- PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Phillips 66 v. Magēmā Technology, LLCInstitution deniedPTAB · Jan 21, 2022 · IPR2021-01173 · APJ Patrick R Scanlon · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that Weiss-based grounds teach or suggest the claimed residual marine fuel oil.
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) (2020). 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.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“D. Discretionary Denial Patent Owner argues that we should exercise our discretion under 35 U.S.C. § 314(a) to deny institution under Apple Inc. v. Fintiv, Inc., IPR2020- 00019, Paper 15 (PTAB May 13, 2020) (precedential). Prelim. Resp. 12–31. Petitioner disagrees. Pet. 6–12. Because we deny institution based on the merits of Petitioner’s unpatentability arguments, we need not decide whether to exercise discretion to deny institution.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine we need not expressly construe any terms of the challenged claims at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“feedstock HMFO and the product HMFO of the challenged claims, as Petitioner argues it does, Petitioner must show that Weiss ’974 teaches or suggests four facts: (1) the pre-hydrotreatment HSFO is a residual petroleum 10 Petitioner defines “HSFO” as being a “high-sulfur HMFO” and “LSFO” as being a “low-sulfur HMFO.” Pet. 1. product, (2) the pre-hydrotreatment HSFO is ISO-8217-compliant, (3) the post-hydrotreatment LSFO is a residual petroleum product, and (4) the posthydrotreatment LSFO is ISO-8217-compliant. Petitioner does not show all four of these facts sufficiently to demonstrate a reasonable likelihood of prevailing in showing that the challenged claims are anticipated by Weiss ’974 or obvious over the combination of Weiss ’974 and Weiss ’515.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 10,584,287 - PTAB · Jan 21, 2022 · IPR2021-01249 · APJ Christopher L Ogden · IPR · Institution
Instituted review of claims 1, 6, 11, 16, 19, 24, 26, 27, and 30 on all petitioned grounds; the Board found a reasonable likelihood of success on the Dimov–Kovac and Park–Kovac obviousness grounds.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Under the circumstances, we disagree with Patent Owner that the Petition is deficient under § 42.104(b)(3) because of how Petitioner addresses claim construction. Petitioner’s main argument is that we do not even need to construe “chamber” or “retaining position” explicitly in this proceeding. See Pet. 9, 12. We agree that neither term needs an explicit construction, at least for our decision to institute trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). That Petitioner alternatively offers two explicit constructions with which it does not agree—and which are, effectively, irrelevant at this stage because we do not need to construe these terms—does not render the Petition insufficient. We do not discern any substantial ambiguity or lack of clarity in how Petitioner applies the terms “chamber” and “retaining position” to the asserted prior art. To the extent that it may become necessary to construe any terms explicitly at trial, we will consider evidence on both sides, and as usual, Petitioner will have the burden of persuasion. 35 U.S.C. § 316(e).” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on Dr. Meinhart’s testimony, Petitioner argues that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, molecular biology, (bio)chemistry, or an equivalent degree relevant to microfluidic biological cell analysis, and three to five years of experience with the construction of and application of microfluidic devices to cell culture and analysis.” Pet. 8–9 (citing Ex. 1002 ¶ 40). Patent Owner does not dispute this proposed level of ordinary skill in its Preliminary Response. See Prelim. Resp. 7. Because it is supported by testimonial evidence and appears reasonable at this stage in light of the subject matter of the ’408 patent, we adopt Petitioner’s proposed level of ordinary skill in the art for this decision. If Patent Owner proposes a different articulation at trial, we will consider any evidence that Patent Owner submits, in light of the full trial record.” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“To establish anticipation, a petitioner must find each and every element in a claim, arranged as recited in the claim, in a single prior art reference. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The limitations may be present in the reference “either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Further, an anticipating prior art reference must be enabling and must describe the “claimed invention sufficiently to have placed it in possession of a person of ordinary skill in the field of the invention.” See Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000). We do, however, consider the reference “together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)). Based on these principles, we agree with Patent Owner that Petitioner has not identified within the four corners of Dimov a sufficient disclosure of selectively recovering a cell based on the response in the monitoring step. Although Dimov discloses non-selective recovery, and although Petitioner has identified techniques that might theoretically be used for selective recovery, Dimov itself does not appear, based on the preliminary record, to disclose selective recovery based on a prior monitoring step. We also agree with Patent Owner that Petitioner’s reliance on Kennametal is misplaced. “Kennametal does not permit the Board to fill in missing limitations simply because a skilled artisan would immediately envision them.” Nidec II, 851 F.3d at 1274–75. Thus, on the present record, Petitioner has not shown sufficiently that Dimov anticipates claim 1.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). For a combination of known elements that are not explicitly found together in the prior art, we consider “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). A successful petition must “articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (citing KSR, 550 U.S. at 418); see also 35 U.S.C. § 322(a)(3); 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(4) (2020). We base our obviousness inquiry on factual considerations 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 skill in the art, and (4) any objective indicia of obviousness or non-obviousness that may be in evidence.9 See Graham, 383 U.S. at 17–18. Based on these factors, we conclude that Petitioner has not made a sufficient showing that claim 1 would have been obvious over Dimov. Petitioner’s proposed modification of Dimov, though remarkably similar to the process of aspirating cells disclosed in the ’408 patent, does not seem to appear expressly in Dimov (see supra part II.B), nor has Petitioner demonstrated persuasively that one of ordinary skill in the art would have been motivated to make the proposed modification with a reasonable 9 At this stage, the parties do not identify any objective indicia of obviousness or non-obviousness, so this does not factor into our decision to institute an inter partes review. expectation of success based on Dimov alone. Thus, on the present record, Petitioner has not shown sufficiently that claim 1 would have been obvious over Dimov without combination with another prior art reference.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,087,408 - Berkeley Lights, Inc. v. The University Of British ColumbiaInstitution deniedPTAB · Jan 21, 2022 · IPR2021-01250 · APJ Christopher L Ogden · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“§ 42.4(a), we may only institute an inter partes review when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.108(c) (2020). Applying that standard, we do not institute an inter partes review, for the reasons explained below.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on Dr. Meinhart’s testimony, Petitioner argues that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, chemical engineering, biomedical engineering, molecular biology, (bio)chemistry, or an equivalent degree relevant to microfluidic biological cell analysis, and three to five years of experience with the construction of and application of microfluidic devices to cell culture and analysis.” Pet. 9 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute this proposed level of ordinary skill in its Preliminary Response. See Prelim. Resp. 5–6. Because it is supported by testimonial evidence and appears reasonable at this stage in light of the subject matter of the ’936 patent, we adopt Petitioner’s proposed level of ordinary skill in the art for this decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Regardless of whether Patent Owner is correct that the Petition is deficient under § 42.104(b)(3), our decision not to institute does not depend on the construction of “chamber” or whether claim 6 invokes § 112 para. 6. Thus, we do not need to construe either term explicitly for our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“Petitioner has the ultimate burden of persuasion on the question of whether a claim is entitled to the priority date of an earlier application. See Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015). “[A] patent application is entitled to the benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). In particular, “[t]o be entitled to a parent’s effective filing date, a continuation must comply with the written description requirement of 35 U.S.C. § 112, ¶ 1.” In re Owens, 710 F.3d 1362, 1366 (Fed. Cir. 2013) (citations omitted). The test for the written description requirement “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A prior application need not contain precisely the same words as are found in the asserted claims. See Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995); Purdue Pharma LP v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”). On the other hand, “[e]ntitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571–72 (Fed. Cir. 1997). A key factor in this written description analysis, which Petitioner did not clearly address in its Petition, is the meaning of “measuring a cell product” in limitation 1D. The ’936 patent discloses that “[t]he measuring the cell product [step] may be selected from one or more of: lineage staining; cell-surface protein staining; antibody staining; enzymatic assay; RT-PCR analysis; PCR analysis; sequencing; functional assay; and bead capture assay to characterize the cells.” Ex. 1001, 6:47–51. This appears to be definitional, such that the meaning of “measuring a cell product secreted by the individual clonal cell populations, or subset thereof,” as in limitation 1D, would include using any one of these listed techniques to analyze cell secretion products. This passage is also consistent with the other claims in the ’936 patent, such as claim 18, which depends from claim 1 and further states that the “measuring the cell product” step “comprises flowing a fluid comprising an immunostaining agent, an enzymatic reagent, a dye or a functionalized bead into the individual chambers.” Id. at 48:29–32; see also id. at 48:33–48 (similar limitations in claims 19–23). As Patent Owner persuasively shows on the present record, the ’213 application discloses many of these analytical techniques, including staining, functional assay, and bead capture. See Prelim. Resp. 15–17. We also find persuasive Dr. Pelanda’s testimony that a person of ordinary skill in the art would have understood that the references in the ’213 application to these analytical techniques relate to analysis of secreted cell products, and that a particular focus of the ’213 application was to use the microfluidic device for analyzing autocrine signaling, which involves detecting or analyzing cell secretions. See Ex. 2008 ¶¶ 22–32. For the above reasons, on the present record, Petitioner has not shown sufficiently that the ’213 application lacks disclosure such that Lecault is prior art to the challenged patent. Accordingly, we determine that Petitioner has not shown that there is a reasonable likelihood that it would prevail on its first and third grounds with respect to any of the challenged claims.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,421,936 - 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
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.