- Foundation Medicine, Inc. v. Guardant Health, Inc.Rehearing deniedPTAB · Dec 20, 2019 · IPR2019-00637 · APJ Tina E Hulse · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show it had adequately supported the claimed ligation efficiency or a specific motivation to modify Schmitt.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000).” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached
“ligation efficiency. Indeed, we expressly acknowledged it. See Dec. 14 (noting Petitioner’s argument that “tagging ‘at least 20% of the cfDNA molecules’ would have been obvious because ligation efficiency ‘could be improved using a variety of techniques’”). After reviewing Petitioner’s evidence and argument, however, we were not persuaded that it was sufficient. Id. Even if the relevance of ligation efficiency was well known to a person of ordinary skill in the art for the reasons stated by Petitioner, the Petition still fails to provide a specific motivation to modify Schmitt. As explained in the Decision, “even if techniques were known that could have improved ligation efficiency, Petitioner has not shown sufficiently why a person of ordinary skill in the art would have modified Schmitt to tag ‘at least 20%’ of the DNA molecules.” Dec. 15; see also 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.”). That is, Petitioner’s motivation is “generic and bears no relation to any specific combination of prior art elements.” (Fed. Cir. 2012). As the Federal Circuit has explained, “knowledge of a problem and motivation to solve it are entirely different from motivation to combine particular references to reach the particular claimed method.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008). It is not until its Rehearing Request that Petitioner specifically ties its ligation efficiency argument to Schmitt. Reh’g Req. 11. Specifically, Petitioner asserts that “[b]ecause it would have been desirable to improve the sequencing library’s diversity or representation of the genome, a [person of ordinary skill in the art] trying to detect genetic aberrations with the DCS method of Schmitt would have been motivated to modify the method of Schmitt to optimize sample preparation, e.g., improve ligation efficiency, based on the techniques known in the art.” Id. As evidenced by the lack of citation, Petitioner did not make this argument in its Petition. We, therefore, do not consider it on rehearing, as a request for rehearing is not an opportunity to present new arguments or evidence that could have been presented in the petition.” slip op. at 5
§ 103 obviousnessPatents in suitUS 9,902,992 - Foundation Medicine, Inc. v. Guardant Health, Inc.Rehearing deniedPTAB · Dec 20, 2019 · IPR2019-00636 · APJ Tina E Hulse · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show that Schmitt and the asserted obviousness rationale taught or motivated the claimed ligation efficiency.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000).” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“ligation efficiency. Indeed, we expressly acknowledged it. See Dec. 14 (noting Petitioner’s argument that “tagging ‘at least 20% of the cfDNA molecules’ would have been obvious because ligation efficiency ‘could be improved using a variety of techniques’”). After reviewing Petitioner’s evidence and argument, however, we were not persuaded that it was sufficient. Id. Even if the relevance of ligation efficiency was well known to a person of ordinary skill in the art for the reasons stated by Petitioner, the Petition still fails to provide a specific motivation to modify Schmitt. As explained in the Decision, “even if techniques were known that could have improved ligation efficiency, Petitioner has not shown sufficiently why a person of ordinary skill in the art would have modified Schmitt to tag ‘at least 20%’ of the DNA molecules.” Dec. 15; see also 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.”). That is, Petitioner’s motivation is “generic and bears no relation to any specific combination of prior art elements.” (Fed. Cir. 2012). As the Federal Circuit has explained, “knowledge of a problem and motivation to solve it are entirely different from motivation to combine particular references to reach the particular claimed method.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008). It is not until its Rehearing Request that Petitioner specifically ties its ligation efficiency argument to Schmitt. Reh’g Req. 11. Specifically, Petitioner asserts that “[b]ecause it would have been desirable to improve the sequencing library’s diversity or representation of the genome, a [person of ordinary skill in the art] trying to detect genetic aberrations with the DCS method of Schmitt would have been motivated to modify the method of Schmitt to optimize sample preparation, e.g., improve ligation efficiency, based on the techniques known in the art.” Id. As evidenced by the lack of citation, Petitioner did not make this argument in its Petition. We, therefore, do not consider it on rehearing, as a request for rehearing is not an opportunity to present new arguments or evidence that could have been presented in the petition.” slip op. at 5
- Strike new argumentNew argument disregardedDecided for patent owner
“It is not until its Rehearing Request that Petitioner specifically ties its ligation efficiency argument to Schmitt. Reh’g Req. 11. Specifically, Petitioner asserts that “[b]ecause it would have been desirable to improve the sequencing library’s diversity or representation of the genome, a [person of ordinary skill in the art] trying to detect genetic aberrations with the DCS method of Schmitt would have been motivated to modify the method of Schmitt to optimize sample preparation, e.g., improve ligation efficiency, based on the techniques known in the art.” Id. As evidenced by the lack of citation, Petitioner did not make this argument in its Petition. We, therefore, do not consider it on rehearing, as a request for rehearing is not an opportunity to present new arguments or evidence that could have been presented in the petition.” slip op. at 6
§ 103 obviousnessPatents in suitUS 9,902,992 - Neptune Generics, LLC v. Aventis Pharma S.A.Rehearing deniedPTAB · Oct 15, 2019 · IPR2019-00136 · APJ Timothy G Majors · IPR · Rehearing
The Board denied Neptune’s rehearing request and left in place its discretionary denial of institution for claims 1 and 2 under § 325(d).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if there was an erroneous interpretation of law, a factual finding not supported by substantial evidence, or an unreasonable judgment in weighing relevant factors. 37 C.F.R. § 42.71(c); Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); The Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). Moreover, the rehearing request “must specifically identify all matters the [requesting] party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“example, that the C-7 and C-10 positions on taxanes were available and/or attractive sites for substitution. Dec. 31–32. Petitioner does not demonstrate persuasively why comparing, for purposes of a § 325(d) analysis, one reliedon reference that discloses potential sites for molecular substitutions to a collection of background references that provide substantially the same teaching is “error” on the record here.5 The POSA’s understanding is informed by all the relevant background knowledge and art, not a figure culled from one reference purporting to summarize otherwise known substitution sites. Dec. 11. Moreover, in reaching our conclusion, we did not overlook or misunderstand Commerçon’s Figure 2 or its other teachings. Quite the opposite, the Decision provides a detailed discussion on Commerçon, and Commerçon’s Figure 2 is itself reproduced in the Decision. Id. at 10–12. As noted in the Decision, Commerçon relates primarily to synthesis of docetaxel and docetaxel side-chain analogs. Id. Indeed, insofar as Commerçon actually describes changes that should be made or investigated, Commerçon’s focus is at the C-3' side-chain position—not individual, much less simultaneous changes to C-7 and C-10 of paclitaxel. In other words, the” slip op. at 10
Discretionary denialPatents in suitUS 5,847,170 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Saint Regis Mohawk Tribe And Allergan, Inc.All claims unpatentablePTAB · Sep 27, 2019 · IPR2016-01129 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–20 are unpatentable based on collateral estoppel from the final judgment that materially similar claims were obvious.
RulingsFinal written decision- BurdenFwd all claims unpatentableUnpatentable
“and 37 C.F.R. § 42.73. Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., and Akorn Inc. (collectively, “Petitioner”) bears the burden of proving unpatentability of the challenged claims, and that burden of persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). For the reasons that follow, we determine that Petitioner has shown, by a preponderance of the evidence, that claims 1–20 of U.S. Patent No. 8,642,556 B2 (Ex. 1001, “the ’556 patent”) are unpatentable.” slip op. at 2
- ExcludeMotion to exclude, grantedOther
“Owner opposed (Paper 51) and Petitioner submitted a reply in support of its motion (Paper 58). Petitioner moves to exclude a) Ex. 2008; b) portions of the Declarations of Dr. Sheppard (Ex. 2024) and Dr. Loftsson (Ex. 2025); c) Exhibit 2038, d) portions of Exhibit 2028; and e) Exhibit 2077–2079. Paper 50, 1. Because we do not rely on any of the exhibits or portions of exhibits sought to be excluded by Petitioner to reach the final decision, we dismiss Petitioner’s motion to exclude as moot.” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“claimed composition and methods in view of Patent Owner’s assertion that the Restasis formulation covered by the claims exhibited unexpected results compared to the prior art, which is the same argument Patent Owner has asserted in this case. Compare Ex. 1167, 34–108, with PO Resp. 21–35. Accordingly, we find that the district court in the prior case, Allergan v. Teva, considered the identical issue before us in this case, i.e., the obviousness of the subject matter in light of Ding ’979, Sall, and Acheampong as well as Patent Owner’s arguments of unexpected results.” slip op. at 19
Patent outcomesUS 8,642,556 unpatentable§ 103 obviousnessPatents in suitUS 8,642,556 - Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Saint Regis Mohawk Tribe And Allergan, Inc.All claims unpatentablePTAB · Sep 27, 2019 · IPR2016-01130 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–24 are unpatentable as obvious under collateral estoppel because materially similar claims were finally adjudged obvious after full litigation.
RulingsFinal written decision- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“(1) a prior action presents [the] identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party.8” slip op. at 13
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“matter claimed by the Representative Claims in view of Ding ’979,11 Sall, and Acheampong, which are the same references asserted in this case. Ex. 1164, 34–108. The district court also considered the obviousness of the claimed composition and methods in view of Patent Owner’s assertion that the Restasis formulation covered by the claims exhibited unexpected results compared to the prior art, which is the same argument Patent Owner has asserted in this case. Compare Ex. 1167, 34–108, with PO Resp. 21–35. Accordingly, we find that the district court in the prior case, Allergan v. Teva, considered the identical issue before us in this case, i.e., the obviousness of the subject matter in light of Ding ’979, Sall, and Acheampong as well as Patent Owner’s arguments of unexpected results.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“c) Exhibit 2038; d) portions of Exhibit 2028; and e) Exhibit 2077–2079. Paper 50, 1. Because we do not rely on any of the exhibits or portions of exhibits sought to be excluded by Petitioner to reach the final decision, we dismiss Petitioner’s motion to exclude as moot.” slip op. at 27
Patent outcomesUS 8,633,162 unpatentable§ 103 obviousnessPatents in suitUS 8,633,162 - Merck Sharp & Dohme Corp. / Merck Sharp & Dohme B.V. et al. v. Microspherix LLCSome claims unpatentablePTAB · Jul 8, 2019 · IPR2018-00393 · APJ James A Worth · IPR · Final written decision
Claims 1–5, 7, 8, and 10–19 are unpatentable as obvious; claims 6 and 9 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed
“B. Motivation to Combine De Nijs and Schopflin The parties dispute whether a person of ordinary skill in the art would” slip op. at 21
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“that Merck failed to add a radiopaque marker to its Implanon device and that the lack of a negative impact on release rates shows unexpected success. PO Resp. 64; see also id. at 54 (“There is no dispute De Nijs does not discuss using a marker, and that Implanon did not use a marker.”). Petitioner states that the Implanon device is the commercial embodiment of Example 5 of De Nijs. Reply 5 (citing Ex. 2002, 3:15–16; Ex. 1067, 297:7–9). Example 5 of De Nijs has no polysiloxane jacket and no sealing of implant ends. Accordingly, this argument would be more relevant to claims 6 and 9 discussed below, which recite open ends or pores. Our analysis of claim 1 focuses on the broader scope of claim 1, which includes both sealed and 14 Patent Owner cited this case in its response. See PO Resp. 32. Accordingly, we do not find Petitioner’s reliance on this case at oral argument to be waived. 15 The Court in Intelligent Bio-Systems emphasized that there is a distinction between reasonable expectation of success and reason to pursue the references’ teachings. Id. at 1366–1368. According to Intelligent Bio- Systems, reasonable expectation of success only looks to “likelihood of success in combining references to meet the limitations of the claimed invention” and that, for example, appropriate cleavage conditions would have been irrelevant to the inquiry where such conditions are not required by the claim at issue. Id. at 1367. Inquiry into motivation to combine, however, considers whether a person having skill in the art would have believed that there was a reason for reaching the claimed invention in the first place. Id. at 1368; see also KSR Int’l Co., 550 U.S. at 418 (“it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does”).” slip op. at 27
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for petitioner
“the examiner during the prosecution of the Veenstra patent. We note, however, that the claims in the prosecution of the unrelated Veenstra patent only reached allowance after incorporation of language that captured Veenstra’s unexpected results for localization of the barium sulfate as set out the specification. In other words, Merck’s other positions during the prosecution of the Veenstra patent were not successful. Because, Merck did not succeed “in persuading a court13 to accept that party’s earlier position” we do not find that estoppel applies to Petitioner in this proceeding. New Hampshire, 532 U.S. at 750–51. Accordingly, we do not agree with Patent Owner’s position that Petitioner is estopped from arguing that the addition of a marker disclosed in Schopflin to De Nijs’s implant is obvious.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“First, Petitioner asserts certain exhibits and testimony should be excluded as irrelevant because they have not been discussed in any substantive paper. Paper 36, 2–4. But, as Patent Owner notes, Dr. Kiser cited the objected-to exhibits in his declarations to show his understanding of the state of the art. Paper 38, 3. Moreover, we agree with Patent Owner that the uncited portions of Dr. Kiser’s declarations include paragraphs of technical and legal background that provide context for his opinions. Id. at 5–6. We agree with Patent Owner that Dr. Kiser’s understanding of the state of the art and the exhibits supporting that understanding are relevant to the understanding of persons of ordinary skill in the art. Id. at 3–5. Accordingly, we deny Petitioner’s motion to exclude such testimony and exhibits.” slip op. at 70
Patent outcomesUS 9,636,402 mixed§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,636,402 - Trans Ova Genetics, LC v. Xy, LLCNo claims unpatentablePTAB · Jun 26, 2019 · IPR2018-00250 · APJ David Cotta · IPR · Final written decision
Claims 1–16 were not proven unpatentable because Petitioner failed to establish that Lu, relied on in every asserted obviousness ground, was prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artNot shown unpatentable
“Inc. v. Apotex Inc., 754 F.3d 952, 968 (Fed. Cir. 2014); In re Katz, 687 F.2d 450, 454 (Fed. Cir. 1982). “The question of whether a reference is a work of others for the purposes of § 102(a) is, like that of inventorship, a question of law based on underlying facts.” Allergan, 754 F.3d at 969 (citing Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)). In determining whether a reference is the work of the named inventor(s), the inquiry focuses on whether the relevant content of the reference – which includes “the design, trial, and analysis of results” – was solely the work of the inventor(s). See Allergan, 754 F.3d at 969; Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity.”).” slip op. at 14
- Expert testimonyPatent owner expert creditedOther
“9 We acknowledge that Mr. Miles, as a former board member of XY, as well as XY’s long-time patent counsel and the filer of the ’769 priority provisional applications, may have some interest in the outcome of this IPR and that Mr. Miles is being compensated by XY for time spent relating to his testimony. Ex. 2003 ¶¶ 4–7; Ex. 1033, 21:7–14, 158:8–22. However, we note that Mr. Miles’ testimony was under oath and subject to cross-examination. We find Mr. Miles’ testimony to be credible as to the facts for which it is cited herein.” slip op. at 10
- ExcludeMotion to exclude, deniedMixed
“Exclude. Paragraph 12 of the Miles Declaration reads as follows: “Also[,] in the late 1990s, XY had a collaborative research agreement with a bull stud called Cogent in the United Kingdom.” Ex. 2003 ¶ 12.11 This statement is not itself hearsay because it was asserted by Mr. Miles while testifying in this proceeding, i.e., “at the current trial.” See Fed. R. Evid. 801(c). Petitioner contends that paragraph 12 is inadmissible because it is based, at least in part, on statements contained in Exhibits 2001 and 2002. We are not persuaded by this argument because paragraph 12 does not rely on Exhibits 2001 and 2002. See Ex. 2003 ¶ 12; Ex. 1033, 59:22–62:18 (Mr. Miles’ testimony on basis and meaning of paragraph 12 of his declaration). Petitioner also argues that paragraph 12 should be excluded as improper opinion testimony because it is based on Exhibits 2001 and 2002, to which, according to Petitioner, Mr. Miles is not competent to testify. Mot. 13–14. We are not persuaded by Petitioner’s argument because, as discussed, paragraph 12 does not rely on Exhibits 2001 and 2002.” slip op. at 22
Patent outcomesUS 8,652,769 not shown unpatentable§ 102 anticipationPatents in suitUS 8,652,769
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.