- Volkswagen Group Of America, Inc. v. Emerachem Holdings, LLCRehearing deniedPTAB · Jan 30, 2019 · IPR2014-01558 · APJ James T Moore · IPR · Rehearing
The Board denied Volkswagen’s rehearing request, leaving claims 3, 16, and 20 not shown unpatentable because Saito, read in context, did not establish the claimed regeneration limitations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We find Petitioner’s position to be lacking in substance. The quotation provided by Petitioner is only a partial quotation. The complete quotation from Saito, with appropriate following context italicized, is as follows: The method of reducing NOx using a reducing agent such as hydrogen is widely known as a nonselective catalytic reduction method, but in this method, if large amounts of oxygen are present in the exhaust gas [amounts of] reducing agent sufficient to react with the oxygen will be added and the NOx will be reduced, which is not economical in so much as large amounts of reducing agent are consumed, and thus the use of nonselective catalytic reduction methods was limited to situations in which oxygen was not present, or situations in which the oxygen concentration had been greatly lowered. In the method of the present invention, the amount of reducing agent consumed is the amount necessary to reduce and remove the NOx that has been absorbed by the catalyst, which is a very small amount, and therefore this is very economically advantageous. Ex. 1008A, 3 column 1, lines 38–54 (emphasis added). The italicized language, to us, indicates that this discussion in Saito is not that simply of one nonpreferred specific embodiment of catalyst renewal taught, but rather a discussion of the reasons why nonselective catalytic reduction methods of exhaust gas directly were not generally used due to their prohibitive costs. Moreover, it is a stretch to say that catalytic reduction methods are the same as renewing a devitalized catalyst as alleged in Petitioner’s request for rehearing. In this we agree with the Patent Owner that this disclosure of a prior art “non-selective catalytic reduction method does not render claims 3, 16, and 20 obvious.” Paper 75, 10. To the extent that Petitioner asserts we did not consider this argument, we have again considered it and again find it to be unpersuasive based upon Saito itself, when taken in complete context. As noted before, Saito’s example is explicit that Saito uses two catalyst beds and regenerates each catalyst bed independently of each other. PO Resp. 21, 24. By the use of valving, the reducing agent is introduced into the catalyst bed through which exhaust gas is not flowing. Id. at 21 (citing Ex. 1008B, 3). As to the several pages of additional argument and evidence provided in the request for rehearing beyond that originally found in the Petition and Reply, we shall not consider it, as it is an improper use of the rehearing process. See 37 C.F.R. § 71(d). The request for rehearing is therefore DENIED.” slip op. at 12
- Strike new argumentNew argument disregardedOther
“As to the several pages of additional argument and evidence provided in the request for rehearing beyond that originally found in the Petition and Reply, we shall not consider it, as it is an improper use of the rehearing process. See 37 C.F.R. § 71(d).” slip op. at 13
- Expert testimonyNot reached
NonePatents in suitUS 5,599,758 - Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution deniedPTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“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.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - K/S Himpp v. III Holdings 4, LLCNo claims unpatentablePTAB · Jun 28, 2018 · IPR2017-00496 · APJ James T Moore · IPR · Final written decision
Claims 1–17 were not shown unpatentable under § 103 over Topholm and Michael because the cited art did not teach adjusting a hearing aid profile.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“The problem we find with this position is that the Petitioner is reading claim elements into the description of these references. Patent Owner points out that the profiles are not being adjusted, but rather being selected from twenty-four previously stored profiles. Resp. 30–31. While the ear module operational profile changes, we observe that this is because it is using a different profile, which was just uploaded from the control unit. The act of moving the finger around on the screen to us perhaps appears to change the profile, when it is in fact moving through a set of preexisting profiles and uploading them to the hearing aid instead, changing operation of the hearing aid itself but not adjusting the profile itself. Michael states: This permits the user to select a hearing profile by simply moving visual indicator 924 over main region 922 while listening to a sound stream broadcast by ear 35 module 10; the sound stream being heard by the user reflects the hearing profile corresponding to the current position of the visual indicator 924 in real-time. Ex. 1005, 8:32–37.” slip op. at 21
- Expert testimonyPetitioner expert creditedOther
“4 Petitioner also relies upon the declaration testimony of Dr. Robert E. Morley, Jr. (Ex. 1002). Both references appear to be prior art under 35 U.S.C. § 102(b). We find Dr. Morley, by virtue of his education and experience, qualified to testify to the subject matter of this proceeding. Ex. 1002 ¶¶ 2–14 and Exhibit A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. PO Resp. 34–36. We give Dr. Morley’s testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2006. We decline to assign generally no weight to his testimony, however.” slip op. at 3
- Skill levelSkill level petitioner adoptedOther
“These underlying factual considerations consist of: (1) the “level of ordinary skill in the pertinent art,”5 (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of non-obviousness such as “commercial success, long felt but unsolved needs, failure of others, etc.”6 KSR, 550 U.S. at 406 (quoting Graham, 383 U.S. at 17–18). 5 Petitioner defines the level of ordinary skill in the art as someone with a B.S. degree in electrical or computer engineering, or the equivalent, and at least two years of experience in the design of audiological products. Pet. 7-8 (citing Ex. 1002, ¶ 32). Patent Owner does not challenge this level. PO Resp., passim. The references in the record tend to support a finding that this is the appropriate level.” slip op. at 12
Patent outcomesUS 8,761,421 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,761,421 - 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 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Rehearing deniedPTAB · Aug 3, 2017 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Rehearing
The Board denied Merial’s rehearing request, leaving institution denied for claims 1–22 because the evidence did not show that the prior art suggested the claimed cyphenothrin concentration.
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 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 Partnership 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 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3 For the foregoing reasons, Petitioner has not demonstrated that we abused our discretion in denying institution of an inter partes proceeding in this case. Consequently, Petitioner’s Request for Rehearing is denied.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We considered this evidence of Dr. Clark’s testimony concerning the teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
§ 103 obviousnessPatents in suitUS 8,614,244 - PTAB · Apr 21, 2017 · IPR2016-01566 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Mylan’s rehearing request, finding no abuse of discretion in denying institution because the petition did not show a reasonable likelihood that the cited combination rendered claims 1–22 obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV. ORDER Accordingly, it is ORDERED that Petitioner’s request for rehearing is denied.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV.” slip op. at 6
- BurdenDecided for patent owner
“as it argues now in its request for rehearing, that we should apply a legal presumption of obviousness. In fact, the Petition did not cite Galderma, or numerous other opinions of the Federal Circuit, district courts, and the Board, which Petitioner now relies on in its request for rehearing. The Board could not have misapprehended or overlooked an argument that was not made and case law that was not cited in the Petition. In addition, we reiterate, as we stated in our Decision denying institution, in an inter parte review, Petitioner has the ultimate burden of persuasion to prove unpatentability. Dec. 8 (citing 35 U.S.C. § 316(e); Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015)). According to Petitioner, Galderma holds “Patent Owner has burden of overcoming obviousness presumption ‘where there is a range disclosed in the prior art, and the claimed invention falls within that range.’” Req. Reh’g 1 (quoting Galderma, 737 F.3d at 737–38). To the extent Petitioner argues for a presumption of obviousness that shifts the burden of persuasion to Patent Owner, such an argument is misplaced. See In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (stating that the “burden-shifting framework does not apply in the adjudicatory context of an IPR”).” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In contrast, here, Petitioner relies solely on the teachings of the ’510 publication—a preferred dose of 1 to 100 mg administered “1 to 4 times a day”— to arrive at the claimed dosage of 2.5 mg or 5 mg. The Petition simply does not provide the same type of evidence and context as those in Galderma, sufficient for us to apply the requested presumption.1” slip op. at 4
§ 103 obviousnessPatents in suitUS 9,173,859 - PTAB · Mar 17, 2017 · IPR2016-01563 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving trial instituted only for claims 1 and 10; it found the Petition lacked reasoned obviousness analysis for claims 2–9 and 11–26.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We will grant a request for rehearing if the requesting party demonstrates “an abuse of discretion” in the decision. 37 C.F.R. § 42.71(c). However, we will grant a request for rehearing only if the requesting party “specifically identif[ies] . . . the place where each matter [that we misapprehended or overlooked] was previously addressed.” Id. § 42.71(d). After considering Petitioner’s Rehearing Request, our Decision, and the evidence currently of record, Petitioner’s Rehearing Request is denied.” slip op. at 2
- BurdenNot shown unpatentable
“See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3), requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.”). In Harmonic, the Federal Circuit held that “it was Harmonic’s burden to explain to the Board how Haskell combined with Rossmere rendered the challenged claims unpatentable. With respect to claim 11 of the ’291 patent, Harmonic did not do so.” Id. Petitioner here also did not meet its burden with respect to claims 2–9 and 11–26 of the ’927 patent.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In Galderma, for example, the claim recited a “topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] . . . Shroot patents disclosed topical adapalene compositions for treating acne “in a preferred range of 0.01%–1%,” including exemplary formulations containing 0.001%, 0.1%, and 1%. Id. at 735–36. The court noted the Shroot patents were listed in the FDA’s Orange Book for “prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.” Id. at 735. The court further noted that other prior art references disclosed the use of 0.3% adapalene lotion in an animal model for acne treatment and taught the use of 0.3% adapalene for other skin conditions “without intolerable irritability.” Id. It was in the foregoing context that the court framed the issue as “whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.” Id. at 737–38. The Petition here simply does not provide the same type of context and analysis with regard to the claimed linagliptin dosages, sufficient for us to apply the requested presumption.3” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,673,927 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentablePTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9
- Expert testimonyDecided for petitioner
“several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11
Patent outcomesUS 8,642,012 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,642,012 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Institution deniedPTAB · Sep 29, 2016 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1–22 were unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“we find that Petitioner has failed to show a reasonable likelihood of success that any of the challenged claims are unpatentable. The key limitation missing from any teaching or suggestion of the combination is “3% to 16% (w/w) cyphenothrin” (or any narrower range therein) combined with fipronil. Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityNot reached
“E. Real Parties-In-Interest Patent Owner asserts that Merial Limited, Merial LLC, and Sanofi had a measure of control over this proceeding requiring them to be named as real parties-in-interest. Pet. 9–17. Because we have found that Petitioner has failed to show a reasonable likelihood that it would prevail on any challenged claim, we need not address whether these parties constitute real parties-in-interest. Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00731, slip op. at 5 (PTAB March 2, 2016) (holding satisfying the requirements of 35 U.S.C. § 312(a) is not jurisdictional). Any real party-ininterest issue is moot.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party believes that any claim term or phrase needs to be expressly interpreted. See Pet. 10; Prelim. Resp. 5–39 (offering no express 1 PCT App. WO 2008/080542 A2, published Jul. 10, 2008 (Ex. 1004, “Sirinyan”). The Sirinyan reference is a German-language reference. Petitioner provided a certified English-language translation (Ex. 1005). 2 US Patent 4,902,510, issued Feb. 20, 1990 (Ex. 1006, “Garden”). 3 Mark Suarez, EPA Product Performance/Efficacy Review for Sergeant’s Cyphenothrin Squeeze-On for Dogs, Sergeant’s Cyphenothrin + IGR Squeeze-On for Dogs, and Sergeant’s Cyphenothrin + Methoprene Squeeze- On for Dogs, Nov. 7, 2006 (Ex. 1007, “the EPA Review”). constructions). We agree that we do not need to interpret expressly any claim term or phrase to resolve whether a trial should be instituted. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 4
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,614,244 - Bioactive Laboratories v. BTG International Inc.Rehearing deniedPTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 8,048,414
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.