• Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentable
  PTAB · Sep 17, 2024 · IPR2023-00876 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–6 are unpatentable: claims 1–4 and 6 as obvious over Linnarsson and McCloskey, and claim 5 as obvious over those references and ordinary skill.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part

    “Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1065 ¶50 (“In view of the foregoing, it is my opinion that [McCloskey] was publicly available no later than [January 3, 2008].”). Thus, the second Hall-Ellis declaration should have been served within ten business days of Patent Owner’s October, 27, 2023, objection to the admissibility of McCloskey. See 37 C.F.R. § 42.64(b)(2) (“The party relying on evidence to which an objection is timely served may respond to the objection by serving supplemental evidence within ten business days of service of the objection.”). Because it was not filed until March 29, 2024, Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration. In its Opposition to the Motion to Exclude, Petitioner argues that, under Hulu LLC v. Sound View Innovations, LLC, No. IPR2018-01039, Paper 29 (Dec. 20, 2019) (precedential), it was allowed to wait until its Reply to file the second Hall-Ellis declaration. Paper 37, 1–2. The Board in Hulu does state that, “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu, at 15 (37 C.F.R. § 42.23). However, the Board’s statement was referring to the scope of permissible reply arguments under 37 C.F.R. § 42.23(b). See Hulu at 14 (quoting 37 C.F.R. § 42.23(b)’s requirement that “[a] reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response”). The Board in Hulu does not purport to interpret 37 C.F.R. § 42.64 or even discuss supplemental evidence. Petitioner clearly missed the deadline imposed by 37 C.F.R. § 42.64(b)(2), which was triggered by Patent Owner’s October 27, 2023, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1065).” slip op. at 16

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “We find that both references are analogous art to the ’981 patent, as there is ample supporting evidence in the record, including that to which the Reply cites (citations identified in the immediately preceding paragraph). Indeed, Patent Owner does not dispute the merits of either argument. PO Sur-Reply 27–28. Rather, Patent Owner, argues that we “should not now permit Petitioner to rewrite its clearly-deficient Petition.” Id. at 28. Petitioner’s Reply does not re-write its Petition. What Petitioner’s Reply does, in response to Patent Owner’s arguments, is precisely what Sanofi-Aventis contemplates as being proper in a reply brief. Indeed, in ruling against the petitioner in Sanofi-Aventis, the Federal Circuit specifically noted that the petitioner could have used its reply brief “to explain how [the prior art reference] is analogous to the [challenged] patent” but did not do so. 66 F.4th at 1379–1380. Here, in contrast, Petitioner used its Reply brief to explain how Linnarsson and McCloskey are analogous to the ’981 patent. Petitioner’s explanation in its Reply brief was both proper and persuasive.” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “That McCloskey is what it purports to be (a journal article) and that it was published in 2007 are corroborated by multiple pieces of evidence. McCloskey names four authors, all four of whom are named inventors of US 2007/0020640 A1, published Jan. 25, 2007 (“McCloskey ’640”). Ex. 1004, 1, Ex. 2001, code (76). Patent Owner concedes that McCloskey and McCloskey ’640 involve the same subject matter, having argued that the consideration of McCloskey ’640 supported discretionary denial of the Petition based on McCloskey. See, e.g., Prelim. Resp. 22 (“Petitioner’s secondary reference, an article by McCloskey, is at best cumulative of the far more detailed McCloskey ’640, which was raised by the Office and substantively discussed as the basis for a potential rejection using its asserted disclosure of a polynucleotide-specific tag—the same purported teaching for which Petitioner relies on McCloskey here.”). Notably, McCloskey ’640 was published on January 25, 2007. Ex. 2001, code (43). That is just days before McCloskey was received by BIOCHEMICAL GENETICS on January 31, 2007. See EX. 1004, 1 (“Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007”). In other words, it appears that the authors sought to have their research published in a scientific journal promptly after the subject matter of their research had been published by the Office. Further, the existence of McCloskey and its publication year of 2007 is confirmed by other sources in the record. See Ex. 1029, code (56) (United States Patent identifying as a cited reference: “McCloskey, et al. Encoding Pcr products with batch-stamps and barcodes. Biochem Genet. Dec. 2007;45(11-12):761-7. Epub Oct. 23, 2007.”); Ex. 1053, code (56) (same); Ex. 1060 (article’s bibliography citing “McCloskey ML, Stöger R, Hansen RS, Laird CD. Encoding PCR products with batch-stamps and barcodes. Biochem. Genet 2007;45:761–767. [PubMed: 17955361]”). Patent Owner’s Motion to Exclude is denied with respect to” slip op. at 19

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

    “The Petition states that “Petitioner does not believe that any terms require explicit construction in view of the prior art being presented.” Pet. 36. Despite this stated position, Petitioner proposed constructions for “multiplex-identifier (MID)” and “providing a sample.” Id. Patent Owner, in its Preliminary Response, stated that it “agrees that at this time, solely for purposes of an institution decision on the Petition, no terms require explicit construction.” Prelim. Resp. 45. In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 6. In the Patent Owner Response, Patent Owner repeats that it “does not believe any term needs construction,” but nonetheless “applies the Petition’s definitions for ‘MID’ and ‘sample.’” PO Resp. 19. The Petition defines MID as “‘a tag or combination of tags associated with a polynucleotide whose identity (e.g., the tag DNA sequence) can be used to differentiate polynucleotides in a sample.’” Pet. 36 (quoting Ex. 1001, 6:33–38). The Petition defines sample as “‘a quantity of material from a biological, environmental medical, or patient source in which detection, measurement, or labeling of target nucleic acids is sought.’” Id. (quoting Ex. 1001, 12:7– 10). We apply these same definitions in our analysis.” slip op. at 6

  Patent outcomesUS 10,155,981 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,155,981
• Masimo Corporation v. Apple Inc.No claims unpatentable
  PTAB · Sep 11, 2024 · IPR2023-00664 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–24 were not determined unpatentable because the cited combinations failed to teach or suggest the claimed selectable widget functionality and lacked a coherent rationale to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that: A POSITA [person of ordinary skill in the art] of the ’352 patent would have had at least a bachelor’s degree in a discipline related to human-computer interaction, such as Human Factors, Computer Science, Computer Engineering, or an equivalent discipline, and at least two years of experience working with touchscreen user interfaces. More education could substitute for less work experience, and vice-versa. Pet. 12 (citing Ex. 1003 ¶ 34).” slip op. at 7

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

    “In our Decision to Institute, we construed “input that is directed to a portion of” a user interface. Paper 8, at 9; see also Pet. 24–25. Because this interpretation is not necessary for our final determination, we do not repeat it here.” slip op. at 9

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Chae’s annotated Figure 6(b) “illustrates unlocking the second SIM (SIM2) according to the method for operating a mobile terminal.” Ex. 1005 ¶ 19. Ex. 1005, Fig. 6(b). Although Figure 6(b) “displays different items” (Ex. 1005 ¶ 109) such as the depictions of people (Lauran and Chris) and partly cloudy weather, Chae does not suggest that selecting these graphics causes display of an application. See PO Resp. 21. Petitioner contends that an ordinary artisan would have understood that selecting one of Chae’s graphics items must cause display of an application (see Pet. 55; Pet. Reply 11), but Chae does not teach or suggest this feature. As Dr. Cockburn persuasively testifies, “nothing in Chae indicates that the icons displayed in Figure 6(b) are dynamic or change in any way in response to content in the corresponding applications, and that the icons when selected causes display of the corresponding applications.” Ex. 2003 ¶ 46. The mere possibility that Chae’s generic graphical objects could perform a function is speculation because nothing in Chae teaches that selecting that graphical object would display a corresponding application. See id. The display of icons in Figure 6(b) does not inform the person of ordinary skill in the art whether the item has to indicate or contain content from an underlying application, and also whether it is selectable to get to that corresponding application as required by the claims. See Tr. 32:21–33:3. Petitioner’s reliance of the testimony of Dr. Rosenberg (see Ex. 1003 ¶ 91) is unpersuasive because Dr. Rosenberg merely restates the Petitioner’s assertions without reliance on persuasive evidence of record. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, at 5 (Feb 10, 2023) (Vidal, Dir.) (“[T]he Board was correct in giving little weight to Petitioner’s expert because the expert declaration merely offered conclusory assertions without underlying factual support and repeated, verbatim, Petitioner’s conclusory arguments.”). When addressing Chae’s three graphics in Figure 6(b) during cross-examination, Dr. Rosenberg testifies that “[t]hey’re not a numbered element, so they’re not spoken about specifically those three ones”). Ex. 2005, 56:9–14, 54:21–22 (“Chae doesn’t talk about the weather icon”). Further, the final record does not support Dr. Rosenberg’s testimony that a person of ordinary skill in the art would have understood that “part of the well-known functionality of widgets was that selecting a widget would cause ‘display of an application corresponding to the respective user interface object.’” Ex. 1003 ¶ 91. None of the references relied upon by Petitioner discloses this alleged “well-known functionality of widgets,” nor does the evidence of record support any industry standard usage of the term widget in the appropriate timeframe. See Ex. 2003 ¶¶ 46–48. Petitioner has also not persuasively shown that selections of Chae’s SIM card icons result in the display of an application as claimed. See Ex. 1005 ¶¶ 152–154, Fig. 22; see also Tr. 43:14–17 (“the claimed interface object causes display of the corresponding application, but selection of this paragraph 152, Figure 22 widget causes selection of something different, a sim environment.”). We find Patent Owner’s position more persuasive, when Chae uses the word widget, it is not using that word to refer to something that launches into an application, but instead Chae’s widgets show use-state information related to a SIM environment. See Ex. 1005 ¶¶ 152–154; Tr. 33:3–12. Specifically, Chae discloses “widgets that show use-state information of the first and second SIMs (SIM1 and SIM2),” and “when a user selects one of [the] widgets,” it “unlocks the SIM corresponding to the dragged widget.” Ex. 1005 ¶¶ 152, 153, Fig. 3 (unlocking SIM displays home screen customized to unlocked SIM). Chae does not support that these widgets relate to the graphic items in its Figure 6(b), nor does Chae explain how its widgets could be understood as the claimed “user interface objects” of the widget screen user interface. As explained persuasively by Dr. Cockburn, “the only widgets that are described in Chae are widgets relating to the use state of the multiple SIM cards,” and “[t]hese widgets described in Chae do not correspond to applications and thus do not cause display of applications when the widgets are selected.” Ex. 2003 ¶ 46 (quoting Ex. 1005 ¶ 152).” slip op. at 25

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

    “Based on the final record before us, we conclude that Petitioner has not persuasively shown that the combination of prior art teaches the required widget limitation of “a respective user interface object . . . when selected, causes display of an application corresponding to the respective user interface object” as recited in claim 1. Petitioner relies on Chae’s Figure 6(b), which is reproduced below: Chae’s annotated Figure 6(b) “illustrates unlocking the second SIM (SIM2) according to the method for operating a mobile terminal.” Ex. 1005 ¶ 19. Ex. 1005, Fig. 6(b). Although Figure 6(b) “displays different items” (Ex. 1005 ¶ 109) such as the depictions of people (Lauran and Chris) and partly cloudy weather, Chae does not suggest that selecting these graphics causes display of an application. See PO Resp. 21. Petitioner contends that an ordinary artisan would have understood that selecting one of Chae’s graphics items must cause display of an application (see Pet. 55; Pet. Reply 11), but Chae does not teach or suggest this feature. As Dr. Cockburn persuasively testifies, “nothing in Chae indicates that the icons displayed in Figure 6(b) are dynamic or change in any way in response to content in the corresponding applications, and that the icons when selected causes display of the corresponding applications.” Ex. 2003 ¶ 46. The mere possibility that Chae’s generic graphical objects could perform a function is speculation because nothing in Chae teaches that selecting that graphical object would display a corresponding application. See id. The display of icons in Figure 6(b) does not inform the person of ordinary skill in the art whether the item has to indicate or contain content from an underlying application, and also whether it is selectable to get to that corresponding application as required by the claims. See Tr. 32:21–33:3.” slip op. at 24

  Patent outcomesUS 11,106,352 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,106,352
• 10x Genomics, Inc. v. Bruker Spatial Biology, Inc.Instituted
  PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution

  The Board instituted IPR on claims 1–13 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of the challenged claims in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12

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

    “Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

    “(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,473,142
• Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Other
  PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand

  On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.

  RulingsRemand decision

  • Director reviewOther

    “Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2

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

    “An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,131,682
• Alivecor, Inc. v. Apple Inc.Rehearing denied
  PTAB · Jul 18, 2024 · IPR2024-00095 · APJ Hyun J Jung · IPR · Rehearing

  The Board denied AliveCor’s rehearing request, finding no abuse of discretion in denying institution because the Petterson–Nakada combinations did not teach or suggest the claimed replacement of one user interface with another.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “When rehearing a decision on institution, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if the decision is based on an erroneous interpretation of law, if substantial evidence does not support a factual finding, or if an unreasonable judgment is made in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000); see also Reh’g Req. 8 (citing 37 C.F.R. § 42.71(c)). Also, 37 C.F.R. § 42.71(d) sets forth, in relevant part that: rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

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

    “Our determinations regarding Nakada did not support Petitioner’s argument that Nakada’s “system is returned to the beginning state of the routine, which in the case of Petterson would be FIG. 2B.” Pet. 71; Dec. 39–40. We also stated that “the proposed combination does not address adequately Nakada’s description of powering down its display.” Id. at 40 (citing Pet. 48–50; Prelim. Resp. 25–26; Ex. 1011, Fig. 4). We, thus, determined Petitioner failed to show sufficiently that either Petterson or Nakada teaches or suggests “replacing display of the second user interface with the first user interface.” Dec. 38–41 (citing Pet. 48–50, 68–69, 70–71; Ex. 1003 ¶¶ 379, 382; Ex. 1011, Fig. 4). The “totality of the combination” lacked replacing a user interface with any other user interface. Dec. 40–41 (determining “the asserted references neither individually nor combined as proposed would have, ‘in response to detecting that the first criteria are no longer met for a second period of time that is longer than the first period of time, replac[ed] display of the second user interface with the first user interface’”); Reh’g Req. 8 (arguing “the Board overlooked the totality of the combination and Petitioner’s arguments and supporting evidence regarding the modification of Petterson that would have been obvious . . . in view of Nakada”).” slip op. at 7

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

    “After considering the arguments and cited evidence of the Petition, we determined that Petitioner did not show a reasonable likelihood of prevailing with respect to at least one of the challenged claims of the ’533 patent. Paper 7 (“Decision” or “Dec.”). Petitioner subsequently filed a Request for Rehearing. Paper 8 (“Reh’g Req.”). For the reasons stated below, Petitioner has not shown that we abused our discretion in denying the Petition, and thus, Petitioner’s Request for Rehearing is denied.” slip op. at 2

  § 103 obviousness
  Patents in suitUS 10,568,533
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. 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 13

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

    “We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35

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

    “Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21

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

  Patent outcomesUS 10,973,649 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,973,649
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityInstituted
  PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution

  The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).

  RulingsInstitution decision

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

    “The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2

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

    “patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17

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

    “H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16

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

    “Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,591,393
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. 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. 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 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61

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

    “Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18

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

    “j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28

  Patent outcomesUS 9,956,087 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 9,956,087
• 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
• Alivecor, Inc. v. Apple Inc.Institution denied
  PTAB · May 10, 2024 · IPR2024-00095 · APJ Hyun J Jung · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 20–22, 24, 29, and 37 obvious over either asserted combination of references.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314, an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and for the reasons explained below, we determine that Petitioner has not shown a reasonable likelihood of prevailing with respect to at least one of the challenged claims. Thus, we do not institute an inter partes review of claims 20–22, 24, 29, and 37 of the ’533 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner argues that a person of ordinary skill in the art would have had “a working knowledge of physiological monitoring technologies and human interface design” and a Bachelor of Science degree in an academic discipline emphasizing the design of electrical, computer, or software technologies, in combination with training or at least one to two years of related work experience with capture and processing of data or information, including but not limited to physiological monitoring technologies and human interface design. Pet. 7; Ex. 1003 ¶ 45. Petitioner alternatively argues that a person of ordinary skill in the art “could have also had a Master of Science degree in a relevant academic discipline with less than a year of related work experience in the same discipline” and that “[m]ore education can supplement practical experience and vice versa.” Id. at 7–8 (citing Ex. 1003 ¶ 45). Patent Owner does not propose a level of ordinary skill in the art and does not dispute Petitioner’s proposal. See generally Prelim. Resp. We adopt Petitioner’s asserted level of ordinary skill to determine whether there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition.” slip op. at 8

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “For support that AHIT would have been understood to display the required “first user interface,” Petitioner only points us to its testimonial evidence; however, the cited testimony is substantively the same as the argument presented in the Petition with no additional citations to the record that indicate that one of ordinary skill in the art would have understood AHIT to disclose the recited “first user interface.” Compare Pet. 20–21, with Ex. 1003 ¶ 199 (citing nothing in the record). Moreover, in its argument regarding the recited “second user interface,” Petitioner contends that “the display of a preset icon via the screen is a different interface (e.g., a first user interface) from the display of progress of collecting the ECG data via the screen (e.g., a second user interface).” Pet. 25–26 (citing Ex. 1003 ¶ 222). Petitioner clearly equates AHIT’s display with a preset icon to the “first user interface,” which is different from its previous argument that one of ordinary skill in the art “would have understood that a screen, and certainly a screen with the disclosed prompt of AHIT’s wearable device, would have displayed a first user interface indicating that the wearable device was ready to detect biometric information” and “that the first user interface was displayed to inform the user, prior to the collection of the ECG data, that the device was ready to collect ECG data because the user would need to be informed that the trigger action could be effectively received by the device.” Compare id. at 20–21, with id. at 25–26. The cited testimonial evidence also opines that “the person of ordinary skill in the art would have understood that the AHIT user interface would transition from a preset icon (e.g., a first user interface) to a display of ¶ 222. Petitioner’s declarant also equates AHIT’s display of a preset icon with the first user interface, which contradicts AHIT’s disclosure that “when collecting ECG data, the wearable device may display a preset icon via the screen.” Ex. 1006 ¶ 39. We, therefore, give little weight to the opinion of Petitioner’s declarant regarding the “first user interface” because it does not make clear what teaches, suggests, or would have been understood to disclose the “first user interface” and conflicts with what AHIT describes. Compare Ex. 1003 ¶ 199, with id. ¶ 222 and Ex. 1006 ¶ 39.” slip op. at 19

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

    “Petitioner, however, provides insufficient argument and evidence that resuming initialization or resetting the data processing device would revert to a first user interface after the first input was no longer detected for a second period of time or replace the information displayed on the user interface. Pet. 16, 34. As implicitly acknowledged by Petitioner, the cited portions of Hooper do not describe replacing displayed information. See Pet. 16, 34; Ex. 1007, 2:22–3:13, 6:15–25, Fig. 2. The cited testimonial evidence also does not cite to any part of the record that would tend to support the opinion that a “person of ordinary skill in the art would have understood that resuming initialization or resetting the data processing device would replace the display” (Ex. 1003 ¶ 181), a “person of ordinary skill in the art would have understood that resuming display” (id. ¶ 249), and “it would have been obvious to a person of ordinary skill in the art to revert to the first user interface after the first input was no longer detected for a second period of time” (id. ¶ 250). Petitioner’s declarant also does not explain why “a change in the display would have been obvious to a person of ordinary skill in the art in view of AHIT’s explicit goal of saving wearable device resources.” Id. ¶ 248. Petitioner does not argue adequately or cite sufficient evidence that changing from one user interface to another would have saved wearable device resources. Pet. 34; Ex. 1003 ¶ 248. As discussed previously, Petitioner does not provide sufficient argument and evidence that its proposed combination would have had “a first user interface indicating that the first electronic device is ready to detect biometric information.” Even if Petitioner did adequately show that its proposed combination would have had the required first user interface, Petitioner fails to show with sufficient argument and evidence that its proposed combination would have “replac[ed] display of the second user interface with the first user interface,” for the above-discussed reasons.” slip op. at 23

  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,568,533

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.