• Apple Inc. v. Masimo CorporationInstituted
  PTAB · Jul 9, 2024 · IPR2024-00243 · APJ Richard H Marschall · IPR · Institution

  The Board instituted IPR on claims 1–25 on all asserted obviousness grounds, finding a reasonable likelihood that Apple would prevail on at least one challenged claim.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

    “based on the Delaware Litigation. Prelim. Resp. 16–33; see Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there is a parallel district court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum, issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).6 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00243 petition or any grounds that could have reasonably been raised in that Petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “At this point in the proceeding, we do not find it necessary, to expressly construe the term “opening” in order to reach a decision on institution and, under the circumstances, we do not find a basis for denying institution in Petitioner’s application of the claim language requiring an “opening.” But see infra Section F.3.b (identifying a potential issue that may benefit from record development on claim construction). Neither party offers an express construction of the term “opening” to the prior art. Pet. 5; Prelim. Resp. 12–15 (arguing inconsistency but declining to offer an express claim construction). On the present record, we are persuaded that the plain and ordinary meaning of “opening” encompasses Iwamiya’s optical filter 17 as mounted within light shielding frame 18. See Pet. 23–24; see infra at Section F.3.b. This is consistent with Patent Owner’s position, in the Delaware Litigation, that a solid material can provide an opening, and with the finding of the panel in the Final Written Decision in IPR2022-01291. Ex. 2035, 26 (Final Written Decision in IPR2022-01291); Ex. 2037 ¶¶ 463–465 (report by Petitioner’s expert, Dr. Sarrafzadeh in the Delaware Litigation, regarding non-infringement, reproducing an image that Petitioner represents is from Patent Owner’s expert, Dr. Madisetti, in which Dr. Madisetti labeled transparent material an “Opening in Dark-Colored Coating,” and in which Dr. Sarrafzadeh asserts that “every space that Dr. Madisetti . . . identified is” slip op. at 16

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “prosecution history of a parent application, this language should be construed to exclude “arrangements of two or three detectors.” Prelim. Resp. 15 (citing Ex. 2057, 322 (prosecution history of U.S. Patent Application No. 15/195,199 (“the ’199 Application”))). Patent Owner notes that the panel in IPR2022-01291 adopted this construction for “a nearly identical limitation in Claim 15 of the related ’745 Patent.” Id. at 15–16 (citing Ex. 2035, 109–112). On this preliminary record, we agree with Patent Owner that, due to statements made during prosecution of a parent application, this claim language should be construed to exclude arrangements of two or three detectors. During prosecution of the ’199 Application, application claim 1 was amended to recite: a “tissue measurement site . . . having an at least partially circular shape bounded by a light block”; the light block comprising “an annular ring having a circular shape”; and a “plurality of detectors . . . arranged in an array having a spatial configuration corresponding to the shape of the irradiated portion of the tissue measurement site.” Ex. 2057, 311. Patent Owner argued to the Examiner that the “array” limitation had support in the ’199 Application specification because: The ordinary meaning of the claim term “correspond” means to “have a close similarity; match or agree almost exactly” or “be analogous or equivalent in character, form, or function” or “represent.” New Oxford American Dictionary, 390 (3rd Edition 2010). Consistent with this exemplary definition and the originally-filed application, the phrase “arranged in an array having a spatial configuration corresponding to the shape of the irradiated portion of the tissue measurement site” . . . would be understood by a person having ordinary skill in the art as requiring a sufficient number of detectors such that, when arranged together in an array, can “match,” “have a close similarity,” or “represent” the “at least partially circular shape” of the irradiated portion of the tissue measurement site. . . . In order for the claimed “plurality of detectors” to “match” or “represent” an “at least partially circular shape” or an “annular shape,” the “plurality of detectors” must include sufficient detectors to represent such shapes. For example, six or more detectors could be arranged in an annular shape and meet the recited limitation. However, two detectors, for example, can only be arranged in a spatial configuration representing a line and three detectors, for example, can only be arranged in a spatial configuration representing a line or a triangle. Thus, when read in view of the originally-filed application, the recited “plurality of detectors” would be understood by a person having ordinary skill in the art as including a sufficient number of detectors to represent the desired geometric shape.” slip op. at 18

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “On the present record, Petitioner’s definition of a POSITA is consistent with the level of skill reflected in the ’159 patent and the asserted prior art. Accordingly, for purposes of this Decision, we adopt Petitioner’s description. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining “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))). We note that we would reach the same outcome in this Decision under either definition of a POSITA. If the parties continue to propose differing levels of ordinary skill in the art during trial, they should state whether any issue in the case turns on those differences.” slip op. at 14

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,722,159
• Apple Inc. v. Masimo CorporationInstituted
  PTAB · Jul 9, 2024 · IPR2024-00241 · APJ David Cotta · IPR · Institution

  Instituted IPR on all grounds for claims 1–25, finding a reasonable likelihood that Apple would prevail on at least one challenged claim.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–25 of the ’743 patent.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there is a parallel district court proceeding). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).6 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00241 petition or any grounds that could reasonably have been raised in that petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv. Patent Owner argues that Petitioner’s stipulation “does not carry the benefits underlying the Director’s Guidance” because it was filed “only after the parties and the court conducted extensive and costly fact and expert discovery, and fully briefed and argued dispositive motions.” Prelim. Sur-reply 2. This argument is not persuasive because the Director’s Guidance does not afford discretion to discount a Sotera stipulation based on how far a parallel district court litigation has progressed when the stipulation was made. Director’s Memo 7 (explaining, without qualification, that “the” slip op. at 11

  • Parallel petitionsNot reached

    “B. Discretionary Denial in View of Multiple Petitions Petitioner filed two petitions for inter partes review of the ’743 patent, this Petition challenging claims 1–25 and the petition filed in IPR2024- 00242 challenging claims 1, 3–14, and 16–25. See Apple Inc. v. Masimo Corp., IPR2024-00242, Paper 3 (PTAB, filed Dec. 12, 2023). Patent Owner argues that Petitioner “fails to establish that two petitions on the ’743 Patent are necessary” and that “if the Board institutes one of the Petitions, it should deny the other.” Paper 9, 1. Petitioner requests that we consider this Petition before we consider the Petition in IPR2024-00242. Paper 2, 1. Accordingly, we reserve consideration of whether multiple petitions are merited for our decision in IPR2024-00242. III.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner contends that “[Petitioner’s] asserted level of ordinary skill in the art is relatively low” which “supports the patentability of the 7 The current record in this proceeding does not include any argument or evidence directed to objective indicia of nonobviousness. claims,” and further “notifies the Board that in the Delaware Litigation, [Patent Owner’s] expert presented a slightly different definition of the level of ordinary skill which includes education and/or experience with optical technologies.” Prelim. Resp. 11–12 (citing Ex. 2002 ¶¶ 48–51). Patent Owner asserts that the difference between the parties’ definitions “does not impact [Petitioner’s] patentability challenges here.” Id. On the present record, Petitioner’s definition of the POSA is consistent with the level of skill reflected in the ’743 patent and the asserted prior art. Accordingly, for purposes of this Decision, we adopt Petitioner’s description. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining “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 13

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 10,687,743
• Apple Inc. v. Willow Laboratories, Inc.Instituted
  PTAB · Jun 27, 2024 · IPR2024-00296 · APJ Alyssa A Finamore · IPR · Institution

  The Board instituted IPR on claims 1–4, 6, 8, 10–13, 15, 17, 19–21, 23–26, and 28 based on the asserted § 103 grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

    “The Director’s Memo7 guides our analysis under Fintiv. Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). In this proceeding, Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00296 petition or any grounds that could reasonably have been raised in that petition.” Ex. 1078, 1. Patent Owner argues that Petitioner’s stipulation “differs from Sotera, who filed its stipulation in the early stages of the parallel litigation” and that Petitioner “belatedly attaching the label ‘Sotera stipulation’ only after the Delaware Litigation is ready for trial does not protect against the concerns underlying the Director’s Guidance—gamesmanship and inefficiency.” Prelim. Sur-reply 2. This argument is not persuasive because the Director’s Memo does not afford us discretion to discount a Sotera stipulation based on how far a parallel district court litigation has progressed when the stipulation was made. Director’s Memo 7 (explaining, without qualification, that “the PTAB will not discretionarily deny institution of an [inter partes review] or [post-grant review] in view of parallel district court litigation where a 7 Memorandum from Katherine K. Vidal, Under Sec. of Commerce for Intellectual Property and Dir. of the USPTO, to Members of the PTAB (June 21, 2022), available at https://www.uspto.gov/sites/default/files/ documents/interim_proc_discretionary_denials_aia_parallel_district_court_ litigation_memo_20220621_.pdf (“Director’s Memo”). same grounds as in the petition or any grounds that could have reasonably been raised in the petition”). Thus, in view of Petitioner’s Sotera stipulation, we do not discretionarily deny institution under Fintiv.” slip op. at 12

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte Advanced Bionics, GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (footnote omitted). If a condition in the first part of the framework is satisfied, and absent a material error, the Director generally will exercise discretion not to institute inter partes review. Id. at 8–9.” slip op. at 13

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The main differences between the parties’ definitions of the POSITA appear to be that Patent Owner specifies that the POSITA’s knowledge and experience may include optical sensors and that the POSITA may have a degree emphasizing software. On the present record, we do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 22; Ex. 2002 ¶ 37. Nonetheless, we find the additional specificity of Patent Owner’s definition to be helpful. Also, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’911 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the POSITA. We note, however, that we would reach the same outcome under either definition of the POSITA. See also Prelim. Resp. 7 (“[Patent Owner] agrees that the claims’ patentability is confirmed regardless of the level of skill.”).” slip op. at 16

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

    “B. Claim Construction 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) (2023). 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. Furthermore, at this stage in the proceeding, we expressly 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))). Petitioner asserts that “[a]ll claim terms should be construed according to the Phillips standard” and that “no express constructions are required to institute review and find the [c]hallenged [c]laims unpatentable.” meaning and thus require no construction” and notes that this is the same position it took in the Delaware Litigation. Prelim. Resp. 9 (citing Ex. 2031, 57–84). On the current record and for the reasons set forth below in sections IV.D–E, we determine that no claim term requires an express construction for the purpose of determining whether to institute inter partes review.” slip op. at 17

  Claim construction§ 103 obviousnessDiscretionary denial
  Patents in suitUS 10,984,911
• Apple Inc. v. Masimo CorporationInstituted
  PTAB · Jun 27, 2024 · IPR2024-00294 · APJ David Cotta · IPR · Institution

  The Board instituted inter partes review of claims 1–20 on all grounds asserted in the Petition.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims are unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–20 of the ’507 patent.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

    “Fintiv, Inc., IPR2020-00019, Paper 11 at 11–12 (PTAB Mar. 20, 2020) (precedential) (holding that PTAB has discretion to deny institution in certain circumstances where there are parallel district court proceedings). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).11 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo, 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00293 petition or any grounds that could have reasonably been raised in that Petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv.” slip op. at 10

  • Parallel petitionsDecided for petitioner

    “Discretionary Denial in View of Parallel Petitions Petitioner filed two petitions for inter partes review of claims 1–20 of the ’507 patent, this Petition and the petition filed in IPR2024-00293. See Apple Inc. v. Masimo Corp., IPR2024-00293, Paper 3 (PTAB, filed December 12, 2023). Patent Owner argues that Petitioner “fails to establish that two petitions on the ’507 Patent are necessary” and that “if the Board institutes one of the Petitions, it should deny the other.” Paper 8, 1. This argument is moot because, concurrently herewith, we deny institution of inter partes review in IPR2024-00293 on the merits. III.” slip op. at 11

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The main differences between the parties’ definitions of the POSA appear to be that Patent Owner specifies that the POSA’s knowledge and experience may include optical sensors and that the POSA may have a degree emphasizing software. On the present record, we do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies and both parties agree that the POSA would have a working knowledge of physiological monitoring technologies. Ex. 1003 ¶ 24; Prelim. Resp. 6. We find the additional specificity of Patent Owner’s definition to be helpful. In addition, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’507 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. 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)). We note that we would reach the same outcome under either definition of the POSA.” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 10,736,507
• Apple Inc. v. Masimo CorporationInstitution denied
  PTAB · Jun 27, 2024 · IPR2024-00293 · APJ David Cotta · IPR · Institution

  The Board denied institution on claims 1–20 because Petitioner did not show a reasonable likelihood that Bailey’s processing board generated the claimed SpO2 measurement values.

  RulingsInstitution decision

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

    “Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Thus, for reasons explained below, we deny institution of inter partes review of claims 1–20 of the ’507 patent.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The main difference between the parties’ definitions of the POSA appears to be that Patent Owner specifies that the POSA’s knowledge and experience may include optical sensors and that the POSA may have a degree emphasizing software. On the present record, we do not deem these differences material, particularly because the optical sensors and technologies at issue are those used in physiological monitoring technologies and both parties agree that the POSA would have a working knowledge of 11 physiological monitoring technologies. Ex. 1003 ¶ 24; Prelim. Resp. 6. We find the additional specificity of Patent Owner’s definition to be helpful. In addition, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’507 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. 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)). We note that we would reach the same outcome under either definition of the POSA.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner does not identify any claim terms as needing formal construction. Pet. 3 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)). Patent Owner asserts that “the claims have 12 their plain meaning and thus require no construction,” noting that this is the same position it took in the Delaware Litigation. Prelim. Resp. 12.11 We determine that no terms require express construction at this stage. See Realtime Data, LLC v. Iancu, 912 F.3d 1368 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 12

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “4. Discussion We agree with Patent Owner that Petitioner’s showing with respect to the claim requirements relating to SpO2 measurement values is deficient. In particular, Petitioner maps the “SpO2 measurement values” “generat[ed]” by the “processing board” to the voltage level signals sent from the microcontroller to the wireless transmitter and then from the wireless transmitter to the mobile device. Pet. 19; Ex. 1004, 47 (“The only data that was actually sent from the digital interface to the user interface [i.e., the mobile device] was the voltage level and its corresponding LED, which was sent over in a 2-bit array of data.”). And Petitioner maps “the SpO2 measurement values” “display[ed]” in a “display portion[]” of the mobile device to a displayed SpO2 percentage. Pet. 21 (relying on Figure 32 of Bailey (reproduced supra § II.D.1), an image of the user interface of Bailey’s mobile device displaying an SpO2 percentage but not a voltage); see also id. at 22 (“As shown in Figure 32 below, Bailey’s mobile device displays at least a SpO2 value and a heart rate (a plurality of physiological parameters comprising at least the SpO2 measurement values).”). Thus, the data generated by the microprocessor (a voltage level) is not the data displayed by the mobile device (an SpO2 percentage). Consistent with this, Bailey indicates that its “User Interface,” i.e., its mobile device, is the system component that calculates the SpO2 level. Ex. 1004, 50 (explaining, in a discussion of the “User Interface,” that blood oxygen saturation was calculated using a “peak detection algorithm”).” slip op. at 20

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,736,507
• Apple Inc. v. Masimo CorporationInstituted
  PTAB · Jun 27, 2024 · IPR2024-00290 · APJ Richard H Marschall · IPR · Institution

  The Board instituted IPR on claims 1–4, 6, 11–22, 27, 28, 32, 34, 36, 37, and 42–44 on all asserted grounds, finding a reasonable likelihood of prevailing on at least one claim.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

    “certain circumstances where there are parallel district court proceedings). Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”).8 Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo, 3 (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A)). Because Petitioner has offered a stipulation like that in Sotera, i.e., a stipulation to “not pursue for the instituted claims, in [the Delaware Litigation], the same grounds as in the IPR2024-00290 petition or any grounds that could reasonably have been raised in that petition” (Ex. 1078, 1), we do not discretionarily deny institution under Fintiv. Patent Owner argues that Petitioner’s stipulation “does not carry the benefits underlying the Director’s Guidance” because it was filed “only after the parties and the court conducted extensive and costly fact and expert discovery, and fully briefed and argued dispositive motions.” Paper 8, 2. We find this argument unpersuasive because the Director’s Guidance does not afford us discretion to discount a Sotera stipulation based on how far a parallel district court litigation has progressed when the stipulation was made. Director’s Memo, 7 (explaining, without qualification, that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of” slip op. at 7

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

    “review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2022). Under 35 U.S.C. § 314(a), we may not authorize an inter partes review unless the information in the petition and the preliminary response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the evidence and arguments in the record, we institute inter partes review of the ’223 patent on all challenges set forth in the Petition.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The main differences between the parties’ definitions of the POSITA appear to be Patent Owner’s inclusion of a number of alternative ways one could qualify as a POSITA, including a Master’s degree combined with less experience, although Petitioner also acknowledges that “[l]ess work experience may be compensated by a higher level of education.” Ex. 1003 ¶ 22. On the present record, we do not deem the differences in the proposals as material given their substantive overlap. In general, we find the additional specificity and alternatives in Patent Owner’s definition helpful. In addition, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’223 patent. Accordingly, for purposes of this Decision, we adopt Patent Owner’s proposed definition of the person of ordinary skill in the art. 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)). We note that we would reach the same outcome in this Decision under either definition of the POSITA. If the parties continue to propose differing levels of ordinary skill in the art during trial, they should explain the differences and their relevance to the patentability issues in this case, and state whether any issue in the case turns on those differences.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

    “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). Under this standard, claim terms are generally given their ordinary and customary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1312–14 (Fed. Cir. 2005) (en banc) (“We have frequently stated that the words of a claim ‘are generally given their ordinary and customary meaning.’” (citations omitted)). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that “no claim terms need to be construed to resolve issues of controversy in the present Petition.” Pet. 3 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)). Patent Owner asserts that we “should give the claims their ordinary and customary meaning” and that the claims “require no construction.” Prelim. Resp. 15 (noting that this is the same position it took in the Delaware Litigation). Patent Owner then asserts that Petitioner proposed constructions in the Delaware Litigation for several claim terms, but that Patent Owner asserts here, as it does in the Delaware Litigation, that those terms do not require construction. Id. at 15–16. We determine that no terms require express construction at this stage.” slip op. at 11

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 8,190,223
• Forte Biosciences, Inc. v. University Of MassachusettsAll claims unpatentable
  PTAB · Jun 24, 2024 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Final written decision

  Claims 1–5 are unpatentable for lack of written description and enablement under § 112(a); the Board did not reach the § 103 challenge.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not contest Petitioner’s proposed definition, except to modify the level such that an ordinarily skilled artisan “would have been familiar with well-known inhibitors of IL-15 and IL-15R as described in the ’505 patent and recognized in the art as of April 2017.” Resp. 26–27 (citing Ex. 2005 ¶ 94). We adopt Petitioner’s level of ordinary skill in the art with Patent Owner’s proposed modification because it appears consistent with the problems addressed in the ’505 patent and the prior art of record.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Resp. 38. We agree. Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Here, we determine that no claim construction is necessary.” slip op. at 8

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

    “Finally, we are reminded that “a sufficient description of the genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. Here, however, the challenged claims are directed to methods using a wide range of different types of compounds purported to be “IL-15/IL-15R inhibitors” that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not appear to always function as inhibitors. See Ex. 1018, Abstr., 1575–77, 1579; Ex. 1046, 189:4–19, 191:15–192:15, 193:18–196:22, 198:21–199:21, 197:12–198:19, 200:1–8, 207:11–14, 203:3–10, 207:15–21, 236:12–24; Ex. 1047 ¶¶ 19–23, 56, 63–64, 80–85. Therefore, we find there is neither a representative number of species disclosed, nor a sufficient” slip op. at 21

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

    “598 U.S. at 610. A “specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.” Id. at 613. But the person of ordinary skill in the art cannot be left with merely “a hunting license” or obligated to engage in “painstaking experimentation” or “trial and error” to “see what works.” Id. at 614. Patent Owner argues that “the IL-15/IL-15R inhibitors disclosed in the specification were known in the art and “share the common ‘general quality’ of inhibiting a pathway known to be relevant to and having ‘particular fitness for the particular purposes’ of (id.) treating certain autoimmune diseases by blocking IL-15 signaling.” Sur-reply 14 (citing Ex. 1011, 22; Ex. 2013, 3; Ex. 2017, Abstr.; Ex. 2024, 17; Ex. 2025, 2–3, 6; Ex. 2027, 4; Ex. 2028, 9; Ex. 2029, 4; Ex. 2031, 23; Ex. 2118, 53:22–54:9; Ex. 1018, 1; Ex. 2005, ¶¶ 52–63, 80–83, 130; Ex. 1046, 231:20–25). Patent Owner’s argument is unavailing, however, because the record shows that different IL-15-specific inhibitors may operate in different ways that may result in differential effects, some of which may not include inhibition at all. See Ex. 1047 ¶¶21, 23, 40, 71; Ex. 1018, Abstr., 1576, 1579; Ex. 2013, 4:1– 8; Ex. 2014, 4:9–15; Ex. 2015 ¶ 22; Ex. 2025, 4:34–5:2; Ex. 1046, 166:21– 24, 168:25–169:5, 207:23–209:22, 210:4–17, 210:24–211:6; Ex. 1011, 1:67–2:4; Ex. 2005 ¶¶ 116, 134. Thus, we find that the record supports Drs. Abbas and Plott’s testimony, which we credit, that a person of ordinary skill in the art would be forced to hunt down and test every compound through painstaking Ex. 1002 ¶¶ 85–90, 92; Ex. 1047 ¶ 53 (Dr. Plott’s testimony that the “specification of the ’505 patent is essentially a black box (so far as which aspects of IL-15 signaling it inhibits and how it operates), leaving the reader to guess through trial and error which molecules might operate similarly to ChMBC7 and which do not.”); Ex. 1004 ¶ 61 (Dr. Plott’s testimony that “from the perspective of a clinician, the amount of experimentation required would be extremely burdensome and success would be speculative.”); Ex. 2007, 93:16–97:25, 38:208; Ex. 1046, 234:20–236:11. This is due to the fact that the claims (without limit) encompass any inhibition of any one of the various types of IL-15 signaling and various versions of the receptor, and even implicate other compounds that act on different targets but which inhibit the IL-15 signaling pathway. See Ex. 1047 ¶¶ 10, 53, 68; Ex. 2005 ¶ 71; Ex. 1046, 254:4–255:11, 158:12–160:20. The evidence has shown that IL-15/IL-15R inhibition is complicated and unpredictable, with some inhibitors also capable of enhancing forms of IL-15 signaling rather than preventing it. See Ex. 1047 ¶¶ 10, 25–26, 53; Ex. 2013, 2:10–18; Ex. 2014, 2:12–20; Ex. 2015 ¶ 3; Ex. 2025, 2:10–18; Ex. 2078, 267.” slip op. at 32

  Patent outcomesUS 11,278,505 unpatentable
  Claim construction§ 112 disclosurecites Phillips
  Patents in suitUS 11,278,505
• Samsung Bioepis Co. Ltd. v. Regeneron Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jun 14, 2024 · IPR2023-00442 · APJ John G New · IPR · Final written decision

  Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as obvious over Dixon because Dixon anticipates them.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “We adopt the same reasoning here, and conclude that the evidence of record and the Specification of the ’681 patent support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to a patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, although the claims “encompass a clinical result, they do not require such a result.” (emphasis added). 8 F.4th 1331, 1343 (Fed. Cir. 2021). We consequently reject Patent Owner’s proposed construction that the language of the preamble reciting a “method for treating an angiogenic eye disorder” requires not only an intent to treat, but, additionally, a high degree of efficacy on par with monthly Lucentis. See PO Resp. 9–10.” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44. Patent Owner does not expressly dispute Petitioner’s construction, other than to argue that, by 2011, a person of ordinary skill in the art would have understood “initial” and “secondary” doses to correspond to loading doses and “tertiary” doses to correspond to maintenance doses. PO Resp. 13 (citing Ex. 2056 ¶ 66; Ex. 2349, 6–11. Patent Owner contends that the purpose (and expected effect) of loading doses was to achieve visual acuity gains and retina drying, and the goal of less frequent maintenance doses was to maintain the efficacy achieved with loading doses. Id. at 14 (citing Ex. 2056 ¶ 66). As we have explained above, we do not find persuasive Patent Owner’s argument that the definition of these terms requires a high, or otherwise defined, degree of efficacy. As we stated in the -00881 and -01225 Decisions: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.”” slip op. at 18

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “If a claim limitation is directed to printed matter, the second step of the Praxair analysis is to determine whether the printed matter is functionally related to its “substrate.” Praxair, 890 F.3d at 1032. Printed matter that is functionally related to its substrate is given patentable weight. Id. (citing DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. (quoting In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). More specifically, printed matter is functionally related to its substrate when the language changes not mere thoughts or outcomes, but provides action steps that the method requires. See C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1381 (Fed. Cir. 2020) (holding that the test for printed matter is whether it “merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to … cause a specific action in a claimed process.”); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating that language “is only a statement of purpose and intended result” where its “expression does not result in a manipulative difference in the steps of the claim”) (emphasis added).” slip op. at 21

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A Person of Ordinary Skill in the Art Petitioner notes that the Petitioner in the ’00881 IPR proposed that a person of ordinary skill in the art would have: (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field. Pet. 17–18 (quoting -00881 IPR, Paper 94 at 9–10). Furthermore, it was asserted that such a person would typically have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders, including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists. Id. at 18 (citing -00881 IPR Paper 94 at 10). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. In the -01225 IPR, we adopted the same definition of a person of ordinary skill in the art for the challenged claims of the ’681 patent, concluding that that definition was consistent with the level of skill in the art. See -01225 IPR, Paper 96 at 52–53. Having previously adopted this definition of the level of skill in the art for the claims of the ’681 patent, we do so again in the present proceeding.” slip op. at 25

  Patent outcomesUS 10,130,681 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,130,681
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityInstituted
  PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution

  The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).

  RulingsInstitution decision

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

    “The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2

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

    “patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. 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) (2019). 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. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

    “Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,591,393
• Foresight Diagnostics, Inc. v. Personalis, Inc.All claims unpatentable
  PTAB · Jun 12, 2024 · IPR2023-00317 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–23 are unpatentable: claims 1–7 and 10–23 as anticipated by Forshew, and claims 1–23 and 1–9 and 11–23 as obvious over Forshew with Wagle and Wagle with Chan, respectively.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner has not subsequently challenged the above definition. See Ex. 2031 ¶ 48 (Dr. Furneaux applying the above definition). For the reasons set forth in our Institution Decision, and because Petitioner’s proposed level is commensurate with the level of skill reflected in the prior art of record, we apply the same definition here. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). C. Claim Construction” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “adopt Petitioner’s proposed definition of “capture probes” as encompassing at least, “PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” See DI 18–24. For the reasons set forth in our Institution Decision, and as further addressed below, we apply that definition here—albeit with a minor modification in wording. In particular, we credit Patent Owner’s argument that the phrase “PCR primer capture probe” is not a recognized term of art and its use in our construction “would improperly inject ambiguity into the claim.” POR 58– 59 (citing, e.g., Ex. 2018, 166:10–169:1, 171:16–175:2; Liquid Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004)). Although we recognize Petitioner’s use of “PCR primer capture probe” as a shorthand for its position that, as read in light of the Specification, PCR primers are a species of, and/or indistinguishable from, the genus of capture probes, Patent Owner’s point is well taken. Accordingly, we clarify the meaning of “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). We do not view this modification as altering the substance of our provisional construction or the analysis in our Institution Decision.” slip op. at 11

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner

    “Ex2112, slide 5 for the ‘plurality of capture probes’ limitation of step 1(a),” Petitioner contends that its “bare reference to ‘pullout’” suggests at most, “that by May 2012, Mr. West contemplated that a particular type of capture probe would be among many other ‘lab solutions’ for addressing accuracy.” Reply 7–8; see Ex. 1225 ¶¶ 123–126. In this respect we note Mr. West’s testimony that he understood “pullout” in Slide 5, as a reference to Agilent SureSelect biotinylated probe system. See Ex. 1222, 83:8–85:22, 88:7–16. We, nevertheless, find persuasive Dr. Quackenbush’s testimony that “a POSA reviewing Slide 5 in light of the overall record on conception would have insufficient information to determine how, specifically, Personalis intended to use the ‘Pullout,’ other than that their purpose was to provide a laboratory solution to improve the accuracy of 2012 sequencing technology in some way.” Ex. 1225 ¶ 125. Considering the evidence of record, we credit Dr. Quackenbush’s testimony that a person of ordinary skill in the art reading Personalis’ conception exhibits, including Exhibit 2112, “would have found, at most, an incipient research project for improving the accuracy of sequencing technology that would involve the use of an undefined combination of various conventional techniques.” Ex. 1225 ¶ 128. In addition to Dr. Quackenbush’s testimony as to claim steps involving capture probes (elements 1(a)–1(c)), we further find persuasive his testimony that Patent Owner provides no corroboration of the conception of steps 1(d)–1(f), which require assaying samples obtained from the same individual obtained at different time points. See id. ¶¶ 120–121, 126–127; Reply 9–10; Sur-Reply 6–8 (citing, e.g., Ex. 2032 ¶¶ 91–134; Ex. 2109; Ex. 2112; Ex. 2036). In sum, we find that Personalis’ exhibits and related testimony do not evidence sufficient conception of the invention set forth in the challenged claims. See, e.g., Ex. 1225 ¶¶ 120–128 (Dr. Quackenbush’s testimony about missing aspects of the claims in Patent Owner’s proofs, such that the “completed thought” is not shown).15 Considering the above, we find that Patent Owner has not satisfied the burden of establishing that its claimed invention is entitled to a priority date that precedes either of the respective publication dates of Forshew and Chan. Accordingly, Forshew and Chan qualify as prior art to the ’033 patent.” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “In Section II.C. above, we construe “capture probes,” as used in the instant Specification, to encompass PCR primers and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits). Accordingly, in disclosing the use of PCR primers, Forshew discloses “capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification. See Pet. 29–33 (citing Ex. 1020 ¶¶ 117–122; Ex. 1030, 2–3). Forshew further satisfies the “plurality of capture probes” “COSMIC: mining complete cancer genomes in the Catalogue of Somatic Mutations in Cancer,” 39 NAR D945-950 (2011)). limitation in disclosing the use of PCR primers for the detection and monitoring of cancer-associated alleles. See, e.g, id.; Ex. 1020, 3 (“We designed 48 primer pairs to amplify 5995 bases of genomic sequence covering coding regions (exons and exon junctions) of TP53 and PTEN, and selected regions in EGFR, BRAF, KRAS, and PIK3CA (table S1) by overlapping short amplicons (Fig. 1A).”). For the reasons set forth above, Petitioner has sufficiently shown that Forshew discloses “capture probes” and “a plurality of capture probes,” as would have been understood by one of ordinary skill reading the ’033 Specification.” slip op. at 36

  Patent outcomesUS 11,408,033 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,408,033

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.