- Juniper Networks, Inc. v. Correct Transmission, LLCInstitution deniedPTAB · Oct 22, 2021 · IPR2021-00814 · APJ Stephen E Belisle · IPR · Institution
The Board denied institution on claims 1–3, 6, 7, 9–15, 18–24, 26, 27, and 30–32 because neither obviousness ground showed a reasonable likelihood of success.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2020). We may not institute an inter partes review “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). Applying those standards, and upon consideration of the information presented in the Petition, Preliminary Response, and supplemental briefing, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to any of challenged claims 1–3, 6, 7, 9–15, 18–24, 26, 27, and 30–32 of the ’928 patent. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Accordingly, constrained by the record before us, we deny institution of an inter partes review of the ’928 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a closely related field, and one to two years of experience in the design and development of network communication systems. Alternatively, a POSITA would have a Master’s degree or similar post-graduate work in electrical engineering, computer engineering, computer science, or a closely related field, and less years of design and development experience. Pet. 7 (citing Ex. 1003 ¶¶ 67–71). Patent Owner does not present an alternative definition at this stage of the proceeding. Prelim. Resp. 30. We regard Petitioner’s proposed definition as reasonable, and” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Petitioner does not propose any claim terms for construction. Pet. 7 (“For purposes of this proceeding, Petitioner construes each of the ’928 claim terms as having its ordinary and custom[ary] meaning.”). Although, Petitioner does submit that, “[f]or purposes of this IPR only, Petitioner relies on the claim scope positions Patent Owner has advanced in district court for ‘port definer module.’” Pet. 8. Similarly, Patent Owner argues each claim term should have its ordinary and customary meaning, except that, as in the parallel district court proceeding, the function of alleged means-plus-function term “port definer module” should be construed to be “designating any one physical link of the logical link and examining the designated link of the logical link.” Prelim. Resp. 11–12. We note that, in the Preliminary Response, Patent Owner does not appear to identify any structure in the Specification for performing that function. See generally Prelim. Resp. Regardless, we do not find that the express construction of any term is necessary for this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Petitioner has not explained sufficiently, let alone with particularity, why the skilled artisan, but for hindsight, would have (1) taken Y.1731, which says nothing concerning aggregated physical links with a single logical link to which packets are directed; (2) then turned to the architectural basis for Y.1731, namely “Ethernet specification G.8010/Y.1306”; (3) then turned to standards “IEEE 802.1D, 802.1Q, and 802.3,” which are “account[ed] for” by G.8010/Y.1306, and specifically selected to pursue 802.3 from among those; (4) then, without any reference or indication in Y.1731 itself, turned specifically to standard IEEE 802.3ad within the set of 802.3 standards, and specifically to its disclosure of aggregated physical links with a single logical link; and then (5) upon making all of these connections, understood Y.1731 itself to disclose or teach aggregated physical links with a single logical link, particularly in the context of the Challenged Claims as a whole. See InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1351 (Fed. Cir. 2014) (“It appears that [the expert] relied on the [] patent itself as her roadmap for putting what she referred to as pieces of a ‘jigsaw puzzle’ together.”); Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing W.L. Gore & Assoc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983)) (“To draw on hindsight knowledge of the patented invention, when the prior art does not contain or suggest that knowledge, is to use the invention as a template for its own reconstruction—an illogical and inappropriate process by which to determine patentability.”). Although “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton” (KSR, 550 U.S. at 421), the Federal Circuit has observed that “‘the prejudice of hindsight bias’ often overlooks that the ‘genius of invention is often a combination of known elements which in hindsight seems preordained.’” Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1068 (Fed. Cir. 2018).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,768,928 - PTAB · Oct 13, 2021 · IPR2021-00713 · APJ Brent M Dougal · IPR · Institution
The Board instituted IPR on claims 7, 8, 10, 11, 14, 15, 17, and 19 on all petition grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner bears the burden to demonstrate unpatentability. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). At this preliminary stage, we determine whether the information presented in the Petition shows a reasonable likelihood that Petitioner would prevail in establishing that at least one of the challenged claims would have been obvious over the proposed combinations of prior art. See 35 U.S.C. § 314(a).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“argue that the reason to combine Ikonen and Gu is insufficient. Prelim. Resp. 47–52. However, Patent Owner’s argument misidentifies the proposed combination. While Patent Owner argues that there is no reason “why a POSA would have been motivated to substitute Ikonen’s Bluetooth solution with Gu’s (HTTP and TCP/IP based) UPnP networking framework,” the actual combination appears to be to implement Gu’s UPnP framework on Ikonen’s wireless LAN. Pet. 42 (“UPnP relies on IP networking . . . which a POSA would have known to be compatible with Ikonen’s wireless LAN option.”); Ex. 1002 ¶ 140 (Petitioner’s declarant explaining that UPnP could be implemented over a wireless LAN); see also Pet. 40–42 (the section entitled “Motivation to Combine” includes no explicit references to Ikonen’s teaching of Bluetooth, but rather only discusses Ikonen’s wireless LAN). All of Patent Owner’s arguments over the reason to combine focus on Ikonen’s teaching of Bluetooth, rather than Ikonen’s wireless LAN. See Prelim. Resp. 47–52. But, as we view the Petition to clearly set forth a reasonable rationale to combine Gu’s UPnP with Ikonen’s wireless LAN, and to provide evidence in support, Patent Owner’s arguments do not identify any shortcomings that undermine Petitioner’s showing at this stage. We do note that the Petition often refers to both of Ikonen’s teachings of Bluetooth and wireless LAN when discussing Ikonen individually. But, the Petition only refers to Ikonen’s teachings of wireless LAN when discussing the combination with Gu.” slip op. at 14
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“the ’101 provisional for each claim element of claims 7, 8, 10, and 11 of the ’066 patent. Prelim. Resp. 39–40. In response to Petitioner’s arguments about the prior art status of Yamaguchi (Reply 1–5), Patent Owner offers the testimony of Todor Cooklev, Ph.D. (Ex. 2029) in support. Sur-reply 1–4. Patent Owner also relies on the testimony of Petitioner’s declarant Samrat Bhattacharjee, Ph.D. (Ex. 1002). Sur-reply 2. Based on the current record, and for the reasons discussed below, we agree with Patent Owner that claims 7, 8, 10, and 11 of the ’066 patent are supported by the ’101 provisional and therefore, Yamaguchi is not prior art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for patent owner
“In essence, Petitioner has offered two positions as to the meaning of “wireless output device” in claim 7; one outlined in the Petition, supported by Petitioner’s declarant, Patent Owner, and Patent Owner’s declarant, and a second position outlined in the Reply that contradicts the Petition and is not supported by either of the declarants.10 It is on the basis of this new claim construction that Petitioner argues that the ’101 provisional does not provide support for this aspect of claim 7. As we reject Petitioner’s new claim construction as unsupported by the evidence, at this stage of the proceeding, it is unnecessary to review Petitioner’s argument that the wireless output device of claim 7 is unsupported by the ’101 provisional based on this claim construction.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,740,066 - Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Nov 10, 2020 · PGR2019-00003 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving in place its determination that claims 1–14 are unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“public accessibility, . . . . which involves examining the evidence for proof that each non-patent reference 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.’” Req. Reh’g 3 (quoting Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 773 (Fed. Cir. 2018)). We do not agree. On the contrary, we addressed with particularity the substantial evidence tending to show that each of Petitioner’s References “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.” Dec. 12. Specifically, in our Decision, we properly credited indicia on the face of Petitioner’s References, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Using Varenna 2012 as an example, those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including the statement “Advance Access publication 30 November 2012,” and a conventional edition identifier from the journal Rheumatology. Dec. 15–16 (quoting Ex. 1005). In the same manner, the totality of evidence supports our finding that each of Petitioner’s References was publicly available prior to the critical date of the invention. Id. at 15– 18.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“public accessibility, . . . . which involves examining the evidence for proof that each non-patent reference 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.’” Req. Reh’g 3 (quoting Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 773 (Fed. Cir. 2018)). We do not agree. On the contrary, we addressed with particularity the substantial evidence tending to show that each of Petitioner’s References “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.” Dec. 12. Specifically, in our Decision, we properly credited indicia on the face of Petitioner’s References, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Using Varenna 2012 as an example, those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including the statement “Advance Access publication 30 November 2012,” and a conventional edition identifier from the journal Rheumatology. Dec. 15–16 (quoting Ex. 1005). In the same manner, the totality of evidence supports our finding that each of Petitioner’s References was publicly available prior to the critical date of the invention. Id. at 15– 18.” slip op. at 3
§ 102 anticipationPatents in suitUS 9,867,839 - Grünenthal GmbH v. Antecip Bioventures II LLCRehearing deniedPTAB · Nov 10, 2020 · PGR2018-00092 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving unpatentable claims 1-4, 9, 10, 12, 14, 16-18, 23-25, and 27-29 based on Varenna 2012 anticipation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must (1) “specifically identify all matters the party believes the Board misapprehended or overlooked” and (2) identify the place “where each matter was previously addressed.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“acknowledged Acceleration Bay and addressed with particularity the evidence of record tending to show that each of Petitioner’s References “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.” Dec. 15. Specifically, in our Decision, we credited indicia on the face of Verrena 2012, such as printed dates and citation information, which are “part of the totality of the evidence” bearing on the issue of public accessibility. Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 17–18 (PTAB Dec. 20, 2019) (precedential). Those indicia included details of the copyright notice, indicating publication of Varenna 2012 “by Oxford University Press on behalf of the British Society for Rheumatology” in “2012;” and also additional legends, including “the statement ‘Advance Access publication 30 November 2012,’” and a conventional edition identifier from the journal Rheumatology. Dec. 17 (quoting Ex. 1005). Patent Owner advanced no” slip op. at 4
- Strike new argumentNew argument consideredDecided for petitioner
“We are not persuaded by Patent Owner’s contentions and note that we addressed these same arguments in our Order denying Patent Owner’s motion to strike. Paper 24; see also Paper 13, 1 (Patent Owner contending that “Exhibit 1044 and related argument are new evidence and argument regarding the alleged accessibility of Varenna 2012 (Ex. 1005) that Petitioner could have submitted with the Petition, but chose not to.”). Rather than pointing out any matters that the panel misapprehended or overlooked, Patent Owner expresses disagreement with that decision, and attempts to offer additional reasoning and argument not advanced during trial. Req. Reh’g, 12–15. That effort is ineffective to establish reversible error. Furthermore, in our Final Written Decision, we noted that Even if we set aside Dr. Robinson’s Declaration, . . . we are persuaded that the indicia of publication on the face of Varenna 2012 are sufficient to establish that Varenna 2012 was “sufficiently accessible to the public interested in the art” and “disseminated or otherwise made available” to the interested public before the critical date, and consequently, a printed publication. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016). Dec. 19 n.4. For that reason also, Patent Owner shows no reversible error in our Final Written Decision holding that Dr. Robinson’s testimony bolsters” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
§ 102 anticipationPatents in suitUS 9,820,999 - 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
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.