14. Patent Owner does not respond to this contention, or otherwise address claim construction in its Response. Accordingly, neither party has identified any claim term for construction.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “in which the pKa of aspartic acid’s R group was the same or even higher than that of glutamic acid when incorporated into a peptide, which directly undermines Petitioner’s position that the relative difference would be the same. Ex. 2045, 37 (Table 1). Petitioner dismisses this evidence, urging that it relates to “residues buried inside a peptide” that “are not analogous to the Asp3 or Glu3 pKas in plecanatide.” Reply 20. But that misses the point. The record shows there are interactions beyond just whether the residue is buried that can affect the pKa. See, e.g., Ex. 1012, 127 (“interactions with other peptide R groups, and other environmental factors can affect the pKa”); Ex. 2069, 96:19–97:2, 97:19–98:1 (Dr. Peterson acknowledging that intrachain hydrogen bonds can affect pKa). Neither Petitioner, nor Dr. Peterson, sufficiently address these other interactions, much less do they do so within the context of the particular amino acid sequences at issue here. Accordingly, we credit Dr. Davies’s testimony that a POSA “would have understood that the pKa values of amino side chain groups could not be predicted when the amino acid was incorporated into a peptide” and therefore would not have expected the Glu3 substitution to result in a peptide that would “remain protonated at a higher pH as compared to Asp or result in better activity in less acidic environments.” Ex. 2024 ¶¶ 178–186.” slip op. at 35

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusMixed

    “For these reasons, Patent Owner has established a sufficient nexus” slip op. at 40

  Patent outcomesUS 7,041,786 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,041,786
• Mylan Pharmaceuticals, Inc. / MSN Laboratories Private Ltd. et al. v. Bausch Health Ireland LimitedNo claims unpatentable
  PTAB · Sep 8, 2023 · IPR2022-00722 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–6 were not shown unpatentable: the unexpected results evidence outweighed the obviousness showing for claim 1, and the other grounds depended on that unproven premise.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “above, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. Indeed, Patent Owner’s unexpected results showing is sufficiently strong that we would reach the same conclusion even if we had found the other rationales Petitioner offers for making the Glu3 substitution (i.e., higher side-chain pKa and avoiding aspartimide formation) to be persuasive. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 60

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia outweighedDecided for patent owner

    “above, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. Indeed, Patent Owner’s unexpected results showing is sufficiently strong that we would reach the same conclusion even if we had found the other rationales Petitioner offers for making the Glu3 substitution (i.e., higher side-chain pKa and avoiding aspartimide formation) to be persuasive. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 60

  • ExcludeMotion to exclude, grantedGranted in part

    “Opp. at 4 (citing FRE 803(14)–(15), 804(b)(3) and 806). But even so, Petitioner’s argument plainly does not apply to the Currie submission, which is not a statement or admission from Patent Owner, but rather statements from an adverse party. Accordingly, we agree with Patent Owner that the Currie submission (i.e., pages 88–98 and 120–127 of Exhibit 1067) is hearsay without exception and therefore should be excluded under FRE 802.” slip op. at 69

  Patent outcomesUS 7,041,786 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 7,041,786

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.