• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision

  The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10

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

    “is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41

  Patent outcomesUS 10,702,385 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,702,385
• Guardant Health, Inc. v. University Of Washington Through Its Center For CommercializationInstitution denied
  PTAB · Nov 17, 2022 · IPR2022-00935 · APJ John G New · IPR · Institution

  The Board denied institution on all grounds because the petition did not show a reasonable likelihood that claims 1–23 were unpatentable over the asserted obviousness combinations.

  RulingsInstitution decision

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

    “review to be instituted unless … the information presented in the petition … and any response … 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.” Upon consideration of the Petition and Preliminary Response, and the evidence of record, we determine that the evidence presented does not demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’631 patent.” slip op. at 2

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

    “Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 17–18; Prelim. Resp. 5. Nor do we perceive, at this stage of the proceeding, a need to construe any claim term of the ’631 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs in the context of an inter partes review).” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “filing would typically have had an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field. Pet. 15 (citing Ex. 1002, ¶¶ 53–54). Alternatively, Petitioner proposes, a skilled artisan could have less education but significant professional experience in one or more of these fields. Id. Patent Owner does not contest Petitioner’s proposed definition of a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we therefore adopt Petitioner’s proposed definition. We find that this definition is consistent with the level of skill in the art as reflected by the prior art. See, e.g., Exs. 1003, 1006, 1007, 1010, 1021; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting” slip op. at 13

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

    “ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig was insufficient for our analysis. IPR2022-00816, Paper 16 at 14 (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (holding that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”)). In the ’816 IPR, we further observed that, to answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe- SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” IPR2022-00816, Paper 16 at 14 (citing Paper 3 at 22, 30). Again, Petitioner repeats the same argument in the present Petition. See Pet. 44; see also Ex. 1002 ¶ 42. But, as we observed in the ’816 proceeding, Kinde does not use Craig’s approach. IPR2022-00816, Paper 16 at 14. Instead, we found that immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Id. (quoting Ex. 1006, 9531). We therefore found that Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs. Id. The same reasoning applies equally here.” slip op. at 33

  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,287,631
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00298 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other instituted grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

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

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).” slip op. at 17

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

    “or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00258 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

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

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” See Claims 1 and 14, Ex. 1001, 23:2–3; 24:3–4. The angiogenic eye disorders in patients. See, e.g., id. at 1:18–20, 63–66, 2:23– 27; 3:19–20; 5:11–13. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. As the Federal Circuit explained in Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), “preamble language will limit the claim if it recites not merely a context in which the invention may be used, but the essence of the invention without which performance of the recited steps is nothing but an academic exercise,” and that this principle frequently holds true for method claims. Id. at 1345 (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)). We find that such is the case here. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, in view of Federal Circuit case law regarding statements of intended purpose in claims directed to method of using compositions, and in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.”” slip op. at 17

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

    “We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “arguments and the evidence, we find that the Specification expressly defines the terms “initial dose,” “secondary doses,” and “tertiary doses.” The Specification states, refer to the temporal sequence of administration of the VEGF antagonist. Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”); the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. Ex. 1001, 3:31–38 (emphasis added). Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist,” and that “the ‘tertiary doses’ are the doses which are administered after the secondary doses.” Ex. 1001, 3:31–38 (emphasis added). Patent Owner has not directed us to any portion of the Specification or other persuasive evidence that supports adding an efficacy requirement to that definition.” slip op. at 24

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2021-00881 · APJ Erica A Franklin · IPR · Final written decision

  Petitioners proved claims 1, 3–11, 13, 14, 16–24, and 26 unpatentable as anticipated by Dixon; the Board did not reach the other grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having considered the arguments and evidence, we maintain that Petitioners’ definition of one of ordinary skill in the art is reasonable and consistent with the ’338 patent and the prior art of record. On the other hand, we find Patent Owner’s definition to be inappropriately limited to those having “firsthand experience” regarding the diagnosis and treatment of angiogenic eye disorders, as explained by Dr. Do. See Ex. 2051 ¶ 28. While it may be that the claimed methods would be performed an ophthalmologist, a person having ordinary skill in the art need not be limited to those more appropriately considers that knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders, may be possessed by other professionals that are not ophthalmologists. Accordingly, we adopt Petitioners’ definition for purposes of this Decision.” slip op. at 10

  • Expert testimonyPetitioner expert creditedOther

    “Insofar as Patent Owner relies on the extrinsic testimony of Drs. Do and Brown for that description, we do not assign that testimony persuasive weight as it lacks sufficient evidentiary support. As discussed above, we find Dr. Do’s testimony at odds with the Specification. In particular, for the reasons discussed above regarding the Specification description of the amount of VEGF antagonist administered to the patient, we find troubling not be a treatment.” Ex. 2051 ¶ 46. Additionally, we find much of her testimony regarding the a so-called “high level of efficacy” based on an asserted existing standard of care for angiogenic eye disorder is supported by little more than evidence relating to FDA approvals for Macugen and Lucentis. Dr. Brown’s testimony cited by Patent Owner to support the asserted efficacy requirement, simply relies on Dr. Do’s testimony without discussing any additional evidentiary support.” slip op. at 22

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

    “preamble of method claims 1 and 14, i.e., “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioners that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” see Pet. 17, that does not the end our inquiry. As noted in the Institution Decision, the Federal Circuit has explained that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Rather, as the Federal Circuit reiterated, “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we consider whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)).” slip op. at 17

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

    “We begin by noting that the claims do not recite any dosage amounts or that the administered doses are “therapeutically effective” separately or cumulatively. Instead, the claimed method focuses on treating an angiogenic eye disorder with a specific compound, i.e., a VEGF antagonist, based on a specific temporal regimen, i.e., sequentially administering an initial dose, followed by a prescribed time frame for secondary and tertiary dose(s). As discussed above, we determined that the preamble limits the claims in terms of requiring the doses of VEGF antagonist administered to be for the purpose of treating an angiogenic eye disorder in a patient. We find that the intrinsic evidence supports finding that it is the administration of the VEGF antagonist to such patient for the purpose of providing an improvement of or beneficial effect on their angiogenic eye disorder that satisfies the “treating” portion of the preamble. regarding the “Amount of VEGF Antagonist Administered.” See Ex. 1001, 6:29–7:14. In that discussion, the Specification explains, The amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount. As used herein, the phrase “therapeutically effective amount” means a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder. Id. at 6:48–55 (emphasis added). That description, along with the absence of the phrase “therapeutically effective” in the claims,11 signals for us the inventors’ intention to not limit the claims to the administration of doses that ultimately prove to be therapeutically effective in a given patient. Instead, the Specification describes administration of VEGF antagonist doses for treating angiogenic eye disorder in a manner that encompasses doses that result in disclosed improvements and benefits, referred to as “therapeutically effective amounts,” and doses that do not. Indeed, as guidance, the Specification discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” without any guarantee that any particular dosage regimen administered within that range of dosage amounts will necessarily be “therapeutically effective,” and without limiting the treatment methods based upon such results. Ex. 1001, 6:55–58 (emphasis added).” slip op. at 19

  Patent outcomesUS 9,254,338 unpatentable
  Claim construction§ 102 anticipationcites Phillips · Graham
  Patents in suitUS 9,254,338
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00257 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 9–12 and claim 8, and the Board also finds the claims obvious over Dixon.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “On February 9, 2022, we instituted an inter partes review in IPR2022- 00257 and granted the motion for joinder with IPR2021-00880, adding Celltrion, Inc. as a petitioner in the instant proceeding. Paper 35. On the same date, we also instituted an inter partes in IPR2022-00301 and likewise granted the motion for joinder with IPR2021-00880, adding Apotex, Inc. as a petitioner in the instant proceeding. Paper 36. We refer to Mylan Pharmaceuticals, Inc., Celltrion, Inc. and Apotex, Inc., collectively, as “Petitioner.”” slip op. at 3

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded by Petitioner’s argument that the challenged Exhibits are not authenticated. Federal Rule of Evidence 901 sets a relatively low bar for authentication. See Comcast, 2020 WL 4687062, at *28. Rule 901(a) states: “To satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a). By way of example, Rule 901(b)(1) states that a witness with knowledge can provide authenticating testimony that an item is what it is claimed to be. Fed. R. 901(b)(1).” slip op. at 15

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30 for angiogenic eye disorders or treating angiogenic eye disorders including through the use of VEGF antagonists.” slip op. at 29

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2022-00301 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates them, including claim 8 through its disclosure of a comparable VEGF Trap-Eye dosing regimen.

  RulingsFinal written decision

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30” slip op. at 29

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

    “Patent Owner does not propose claim construction positions for these terms because construction of these terms is not necessary to resolve the arguments presented in Mylan’s Petition. PO Resp. 8 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)). We agree that it is unnecessary to construe these claim terms in view of the express definitions set forth in the Specification. DePuy, 469 F.3d at 1014. Because the claim terms are undisputed, we adopt the definition of the claim terms “initial dose,” “secondary dose,” and “tertiary dose” as expressly defined by the Specification of the ’069 patent. Nidec, 868 F.3d at 1017.” slip op. at 32

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

    “Patent Owner’s arguments are unavailing. The test for whether a reference inherently anticipates a claim is whether a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010) (emphasis added). Patent Owner has made multiple acknowledgements that the VEGF Eye-Trap used in the VIEW 1/VIEW 2 test disclosed by Dixon possessed the amino acid sequence recited in claim 1 of the ’069 patent.” slip op. at 54

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Mylan Pharmaceuticals Inc. / Celltrion, Inc. et al. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Nov 9, 2022 · IPR2021-00880 · APJ John G New · IPR · Final written decision

  Claims 1 and 8–12 are unpatentable: Dixon anticipates claims 1 and 8–12 and renders claims 1 and 9–12 obvious; other grounds were not reached.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “We therefore conclude that Patent Owner has met the standard set forth in Rule 901(b)(1) of presenting a witness with knowledge to authenticate the challenged Exhibits as being true and correct copies of records that are in the possession of Patent Owner. As a Senior Litigation Support Specialist, working in consultation with a Regeneron custodian of records, and with access to the restricted Regeneron server where the 16 Exhibits at issue are kept, Ms. Weber qualifies as a person with knowledge, under Rule 901(b)(1), that the Exhibits were true and correct copies of the records in Regeneron’s possession. Ms. Weber’s testimony does not speak to the substance of the challenged Exhibits, but merely that these are accurate copies of records that are in the possession of, and controlled by, Regeneron. As such, her testimony is sufficient to authenticate, under Federal Rule of Evidence 901, the challenged Exhibits as being what Patent Owner claims them to be. Petitioner’s Motion to Exclude the challenged Exhibits upon this ground is consequently denied.” slip op. at 16

  • Strike new argumentNew argument consideredDenied

    “We deny the motion to exclude the referenced argument in Petitioners’ Reply, as well as the invitation to consider the motion as one to strike the argument. As Patent Owner notes in the motion, Patent Owner raised this issue previously in this proceeding. PO Mot. Exclude 5. At that time, we denied Patent Owner’s request for authorization to file a motion to strike the referenced argument in the Reply. It is improper for Patent Owner to now seek to strike the argument in a motion to exclude. A motion to exclude is not the proper vehicle to address arguments or evidence that a party believes exceeds the proper scope of a reply. See USPTO, Consolidated Trial Practice Guide (2019) at 79, available at: https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL= (last visited October 27, 2022) (“CTPG”). Moreover, as Petitioners correctly assert, Patent Owner has failed to satisfy the prerequisite for filing a motion to exclude by failing to timely file an objection. See 37 C.F.R. 42.64(b)(1); CTPG 78–79. Patent Owner has not been left without an opportunity to address the Reply argument. When we denied authorization to file a motion to strike, we authorized Patent Owner to file, with its Sur-Reply, a table identifying any portion of the Reply that Patent Owner considers to have exceeded the scope of the Reply. Further, we explained that Patent Owner, alternatively, may address that contention, or the merits of any newly-raised arguments or evidence in its Sur-Reply. Indeed, Patent Owner addressed the issue in its 26 Sur-Reply for our consideration. Thus, Patent Owner had sufficient opportunity to identify in its Sur-Reply its contentions regarding Petitioners’ allegedly inappropriate Reply argument and took advantage of that opportunity. That is sufficient for us to consider the issue and determine whether such argument should be disregarded. See CTPG 80.” slip op. at 26

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find that Petitioner’s definition is the better definition for purposes of this proceeding. We acknowledge that the claims of the ’069 patent are directed to a “method for treating an angiogenic eye disorder in a patient” 29 and that the actual practice of the method would therefore seem to be limited to those who have the ability to treat patients, i.e., physicians, etc. However, we find Patent Owner’s definition to be unduly limiting. Individuals who are involved in drug development or sub-clinical level testing of drugs for treating eye disorders may be extremely knowledgeable about the development of the treatment of eye disorders and drug development, and able to comprehend and evaluate the teachings of the prior art. See, e.g., Pet. 25. Such individuals might not possess an M.D. degree, but instead possess a Ph.D. in a “biotechnological, or pharmaceutical field,” or a lesser degree with a corresponding increased depth of experience, as suggested by Petitioner. We agree that such individuals should be considered persons of ordinary skill in the art. We also find that Petitioner’s definition is commensurate with the level of skill reflected in the prior art. See, e.g., Exs. 1006, 1010, 1030, 1033; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). We consequently adopt Petitioner’s definition of a person of ordinary skill in the art has having an M.D. or Ph.D. or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field, and having practical academic or medical experience in developing treatments 30” slip op. at 29

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

    “We agree that it is unnecessary to construe these claim terms in view of the express definitions set forth in the Specification. DePuy, 469 F.3d at 1014. Because the claim terms are undisputed, we adopt the definition of the claim terms “initial dose,” “secondary dose,” and “tertiary dose” as expressly defined by the Specification of the ’069 patent. Nidec, 868 F.3d at 1017.” slip op. at 32

  Patent outcomesUS 9,669,069 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 9,669,069
• Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.Instituted
  PTAB · Oct 26, 2022 · IPR2022-00886 · APJ John G New · IPR · Institution

  The Board instituted review of claims 1–4 on all petition grounds, finding a reasonable likelihood that Mutz anticipates the claims.

  RulingsInstitution decision

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

    “of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, June 21, 2022 available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited October 11, 222) (the “Guidance”). As stated by the Guidance, the Board will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation when: (1) a petition presents compelling evidence of unpatentability; (2) a petitioner presents a stipulation (a “Sotera stipulation”) not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB9; and (3) if all other Fintiv factors weighing against exercising discretion to deny institution, or are neutral, the proximity to trial should not alone outweigh all of those other factors.10 Guidance at 1–8.” slip op. at 40

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

    “In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 45

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

    “of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 9,266,816
• Guardant Health, Inc. v. University Of WashingtonInstituted
  PTAB · Oct 13, 2022 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Institution

  The Board instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over the Travers references.

  RulingsInstitution decision

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

    “We have authority under 35 U.S.C. § 314, which provides that 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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

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

    “two-prong framework: (1) whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 7

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

    “In general, unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (stating that “not every process claim is limited to the performance of its steps in the order written”). Such a result can ensue, however, when the method steps implicitly require that they be performed in the order written. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001). Based on the current record, we find Patent Owner’s argument concerning the sequential order of the steps is supported by the claim language and the disclosures in the specification. See, e.g., Ex. 1001, 37:31–52 (claim 1), 39:56–40:25 (claim 22), 3:21–27, 15:27–34, Fig. 1. Therefore, we agree with Patent Owner that “(i) the claimed methods require that the amplification step occurs after adapter attachment; but before the sequencing step; and (ii) the sequencing step requires sequencing the amplified adapter-DNA products from the amplification step.” Prelim. Resp. 8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address any other claim term.” slip op. at 10

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

    “In general, unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (stating that “not every process claim is limited to the performance of its steps in the order written”). Such a result can ensue, however, when the method steps implicitly require that they be performed in the order written. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001). Based on the current record, we find Patent Owner’s argument concerning the sequential order of the steps is supported by the claim language and the disclosures in the specification. See, e.g., Ex. 1001, 37:31–52 (claim 1), 39:56–40:25 (claim 22), 3:21–27, 15:27–34, Fig. 1. Therefore, we agree with Patent Owner that “(i) the claimed methods require that the amplification step occurs after adapter attachment; but before the sequencing step; and (ii) the sequencing step requires sequencing the amplified adapter-DNA products from the amplification step.” Prelim. Resp. 8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address any other claim term.” slip op. at 10

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 10,760,127

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.