- PTAB · Jul 19, 2023 · IPR2023-00442 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is obvious over Dixon, CATT, MACTEL, and PIER.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’681 patent. We therefore institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses. General Plastic, Paper 19 at 9–10. Patent Owner is quite correct, however, that, under Valve Corp., we can consider the relationship between different parties bringing successive challenges to a given patent. Valve Corp., Paper 11, at 2, 9. However, the facts of the present Petition render this present situation readily distinguishable from the facts in Valve Corp. In Valve Corp., we found that the parties bringing successive challenges to the patent-in-suit were “named as co-defendants in that lawsuit and were accused of infringing the ’934 patent based on [co-defendant] HTC’s VIVE devices that incorporate Valve’s technology.” Valve Corp., Paper 11, at 9–10. Furthermore, in that litigation, Valve represented that “HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,” and that “Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.” Id. at 10. The Board consequently concluded that “there is a significant relationship between Valve and HTC with respect to Patent Owner’s assertion of the ’934 patent. The complete overlap in the challenged claims and the significant relationship between Valve and HTC favor denying institution.” Id. No such facts obtain in the present instance. Petitioner is not a co- defendant with Mylan in the district court infringement action, Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-00061-TSK (N.D.W. Va.).11 There is no credible evidence of record that Petitioner and Mylan, potential business competitors, have developed any significant relationship, as in Valve Corp. Petitioner has joined the -01226 inter partes review as a “silent” slip op. at 44
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“skill in the art would have been motivated to adopt the exclusion criteria when administering aflibercept via intravitreal injection to minimize the risks of intravitreal infection and complications such as endophthalmitis and that adoption of these criteria reflected basic safety precautions developed to address the risks associated with intravitreal injections generally, regardless of the specific anti-VEGF agent injected. See Pet. 48–52. Petitioner has shown sufficient support on the record before us for such a view. Patent Owner also argues that Petitioner: (1) has not shown motivation to modify the exclusion criteria of PIER by adding the third exclusion criterion; and (2) has not shown motivation to modify the exclusion criteria of CATT and/or MACTEL. We disagree. We have explained above why we conclude that a person of ordinary skill in the art would have found exclusion criterion three to be obvious over not CATT and MACTEL individually and together. See KSR, 550 U.S. at 416. Moreover, Petitioner has, as we have also explained, asserted a persuasive reason why a skilled artisan would have been motivated to adopt the teachings of MACTEL and CATT to reduce the risk of intravitreal infection subsequent to injection of a VEGF receptor antagonist, such as aflibercept. Furthermore, Petitioner has persuasively argued that a person of ordinary skill in the art would also have had a reasonable expectation of success in adopting the exclusion criteria to the studies disclosed by Dixon, viz., that a person of ordinary skill in the art would therefore have reasonably expected that the exclusion criteria developed for prior art VEGF receptor antagonists could be successfully applied to aflibercept. Pet. 53 (citing Ex. 1002 ¶¶ 156–158).” slip op. at 39
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition of a person of ordinary skill in the art, arguing that the skilled artisan is an ophthalmologist experienced in treating angiogenic eye disorders, including with VEGF antagonists. Prelim. Resp. 11. Patent Owner acknowledges, however, that the parties’ differing definitions of a person of ordinary skill in the art do not affect any argument presented with respect to our present Decision to Institute. Id. As we explain below, with the exception of the exclusion criteria, claim 1 of the ’681 patent is identical to claim 1 of the ’388 patent in the -00881 IPR. We again determine that our definition of a person of ordinary skill in the art is reasonable and consistent with the prior art of record at this stage of the proceeding. For the purposes of this decision, and for the sake of consistency, we adopt our prior definition, quoted above, as the definition of a person of ordinary skill in the art.” slip op. at 10
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - 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 · GrahamPatents in suitUS 11,278,505 - Intuit Inc. v. Samesurf, Inc.InstitutedPTAB · Jun 28, 2023 · IPR2023-00342 · APJ Phillip A Bennett · IPR · Institution
The Board instituted IPR of claims 1–18 on all asserted grounds, finding a reasonable likelihood that claims 1 and 10 would be obvious over Lebrun and Wang.
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
“factors, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). The prior art of record also reflects the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Expert testimonyDecided for patent owner
“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.” Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). Patent Owner is correct that Dr. Lieberman’s CV on its face does not include two years in a position titled as software developer, web-based developer, or the like. See generally Ex. 1004. Dr. Lieberman, however, has a degree in “Informatique” from the University of Paris VI (Sorbonne), as Patent Owner acknowledges (Prelim. Resp. 34), and this degree is in addition to Dr. Lieberman’s Bachelor of Science degree from the Massachusetts Institute of Technology (MIT). Ex. 1004, 12–13. This University of Paris VI (Sorbonne) degree is additional education beyond the required bachelor’s degree and could have substituted for some amount of professional experience, as we note in our determination of the level of ordinary skill for this institution decision in Section II.A. slip op. at 42
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“creation message to the group-surfing server 140 to create a group-surfing session (Ex. 1005, 32:9–11), a second web client 110 can “add itself to the session” by sending “a session-join message 151 to the group surfing server 140” (id. at 33:2–3). The session creation message sent by second web client, which corresponds to the recited guest device, is sufficient to teach or suggest detecting an activation associated with the synchronized browsing session at this preliminary juncture. Lebrun differs from the detecting limitation in that it does not expressly describe that the session creation message is sent by activating a hyperlink. However, Wang’s description of a second client device joining a group session via the myURL address is sufficient at this preliminary stage to address the deficiency in Lebrun. On this preliminary record, Petitioner’s showing of a rationale to combine Lebrun and Wang is also sufficient for purposes of institution. Specifically, the proffered reasoning that utilizing Wang’s designated URL address to activate a session join invitation would enable Lebrun’s group-surfing server to coordinate and manage the group-surfing session and further Lebrun’s goal of providing improved group access to web sites (see Pet. 25), is sufficient at this early stage. Patent Owner does not address Petitioner’s showing as to this limitation. See generally Prelim. Resp.” slip op. at 18
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,527,591 - Intuit Inc. v. Samesurf, Inc.InstitutedPTAB · 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 · GrahamPatents in suitUS 9,483,448 - Intuit Inc. v. Samesurf, Inc.InstitutedPTAB · 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 · GrahamPatents in suitUS 9,185,145 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - PTAB · Jun 13, 2023 · IPR2023-00224 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–19 on all three asserted § 103 grounds, 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
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 13
- 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 12; Pet. 8. 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 12–14 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 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In considering the scope of “whole genome sequencing” we take particular note of the Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35–58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42). In this respect, we find it pertinent that Leary’s PARE studies began with sheared genomic DNA, and presumably resulted in non-targeted, randomly-distributed sequencing reads throughout the genome.10 We also find it pertinent that Forshew, a contemporary of Leary, described the matepaired technique as employed in Leary’s PARE approach as whole genome sequencing. Ex. 1030, 10. In light of the evidence and argument presently of record, we preliminarily interpret “whole genome sequencing,” as used in claim step 1(b), to mean “a non-targeted approach to sequencing all or almost all of a genome.” The panel may reconsider on the more complete record developed at trial, whether one of ordinary skill in the art would have understood that Leary’s mate-paired / PARE approach to detecting genomic rearrangements to teach or suggest sequencing all or almost all of the genome. See Ex. 1020” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“More importantly, in determining obviousness, “a reference . . . is prior art for all that it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). Considering the comparison of serial tumor samples illustrated in Ley’s Figure 3, and the related testimony of Dr. Quackenbush (Ex. 1020 ¶¶ 81–82), we presently agree with Petitioner that one of ordinary skill in the art reading Ley, “would have been motivated to include known mutations (such as those derived from a database of known cancer mutations) in a panel of polymorphisms for serial monitoring at multiple time points; and (ii) that a POSA would have had a reasonable expectation of success in successfully monitoring such polymorphisms.” See Pet. 56–57. And to be clear, at this stage of the proceeding, Patent Owner presents no credible evidence of teaching away. For the reasons set forth with respect to Leary in Ground 1, and having further considered the arguments and evidence with respect to the combination of Leary and Ley in Ground 2, we determine that Petitioner has demonstrated a reasonable likelihood that claims 1–11 and 13–19 are unpatentable in view of Leary and Ley.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,384,394 - 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 · GrahamPatents in suitUS 11,408,033 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. 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. at 23– 24. 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 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 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. 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 sequence in a 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 16 (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 16. 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, 6:56–7:1. 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 19. 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. 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 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“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. 25–26 (citing evidence). 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 22
- 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 “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] 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 ¶ 78 (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. 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 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,337,001
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.