- PTAB · Jan 13, 2022 · IPR2021-01136 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted review of claims 1 and 2 on the § 103 ground over Popplewell and Sazani, finding a reasonable likelihood that the claims would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“We determine that the Popplewell article relied upon by Petitioner in this proceeding is the same or substantially the same as the art previously presented to the Office. As noted by Patent Owner, Popplewell was cited in an IDS and indicated as being considered by the Examiner during prosecution. Prelim. Resp. 1, 16; Ex. 2012, 2; Ex. 2007, 15. Moreover, Popplewell is discussed in the Specification of the ’461 patent as prior art in which “a technique for skipping exon 53 with a high efficiency has not yet been established.” Ex. 1001, 2:55–56, 3:5–6. This is sufficient under the under the first part of the Advanced Bionics framework. As explained in Advanced Bionics, “[p]reviously presented art includes art made of record . . . such as on an [IDS].” Advanced Bionics at 7–8. We further note that the Popplewell ’212 reference that formed the basis of the Examiner’s rejection during prosecution appears to include substantially similar disclosures as Popplewell, including with regard to the 25-mer PMO-A, which form the primary basis for Petitioner’s unpatentability arguments in this proceeding. See, e.g., Ex. 1023 ¶ 87 (“When tested and compared directly at 300 nM doses by nucleofection, PMO-G, PMO-H and PMO-A were most active producing in the order of 60% exon skipping”). To be sure, we recognize that the Examiner does not appear to have specifically considered, nor did Patent Owner otherwise highlight during prosecution, Popplewell’s or Popplewell ’212’s teachings regarding the viability of PMO-A. We address this failure under the second part of the Advanced Bionics framework.” slip op. at 23
- Other 314aInstitution denied discretionary otherDenied
“2. 35 U.S.C. § 314(a). Patent Owner contends that we should exercise our discretion to deny institution under § 314(a) because of a Mutual Confidentiality Agreement between the parties. Prelim. Resp. 65–73. Patent Owner argues that filing a petition for inter partes review violates the Agreement’s forum selection clause, which requires all potential actions to be filed in the United States District Court for the District of Delaware. Id. at 66–68 (citing Ex. 2026 § 1). Patent Owner acknowledges that the District of Delaware has already denied Patent Owner’s Motion for Preliminary Injunction seeking withdrawal of this and related Petitions due to the Agreement. See id. at 67– 68. Nevertheless, Patent Owner argues that the Board should deny this Petition so that the Federal Circuit can address the issue on appeal. Id. at 74. Finally, Patent Owner argues that considerations of efficiency, fairness, and the merits favor discretionary denial. Id. at 71–73. Petitioner responds that “[t]he Board has consistently refused to interpret and enforce contractual forum-selection clauses in deciding whether to institute post-grant proceedings.” Reply 6–7 (citing Samsung Elecs. Co. v. NuCurrent, Inc., IPR2019-00861, Paper 15, 20 (PTAB Feb. 7, 2020); Bally Gaming, Inc. v. New Vision Gaming & Dev., Inc., CBM2018- 00006, Paper 47, 7–8 (PTAB June 19, 2019); Dot Hill Sys. Corp. v. Crossroads Sys., Inc., IPR2015-00822, Paper 18, 6–10 (PTAB Sept. 17, 2015)). Petitioner further contends that the District of Delaware has already denied Patent Owner’s request for preliminary injunction on this issue, finding that the Agreement indicates that the parties intended to allow IPRs to proceed. Id. at 7 (citing Ex. 1103, 5). We have considered Patent Owner’s arguments related to the forum selection clause in the parties’ Agreement. We determine, however, that the particular facts of this case, including the District of Delaware’s denial of a preliminary injunction, do not warrant exercise our discretion to deny institution on this basis.” slip op. at 28
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“III. CONCLUSION After considering the evidence and arguments presented in the current record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that the challenged claims of the ’461 patent are unpatentable. We therefore institute trial on all challenged claims under the ground raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (Indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); 37 C.F.R. § 42.108(a). At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have a Ph.D. in chemistry, biochemistry, cell biology, genetics, molecular biology, or an equivalent, and several years of experience with AOs for inducing exon skipping. A POSA would also have familiarity with methods for making and testing the safety and efficacy of such AOs, both in vitro and in vivo, and the use of AOs for inducing exon skipping in the context of medical conditions, such as DMD, that may be treated by administering such AOs. Further, a POSA would have knowledge of and experience with chemical modifications that may be incorporated into AOs, such as modifications to the backbone and/or nucleobases of the AOs, and the potential impact of those modifications on the utility of the AOs. Pet. 28–29 (citing Ex. 1097 ¶¶ 91, 92). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. Prelim. Resp. 14. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 14
§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,407,461 - PTAB · Jan 13, 2022 · IPR2021-01138 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–12 based on the §103 ground combining Popplewell and Sazani.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” 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”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of 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 ordinary skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations and citations omitted). slip op. at 10
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“325(d), the Board applies a two-part framework: (1) first, we determine whether the same or substantially the same art previously was presented to the Office, or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, we examine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, 8.” slip op. at 39
- Other 314aInstitution denied discretionary otherDenied
“institution under § 314(a) because of a Mutual Confidentiality Agreement between the parties. Prelim. Resp. 71. Patent Owner argues that filing a petition for inter partes review violates the Agreement’s forum selection clause, which requires all potential actions to be filed in the United States District Court for the District of Delaware. Id. at 66–67 (citing Ex. 2026 § 1). Patent Owner acknowledges that the District of Delaware has already denied Patent Owner’s Motion for Preliminary Injunction seeking withdrawal of this and related Petitions due to the Agreement. See id. at 68. Nevertheless, Patent Owner argues that the Board should deny this Petition so that the Federal Circuit can address the issue on appeal. Id. at 73. Finally, Patent Owner argues that considerations of efficiency, fairness, and the merits favor discretionary denial. Id. at 70–72. Petitioner responds that “[t]he Board has consistently refused to interpret and enforce contractual forum-selection clauses in deciding whether to institute post-grant proceedings.” Reply 6–7 (citing Samsung Elecs. Co. v. NuCurrent, Inc., IPR2019-00861, Paper 15, 20 (PTAB Feb. 7, 2020); Bally Gaming, Inc. v. New Vision Gaming & Dev., Inc., CBM2018- 00006, Paper 47, 7–8 (PTAB June 19, 2019); Dot Hill Sys. Corp. v. Crossroads Sys., Inc., IPR2015-00822, Paper 18, 6–10 (PTAB Sept. 17, 2015)). Petitioner further contends that the District of Delaware has already denied Patent Owner’s request for preliminary injunction on this issue, finding that the Agreement indicates that the parties intended to allow IPRs to proceed. Id. at 7 (citing Ex. 1103, 5). We have considered Patent Owner’s arguments related to the forum selection clause in the parties’ Agreement. We determine, however, that the particular facts of this case, including the District of Delaware’s denial of a preliminary injunction, do not warrant exercise our discretion to deny institution on this basis.” slip op. at 46
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art would have had “a Ph.D. in chemistry, biochemistry, cell biology, genetics, molecular biology, or an equivalent, and several years of experience with AOs for inducing exon skipping” and would “have familiarity with methods for making and testing the safety and efficacy of such AOs, both in vitro and in vivo, and the use of AOs for inducing exon skipping in the context of medical conditions, such as DMD, that may be treated by administering such AOs.” Pet. 31–32 (citing Ex. 1099 ¶ 98). Petitioner also proposes that a person of ordinary skill in the art “would have knowledge of and experience with chemical modifications that may be incorporated into AOs, such as modifications to the backbone and/or nucleobases of the AOs, and the potential impact of those modifications on the utility of the AOs.” Id. at 32 (citing Ex. 1099 ¶ 99). Patent Owner states, “[s]olely for purposes of this IPR, Patent Owner does not dispute Petitioner’s definition of a POSA. To the extent the Board decides to institute this Petition, Patent Owner reserves the right to present a different definition post-institution.” Prelim. Resp. 14. Because Petitioner’s proposed definition is unopposed at this stage of the proceeding and appears consistent with the Specification and art of record, we apply it here.” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,647,741 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00972 · APJ David Cotta · IPR · Institution
Instituted IPR of claims 1–23 on all three asserted §103 grounds; Apple showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“We typically take courts’ trial schedules at “face value,” and decline Petitioner’s invitation to speculate that the target date for completion of the ITC Investigation will slip as a result of the COVID-19 pandemic. Fintiv, IPR2020-00019, Paper 15 at 13 (informative). Accordingly, for purposes of analyzing this factor, we assume that the ITC Investigation will conclude on October 26, 2022. We also decline Petitioner’s invitation to assume an earlier date for issuance of our FWD. Although we appreciate Petitioner’s willingness to expedite resolution of this case, Patent Owner raises valid concerns that compressing the reply period will also compress the window for taking depositions. Moreover, the statutory due date for our FWD is triggered by the date of our institution decision and is unaffected by the date on which Petitioner files its reply. See 35 U.S.C. § 316(a)(11). Given that our FWD in this case is due seven weeks after the targeted completion of the ITC Investigation, we determine that this factor weighs marginally in favor of exercising our discretion to deny institution.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner shows, based on this preliminary record, where each of the limitations of the challenged claims is taught or suggested by the combination of Shmueli and Osorio. Pet. 11–64. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Chaitman. Id.; see also Ex. 1003 ¶¶ 68–150. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on Patent Owner’s arguments that Petitioner has not sufficiently supported a motivation to combine Shmueli and Osorio and that Shmueli and Osorio do not disclose “key elements” of the independent claims. Prelim. Resp. 30–42.” slip op. at 36
- Skill levelSkill level board ownOther
“As such, Dr. Chaitman would appear to qualify as one of ordinary skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we note that we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., No. 10-CV-1835 JAP TJB, 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶¶ 52–53 (emphasis added).9 Indeed, considering that the claims of the ’941 patent relate to, e.g., “method[s] of cardiac monitoring” to “confirm a presence of the arrhythmia,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. Ex. 1001, 17:1–18. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial. C. Claim Construction” slip op. at 25
- Expert testimonyPetitioner expert creditedOther
“cardiac arrhythmia as opposed some other heart condition. Id. at 31–32. In this respect Patent Owner’s declarant, Dr. Efimov, testifies that Shmueli makes no attempt to define “irregular heart condition” with any specificity, and “one can only speculate” as to its meaning because “numerous conditions can be considered heart irregularities: normal autonomic nervous system control, autonomic dysfunction, heart failure, ischemia, myocardial infarction, heart block, etc.” Ex. 2001 ¶ 69. At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that Shmueli discloses “both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 54 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of the ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, which is “one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 13–14 (citing, e.g., Ex. 1003 ¶ 54).” slip op. at 37
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,638,941 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00971 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–30 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 58 & n.2, (“Trial Practice Guide”).6 We consider the following factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding”: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). In evaluating these factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Upon consideration of these factors, we decline to exercise our discretion to deny the Petition. A. Whether the Court Granted a Stay or Evidence Exists That One May Be Granted if a Proceeding is Instituted” slip op. at 10
- Skill levelSkill level board ownOther
“skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary.” Ex. 2001 ¶¶ 52–53 (emphasis added).10 Indeed, considering that the ’731 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). At this stage of the proceeding, no term requires construction. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli” slip op. at 29
- Expert testimonyPetitioner expert creditedDecided for petitioner
“At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that, “Shmueli discloses both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 48 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, “which is one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. (citing, Ex. 1016, 6081; Ex. 1020, Abstract, 44:29– 32; Ex. 1011, Abstract; Ex. 1023, 2; Ex. 1047, 320–321; Ex. 1001, 1:40–42; Ex. 1004, 8:11–13, 15:3–5) (alteration in original). Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 10–12 (citing, e.g., Ex. 1003 ¶ 48).” slip op. at 33
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,595,731 - Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentablePTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision
Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34
Patent outcomesUS 9,693,961 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites NautilusPatents in suitUS 9,693,961 - Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentablePTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision
Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20
- Strike new argumentNew argument disregardedDecided for patent owner
“Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18
Patent outcomesUS 10,195,214 not shown unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,195,214 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 17, 2020 · IPR2019-00338 · APJ Ken B Barrett · IPR · Rehearing
The Board denied Cooler Master’s rehearing request, leaving intact the determination that claim 8 was not shown obvious over Morikawa and Takahashi because the petition did not establish the claimed top shoulder.
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 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.” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“that “Petitioner has not demonstrated that Morikawa discloses the recited [top shoulder limitation].” Final Dec. 45. In other words, our determination was that Petitioner had not met its burden of proving that a limitation was taught by the prior art, and therefore had not met its burden of proving that the challenged claim is unpatentable.” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the Final Decision, we stated: Petitioner’s implied construction is that the claimed “shoulder” is the top end of a column. This is inconsistent with the claim language which recites that the “hollow column . . . has a top shoulder disposed near a top end” thus indicating that the top shoulder is not merely the top end of the column but a structure “near” and discernable from the top end of the hollow column.” slip op. at 8
- Strike new argumentNew argument disregardedDecided for patent owner
“based on a misapprehension of the arguments associated with a figure . . . [from page 57] in the Petition,” and that “the Board incorrectly inferred Petitioner’s ‘implied construction’ for the term, ‘[a top] shoulder,’ in claim 8 of the ’680 patent as ‘the top end of a column.’” Req. Reh’g 1 (citing Final Dec. 45). Petitioner further argues that it “has always and consistently pointed to the corner portions located around the top outer rim of the hollow column as meeting the limitation of ‘a top shoulder,’ as shown [in the two figures from pages 56 and 57 of Petition and reproduced above].” Id. at 5–6.” slip op. at 8
Claim construction§ 103 obviousnessPatents in suitUS 7,100,680 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 16, 2020 · IPR2019-00334 · APJ Linda E Horner · IPR · Rehearing
The Board denied Petitioner’s rehearing request, leaving in place its determination that claim 1 was not shown unpatentable over Morikawa, Takahashi, and Nakamura.
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 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.” slip op. at 2
- Expert testimonyPatent owner expert creditedDecided for patent owner
“criticism of Morikawa’s heat pipe in its Reply, Petitioner failed to provide any expert testimony to support its argument as to how a person of ordinary skill in the art would understand Nakamura. Instead, Petitioner argued that “Nakamura describes some of its advantages over Morikawa’s ‘metal pipe 6’ only” and that “Nakamura is not describing any disadvantages at all associated with Morikawa’s ‘conventional spacer’ by ‘welding and fixing a metal column to upper and lower inner surfaces of the panel.” Pet. Reply 31–32 (citing Nakamura at 4; Morikawa, 4:31‒33). Patent Owner, however, provided expert testimony as to how a person having ordinary skill spacers. PO Resp. 57 (citing Ex. 2002 ¶ 160). We credited this testimony in our Final Decision. Final Dec. 47 (citing PO Resp. 58); id. at 47–48 (agreeing with Patent Owner’s argument).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“improvement to Morikawa’s heat pipe, and, in fact, found that Nakamura’s teaching of an improvement and criticism of Morikawa’s configuration would have led one having ordinary skill in the art to replace all of Morikawa’s spacers with Nakamura’s concavities. See Final Dec. 47–48 (agreeing with Patent Owner’s arguments as to the manner in which Morikawa would have been modified in light of Nakamura’s disclosure); id. at 69–70 (finding, in the context of independent claim 3, that Petitioner provided adequate reasoning, premised on Nakamura’s criticism, to substitute Nakamura’s concavity for the pipe of Morikawa). Petitioner’s citation to pages 58–59 is misplaced to the extent Petitioner relies on this portion of the Petition for a reason to modify Morikawa to replace only some of Morikawa’s spacers with Nakamura’s concavities. Pages 58–59 of the Petition address Petitioner’s proposed modification of Morikawa to substitute Nakamura’s concavities for Morikawa’s pipes to meet the “depression” limitation found earlier in claim 1. See Pet. 55, 62–63 (Petitioner explaining that the proposed combination is the modification of Morikawa’s pipes “to solve these problems.”). The “spacer” limitation appears later in claim 1 and, similarly, Petitioner’s purported reasoning associated with that spacer limitation appears later in the Petition. See Pet. 71–75. The Petition’s discussion of the earlier “depression” limitation does not include a reason to replace only some of Morikawa’s spacers with Nakamura’s concavities.” slip op. at 5
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,100,680 - Cooler Master Co., Ltd. v. Aavid Thermalloy LLCRehearing deniedPTAB · Sep 16, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Rehearing
The Board denied the petitioner’s rehearing request, leaving claim 11 not shown unpatentable because the petition did not adequately explain why only some Morikawa spacers would be replaced with Nakamura depressions.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“As explained in the Final Decision, upon review and consideration of the arguments and evidence submitted by the parties, Petitioner failed to show that the combined teachings of Morikawa and Nakamura would have led one having ordinary skill in the art to the combination of conventional spacers, as discussed in Morikawa, and depressions formed by Nakamura’s concavities, as recited in claim 11. Petitioner’s arguments in the Request for Rehearing do not persuade us that we erred in our application of the facts as presented by Petitioner to the standard for determining obviousness, as set forth in KSR, in finding that Petitioner failed to show unpatentability of claim 11. C. Conclusion For the foregoing reasons, Petitioner has not shown that we misapprehended or overlooked Petitioner’s arguments or evidence in determining that Petitioner did not show by a preponderance of evidence that challenged claim 11 of the ’240 patent is unpatentable.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“not in accordance with the law.” Request 2; see also id. at 6 (arguing that “Petitioner need only provide ‘a reason’ as to why a [person having ordinary skill in the art] would substitute Nakamura’s depressions for some, but not all, of Morikawa’s columns in Morikawa’s device.”). Petitioner discusses the proposed replacement of Morikawa’s “through path” spacers with Nakamura’s concavities, but Petitioner does not discuss why Morikawa’s remaining spacers would also not be similarly replaced. In other words, as explained above, Petitioner provided no reason in its Petition to explain why one would have modified Morikawa by substituting only some spacers with Nakamura’s concavities, when Nakamura teaches making all of its spacers using abutting concavities. Pet. 88‒89 (citing Pokharna ¶ 93, which cross-references itself); Final Dec. 57 (describing Nakamura). As explained in the Final Decision, upon review and consideration of the arguments and evidence submitted by the parties, Petitioner failed to show that the combined teachings of Morikawa and Nakamura would have led one having ordinary skill in the art to the combination of conventional spacers, as discussed in Morikawa, and depressions formed by Nakamura’s concavities, as recited in claim 11. Petitioner’s arguments in the Request for Rehearing do not persuade us that we erred in our application of the facts as presented by Petitioner to the standard for determining obviousness, as set forth in KSR, in finding that Petitioner failed to show unpatentability of claim 11.” slip op. at 11
- BurdenNot shown unpatentable
“2. Petitioner’s Burden As also explained in the Final Decision, “Petitioner bears the burden of proving unpatentability of the claims challenged in the Petition, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish by a preponderance of the evidence that the challenged claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R. § 42.1(d) (2018).” Final Dec. 9.” slip op. at 5
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,066,240 - Boragen, Inc. v. Syngenta Participations AGRehearing deniedPTAB · Aug 10, 2020 · IPR2020-00124 · APJ Timothy G Majors · IPR · Rehearing
The Board denied Boragen’s rehearing request and left in place the denial of institution under § 325(d), finding no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“whether to institute trial for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if there was an erroneous interpretation of law, a factual finding not supported by substantial evidence, or an unreasonable judgment in weighing relevant factors. 37 C.F.R. § 42.71(c); Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); The Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). The rehearing request “must specifically identify all matters the [requesting] party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for patent owner
“Petitioner contends the Board “failed to exercise its discretion under 325(d)” (Req. 2), but this is plainly inconsistent with the Decision, because we did exercise discretion under § 325(d) and denied the Petition because it was based on substantially the same prior art as already considered by the Office. See Dec. 6–35 (analyzing, inter alia, the asserted prior art, the prosecution history, declarant testimony, and the precedential Becton, Dickinson factors under a framework explained further in Advanced Bionics, in route to denial under § 325(d)).1 Petitioner continues, arguing the Board “improperly” slip op. at 3
- Expert testimonyPetitioner expert discountedDecided for patent owner
“expert” may opine on the unpatentability of the challenged claims generally represents one factor that we account for in exercising our discretion under § 325(d) (e.g., insofar as it may comprise “additional evidence” addressing prior art that the Office may have already considered). Becton, Dickinson at 17–18. It is not, however, a super-factor that overrides others in the manner urged by Petitioner that would, in effect, require we institute inter partes review so long as the challenge is accompanied by “new” testimony slip op. at 4
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“precedential after the Petition was filed, and requests “additional briefing to directly address the Advanced Bionics factors” if this Request is denied. Req. 1 n.1. Petitioner’s request for additional briefing is denied. Additional briefing is unnecessary because the arguments and evidence already submitted by the parties is sufficient for us to make a determination based on the two-part framework in Advanced Bionics. Furthermore, we have reviewed the arguments based on Advanced Bionics submitted by Petitioner on rehearing and do not find them persuasive. Req. 8–10 (“Petitioner highlights such errors herewith separately under the guidelines set forth in Advanced Bionics”). Moreover, Advanced Bionics became precedential six weeks before we denied institution in this case, where discretionary denial” slip op. at 10
Discretionary denialPatents in suitUS 10,130,096
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.