- Intel Corporation v. Interdigital, Inc.Institution deniedPTAB · Apr 1, 2025 · IPR2024-01441 · APJ Lisa A Murray · IPR · Institution
The Board denied institution on all four grounds for claims 1–8 under § 325(d), finding the art or arguments previously presented and no material Examiner error shown.
In the decision…filter is a sparse filter.” Ex. 1005, 304; Prelim. Resp. 4. The Examiner then stated that even so, “it would have been obvious . . . to use the teachings of the Applicant’s Admitted prior art to modify the apparatus of Lee by using a sparsity based de-noising filter[.]” Ex. 1005, 304; Pet. 10;…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). The Board uses a two-part framework for evaluating arguments under Section 325(d): (1) 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, whether the petitioner has demonstrated that the” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“CLAIM CONSTRUCTION Both Petitioner and Patent Owner argue that the Board can determine whether to grant or deny institution without construing any claim terms. Pet. 16; Prelim. Resp. 17. They represent, however, that the construction of the term “sparse de-noising filter” is contested in the co-pending investigation under 19 U.S.C. § 1337 at the U.S. International Trade Commission (“ITC”). Pet. 13; see Prelim. Resp. 6–8. In that litigation, four constructions were proposed for that term: ITC Complainants’ proposal, ITC” slip op. at 6
Claim constructionDiscretionary denialPatents in suitUS 9,674,556 - Risen (Suzhou) Pharma Tech. Co. Ltd. v. Alzheon, Inc.Institution deniedPTAB · Jan 9, 2023 · IPR2022-01200 · APJ Devon Zastrow Newman · IPR · Institution
The Board denied institution for claims 1–14 under § 325(d), finding the petition relied on substantially the same art and arguments previously presented and did not show material examiner error.
In the decision…claims under 35 U.S.C. § 103 over Caltagirone and over Caltagirone in view of Kong. See, e.g., Ex. 1002, 204–208. The Examiner cited Caltagirone’s teachings, which were based on post-hoc analysis of data obtained from the ALPHASE study. Id. Caltagirone’s analysis showed a positive and significant…
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“ApoE4+ patient with AD using tramiprosate over the Caltagirone reference, which disclosed treatment of ApoE4+ “all-comers” (containing at least one ApoE4 allele, either heterozygous or homozygous) with tramiprosate. See, e.g., Ex. 1002, 204–208. When Patent Owner responded to the Examiner by highlighting data (i.e., Figure 8 of the specification giving rise to the ’029 patent) showing a notable increase in cognitive function in patients with two ApoE4 alleles (homozygous) who were administered tramiprosate as compared to the ApoE4 “all-comers” (mixed homozygous/heterozygous population), the Examiner suggested narrowing the pending claims to treatment of ApoE4 homozygotes. Ex. 1002, 342. Patent Owner submitted amended claims requiring selection of patients for treatment who were homozygous for ApoE4, and argued: The presently amended claims . . . select only ApoE4 homozygotes for treatment with tramiprosate or a prodrug thereof, necessarily omitting ApoE4 heterozygotes from such treatment. . . . Caltagirone fails to teach or suggest a patient selection strategy that would limit tramiprosate treatment to patients having two ApoE4 alleles and, in fact, teaches away from such selection. Kong fails to contradict or overcome these deficiencies in Caltagirone. Kong does not refer to any patient selection strategy, much less one that would limit tramiprosate prodrug treatment to ApoE4 homozygotes. The Office's reliance on Kong is solely for its teaching of a tramiprosate prodrug. Thus, the combination of Caltagirone and Kong, taken under the Office’s interpretation, suggests treatment of all ApoE4+ patients with a prodrug of tramiprosate. This falls far short of suggesting the presently claimed patient selection and treatment strategy which selects only ApoE4 homozygotes for treatment and does not treat ApoE4 heterozygotes. Id. at 338–39 (emphasis added). The Examiner acknowledged the” slip op. at 16
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“skilled artisan”) at the time of the invention would have had at least an M.D. or Ph.D. degree in a biomedical science or equivalent field. They would also have several years of clinical experience treating and/or conducting clinical trials of drugs for AD patients, or professional experience working in clinical trial design and execution related to drugs for AD or supervising such work. Pet. 19 (citing Ex. 1003 ¶¶ 52–53). Patent Owner does not contest the characterization offered by Petitioner. Prelim. Resp. 14–15. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’029 patent and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 12
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office (Advanced Bionics, Paper 6 at 10). 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 (Advanced Bionics, Paper 6 at 10). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated a material error by the Office (Advanced Bionics, Paper 6 at 10). “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown” (Advanced Bionics, Paper 6 at 9).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached
“Babic ascertained that “different effects of a drug could be observed in different subpopulations of patients based on ApoE4 carrier status”” and that “drug effects in homozygous carriers could be greater than those in the heterozygous carriers and non-carriers who did not respond to the drug.” Ex. 1003 ¶ 107. As stated, this testimony does not support Petitioner’s contention that an ordinary artisan would have been motivated “to select homozygous ApoE4 carriers for treatment with any drug for which response has been correlated to ApoE4 carrier status.” See Pet. 41 (emphasis added). In particular, we find an insufficient factual basis for Petitioner’s contention that results obtained for galantamine, an acetylcholinesterase inhibitor (Ex. 1003 ¶ 105) would have motivated an ordinary artisan to replace the galantamine taught in Babic with tramiprosate (homotaurine), a GABA receptor agonist that works by a different mechanism (Ex. 1007, 582). We have also considered Dr. Ruffalo’s testimony that the ordinary artisan would have been motivated to replace Babic’s galantamine with tramiprosate as taught in Caltagirone or Val-APS as taught in Kong. Ex. 1003 ¶¶ 276–277. Dr. Ruffalo posits that Babic’s disclosures would have motivated the ordinary artisan to analyze Caltagirone’s data to ascertain if tramiprosate is more effective in homozygotes, and to replace galantamine with tramiprosate or Val-APS as taught in Kong because of their improved safety profiles as compared to galantamine, and because the replacement drugs target the underlying disease and not symptom amelioration as does galantamine. Id. Dr. Ruffalo also posits that the prior art would have imparted the following knowledge to the ordinary artisan: because the effect of tramiprosate was dependent on the required ApoE4 allele, homozygotes having the highest number of ApoE4 allele copies would derive, at the very least, as much benefit as from the drug as the heterozygotes having only one copy of the allele, and most likely the homozygotes would have the greatest therapeutic response to tramiprosate since they have the maximum number of copies of the required allele. Having done this simple assessment, A POSA would conclude that tramiprosate would be expected to exhibit a greater therapeutic effect in homozygotes and thus would have been motivated to treat homozygotes with tramiprosate, including in an oral dosage form as taught by Aisen. Id. Dr. Ruffalo further posits that the skilled artisan would have had a reasonable expectation of success in administering tramiprosate to treat homozygous ApoE4 patients because they “would almost certainly have the greatest response to the drug.” Id. ¶ 286. Patent Owner argues that the Examiner previously examined the issue of whether ApoE4 genotypes in treatment decisions should be considered during prosecution, with respect to Caltagirone, where ApoE4 genotypes were included, and Sleegers (Ex. 1002, 685, 1137), where studies led away from such inclusion. Prelim. Resp. 30–31. We find Sleegers’ disclosure” slip op. at 29
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,471,029 - Apotex Inc. / Apotex Corp. v. Auspex Pharmaceuticals, Inc.Institution deniedPTAB · Mar 9, 2022 · IPR2021-01507 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution of review of claims 1–3 under § 325(d), finding the petition relied on substantially the same art or arguments previously presented and did not show material Examiner error.
In the decision…claimed d6deutetrabenazine compound to a non-deuterated dosage form of tetrabenazine. Ex. 1027, 33–48. Patent Owner argued to the Examiner that the teachings “of Zheng and Schwartz that tetrabenazine is metabolized at the O-methyl groups does not support a conclusion that deuteration of those…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of the prior art or arguments. Id. In general, only if the same, or substantially the same, art or arguments previously were presented to the Office, do we turn to whether Petitioner has established a material error. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 24
Discretionary denialPatents in suitUS 8,524,733 - Atrium Medical Corporation v. Bard Peripheral Vascular, Inc.Institution deniedPTAB · Jan 20, 2022 · IPR2021-01200 · APJ James A Tartal · IPR · Institution
The Board denied institution on all challenged claims and grounds under § 325(d), finding substantially the same art had been presented to the Office and no material error was shown.
In the decision…The identical question and answer appears on multiple pages of Exhibit 1012. See Ex. 1012, 21–22, 27–28, 33–34. 14 IPR2021-01200 Patent 7,947,022 B2 teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20
- Expert testimonyPetitioner expert discountedOther
“Pet. vi. Although both citations above refer to “Herts” as an author, it is apparent that the citations to the two articles provide different article titles, different publications, and different publication dates. Accordingly, Petitioner’s assertion that “Bardport specifically identifies Herts as ‘on the subject’ of, and ‘of help’ regarding, the use of power injectors with Bard’s venous access port assembly,” is incorrect, because the article Petitioner relies on as Herts is not the article cited in Bardport authored by “Herts.” See Pet. 22 (citing Ex. 1012, 27–28; Ex. 1038, 1–2). Mr. Leschinsky’s testimony regarding Bardport on this point is likewise incorrect. See Ex. 1003 ¶ 94. Mr. Leschinsky states that “[i]t is my opinion that a [person of ordinary skill in the art] would have been motivated to combine the 9 The identical question and answer appears on multiple pages of Exhibit 1012. See Ex. 1012, 21–22, 27–28, 33–34. teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an catheters be used in the Radiology Department with the Power Injector?’ Bardport cites to Herts.” Id. (citing Ex. 1012, 21–22). As explained above, Bardport does not cite to Herts, the reference relied upon by Petitioner, but instead refers to a different article identifying “Herts” as the author.” slip op. at 14
Discretionary denialPatents in suitUS 7,947,022 - Atrium Medical Corporation v. Bard Peripheral Vascular, Inc.Institution deniedPTAB · Jan 20, 2022 · IPR2021-01199 · APJ James A Tartal · IPR · Institution
The Board denied institution on all challenged claims and grounds under § 325(d), finding the art previously presented to the Office and no material Office error.
In the decision…Ex. 1003 ¶ 100. Mr. Leschinsky states that “[i]t is my opinion that a [person of ordinary skill in the art] would have been motivated to combine the teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 20
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board has discretion to deny a request for institution when the information presented shows that the petitioner raises “the same or substantially the same prior art or arguments previously presented to the Office,” for example, during patent examination or” slip op. at 2
- Expert testimonyPetitioner expert discountedOther
“See Pet. 54 (citing Ex. 1012, 27–28; Ex. 1038, 2). Mr. Leschinsky’s testimony regarding Bardport on this point is likewise incorrect. See Ex. 1003 ¶ 100. Mr. Leschinsky states that “[i]t is my opinion that a [person of ordinary skill in the art] would have been motivated to combine the teachings of Herts . . . because Bardport itself acknowledges Herts’ findings,” and “in response to a ‘frequently asked question’ titled ‘[c]an catheters be used in the Radiology Department with the Power Injector?’ Bardport cites to Herts.” Id. (citing Ex. 1012, 21–22). As explained above, Bardport does not cite to Herts, the reference relied upon by Petitioner, but instead refers to a different article identifying “Herts” as the author.” slip op. at 15
Discretionary denialPatents in suitUS 7,785,302 - Atrium Medical Corporation v. Bard Peripheral Vasulcar, Inc.Institution deniedPTAB · Jan 10, 2022 · IPR2021-01197 · APJ Ryan H Flax · IPR · Institution
The Board denied institution of IPR challenging claims 8, 9, and 11 under § 325(d), finding the same art had been presented before and no material Office error was shown.
In the decision…recite that the claimed access port assembly is power injectable.” Id. at *7, *13. In its decision, the Board provided an analysis of the relevant teachings of Reuter, Sanfilippo, and Bunodiere. Id. at *7–*10. Patent Owner appealed the Board’s decision to the U.S. Court of Appeals for the Federal…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 18
- Expert testimonyOther
“5 It is specifically this portion of Melsky that Petitioner cites as teaching a power-injectable access port, as claimed. See Pet. 27, 31, 36; see also Ex. 1003 ¶¶ 66, 70, 74 (analyzing Melsky and concluding it teaches a power injectable port, as claimed). We note that Melsky never expressly mentions a power injectable port. See generally Ex. 1008. Petitioner’s witness relies on Melsky’s disclosure that its port can withstand pressures of 200 psi or more as inherently disclosing a power injectable port; however, the witness merely concludes this without citation to supporting evidence. This is meager evidence of an alleged inherent disclosure intended to be a foundation of Petitioner’s challenges in this proceeding. “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a); see TQ Delta, LLC v. CISCO Sys., Inc., 942 F.3d 1352, 1358–59 (Fed. Cir. 2019) (“conclusory expert testimony is inadequate to support an obviousness determination on substantial evidence review.”).” slip op. at 16
Discretionary denialPatents in suitUS 7,959,615 - 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.
In the decision…Req. 5–6. We turn next to the Sibley reference. Petitioner argues the Board “misapprehended the evidence by improperly narrowly interpreting the teachings of Sibley.” Req. 7. Here again, this is not an argument that supports the grant of Petitioner’s rehearing request. That the Board disagreed…
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 - Dorco Company, Ltd. v. The Gillette Company, LLCRehearing deniedPTAB · Aug 21, 2017 · IPR2017-00500 · APJ Elizabeth M Roesel · IPR · Rehearing
The Board denied Dorco’s rehearing request, leaving institution denied because the petition presented substantially the same patentability issue previously considered during prosecution.
In the decision…1002, 51–52). Applicants also argued that there is “no motivation to combine, as Hahn teaches directly bonding the PTFE to the hard coating, thus teaching away from any use of an intermediate layer as in Lane.” Id. at 9 (quoting Ex. 1002, 80). Even if Goel provided more compelling reasons to…
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioner’s arguments do not persuade us to grant rehearing for two reasons: First, Petitioner’s arguments could not have been misapprehended or overlooked because they were not raised in the Petition; and second, even if Petitioner’s rehearing arguments had been raised in the Petition, they do not persuade us that we abused our discretion in denying institution.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“Petition, they do not persuade us that we abused our discretion in denying institution. More specifically, Petitioner’s rehearing arguments do not persuade us that it was an abuse of discretion to find that Petitioner’s Ground 1 presents essentially the same question of patentability as was previously presented to the Office during prosecution. Dec. 15. Petitioner contends that there would have been more compelling reasons for a POSA to combine Goel and Lane than there would have been to combine Hahn and Lane. Reh’g Req. 1–2, 7–11, 13. Even if we accept Petitioner’s contention, it does not change our analysis of whether the Petition presented the same or substantially the same prior art or arguments as were previously presented to the Office. Petitioner’s rehearing arguments are premised on the mistaken” slip op. at 7
Discretionary denialPatents in suitUS 6,684,513 - Dorco Company, Ltd. v. The Gillette Company, LLCInstitution deniedPTAB · Jun 21, 2017 · IPR2017-00500 · APJ Elizabeth M Roesel · IPR · Institution
The Board denied institution on all asserted grounds, finding the petition presented the same or substantially the same prior art or arguments previously considered by the Office.
In the decision…or suggest a hard coating of an amorphous material and that Hahn and Decker “teach away from the 7 IPR2017-00500 Patent 6,684,513 B1 invention in teaching that a PTFE layer should be deposited directly on the amorphous hard coat carbon layer. . . .” Id. In an Office Action mailed February 5,…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Section 325(d) and decline to institute an inter partes review based on any ground asserted in the Petition. We find that the Petition presents “the same or substantially the same prior art or arguments” as were previously presented to the Office during prosecution of the ’513 patent. 35 U.S.C. § 325(d).” slip op. at 15
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Petitioner relies on the Watts Declaration (Ex. 1007), which was not presented to the Office during prosecution of the ’513 patent. We agree with Patent Owner, however, that Dr. Watts’ testimony does not add facts or analysis substantially beyond what was considered by the Office during prosecution. Prelim. Resp. 27–29.” slip op. at 18
Discretionary denialPatents in suitUS 6,684,513 - Fustibal LLC v. Bayer Healthcare LLCInstitution deniedPTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.
In the decision…v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006). Therefore, to anticipate a later-claimed species, a pattern of preferences or other related teaching or suggestion must 12 Case IPR2016-01490 Patent 8,637,553 B2 lead to a genus small enough that a person of ordinary skill in the art would at…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17
- Skill levelSkill level petitioner adoptedOther
“Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,637,553
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.