- PTAB · Apr 7, 2022 · PGR2021-00042 · APJ Sheridan K Snedden · PGR · Rehearing
The Board granted rehearing, reversed its discretionary denial, and instituted PGR on claims 6–8 based on the threshold showing of likely lack of enablement and anticipation.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We agree with Petitioner that a rehearing of our prior decision to deny institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“institution is appropriate due to the changed circumstances of claims 6–8 of” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“35 U.S.C. § 324(a) provides that a post-grant review may not be instituted “unless the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, and the evidence cited therein, we determine that Petitioner has shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Therefore, we grant institution of a post-grant review.” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we accept Petitioner’s proposed definition, which is supported by Dr. Lambert’s testimony (Ex. 1002 ¶ 20) and is consistent with the scope and content of the ’039 patent and the asserted prior art.” slip op. at 17
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - PTAB · Apr 7, 2022 · PGR2021-00030 · APJ Sheridan K Snedden · PGR · Rehearing
Granted Petitioner’s rehearing request and instituted PGR on claims 1–5, 9, and 10 based on the more-likely-than-not enablement showing and efficiency considerations.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“3. Analysis “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366. Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner has established that it is more likely than not that claims 1–5, 9, and 10 of the ’039 patent lack enablement. In particular, we are persuaded based on the record at this stage of the proceeding that the Specification does not enable the full scope of the claims. The Specification focuses on dolastatin/auristatin derivatives and does not describe novel ADCs having non-dolastatin/auristatin derivative drug moieties. Ex. 1001, Abstract. For example, the Specification states that “there is a clear need in the art for dolastatin/auristatin derivatives having significantly lower toxicity, yet useful therapeutic efficiency [sic]” and purports that “[t]hese and other limitations and problems of the past are addressed by the present invention.” Id. at 4:25–29 (emphasis added). Moreover, each embodiment, example, figure, and assay disclosed in the Specification appears to use a drug moiety that is a dolastatin/auristatin derivative. See, e.g., Ex. 1001, Abstract, 4:22–29, 50:56–52:30, 71:19–22, 131:23–48, Figs. 1–19, Examples 2–16. Claim 1, however, recites ADCs” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“As acknowledged by both Petitioner and Patent Owner, this proceeding and PGR2021-00042 involve essentially identical issues. See 6 Reh’g Req. 15; Prelim. Resp. 19 n.3. In particular, we note that claims 6–8 of the ’039 patent challenged in PGR2021-00042 depend from claim 1 of the ’039 patent challenged in this proceeding, and are challenged under essentially identical written description, enablement and prior art issues. Reh’g Req. 15. Thus, our decision to institute post-grant review in PGR2021-00042 effectuates our review of issues almost identical to those in this proceeding. Petitioner further argues that this proceeding and PGR2021-00042 involve related issues, and that “considerations of efficiency . . . therefore counsel in favor of the Board reviewing the patentability of claims 1–5, 9, and 10 of the ’039 patent as well.” Id. We agree with Petitioner that, because we are to review practically the same issues of this proceeding in PGR2021-00042, considerations of efficiency (i.e., efficient use of the Board’s resources) strongly weigh in favor of also instituting trial in this proceeding. See Reh’g Req. 15. Considering all the factors together as a whole, we determine that, under the particular circumstances of this case, the interests of efficiency and integrity of the patent system weigh against exercising discretionary denial under § 324(a). Accordingly, we grant Petitioner’s Request for Rehearing and decline to exercise our discretion to deny institution. We consider the merits of the Petition with respect to the threshold for institution below.” slip op. at 6
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Instituted
“skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)) (alteration in original). “The enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. The scope of the claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195–96 (Fed Cir. 1999). [Although] a specification need not disclose what is well known in the art . . . , that general, oft-repeated statement is merely a rule 24 of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc., 108 F.3d at 1366.” slip op. at 24
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,808,039 - Neumodx Molecular, Inc. v. Handylab, Inc.Rehearing grantedPTAB · Aug 6, 2021 · IPR2020-01133 · APJ Jo-Anne M Kokoski · IPR · Rehearing
Granted Petitioner’s rehearing request and instituted review of claims 1–15 on all asserted grounds because the Petition showed a reasonable likelihood of unpatentability.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“Rehearing Request and conclude that we misapprehended the law of incorporation by reference when evaluating the grounds based on Ganesan- Publ’424, and that the Petition sets forth sufficient grounds and evidence to justify institution of trial.8 We, therefore, grant Petitioner’s Rehearing 8 Because our determination that we misapprehended the law of incorporation by reference is dispositive, we need not address Petitioner’s other arguments in the Rehearing Request. Request and institute an inter partes review of claims 1–15 of the ’103 patent on all the grounds asserted in the Petition.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“‘generally incorporates’ Ganesan-Prov’264, and did not ‘identif[y] with particularity’ any specific subject matter from Ganesan-Prov’264 . . . misapprehended the law of incorporation by reference in a way that is contrary to both Federal Circuit precedent and other Board decisions.” Req. Reh’g 10 (citing Dec. 18; Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000)). In particular, Petitioner argues that Advanced Display’s statement that “[t]o incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents” (212 F.3d at 1282) does not mean that the host document must identify some specific subject matter or subpart of the incorporated document (such as by page/line). Rather, the quoted statement simply means that the host document must clearly identify what is being incorporated and where it can be found—even when the incorporation applies to the entire document.” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“with sufficient particularity such that the entirety of Ganesan-Prov’264 is incorporated therein, and Ganesan-Prov’264 forms a part of Ganesan- Publ’424 for purposes of anticipation. Ganesan-Prov’264 “relates generally to techniques for thermal control of microfluidic devices.” Ex. 1208, 2:29– 30. Ganesan-Prov’264 teaches that “heater/sensors in accordance with the invention may be integral with a microfluidic device or separate from a microfluidic device,” and “may be formed separately from the microfluidic device.” Id. at 12:16–21 (emphases added). Ganesan-Prov’264 further teaches that “one or more heater/sensors may be formed as part of a device configured to operatively receive a microfluidic device,” and “[t]he device may include one or more heater sensors positioned to be in thermal contact with portions of the operatively received microfluidic device.” Id. at 12:21– 26. Based on these teachings, Petitioner’s declarant, Dr. Mark Burns, testifies that “the heater array of Ganesan-Publ’424 may be formed integrally with the network-containing microfluidic substrate, or may be formed separately in a testing device into which the microfluidic substrate is placed or another part of the system.” Ex. 1101 ¶ 345 (citing Ex. 1109 ¶ 79; Ex. 1208, 12:20–25).” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“to begin on April 11, 2022. Prelim. Resp. 45. We note, however, that the parties recently filed a Stipulation and Proposed Order to Extend Case Schedule, pushing the trial to December 2022, which the district court granted. Ex. 3001. Given the statutory deadlines, our latest possible date for issuance of a final written decision in this proceeding is in July, 2022, one year after we issue this decision instituting an inter partes review. 35 U.S.C. §§ 314(c), 316(a)(11); see also 37 C.F.R. § 42.100(c). Thus, our final written decision would issue at least four months before trial. “If the court’s trial date is earlier than the projected statutory deadline, the Board generally has weighed this fact in favor of exercising authority to deny institution under NHK.” Fintiv Order 9. We find that this factor weighs strongly against exercising discretion to deny institution.” slip op. at 12
§ 102 anticipationDiscretionary denialPatents in suitUS 8,415,103 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441 - Blue Coat Systems, Inc. v. Finjan, Inc.Rehearing grantedPTAB · Jul 18, 2017 · IPR2016-01444 · APJ Patrick M Boucher · IPR · Rehearing
Granted Blue Coat’s rehearing request and instituted review of claims 1, 4–6, 9, 12–14, 17, 24, 35, and 37; the petition showed a reasonable likelihood of prevailing on the asserted § 103 grounds.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“reexamination proceeding. Of particular relevance, the reexamination concluded with a Reexamination Certificate issued on November 28, 2016, including a claim for the benefit of the November 8, 1996 filing date of U.S. Provisional Appl. No. 60/030,639 (“the ’639 provisional application”). Ex. 3006 at [60]. In denying the Petition, the Prior Decision noted that “Petitioner has taken no steps to explain or respond to the effect of these developments on its argument.” Dec. 7. This remains true. Nevertheless, we agree with Petitioner that our Prior Decision gave insufficient consideration to the Petition’s assertion that “U.S. Patent No. 7,613,926 [(“the ’926 patent”), i.e., an intermediate patent in the priority chain of the ’086 patent] fails to claim priority to the ’639 provisional application and instead the earliest priority document cited in the ’926 patent is [the ’194 patent].” Pet. 5 (citing Ex. 1012, col. 1, ll. 8–32); see Req. Reh’g 4–5, 6 n.4, 7–9. For a claim of a patent to be entitled to the effective filing date of an earlier filed application, each application in the priority chain must refer to the earlier filed application. Encyclopaedia Britannica, Inc. v. Alpine Elecs. of Am., Inc., 609 F.3d 1345, 1350–52 (Fed. Cir. 2010). Accordingly, we grant Petitioner’s Rehearing Request and proceed to the merits of the Petition.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedMixed
“a formally defined safety policy” and allows checking “with certainty, that the proof is valid and hence the foreign code is safe to execute.” Ex. 1004, 107. Thus, Petitioner argues that one of ordinary skill in the art would reasonably understand Necula to teach that its proof-carrying code adds to the foreign code, consistent with the construction of “append” that we apply herein, and Petitioner articulates sufficient reasoning with rational underpinning to apply that teaching to Swimmer’s representation of DSP data. See Pet. 46–49. This is not an instance, for example, in which Petitioner relies on a characterization of the problem provided by the patent to derive its reasoning. Cf., e.g., Mintz v. Dietz & Watson, Inc., 679 F.3d 1372 (Fed. Cir. 2012). Indeed, Patent Owner’s contention that “the storage of the DSP in a database is one of the key features that distinguishes the ‘086 Patent over the prior art” dilutes the strength of its argument. The contrary positions of the parties’ declarants in their testimonial evidence creates a genuine issue of material fact, which we resolve in the light most favorable to Petitioner for purposes of this Decision. 37 C.F.R. § 42.108(c). Accordingly, we conclude that Petitioner has made a sufficient showing also with respect to these elements, and that Petitioner demonstrates a reasonable likelihood of prevailing on its challenge of claims 1 and 9. See infra Section II.E.10 (discussing limits in our weighing of Patent Owner’s Secondary Considerations evidence in this Preliminary Proceeding).” slip op. at 21
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“be considered under 35 U.S.C. § 312 because Petitioner has failed to name all real parties in interest, as required by the statute.” Prelim. Resp. 9. The parties agree that, on June 12, 2016, Symantec Corporation (“Symantec”) announced that it was acquiring Petitioner. Pet. 13; Prelim. Resp. 9. The Petition discloses that “[t]he transaction is expected to close in the third quarter of 2016,” and that “[a]s of the filing date of this petition the transaction has not been executed.” Pet. 13. The Petition further represents that “Symantec has not controlled or had the ability to control the filing of this petition, whether through funding or strategy.” Id. As noted above, Petitioner expressly identified Symantec as a real party in interest before any decision on institution of an inter partes review was made. Paper 8, 2. Patent Owner contends that “Symantec had control over the filing of the Petition during the period between the announcement of the acquisition and the closing of the acquisition,” which it asserts occurred on August 1, 2016. Prelim. Resp. 9. Patent Owner also contends that it “understands from the underlying litigation that ‘Blue Coat Systems, Inc.’ no longer exists 1 A petition to accept an unintentionally delayed claim of priority for the ’926 patent, claiming the benefit of U.S. Patent Appl. No. 08/790,097 which was filed January 29, 1997, was dismissed by the Office on June 13, 2017. Exs. 1027, 3007. A renewed petition was filed on June 16, 2017. Ex. 3008. At this time, the Office has not ruled on the renewed petition, and that pending petition accordingly does not affect our determination of the challenged claims’ effective filing date for purposes of this Decision. as an entity, or at least goes by ‘Blue Coat Systems LLC’ for at least the last two months.” Id. at 10. We have reviewed the evidence provided by Patent Owner and find it insufficient to support Patent Owner’s allegation that Petitioner has failed to comply with 35 U.S.C. § 312(a) or 37 C.F.R. § 42.8(a)(3). That evidence is, at best, suggestive regarding an issue that is not jurisdictional. Lumentum Holdings, Inc. v. Capella Photonics, Inc., Case IPR2015-00739, slip op. (PTAB Mar. 4, 2016) (Paper 38) (precedential).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “Downloadable” Every challenged independent claim recites a “Downloadable,” and Petitioner contends that “[t]he broadest reasonable interpretation of the term ‘downloadable’ includes ‘an executable application program, which is downloaded from a source computer and run on a destination computer.’” Pet. 15. Petitioner’s proposed construction parallels a statement made in the Specification of the ’194 patent. Ex. 1012, col. 1, ll. 44–47. Patent Owner “does not dispute” this proposed construction, which we adopt for purposes of this Decision. Prelim. Resp. 5. 2. “database” Challenged independent claim 42 recites “a database of Downloadable security profiles.” Petitioner contends that “[t]he broadest reasonable interpretation of the term ‘database’ includes ‘a collection of interrelated data organized according to a database schema to serve one or more applications.’” Pet. 15. Patent Owner also “does not dispute” this proposed construction, but argues that “the practical import of Petitioner’s proposed construction for the term ‘database,’ is that log files, such as Swimmer’s audit trail, do not fall within the scope of the claims.” Prelim. Resp. 5–6. That is, Patent Owner contends that “logging functionality is distinct from storing in a database, which allows DSP to be efficiently retrieved from the database,” as compared with the “record-keeping” functionality of an “event log.” Id. at 7. Patent Owner’s argument was considered by the panel in IPR2015- 01892, which concluded that, “[t]o the extent that construction would exclude a log file consisting of an ‘unstructured collection of data on a computer,’ . . . [an] unstructured log file would not be a database,” but the construction does not “necessarily exclude[] all log files from being databases.” 1892 Dec. 16 (emphasis in original). We agree with the reasoning expressed in the Final Written Decision of IPR2015-01892. Id. at 12–17. For purposes of this Decision, we adopt Petitioner’s proposed construction.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,079,086 - Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing grantedPTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing
On rehearing, the Board modified its decision and held claims 1–20 unpatentable as obvious over Pinchasi with the 1996 SBOA and over Pinchasi with Flechter.
RulingsRehearing decision- RehearingGranted in part
“we entered a Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Patent Owner filed a request for rehearing of our decision. Paper 87. In a concurrently issued Order, we grant-in-part Patent Owner’s request and vacate our original decision. Paper 89. We hereby issue this modified Final Written Decision.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“in the art. Petitioner contends that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or an M.D. with experience in clinical pharmacology. Pet. 13. In its Preliminary Response, Patent Owner asserted that a skilled artisan would have had knowledge of, and experience with, both MS and GA. Prelim. Resp. 33–34. In the Decision to Institute, we agreed with Patent Owner. Dec. 9. We noted that Dr. Green, one of Petitioner’s declarants, states that a person of ordinary skill in the art would have had “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither party contests our findings of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination. Thus, we reiterate that in addition to the qualifications specified by Petitioner, a person of ordinary skill in the art would also have experience treating MS with GA.” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“As an initial matter, we note that, in its Preliminary Response, Patent Owner challenged the status of the 1996 SBOA as a printed publication under 35 U.S.C. § 102(b). Prelim. Resp. 47–48. In the Decision to Institute, we determined that, based on the record available then, the 1996 SBOA constitutes prior art under § 102(b). Dec. 12–13. In its Response, Patent Owner does not dispute this finding. Having considered the complete record developed at trial, we reiterate that Petitioner has presented sufficient evidence (see Ex. 1007) to show that the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008). See Dec. 12–13. Thus, the 1996 SBOA constitutes prior art under § 102(b).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Upon considering the evidence as a whole, we also find that an ordinary artisan would have been motivated to administer GA three times over a period of seven days to increase patient compliance. We note again that Pinchasi teaches administering 40 mg GA every other day, which equates to seven doses over two weeks. Ex. 1005, 9. Thus, the difference between the challenged claims (three doses over a period of seven days, or six doses over two weeks) and the prior art is one less injection every two weeks. Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 101. The desirability of less frequent injections is supported by the 1996 SBOA, in which the reviewer recommended that Teva evaluate the necessity of daily injections as opposed to more infrequent intermittent administration of Copaxone®. Ex. 1007, 252.” slip op. at 13
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,232,250
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.