• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · 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.

  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 · Graham
  Patents in suitUS 8,536,122
• Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Bayer Pharma AktiengesellschaftAll claims unpatentable
  PTAB · Jul 28, 2023 · IPR2022-01513 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–8 are unpatentable: claims 1–2 as anticipated by Foley, claims 1–2, 5, and 8 as obvious over Foley, and claims 3–4, 6–7 as obvious over Foley and Plosker.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We find Petitioner has the better position. We agree with Petitioner and Dr. Zusman that an M.D. with experience treating patients who worked in consultation with a team of specialists would include the qualifications recited by Patent Owner. Ex. 1037 ¶¶ 7–11. We, therefore, adopt Petitioner’s definition of a POSA, which indicates a high level of skill in the relevant art and is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). Even if there were a distinction between the parties’ respective definitions of the level of ordinary skill in the art, Patent Owner’s expert, Dr. Weitz, notes that his opinion would not change regardless of which definition is applied. See Ex. 2060 ¶ 26. Moreover, we find both Dr. Zusman and Dr. Weitz qualified to opine from the perspective of a POSA for purposes of this Decision as both possess at least the level of ordinary skill in the art. See Ex. 1002 ¶¶ 1–11; Ex. 2060 ¶¶ 1–11; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369,” slip op. at 10

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

    “3. Remaining Claim Terms Patent Owner also offers constructions for “coronary artery disease,” and the preamble (PO Resp. 23–32, 39–40), but none of these claim phrases Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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))). We now turn to the patentability challenges presented by Petitioner.” slip op. at 21

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

    “construction and determine that the term “clinically proven effective” is nonlimiting, as Petitioner asserts. See Pet. 11; Pet. Reply 8–9, 16. We begin our analysis with the language of the claims, which recite administering rivaroxaban and aspirin in amounts that are “clinically proven effective,” “wherein rivaroxaban is administered in an amount of 2.5 mg twice daily and aspirin is administered in an amount of 75–100 mg daily.” Ex. 1001, claims 1 and 5. We are persuaded that a POSA would have understood from a plain reading of the claims that the specific recited “amounts” of 8 We also noted in our Institution Decision that in the Delaware MDL, the parties stipulated that claim 1 “does not require FDA approval.” Dec. Inst. 15 n.6 (quoting Ex. 2019, 2). That is, the independent claims expressly recite that the rivaroxaban is administered in an amount of 2.5 mg twice daily, and that aspirin is administered in an amount of 75–100 mg daily. Ex. 1001, claims 1 and 5. Because the claims expressly recite the amounts of rivaroxaban and aspirin, further identifying these amounts as “clinically proven effective” is redundant and unnecessary, and does nothing to alter the method steps of administering the pharmaceutical, as otherwise recited by these claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (finding claim term “antineoplastically effective” not limiting where express dosage amounts are material claim limitations that do not change based on the intended result).” slip op. at 13

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

    “Patent Owner again, however, misses the point. The question is not whether clinical trials may exist where the disclosed dosing regimen may not be clinically proven effective, or whether a POSA would necessarily recognize clinical proof of efficacy from the COMPASS protocol taught by Foley. Id. at 53–54. On the contrary, the question is whether “the [prior art] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010) (citation omitted). If it is, the Federal Circuit has held that it is “well-settled that the disclosure should be regarded as sufficient.” Id. As such, here, we consider whether the disclosure in Foley is sufficient to show that the natural result of the disclosed dosing regimen would be “clinically proven effective” by the COMPASS study disclosed by Foley. In this case, we know that to be true because the claimed process was confirmed by the same COMPASS study disclosed by Foley. See Bristol- Myers, 246 F.3d at 1376; see also Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1369 (Fed. Cir. 2006) (finding method claims anticipated where prior art method disclosed the same steps in furtherance of the same purpose, and all that was contributed by the patent claims is the the claim term were limiting, we find Foley inherently discloses “clinically proven effective” amounts of rivaroxaban and aspirin. Having considered the arguments and evidence presented at trial, we find Petitioner has shown by a preponderance of the evidence that claims 1 and 2 are anticipated by Foley.” slip op. at 26

  Patent outcomesUS 10,828,310 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,828,310
• Forte Biosciences, Inc. v. University Of MassachusettsInstituted
  PTAB · Jul 3, 2023 · PGR2023-00014 · APJ Georgianna W Braden · PGR · Institution

  The Board instituted PGR on claims 1–5 and all asserted challenges, finding written description and enablement challenges met the threshold but the Harris–Xing obviousness challenge did not.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “Patent Owner’s argument is unpersuasive because the combination of Harris with Xing is not cumulative of Pavlakis, Harris-2015, and Damsky. Here the combination of Harris with Xing is argued in different ways compared to what was made to the Examiner. Additionally, we agree with Petitioner that Xing discloses information the Examiner indicated were absent from the prior art. See Ex. 1010, 14–15. For example, Xing teaches administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor is administered to the subject. Compare id. at 15, with Ex. 1007, 3. Xing also teaches that TM-β1-mediated blockade of CD122 prevented disease development and progression and that inhibiting IFN-γ production downstream of IL-15 through topical administration of JAK inhibitors effectively eliminated existing lesions. Thus, we do not find that the same or substantially the same arguments were presented previously to the Office, nor do we find that the same or substantially the same art was previously presented to the Office. Thus, the first part of the Advanced Bionics framework is not satisfied for Petitioner’s § 103 challenge, and we decline to exercise our discretion under 35 U.S.C. § 325(d) to deny institution of a trial proceeding on this challenge.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “At this stage of the proceeding, Patent Owner does not assert a different level of skill in the art at the time of the alleged invention and uses Petitioner’s proposed level of skill. Prelim. Resp. 16. For the purposes of this Decision, we too adopt Petitioner’s level of ordinary skill in the art 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)Plain and ordinary meaningOther

    “Both parties state that express claim construction is unnecessary at this stage of the proceeding and that all terms are to given their plain and ordinary meaning. Pet. 23; Prelim. Resp. 17. 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 terms for purposes of institution.” slip op. at 7

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

    “review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4. A post-grant review may not be instituted unless it is determined that “the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324 (2018); see also 37 C.F.R § 42.4(a) (2022) (“The Board institutes the trial on behalf of the Director.”). The “more likely than not” standard requires greater than 50% chance of prevailing. Consolidated Trial Practice Guide 58 (Nov. 2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated. For the reasons provided below and based on the record before us, we determine Petitioner has demonstrated that it is more likely than not that it would prevail in showing the unpatentability of at least one of the challenged claims. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Accordingly, we institute a post-grant review of the ’505 patent and all of the asserted challenges to patentability.” slip op. at 2

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,278,505
• Intuit Inc. v. Samesurf, Inc.Instituted
  PTAB · Jun 28, 2023 · IPR2023-00341 · APJ Barbara A Benoit · IPR · Institution

  Instituted IPR of claims 1–16 on all asserted grounds after finding a reasonable likelihood that Lebrun and Wang render at least claim 1 obvious.

  RulingsInstitution decision

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

    “review is under 35 U.S.C. § 314. See also 37 C.F.R. § 42.4(a) (2020). To institute an inter partes review, the information presented in the Petition must show “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).” slip op. at 2

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

    “claim construction standard employed in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100(b) (2020). Under the principles set forth by our reviewing court, the “words of a claim ‘are generally given their ordinary and customary meaning,’” as would have been understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “In determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). We construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither Petitioner nor Patent Owner propose express constructions for any claim terms. Pet. 12; Prelim. Resp. 34. For purposes of this decision, we agree that no claim terms need be expressly construed. Patent Owner arguments regarding the asserted grounds of unpatentability, however, raise particular claim scope contentions, particularly regarding “information related to the shared web browsing interaction” recited in each of the independent claims. We preliminarily address issues of claim scope in our later discussion of the asserted grounds of unpatentability.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Accordingly, based on this preliminary record, we find Patent Owner’s assessment of “internet web browsing software development, web connectivity software development, or networking software development” to be too narrow in view of the asserted prior art that describes in large measure requesting and receiving web pages from web servers. Thus, we find that Petitioner’s assessment of “software development and/or web- based software” more appropriate for purposes of institution on this limited record. We also agree with Petitioner that additional education could have substituted for professional experience, and significant work experience could have substituted for formal education. For the purpose of this decision, for these reasons, we find that a person of ordinary skill in the art would have had (1) at least a bachelor’s degree in computer science, computer engineering, electrical engineering, or a similar field, and (2) at least two years of work experience in software development and/or web-based software. We apply that level of ordinary skill in this decision. Our decision, however, would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Accordingly, there is evidence to consider in making a determination whether Dr. Lieberman possesses the requisite ordinary level of skill. We, however, need not make such a determination for purposes of this decision because it has not been necessary for us to rely on Dr. Lieberman’s declaration in this decision. “No rule requires a Petition to be accompanied by any declaration, let alone one from an expert guiding the Board as to how it should read prior art.” Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1079 (Fed. Cir. 2015). “[E]xpert testimony is not required when the references and the invention are easily understandable.” Id. (quoting Wyers v. Master Lock Co., 616 F.3d 1231, 1242 (Fed. Cir. 2010)). “Board members, because of expertise, may more often find it easier to understand and soundly explain the teachings and suggestions of prior art without expert assistance.” Id. Here, the invention and prior art are presented in high-level functional terms and are easily understandable, as we indicated previously in Section II.A and as shown by our discussion of the invention and prior art throughout this decision. To determine that the Petition met the institution threshold of showing “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition,” we have not relied on Dr. Lieberman’s declaration testimony. Patent Owner, of course, may raise the issue of Dr. Lieberman’s qualifications during trial.” slip op. at 58

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,483,448
• Intuit Inc. v. Samesurf, Inc.Instituted
  PTAB · Jun 28, 2023 · IPR2023-00339 · APJ Barbara A Benoit · IPR · Institution

  Instituted review of claims 1–18 on all asserted grounds because the petition showed a reasonable likelihood that at least one challenged claim was obvious.

  RulingsInstitution decision

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

    “review is under 35 U.S.C. § 314. See also 37 C.F.R. § 42.4(a) (2020). To institute an inter partes review, the information presented in the Petition must show “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).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Accordingly, based on this preliminary record, we find Patent Owner’s assessment of “internet web browsing software development, web connectivity software development, or networking software development” to be overly narrow in view of the asserted prior art that describes in large measure requesting and receiving web pages from web servers. Thus, we find that Petitioner’s assessment of “software development and/or web-based software” more appropriate for purposes of institution on this limited record. We also agree with Petitioner that additional education could have substituted for professional experience, and significant work experience could have substituted for formal education. For the purpose of this decision, for these reasons, we find that a person of ordinary skill in the art would have had (1) at least a bachelor’s a similar field, and (2) at least two years of work experience in software development and/or web-based software. We apply that level of ordinary skill in this decision. Our decision, however, would not change, however, if we had applied Patent Owner’s proposed level of ordinary skill.” slip op. at 11

  • Expert testimonyDecided for petitioner

    “Accordingly, there is evidence to consider in making a determination whether Dr. Lieberman possesses the requisite ordinary level of skill. We, however, need not make such a determination for purposes of this decision because it has not been necessary for us to rely on Dr. Lieberman’s declaration in this decision. “No rule requires a Petition to be accompanied by any declaration, let alone one from an expert guiding the Board as to how it should read prior art.” Belden Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1079 (Fed. Cir. 2015). “[E]xpert testimony is not required when the references and the invention are easily understandable.” Id. (quoting Wyers v. Master Lock Co., 616 F.3d 1231, 1242 (Fed. Cir. 2010)). “Board members, because of expertise, may suggestions of prior art without expert assistance.” Id. Here, the invention and prior art are presented in high-level functional terms and are easily understandable, as we indicated previously in Section II.A and as shown by our discussion of the invention and prior art throughout this decision. To determine that the Petition met the institution threshold of showing “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition,” we have not relied on Dr. Lieberman’s declaration testimony. Patent Owner, of course, may raise the issue of Dr. Lieberman’s qualifications during trial.” slip op. at 46

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

    “Neither Petitioner nor Patent Owner propose express constructions for any claim terms. Pet. 12; Prelim. Resp. 32. For purposes of this decision, we agree that no claim terms need be expressly construed. Patent Owner particular claim scope contentions regarding “web browsing interaction data” recited in each of the independent claims. We preliminarily address those issues of claim scope in our later discussion of the asserted grounds of unpatentability.” slip op. at 12

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,185,145
• Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentable
  PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

  The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77

  • ExcludeMotion to exclude, deniedDenied

    “A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29

  • Skill levelSkill level board ownOther

    “Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25

  Patent outcomesUS 10,766,685 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,766,685
• Foresight Diagnostics, Inc. v. Personalis, Inc.Instituted
  PTAB · Jun 13, 2023 · IPR2023-00317 · APJ Robert A Pollock · IPR · Institution

  The Board instituted inter partes review of claims 1–23 on all petitioned grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’033 patent is unpatentable. We therefore institute trial on all challenged claims under the grounds raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); Guidance, 2–3; 37 C.F.R. § 42.108. At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 10; Pet. 6. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 10–12 of Patent Owner’s Preliminary Response. Cf. 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)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 16

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

    “In view of the above, we preliminarily conclude that one of ordinary skill reading the ’033 patent would understand that there is no discernable physical distinction between capture probes and amplification primers, and that Patent Owner’s functional distinction—hybridizing to target DNA so as to form subsets of molecules that are/are not hybridized—is a commonly desired trait for nucleotides used as in hybridization-based methods including PCR. Considering the argument and evidence presently of record, we agree with Petitioner that the claimed “capture probes” encompass, at a minimum,10 PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” slip op. at 24

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

    “Forshew’s capture probes hybridize to a plurality of polymorphisms because, upon replication, its PCR primers hybridize to DNA fragments containing a plurality of polymorphisms, for example, known point mutations in cancer-related genes. Patent owner, by contrast, more narrowly interprets claim step 1a as requiring that, absent replication, the nucleotide sequence of Forshew’s PCR primers must, encompass and hybridize to, polymorphic target sites. This issue may benefit from further exploration at trial. For the purpose of institution, however, we rely on Dr. Quackenbush’s testimony that one of ordinary skill in the art would have “understood that Forshew’s PCR primer capture probes are the claimed ‘capture probes’ because they are nucleic acid sequences that ‘hybridize to’ the complementary sequences on the nucleic acid harboring the polymorphic gene.” Ex. 2020 ¶ 121; see also id. ¶¶ 119–120, 122–123.” slip op. at 26

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,408,033
• Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentable
  PTAB · May 17, 2023 · IPR2022-00402 · APJ Michael A Valek · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–7, 9, 10, 12–15, 17, 18, 20–25, and 27–30 are anticipated; the remaining challenged claims are obvious.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Petitioner further asserts that “[a] POSA would have understood the chemical structure of nucleic acids, such as DNA and RNA, and would have understood the role of such nucleic acids in cellular biology” and been aware of various prior art “methods to chemically modify RNA, including gRNAs for use in gene regulation.” Id. at 12–13 (citing Ex. 1003 ¶¶ 61–72, 80). Patent Owner agrees that a POSA would have this educational level. Resp. 24. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties may disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 8

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

    “Independent claims 1 and 12 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to a target polynucleotide.” Ex. 1001, 243:20–22, 244:28–31. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 17 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 17. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:36–40. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 12. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24–25. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “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 9

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

    “We find Petitioner’s arguments and evidence persuasive. It is well established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 24–26. There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. Smithkline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 21

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional. Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 79 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 79, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 23

  Patent outcomesUS 10,337,001 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,337,001
• Slayback Pharma LLC v. Eye Therapies, LLCAll claims unpatentable
  PTAB · May 15, 2023 · IPR2022-00142 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over Gil, Norden, Dean, Alphagan, and Federal Register; anticipation over Gil and Walters was not shown for claims 1–2.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Although the parties disagree as to the specific qualifications of a person of ordinary skill in the art, the parties’ experts agree that their Ex. 1049 ¶ 6 (Sher); Ex. 2020 ¶ 28 (Noecker); Ex. 2021 ¶ 34 (Williams); Ex. 2022 ¶ 23 (Davies). Both parties’ proposed definitions and the prior art of record indicate a high level of skill in the relevant art. Because the parties’ respective experts agree that any dispute as to the level of ordinary skill in the art is not material to their opinions, we adopt Patent Owner’s definition as consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Ex. 2020 ¶¶ 28–31; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

  • Expert testimonyPetitioner expert creditedOther

    “We are not persuaded. We credit the testimony of Petitioner’s expert, Dr. Sher, who explains that because of the “high degree of imprecision of Figures 2 and 6,” a POSA would be unable to reach any quantitative conclusions from the figures or “clinically distinguish” between brimonidine concentrations that differ by only five-thousandths of a percent. Ex. 1049 ¶¶ 10–18. For example, as Dr. Sher notes, there are no incremental hash marks that indicate where any non-enumerated concentrations such as 0.02% or 0.025% would fall. Id. ¶¶ 11–12. Moreover, the x-axis of both figures appears to be neither linear nor logarithmic. Id. The uncertainty of the scale of the x-axis calls into question the assumption by Dr. Noecker that the blue dot on the x-axis of Figure 6 is necessarily 0.025% as opposed to, for example, 0.02%, which is specifically called out in the Specification’s description of Figure 6 as a preferred concentration. See Ex. 1001, 19:57 (stating Figure 6 demonstrates that “the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably between about 0.012% and about 0.02%”) (emphasis added). Moreover, like Dr. Sher, we question the accuracy of Dr. Noecker’s statement that concentrations less than 0.03% have no rebound hyperemia. See Ex. 1049 ¶ 19 (citing Ex. 2020 ¶ 94). As seen by a magnified portion of Figure 2, reproduced below, the dark gray, solid line indicating rebound hyperemia appears to show at least some amount of rebound hyperemia below 0.03%: That is, the magnified portion of Figure 2 depicts the dark gray rebound hyperemia curve between 0.01% and 0.03% to be above the x-axis, indicating—on its face—that some rebound hyperemia occurs, contrary to Dr. Noecker’s testimony. Id. We, therefore, credit the reasoning of Dr. Sher, who explains that, in light of the imprecision of the figures, a POSA would not rely on the figures to discern when rebound hyperemia begins, but would rather rely on the Specification, which states “rebound hyperemia begins at around 0.03%.” Id. We are persuaded that those words of approximation suggest that rebound hyperemia could begin either a little less than, at, or a little more than 0.03% brimonidine. See Ex. 1049 ¶ 25. Thus, we agree with Dr. Sher that “a POSA would read the ’742 patent’s description of Figure 6 and reasonably conclude that ‘at around 0.03%’ includes 0.025%.” Id.” slip op. at 25

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

    “As an initial matter, we agree with the parties that the preamble of the claims is limiting. “Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.” Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003). The Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a composition for a specific purpose (i.e., reducing eye redness), and the method comprises a single step of administering that composition, the Federal Circuit “has generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. agree with Petitioner that it does not and find Eli Lilly to be instructive. In Eli Lilly, the preambles of the claims recite a “method for reducing incidence of or treating at least one vasomotor symptom in an individual” and a “method for treating headache in an individual.” 8 F.4th at 1335. There, the Federal Circuit held that the preambles “are not merely statements of effect but rather statements of the intentional purpose for which the methods must be performed.” Id. at 1342. Thus, the Federal Circuit did not require proof of actual clinical results from performing the claimed method, even though the claims also recited an “effective amount.” Id. The Federal Circuit held that because the specification defined an “effective amount” as an “an amount sufficient to effect beneficial or desired results” and provided examples of such results in the context of prophylactic or therapeutic uses, the claims “encompass a clinical result, [but] they do not require such a result.” Id. Here, similarly, the ’742 patent claims simply recite administering the brimonidine composition (at a concentration range) and do not recite any efficacy requirement, nor even the “effective amount” of note in the Eli Lilly claims. But, like Lilly and as explained below, the “ocular conditions” of the claims encompass prophylactic reduction of hemorrhage and hyperemia in addition to therapeutic uses. See Ex. 1001, 12:13–19. We, therefore, find the claims here do not require actual redness reduction and, thus, no clinical result is required to satisfy the claimed method. Thus, having considered the arguments and evidence presented at trial, we determine that the preamble of the claims is limiting and requires that the claimed brimonidine composition be administered with the actually reduced.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “evidence presented at trial, we agree with Petitioner that the term “about 0.025%” includes 0.03%. Our construction is supported not only by intrinsic evidence, but also by extrinsic evidence that demonstrates the alleged criticality of the “about 0.025%” limitation. terms of a specific numerical range. We must, therefore, determine how broadly a POSA reading the ’742 Specification would extend the numerical range around 0.025%. In doing so, we consider the described criticality of “about 0.025%” brimonidine and its purpose to the claimed invention. See Cohesive, 543 F.3d at 1368. The ’742 patent makes clear that the purpose of the “about 0.025%” limitation in the claims is to use “low doses of highly selective a-2 adrenergic receptor agonists to achieve vasoconstriction with significantly reduced hyperemia.” Ex. 1001, 2:39–41. Furthermore, the Specification explains that there is a need for methods that provide “safe and long term vasoconstriction with reduced or minimized side effects, such as rebound hyperemia.” Id. at 2:30–33. There is no dispute that both 0.025% and 0.03% constitute low doses of brimonidine, as described by the Specification. See id. at 3:60–65 (defining “low concentrations” as “between about 0.0001% to about 0.05%”). Thus, the question is whether there is a critical distinction between the two concentrations and their ability to provide vasoconstriction with reduced rebound hyperemia. Patent Owner argues they are clinically distinct, whereas Petitioner argues they are not. In light of the intrinsic evidence discussed below, we agree with Petitioner.” slip op. at 22

  Patent outcomesUS 8,293,742 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,293,742
• Butterfly Network, Inc. v. Fujifilm Sonosite, Inc.Instituted
  PTAB · Apr 13, 2023 · IPR2022-01577 · APJ William V Saindon · IPR · Institution

  The Board instituted IPR on claims 1–4 and 6–10 on all petitioned grounds, finding a reasonable likelihood that claim 1 was anticipated by the HDI 3000 Manual.

  RulingsInstitution decision

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

    “review under 35 U.S.C. § 314(b) and 37 C.F.R. § 42.4(a) (2020). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an 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.” For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’157 patent is unpatentable, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. 37 C.F.R. § 42.08(a).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art: would have a degree in electrical engineering, biomedical engineering, or a related discipline, along with relevant experience (at least 2–3 years for a Ph.D., 3–5 years for a Master’s, and 5+ years for a Bachelor’s) researching or developing ultrasound systems or other medical imaging devices. EX1008, ¶¶21–26. The POSA would have general knowledge of ultrasound systems and related technologies as of January 15, 2001. Id. Pet. 7–8. Patent Owner applies Petitioner’s definition for purposes of its Preliminary Response. Prelim. Resp. 5. We adopt the parties’ accepted definition for purposes of this Decision.” slip op. at 6

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

    “In this case, Patent Owner’s assertion that its proposed construction is “consistent with the specification” fails to articulate or apply the proper standard. For example, any interpretation whose scope is equal to or narrower than a proper construction would logically be consistent with that proper construction. Thus, Patent Owner could only establish that its proposed interpretation is equal to or narrower in scope than the proper interpretation. Comparing the claims to prior art using a claim construction potentially narrower than what is claimed would not be a fruitful exercise because the claim could read on the prior art but not on the unduly narrow interpretation. Cf. Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (holding that a broad claim is anticipated by any narrow disclosure falling within the broad claim). Patent Owner’s assertion that its proposed construction is consistent with examples in the specification is also not persuasive, and no more persuasive than its prior implication that its proposed construction is not inconsistent with the specification. i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 843–44 (Fed. Cir. 2010) (“[A] claim is not limited to the embodiments described in the specification unless the patentee has demonstrated a clear intention to limit the claim’s scope with words or expressions of manifest exclusion or restriction.” (internal quotation omitted)). Similar to the situation in i4i, Patent Owner here has failed to explain how the claim is clearly limited to the examples in the specification. Instead, we construe “information of object” to be an identification of the object to be studied in the ultrasound examination, based on its plain language in the context of the claimed ultrasound device. We are not apprised of any language, on this record, in the ’157 patent or prosecution history that otherwise constrains what types of “object” would be inspected by the claimed device. For example, there is no indication that the machine is less capable than other ultrasound machines in a way that limits its use to examinations of certain things in a body such as a liver or a heart, but not simpler things in a body such as blood vessels or more complex things such as a fetus. Accordingly, we see no reason to constrain “object” to something other than those things in a body that a person of ordinary skill in the art would investigate during an ultrasound examination.” slip op. at 7

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

    “It does not appear necessary at this time to specifically construe any other claim terms. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (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 9

  Claim construction§ 102 anticipationcites Phillips · KSR
  Patents in suitUS 6,901,157

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.