- Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jul 28, 2020 · PGR2019-00027 · APJ Grace Karaffa Obermann · PGR · Final written decision
Claims 1–29 are unpatentable as obvious over Harden combined with one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge was not proven.
RulingsFinal written decision- BurdenUnpatentable
“Based on the full trial record, we find that Petitioner demonstrates by a preponderance of the evidence that the subject matter of claim 1 would have been obvious. Varenna 2011 teaches that neridronate “seems to possess an excellent efficacy profile” in treating CRPS. Ex. 1006, 233. In the context of reporting the use of “[n]eridronic acid for the treatment of bone metabolic diseases,” Gatti teaches that “[i]ntravenous high doses of bisphosphonates are increasingly used for the treatment of [CRPS].”13 Ex. 1008, 1305, 1308. Gatti also reports that a clinical trial of neridronic acid “is underway.” Id. Muratore teaches that neridronate was “efficacious in the treatment of [CRPS].” Ex. 1007, 89. Thus, on this record, each of these references sufficiently teaches the efficacy of neridronic acid or its salt in treating CRPS, suggesting that a person of ordinary skill in the art would have been motivated to use neridronic acid in treating CRPS. With respect to the limitation of claim 1 requiring that the neridronic acid be “parenterally administer[ed],” each of Varenna 2011, Gatti, and Muratore teaches intravenous administration of neridronic acid. Ex. 1006, 233; Ex. 1007, 89; Ex. 1008, 1308. Intravenous administration is a type of parenteral administration. Ex. 1004 ¶ 44. 13 Gatti uses the terms “reflex sympathetic dystrophy syndrome” and “algodystrophy.” Ex. 1008, 1308. On the present record, we interpret both of these terms as synonymous with “complex regional pain syndrome,” “CRPS,” “complex regional pain syndrome type I,” “CRPS I,” “reflex sympathetic algodystrophy,” “reflex sympathetic dystrophy,” and “causalgia.” Ex. 1006, 227 (equating “algodystrophy,” “complex regional pain syndrome type I,” and “CRPS I”); Ex. 1007, 89 (using the term “reflex sympathetic algodystrophy”); Ex. 1019, 713 (equating “complex regional pain syndrome,” “CRPS,” “reflex sympathetic dystrophy,” and “causalgia”). Harden teaches that the Budapest Criteria are used as “clinical diagnostic criteria for CRPS” and that they include changes in skin blood flow, by reference to the symptoms of “temperature asymmetry” and “skin color asymmetry.” Ex. 1009, 274 (Appendix II). Further, Harden teaches that 69.4% of patients diagnosed with CRPS were observed on examination to exhibit temperature asymmetry, and 83.9% were observed on examination to exhibit skin color asymmetry. Id. at 271 (Table 2). Thus, Harden teaches that a majority of patient with CRPS suffer from changes in skin blood flow. Because Varenna 2011, Gatti, and Muratore teach that neridronic acid is effective in treating CRPS, the combination of any of those references with Harden14 would have suggested to a person of ordinary skill in the art that neridronic acid would be effective in alleviating changes in skin blood flow associated with CRPS. Thus, the combination of Harden and one or more of Varenna 2011,” slip op. at 26
- ExcludeMotion to exclude, deniedMixed
“Assuming that “October 2011” is hearsay, it is still admissible evidence under Rule 807 of the Federal Rules of Evidence. See Opp. Mot. 3–4 (asserting this hearsay exception). Under Rule 807, a statement “is not excluded,” even if it is hearsay, if it meets two requirements. First, the statement must be “supported by sufficient guarantees of trustworthiness— after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement.” Fed. R. Evid. 807(a)(1). Second, the statement must be “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Id. at 807(a)(2). Here, both requirements are satisfied. The statement “October 2011” on the face of Varenna 2011 is offered to prove that Varenna 2011 was published in October 2011. This statement is accompanied by several guarantees of trustworthiness. The statements “Received on July 15, 2011” and “Accepted on August 30, 2011,” when offered as corroboration of the October 2011 publication date, are not hearsay. Fed. R. Evid. 801 (statement is hearsay only if offered in evidence “to prove the truth of the matter asserted in the statement”). Accordingly, they may be admitted for this purpose, and they corroborate a publication in October 2011. Moreover, Exhibits 1038 and 1040 also provide some evidence that Varenna 2011 was published in October 2011. Ex. 1038, 1 (article with same title as Varenna 2011 published in “Fascicolo 5 2011”); Ex. 1040, 1 (“Fascicolo 5 2011” published in 2011). Thus, the record contains sufficient guarantees of trustworthiness of Varenna 2011’s statement that Varenna 2011 was published in October 2011. See Opp. Mot. 3 (citing Ex. 1004 ¶¶ 39–40). We find that Varenna 2011’s statement, indicating that the reference was published in October 2011, is “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Fed. R. Evid. 807(a)(2). It is difficult to imagine evidence more probative of the publication date of a journal article than the article’s own contemporaneous statement about when it was published.19 See Opp. Mot. 2–4 (for well-supported arguments on point). Accordingly, we determine that the exception of Rule 807 applies, and we conclude that the statement “October 2011” in Varenna 2011 should not be excluded.” slip op. at 48
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 9
Patent outcomesUS 10,039,774 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurePatents in suitUS 10,039,774 - Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentablePTAB · Jul 28, 2020 · PGR2019-00026 · APJ Grace Karaffa Obermann · PGR · Final written decision
Claims 1–30 are unpatentable as obvious over Harden and one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge fails.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“INTRODUCTION A. Background Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting a post-grant review of claims 1–30 of U.S. Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Antecip Bioventures II LLC (“Patent Owner”) did not file a Preliminary Response. We instituted review of all challenged claims on each of the grounds asserted in the Petition. Paper 6 (“Dec. Inst.”).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’352 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1001, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’352 patent, “[a] method of treating” hyperalgesia (claim 1) or edema (claim 17) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from hyperalgesia (claim 1) or edema (claim 17) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1001, 90:39–43, 91:23–27, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting, and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner’s asserted references provides data showing that administering neridronic acid improves the symptoms of CRPS. PO Resp. 18–19. But “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011, Gatti, and Muratore would have informed the ordinarily skilled artisan that successful treatment of CRPS and its symptoms was likely; there is no requirement that Petitioner show that the prior art taught that success was certain.” slip op. at 15
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“qualifies as a printed publication under 35 U.S.C. § 102. PO Resp. 4–17; PO Sur-Reply 14–21. “To qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are two ways to show that a reference was sufficiently accessible: show it was disseminated or show it was “otherwise made available to the extent that” interested people of ordinary skill in the art could have located it after exercising reasonable diligence. Id. Here, according to Petitioner, the asserted references “are articles published in periodical journals by an identified and reputable publisher.” Reply 3.11 Petitioner argues that the references were “disseminated on the[ir] stated publication date[s].” Id. at 5. We agree.” slip op. at 18
Patent outcomesUS 9,931,352 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurePatents in suitUS 9,931,352 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 20, 2020 · IPR2019-01453 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–11 and 13 unpatentable over Szekeres, Smith, or their combination.
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). For the reasons provided below, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Neither Szekeres nor Smith was cited during examination of the ’509 patent. Pet. 87–88. Instead, they “were considered during examination of a subsequently filed application.” Id. at 88; see also Prelim. Resp. 20 (Patent Owner conceding that “the Examiner considered Petitioner’s asserted references in the ’191 patent after the ’509 patent issued”). Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to decide whether institution should be denied on a discretionary basis under § 325(d).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“facts unique to each patent. See, e.g., Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373–76 (Fed. Cir. 2019) (affirming construction that result or efficacy language appearing in a wherein clause was limiting in light of the intrinsic evidence as a whole). Indeed, determining whether allegedly non-limiting language in a preamble or otherwise “involves examination of the entire patent record to determine what invention the patentee intended to define and protect.” Rowe v. Dror, 112 F.3d 473, 478–80 (Fed. Cir. 1997); Allergan, 935 F.3d at 1374 (holding the court “must read the claims in view of the entire specification” and prosecution history) (internal quotation marks and citations omitted). Based on the entire intrinsic record, we find “protection” is at the heart of the ’509 patent’s invention. In the body of claim 1, step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1001, 12:41–42 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis. Also, the preamble provides meaning about the nature of the infection recited in the body of the claim: “a self-replicating infection by an immunodeficiency retrovirus.”4 Id. at 12:38–39.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, the brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not 18 ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983); see also Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”). Here, Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada.5 Pet. 38–42. But Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. In sum, Szekeres does not disclose step (b).” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,044,509 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 20, 2020 · IPR2019-01454 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–11 and 13 unpatentable; claims 12 and 14–17 were disclaimed.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Neither Szekeres nor Smith was cited during examination of the ’333 patent. Pet. 87. Instead, they “were considered during examination of a subsequently filed application.” Id. at 88; see also Prelim. Resp. 20 (Patent Owner concedes that “the Examiner considered Petitioner’s asserted references in the ’191 patent after the ’333 patent issued”). Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to decide whether institution should be denied on a discretionary basis under § 325(d).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“facts unique to each patent. See, e.g., Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373–76 (Fed. Cir. 2019) (affirming construction that result or efficacy language appearing in a wherein clause was limiting in light of the intrinsic evidence as a whole). Indeed, determining whether allegedly non-limiting language in a preamble or otherwise “involves examination of the entire patent record to determine what invention the patentee intended to define and protect.” Rowe v. Dror, 112 F.3d 473, 478–80 (Fed. Cir. 1997); Allergan, 935 F.3d at 1374 (holding the court “must read the claims in view of the entire specification” and prosecution history) (internal quotation marks and citations omitted). Based on the entire intrinsic record, we find “protection” is at the heart of the ’333 patent’s invention. In the body of claim 1, step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1003, 12:51–52 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis. Also, the preamble provides meaning about the nature of the infection recited in the body of the claim: “a self-replicating infection by an immunodeficiency retrovirus.”5 Id. at 12:48–49. Furthermore, the body of claims 1 and 13 requires administering “a pharmaceutically effective amount” of each agent. The preamble and other allegedly non-limiting portions of the claims provide necessary context for the “effective amount” language. That is, these are amounts that can bring 5 Reliance on the preamble also appears in claim 13. There, step (a) recites “selecting an uninfected human that does not have the self-replicating infection.” Ex. 1003, 14:1–2 (emphases added). 11 on the recited efficacy—in claim 1, “protecting” the host from infection.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, the brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP 22 treatment that satisfies step (b) of the claims. When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983); see also Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”). Here, Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada. Pet. 38–42. For example, Petitioner argues that Szekeres’s teaching of a potential for mutation and resistance with FTC monotherapy “would have been understood by the skilled person as indicating FTC should be co-administered with another antiretroviral.” Id. at 39. From that, Petitioner contends Szekeres suggests FTC should be combined with TDF (the known agent actually being investigated in the PrEP studies described in Szekeres), with Truvada hence representing the combination of those therapeutic agents. Id. at 39–40. But 23 Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. In sum, Szekeres does not disclose step (b). Efficacy Requirement” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 9,579,333 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 5, 2020 · IPR2019-01456 · APJ Timothy G Majors · IPR · Institution
The Board denied institution on claims 1–19 because the petition did not show a reasonable likelihood that any challenged claim was unpatentable over Szekeres or Smith and Szekeres.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008); In re Chudik, 851 F.3d 1365, 1372 (Fed. Cir. 2017) (“[A] prior art reference anticipates a claim only if it discloses all the elements in the same form and order as in the claim.”) (internal quotation marks and citation omitted). Turning to obviousness, a claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) 19 objective evidence of nonobviousness when presented. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). A party who petitions the Board for a determination of unpatentability” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“claim’s preamble is limiting when it is “necessary to give life, meaning, and vitality to the claim.” MBO Labs., Inc. v. Becton Dickinson & Co., 474 F.3d 1323, 1330 (Fed. Cir. 2007). As an initial matter, we observe that claim 1’s step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1007, 13:1–2 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis, and the preamble provides further meaning about the nature of the infection to which the claim is directed—“a self-replicating infection by an immunodeficiency retrovirus.”16 Id. at 12:65–67;” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“It is not clear that further interpretation of this phrase is needed to resolve the dispute presented here. Nevertheless, Petitioner provides sufficient support for its interpretation on this record and, as it is unopposed at present by Patent Owner, we will adopt Petitioner’s interpretation of this phrase for purposes of this Decision.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInherency not foundNot shown unpatentable
“The brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. Although claim language need not appear ipsissimis verbis in the allegedly anticipating prior art,24 the test remains one of “strict identity.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”). When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (internal citation omitted). Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously 24 In re Schaumann, 572 F.2d 312, 317 (CCPA 1978). 40 describes PrEP combination therapy with Truvada. Pet. 38–42 (asserting that Szekeres “teaches orally administering Truvada in a tablet to an uninfected individual before an HIV exposure”).25 But Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. To our eyes, Petitioner’s theory invokes obviousness (if anything), not anticipation. See Net MoneyIN, 545 F.3d at 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”).” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,335,423 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 5, 2020 · IPR2019-01455 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner had not shown a reasonable likelihood that claims 1–19 were unpatentable over Szekeres or Smith and Szekeres.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“claim’s preamble is limiting when it is “necessary to give life, meaning, and vitality to the claim.” MBO Labs., Inc. v. Becton Dickinson & Co., 474 F.3d 1323, 1330 (Fed. Cir. 2007). As an initial matter, we observe that claim 1’s step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1005, 12:35–36 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis, and the preamble provides further meaning about the nature of the infection to which the claim is directed—“a self-replicating infection by an immunodeficiency retrovirus.”17 Id. at 12:32–33; Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) (“When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.”). Furthermore, the body of claims 1 and 13 requires, inter alia, administering “pharmaceutically effective amount[s]” of the combined agents. Without the preamble and other allegedly non-limiting portions of the claims, sufficient context for the “effective amount” language is lacking. Rather, these are amounts that can bring on the recited efficacy—in claim 1, “protecting” the host from infection. Otherwise the claims, focusing on the” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“in time after an HIV exposure when the body’s immune system alone cannot prevent progression of the HIV infection.” Pet. 24 (citing 1009 ¶¶ 187– 188). Petitioner asserts that this corresponds to a time about 72 hours after exposure “when infected CD4+ cells are being produced faster than the immune system can destroy them.” Id. at 24–25; Ex. 1005, 1:45–49 (describing retroviral particles being transferred to an individual and “self-replicating” “within a few days”). Petitioner, thus, asserts that “self-replicating infection” means “an HIV infection that can no longer be suppressed solely by the host’s immune system.” Pet. 25 (italics omitted). 30 Patent Owner does not challenge Petitioner’s interpretation of this phrase or offer an interpretation of its own. Prelim. Resp. 26–31. It is not clear that further interpretation of this phrase is needed to resolve the dispute presented here. Nevertheless, Petitioner provides sufficient support for its interpretation on this record and, as it is unopposed at present by Patent Owner, we will adopt Petitioner’s interpretation of this phrase for purposes of this Decision.” slip op. at 30
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Patent Owner on this record. Szekeres describes PrEP monotherapy using TDF as the agent. Indeed, that is the only agent Szekeres describes being used in the numerous ongoing PrEP studies/trials or even projected for use in PrEP studies planned for the future. Ex. 1011, 6–11 (“These studies all make use of tenofovir disoproxil fumarate (TDF) as the investigational PrEP agent.”). And, even with respect to those studies, Szekeres expresses reservations as to whether TDF monotherapy, much less a combination therapy like claimed, would be safe or effective. See id. at 1 (“If PrEP proves to be safe and effective, numerous clinical questions will need to be resolved”), 3 (“It is not yet known whether PrEP is a safe or effective approach to HIV prevention.”), 12 (describing questions about PrEP’s use as “currently unanswerable and may or may not be clarified by currently planned studies”) (emphases added). We are unpersuaded on this record that those reservations reflect only “epidemiological” issues or questions, and that they are inapplicable to whether PrEP would be seen as safe or effective in particular individuals following a course of treatment. The brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. Although claim language need not appear 39 ipsissimis verbis in the allegedly anticipating prior art,25 the test remains one of “strict identity.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”). When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (internal citation omitted). Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada. Pet. 38–42 (asserting that Szekeres “teaches orally administering Truvada in a tablet to an uninfected individual before an HIV exposure”).26 But Szekeres simply” slip op. at 39
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot reached
“On whether the ordinarily skilled person would have combined Smith and Szekeres to produce the claimed subject matter with a reasonable expectation of success, we have doubts on this record. From the prior art and other evidence here, a theme emerges. That is, while some of the evidence might indicate promise with TDF and TDF-combination therapies in PEP or PrEP, other (and sometimes the same) evidence casts doubts on whether those therapies would be safe or effective. For example, Subbarao notes a “partial protection” with TDF monotherapy among the group of treated primates, but data show that only 1 of the 8 subjects receiving TDF remained uninfected. See Ex. 1050, 907 (Fig. 1, showing all 4 subjects receiving weekly administration became infected, and 3 of 4 receiving daily, oral administration became infected). Subbarao further explains that whatever delay in infection was seen was not statistically significant. Id. at 904, 909 (explaining, in 2006, that there “exists no precedent for giving chemoprophylaxis to large populations of people at risk for infection through repeated exposure to HIV”). Grant-2006 (cited by Petitioner) notes that Subbarao’s model “set the bar much higher for chemoprophylaxis” and remarks that “[a]t the end of 14 weeks, all animals were infected.” Ex. 1051, 874. According to Grant-2006, however, the “limited efficacy of TDF alone in highly stringent monkey models . . . raise the possibility that combinations of agents may be more suited to PrEP,” and hypothesizes that Truvada might be a promising drug combination. Id. at 874–875. Yet, with respect to the then-ongoing 48 investigations with TDF, Grant-2006 explains that “[l]imited information about safety . . . may become available by the end of 2006, whereas information about efficacy is not expected until 2008-2009,” and “[u]ntil then, PrEP is not recommended for clinical use.” Id. at 875. A similar pattern is present in Szekeres and Smith. For example, Szekeres discloses that “[a]lthough some guidelines exist for nonoccupational PEP, the safe and effective delivery of PEP remains complex, and reliable data on the use of PEP in settings in the United States is not available.” Ex. 1011, 4. With respect to PrEP, Szekeres notes that studies investigating TDF’s efficacy are “just beginning to get underway” and questions about how PrEP should be used were, at that time, “unanswerable.” Id. at 12, 23 (“Ultimately, however, data from planned PrEP studies will be needed before it can be determined for whom PrEP is an appropriate strategy.”). On the other hand, Szekeres discloses that “models” about the potential impact in California “indicate that introduction of PrEP may quickly reduce incidence, with effects on prevalence being less dramatic and over a longer period of time.” Id. at 1; see also id. at 11–12 (“As prescription medicines go—and HIV drugs in particular—TDF appears to be a relatively safe agent with few adverse side effects and interactions with other drugs.”). Smith teaches, for example, that “data indicate that nPEP might sometimes reduce the risk of HIV infection,” but also discloses that “[a]nimal studies have demonstrated mixed results,” that “[a]ntiretriviral PEP does not prevent all infections” and “PEP failures have been documented,” and “[b]ecause nPEP is not 100% effective in preventing transmission” and carries risks for “serious toxicities, nPEP should be used 49 only for infrequent exposures.” Ex. 1012, 2, 5, 6 (disclosing that persons who engage in conduct “that result[s] in frequent, recurrent exposures . . . should not take nPEP”).” slip op. at 48
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,937,191 - PTAB · Mar 29, 2019 · IPR2018-01574 · APJ Christopher M Kaiser · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1–3, 6, or 7 were unpatentable over any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), 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.” After considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has not shown a reasonable likelihood of prevailing with respect to at least one challenged claim. Accordingly, we do not institute inter partes review of any claim of the ’719 patent on the grounds asserted in the Petition.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“specification of the patent in which they appear.7 37 C.F.R. § 42.100(b) (2016). Claim terms generally are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner does not request an explicit construction for any of the claim terms. Patent Owner argues that we should construe the term “a dielectric spacer surrounding the gate line.” Prelim. Resp. 9–10. Specifically, Patent Owner argues that we should interpret this phrase as “forming a dielectric spacer enclosing the gate line on all side surfaces.” Id. Petitioner does not argue to the contrary, Pet. 1–87, and Petitioner appears tacitly to accept this construction, because Petitioner argues that the asserted prior-art references disclose the formation of dielectric spacers enclosing gate lines on all side surfaces. See, e.g., Pet. 34 (“Because sidewall spacers on the long lateral sides and the ends of the gate line are on substantially vertical surfaces, the etching technique disclosed in Liaw and Mandelman [which removes material from horizontal surfaces while leaving material in place on vertical surfaces] resulted in sidewall spacers surrounding the gate lines.”). Moreover, Patent Owner’s proposed construction is consistent with 7 A recent amendment to this rule does not apply here, because the Petition was filed before November 13, 2018. See “Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board,” 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be codified at 37 C.F.R. pt. 42). the language of the ’719 patent. Ex. 1001, 6:18–21 (“dielectric spacer layer 1005 is formed on opposite lateral outer sides of the respective gate lines 1004 in the horizontal direction of the figure, besides those formed at the ends of the gate lines 1004 in the vertical direction of the gate line”). Accordingly, on the present record, we adopt Patent Owner’s proposed construction, and we interpret “a dielectric spacer surrounding the gate line” as “forming a dielectric spacer enclosing the gate line on all side surfaces.”” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner. Petitioner’s argument rests on the idea that all processes that involve blanket deposition of a dielectric spacer layer over a gate line followed by anisotropic etching to remove spacer material from horizontal surfaces will result in spacer material being present on the vertical end faces of the gate line. Pet. 33–34. For example, Dr. Thompson, Petitioner’s declarant, testifies that “[b]lanket deposition [in general] is a process in which the sidewall spacer material is laid across the entire circuit structure, including around all sides of and on top of any gate line found on top of the substrate.” Ex. 1002 ¶ 223. Dr. Thompson also testifies that “[t]he term ‘blanket’ is used because the sidewall spacer material covers every exposed surface in the semiconductor substrate being processed.” Id. Because the material is placed on every surface, and because anisotropic etching removes the material only from the horizontal surfaces of the structure, Dr. Thompson testifies that the process of blanket deposition followed by anisotropic etching must leave spacer material on all vertical surfaces, including the end faces of the gate line. Id. But Liaw itself contradicts this testimony. Liaw discloses a method for forming “first spacers 211” on dummy layers 207 and 209. Ex. 1003, 3:61–4:6, Figs. 2B, 2C. As with Liaw’s process for forming permanent spacers, on which Petitioner relies, this process involves “blanket depositing a spacer layer over the previously formed structure,” and “anisotropically etching and removing the spacer layer 210 from the horizontal surfaces of the structure.” Id. at 3:61–4:6. The blanket deposition covers at least one end of each dummy layer. Id. at Fig. 2C (depicting spacer layer 210 as covering one end of dummy layers 207 and 209). The spacers formed by this process, however, are formed only on the long lateral surfaces of the dummy layers, and not on the end faces of the dummy layers. Id. at Figs. 2C, 2E, 2G. Thus, despite Dr. Thompson’s testimony, it is not necessarily the case that all processes involving blanket deposition of spacer material over a gate line followed by anisotropic etching of that material necessarily leave spacer material on all side surfaces of the gate line, including the end faces. Accordingly, simply showing that Liaw discloses a process of spacer formation in which spacer material is blanket deposited over a gate line and then anisotropically etched is not sufficient to show that Liaw discloses a process of spacer formation that results in spacer material being placed on all side surfaces of the gate line. Because Petitioner has not shown sufficiently that Liaw discloses “forming a dielectric spacer surrounding the gate line,” we conclude that Petitioner has not established a reasonable likelihood of prevailing in showing the unpatentability either of claim 1 or of claims 2 and 6, which depend from claim 1, as anticipated by Liaw.” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“On the present record, Okuno itself suggests that spacer material is not present on the end faces of its gate lines. Both Figure 6C and Figure 7B depict only spacers10 formed on the long lateral surfaces of the gate electrodes, without depicting the end faces of those lines, which is at best ambiguous evidence that could not prove either the presence or the absence of spacer material on the end faces of the gate lines. Ex. 1005, Figs. 6C, 7B. Accordingly, these figures do not themselves depict spacer material enclosing the gate line on all side surfaces. Petitioner argues that Figure 7B 10 The parties dispute whether Okuno’s sidewall spacers 27 are dielectric spacers of the type recited in the challenged claims or whether they are instead extension implantation regions buried in the substrate. Pet. 49–52; Prelim. Resp. 23–26; Reply 1–6; Sur-Reply 1–4. On the present record, it is unclear which party is correct in its interpretation of Okuno. supports the argument that spacer material is present on the end faces of the lines by noting that the “curvilinear ends” on the gate lines in Figure 7B “indicate that the gate lines continue to the left and right.” Pet. 50 (citing Ex. 1002 ¶ 266). Petitioner is correct that Figure 7B indicates the continuation of the gate lines beyond the edges of the illustration, but the fact that the gate lines continue beyond the edges of the illustration says nothing about the presence or absence of spacer material on the end faces of the gate lines. Moreover, Okuno states that its sidewall spacers “are provided only in the longitudinal direction of the gate (i.e. along the gate length direction),” which is evidence that the spacers actually are not placed on the end faces of the gate lines. Ex. 1005 ¶ 28. As it argued with respect to Liaw, Pet. 33, Petitioner argues that Okuno teaches using a deposition process to form its sidewall spacers that will always result in spacer material covering the end faces of the gate lines as well as their long lateral surfaces. Id. at 49. Specifically, Petitioner argues that “[a] person of skill in the art would have understood that” the CVD oxide film of Okuno “would cover the entire surface of the semiconductor substrate, including the long sides and ends of the gate lines.” Id. (citing Ex. 1002 ¶¶ 265–266). This argument is supported by the testimony of Dr. Thompson, who testifies that “the conventional CVD . . . technique used to form the dielectric oxide sidewall spacers on the sidewalls of the gate lines in Okuno” would always result in “sidewall spacers [being] formed on all sides of the gate line, both the lateral sides and the end faces.” Ex. 1002 ¶ 266. As discussed above with respect to the Liaw anticipation ground, however, the disclosure of Liaw makes clear that not all processes involving blanket deposition of spacer material over gate lines followed by anisotropic etching necessarily result in spacer material being present on the end faces of the gate lines. Ex. 1003, 3:61–4:6, Figs. 2B, 2C, 2E, 2G; Section B.2, supra. Accordingly, simply showing that Okuno discloses a process of spacer formation in which spacer material is blanket deposited over a gate line and then anisotropically etched is not sufficient to show that Okuno teaches or suggests a process of spacer formation that results in spacer material being placed on all side surfaces of the gate line. Thus, Petitioner has not shown sufficiently that either Okuno or Liaw teaches or suggests “forming a dielectric spacer surrounding the gate line.” Because claims 1–3 and 6 all include this limitation directly or through their dependence from claim 1, we conclude that Petitioner has not established a reasonable likelihood of prevailing in showing the unpatentability of claims 1–3 and 6 as obvious over the combination of Okuno and Liaw.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,070,719 - Bedra, Inc. / Berkenhoff GmbH et al. v. Seong, Ki ChulRehearing deniedPTAB · Feb 4, 2019 · IPR2018-00668 · APJ Jo-Anne M Kokoski · IPR · Rehearing
The Board denied the rehearing request, leaving in place denial of institution for claims 2, 5, 7, 8, and 10 because Petitioner did not show the claims lacked Korean Application priority support.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d). Additionally, Petitioner, as the party challenging the Decision, has the burden of showing it should be modified. Id. When rehearing a decision on a petition, the Board will review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined “if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors.” Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004) (citing In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000)).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner
“we are not persuaded that we abused our discretion in determining that the Korean Application adequately describes cracks in the alloy layer and the coating layer as required by the challenged claims. Dec. 9–11. Assuming arguendo that Petitioner is correct that Figure 2a2 does not show such cracks, our Decision is supported by other evidence of record that Petitioner does not dispute. For example, in response to Petitioner’s argument that the Korean Application “only describes cracks within the ‘coating layer’ and not within any ‘alloy layer,’” (Pet. 20), we stated that the Korean Application “describes the ‘coating layer’ as comprising two sub-layers, one of which is the outer zinc coating layer of the ’036 patent and the other of which is the inner copper-zinc alloy layer of the ’036 patent.’” Dec. 9–10 (quoting Ex. 1013, 7; citing Ex. 1013, Fig. 3; Ex. 1003, Fig. 3b). Based on this disclosure, we concluded that “the Korean Application’s description of cracks in the ‘coating layer’ does not necessarily mean that those cracks are confined to the outer zinc layer and fail to reach the inner alloy layer.” Id. at 10.” slip op. at 4
§ 112 disclosurePatents in suitUS 6,492,036 - Donghee America, Inc. / Donghee Alabama, LLC v. Plastic Omnium Advanced Innovation And ResearchAll claims unpatentablePTAB · Jan 16, 2019 · IPR2017-01654 · APJ Mitchell G Weatherly · IPR · Final written decision
Claims 1, 2, 7–9, and 12–14 are unpatentable: Borchert anticipates claims 1, 2, 8, and 12–14; Borchert alone or with Van Schaftingen renders claim 7 obvious; Borchert and Kachnic render claim 9 obvious.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for determining obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1 (1966). The KSR Court summarized the four factual inquiries set forth in Graham that we apply in determining whether a claim is reasonably likely to be unpatentable as obvious under 35 U.S.C. § 103(a) as follows: (1) determining the scope and content of the prior art, (2) ascertaining the differences between the prior art and the claims at issue, (3) resolving the level of ordinary skill in the pertinent art, and (4) considering objective evidence indicating obviousness or nonobviousness. KSR, 550 U.S. at 406 (citing Graham, 383 U.S. at 17–18). In an inter partes review, Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Thus, to prevail Petitioner must explain how the proposed combinations of prior art would have rendered the challenged claims unpatentable. With these standards in mind, we address each challenge below. slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentable
“inventors, Hervé Lemoine and Frédéric Jannot, were obligated to assign their inventions, including the subject matter of both Jannot and the application that led to the issuance of the ’490 patent, to Patent Owner.2 PO Resp. 16–17. Patent Owner proffers testimony from both men that supports its argument. Id. (citing Ex. 2007; Ex. 2008). Messrs. Lemoine and Jannot each testify that at all times while they have been employed by Patent Owner, including the time at which they developed the subject matter claimed in the ’490 patent, they have been obliged to assign to Patent Owner or its predecessor all rights and resulting patent applications for any invention made in the course of their employment. Ex. 2007 ¶ 2–4; Ex. 2008 ¶ 2–4. This testimony is unrebutted. Tr. 12:21–13:7. Petitioner contends that Jannot is prior art under § 102(e). Pet. 16. (noting that the effective filing date of Jannot in the U.S. predates the priority date of the ’490 patent). Patent Owner has established with unrebutted evidence that Messrs. Jannot and Lemoine were obliged to assign rights to the subject matter of both Jannot and the ’490 patent at the time they developed the subject matter of the ’490 patent. Ex. 2007 ¶¶ 2–4; Ex. 2008 ¶¶ 2–4. Under § 103(c), commonly owned subject matter is removed from the scope of prior art under § 102(e). Accordingly, we” slip op. at 20
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“a parison that is divided into two parts. Pet. 36–37 (citing Ex. 1003 ¶ 3). Petitioner concedes that Borchert does not expressly describe cutting a parison “along two diametrically opposed lines” as recited in claim 7. Id. at 37. However, Petitioner contends that an ordinarily skilled artisan would have considered doing so to have been obvious. Id. (citing Ex. 1007 ¶ 65). Dr. Kazmer testifies that an ordinarily skilled artisan would have considered it obvious to divide Borchert’s parison into two parts with equal width because Borchert’s mold halves 9a and 9b are shown as being the same width. Ex. 1007 ¶ 65. Alternatively, Petitioner relies upon Van Schaftingen as expressly describing “extruding a single parison that is cut over an entire length along two diametrically opposed lines.” Pet. 37–38 (citing Ex. 1004, 3:15–23). Dr. Kazmer testifies that an ordinarily skilled artisan would have been motivated to use Borchert’s process as modified by Van Schaftingen to obtain sheets of equal width for use in Borchert’s equal-width mold halves 9a and 9b and because Van Schaftingen describes its diametrically opposed cuts as being “very particularly preferred.” Id. at 38 (citing Ex. 1007 ¶ 68).” slip op. at 21
Patent outcomesUS 9,079,490 unpatentable§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 9,079,490 - Donghee America, Inc. / Donghee Alabama, LLC v. Plastic Omnium Advanced Innovation And ResearchAll claims unpatentablePTAB · Dec 11, 2018 · IPR2017-01605 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–3, 7, 11, 12, and 14 are unpatentable: claims 1–3, 12, and 14 are anticipated by Linden, and claims 7 and 11 are obvious over Linden and Hata.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“article whose surface has at least one empty or concave part.” Id. at 11 (citing Ex. 1001, 1:66–67; Ex. 1007 ¶ 15). Patent Owner agrees. PO Resp. 15. The ’253 patent states that “[t]he term ‘hollow body’ is understood to mean any article whose surface has at least one empty or concave part.” Ex. 1001, 1:66–67. Where an inventor defines specific terms used to describe an invention, we will give effect to those definitions, as long as they are set out “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Here, the phrase “is understood to mean,” as used in the ’253 patent, signals that the inventor presents a clear, deliberate, and precise definition. Accordingly, we interpret “hollow body” as having the definition given it in the ’253 patent, “any article whose surface has at least one empty or concave part.”” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“supporting its proposed construction of “incorporate” as “insert.” First, Petitioner argues that the language of the ’253 patent requires a construction of “incorporating” as encompassing “inserting” rather than as limited to “attaching.” Reply 2–4. Both parties argue that the “incorporating” recited in the challenged claims must occur before the mold closes to form the hollow body. PO Resp. 16; Reply 2–3. We agree. Ex. 1001, 6:2–14 (“. . . after said step of incorporating, closing said mould . . .”). Thus, it is important to note the processes that the ’253 patent describes as occurring before, during, and after mold closure. Because “incorporating” must occur before mold closure, the process of “incorporating” may not be limited to any process that the patent describes as occurring during or after mold closure. Petitioner is correct that the ’253 patent describes a process in which a preassembled structure for supporting an accessory “may . . . be fastened by welding to the wall of the hollow body, upon closing the mould,” i.e., during, not before, mold closure. Ex. 1001, 4:23–30. Thus, the language of the ’253 patent does not support construing the term “incorporating” as limited to “attaching.” Petitioner also argues that both parties agreed in the related infringement suit in District Court that the proper construction of “incorporating” under the Phillips standard, used in that forum, was “inserting.” Reply 7–8 (citing Ex. 1010, at Ex. A, 4). Specifically, in that litigation, Patent Owner agreed that the correct construction of “incorporating at least one of an accessory or a duct within the hollow body” was “inserting an accessory or duct into the hollow body.” Ex. 1010, at Ex. A, 4. Here, we apply the broadest-reasonable-interpretation standard. 37 C.F.R. § 42.100(b) (2016). “The broadest reasonable interpretation of a claim term may be the same as or broader than the construction of a term under the Phillips standard. But it cannot be narrower.” Facebook, Inc. v. Pragmatus AV, LLC, 582 F. App’x 864, 869 (Fed. Cir. 2014) (non-precedential). Here, for the term “incorporating,” Patent Owner’s proposed broadest reasonable interpretation (“attaching”) is narrower than the Phillips construction Patent Owner has advanced (“inserting”). Thus, “attaching” cannot be the broadest reasonable interpretation of “incorporating.” Other than Patent Owner’s proposed “attaching” construction, the only construction the parties have proposed either in this case or in the related District Court case is Petitioner’s proposed “inserting” construction. PO Resp. 15–20 (discussing only “inserting” and “attaching” constructions); Reply 2–9 (Petitioner arguing in favor of “inserting”); Ex. 1010, at Ex. A, 4 (both parties proposing “inserting”). The ’253 patent supports such a construction, because it describes at least some of its embodiments as involving only insertion of an object between the sheets that will form the hollow body before mold closure. Ex. 1001, 4:23–30. Accordingly, for the foregoing reasons, we adopt Petitioner’s proposed construction of “incorporating” as “inserting.”” slip op. at 10
- Expert testimonyPatent owner expert discountedDecided for petitioner
“Finally, Patent Owner directs us to the testimony of Professor Tim Osswald as support for its view that “incorporate” should mean “attach.” PO Resp. 16 (citing Ex. 2001 ¶¶ 40–42). In relevant part, this testimony states that, “[a]fter reading the specification of the ’253 patent, one of ordinary skill in the art would understand and interpret the word ‘incorporating’ to mean ‘fastening’ or ‘attaching’ so that the accessory or duct becomes part of the hollow body.” Ex. 2001 ¶ 42. Professor Osswald does not cite any evidence in support of his testimony. “[C]onclusory, unsupported assertions by experts as to the definition of a claim term are not useful.” Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (en banc). Accordingly, we give little weight to Professor Osswald’s statement regarding the proper construction of “incorporate.” See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he [PTAB] is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations . . . .” (citations omitted)).” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“preform which has at least one opening for that purpose, to be applied to the inside surface of the wall of the expanded hollow body.” Id. at 3:62–4:3. Patent Owner argues that this teaching is insufficient to disclose attaching the surge cup to the wall of the hollow body before the mold closes. PO Resp. 23–24. We agree that Linden does not teach attaching its accessory to the inside wall of the fuel tank before the mold closes around the preform. Instead, in Linden, the mold halves are closed around the preform and the mandrel, and “a suitable blowing agent . . . is introduced under pressure” through the mandrel, causing the preform to expand to press “against the inside wall defining the mold cavity,” and only then is the holding means for the accessory displaced to be brought into contact with the inner wall of the expanded preform, welding the holding means to the wall. Ex. 1003, 7:27–55, 8:11–29, Figs. 1–3. But, as discussed above, we disagree with Patent Owner about the proper construction of “incorporating” in the challenged claims. Claim 1 requires only that an accessory or a duct be “incorporat[ed] . . . within the hollow body” before mold closure occurs, and we construe “incorporating” to mean “inserting,” without requiring “attaching.” Thus, it is unimportant that Linden fails to teach attaching the surge cup to the wall before mold closure. All that is required is that Linden disclose inserting the surge cup into the preform before mold closure, and Linden does disclose this. Id. at 3:62–4:3, 7:27–49, Figs. 1–3. The next question is whether Linden discloses “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” As discussed above, Linden discloses closing the mold halves after placing the additional body within the preform. But Linden discloses that “[a]t its lower end the preform 28 is pressed around the mandrel 14 by virtue of closure of the mold halves 10a and 10b.” Id. at 7:40–42, Fig. 2. Because mandrel 14 is hollow, id. at 6:35–39; 6:46–54, it is not completely clear that closure of Linden’s hollow body around mandrel 14 necessarily eliminates any interface between the additional body inside Linden’s hollow body and the atmosphere outside the hollow body. On the other hand, the closure of the mold described in the ’253 patent occurs with blowing nozzle 6 “positioned between the two parts of the [mold],” and “blowing air is injected under pressure via the nozzle,” which is quite similar to the use of hollow mandrel 14 in Linden. Ex. 1001, 5:50–57. Given the similarity between Linden’s method and the method described in the ’253 patent, we determine that Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring the step of, “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” The final question with respect to claim 1 is whether Linden discloses that the additional body incorporated within the hollow body “is supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.” Petitioner argues that Linden’s “[h]olding means 24 is a preassembled structure” in which “leg members 44, 45” have “enlarged foot portion[s] 36.” Pet. 18 (citing Ex. 1003, 9:23–34). We agree. “[H]olding means 24 . . . substantially comprises first and second support or leg members 44, 45,” and “support or leg members 44, 45 are each provided with an enlarged foot portion 36 of substantially plate-like configuration.” Ex. 1003, 9:23–34. Even if Linden’s holding means 24 were not in the aggregate the recited “preassembled structure,” each leg member 44, 45, taken together with its respective foot portion 36 is. Ex. 1001, 4:26–28 (describing a “preassembled structure” as “for example, an arm provided with a tab for fastening to the wall of the hollow body”). Linden’s “foot portions 36 are pressed against the inside surface, which is still hot and thus plastic, . . . of the hollow body . . . thereby to produce a welded joint between the foot portions 36 and the inside surface.” Id. at 9:34–42. Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring that the accessory or duct be “supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.”” slip op. at 19
Patent outcomesUS 7,166,253 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 7,166,253
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.