- Aquestive Therapeutics, Inc. v. Neurelis, Inc.Rehearing deniedPTAB · Sep 27, 2019 · IPR2019-00451 · APJ Jamie T Wisz · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review of claims 1–36 because Patent Owner did not show entitlement to the provisional priority date.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify 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 reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s 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).” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
“burden of going forward to show that there is invalidating prior art. Dynamic Drinkware, 800 F.3d at 1379. As discussed in our Decision, Petitioner satisfied its initial burden of production on the issue of whether Gwozdz is prior art by establishing that Gwozdz is entitled to the effective filing date of the Gwozdz provisional. Decision 7. Therefore, Gwozdz is prior art to the ’876 patent under 35 U.S.C. § 102(e)(1) unless Patent Owner can show that the ’876 patent is entitled to the effective filing date of its provisional application (“the ’558 provisional”). Id. Thus, the burden of production shifts to Patent Owner, who must show not only the existence of earlier applications, but also how the written description in the earlier applications supports the challenged claims. Dynamic Drinkware, 800 F.3d at 1379–80. “[T]o gain the benefit of the filing date of an earlier application 4 under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112.” Zenon Envtl., Inc. v. U.S. Filter Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007) (quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997)); see also In re Hogan, 559 F.2d 595, 609 (CCPA 1977) (“[T]here has to be a continuous chain of copending applications each of which satisfies the requirements of § 112 with respect to the subject matter presently claimed.” (alteration in original) (quoting In re Schneider, 481 F.2d 1350, 1356 (CCPA 1973))). Thus, as discussed in our Decision, Patent Owner must show that each application in the priority chain1 makes the requisite disclosure of subject matter; otherwise, the ’876 patent is not entitled to the benefit of the filing date of the ’558 provisional. Decision 7 n.6. On this record, Patent Owner fails to satisfy its burden of production to show entitlement to an earlier filing date. All of Patent Owner’s arguments are focused on the alleged deficiencies with Petitioner’s contentions regarding the disclosure of alkyl glycosides in the ’558 provisional. Prelim. Resp. 24–27. Patent Owner offers no analysis demonstrating that every patent application along the priority chain conveys with reasonable clarity to those skilled in the art that the inventors were in possession of each limitation of each of the challenged claims, as well as the 1 In this case, the priority chain for the ’876 patent includes a provisional application and a continuation-in-part application. Decision 6. 5 claimed invention as a whole. See Lockwood, 107 F.3d at 1572. Therefore, on this record, Patent Owner has not demonstrated that the claims of the ’876 patent are entitled to the priority date of the ’558 provisional.” slip op. at 4
§ 102 anticipationPatents in suitUS 9,763,876 - Eset, LLC / Eset Spol S.R.O. v. Finjan, Inc.Rehearing deniedPTAB · Aug 10, 2018 · IPR2017-01738 · APJ Patrick M Boucher · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving review instituted on all challenged claims and all grounds presented in the Petition.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Nevertheless, like Petitioner, the panel “is not aware of a single case where a partially-instituted IPR was de-instituted post-SAS, as requested by Patent Owner.” Opp. 5. The panel is sympathetic to the position in which institution of the Freund-based grounds places Patent Owner. If now faced with the Petition in the first instance, and understanding that we have only a “binary choice,” it may well be appropriate to deny the Petition in its entirety. But we have been instructed that the Office SAS Guidance is to be interpreted with the weight of Office policy as precluding termination of a partially instituted proceeding in response to SAS Institute. Given that constraint, we are not persuaded that we abused our discretion in our modification Order to include review of all challenged claims and all grounds presented in the Petition. See 37 C.F.R. § 42.71(c). Thus, notwithstanding the panel’s significant reservations, we continue to give effect to the Director’s policy guidance, and deny Patent Owner’s Rehearing Request.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“SAS procedure outlined herein and determines that the trial must be instituted on all grounds or none, Patent Owner requests that the proceedings be terminated pursuant to 35 U.S.C. § 325(d).” Req. Reh’g 10. In making this request, Patent Owner raises important issues regarding the interplay of SAS Institute and 35 U.S.C. § 325(d). The panel is sensitive to Patent Owner’s concern that Under the full-institution full-review paradigm laid out in the Board’s Modified Institution Order and envisioned by the Guidelines, Patent Owners will be forced to defend against the very types of harassing challenges that these sections of the America Invents Act [35 U.S.C. §§ 314(a) and 325(d)] were designed to prevent, namely to “prevent parties from mounting attacks on patents that raise issues that are substantially the same as issues that were already before the Office with respect to the patent.” Id. at 6 (quoting 157 Cong. Rec. S1360 at S1376 (Mar. 8, 2011) (remarks of Senator Kyl); citing H.R. Rep. No. 112-98, pt. 1, at 48 (2011) (warning the AIA’s procedures should not be used as tools for harassment)).5 Nevertheless, like Petitioner, the panel “is not aware of a single case where a partially-instituted IPR was de-instituted post-SAS, as requested by Patent Owner.” Opp. 5. The panel is sympathetic to the position in which institution of the Freund-based grounds places Patent Owner. If now faced with the Petition in the first instance, and understanding that we have only a “binary choice,” it may well be appropriate to deny the Petition in its entirety. But we have been instructed that the Office SAS Guidance is to be interpreted with the weight of Office policy as precluding termination of a partially instituted proceeding in response to SAS Institute. Given that constraint, we are not persuaded that we abused our discretion in our modification Order to include review of all challenged claims and all grounds presented in the Petition. See 37 C.F.R. § 42.71(c).” slip op. at 9
Discretionary denialPatents in suitUS 7,975,305 - Hospira, Inc. v. Genentech, Inc.Rehearing deniedPTAB · Jul 9, 2018 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, upholding its requirement that Patent Owner show good cause before seeking a second motion to amend.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“rehearing. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify 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. 37 C.F.R. § 42.71(d).” slip op. at 4
- PTAB / AIA Trials › Motions to amend / substitute claimsDenied
“As previously explained, under the statute, generally, during an inter partes review, “the patent owner may file 1 motion to amend.” 35 U.S.C. § 316(d)(1); see also 37 C.F.R. § 42.121(a). “Additional motions to amend may be permitted upon the joint request of the petitioner and the patent owner to materially advance the settlement of a proceeding under section 317, or as permitted by regulations prescribed by the Director.” 35 U.S.C. § 316(d)(2). The Regulation provides that “[a]n additional motion to amend may be authorized when there is a good cause showing or a joint request of the petitioner and the patent owner to materially advance a settlement.” 37 C.F.R. § 42.121(c) (emphasis added). Because we clearly explained that the Rule, which states that we may not authorize an additional motion to amend without a good cause showing, we did not misapprehend or overlook any matter, or abuse our discretion, in requiring Patent Owner to first file a motion to show good cause.” slip op. at 4
NonePatents in suitUS 7,846,441 - Boehringer Ingelheim Pharmaceuticals, Inc. v. Genentech, Inc.Rehearing deniedPTAB · Jul 9, 2018 · IPR2017-02032 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, upholding institution on all challenged claims and all petition grounds under SAS and the Office’s Guidance.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Our decision to proceed on all grounds is based upon the policy set forth in the Guidance, in view of SAS, along with our determination that Petitioner has shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim in the petition. Regarding that determination, Patent Owner has not persuaded us that we have misapprehended or overlooked any matters. See 37 C.F.R. § 42.71(d).” slip op. at 5
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institution decision left claim 72 unchallenged. Paper 21, 1, 3. After Petitioner filed its rehearing request, the Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., 138 S. Ct. at 1359. In addition, the Office’s Guidance instructs that “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”8 See Guidance. As a result, we granted Petitioner’s rehearing request and instituted trial on all of 8 The Federal Circuit appears to have embraced the approach set forth in the Guidance. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (reading “the SAS opinion as interpreting the statute to require a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). the challenged claims and all of the grounds presented in the Petition. Paper 23, 5.” slip op. at 4
NonePatents in suitUS 6,407,213 - Apotex Inc. / Apotex Corp. et al. v. Osi Pharmaceuticals LLCRehearing deniedPTAB · Mar 5, 2018 · IPR2016-01284 · APJ Lora M Green · IPR · Rehearing
The Board denied the Patent Owner’s rehearing request and left intact its determination that claims 44–46 and 53 are unpatentable as obvious over Schnur combined with OSI’s 10-K or Gibbs.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a final written decision the Board reviews the decision to determine whether we misapprehended or overlooked a matter. See 37 C.F.R. § 42.71(d). Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial 1 Schnur et al., U.S. Patent No. 5,747,498, issued May 5, 1998 (Ex. 1009) (“Schnur”). 2 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Fiscal Year Ended September 30, 1998, Commission File Number 0-15190, OSI Pharmaceuticals, Inc. (Ex. 1011) (“OSI’s 10-K”). 3 J.B. Gibbs, “Anticancer Drug Targets: Growth Factors and Growth Factor Signaling,” 105 J. CLIN. INV. 9‒13 (2000) (Ex. 1010) (“Gibbs”). Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify 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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for petitioner
“In declining to adopt Petitioner’s definition of skill of the ordinary artisan, we noted that the claims encompassed cancers other than non-small cell lung cancer, and, thus, found that “the ordinary artisan would be a medical oncologist who would hold an M.D. degree and would have completed several years of practice in the field of oncology.” FWD 9. We did not just rely on Dr. Bunn’s testimony as to the level of skill on the ordinary artisan, however, but noted that “the level of ordinary skill in the art in this proceeding is reflected by the prior art of record.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)). In defining the level of ordinary skill, we also stated: [D]uring oral hearing, counsel for both parties opined that the outcome of the obviousness analysis would be the same under either parties’ definition of the ordinary artisan. Tr. 22:3‒8, 37:9‒11. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition of the ordinary artisan. FWD 9.” slip op. at 5
- Expert testimonyPetitioner expert creditedDecided for petitioner
“weight in determining whether the Gibbs reference was referring to CP- 358,774 when referring to “good anti-cancer activity” and “an acceptable therapeutic index,” we cited the Gibbs reference itself, which explicitly discloses: The EGF receptor is also the target for the development of inhibitors of the intracellular tyrosine kinase domain. ZD-1839 and CP-358,774, competitive inhibitors of ATP binding to the receptor’s active site, are currently in clinical trials (12, 13). Their mechanism of action has led to some concern about safety, given the variety and physiological significance of protein kinases and other enzymes that bind ATP. However, these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. Id. at 39 (quoting Ex. 1010, 10). That is, Gibbs refers to two compounds, ZD-1839 and CP-358,774, and refers to compounds in the plural in stating that the compounds have anticancer activity. See id. Thus, we found that “the clear inference [of the Gibbs reference] is that erlotinib has anti-cancer activity against non-small cell lung cancer.” Id. In that regard, we credited the testimony of Dr. Giaccone, noting that Dr. Giaccone testified that the statement in Gibbs “is a pretty strong and precise statement saying, there is activity in non-small cell lung cancer patients.” Ex. 2020, 115:12‒20. In addition, Dr. Giaccone testified further that statement by Dr. Gibbs would have been based on the information he had at the time, and that as Dr. Gibbs was a reputable pharmacologist, and as the statement was made in “a peer-reviewed journal of high impact,” he would have trusted that Dr. Gibbs “was saying something very important.” Ex. 2020, 115:12‒20. Id.” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In finding that Patent Owner’s evidence of long-felt need was weak, however, we noted that “[a]ll types of objective evidence of nonobviousness must be shown to have a nexus to the claimed invention.” Id. at 42‒43 (citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus 4 Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774, an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase. 57 CANCER RESEARCH 4838‒4848 (1997) (Ex. 1016) (“Moyer”). generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need)). In particular, we stated that the challenged claims were not limited to the treatment of patients with non-small cell lung cancer, but included treatment of mammals, and that the challenged claims did not require a clinical effect. Id. at 43. In addition, we noted that Patent Owner acknowledged in its Response that “the FDA required it to change its label as it is only effective in treating approximately 10% of patients with non-small cell lung cancer.” Id. Therefore, our finding that the evidence of long-felt need is weak relied primarily on a lack of nexus. Id. at 42. To the extent we relied on the testimony of Dr. Giaccone that erlotinib was only approved for treatment of subset of non-small cell lung cancer, that testimony is supported by Patent Owner’s admission that “Tarceva is currently approved for the treatment of a subset of NSCLC patients,” as well as the evidence that Patent Owner relied upon to support that statement. PO Response 12 (citing Ex. 2030, 1; Ex. 2021 ¶¶ 41, 102‒107; Ex. 2023 ¶ 7).” slip op. at 12
§ 103 obviousnessPatents in suitUS 6,900,221 - Taro Pharmaceuticals U.S.A., Inc. v. Apotex Technologies, Inc.Rehearing deniedPTAB · Jan 11, 2018 · IPR2017-01446 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review because the record showed a reasonable likelihood of inherent anticipation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify 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. Patent Owner “submits that the evidence of record fails to show that” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“THRESHOLD – The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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. As also noted in the decision on institution, we have considered both the Petition and Patent Owner Preliminary Response, and determined that the information presented in the Petition demonstrates that there is a reasonable likelihood that Petitioner would prevail with respect to the challenged claims. Dec. 2. Therefore, we applied the correct threshold standard for instituting the inter partes review.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundOther
“We agree with Patent Owner on the legal standard for inherency. As we acknowledged in our Decision, “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14. However, we remain persuaded at this stage of the proceeding on the current factual record based on Hoffbrand 1998 and the Mehta Declaration, that Petitioner established a “reasonable likelihood” that Hoffbrand 1998 necessarily disclosed treatment of patients with “an iron overload condition of the heart” with a therapeutically effective amount of deferiprone. See Dec. 16–20; 35 U.S.C. § 314(a). Patent Owner does not identify a definition of the phrase “iron overload condition of the heart” in the ’328 patent Specification that distinguishes the claimed patient population from Hoffbrand’s disclosure of “10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie, falling within the range that has been associated with cardiac disease.” Ex. 1007, 297. The reasonable understanding of Hoffbrand’s teaching of this association between liver iron content and cardiac disease is that all ten patients with the elevated iron levels also necessarily fell into the spectrum of having “an iron overload condition of the heart.” Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching that liver iron content above 15.0 mg/g identifies patients with cardiac disease, and, therefore, with “an iron overload condition of the heart.” Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients suffered fatal complications. . . . Four of the five reported fatalities resulted from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003 ¶ 37. That statement supports the position that Hoffbrand 1998 treated patients who inherently had an ultimately fatal “iron overload condition of the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328 patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001, 28:33–37. We recognize that Dr. Pennell stated that “a patient with a liver iron content above 15 mg/g dry weight is at risk of developing cardiac disease not that such liver iron content definitely establishes cardiac disease.” Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits cited by Dr. Pennell do not identify evidence showing a single patient with a liver iron content that exceeds 15.0 mg/g but failed to display an “iron overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states “while whole liver iron levels >15 mg/g dry weight . . . have been shown to predict patients at highest risk of cardiac death, it is not known how these variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient data is provided in Exhibit 2007 comparing liver iron levels of particular patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016 also do not identify any patients with elevated liver iron content >15 mg/g dry weight with normal cardiac iron levels. Therefore, the evidence currently of record in Hoffbrand 1998,” slip op. at 3
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Regarding the second argument, Dr. Mehta relied upon specific facts within the Olivieri Abstract 1995 itself to support the conclusion that “lower TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states “MRI demonstrates changes consistent with reduction in cardiac iron in L1 [deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of 23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010. Olivieri Abstract 1995’s identification of the value of “32” as normal for TRT levels with lower values such as “23.9±6.4” as associated with elevated cardiac iron levels that require treatment with deferiprone, provides factual support for Dr. Mehta’s conclusion that patients with these lower TRT values inherently have “an iron overload condition of the heart.” See Ex. 1002 ¶ 75.” slip op. at 6
§ 102 anticipationPatents in suitUS 7,049,328 - Argentum Pharmaceuticals LLC v. Cipla Ltd.Rehearing deniedPTAB · Oct 31, 2017 · IPR2017-00807 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in declining to construe the terms or in reserving disputed motivation and reasonable-expectation issues for trial.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 4
- Expert testimonyOther
“osmolality, poor spray quality, and unacceptable settling and caking” resulting from the attempted formulation of Cramer’s Example III. Id. at 8– 10; see also Prelim. Resp. 25. The Board, however, addressed those issues in the Institution Decision and determined that “Patent Owner’s arguments and expert testimony highlight disputed issues of fact about whether the skilled artisan would have been motivated to combine the teachings of Hettche, Phillipps, and Segal to arrive at the claimed subject matter, and would have had a reasonable expectation of success.” Instit. Dec. at 20 (citing Ex. 1002, 268–87; Ex. 2007 ¶¶ 40–47; Ex. 2111, 1; Ex. 2044, 1–2). The Board concluded that those “issues are best resolved following trial with the benefit of a full record.” Id. We are still of that view. Accordingly, we are not persuaded that the Board misapprehended or overlooked the issue of reasonable expectation of success.” slip op. at 5
- BurdenOther
“II. 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). The party must identify all matters the party 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 1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992) (“Hettche”). Ex. 1007. 2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15, 1982) (“Phillipps”). Ex. 1009. 3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5, 1998) (“Segal”). Ex. 1012. 4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product Information (Dec. 1998) (“Flonase Label”). Ex. 1010. 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 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“In the Institution Decision, the Board determined that “no claim term requires express interpretation for purposes of this Decision.” Instit. Dec. 7. In its Rehearing Request, Patent Owner argues that the Board “misapprehended or overlooked the importance of construing the terms ‘nasal spray’ and ‘suitable for nasal administration’” found in all the challenged claims. Reh’g Req. 2. In particular, Patent Owner asserts that those terms mean “pharmaceutical formulations that are tolerable to patients, homogeneous, and can be suitably deposited onto the nasal mucosa.” Id. (citing Paper 7, Preliminary Response (“Prelim. Resp.”), 9). Patent Owner alleges that, had the Board construed “nasal spray” and “suitable for nasal administration,” then the Board would have denied the obviousness grounds because “none of the combinations of cited art teach a person of ordinary skill in the art how to make the claimed fixed-dose combination ‘nasal spray’ or formulation ‘suitable for nasal administration’ with a reasonable expectation of success.” Id. at 2–3 (citing Prelim. Resp. 9). We are not persuaded that the Board abused its discretion by declining to expressly interpret “nasal spray” and “suitable for nasal administration” in the Institution Decision. As the Board explained in the Institution Decision, Petitioner showed sufficiently for the purpose of institution that the prior art teaches pharmaceutical compositions in the form of nasal sprays. Instit. Dec. 14. Specifically, the Board found that the prior-art references explicitly teach nasal sprays that are administered nasally. See id. (citing Ex. 1007 (Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57– 60, 33:12–14). Patent Owner does not allege its proposed construction of “nasal spray” and “suitable for nasal administration” is different from the plain and ordinary meaning of those terms to an ordinarily skilled artisan. Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not persuaded that the Board overlooked or misapprehended this matter or that the Board would have declined institution on the obviousness grounds had it explicitly adopted Patent Owner’s proposed interpretation.” slip op. at 3
Claim construction§ 103 obviousnessPatents in suitUS 8,168,620 - Sienna Biopharmaceuticals, Inc. v. William Marsh Rice UniversityRehearing deniedPTAB · Aug 21, 2017 · IPR2017-00046 · APJ Georgianna W Braden · IPR · Rehearing
The Board denied the Patent Owner’s rehearing requests, finding no abuse of discretion in instituting review because the reexamination amendments were not yet effective.
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). 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 in a motion, an opposition, or a reply.” Id. When rehearing a decision on a petition, we review the decision for an abuse of discretion. Id. § 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. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 3
NonePatents in suitUS 6,685,730 - PTAB · Aug 1, 2017 · IPR2016-01565 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving claims 6–8, 10–18, 24, and 25 uninstituted because the Petition did not show the Januvia Label and Huettner were printed publications.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS 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 specifically identify 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.” Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“a trial is based on “the information presented in the petition.” 35 U.S.C. § 314(a). Under 35 U.S.C. § 311(b), in an inter partes review, a petitioner may only challenge the claims of a patent based on “prior art consisting of patents or printed publications,” and the petitioner has the initial burden of production to show that an asserted reference is prior art to the challenged claims under a relevant subsection of 35 U.S.C. § 102. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015); Dec. 16. As explained in our Decision, we have often required a petitioner to make a threshold showing that the reference relied upon was publicly accessible as a printed publication prior to the effective filing date of a challenged patent to satisfy the initial burden of production. See, e.g., Apple Inc. v. DSS Tech. Mgmt., Inc., Case IPR2015-00369, slip op. at 5 (PTAB Aug. 12, 2015) (Paper 14) (noting that petitioner has the burden to make a threshold showing that a reference is “printed publication” prior art under 35 U.S.C. §§ 102 and 311(b)); Frontier Therapeutics, LLC v. Medac Gesellschaft Für Klinische Spezialpräparate MBH, Case IPR2016-00649, slip op. at 22 (PTAB September 1, 2016) (Paper 10). We further explained that “[a] given reference is ‘publicly accessible’ ‘upon a satisfactory showing that such document has been 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.’” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)); Dec. 17.” slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“To the extent Petitioner now argues that “the declaration testimony of Dr. Davidson and the facial indicia on Huettner are sufficient” to make a threshold showing that Huettner was publically accessible as of the relevant date (Reh’g Req. 13), we are not persuaded. We note that Dr. Davidson testifies, without elaboration, that “Huettner was published in June 2007.’” Ex. 1002 ¶ 56. Petitioner, however, did not rely on Dr. Davidson’s testimony on this issue in the Petition. Moreover, even if Dr. Davidson’s testimony had been relied on, Petitioner does not point to any evidence—nor can we discern any in Dr. Davidson’s Declaration—that would reasonably suggest that Dr. Davidson has personal knowledge as to when and how Huettner was made available to the public. Accordingly, Dr. Davidson’s conclusory declaration of Huettner’s publication date is entitled to little or no weight. See Dell, Inc. v. Selene Commc’n Techs., LLC, Case IPR2014- 01411, slip op. at 22–23 (PTAB Feb. 26, 2015) (Paper 23) (explaining that an expert declaration is not enough to prove a prior art reference’s publication date where the expert declaration merely repeats assertions made by the petitioner).” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied merits
“Decision on Institution, and Petitioner’s Request for Rehearing, we are not persuaded that we erred in declining to institute trial on claims 6–8, 10–18, 24, and 25. Petitioner, having failed to meet its burden of providing a threshold showing that the Januvia Label and Huettner are printed publications under 35 U.S.C. §§ 102 and 311(b), did not demonstrate a reasonable likelihood of prevailing in its assertion that the subject matter of claims 6–8, 10–18, 24, and 25 of the ’156 patent would have been obvious over the Januvia Label, Huettner, and Mikhail or the Knowledge of one of ordinary skill in the art..” slip op. at 8
§ 102 anticipationPatents in suitUS 8,853,156 - Palo Alto Networks, Inc. / Blue Coat Systems LLC v. Finjan, Inc.Rehearing deniedPTAB · Jul 17, 2017 · IPR2016-00159 · APJ Charles J Boudreau · IPR · Rehearing
The Board denied the Patent Owner’s rehearing request, leaving claims 1, 2, and 6 unpatentable over Swimmer under § 103(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS “The burden of showing a decision should be modified lies with the party challenging the decision[,]” which party “must specifically identify 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.” 37 C.F.R. § 42.71(d).” slip op. at 4
- ExcludeMotion to exclude, grantedGranted
“Lastly, because our rules do not authorize the filing or introduction of new evidence with a request for rehearing, we exercise our authority under 37 C.F.R. § 42.7(a) to expunge Exhibits 2050–2052 filed with Patent Owner’s Request for Rehearing. See, e.g., Cox Commc’ns, Inc. v. AT&T Intellectual Prop. I, L.P., Case IPR2015-01227, slip op. at 2 (PTAB Sept. 22, 2016) (Paper 67) (expunging request for rehearing and exhibits filed therewith).” slip op. at 7
NonePatents in suitUS 8,677,494
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.