- Nokia Of America Corporation v. Alexander Soto And Walter SotoInstitution deniedPTAB · Nov 3, 2023 · IPR2023-00682 · APJ Patrick M Boucher · IPR · Institution
The Board denied institution under § 325(d), finding substantially the same art had been presented to the Office and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“GMBH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”), the Board applied a two-part framework in considering whether to exercise discretion to deny institution under § 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 first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics at 8.” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“D. Conclusion We conclude that (1) substantially the same art was previously presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review.5 IV. ORDER In consideration of the foregoing, it is ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 25
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“5 Because we deny the Petition under 35 U.S.C. § 325(d), we do not reach Patent Owner’s request that we deny the Petition under Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 13–14 (PTAB Mar. 20, 2020) (precedential). See Prelim. Resp. 53–60. Nor do we reach the parties’ merits arguments.” slip op. at 26
Discretionary denialPatents in suitUS 10,771,181 - Gator Bio, Inc. v. Sartorius Bioanalytical Instruments, Inc.Institution deniedPTAB · Jun 20, 2023 · IPR2023-00215 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution of review of claims 1–19 under § 325(d), finding substantially the same art or arguments had been considered and no material Examiner error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“We have authority to institute an inter partes review only where the information presented establishes “a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board also has discretion to deny review if “the same or substantially the same prior art or arguments previously were presented to the Office,” for example, during patent prosecution. 35 U.S.C. § 325(d). We exercise our discretion under § 325(d) and decline to institute an inter partes review of the ’585 patent without addressing whether Petitioner satisfies the evidentiary threshold for review under § 314(a).” slip op. at 2
Discretionary denialPatents in suitUS 8,305,585 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01533 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of review of claims 1, 2, 5, 7, 8, 10, 11, 15, 18, 21, 23, 32, 33, 36, 38, 39, 41, 42, 46, 49, 52, 54, 63, 65, 68–70, 73, 77, …
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“(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 first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Id. at 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“6 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 9
Discretionary denialPatents in suitUS 8,287,482 - Ivantis, Inc. / Alcon Research, LLC et al. v. Sight Sciences, Inc.Institution deniedPTAB · Mar 27, 2023 · IPR2022-01530 · APJ Ulrike W Jenks · IPR · Institution
The Board denied institution of IPR for claims 1–3, 6–9, 12, 13, 15, and 17–20 under § 325(d), finding the art or arguments substantially similar to those previously considered and no material examiner error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“4. Summary Considering the above Becton Dickson factors as they are incorporated into the two-part Advanced Bionic framework, we find that the factors weigh in favor of exercising our discretion and denying institution under § 325(d). The asserted art is either the same as, or cumulative to, the prior art that Examiner has already considered during prosecution of the ’742 patent and its parent application. Further, the arguments Petitioner Examiner during prosecution. Thus, we deny institution under § 325(d). III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent.” slip op. at 29
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Not reached
“A. Discretion Under 35 U.S.C. 325 (d) We first consider Patent Owner’s request that we deny institution7 under 35 U.S.C. § 325(d). Prelim. Resp. 9–52. Patent Owner contends that Petitioner’s alleged prior art was presented previously to Examiner during prosecution of the ’742 patent and its parent applications. Id. In the Patent Owner Response, Patent Owner provides a patent family tree, reproduced below. The patent family tree shows that “[t]he ’443 is a parent and the ’789 is a grandparent of the ’742” patent. Prelim. Resp. 8. Patent Owner argues that the same “Primary Examiner . . . examined all patents in this family. (See 7 Patent Owner presents an alternative basis for denying institution under 35 U.S.C. § 314(a) based on Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) and the Director’s Memo re Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Vidal Memo”), at 4 (June 21, 2022). Prelim Resp. 76–81. Because we deny institution based on 35 U.S.C. § 325(d) need not separately reach a conclusion based on Fintiv in this decision.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Because the same or substantially the same art previously were presented to the Office and Petitioner has not demonstrated that Examiner materially erred when considering the prior art, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’742 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner’s request for an inter partes review, pursuant to 35 U.S.C. § 314(a), of claims 1–3, 6–9, 12, 13, 15, and 17–20 of the ’742 patent is denied, and no trial is instituted.” slip op. at 30
Discretionary denialPatents in suitUS 10,314,742 - Motorola Mobility LLC v. Maxell, Ltd.Institution deniedPTAB · Feb 2, 2023 · IPR2022-01287 · APJ Kevin C Trock · IPR · Institution
The Board denied institution on claims 1–6 under § 325(d), finding substantially the same prior art had been presented and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“cumulative to at least Kijima and Tani, as well as Petitioner’s cumulative use of Sawanobori, Silver, and Teranishi, we find that part one of the Advanced Bionics framework is met. Other Board decisions have reached the same conclusion given circumstances similar to this case. See, e.g., Samsung Elecs. Co. v. Power2B, Inc., IPR2021-01190, Paper 11 at 15–17 (PTAB Jan. 6, 2022).” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary response “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.”” slip op. at 2
Discretionary denialPatents in suitUS 8,059,177 - 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.
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 - Google LLC v. Valtrus Innovations LimitedInstitution deniedPTAB · Jan 3, 2023 · IPR2022-01197 · APJ Sheldon M Mcgee · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on the Ogawa grounds and § 325(d) barred the Vea grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“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) (2018). The findings and conclusions set forth in this Decision are provided for the exclusive purpose of explaining our determination that Petitioner has not met that standard on this record. slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“framework set forth under Advanced Bionics, LLC v. Med-El Electromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Under that framework, we must first determine whether the same or substantially the same art or arguments previously were presented to the Office. If so, we must then determine whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Id. at 8.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the 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, 163–64 (Fed. Cir. 1985))). A more specific definition is not necessary for purposes of deciding whether to institute review. To the extent a more specific definition is required, however, we adopt Petitioner’s proposed definition because, on this record, it is consistent with the disclosures of the asserted prior art references.” slip op. at 10
- Expert testimonyPetitioner expert discountedDecided for patent owner
“12 Dr. Madisetti’s testimony here is entitled to little to no weight as it merely parrots the Petition. 37 C.F.R. § 42.65(a).” slip op. at 19
§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 6,816,809 - Darfon Electronics Corp. v. Michael ShipmanInstitution deniedPTAB · Dec 2, 2022 · IPR2022-01008 · APJ Debra K Stephens · IPR · Institution
The Board denied institution under § 325(d), finding the asserted art cumulative of art previously presented to the Office and no material Office error shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“In evaluating arguments under § 325(d), we use [a] two-part framework: (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 first part of the framework is satisfied, whether the petitioner slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“(a) THRESHOLD.—The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition (35 U.S.C. § 314(a)). Petitioner challenges claims 1–20 as unpatentable under 35 U.S.C. § 103 in twelve grounds of unpatentability (Pet. 7). Generally, Patent Owner contends that the Petition should be denied as to all challenged claims (see Prelim. Resp.). We do not reach whether Petitioner has shown a reasonable likelihood of prevailing on at least one claim. For reasons discussed below, we discretionarily deny the Petition under 35 U.S.C. § 325(d).” slip op. at 2
Discretionary denialPatents in suitUS 10,942,581 - Miltenyi Biomedicine GmbH / Miltenyi Biotec Inc. v. The Trustees Of The University Of PennsylvaniaInstitution deniedPTAB · Oct 11, 2022 · IPR2022-00853 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on all challenged claims under § 325(d), finding substantially the same art had been presented to the Office and no material examination error was shown.
RulingsInstitution decision- Skill levelSkill level board ownOther
“In addressing the level of ordinary skill in the art, Petitioner contends that: A POSA is a person skilled in the art of administering CAR T-cell therapies. The person would possess a relatively high level of skill and have at least an MD, together with several years of experience in administering CAR T-cell therapies. The person would also have experience designing CARs. The POSA would have knowledge of the scientific literature pertaining to immunology, including CARs and methods for utilizing CARs before the priority date. A POSA would also be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells. A POSA would also be knowledgeable about designing clinical trials, including selecting dose ranges, that evaluate CAR T-cell therapies. Pet. 10. Patent Owner does not presently contest this definition. Although Petitioner’s definition generally comports with our understanding of the high level of skill in the art, we are not persuaded all of the asserted qualifications must be embodied in a single person. For example, it seems unduly limiting to require that the person of ordinary skill in the art have “at least an MD” degree, and “be knowledgeable about laboratory techniques related to engineering and testing the function of CAR T-cells,” as Petitioner suggests. Accordingly, we provisionally adopt Petitioner’s definition with the caveat that the asserted qualifications may be shared among multiple individuals working as part of a multidisciplinary team. C. Claim Construction” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached
“Patent Owner points out that the structure of independent claim 1 here is similar to those addressed in Eli Lilly. Prelim. Resp. 18. And, as in Eli Lilly, the Specification of the ’140 patent underscores the centrality of the method recited in the preamble. Id. (citing Ex. 1001, codes (54), (57), 1:55– 57). Unlike in Eli Lilly, however, the body of independent claim 1 does not recite merely “an effective amount” but “an anti-tumor effective amount” of the composition administered. Petitioner argues that whereas the preambles in Eli Lilly “provide the only metric by which one practicing the claim could determine whether the amount administered is an ‘effective amount,’” the term “anti-tumor effective amount” in independent claim 1 “is well-defined by the specification and provides sufficient guidance for determining effectiveness.” Prelim. Reply 3 (citing Eli Lilly at 1342). On balance, Petitioner appears to have the better argument. Nonetheless, even if we were to construe the treatment language of the preamble to mean “reducing the frequency or severity of at least one sign or symptom of cancer” as Patent Owner proposes, this definition is coextensive with, if not subsumed by, the term “anti-tumor effective amount,” discussed below. As such, the outcome of this proceeding does not turn on whether the preamble is limiting.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“As we understand it response, Patent Owner does not appear to contest that “anti-tumor effect” can comprise a decrease in the number of tumor cells, but argues that the claim term requires “a palpable therapeutic effect,” which is more than “just the death of a single cancer cell or handful of cells.” Prelim. Resp. 19–23; Prelim. Sur-reply 4–5. In support, Patent Owner points to the ’140 patent’s express definition of “[a]n ‘effective amount’” as meaning “an amount which provides a therapeutic or prophylactic benefit.” Pet. 20 (citing Ex. 1001, 13:53–54). Relatedly, we note that the Specification also teaches that a “‘therapeutically effective amount’ includes that amount of a compound that, when administered, is sufficient to prevent development of, or alleviate to some extent, one or more of the signs or symptoms of the disorder or disease being treated.” Ex. 1001, 18:12–15. Patent Owner further contends that “[t]he specification teaches that ‘an antitumor effective amount’ is an amount to be administered that is “determined by a physician” as part of determining ‘[t]he optimal dosage and treatment regime for a particular patient . . . by monitoring the patient for signs of disease and adjusting the treatment accordingly.’” Prelim. Resp. 22 (citing Ex. 1001, 37:53–38:5). Considering the argument and evidence of record, we agree with Patent Owner that one of ordinary skill in the art would understand an “anti- tumor effective amount” as used in claim 1 to require more than the killing of a single tumor cell. Accordingly, we provisionally construe “anti-tumor effective amount” as any amount of CAR T-cells administered to a patient in need of cancer treatment that reduces the frequency or severity of at least one clinically relevant sign or symptom of the disease. To the extent this functional limitation is satisfied, claim 2 indicates that an “anti-tumor effective amount” may be limited to between 104 to 109 CAR T-cells/kg body weight. At this stage of the proceeding, no other term requires construction.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“reasonable expectation of success in light of the unpredictability of cancer therapy and the “uninspiring” results and failures of earlier CAR-T clinical trials. Prelim. Resp. 23–28 (citing e.g., Ex. 2037, 1036; Ex. 2010, 1824– 1825; Ex. 2032, 1250–1251). In support, Patent Owner points to OSI Pharms. as “directly on-point.” Id. at 24 (citing OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019)). The claims at issue in OSI Pharms., were structurally similar to those at issue here and directed to a method of treating non-small cell lung cancer (“NSCLC”) in a mammal using a therapeutically effective amount of erlotinib, which had previously been shown to inhibit the epidermal growth factor receptor (“EGFR”) in vitro. 939 F.3d at 1378–79. The court stated: Cancer treatment is highly unpredictable. Even though the EGFR was identified in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons. Id. at 1377; see also id. at 1386 (“1,630 other new drug compounds that, like erlotinib, targeted NSCLC and were studied in Phase II trials. The failure rate for these compounds was 99.5%”). Against this backdrop, the court reversed the Board over its unsupported reading of the two cited references, finding that: the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC. The record does not contain any clinical (human) data or preclinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. Id. at 1384. Considering the promising in vitro data presented in Campana and Jensen, Petitioner here has a somewhat better position than the Appellees in OSI Pharms. At core, Grounds 1 and 2, require us to find a reasonable expectation of success in treating a human cancer based on in vitro experiments, the mere existence of a clinical trial, and absent any of the “clinical (human) data or preclinical (animal) data,” highlighted by the court. See id. Considering the inherent unpredictability of the field and the history of failures of similar technology documented by Patent Owner, we do not find Petitioner’s arguments persuasive. As such, Petitioner has not demonstrated a reasonable likelihood of success in proving that any claim of the ’140 patent is unpatentable under Grounds 1 and 2.” slip op. at 40
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,464,140 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Aug 1, 2022 · IPR2022-00449 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the written-description priority arguments were substantially the same as those considered by the Office, and Petitioner did not show material error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Based on this record, we find Petitioner’s arguments challenging written description support are the same or substantially the same as those considered by the examiner during the prosecution of the ’045 application. 4. Material Error Having found that the condition in the first part of the two-prong framework is satisfied, we next evaluate whether Petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, 8. Based on the current record, we determine Petitioner has not met its burden to show the examiner materially erred.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“Specifically, Petitioner argues that the ’785 application lacks written description support for “converting” or “attaching” tags to “circulating DNA molecules,” as recited in independent claims 1 and 20. Id. at 17–30. Patent Owner argues that we should deny institution under § 325(d) “because the Office already found that the specification provides § 112 support for tagging circulating DNA.” Prelim. Resp. 10. For the reasons explained below, we find Patent Owner’s arguments persuasive.5 5 As another basis for its priority arguments, Petitioner contends that the ’785 application does not enable methods for “converting” or “attaching” tags to “circulating DNA molecules.” Pet. 30. Patent Owner asserts that “[t]he Petition gives enablement only cursory treatment.” Prelim. Resp. 36. We agree with Patent Owner. Petitioner disposes of the entire enablement argument in a single seven-line paragraph. See Pet. 30. It provides no meaningful analyses of the factors set forth in In re Wands, 858 F.2d 731,” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“III. CONCLUSION Petitioner’s anticipation and obviousness grounds rest on the priority date of the challenged claims. Because we decline to reconsider Petitioner’s challenge of priority date based on lack of written description support, we exercise our discretion under § 325(d) and decline to institute inter partes review of the ’699 patent. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied.” slip op. at 18
§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,689,699
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.