• 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
• Snap Inc. v. Sanderling Management Ltd.All claims unpatentable
  PTAB · Oct 31, 2022 · IPR2021-00780 · APJ Eric C Jeschke · IPR · Final written decision

  Claims 1, 2, 4–6, 8–16, 18, 19, 21–23, and 25–33 are unpatentable as obvious over Hogeg.

  RulingsFinal written decision

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

    “We agree with Patent Owner, however, that the patentee acted as his own lexicographer with the passage from column 6 discussed by the parties. Indeed, the sentence at issue begins with the exact same term—“distribution rule”—and continues by explaining what that term “is.” See Ex. 1001, 6:13– 14 (“A distribution rule is a rule used in determining how to target a group of end-users . . . .” (emphasis added)); see also Ex. 1001, code (57) (the Abstract, providing that “[a] distribution rule is used to target a group of end users . . . ”). As argued by Patent Owner, this is sufficiently clear language to express an intent by the patentee to define that term. See PO Sur-reply 6 (citing Sinorgchem Co., Shandong v. Int’l Trade Comm’n, 511 F.3d 1132, 1136 (Fed. Cir. 2007) (stating that “the word ‘is,’ again a term used here in the specification, may ‘signify that a patentee is serving as its own lexicographer’”); see also Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016) (“To act as a lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ and ‘clearly express an intent to redefine the term.’” (quoting Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)). Further, we disagree with Petitioner’s assertion that the definition should include the rest of the passage in column 6 (i.e., the language from “for instance” to the end of the sentence). See Pet. Reply 4. By beginning with “for instance,” the express language of that portion of the sentence makes clear that it merely provides examples of “rule[s]” that fall within the definition previously provided in the sentence, as acknowledged by Petitioner and Mr. Parulski. Cf. id. (“The language following that clipped by [Patent Owner] (‘for instance . . . ’) is what provides ‘distribution rules’ examples.”); Parulski Reply Decl. ¶ 15 (“The language following that identified by [Patent Owner] (beginning with ‘for instance, a rule . . . ’) provides examples of what a ‘distribution rule’ may be.”).6 For these reasons, we construe “distribution rule” in elements 1b and 18c in the manner proposed by Patent Owner—“a rule used in determining how to target a group of end-users.”” slip op. at 11

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

    “Petitioner discusses the term “digital media content processing function” in claims 1 and 18 (Pet. 21–23), but states that “the Board needn’t construe [that term] to determine patentability” (Pet. 23). We did not construe that term in the Decision on Institution (Dec. Inst. 26–27), and Patent Owner takes the position in the Response that that term still does not need construction (PO Resp. 11). We continue to agree with both parties that “digital media content processing function” need not be construed because doing so would not change the outcome of the analysis below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (stating that “we 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 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends, with accompanying declaration testimony, that a person having ordinary skill in the art at the time of the alleged invention “would have had at least a bachelor’s degree, or the equivalent, in electrical engineering, computer science, or a related field, and 2–3 years of experience in research, design, or development of mobile imaging systems and related hardware, software, and firmware, or equivalent experience.” Pet. 19. According to Petitioner, “[a] person with less education but more relevant practical experience, or more education and less experience, may also meet this standard.” Pet. 19–20 (citing Parulski Pet. Decl. ¶¶ 173–174). Prior to institution, Patent Owner did not address or dispute Petitioner’s proposed definition of the level of ordinary skill in the art. In the Decision on Institution, we adopted Petitioner’s proposed definition, stating that it “appear[ed] consistent with the record at th[at] stage of the proceeding, including the prior art.” Dec. Inst. 26. In the Response, Patent Owner also does not dispute Petitioner’s proposed definition of the level of ordinary skill in the art. See PO Resp 10–11. We maintain the definition of the level of ordinary skill in the art adopted as of institution.” slip op. at 9

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

    “The record supports Petitioner’s argument that the system in Hogeg “targets a group of end-users” in that it assesses which of the users are, for example, at a specific location and then sends only those users a visual editing function relevant to the users’ location. For example, in a passage cited by Petitioner as to a “conditional selection process to select/distribute a subset of functions” (Pet. 33), Hogeg discloses that “if the positional data is indicative that the visual content was captured in New York, a visual content editing function which provides an overlay of the statue of liberty and/ or a sound overlay of the song New York [N]ew York may be provided.” Ex. 1004 ¶ 58, cited at Pet. 33. This system “target[s] a group of end-users” in New York based on sensor data in that other end-users—such as ones indicated as being in California—do not receive the New York overlay. Patent Owner attempts to distinguish Hogeg’s process in that the content editing functions are sent in response to image selection by the user. See PO Resp. 16 (“Thus, what Hogeg discloses is a process for sending content editing functions ad hoc based on the characteristics of specific pieces of content that are manually identified by a user. Nothing in Hogeg, however, teaches a system or process capable of targeting a group of end-users based on a sensor data condition from their mobile devices.”). This distinction, however, is not supported by the claims. Elements 1b and 18c require a certain type of “distribution rule”— specifically one “defining a sensor data condition”—which Hogeg teaches for the reasons discussed above, but the claims do not preclude a user initiating the overall process with selection of an image. Stated differently (by Petitioner in the Reply), “whatever initiates Hogeg’s process makes no difference to Hogeg’s ‘distribution rules’” because “Hogeg’s content editing functions are still distributed according to, for example, client terminal location . . . and therefore Hogeg still uses distribution rules that target end users (e.g., users at a particular location).” Pet. Reply 8 (citing Parulski Reply Decl. ¶ 40)).” slip op. at 21

  Patent outcomesUS 10,108,986 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,108,986
• Amphenol Corp. v. PPC Broadband, Inc.Instituted
  PTAB · Oct 26, 2022 · IPR2022-00721 · APJ George R Hoskins · IPR · Institution

  The Board instituted review of claims 1–6, 8–19, 21–33, 35–43, 45–50, and 52–62 on both grounds, finding a reasonable likelihood of obviousness over Youtsey, Lionetto, and Horak.

  RulingsInstitution decision

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

    “When applying § 325(d), we utilize a two-part framework. See Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). First, we determine “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.” Id. Second, “if either condition of [the] first part of the framework is satisfied,” we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Id. In the second part, we consider: (i) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (ii) whether Petitioner has pointed out sufficiently how the Examiner erred in evaluating the asserted prior art; and (iii) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art. Id. at 10–11 (citing factors (c), (e), and (f) of Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential)).” slip op. at 10

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

    “analysis overlook that the specific solution proposed by Petitioner’s combination is much simpler than that suggested by Patent Owner. Patent Owner acknowledges the negative effects of RF interference and Petitioner’s evidence, including the discussion in the background section of the ’083 patent, establishes on this record that it was known that preventing RF interference was an important consideration in cable connector design, and that interference is particularly disruptive where an electromagnetic buffer is not provided by an adequate electrical and/or physical interface between the port and the connector. See, e.g., Pet. 17 (quoting Ex. 1001, 1:51–67) (citing Ex. 1005 ¶¶ 61–62). Petitioner’s evidence also establishes that Youtsey’s o-rings protect a center conductor from degradation due to moisture. See id. at 17–18 (citing Ex. 1007, 1:19–22, 2:14–16, 5:50–53). And, Horak specifically provides that a conductive, compressible o-ring can address both issues by blocking RF interference and sealing from the weather, e.g., moisture. See id. at 18 (citing Ex. 1009, 5:4–7; Ex. 1005 ¶¶ 64–66). Thus, we do not agree with Patent Owner that one of ordinary skill in the art needed to be motivated to create a coupler-body grounding path in particular, as opposed to being motivated to modify Youtsey such that the connector was not only sealed off from moisture (which Youtsey already taught), but also blocked RF interference, which was a known issue of concern and which Horak taught could be addressed with the same component that also seals off from moisture. Thus, Horak’s teaching, as applied to Youtsey’s o-rings, results in the element that Patent Owner asserts does not exist in the prior art—a coupler-body grounding path—whether or not creating that coupler-body grounding path was a specific, intended goal prompting one of ordinary skill in the art to make the proposed modification to Youtsey. Accordingly, on the present record, Patent Owner’s argument does not detract from Petitioner’s stated motivation and reasons for the proposed combination.” slip op. at 62

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

    “Patent Owner’s piecemeal arguments in response to Petitioner’s analysis overlook that the specific solution proposed by Petitioner’s combination is much simpler than that suggested by Patent Owner. Patent Owner acknowledges the negative effects of RF interference and Petitioner’s evidence, including the discussion in the background section of the ’083 patent, establishes on this record that it was known that preventing RF interference was an important consideration in cable connector design, and that interference is particularly disruptive where an electromagnetic buffer is not provided by an adequate electrical and/or physical interface between the port and the connector. See, e.g., Pet. 17 (quoting Ex. 1001, 1:51–67) (citing Ex. 1005 ¶¶ 61–62). Petitioner’s evidence also establishes that Youtsey’s o-rings protect a center conductor from degradation due to moisture. See id. at 17–18 (citing Ex. 1007, 1:19–22, 2:14–16, 5:50–53). And, Horak specifically provides that a conductive, compressible o-ring can address both issues by blocking RF interference and sealing from the weather, e.g., moisture. See id. at 18 (citing Ex. 1009, 5:4–7; Ex. 1005 ¶¶ 64–66). Thus, we do not agree with Patent Owner that one of ordinary skill in the art needed to be motivated to create a coupler-body grounding path in particular, as opposed to being motivated to modify Youtsey such that the connector was not only sealed off from moisture (which Youtsey already taught), but also blocked RF interference, which was a known issue of concern and which Horak taught could be addressed with the same component that also seals off from moisture. Thus, Horak’s teaching, as applied to Youtsey’s o-rings, results in the element that Patent Owner asserts does not exist in the prior art—a coupler-body grounding path—whether or not creating that coupler-body grounding path was a specific, intended goal prompting one of ordinary skill in the art to make the proposed modification to Youtsey. Accordingly, on the present record, Patent Owner’s argument does not detract from Petitioner’s stated motivation and reasons for the proposed combination.” slip op. at 62

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, . . . would be led in a direction divergent 9 Lionetto teaches that leaf spring 22 also provides electrical contact through the conductors. Ex. 1008, 2:34–36. from the path that was taken by the applicant.” In re Haruna, 249 F.3d 1327, 1335 (Fed. Cir. 2001) (quoting Tec Air, Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1360 (Fed. Cir. 1999)); see In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (holding that, to teach away, the prior art must “criticize, discredit, or otherwise discourage the solution claimed”). We do not agree with Patent Owner that one of ordinary skill in the art would have been led in a direction divergent from that taken by Patent Owner. Although we agree with Patent Owner that Lionetto attributes importance to annular leaf spring 22, Lionetto also attributes importance to conductive elastomer gasket ring 34. In particular, Lionetto expressly attributes the electrical contact to both the spring and the gasket ring. See Ex. 1008, 2:34–36 (“the electrical contact is essentially through the leaf spring 22 and a conductive elastomer 34 against which the tapered surface 27 abuts”). And, Lionetto’s claims repeat the importance of both structures in providing continuous electrical contact and RFI suppression. See id. at 2:50–58 (claim 1) (“an annular electrical spring contact member which functions to provide continuous annular outer conductor electrical contact and RFI suppression . . . even during slight conductor misalignment”), 3:14–20 (“A connector of claim 1, and further comprising an electrically conductive elastomer gasket ring, carried on said male member against which said outer end taper of said female member may engage and compensates for misalignment of said male and female connector halves when fully engaged, providing continuous circumferential electrical contact and RFI suppression.”). Thus, Lionetto supports a finding that one of ordinary skill in the art would have been prompted to use an annular spring, a conductive gasket ring, or both to provide continuous electrical contact and RFI suppression across the connector. But, we disagree with Patent Owner that Lionetto would have led one of ordinary skill in the art away from using a conductive gasket ring in Youtsey, as proposed by Petitioner, because, as explained above, Lionetto uses a conductive gasket ring and expressly attributes the benefits noted above to its use (i.e., continuous electrical contact and RFI suppression). slip op. at 56

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 9,225,083
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Oct 11, 2022 · IPR2022-00747 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood that claims 1–29 were obvious over the cited art.

  RulingsInstitution decision

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

    “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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6

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

    “Petitioner sets forth proposed constructions for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. 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 7

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

    “merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id. Moreover, a person of ordinary skill in the art must have had a reasonable expectation of success of doing so. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).” slip op. at 11

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,889,858
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Oct 11, 2022 · IPR2022-00746 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–28 would have been obvious over the asserted combinations.

  RulingsInstitution decision

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

    “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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 18 (citing Ex. 1002 ¶¶ 26–29). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. See generally Prelim. Resp. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See 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))).” slip op. at 7

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

    “Having considered the parties’ respective arguments, we determine that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. 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 8

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

    “We are not persuaded by Petitioner’s arguments. Although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner fails to sufficiently explain why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Murtaza’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters, and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared” slip op. at 13

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,801,063
• Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution denied
  PTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.

  RulingsInstitution decision

  • Skill levelSkill level board ownOther

    “In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17

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

    “As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19

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

    “reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,464,140
• Sabinsa Corporation v. Franco CavaleriInstituted
  PTAB · Jun 15, 2022 · PGR2022-00015 · APJ Susan L C Mitchell · PGR · Institution

  Instituted PGR of claims 1–7 on all petition grounds; the Board found claims more likely than not indefinite because the claimed curcumin percentages lacked a clear measurement basis.

  RulingsInstitution decision

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

    “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would comprise an individual with a Ph.D in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, or an M.S. or B.S. degree in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, with an additional 3–5 years of practical experience in pharmaceutical or nutraceutical product development of characterization.” Pet. 17 (citing Ex. 1019 ¶ 94 (Dr. Amiji Declaration)). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’970 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8

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

    “Petitioner asserts that the term “about” in relation to the percentages of curcumin I, II, and III in claims 2 and 5 of the ’970 patent “should be given its ordinary meaning of ‘approximately’ rather than a particular numerical range.” Pet. 18. On this record, we agree with Petitioner that “about” generally means “approximately,” but how much this term numerically affects the express boundaries for ranges set forth in the claims that the term “about” modifies is not clarified by the proposed construction. See Ortho-McNeil Pharmas., Inc. v. Caraco Pharma., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (“Although both parties and the district court seem to agree that the term “about” means “approximately,” the parties and the district court disagree over the numerical limits that that term imparts to the limitation “1:5” in this case.”).” slip op. at 10

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteInstituted

    “We agree with Dr. Amiji’s analysis and determine, based on the present record, that Petitioner has established that it is more likely than not that claims 1–7 are indefinite. Claims 1–7 are unclear because these claims do not specify how the percentages of curcumin I, II, or III, are to be measured, but instead only provide raw percentages for each curcumin species. See Ex. 1001, 14:10–49. The Specification of the ’970 patent mentions a weight-by-volume measure for curcumin species for only Examples 6 through 8, but as Dr. Amiji testifies, these Examples are formulated as capsules with optional fillers that may be liquid including water. See id. at 13:15–19, 34–38. The remaining Examples 4 and 5 setting” slip op. at 15

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,945,970

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.