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  • PTAB · Mar 15, 2024 · IPR2023-00921 · APJ Amee A Shah · IPR · Rehearing

    Granted petitioner’s rehearing request and instituted IPR of claims 1–4 on all asserted grounds, finding a reasonable likelihood of prevailing based on the preliminary construction of “transaction data.”

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “institute has the burden of showing the decision should be modified, and the request for rehearing must specifically identify all matters the party believes the Board misapprehended or overlooked and the place where each matter was previously addressed in its papers. 37 C.F.R. § 42.71(d). “When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” Id. § 42.71(c).” slip op. at 5

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “Although the ’286 patent distinguishes “account data” from “transaction data” in the embodiment of Figure 11, the “transaction data” is submitted by the user to perform a series of banking transactions after manually entering a PIN code, whereas the “account data” is stored on the server, and the token information is accepted from the smart card’s embedded token, i.e., the output interface of the transaction card. See Ex. 1001, 10:12–18, 10:30–35, 10:40–42, 11:21–22, 11:65–12:4, 12:22–36. Thus, the claimed “transaction data” that is “accepted . . . from an output interface of a transaction card” and “accepted . . . from a transaction card at an input interface of the card reader,” as recited in independent claims 1 and 3, comprises data stored on and read from a card, such as an ID number, password, authentication information, or session information, that can be used to facilitate a transaction. Such claimed “transaction data” is distinct from the “transaction data” described in connection with the Figure 11 embodiment. We therefore do not limit the claimed “transaction data” and instead preliminarily construe that term as encompassing any data involved in a transaction, including account data. As described above, the claimed transaction data must come from the output interface of a transaction card. Should either party believe that a different construction should apply in the instituted trial, it should explain the proposed construction, how the construction is supported by the record, and how the construction affects our unpatentability analysis.” slip op. at 8

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateInstituted

      “The dispute relates to whether the ’030 application describes the claimed “smart telephone” accepting transaction data and executing coded instructions to convert the analog signal to digital data representing transaction data as digital data. See Pet. 14–15, 19–27. In Petitioner’s view, that term is supported only by language added to the “Brief Summary of the Invention” during prosecution of the application resulting in the ’286 patent. Id. at 17. In contrast, argues Petitioner, the corresponding section of the ’030 application instead describes transmitting sound to a PC, not a smart telephone. Id. at 19–26. Patent Owner submits that the ’030 application describes generating sounds from a smart phone and using a “key jack sound pass generator” to communicate sounds. Prelim. Resp. 16. Patent Owner contends that the claim language is supported by disclosure of receiving the audio signal at a microphone port and converting the signal to transaction data. Id. at 16–18. Patent Owner points also to description of direct communication between a “client device” and server. Id. at 19. On the present record, we find that Petitioner, at this stage in the proceeding, has shown sufficiently how it contends that the earliest possible effective filing date for claims 1–4 of the ’286 patent is March, 3, 2015, such that the Cho, Aaron, Carpenter, and de Geer references qualify as prior art. Patent Owner has identified a factual dispute regarding the significance of the ’030 application’s disclosures, and we view that dispute as best resolved through trial.” slip op. at 9

    • PTAB / AIA Trials › Real party in interest / privityDecided for petitioner

      “35 U.S.C. § 312(a)(2) provides that one of the “Requirements of Petition” is that “the petition identifies all real parties in interest.” “Whether a non-party is a RPI is a ‘highly fact-dependent question’ and must be considered on a case-by-case basis.” SharkNinja Operating LLC. v. IROBOT Corp., No. IPR2020-00735, 2020 WL 6050687, at *4 (PTAB Oct. 13, 2020) (precedential) (citing Ventex Co. v. Columbia Sportswear N. Am., Inc., IPR2017-00651, Paper 148 at 6 (PTAB Jan. 24, 2019) (Paper 148) (precedential) (citing Office Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012))). Here, addressing whether TCH is an unnamed RPI would not create a time bar or estoppel under 35 U.S.C. § 315. There is no allegation or evidence that TCH is “barred or estopped from this proceeding or that Petitioner purposefully omitted [TCH] to gain some advantage.” SharkNinja at *4. Rather, Patent Owner argues that for “once again willfully fail[ing] to identify TCH as a real party in interest, . . . the Petition should be denied on that basis.” Prelim. Resp. 7. In other words, Patent Owner contends only that we deny institution because of “the alleged failure of a procedural requirement that can be corrected under our precedent.” SharkNinja at *4. We understand that” slip op. at 11

    Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denial
    Patents in suitUS 9,679,286
  • PTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing

    On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.

    RulingsRehearing decision
    • RehearingRehearing, grantedGranted

      “We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

      “In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3

    § 112 disclosure
    Patents in suitUS 10,993,942
  • 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 Phillips
    Patents 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 Phillips
    Patents in suitUS 10,808,039
  • PTAB · Aug 12, 2021 · PGR2021-00026 · APJ Jamie T Wisz · PGR · Rehearing

    The Board denied rehearing, leaving institution denied for claims 1–20 because Petitioner did not show error in the priority-support finding or improper burden shifting.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. ANALYSIS Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 2

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “The ’611 provisional application discloses a first side (8) and a second side (9) of the beveled platform (5)/distal member wherein the first lateral blade (10) and the second lateral blade (11) are “along the sides of said beveled platform.” Ex. 1007, 38. As shown in the annotated figures below, the ’611 provisional application depicts right and left edges, which are the lines/borders between the sides (8, 9) and top of the distal member, wherein these edges extend towards the rearward end from the tip (6). Decision 39–40 (citing Prelim. Resp. 21, 45–46 (citing Ex. 1007, Figs. 1, 3)). Annotated Figures 1 and 3 include added lines and labels indicating the edges of the distal member. Petitioner’s argument appears to hinge on the contention that the beveled nature of the platform prevents it from being an edge. See Req. Reh’g 4, 6. However, Petitioner provides no persuasive arguments or evidence for this contention. We understand that Petitioner disagrees with the Board’s assessment, but simple disagreement is not effective to demonstrate an abuse of discretion.” slip op. at 5

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner

      “The ’611 provisional application discloses a first side (8) and a second side (9) of the beveled platform (5)/distal member wherein the first lateral blade (10) and the second lateral blade (11) are “along the sides of said beveled platform.” Ex. 1007, 38. As shown in the annotated figures below, the ’611 provisional application depicts right and left edges, which are the lines/borders between the sides (8, 9) and top of the distal member, wherein these edges extend towards the rearward end from the tip (6). Decision 39–40 (citing Prelim. Resp. 21, 45–46 (citing Ex. 1007, Figs. 1, 3)). Annotated Figures 1 and 3 include added lines and labels indicating the edges of the distal member.” slip op. at 5

    • BurdenDecided for patent owner

      “We are not persuaded by Petitioner’s arguments. Contrary to Petitioner’s assertions, Patent Owner’s arguments regarding the claim terms raised by Petitioner were not limited to only showing support in the ’391 patent. In fact, Patent Owner’s Preliminary Response discusses in detail where these claim terms are supported in the ’611 provisional application. See Prelim. Resp. 12–24, 39–41, 43–59. We also disagree with Petitioner’s contention that Patent Owner only provided “conclusory remarks” that the challenged claims were supported by priority applications other than the ’611 provisional. Req. Reh’g 11. For example, the Preliminary Response discusses how the challenged claim terms are supported by U.S. Patent No. 15/207,329 (“the ’329 application”). See Prelim. Resp. 24–27, 61, 63–64. Further, as noted in our Decision, Patent Owner also submitted a claim chart providing exemplary excerpts from the ’611 provisional, the ’329 application, and the ’391 patent to establish support for all elements of several exemplary challenged claims. See Decision 26 n.4 (citing Prelim. Resp., Appx. A). Petitioner has not demonstrated that we improperly shifted the burden to Petitioner. Instead, we concluded that the record before us supported Patent Owner’s contention that the non-disclaimed ’391 patent claims should receive priority to the ’611 provisional application. Decision 42.” slip op. at 8

    § 112 disclosure
    Patents in suitUS 10,786,391
  • PTAB · May 13, 2021 · IPR2019-01595 · APJ Minn Chung · IPR · Rehearing

    The Board denied rehearing of its decision denying institution on claims 1 and 2, finding no abuse of discretion on priority entitlement or motivation to combine Darbee and Golender.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. STANDARD OF REVIEW “The burden of showing a decision should be modified lies with the party challenging the decision,” and the challenging party “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed” in a 1 Petitioner also filed a request for the Precedential Opinion Panel (“POP”) to review the Decision (Paper 13 (Notification of Receipt of POP Request)), which the POP denied (Paper 14 (Order)). paper of record. 37 C.F.R. § 42.71(d). Because Petitioner seeks rehearing of our Decision denying institution of trial based on the Petition, it must show an abuse of discretion. See 37 C.F.R. § 42.71(c) (“When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.”). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence that could have been presented in the Petition.” slip op. at 2

    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner

      “issue upon which the priority determination turns—what the priority applications reasonably would have conveyed to a person of ordinary skill in the art—because Dr. Medvidovic did not provide any testimony on that issue. And we did not overlook or misapprehend any testimony of Dr. Medvidovic regarding what the priority applications reasonably would have conveyed to a person of ordinary skill in the art because we could not have overlooked or misapprehended any testimony that was not presented in the Medvidovic Declaration. As discussed above, Dr. Medvidovic’s testimony based on what is expressly disclosed in or necessarily follows from the disclosures of the priority applications was insufficient because Dr. Medvidovic did not explain adequately why the disclosures in the priority applications would not reasonably have conveyed to a person of ordinary skill in the art the subject matter of the User Action Limitation. Thus, Dr. Medvidovic’s testimony was insufficient to raise a genuine issue of material fact on the issue of what the priority applications reasonably would have conveyed to a person of ordinary skill in the art. Although Patent Owner’s declarant, Mr. Bear, provided detailed testimony and explanations regarding how a person of ordinary skill in the art would have understood the priority applications to describe the subject matter recited in the User Action Limitation (see Ex. 2001 ¶¶ 111–122, 126–127), Dr. Medvidovic did not provide adequate testimony or explanations to the contrary on the issue (see Ex. 1010 ¶¶ 53–63).” slip op. at 9

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “misapprehend or overlook 37 C.F.R. § 42.108(c). The mere fact that Dr. Medvidovic provided testimony different from the testimony of Mr. Bear does not by itself raise a genuine issue of material fact. See Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1325–26 (Fed. Cir. 2016) (“The mere existence in the record of dueling expert testimony does not necessarily raise a genuine issue of material fact.”). As the Request acknowledges, Dr. Medvidovic in his Declaration (Ex. 1010, “Medvidovic Declaration”) testified that the subject matter of the User Action Limitation is “neither expressly disclosed [in] nor necessarily follows from” the descriptions in the priority applications about event journal data. Req. 3 (emphases added) (citing Ex. 1010 ¶¶ 57–62). As discussed above, however, the test for determining compliance with the written description requirement under 35 U.S.C. § 112 is whether the original disclosure of the earlier-filed application reasonably would have conveyed to a person of ordinary skill in the art that the inventor had possession of the claimed subject matter at the time of the earlier-filed application. Ariad Pharm., 598 F.3d at 1351. The record shows that Dr. Medvidovic did not provide any testimony in his Declaration as to what the disclosures in the priority applications reasonably would have conveyed to a person of ordinary skill in the art. See Ex. 1010 ¶¶ 53–63. Nor did Dr. Medvidovic explain adequately in his Declaration why the disclosures in the priority applications would not reasonably have conveyed to a person of ordinary skill in the art the subject matter of the User Action Limitation. See id.” slip op. at 8

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Under Petitioner’s definition of the level of ordinary skill in the art, however, “less education can be remedied with additional work experience (e.g., 5–6 years).” Pet. 7 (citing Ex. 1010 ¶¶ 64–67). As stated in the Bear Declaration, Mr. Bear’s work experience includes at least 9 years of computer software programming using a variety of coding languages, such as BASIC, Pascal, C, C++, and 68000 Assembly Language. See Ex. 2001 ¶¶ 10–12. Thus, Mr. Bear is qualified to testify from the perspective of a person of ordinary skill in the art under Petitioner’s definition of a person of ordinary skill in the art. As discussed in the Decision, although we did not find the parties’ proposals for the level of ordinary skill in the art to be materially different, to the extent the testimony from the parties’ declarants on the level of ordinary skill in the art raised a genuine issue of material fact, we adopted and applied Petitioner’s definition for purposes of the Decision, being mindful of the rule that “a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.” Dec. 9 (citing 37 C.F.R. § 42.108(c)). Thus, the record shows that, under Petitioner’s definition of the level of ordinary skill in the art adopted in consideration of § 42.108(c), the Decision appropriately credited Mr. Bear’s testimony on what the priority applications reasonably would have conveyed to a person of ordinary skill in the art.” slip op. at 11

    § 103 obviousness§ 112 disclosure
    Patents in suitUS 8,015,446
  • PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

    The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

      “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

      “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

    • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

      “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

    Claim construction§ 112 disclosure
    Patents in suitUS 10,155,039
  • PTAB · Sep 16, 2020 · IPR2020-00261 · APJ Jo-Anne M Kokoski · IPR · Rehearing

    The Board denied Patent Owner’s rehearing requests, leaving institution of review of claims 1–7, 11, 15–18, 20–22, 32, and 47 in place.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d). Patent Owner, as the party challenging the Decisions, has the burden of showing that the Decisions should be modified. Id. When rehearing a decision on a petition, the Board reviews the decision for an abuse of discretion. Id. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of the law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “in our Decision on Institution. In the Decision, we directly addressed Patent Owner’s arguments that Dr. Baker is not qualified to testify in this proceeding because he is neither a person of ordinary skill in the art, nor an expert in the relevant art. See Dec. 7–8. In particular, we explained that there is no requirement “that the expert’s experience perfectly match the relevant field, or that the expert is a person of ordinary skill in the art.” Id. at 7. We also explained that Dr. Baker testifies as to his education and qualifications and provides his curriculum vitae. See Ex. 1002 ¶¶ 3–12; Ex. 1003. At this preliminary stage, we cannot say that Dr. Baker’s scientific, technical, and other specialized knowledge will not be helpful in understanding the evidence. See Fed. R. Evid. 702(a). On this record, we are not persuaded that Dr. Baker’s testimony should be disregarded. Id. at 8. Therefore, even if Dr. Baker were not a person of ordinary skill in the art as Patent Owner contends, it does not follow that he is unqualified to testify in these proceedings. Nothing was misapprehended or overlooked in considering Dr. Baker’s testimony.” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “(Ex. 2001). In the Preliminary Response, Patent Owner cited the Konda Declaration when discussing the experience and qualifications of the named inventor of the ’523 patent. Prelim. Resp. 8–9. The education level of the inventor, however, is just one of several factors that we may consider in determining the level of ordinary skill in the art. See Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (enumerating six factors that “may be considered in determining the level of ordinary skill in the art” (quoting Evt’l Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983))). And, as Patent Owner noted in the Preliminary Response, “these factors are merely a guide to determining the level of ordinary skill in the art.” Prelim. Resp. 7–8 (citing Daiichi Sankyo, 501 F.3d at 1256). In any event, in the Decision we also considered Petitioner’s and Patent Owner’s proposed definitions of the level of ordinary skill in the art, noted the differences between them, and stated that “[o]ur determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s definitions.” Dec. 7. Therefore, our evaluation of Petitioner’s challenges and Dr. Baker’s testimony in support thereof would have been the same under Petitioner’s and Patent Owner’s proposed definitions of the level of ordinary skill in the art. See id. (“[W]e note that our conclusions would be same under either definition.”).” slip op. at 7

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot reached

      “Moreover, in the Decision, we directly addressed Patent Owner’s argument with respect to whether the ’394 provisional and ’605 PCT provided support for the claim limitation “said routing network comprising a plurality of stages y, in each sub-integrated circuit block, starting from the lowest stage of 1 to the highest stage of y, where y≧1” when y=1. Dec. 14. In particular, we found that Patent Owner’s arguments, as we understand them, are directed only to the disclosure of a network with only one stage (y=1). [Prelim. Resp.] at 15–39. Patent Owner does not address the other limitations of claim 1, and does not point to any disclosures in the priority applications that describe a sub-integrated circuit block with only one stage that also comprises pluralities of forward connecting links and backward connecting links as required by claim 1. Id. Thus, we did not overlook Patent Owner’s arguments, but rather evaluated the disclosures in the ’394 provisional and ’605 PCT and determined, on the record at this stage of the proceeding, that they do not provide sufficient written description support for the challenged claims. The parties will have the opportunity to further develop the record on these issues during trial, and the Board will evaluate the fully-developed record at the close of the evidence. D. Public Availability of the ’394 provisional” slip op. at 9

    § 102 anticipation§ 112 disclosure
    Patents in suitUS 8,269,523
  • PTAB · Sep 16, 2020 · IPR2020-00260 · APJ Jo-Anne M Kokoski · IPR · Rehearing

    The Board denied the Patent Owner’s rehearing requests, leaving institution in place for claims 1–7, 11, 15–18, 20–22, 32, and 47.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d). Patent Owner, as the party challenging the Decisions, has the burden of showing that the Decisions should be modified. Id. When rehearing a decision on a petition, the Board reviews the decision for an abuse of discretion. Id. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of the law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

    • Strike new argumentNew argument disregardedOther

      “Consolidated Trial Practice Guide, 90. The Consolidated Trial Practice Guide goes on to state that “[a]bsent a showing of ‘good cause’ prior to filing the request for rehearing or in the request for rehearing itself, new evidence will not be admitted.” Id. (citing Huawei, Paper 19 at 4).” slip op. at 4

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Dr. Baker testifies as to his education and qualifications and provides his curriculum vitae. See Ex. 1002 ¶¶ 3–12; Ex. 1003. At this preliminary stage, we cannot say that Dr. Baker’s scientific, technical, and other specialized knowledge will not be helpful in understanding the evidence. See Fed. R. Evid. 702(a). On this record, we are not persuaded that Dr. Baker’s testimony should be disregarded. Id. at 8. Therefore, even if Dr. Baker were not a person of ordinary skill in the art as Patent Owner contends, it does not follow that he is unqualified to testify in these proceedings. Nothing was misapprehended or overlooked in considering Dr. Baker’s testimony.” slip op. at 6

    • Skill levelOther

      “(Ex. 2001). In the Preliminary Response, Patent Owner cited the Konda Declaration when discussing the experience and qualifications of the named inventor of the ’523 patent. Prelim. Resp. 8–9. The education level of the inventor, however, is just one of several factors that we may consider in determining the level of ordinary skill in the art. See Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (enumerating six factors that “may be considered in determining the level of ordinary skill in the art” (quoting Evt’l Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983))). And, as Patent Owner noted in the Preliminary Response, “these factors are merely a guide to determining the level of ordinary skill in the art.” Prelim. Resp. 7–8 (citing Daiichi Sankyo, 501 F.3d at 1256). In any event, in the Decision we also considered Petitioner’s and Patent Owner’s proposed definitions of the level of ordinary skill in the art, noted the differences between them, and stated that “[o]ur determination regarding Petitioner’s challenge does not turn on the differences between Petitioner’s and Patent Owner’s definitions.” Dec. 7. Therefore, our evaluation of Petitioner’s challenges and Dr. Baker’s testimony in support thereof would have been the same under Petitioner’s and Patent Owner’s proposed definitions of the level of ordinary skill in the art. See id. (“[W]e note that our conclusions would be same under either definition.”).” slip op. at 7

    § 102 anticipation§ 112 disclosure
    Patents in suitUS 8,269,523
  • PTAB · Mar 26, 2020 · PGR2018-00001 · APJ Grace Karaffa Obermann · PGR · Rehearing

    The Board denied Patent Owner’s rehearing request, leaving claims 3–30 unpatentable for lack of enablement because the specification does not guide an artisan to practice their full scope without undue experimentation.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “Upon request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. Based on an application of those principles, we deny the Request for Rehearing.” slip op. at 2

    • Expert testimonyOther

      “zolendronic acid dosage forms could achieve bioavailabilities as high as 1.1% to “a belie[f] in ‘fairies.’” Req. Reh’g 2 (quoting Dec. 14; Ex. 2014, 137:21–138:8). That testimony represents a small fraction of the totality of evidence that undergirds our finding that an ordinarily skilled artisan generally would have expected that attaining a human bioavailability for zolendronic acid above 1% required an enhancer. See Dec. 12–21 (citing substantial evidence for that proposition). Even if we set aside the testimony misattributed to Dr. Wargin, substantial evidence supports that finding.” slip op. at 3

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

      “unenhanced dosage form of zoledronic acid disclosed in Aronhime or Exhibit 2026 would have attained a bioavailability that falls within the scope of the challenged claims. The key is whether an ordinarily skilled artisan, reading the disclosure of the ’268 Patent, would have been equipped to practice the full scope of the claimed invention. We did not overlook or misapprehend Exhibit 2026. We correctly determined that, in this unpredictable field of pharmaceutical formulation, an ordinarily skilled artisan would have required direction (lacking in the Specification or the prior art) explaining how to prepare dosage forms that meet the full range of bioavailabilities embraced by the challenged claims, including the specified high endpoint human bioavailability of about 4%. See, e.g., Dec. 11–12 (citing undisputed evidence of unpredictable nature of the field of invention (Ex. 1005 ¶ 60)).” slip op. at 7

    § 112 disclosure
    Patents in suitUS 9,539,268
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