- Illumina, Inc. v. Natera, Inc.No claims unpatentablePTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable
“In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48
- ExcludeMotion to exclude, deniedDenied
“As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54
- Strike new argumentNew argument disregardedDecided for patent owner
“success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30
Patent outcomesUS 8,682,592 not shown unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,682,592 - 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 LLCRehearing grantedPTAB · Nov 10, 2020 · PGR2018-00092 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted the petitioner’s rehearing request, vacated the final written decision, and will issue a revised decision after overlooking Varenna 2012 in Grounds 5–7.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“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
NonePatents in suitUS 9,820,999 - Unified Patents, Inc v. Mv3 Partners LLCRehearing deniedPTAB · Oct 2, 2020 · IPR2019-00474 · APJ Jean R Homere · IPR · Rehearing
Rehearing denied; the Board maintained that claims 1–6, 8, 10–21, 23–38, 40, 42–53, and 55–61 were not shown unpatentable because Wang did not teach the separate determining limitation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. With this in mind, we address the arguments presented by Petitioner.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“of the “determining” limitation, not a construction of the language in that limitation. As noted in the Decision, the claim language plainly requires that the STB separately determine whether the user is permitted to provide to the external display device a specific media content received at the mobile device. Id. at 16–17. This is consistent with Petitioner’s view expressed at the hearing. See Tr. 20:6–16 (Petitioner acknowledging that the claim recites the “authenticating” step and “a separate determining step” where “the determining step happens after the authenticating step” (emphasis added)). Although Petitioner disputes that the Specification adequately supports the “determining” limitation, it is not an issue necessitating review by our mere recitation of the claim language. Further, we are not at liberty to ignore the “determining” limitation, despite its alleged lack of written description, in assessing it during a prior art challenge. As set forth in the Decision, we fully addressed the language of the claims as challenged in the Petition. We are not persuaded that in doing so we misapprehended or overlooked any argument raised by Petitioner. In particular, we noted that Petitioner provided sufficient evidence to show that Wang teaches integrating the authentication feature into the STB to authenticate mobile users to access content. Final Dec. 16–17. However, we found such teaching to fall short of satisfying the separate and distinct “determining” limitation, as required by the claim. Id. at 18. As explained in the Decision, Petitioner and its expert addressed the “authenticating” and “determining” limitations together, even though they are separate limitations of the claim. Id. (citing Pet. 39–41; Ex. 1003 ¶ 73). We were unpersuaded by Petitioner’s theory that the “determining” limitation “automatically” occurs by virtue of the authenticating step. Id. Furthermore, we noted the evidence of record was insufficient to show by a preponderance of the evidence that the proposed modification of Wang would have taught or suggested “any additional determination beyond authenticating the user.” Id. at 19.” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,863,223 - Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · Sep 25, 2020 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Rehearing
Granted EIS GMBH’s rehearing request and instituted IPR of claims 1–3, 5, 7, 8, 11, 14, 15, 17–21, and 23–26 on all asserted grounds.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“We conclude from a review of Fang and Taylor that they are not substantially the same art nor is Petitioner making substantially the same argument as was presented the Office during prosecution of the ’061 Patent based on Fang. We find that the way in which Fang and Taylor work appear to be materially different. Fang appears to apply only suction to the skin whereas Taylor, with the sealingly connected suction cup, appears to apply a cyclical vacuum that Dr. Prisco testifies meets the claim limitations requiring generation of a pattern of negative and positive pressures, modulated with respect to a reference pressure. Ex. 1002 ¶¶ 62–64, 75. Thus Taylor appears to teach the claim element Patent Owner argued during prosecution was missing from Fang. Also, in applying factors (b) and (d) of Becton, Dickinson, because of such differences noted above, we find that Taylor is not cumulative of Fang, which was considered and applied by the Office during prosecution of the ’061 Patent. 4. Conclusion Thus, we find that Taylor and Fang are not substantially the same art, nor were substantially the same arguments based on these references presented in the Petition and during prosecution of the ’061 Patent, respectively. As discussed above, because Petitioner primarily relies on Taylor in all four grounds for teaching the modulation of positive and negative pressures with respect to a reference pressure as required by all of the challenged claims, we also find that, overall, the same or substantially the same art was not previously presented to the Office nor were the same or substantially the same arguments previously presented to the Office. Therefore, we do not need to reach the application of the remaining Becton, Dickenson factors relating to whether the Petitioner has demonstrated a material error by the Office. Thus, we decline to exercise our discretion under § 325(d) to deny institution of an inter partes review here.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We find that Dr. Prisco’s testimony is a reasonable interpretation of how Taylor works if the bellows are bidirectional, and the bellows are expanded and contracted when the suction cup is sealingly engaged. Figure 3 of Taylor shown above appears to support Dr. Prisco’s testimony that the bellows may be expanded or contracted from the initial position shown in Figure 3 and does not appear to show any valve or second opening in the bellows to provide unidirectional flow as Dr. Jensen, Patent Owner’s declarant, asserts. Also, as Petitioner asserts, Taylor indicates that a squeeze ball may be substituted for the bellows expressly indicating a device with a bidirectional flow. Although Patent Owner raises valid arguments concerning a common definition of bellows indicating unidirectional flow and provides testimony from Dr. Jensen reasonably supporting such a position, these dueling positions create a genuine issue of material fact that we weigh in favor of Petitioner on institution. See 37 C.F.R. 42.108(c).” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,849,061 - 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 - PTAB · Jun 30, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood that claims 21–28 and 31 were obvious over Voyksner, Watson, and Rainbow.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The party challenging a decision in a request for rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. Upon a request for rehearing, the decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). III. ANALYSIS” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“precursor of 25-hydroxvitamin D2 having a molecule weight of 412.7 g/mol.” Id. (citing Pet. 27; Ex. 1002 ¶ 57). Petitioner’s arguments explain what a skilled artisan could have done, i.e., select an appropriate precursor ion. However, as discussed in the Decision, the Petition, even when considered along with Dr. Fitzgerald’s testimony, “does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion” (Dec. 19), when as discussed above, multiple precursors are possible.5 See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“prior art teaches determining the presence or amount of 25-hydroxyvitamin D2 in a sample. However, as discussed in the Decision, claim 21 “requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample.” Id. at 18. Petitioner does not argue that our interpretation of the plain meaning of claim 21 is incorrect or that we should disregard the step of generating “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” See id. Accordingly, we are not persuaded that we overlooked Petitioner’s arguments. Further, we agree with Patent Owner that the Petition lacks sufficient explanation of why a person of ordinary skill in the art “would have chosen to [specifically] investigate 25-hydroxyvitamin D2 using Voyksner’s methods in the first place, particularly since Voyksner only discusses ‘dihydroxyvitamin D3’ for the purposes of evaluating the orientation of certain mass spectrometry equipment.” Opp. 5 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362–63 (Fed. Cir. 2016) (noting that it is error to accept general knowledge in the art without evidence on the record for limitations that are “not evidently and indisputably within the common knowledge of those skilled in the art”) (emphasis in original)).” slip op. at 9
§ 103 obviousnessPatents in suitUS 7,972,867 - PTAB · Jun 19, 2020 · IPR2019-00834 · APJ Christopher M Kaiser · IPR · Rehearing
The Board denied Intel’s rehearing request and left in place its denial of institution for claims 1–3, 6, and 7 under §§ 325(d) and 314(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d) (2018). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“§ 325(d). Inst. Dec. 7–16. We evaluated each of the factors presented in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“the Becton, Dickinson factors”). Id. We concluded that, “[o]f the six Becton, Dickinson factors, the first factor weighs strongly in favor of denying institution, the third and fifth factors weigh somewhat in favor of denying institution, the second and fourth factors are neutral, and the sixth factor weighs somewhat against denying institution.” Id. at 15–16. Petitioner now argues that this analysis was flawed, with the fourth, fifth, and sixth Becton, Dickinson factors all “strongly favor[ing] reaching the merits and instituting” inter partes review. Req. Reh’g 5–11.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticInstitution denied
“decision denying institution in the earlier proceeding. But the third General Plastic factor does not require access to the earlier institution decision; it requires only access to either that decision or the corresponding preliminary response. Here, at the time Petitioner filed this Petition, it already had received Patent Owner’s preliminary response in IPR2018-01574. This is sufficient to satisfy the third factor.” slip op. at 8
- Other 314aInstitution denied discretionary otherInstitution denied
“we interpret the Request for Rehearing as arguing that discretionary denial of a second petition is always improper whenever a first petition remains pending.7 Petitioner does not explain the authority for that legal position, and we can find none in either § 314(a) or § 325(d). Institution of inter partes review is never compulsory under § 314(a). Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367–68 (Fed. Cir. 2016) (“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). As for § 325(d), the statutory language appears to refute Petitioner’s position directly. As long as “the same or substantially the same prior art or arguments previously were presented to the Office,” discretion exists to “reject the petition.” 35 U.S.C. § 325(d). There is no mention in the statute 7 Alternatively, the Request for Rehearing could be interpreted as arguing that we should have withheld any decision on the second petition until the rehearing request on the first petition was decided. If we were to interpret the argument this way, we would find it unpersuasive because it would have required us to violate 35 U.S.C. § 314(b)(1), which requires us to issue a decision on institution no later than three months after the filing of the preliminary response. of a limitation on that discretion that requires us to avoid “reject[ing] the petition” whenever the earlier proceeding in which “the same or substantially the same prior art or arguments previously were presented” remains pending. Id. Thus, we are not persuaded that any of the special circumstances that Petitioner describes warrants a conclusion that we abused our discretion in denying institution.” slip op. at 14
Discretionary denialPatents in suitUS 9,070,719
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.