- PTAB · Dec 8, 2023 · IPR2023-00999 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–10 on all five grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…J. Evans, Russell P. Rother, and Thomas C. Thomas. Id. at code (75). Evans is cited in the ’504 patent, as well as by other evidence of record, as teaching a “[s]uitable anti-C5 antibod[y] known to those of skill in the art” and the “antibod[y] . . . specific to human complement[,] . . . whole…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and accompanying evidence under 35 U.S.C. § 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any 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.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“As such, we find it error for the Examiner to have not expressly considered Tacken in the context of the other references Alexion pointed to as allegedly demonstrating the “consistent teachings as of March 15, 2007 that ‘eculizumab was the IgG4 antibody of Thomas.” Ex. 2102, 14840– 14843, 14854. But for this error, the Examiner would have better appreciated the disclosure of Mueller PCT. See Ex. 1003 ¶¶ 178, 180–182 (Dr. Ravetch’s testimony that “most critically, Alexion failed to provide its own 2005 publication, the Tacken article, that teaches that “eculizumab” contains an IgG2/G4 constant domain”).” slip op. at 62
- Other 314aDenied
“IV. DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a) Patent Owner points to § 314(a)27 as a basis for denying institution but provides no substantive argument or evidence on this point. See Prelim. Resp. 2 (citation), 4 (citation), 17 (section heading), 32 (citation in parenthetical). At best, Patent Owner asserts that if we find “that fewer than all five Grounds meet the standard for Section 325(d), institution of Samsung’s petition should still be denied in full, because institution on all five Grounds ‘would not be an efficient use of the Board’s time and resources.’” Prelim. Resp. 32 (citing Deeper, UAB v. Vexilar, Inc., IPR2018- 01310, Paper 7 at 41–43 (PTAB Jan. 24, 2019) (informative)). Because we decline to exercise our discretion with respect to any of the Grounds under § 325(d), the Board’s Deeper decision is inapposite.” slip op. at 65
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not presently dispute this definition “except to clarify that the POSA would have at least two years of experience in engineering monoclonal antibodies for human therapeutic use, either in the laboratory or industry.” Prelim. Resp. 51 (further arguing that Petitioner cannot prove unpatentability of the challenged claims under either party’s definition). At this stage in the proceeding, we accept and use Petitioner’s proposed definition of the skilled artisan, as being both unopposed by Patent Owner and inclusive of Patent Owner’s additional qualification. In this respect, it appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” encompasses Patent Owner’s proposed modification, and is consistent with the level of skill in the art reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,725,504 - PTAB · Dec 8, 2023 · IPR2023-00998 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–3 over all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…J. Evans, Russell P. Rother, and Thomas C. Thomas. Id. at code (75). Evans is cited in the ’880 patent, as well as by other evidence of record, as teaching a “[s]uitable anti-C5 antibod[y] . . . known to those of skill in the art” and the “antibod[y] . . . specific to human complement[,] . . .…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and accompanying evidence under 35 U.S.C. § 314. An inter partes review may not be instituted unless “the information presented in the petition . . . and any 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.” 35 U.S.C. § 314(a). Further, a decision to institute may not do so on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition and Preliminary Response, Reply, and Sur-Reply, we determine that Petitioner demonstrates a reasonable likelihood of prevailing in showing that at least one of the challenged claims of the ’880 patent is unpatentable. Accordingly, we institute an inter partes review as to all the challenged claims of the ’880 patent on all the grounds of unpatentability set forth in the Petition. We note that there are disputed issues in this proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary denial; however,” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not presently dispute this definition “except to clarify that the POSA would have at least two years of experience in engineering monoclonal antibodies for human therapeutic use, either in the laboratory or industry.” Prelim. Resp. 48; see also id. at 48–49 (arguing that Petitioner cannot prove unpatentability of the challenged claims under either party’s definition). 23 At this stage in the proceeding, we accept and use Petitioner’s proposed definition of the skilled artisan, as being both (largely) unopposed by Patent Owner and inclusive of Patent Owner’s additional qualification. In this respect, it appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” encompasses Patent Owner’s proposed modification, and is consistent with the level of skill in the art reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Our decision whether to institute, however, does not turn on which party’s definition of the skilled artisan is used, and our determinations would be unchanged if we applied Patent Owner’s definition. Further, we note that evidence may be presented as the case progresses to support some other proposed definition of the skilled artisan, which may influence our determination of this issue. C. Claim Construction” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Neither party requests the construction of any claim term. See, e.g., Pet. 18. We need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). At this stage in the proceeding, we find it unnecessary to construe the language of any challenged claim because the claim language is readily understandable to the person of ordinary skill in the art on its face, within the context of the claims.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“TPO mimetic peptide graft in Fab clone X4b has been transplanted into the heavy chain CDR3 region of another antibody framework, 5G1.1. . . . Construction of 5G1.1 is described in U.S. Application Ser. No. 08/487,283, incorporated herein by reference.” Prelim. Resp. 50 (emphasis added); Ex. 1004 ¶ 191. It is not disputed here that U.S. Patent Application 08/487,283 issued as Evans. See Ex. 1005, code (21); see generally Prelim. Resp. The portion of Evans relating to “Construction of 5G1.1” (Ex. 1004 28 ¶ 191, emphasis added) appears to be (or at least includes) Example 11, which is titled “Construction and Expression of Recombinant mAbs.” Ex. 1005, 42:55–58 (emphasis added). According to Dr. Ravetch, “Evans’[s] Example 11 teaches construction of . . . humanized 5G1.1 scFv constructs.” Ex. 1003 ¶ 177. And, none of the other Evans Examples addressing an anti- C5 antibody or a 5G1.1 antibody designate their respective disclosure as relating to “construction,” as per the title of Example 11 and the sentence of Bowdish expressly incorporating Evans. See Ex. 1005, 33:1–42:54 (Examples 1–10); Ex. 1003 ¶ 177. Thus, on this record, we find that Petitioner’s pointing to the antibodies (or fragments) of Evans’s Example 11 for use as a starting point for Bowdish’s invention to be more reasonable than Patent Owner’s arguments that antibodies would have been selected from some other Example. Furthermore, Patent Owner does not dispute that, if Bowdish and Evans are read as asserted by Petitioner and Dr. Ravetch, the antibody sequences of claim 2, i.e., SEQ ID NO: 2 and SEQ ID NO: 4, are disclosed. Petitioner’s reading is also consistent with the Specification of the ’880 patent, which cites Evans (among others) for the proposition that “[s]uitable anti-C5 antibodies are known to those of skill in the art” and, in particular, that Evans discloses “antibodies which are specific to human complement . . . . includ[ing] a preferred whole antibody (now named eculizumab),” and “methods of engineering such antibodies.” Ex. 1001, 10:57–65, 12:13–21, 12:43–47. Therefore, we do not find any error in Petitioner’s assertion that Bowdish/Evans discloses the antibody of claim 2.” slip op. at 28
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,718,880 - PTAB · Dec 8, 2023 · IPR2023-00933 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claim 1 under all four asserted grounds, finding a reasonable likelihood that the claim is anticipated or obvious.
In the decision…discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole, or that it includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed.…
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The two proposed definitions of the ordinarily skilled artisan are very similar, except that Patent Owner’s description more-specifically defines the field of experience of the artisan. At this stage in the proceedings, we accept and use Petitioner’s proposed definition of the ordinarily skilled artisan, as being both generally unopposed by Patent Owner and inclusive of Patent Owner’s supplemental definition. It appears that Petitioner’s language “at least two years of experience in the discovery, development, and design of therapeutic antibodies for use as potential treatments in human disease” includes Patent Owner’s proposed level of experience. Pet. 12–13. We also take into account the level of skill in the art reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Our decision whether to institute does not turn on which party’s definition of the skilled artisan is used, and our determinations would be unchanged if we applied Patent Owner’s supplemented definition. Further, we note that evidence may be presented as the case progresses to support some other proposed definition of the skilled artisan, which may influence our determination of this issue. C.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“CLAIM CONSTRUCTION Petitioner states, “Petitioner does not believe claim construction is necessary at this time.” Pet. 15. Patent Owner does not mention claim construction at this stage of the proceeding. See generally Prelim. Resp. At this stage in the proceedings, and for the purposes of this decision, we find it unnecessary to construe the language of claim 1 because the claim language is readily understandable on its face and there is no dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). As the case continues, we may determine that certain claim language should be interpreted. D.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In view of the unique record before us, we agree with Patent Owner that all of the references relied on by Petitioner here, “were previously presented to the Office” as required by § 325(d) and Advanced Bionics. Prelim. Resp. 19. Accordingly, we proceed to part two of the analysis.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied discretionary otherDenied
“DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a) AND FINTIV Patent Owner points to § 314(a) as a basis for denying institution, but provides no substantive argument or evidence on this point. See Prelim. Resp. 17–32; see generally Prelim. Sur-Reply 6. Under certain circumstances, the Board may apply our discretion under 35 U.S.C. § 314(a) to deny institution in light of a parallel district court proceeding involving the same patent. See, e.g., Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential). But, as noted by Petitioner, the patent at issue here “has never been asserted in any litigation.” Pet. 49. Accordingly, we also decline to exercise our discretion under Section 314(a) to deny institution.” slip op. at 61
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,732,149 - PTAB · Dec 8, 2023 · IPR2023-01017 · APJ Meredith C Petravick · IPR · Institution
The Board instituted review of claims 1–26 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…shown,’ indicating that these are not contained by the objects 29.” Id. at 18 (citing Ex. 1007, 4:45–47). Patent Owner contends that “Suomela’s teaching of separate indicators for distance and direction teaches against an OVI containing distance and direction or, at the very least, provide…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“discretionarily deny institution under §314(a) when a petitioner submits a so-called Sotera stipulation, i.e., the petitioner “stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Memorandum 7 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020- 01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Such a stipulation mitigates concerns of potentially conflicting PTAB and district-court decisions and duplicative efforts between the district court and PTAB. Id. Patent Owner contends that in light of “parallel District Court Litigation,” i.e., NorthStar Sys. LLC v. Bayerische Motoren Werke AG, No. 2:22-cv-00496-JRG (E.D. Tex.), the Fintiv factors weigh in favor of denying institution under 35 U.S.C. § 314(a). Prelim. Resp. 20–26. Petitioner responds that discretionary denial is not appropriate because it “has stipulated that if the Board institutes IPR on this Petition, it will not pursue 9 Available at: https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_m emo_20220621_.pdf or reasonably could have raised’ during this proceeding.” Pet. Prelim. Reply 1 (citing Sotera, Paper 12 at 18–19; Ex. 1021). Under the mandatory Fintiv guidance discussed above, this stipulation is dispositive. Memorandum 7. Patent Owner responds, however, that Petitioner “should not be credited with this stipulation as it has come at the eleventh hour.” PO Prelim. Sur-Reply 2. Petitioner submitted its Sotera stipulation to Patent Owner by email dated September 22, 2023, several days after Patent Owner filed its Preliminary Response.10 Patent Owner has not brought to our attention any binding precedent that establishes a time limit by which a Sotera stipulation must be submitted before we enter our decision on institution, and we are not aware of any such precedent. Nor does Patent Owner allege that it has been prejudiced by the timing of the stipulation.11 Therefore, we are not persuaded that we should disregard Petitioner’s Sotera stipulation because of its timing.” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, the Reply, the Sur-Reply, and the evidence of record, we determine the information presented shows a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one of the challenged claims of the ’943 patent. Accordingly, we institute an inter partes review of claims 1–26 of the ’943 patent on the grounds asserted in the Petition.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Second, Patent Owner improperly interprets the term “OVI” to require distance information. At the outset we note that Patent Owner has not expressly requested that any claim terms should be construed in this proceeding. See supra Section II.D. Patent Owner apparently reads the embedded term “vector” in isolation rather than as part of the term “object vector indicator.” See IGT v. Bally Gaming Int’l, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011) (“Extracting a single word from a claim divorced from the surrounding limitations can lead construction astray.”); Trivascular, Inc. v. 13 Patent Owner alleges that “[t]he placement of the ‘south’ icon is likely hard coded as static information and therefore not computed by Kreitler.” Prelim. Resp. 12. This allegation is unsupported attorney argument to which we give little weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). without considering the context in which those terms appear is not reasonable). Even if “vector,” read in isolation, means something akin to a “Euclidean vector” that would arguably contain both a “magnitude” (which we understand Patent Owner to mean distance) and a direction, an “OVI” would not necessarily contain this exact information. Moreover, defining “OVI” to contain both distance and direction would render superfluous the language in claim 1 that expressly requires the created OVI to “contain[] the distance . . . information.” See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (construing a claim in a way that renders a term superfluous is “a methodology that [our reviewing court] has denounced”). We discern no reason to limit the claim language in such a way. Construing “OVI” as a “Euclidian vector” that necessarily contains both distance and direction information would also be contrary to the ’943 patent’s written description. The written description indicates that the word “vector” is broader than “Euclidean vector,” in that it may simply be an “arrow” that is “pointing in the direction of the referenced remote location marker.” Ex. 1001, 3:66–4:4. The written description states that “[i]nformation displayed in the OVI . . . may include a vector (e.g. arrow) pointing in the direction of the referenced remote location marker, the distance and travel time to the remote location marker.” (Ex. 1001, 3:66–4:3 (emphasis added)), indicating that such information is optional rather than always present.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner contends that the combination of Kreitler, Altman690, and Suomela teaches or suggests all of the limitations of claim 1, that the asserted references constitute analogous art, that the ordinarily skilled artisan would have had reason to combine the references, and such a person of ordinary skill would have had a reasonable expectation of success. Pet. 6– 22. Petitioner supports its contentions with citations to Kreitler, Altman690, Suomela, and Dr. Rosenberg’s declaration. Id. Turning to the elements of claim 1, Petitioner contends that Kreitler in combination with Altman690 teaches the preamble of claim 1 and limitations 1a, 1b, 1c, 1d, 1e and 1f. Pet. 23–32 (citing Ex. 1005, 1:38–46, 2:20–24, 5:36–37, 6:43–45, 6:50–55, 6:67–7:4, 10:27–29, 12:3–10, 12:16– 18, Figs. 1, 2, 4, 15; Ex. 1006 ¶¶ 8, 9, 41, 55, 77, Fig. 8B; Ex. 1003 ¶¶ 101– 114, 116–118). Petitioner contends, for example, that Kreitler’s special icon 110 corresponds to the claimed OVI that is placed in a position corresponding to an off-map MO. Id. at 23–24 (citing Ex. 1005, 6:43–62, Fig. 1; Ex. 1003 ¶ 97). Petitioner further contends that “Altman690 discloses a social-networking system for displaying electronic maps with icons representing real-time locations of social network users and POIs.” “a POSITA would have found it obvious and advantageous to include Altman690’s social-networking functionality within Kreitler’s location-based items to enable sharing/accessing POIs between users.” Pet. 11 (citing Ex. 1003 ¶ 68). For limitations 1e and 1g, Petitioner relies on Kreitler individually and in combination with Suomela. Pet. 29–30, 32–34 (citing Ex. 1005, 5:36–41, 6:43–45, 6:51–57, Fig. 1; Ex. 1007, Abstract, 2:1–15, 4:34–41, Fig. 5; Ex. 1003 ¶¶ 115, 119–123). Petitioner asserts, for example, that Suomela “expressly discloses displaying both distance and travel-related information,” and specifically discloses “‘a digital map’ including objects ‘in a peripheral portion’ representing off-map locations, placed according to the direction to the off-map locations.” Id. at 33 (citing Ex. 1007, Abstract, 2:1–15, 4:34–41, Fig. 5; Ex. 1003 ¶¶ 121–122). According to Petitioner, “[a] POSITA would have been motivated to add Suomela’s distance and travel-related information to Kreitler[’s OVI] to provide further helpful information to a user.” Id. at 33 (citing Ex. 1003 ¶ 123). Petitioner further contends that: The ’943, Kreitler, Altman609, and Suomela are all in the field of mapping on electronic devices. All four address the known problem of displaying MO information, with Kreitler, Altman609, and Suomela disclosing known solutions, the combination of which yields predictable results. Therefore, it would have been obvious for a POSITA to combine Kreitler, Altman690, and Suomela for a more effective and efficient navigation system showing POIs on electronic maps.” slip op. at 17
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,014,943 - PTAB · Dec 8, 2023 · IPR2023-00934 · APJ Meredith C Petravick · IPR · Institution
Instituted IPR of claims 1–30 on all asserted grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable, including claims 1, 13, and 18 over Kreitler and Suomela.
In the decision…shown,’ indicating that these are not contained by the objects 29.” Id. at 17 (citing Ex. 1006, 4:45–47). Patent Owner contends that “Suomela’s teaching of separate indicators for distance and direction teaches against an OVI containing distance and direction or, at the very least, provide…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“(setting out six nonexclusive factors that the Board may consider in determining whether to deny institution because of a parallel district-court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s June 21, 2022 Memorandum titled Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Memorandum”).11 The Memorandum sets forth, inter alia, that the Board will not discretionarily deny institution under §314(a) when a petitioner submits a so-called Sotera stipulation, i.e., the petitioner “stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Memorandum 7 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Such a stipulation mitigates concerns of potentially conflicting PTAB and district-court decisions and duplicative efforts between the district court and PTAB. Id.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering Petitioner’s evidence and analysis, and taking into account Patent Owner’s arguments, based on the record before us at this stage of the proceeding, we determine that Petitioner has shown a reasonable likelihood that claim 1 is unpatentable over Kreitler and Suomela.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“Second, Patent Owner improperly interprets the term “OVI” to require distance information. Patent Owner apparently reads the embedded term “vector” in isolation rather than as part of the term “object vector indicator.” See IGT v. Bally Gaming Int’l, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011) (“Extracting a single word from a claim divorced from the surrounding limitations can lead construction astray.”); Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016) (construing claim terms without considering the context in which those terms appear is not reasonable). Thus, even if “vector,” read in isolation, means something akin to a “Euclidean vector” that would arguably contain both a “magnitude” (which we understand Patent Owner to mean distance) and a direction, an “OVI” would not necessarily contain this exact information. Moreover, defining “OVI” to contain both distance and direction would render superfluous the language in claim 1, limitation 1d, that expressly requires the created OVI to “contain[] the distance . . . information.” See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (construing a claim in a way that renders a term superfluous is “a methodology that [our reviewing court] has denounced”).” slip op. at 27
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“1d. Pet. 6–14, 19–22. Petitioner argues that Kreitler “teaches [1c] via determining navigational information including distance and direction (distance and travel-related information) to an item of interest (MO)” (id. at 19 (citing Ex. 1005, 5:36–41, 6:43–45, 7:5–31; Fig. 1)) and “discloses creating and displaying a special icon (OVI) indicating an off-map MO including the direction of the MO (travel-related information)” (Pet. 19 (citing Ex. 1005, 6:51–57)). Petitioner indicates that Kreitler does not expressly disclose OVI’s that contain distance-related information. Pet. 8. Petitioner contends that Suomela discloses displaying objects representing geographic points of interest that indicate direction and distance from the center of the map. Pet. 9 (citing Ex. 1006, Abstract 2:1–13, 4:34–56; Ex. obvious and advantageous to include distance indicators, as taught by Suomela, within Kreitler’s special icons to provide a user the distance from a position within the selected map to off-map POIs referenced by special icons.” Pet. 11 (citing Ex. 1003 ¶ 66). Based on the current record, and taking into account Patent Owner’s arguments, which we discuss below (see, supra, § II.E.4) we agree with Petitioner that a POSITA would have been motivated to include Suomela’s distance indicators within Kreitler’s special icons in order to advantegously provide distance information to a user. Ex. 1003 ¶ 66. We determine that Petitioner’s analysis and evidence sufficiently shows that the combination of Suomela and Kreitler discloses these steps.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,478,527 - PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
In the decision…In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res.…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166 - PTAB · Nov 9, 2023 · IPR2023-00890 · APJ Benjamin D M Wood · IPR · Institution
The Board instituted IPR of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claims 1–30 would be unpatentable.
In the decision…shown,’ indicating that these are not contained by the objects 29.” Id. at 17 (citing Ex. 1006, 4:45-47). Patent Owner contends that “Suomela’s teaching of separate indicators for distance and direction teaches against an OVI containing distance and direction or, at the very least, provide…
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“same parties and invalidity challenges. Apple Inc. v. Fintiv, Inc., IPR2020- 00019, Paper 11 at 5–6, 12-13 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”) (setting out six nonexclusive factors that the Board may consider in determining whether to deny institution because of a parallel district-court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s June 21, 2022 Memorandum titled Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (“Memorandum”).8 The Memorandum sets forth, inter alia, that the Board will not discretionarily deny institution under § 314(a) when a petitioner submits a so-called Sotera stipulation, i.e., the petitioner “stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Memorandum 7 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Such a stipulation mitigates concerns of potentially conflicting PTAB and district-court decisions and duplicative efforts between the district court and PTAB. Id.” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . 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). Upon considering the Petition, Preliminary Response, Preliminary Reply, Preliminary Sur- Reply, and the present record, we determine that Petitioner has satisfied this threshold requirement, and therefore we institute inter partes review of claims 1–30 of the ’297 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“See IGT v. Bally Gaming Int'l, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011) (“Extracting a single word from a claim divorced from the surrounding limitations can lead construction astray.”); Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016) (construing claim terms without considering the context in which those terms appear is not reasonable). Thus, even if “vector,” read in isolation, means something akin to a “Euclidean vector” that would arguably contain both a “magnitude” (which we understand Patent Owner to mean distance) and a direction, an “OVI” would not necessarily contain this exact information. Moreover, defining “OVI” to contain both distance and direction would render superfluous the language in claim 1 that expressly requires the created OVI to “contain[] the distance . . . information.” See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (construing a claim in a way that renders a term superfluous is “a methodology that [our reviewing court] has denounced”). Construing “OVI” as a “Euclidian vector” that necessarily contains both distance and direction information would also be contrary to the ’297 patent’s written description. The written description indicates that the word “vector” is broader than “Euclidean vector,” in that it may simply be an “arrow” that is “pointing in the direction of the referenced remote location marker.” Ex. 1001, 3:43–45. The written description states that “[i]nformation displayed in the OVI . . . may include a vector (e.g. arrow) pointing in the direction of the referenced remote location marker, the distance and travel time to the remote location marker, etc.” (Ex. 1001, 3:43–46 (emphasis added)),12 indicating that such information is optional rather than always present.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had at least a bachelor’s degree in Computer or Electrical Engineering or equivalent engineering discipline, and approximately three years’ experience in telecommunications, navigation, or geolocation systems,” but “[a]dditional education could substitute for professional experience, and significant work experience could substitute for formal education.” Pet. 3–4. Patent Owner does not oppose Petitioner’s contention. See Prelim. Resp. 6 (stating that, “[f]or the purposes of this Preliminary Response only, Patent Owner utilizes Petitioner’s proposed level of ordinary skill in the art”). At this stage of the proceeding, we adopt Petitioner’s unopposed definition for purposes of this Decision. We also look to the cited prior art references as evidence of the level of ordinary skill at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)” slip op. at 11
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,032,297 - PTAB · Oct 20, 2023 · IPR2023-00739 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 10–12, 18, 19, 21, and 26–28 are obvious over the 2009 Press Release and Shams.
In the decision…the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Release nor Shams expressly teaches the dosing regimen of “2 mg approximately every 4 weeks for the first 5 injections followed by 2 mg approximately once every 8 weeks or once every 2 months,” as recited in the independent claims. However, the question guiding our analysis is not one of anticipation, but of obviousness. Specifically, the question is whether the differences between the claimed subject matter and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR, 550 U.S. at 406. We therefore turn to that analysis.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“We conclude that, on the record as presently developed, Petitioner has demonstrated a reasonable likelihood of success in demonstrating that a person of ordinary skill in the art would have found it obvious to modify the dosage regiment of the 2009 Press Release by adding a single dose at week twelve, in view of the teachings of Shams, to arrive at the claimed invention. We find that a person of ordinary skill in the art would have considered this addition of a single dose to be routine optimization to ensure, as Dr. Chaum relates, “to determine the optimal number of initial injections, before moving to eight-week dosing.” Ex. 1002 ¶ 151. Furthermore, and at this stage of the proceeding, we agree with Petitioner that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the 2009 Press Release dosing protocol to include an additional dose at week twelve to ensure sufficient “drying” of the inner wall of the retina prior to increasing the interval of the doses two eight weeks/two months.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“claimed method. A reference teaches away when “a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner points to Shams’ Example 1, which it cites as representing Genentech’s PIER Phase IIIb study. See Prelim. Resp. 18. The PIER study, argues Patent Owner involved three monthly loading doses of a different VEGF antagonist (ranibizumab) followed by quarterly dosing, and, according to Patent Owner, was widely perceived as a failure. Id. Patent Owner contends that, based upon this single example, a person of ordinary skill in the art would have been discouraged from following the teachings of Shams. Id. We disagree. As we have explained above, the disclosures of Shams encompass a larger variety of regimen options than merely that embodied in Example 1. Shams is directed expressly to “methods including administering … a number of first individual doses of a VEGF antagonist, followed by administering … a number of second individual doses of the antagonist, wherein the second individual doses are administered less frequently than the first individual doses.” Ex. 1010, 4–5; see also id., claim 1. Furthermore, Shams expressly teaches that “[t]he doses may be administered according to any time schedule which is appropriate for treatment of the disease or condition.” Id. at 22. We find that these broad teachings of Shams would, rather than discouraging a skilled artisan from following its teachings, encourage a person of ordinary skill in the art to optimize the number of first and second individual doses to maximize the therapeutic effect of the regimen of VEGF antagonist dosage administration. Shams places no express limits upon the number of first individual doses and, as we have explained above, the addition of a single additional dose at week twelve would fall well within the scope of Shams’ disclosures.” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“A method for treating….” Petitioner initially accepts, for the purposes of this Decision, that the preamble of claim 1 is limiting, and agrees with the Board’s prior rejection, in the related IPR2021-00881 Final Written Decision, of Patent Owner’s position that the preamble requires a particular level of efficacy. Pet. 16 (citing Ex. 1002 ¶¶ 82–91). Specifically, Petitioner notes that the Board found that administering a compound—the recited VEGF antagonist—“to [a] patient for the purpose of improving or providing a beneficial effect on their angiogenic eye disorder” satisfies the “treating” portion of the preamble. Id. at 17 (quoting Ex. 1025, 19; and citing id. at 23; Ex. 1053, 9– 10; Ex. 1054). Patent Owner states that, for the purposes of this Decision only, it does not contest Petitioner’s proposed construction. Prelim. Resp. 11. Therefore, for the same reasons we explained in the Final Written Decision in related IPR2022-00881 concerning a related patent having claims with language similar to the presently challenged claims, and for the purposes of this Decision, we adopt Petitioner’s proposed construction of “a method for treating….” slip op. at 8
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
In the decision…prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
In the decision…prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem…
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122
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.