• Parse Biosciences, Inc. v. 10x Genomics, Inc.All claims unpatentable
  PTAB · Jan 31, 2025 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–26 are unpatentable as obvious: claims 1–4, 6–11, 20, and 23–25 over Linnarsson and McCloskey; claims 5, 12, 21, 22, and 26 with ordinary-skill knowledge; claims 13–19 with McCloskey II.

  RulingsFinal written decision

  • ExcludeMotion to exclude, grantedGranted in part

    “Clearly, the second Hall-Ellis declaration is offered to prove that McCloskey is a prior art printed publication. See, e.g., Ex. 1085 ¶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 February 15, 2024, 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.”). 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, 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 in the prior sentence and in the subtitle to the relevant portion of its Objection. Id. 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 February 15, 2024, objection to McCloskey. Patent Owner’s Motion to Exclude is granted with respect to the second Hall-Ellis declaration (i.e., Ex. 1085). Despite the exclusion of the second Hall-Ellis declaration, there is ample evidence in the record demonstrating that McCloskey is a prior art printed publication. McCloskey itself states: “Received: 31 January 2007 / Accepted: 29 May 2007 / Published online: 23 October 2007.” Ex. 1004, 1. McCloskey additionally states that it was published in a 2007 print issue of “Biochem Genet,” with Petitioner adding that the full name of the journal is BIOCHEMICAL GENETICS and that McCloskey was published in a December 2007 volume of the journal. Id.; Pet. 29. McCloskey also includes a copyright notice by “Springer Science+Business Media, LLC” with a date of date of 2007. Ex. 1004, 1. Patent Owner argues that this is unreliable hearsay that should be excluded. PO Mot. To Exclude 4 (citing Neste Oil Oyj v. REG Synthetic Fuels, LLC, No. IPR2013-00578, Paper 53 at 5–7 (Mar. 12, 2015); Standard Innovation Corp. v. Lelo, Inc., No. IPR2014- 00148, Paper 4210 at 13–18, 21–22 (Apr. 23, 2015)). We are not persuaded 10 Patent Owner actually cited to “Pap.41” of Standard Innovation. PO Mot. To Exclude 4. There is no Paper 41 in the record of that case. We presume Patent Owner intended to cite Paper 42, which is the final written decision in that case. by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1.” slip op. at 18

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

    “Patent Owner is correct that, under Sanofi-Aventis, a petitioner bears the burden of persuasion to establish that an asserted prior art reference is analogous art to the claimed invention. See Sanofi-Aventis, 66 F.4th at 1377 (“We agree with [the patent owner] that [the petitioner] did not carry its burden to argue that de Gennes is analogous to the [challenged] patent.”); id. (“In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent.”); id. at 1378–79 (“We have routinely held that the petitioner has the burden of proving unpatentability.”). However, as we noted when instituting this proceeding, “Sanofi-Aventis further held: ‘A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.”’” Dec. on Reh’g 15 (quoting Sanofi- Aventis, 66 F.4th at 1379 (quoting 37 C.F.R. § 42.23)).” slip op. at 14

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

    “by Patent Owner’s argument or its reliance on these cases. The facts before us are different. In Neste Oil, the Board “note[d] that the alleged ‘stamps’ of Exhibits 1125 and 1132 are actually handwritten dates, added to the documents by an unknown person at an unknown time.” Neste Oil, Paper 53 at 6. In contrast, the dates relied upon by Petitioner are printed, appear to have been included at the time of printing, and appear to have been printed by, or at the direction of, the journal and/or copyright holder, both of which are identified by McCloskey. Ex. 1004, 1. In Standard Innovation, the alleged prior art exhibits were “printouts of … webpages” bearing a copyright indication of “© 2003-2013,” which the petitioner argued was proof of subset of the webpages being disseminated publicly in 2003. Standard Innovation, Paper 42 at 13. This is a far cry from McCloskey, which is a journal article and which includes specific date information, not only of publishing, but also of when the journal received and accepted the article for publication as well as when it was copyrighted. Ex. 1004, 1. 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.” slip op. at 20

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

    “In sum, we find Petitioner’s rationale that a skilled artisan would have made the proposed combination to solve the problem of amplification bias persuasive.” slip op. at 44

  Patent outcomesUS 10,240,197 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,240,197
• 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
• 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
• 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
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.

  RulingsFinal written decision

  • Skill levelOther

    “B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11

  • Strike new argumentNew argument consideredDenied

    “9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65

  Patent outcomesUS 10,137,001 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,137,001
• Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentable
  PTAB · Apr 15, 2024 · IPR2022-01599 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 7–13, and 16 are unpatentable as obvious over the cited prior art.

  RulingsFinal written decision

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

    “Petitioner that Patent Owner’s proposed construction improperly reads in limitations from example embodiments in the Specification. See Inst. Dec. 20. We noted that the Specification uses the term “extension” to refer to a variety of additions to a main structure having a variety of shapes, not all of which “increase the length” of the main structure. Id. at 21. Accordingly, we construed the term “central ramp extension” in accordance with its plain and ordinary meaning, i.e., “an addition to the central ramp.” Id.” slip op. at 25

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

    “5. Conclusion—Obviousness Based on Chung with Boehm and/or Song On this record, we determine that Petitioner has shown by a” slip op. at 64

  Patent outcomesUS 8,845,732 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,845,732
• Agrofresh Solutions, Inc. v. Lytone Enterprise, Inc.All claims unpatentable
  PTAB · Jul 25, 2022 · IPR2021-00451 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 3 and 11 are unpatentable as obvious over Hisano and Daly, and over Daly and Hisano, because the skilled artisan would have been motivated to combine the teachings with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “definition focuses on chemistry and materials science without a specific focus to the application of that knowledge to the subject matter of the invention, while Patent Owner’s proposal permits the artisan’s degree to be in horticulture or plant science, requires at least 2–4 years of experience in the area of postharvest biology and technology, and specifically requires “working with encapsulated gaseous agents such as the 1-MCP encapsulation complex.” PO Resp. 14. It is not clear on the record before us nor does Patent Owner’s expert explain why the additional, specific expertise in postharvest biology and technology would have been required to understand the teachings of the ’185 patent in a manner necessary to apply them. Moreover, the proposed additional skill level does not appear to be necessary in light of the skill level reflected by the asserted prior art. See specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985)). For instance, Hisano measures preservation visually, by ascertaining whether the flowers looked fresh or appeared to have been harmed by effects of the chemicals added, and whether the water the flowers were stored in was cloudy. Ex. 1004 ¶ 24. This observation does not require specific expertise in postharvest biology and technology. Petitioner’s assessment appears consistent with the level of ordinary skill in the art at the time of the invention as reflected in the prior art in this proceeding, although we agree with Patent Owner that a degree in plant physiology, horticulture, plant science or the like along with work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds would provide sufficient expertise to understand the teachings of the ’185 patent in a manner necessary to apply them. Accordingly, we adopt the following definition of the skilled artisan for purposes of this Decision: a bachelor’s degree in chemistry, chemical engineering, materials science, plant physiology, horticulture, plant science or the like, and 1–2 years of work experience, or a master’s degree in exchange for such work experience, in the area of controlled release of compounds, such as those used to inhibit ethylene response in plants.” slip op. at 11

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

    “Neither party advances any claim terms for construction. Pet. 20; PO Resp. 15. We find that no express construction is necessary for purposes of rendering this Decision and apply the plain meaning of all terms. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/TrialPracticeGuide Consolidated).” slip op. at 7

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

    “We find that the ordinarily skilled artisan would have looked at Hisano as an analogous reference and would have been motivated to try scaling up its smaller-scale solution of effervescent tablets for delivery on a larger scale than single flower vases. We further find that the artisan would not have been deterred by Hisano’s lack of embodiments including gas agents and disclosing local use only that would have prevented use of 1- MCP directly with plants. Ex. 2013 ¶¶ 52–54. In particular, because Daly suggested the molecularly encapsulated 1-MCP could be made in powder form (Ex. 1005, 11:1–11), which is the form Petitioner suggested for use in the proposed obviousness combination (e.g., Pet 36–37), we are not persuaded by Patent Owner’s arguments regarding concerns the skilled artisan would have had about working with 1-MCP gas that is released into the atmosphere where the atmosphere becomes the treatment medium as opposed to a liquid medium. agent, along with Daly’s teachings that 1-MCP is a known substitute for STS without STS’s toxic waste byproduct would have motivated the artisan to explore use of 1-MCP. Daly’s teaching of using a cyclodextrin cage-stabilized and powdered version of 1-MCP to inhibit ethylene binding in plants would have motivated the skilled artisan to try this stabilized version in Hisano’s effervescent tablet preparation because of the benefits of effervescent ingredients for dissolution and dispersion, to treat plants on a larger scale. See Ex. 1005 11:1–20; Ex. 1006 ¶¶ 29, 110–115; Ex. 1035 ¶¶ 11–18. Hisano instructs the artisan about optimization by creating tablets with a proper “effervescence component: freshness preserving component to a weight ratio of between 6.5:3.5 and 5.0:5.0 to create a large, compact tablet agent that can secure some degree of the freshness preserving component” while also stabilizing the tablet for transportation and adjusting the ratios of components to affect the “target quality, effervescence effects, and dissolution time, etc. of the final product.” Ex. 1004 ¶¶ 12, 14. These additional teachings would have led the skilled artisan to understand that an effervescent tablet dosage made with cyclodextrin-stabilized 1-MCP could be made for larger scale production and use. In particular, we find that the artisan would have been motivated to combine the teachings of Hisano and Daly because of 1) Daly’s teaching that STS is problematic for use in inhibiting ethylene in plants due to difficulties in silver waste byproduct disposal, leading to “a great desire among postharvest physiologists to find alternatives to STS” (Ex. 1005, 2:42–64); 2) Daly’s teachings that cyclopropene and its derivatives, including 1-MCP, are “commercially acceptable replacement[s] for STS”) (id. at 1005) and that powder complexes provided advantages over 3) Hisano’s teaching that an ethylene suppressing agent could be delivered via an effervescent tablet, which when dissolved in water, creates “generated carbonic acid gas [that] will promote assimilation action, which will be effective for cultivating, and preserving the freshness of, the cut flowers (plants).” Ex. 1004 ¶ 25; see also Ex. 1006 ¶¶ 113–115 (opining that the skilled artisan would have understood encapsulated 1-MCP, a powder-based form, to be one of a finite number of safer substitutes for STS that could be incorporated into an effervescent tablet using methods known to the skilled artisan at the time); Ex. 1013 at 9 (identifying 1-MCP as a newly discovered “ethylene inhibitor [that acts] as a binding site competitor and is very promising as a postharvest treatment for both potted plants and fresh cut flowers [giving] ethylene protection equal to that obtained from STS, but without silver” and noting that a “company plans to sell the product in a powder form that will release MCP gas when mixed with water”). The art suggested finding substitutes for STS, meaning that the skilled artisan would have looked for likely substitutes such as this stable form of 1-MCP for use in various delivery methods. See, e.g., In re Kerkhoven, 626 F.2d 846, 850 (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.”).” slip op. at 25

  Patent outcomesUS 6,897,185 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,897,185
• New World Medical, Inc. v. The Regents Of The University Of CaliforniaAll claims unpatentable
  PTAB · Mar 11, 2022 · IPR2021-00066 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–11 are unpatentable: claims 1–11 are anticipated by Quintana and obvious over Quintana; the Board did not reach the Jacobi ground.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Patent Owner filed a motion to exclude evidence (Paper 38); Petitioner opposed (Paper 41); and Patent Owner filed a reply in support of its motion (Paper 43). Petitioner also filed a motion to exclude evidence (Paper 39); Patent Owner opposed (Paper 40); and Petitioner filed a reply in support of its motion (Paper 42). We addressed (and denied) the parties’ motions to exclude in Paper 49.” slip op. at 3

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it little weight, as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider and analyze Dr. Condon’s testimony here.” slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 22 (citing Ex. 1003 ¶ 24). On page 18 of our Institution Decision, we provisionally accepted Petitioner’s proposed definition, which was not opposed by Patent Owner, and is consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’544 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). As Patent Owner expressly agrees with our analysis, we apply Petitioner’s proposed definition here. See PO Resp. 11, n.4. C.” slip op. at 25

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

    “1. “A device useable to create an opening in the trabecular meshwork of the eye” Independent claim 1 is directed to “[a] device useable to create an opening in the trabecular meshwork of the eye” and having a “foot member . . . advanceable, tip first, through Schlemm’s Canal to facilitate performance of a surgical procedure using the surgical instrument.” Ex. 1001, 23:4–5, 23:18–20. As an initial matter, we consider the preamble of claim 1 limiting here because a device that “create[s] an opening in the trabecular meshwork” recites or, at a minimum, implies, “essential structure or steps” required for the insertion and advancement of the instrument through Schlemm’s Canal as set forth in [1.d]. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).8” slip op. at 26

  Patent outcomesUS 9,999,544 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,999,544
• Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentable
  PTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8

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

    “We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34

  Patent outcomesUS 9,693,961 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 9,693,961
• Apple Inc. v. Corephotonics Ltd.All claims unpatentable
  PTAB · Apr 6, 2020 · IPR2019-00030 · APJ Monica S Ullagaddi · IPR · Final written decision

  Claims 1–5 are unpatentable as obvious over Ogino and Beich; claims 1–4 are also unpatentable over Ogino alone, but claim 5 is not shown unpatentable on that ground.

  RulingsFinal written decision

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

    “We construe claim terms to the extent necessary. See, e.g., 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 7

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

    “supported by the cited evidence. We are persuaded, instead, that “the image plane and the sensor are taught by the ’568 patent to be coincident,” and “[t]hus, there is no ambiguity in the ’568 patent about where the image plane is located or that TTL is measured to the image plane,” as Petitioner argues in its Reply. Reply 13 (Ex. 1026 ¶ 5; Ex. 1003, 33–35). Patent Owner acknowledges as much, noting that “as these terms[, i.e., the image plane and the sensor,] are used in the specification of the ’568 patent, the image plane is the surface of the sensor.” Sur-reply 2. We find that the ’568 patent discloses that the electronic sensor corresponds to or is coincident with the image plane and thus, the TTL could be measured with respect to either the sensor (electronic or film) or the image plane and reach the same result. Based upon the complete trial record, we maintain our construction of TTL from the ’1140IPR and the ’1146IPR3, which encompasses “the length of the optical axis spacing between the object-side surface of the first lens element and one of: an electronic sensor, film, and an image plane corresponding to either the 3 The panel authorized, and the parties filed, supplemental briefing to address this construction before it was adopted in both the related ’1140IPR and ’1146IPR, and that the parties responded to this construction in the hearing in this proceeding (with citations to the transcript). See, e.g., Paper 28 (PO’s demonstratives), 5; ’1140IPR, Paper 31; ’1146IPR, Paper 30; see also Trial Practice Guide Update 13–14 (July 2019), https://www.uspto.gov/sites/default/files/documents/trial-practice-guide-update3.pdf; Hamilton Beach Brands, Inc. v. f’real Foods, LLC, 908 F.3d 1328, 1339 (Fed. Cir. 2018) (finding that the Board did not violate the Administrative Procedure Act when it adopted its own claim construction in the final decision because the parties had notice and an opportunity to be heard). electronic sensor or a film sensor.” See ’1140IPR, Paper 37, 18; ’1146IPR, Paper 37, 14.” slip op. at 14

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Even assuming, arguendo, we were to credit Patent Owner’s expert testimony as to the disjointed nature of optical lens assembly design experience and manufacturing experience, we are not persuaded that a person of ordinary skill in the art at the time of the invention having only design experience would be so completely unaware of manufacturing considerations so as to preclude taking into account the very general guidance of Beich. See Reply 24–25. Beich teaches that a lens designer should have a basic understanding of the manufacturing process, which would include the limits for fabricating lens elements in an optical lens assembly. Ex. 1020, 7. We are persuaded that the information conveyed in Beich would have been understood, known, and applied by the ordinarily skilled lens designer (see Reply 4–6 (citing Ex. 2014, 4, 9, 11, Fig. 9.2)), irrespective of whether such person had manufacturing experience. Stated differently, although an ordinarily skilled designer of an optical lens assembly may not have had any real-world manufacturing experience, we are persuaded that such person would still have taken into account manufacturing concerns. Although there are differences between the definitions proposed, our conclusions rendered in this decision do not turn on selecting a particular definition for the level of ordinary skill in the art, for the reasons discussed above. We determine, on this record, that the level of ordinary skill proposed by Patent Owner is consistent with the ’568 patent and the asserted prior art. We agree with Patent Owner’s proposal regarding the level of ordinary skill except for Patent Owner’s arguments about manufacturing discussed above. As such, we adopt Patent Owner’s proposal.” slip op. at 18

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

    “As noted by Petitioner, The Handbook of Optics discloses that “[i]n the case of both negative and positive lens elements, it is good policy to avoid element forms wherein the center-to-edge thickness ratio exceeds three for positive elements.” Ex. 1019 § 34.15. Thus, we are persuaded by Petitioner’s fourth reason that the cited disclosure provides evidence that the ordinarily skilled artisan would have selected a particular diameter for the first lens element disclosed in Ogino in conformance with manufacturing considerations known to the ordinarily skilled artisan. We are further persuaded that, from the selection of that particular diameter, a Z1 value for the object-side surface and a Z2 value for image-side surface at the minimum usable edge of the first lens element can be obtained and, in turn, circumferential edge thickness L1e can be obtained. Pet. 35–36 (citing Ex. 1003, 42; Ex. 1005, 15:1–3). We are further persuaded by Petitioner’s supporting reasoning that “a POSITA would understand the manufacturing benefits of maintaining the lowest possible center-to-edge thickness ratio since ‘the preferred shape of a molded element is one that has fairly uniform thickness.’” Id. at 42 (quoting Ex. 1018, 92) (citing Ex. 1003, 48). Based on our review of the complete record, we find that the record supports Petitioner’s contentions concerning claim 1. Petitioner demonstrates by a preponderance of the evidence that claim 1 is unpatentable as obvious over Ogino.” slip op. at 37

  Patent outcomesUS 9,857,568 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,857,568

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.