- Apotex Inc. / Apotex Corp. v. Celgene CorporationRehearing deniedPTAB · Apr 30, 2020 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution on all challenged claims under § 325(d) for grounds I and II and for failure to establish printed-publication status for ground III.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“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 it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (Feb. 13, 4 2020) (precedential). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. If the same or substantially the same art or arguments were previously presented to the Office, we then consider whether petitioner has demonstrated the Office erred. Id. In evaluating the Petition and accompanying evidence in light of the Becton, Dickinson factors, we determined that grounds I and II were “based on substantially the same prior art and arguments previously presented to the office,” and that Petitioner had “neither sufficiently pointed out how the Examiner erred, nor provided additional evidence or facts that warrant reconsideration of the Examiner’s decision.” Inst. Dec. 26. Accordingly, we exercised our discretion under 35 U.S.C. §325(d) and denied institution of grounds I and II on that basis.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“we determined that the Petition failed to establish a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one claim challenged in the Petition, and declined to institute an inter partes review on any of the three grounds asserted. Specifically, with respect to grounds I and II, we declined to institute pursuant to our discretion under 35 U.S.C. § 325(d). Inst. Dec. 22–26. With respect to ground III, we determined that Petitioner had not met its burden of establishing that the Celgene Press Release was available as a printed publication. Id. at 27–31.” slip op. at 3
§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - L’Oréal USA, Inc. v. Liqwd, Inc.Rehearing deniedPTAB · Oct 18, 2018 · PGR2018-00024 · APJ Christopher M Kaiser · PGR · Rehearing
The Board denied rehearing, leaving in place its denial of institution because Petitioner did not show an abuse of discretion in construing “bleach powder” or assessing written-description support.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). We “review [our] decision for an abuse of discretion.” Id. § 42.71(c). In addition, we may not consider an argument made in a request for rehearing unless the request “specifically identif[ies] . . . the place where [that argument] was previously addressed in a motion, an opposition, or a reply.” Id. § 42.71(d). After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing. slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“reconsider the issue of our construction of “bleach powder.” The parties agree that the specification of the ’954 patent does not contain an express definition of “bleach powder,” so we are required to give the term its “ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure.” Translogic, 504 F.3d at 1257; see Pet. 27–28 (arguing that, “[a]bsent any . . . clear intent, the BRI must be consistent with the interpretation that those skilled in the art would reach,” then offering no particular construction of “bleach powder”); Prelim. Resp. 29–30 (“A person of ordinary skill in the art would have understood that bleach powder combines persulfates with alkalinizing compounds . . . in a fine dry particulate form.” (citing only sources outside the ’954 patent)). In arguments that we may consider, the parties draw our attention to six sources of evidence about the ordinary understanding in the art of “bleach powder.” Req. 2–5 (citing Ex. 1039, 48:9–49:9); Prelim. Resp. 29– 30 (citing Ex. 1002, 15:45–65; Ex. 1011, 17; Ex. 2005, 6; Ex. 2007, 3; Ex. 2012 ¶¶ 34–36). There is evidence that supports Patent Owner’s view that the ordinary meaning of “bleach powder” is a powder that contains an alkalizing agent in addition to persulfates, as opposed to merely a persulfate powder. A textbook called “Hair Preparations” by Thomas Clausen and others states that, at least in paste bleaches, “a bleach powder” is used that “consists of a peroxodisulfate, an alkalinizing agent,” and other ingredients. Ex. 1011, 17. In the context of cream and gel bleaches, this reference teaches that “[p]eroxosulfate . . . can be added as a bleaching powder” but is silent about whether the “bleaching powder” contains any additional ingredients. Id. In a book chapter on “Hair Coloring” by Keith C. Brown, a “bleach booster” powder is discussed that “is usually a mixture of ammonium and potassium persulfates” and that has “metasilicates mixed in with the persulfates” to provide “[a]lkaline pH.” Ex. 2005, 6. Against this evidence is the testimony of Dr. Borish that “powder lighteners” or “bleach powders” include “persulfate salts.” Ex. 1039, 48:9–49:9. But Dr. Borish does not state affirmatively that the persulfate salt is all that is required for a powder to be a bleach powder, only that a persulfate salt is a necessary component of a bleach powder. Id. Accordingly, his testimony does not outweigh the evidence that, to a person of ordinary skill in the art, a bleach powder contains both a persulfate salt and an alkalizing agent. We are not persuaded, therefore, that we abused our discretion by construing “bleach powder” to require both of those components.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing.” slip op. at 2
Claim constructionPatents in suitUS 9,668,954 - 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 - Merck Sharp & Dohme Corp. v. Wyeth LLCRehearing deniedPTAB · Jan 22, 2018 · IPR2017-01211 · APJ Grace K Obermann · IPR · Rehearing
Denied rehearing of the refusal to institute IPR on claims 1 and 4–13 because Petitioner did not show the Board misapprehended or overlooked matters establishing the institution threshold.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We did not overlook or misapprehend those cases and were under no obligation to expressly address them, having determined that the Petition rests on a faulty assertion “that claim 1 ‘covers over 4 million possible combinations,’ when one selects additional serotypes” over those 1 As we explained in our decision declining to institute trial, the enablement inquiry focuses on whether the disclosure of the parent application would have enabled a person to practice the claimed invention by exercising no more than ordinary skill in the art, without resorting to “undue experimentation,” which “is analyzed by applying the factors set forth In re Wands, 858 F.2d 731 (Fed. Cir. 1988).” Dec. 12. specifically identified in the claim and identified as 13vPnC.2 Dec. 14 (quoting Pet. 37). Under these particular facts and circumstances, the request for rehearing does not establish that the Board applied an incorrect enablement standard in denying inter partes review of claims 1 and 4–13.” slip op. at 4
- Other 314aDenied
“In this case, the Chief Judge has considered Petitioner’s request for an expanded panel, but has determined that an expanded panel is not warranted. Accordingly, Petitioner’s request for panel expansion is denied.” slip op. at 3
Discretionary denialPatents in suitUS 9,399,060 - Merck Sharp & Dohme Corp. v. Wyeth LLCRehearing deniedPTAB · Jan 22, 2018 · IPR2017-01194 · APJ Grace K Obermann · IPR · Rehearing
The Board denied rehearing of its decision declining to institute IPR on claims 1–5, finding no overlooked error in its enablement and priority analysis.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioner has not shown that the panel misapprehended or overlooked any evidence or argument directed to this “second, independent” rationale for denying the Petition. Dec. 13. Accordingly, Petitioner has not shown reversible error in our decision to deny institution of trial with respect to claims 1–5. IV. CONCLUSION For the above reasons, we deny both Petitioner’s request for panel expansion and Petitioner’s request for rehearing of our decision declining to institute inter partes review of claims 1–5 of the ’024 patent.” slip op. at 7
- Skill levelSkill level patent owner adoptedDecided for patent owner
“the Petition “deficient” in establishing a reasonable likelihood of prevailing at trial with respect to claims 1–5. Dec. 13. Specifically, the Petition does not adequately analyze the level of ordinary skill in the art as of the filing date of each parent application through which priority is claimed. Id. at 13– 14; see In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (enumerating factors that bear on enablement, including the level of ordinary skill in the art at the time of filing of the parent application at issue). In that regard, Petitioner argues that “the Board overlooked the Petition’s substantial evidence with respect to the enumerated Wands factors.” Req. Reh’g 9. In our decision, however, we found significant that “[e]ven Petitioner acknowledges that the level of ordinary skill in this particular field of endeavor, including one’s understanding of ‘the universe of clinically relevant serotypes,’ would not ‘remain static’ during the relevant span of time.” Dec. 14 (citing Pet. 45 (quoting Ex. 1009 ¶ 129). “Yet the Petition does not clearly articulate the level of ordinary skill in the art applicable at the time of filing for each parent application. Instead, Petitioner focuses on the state of the art as of the earliest possible priority date of ‘April 8, 2005.’” Id. (quoting Pet. 9 (heading “A”).” slip op. at 7
- PTAB / AIA Trials › Discretionary denialInstitution denied meritsDenied
“the Petition “deficient” in establishing a reasonable likelihood of prevailing at trial with respect to claims 1–5. Dec. 13. Specifically, the Petition does not adequately analyze the level of ordinary skill in the art as of the filing date of each parent application through which priority is claimed. Id. at 13– 14; see In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (enumerating factors that bear on enablement, including the level of ordinary skill in the art at the time of filing of the parent application at issue). In that regard, Petitioner argues that “the Board overlooked the Petition’s substantial evidence with respect to the enumerated Wands factors.” Req. Reh’g 9. In our decision, however, we found significant that “[e]ven Petitioner acknowledges that the level of ordinary skill in this particular field of endeavor, including one’s understanding of ‘the universe of clinically relevant serotypes,’ would not ‘remain static’ during the relevant span of time.” Dec. 14 (citing Pet. 45 (quoting Ex. 1009 ¶ 129). “Yet the Petition does not clearly articulate the level of ordinary skill in the art applicable at the time of filing for each parent application. Instead, Petitioner focuses on the state of the art as of the earliest possible priority date of ‘April 8, 2005.’” Id. (quoting Pet. 9 (heading “A”). Petitioner has not shown that the panel misapprehended or overlooked any evidence or argument directed to this “second, independent” rationale for denying the Petition. Dec. 13. Accordingly, Petitioner has not shown reversible error in our decision to deny institution of trial with respect to claims 1–5.” slip op. at 7
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“In this case, the Chief Judge has considered Petitioner’s request for an expanded panel, but has determined that an expanded panel is not warranted. Accordingly, Petitioner’s request for panel expansion is denied.” slip op. at 3
Discretionary denialPatents in suitUS 8,895,024 - Bioeq IP AG v. Genentech, Inc.Rehearing deniedPTAB · Aug 30, 2017 · IPR2016-01608 · APJ Erica A Franklin · IPR · Rehearing
The Board denied rehearing and left in place its denial of institution because Petitioner did not show Seeger reduced metabolic rate at induction or that the Board overlooked its arguments.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “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.” Id. § 42.71(d). Because Petitioner has not met its burden, as discussed below, the Rehearing Request is denied.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner’s assertion is not supported by the evidence of record. Dr. Rosenberg’s discussion of his calculation for the GUR in the paragraph cited by Petitioner explains only that Seeger increased the temperature, without describing or suggesting that he considered that temperature increase in his calculation or conclusions. Ex. 1002 ¶ 56. Moreover, as Patent Owner has asserted, Dr. [Rosenberg’s] calculation set forth in Appendix A does not include a variable accounting for the temperature shift. Ex. 1002, App. A. Thus, Petitioner has not shown persuasively that a person of skill in the art would have understood Seeger’s method to have included reducing the metabolic rate of the cultured recombinant host cells at the time of expression induction. See MEHL/Biophile Int'l. Corp., 192 F.3d at 1365.” slip op. at 5
- BurdenDecided for patent owner
“Petitioner’s assertion is not supported by the evidence of record. Dr. Rosenberg’s discussion of his calculation for the GUR in the paragraph cited by Petitioner explains only that Seeger increased the temperature, without describing or suggesting that he considered that temperature increase in his calculation or conclusions. Ex. 1002 ¶ 56. Moreover, as Patent Owner has asserted, Dr. [Rosenberg’s] calculation set forth in Appendix A does not include a variable accounting for the temperature shift. Ex. 1002, App. A. Thus, Petitioner has not shown persuasively that a person of skill in the art would have understood Seeger’s method to have included reducing the metabolic rate of the cultured recombinant host cells at the time of expression induction. See MEHL/Biophile Int'l. Corp., 192 F.3d at 1365.” slip op. at 5
NonePatents in suitUS 6,716,602 - 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 · 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 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Indivior UK LimitedRehearing deniedPTAB · Jun 23, 2017 · IPR2016-01113 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied rehearing of its decision denying institution because the petition did not show the claimed local pH range was known or obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“a panel will review the decision for an abuse of discretion.” 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). The 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.” 37 C.F.R. § 42.71(d). A party who requests rehearing bears the burden of showing that a decision should be modified. Id. II.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“obviousness analysis. In stating that Petitioner did “not point to where the SBOA, the Suboxone® 2002 Label, and/or LabTec suggest that anyone actually measured a local pH for the Suboxone tablets in an oral cavity, much less determined that local pH should be from about 3 to about 3.5, as recited in the challenged claims,” we addressed Petitioner’s reliance on those three references as collectively teaching or suggesting the claim limitations “[a] buffer in an amount to provide a local pH” of “about 3 to about 3.5.” Dec. 13 (citing Pet. 27–32). We concluded that those three references did not provide sufficient evidence to establish those claim limitations as known prior art elements. See id. at 13–14. Petitioner is incorrect that we ignored teachings in those three references concerning pH. Rather, we considered the Suboxone® Label’s disclosure of a buffering system consisting of citric acid and sodium citrate and Petitioner’s contention, relying on Dr. Çelik’s testimony, that a citric acid and sodium citrate buffer operates within the range of 3.0 to 6.2. Id. at 12–13 (citing Pet. 31–32). We also considered the SBOA’s disclosure of in vitro dissolution studies identifying redacted pH values, and Petitioner’s conclusion based on the SBOA, “that in order for buprenorphine to dissolve, the local pH of the saliva had to be below a certain value, and for naloxone to dissolve, the pH had to be above a certain value because the solubility profiles of these drugs are dependent on pH.” Id. at 11 (quoting Pet. 29); id. at 13 (citing Pet. 29–32). And we further considered LabTec’s disclosure of the relationship between pH and absorption. Id. at 11 (citing Pet. 27–28); id. at 17. We found, however, insufficient evidence to support a conclusion that a local pH value for Suboxone® in the oral cavity or a local pH range of about 3 to about 3.5 were known or obvious. Id. at 11–14.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We considered Petitioner’s argument that “‘it would have been nothing more than routine experimentation’ to identify ‘the claimed pH range of 3 to 3.5 as optimal.’” Id. at 16 (quoting Pet. 33). As we discussed in our Decision, however, the relationship between pH and absorption that LabTec discloses is that “[f]or a basic active ingredient, one would adjust the pH of the solution to below the pKa of the conjugate acid” as a “means for retarding absorption of the active ingredient through the oral mucosa.” Id. at 17 (alteration in original) (emphasis omitted) (quoting Ex. 1007, at 15). In other words, for a basic active ingredient like buprenorphine, this teaching suggests to lower the pH where the goal is to retard oral absorption. See id.; see also Ex. 1009, at 28 (describing buprenorphine as a “weak base” and stating that “[a]bsorption of lipophilic weak bases should increase with salivary pH increases”). As such, as noted in our Decision, LabTec does not suggest preparing a film that lowers a local pH to 3–3.5 in the saliva for the purpose of increasing absorption of an active ingredient such as buprenorphine. Dec. 17. In contrast, the claims of the ’832 patent require adjusting the local pH to “optimize absorption of said buprenorphine,” and the specification further explains that “[i]n a dosage form that is to be placed in the oral cavity, it is desired to absorb the agonist [buprenorphine] buccally, so as to provide rapid integration of the agonist into the body of the user.” Ex. 1001, 11:10–13, 23:65–67, 24:33–35.” slip op. at 6
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We disagree with Petitioner that we erred in finding Dr. Çelik’s statement that the “anatomy of the oral and nasal mucosa is quite similar, thus, one of ordinary skill would expect that the same principle of drug delivery will apply to both tissues” (Ex. 1003 ¶ 105) is merely conclusory. In the Request for Rehearing, Petitioner argues that Dr. Çelik’s testimony in the same paragraph as this statement provides support. Req. Reh’g 12 (citing Ex. 1003 ¶ 105). We have reviewed this paragraph of Dr. Çelik’s declaration, however, and we find that with the exception of the paragraph’s final sentence (which is the statement at issue), the entirety of the paragraph is a summary of Birch’s disclosures and concerns delivery to the nasal mucosa. See Ex. 1003 ¶ 105. Before the final sentence of the paragraph, the testimony in this paragraph fails to mention oral mucosa, let alone provide reasoning or support for why Dr. Çelik concludes that “[t]he anatomy of the oral and nasal mucosa is quite similar” or why it would have been expected “that the same principle of drug delivery will apply to both tissues.” See id.” slip op. at 8
§ 103 obviousnessPatents in suitUS 8,475,832 - Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Pozen Inc.Rehearing deniedPTAB · May 24, 2017 · IPR2015-01774 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving its denial of institution on the §103 grounds for claims 1–6 and 13–15 unchanged because Petitioner showed no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 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). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, 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 Petitioner’s arguments with these principles in mind.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“determined that Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of challenged claims 1–6 and 13–15 of U.S. Patent 8,852,636 B2 (Ex. 1001, “the ’636 patent”) on any of the five grounds advanced in the Petition (Paper 4, “Pet.”). Paper 15 (“Decision” or “Dec.”). Subsequently, Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively “Petitioner”) filed a Request for Rehearing (Paper 16, “Reh’g Req.” or “Request”) asking us to reconsider our Decision denying an inter partes review on two of the grounds advanced in the Petition: (1) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Chen1 and Gimet;2 and (2) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Gimet, Chandramouli,3 and Phillips.4” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 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). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, 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 Petitioner’s arguments with these principles in mind.” slip op. at 3
§ 103 obviousnessPatents in suitUS 8,852,636
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.