- PTAB · Oct 19, 2022 · IPR2022-01513 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8 on all five grounds previously instituted in IPR2022-00517 and granted Teva’s motion to join that proceeding.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Teva’s Petition here is substantively identical to Mylan’s Petition in the -517 IPR, challenging the same claims based on the same art and the same grounds. Compare IPR2022-00517, Paper 1 with IPR2022-01513, Paper 2. For the same 1 European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012 (2013). Ex. 1005 (“EMA”). 2 Foley et al., Antithrombotic therapy in peripheral artery disease, 21 VASCULAR MED. 156–69 (2016). Ex. 1006 (“Foley”). 3 Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, 74 DRUGS 451–64 (2014). Ex 1007 (“Plosker”). reasons stated in our Decision Granting Institution of Inter Partes Review in IPR2022-00517, we institute trial in this proceeding on the same five grounds. See IPR2022-00517, Paper 15.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Motion for Joinder. Based on authority delegated to us by the Director, we have discretion to join an inter partes review to a previously instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311.” Id. When determining whether to grant a motion for joinder, we consider factors such as timing and impact of joinder on the trial schedule, cost, discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 4
NonePatents in suitUS 10,828,310 - PTAB · Sep 21, 2022 · IPR2022-00684 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–18 across all petitioned 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
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’460 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had either “a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery,” or “an undergraduate or graduate degree in biomedical or mechanical engineering and at least five years of work experience in the area of ophthalmology, including familiarity with ophthalmic anatomy and glaucoma surgery.” Pet. 22–23 (citing Ex.1003, ¶ 26). In the absence of any preliminary response, Patent Owner, at this stage of the proceeding, takes no position on the definition of the person of ordinary skill in the art. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, or skilled artisan, which is not opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’460 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)” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner suggests, generally, that “all terms should be given their plain and ordinary meaning” and notes that in the related proceedings the Board “gave the term ‘dual blade device’ its ordinary meaning, noting ‘dual refers to two, and blade, in context, refers to a cutting part,” and construed “ab interno” as generally meaning “from the inside or from within the eye.” Pet. 23, 27, 30–31 (citing Ex. 1056, 22–23). We find that an express construction of any claim term is not necessary for purposes of rendering this Decision. See Wellman, Inc. v. 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)).” slip op. at 10
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 10,888,460 - PTAB · Sep 8, 2022 · IPR2022-00556 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all seven grounds, finding a reasonable likelihood that at least one challenged claim would have been obvious.
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 and the Preliminary Response, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’236 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“used to construe the claim in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 100(b) (2020). Under that standard, claim terms “are generally ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). “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). Extrinsic evidence may also be considered, but is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 29; see generally Prelim. Resp. Nor do we perceive, at this stage of the proceeding, a need to construe any claim terms of the ’236 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. Pet. 28. Petitioner contends that this combination with a medical device engineer to experiment with or manufacture a prosthetic heart valve. Id. at 28–29 (citing Ex. 1003 ¶ 45). Patent Owner does not argue otherwise or propose an alternative definition. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s definition because we find that that definition is consistent with the level of skill in the art, as reflected by the prior art. See, e.g., Exs. 1007–1012; 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 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Petitioner contends that a skilled artisan would have found it obvious to deploy the valve within a patient’s native valve so that the outer cloth forms a sealing interface with the annulus and native leaflets, and would have been motivated to apply Walther’s outer cloth covering to reduce paravalvular leakage (“PVL”), a problem well known in the contemporaneous art. Pet. 42 (citing KSR Int’l Co. v. Teleflex, Inc., 550 U.S. skill in the art would also have had a reasonable expectation of success in deploying the cloth-covered SAPIEN in a patient’s native aortic valve based upon Walther’s teaching of a successful balloon deployment of the cloth-covered SAPIEN that “demonstrated excellent hydrodynamic performance” and that an in-patient procedure “is feasible.” Id. (citing Ex. 1007, 1125; Ex. 1003 ¶ 125).” slip op. at 19
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,987,236 - PTAB · Aug 9, 2022 · IPR2022-00517 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8, finding a reasonable likelihood of success on the asserted grounds, including anticipation by EMA.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)InstitutedDecided for petitioner
“The Board has set forth certain factors (“the Fintiv factors”) that may be considered in determining whether to exercise its discretion to deny institution based on the advanced stage of a parallel proceeding: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv, IPR2020-00019, Paper 11, at 5–6. On June 21, 2022, the Director of the Office issued a Memorandum to clarify how the Board should apply certain Fintiv factors when determining whether to exercise its discretion to deny institution under § 314(a).4 The 4 Memorandum Re: Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022), available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_memo_2 0220621_.pdf. (“Memo”). Memorandum explains that the Board should decline to exercise its discretion to deny institution where: (1) a petition presents compelling evidence of unpatentability; (2) a request for denial under Fintiv is based on a parallel ITC proceeding; or (3) a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition. Memo 2–3. Moreover, when analyzing Fintiv’s second factor, the Board will consider the published median time to trial in the district court in which the parallel litigation resides. Id. at 3. B. Analysis of the Relevant Fintiv Factors As explained further below, we find the Petition presents compelling evidence of unpatentability with respect to the challenges over the EMA reference, which precludes us from exercising our discretion to deny institution under Fintiv. Memo 4–5. Although that factor alone is sufficient to end our analysis, we further note that several other factors support declining to exercise our discretion, as well.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitutedDecided for petitioner
“In performing an analysis under § 325(d), the Board uses a two-part framework: (1) We consider whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) If either condition of the first part of the framework is satisfied, we consider whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–8 (all claims) of the ’310 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention would have had “the equivalent of an M.D. degree, knowledge, and experience regarding the diagnosis and treatment of patients with CAD and PAD, including administering antiplatelet and anticoagulant agents to such patients.” Pet. 10 (citing Ex. 1002 ¶¶ 50–52, 89–95). Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 10. We adopt Petitioner’s definition as it appears to be 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))).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,828,310 - PTAB · Jul 27, 2022 · IPR2022-00605 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on claims 1–28 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Gravesen and Brister.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the same or substantially the same prior art or arguments previously were presented to the Office.” The Board analyzes this issue under a two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The person of ordinary skill in the art as of the earliest possible effective filing date (“POSITA”) would have had a Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, or a related subject, and one or more 10 Patent Owner also argues that Brister is cumulative of Bobroff (Ex. 1021). Prelim. Resp. 72–73. We need not consider this argument, because Brister itself was before the Examiner. See Ex. 1002, 105. years of experience researching, developing and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a Master’s Degree, and vice versa. Pet. 14–15 (citing Ex. 1003 ¶ 22). For purposes of the Preliminary Response, Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 22. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this preliminary stage, we are more inclined to agree with Petitioner’s views on the meaning of “rotor.” The claims themselves do not appear to support Patent Owner’s required “central” axis. Rather, the claims more broadly embrace rotors of various shapes, such that it is not clear that the rotor would necessarily have a “central” axis. For example, claim 1 recites that the rotor itself comprises “a rotor follower projection,” which, on this record, appears to encompass irregularly-shaped rotors that may not have a “central” axis. Similarly, claims 11 and 18 specify that the rotor comprises a “cylindrical shape.” These claims are not limited to cylindrical rotors (which may have a central axis). Indeed, the language of the claims does not appear to speak to any requirement of a particular axis, whether it be a “central axis” per Patent Owner’s proposal, or an object’s “own axis” as stated in Petitioner’s Exhibit 1024. Neither party points to persuasive evidence from the intrinsic record in support of their arguments. Patent Owner cites Figure 45 of the ’649 patent (Prelim. Resp. 47), but fails to explain why the embodiment depicted in this figure should be understood to limit the claims. See, e.g., Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.”); SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“[A] particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). Turning to the extrinsic evidence of record, Petitioner’s declarant Dr. Fletcher points to a general dictionary definition indicating that a rotor is simply a “rotating member.” Ex. 1003 ¶ 81 (citing Ex. 1025, 1).11 In contrast, Patent Owner’s declarant Dr. Cima provides no evidence corroborating his views that a person of ordinary skill in the art would not have understood “rotor” to broadly mean a rotating member, but rather would have understood that a rotor must rotate on a central axis. See Ex. 2001 ¶¶ 99, 102; see also 37 C.F.R. § 42.65(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.”). Petitioner’s definition of “rotor” as meaning a “rotating member” appears to be consistent with the intrinsic record, which as noted above, does” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“d) Conclusion on Claim 1 On this record, Petitioner has established a reasonable likelihood of prevailing in demonstrating that claim 1 would have been obvious over Gravesen and Brister. 5. Analysis of Claims 2–28 As discussed above in Section II.D.4, we determine that Petitioner has shown a reasonable likelihood of establishing that claim 1 is unpatentable as obvious over Gravesen and Brister. On that basis, we institute inter partes review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims.”). To provide the parties guidance, below we address Petitioner’s arguments that claims 2–28 are unpatentable as obvious over Gravesen and Brister.” slip op. at 32
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,945,649 - PTAB · Jun 16, 2022 · PGR2022-00014 · APJ Christopher G Paulraj · PGR · Institution
The Board instituted PGR on claim 13, finding it more likely than not unpatentable as obvious over Silvestre or over Du, Choi, and Zitvogel.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute a post-grant review, we must determine whether the information presented in the Petition, “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(a). Upon consideration of the Petition and the Preliminary Response, for the reasons set forth below, we determine that the evidence and arguments presented in the Petition are sufficient to satisfy the “more likely than not” standard regarding the asserted unpatentability of claim 13 in the ’513 patent. Therefore, we authorize a post-grant review to be instituted as to claim 13.” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“1. Legal Framework Pursuant to 35 U.S.C. § 325(d), in determining whether to institute an post-grant review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art. or arguments previously were presented to the Office.” The Board evaluates two issues in addressing 35 U.S.C. § 325(d): (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). With respect to the first issue, previously “presented” art includes, among other things, “art provided to the Office by an applicant, such as on an Information Disclosure Statement (IDS), in the prosecution history of the challenged patent.” Id. at 7–8. With respect to the second issue, institution generally will be denied if a “petitioner fails to make a showing of material error,” and “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 8–9. “[T]his framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA”) “would have had a Ph.D. in molecular biology, or a related field, with expertise in virology (including expertise growing, isolating, and rescuing viruses), immunology, and cancer biology with at least four years of post- Ph.D. experience in those areas.” Pet. 6 (citing Ex. 1007 ¶¶ 35, 96). Patent Owner does not argue otherwise. See Prelim. Resp. 16–17. At this stage of the proceeding and for purposes of our analysis in this Decision, we adopt Petitioner’s uncontested definition as that definition is consistent with the level of skill in the art reflected by the prior art. 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))). It is from the perspective of such a person of ordinary skill that we consider the claims and prior art.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on the present record, we find that Petitioner has shown that it is more likely than not that inserting the GM-CSF gene and the CTLA-4 inhibitor encoding gene in a back-to-back orientation in relation to each other would have been known to a person of ordinary skill in the art. Petitioner’s expert Dr. Bell states that “[w]hen inserting two genes into a given locus, the simplest and most common way to do so is to insert them in a back-to-back orientation under control of separate regulatory elements.” Ex. 1007 ¶ 230. While Patent Owner is correct in stating that no sources are cited in paragraph 230, Dr. Bell does cite back to paragraphs 73–81 and 87– 88 of his own declaration. See id. In those paragraphs, Dr. Bell explains that the “deletion of endogenous nucleotides requires either pre-existing knowledge of the effect of disrupting the particular gene at the insertion site or requires a difficult and time-consuming trial-and-error process to gain such knowledge.” Id. ¶ 73 (citing Ex. 1035). Exhibit 1035 is a review article entitled “Unconventional viral gene expression mechanisms as therapeutic targets.” See Ex. 1035. Dr. Bell points to Figure 1 of this article as showing that certain viral genomes include genes that are overlapping and/or that encode polyproteins, which can add to a further level of difficulty in identifying a suitable insertion locus. Ex. 1007 ¶ 74 (citing Ex. 1035, 364, Fig. 1). Dr. Bell further explains that “inactivation of the neurovirulence factor ICP34.5 in HSV1 has been well-known to direct tumor-specific cell lysis, making HSV1 ICP34.5 knock-outs useful oncolytic virus vectors,” but also notes that “unless such a well-known insertion site is used, determining whether insertion of a heterologous gene at any particular site will be successful requires a difficult and time-consuming trial-and-error process.” Id. ¶ 77 (citing Ex. 1039, 292, Ex. 1040, 4–7, Ex. 1041, 575). Accordingly, within paragraphs 73–81 and 87–88, Dr. Bell provides evidentiary support for his conclusions in paragraph 230. See Ex. 1007 ¶¶ 73-81, 87-88. We are not persuaded by Patent Owner’s reliance upon the Arendi case to argue that Petitioner improperly relies upon common sense to supply a missing limitation. In Arendi, the court noted that “the Board’s presumption that adding a search for phone numbers to [the prior art refence] would be ‘common sense’ was conclusory and unsupported by substantial evidence, the missing limitation is not a ‘peripheral’ one, and there [was] nothing in the record to support the Board’s conclusion that supplying the missing limitation would be obvious to one of skill in the art.” 832 F.3d at 1366–67. But here, as noted above, Dr. Bell cites to several references in support of his rationale that one of ordinary skill in the art seeking to insert both the genes would have started with the known ICP34.5 locus rather than undertaking a rigorous trial-and-error process to find an altogether new insertion locus. We do not find the concern stated in Arendi about using common sense “as a wholesale substitute for reasoned analysis and evidentiary support” to be present in this case. See id. at 1362. Here, the “common sense” challenged by Patent Owner refers to the “common knowledge” of the ordinarily skilled artisan as of the invention referenced in the Petition and by Dr. Bell, and it is from such a person’s perspective that we must read Silvestre. Thus, based on the current record, we determine that Petitioner has provided sufficient evidence beyond merely a conclusory assertion of “common sense” to show that inserting the genes at issue in a back-to-back orientation would have been known in the art.7” slip op. at 14
§ 103 obviousnessDiscretionary denialPatents in suitUS 10,947,513 - New World Medical, Inc. v. Microsurgical Technology, Inc.All claims unpatentablePTAB · Apr 20, 2022 · IPR2020-01711 · APJ James A Tartal · IPR · Final written decision
Claims 1–7 are unpatentable because the Board found them obvious over Quintana and Lee; it did not reach the alternative Quintana and Jacobi grounds.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have jurisdiction to conduct this inter partes review under 35 U.S.C. § 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2020). For the reasons discussed below, we determine New World Medical, Inc., (“Petitioner”)1 has shown by a preponderance of the evidence that claims 1–7 (“the Challenged Claims”) of U.S. Patent No. 9,358,155 B2 (“the ’155 patent,” Ex. 1001) are unpatentable. I. INTRODUCTION A. Summary of Procedural History Petitioner filed a Petition pursuant to 35 U.S.C. §§ 311–319 requesting an inter partes review of the Challenged Claims. Paper 1 (“Pet.”). We instituted an inter partes review of the Challenged Claims on all grounds of unpatentability asserted in the Petition. Paper 11. MicroSurgical Technology, Inc., (“Patent Owner”)2 filed a Patent Owner Response. Paper 17 (“Resp.”). Petitioner filed a Reply to the Patent Owner Response. Paper 27 (“Reply”). Patent Owner filed a Sur-reply in support of the Patent Owner Response. Paper 34 (“Sur-reply”).” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“angling the end of the device “depending on surgical requirements.” Id. at 55 (citing Ex. 1006, 4:49–54). We note this portion of Lee states “[t]he angle of cutting edge 14, however, may vary from as little as 0 degrees to greater than 45 degrees depending on surgical requirements,” which evidences that such an angle is a result-effective, optimizable variable, which would have been obvious to modify in Quintana’s or Lee’s devices, which are disclosed as used for the same purpose. Ex. 1006, 4:49–54; see also Ex. 1003 ¶¶ 206–211 (reaching this conclusion on modifying the bend angle of Quintana’s device).” slip op. at 71
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“angling the end of the device “depending on surgical requirements.” Id. at 55 (citing Ex. 1006, 4:49–54). We note this portion of Lee states “[t]he angle of cutting edge 14, however, may vary from as little as 0 degrees to greater than 45 degrees depending on surgical requirements,” which evidences that such an angle is a result-effective, optimizable variable, which would have been obvious to modify in Quintana’s or Lee’s devices, which are disclosed as used for the same purpose. Ex. 1006, 4:49–54; see also Ex. 1003 ¶¶ 206–211 (reaching this conclusion on modifying the bend angle of Quintana’s device).” slip op. at 71
Patent outcomesUS 9,358,155 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,358,155 - PTAB · Mar 14, 2022 · IPR2021-01446 · APJ Alyssa A Finamore · IPR · Institution
The Board instituted IPR on claims 1–4, 6, 10, 12–17, 19–21, and 31 on all asserted grounds, finding a reasonable likelihood of success on at least one claim and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). We may not authorize an inter partes review to be instituted “unless . . . the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the arguments and evidence presented by both parties, we determine Petitioner has demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition, and we decline to exercise discretion to deny institution. Therefore, we institute an inter partes review of the challenged claims (1–4, 6, 10, 12–17, 19–21, 31) under the grounds raised in the Petition, pursuant to 35 U.S.C. § 314(a). See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“Factor 6: Other Circumstances, Including the Merits Although we need not undertake a full merits analysis when evaluating Fintiv factor 6, we consider the strengths and weaknesses of Petitioner’s case, where stronger merits may weigh against discretionary denial and weaker merits may favor exercising discretion to deny institution. Fintiv at 15–16. In our view, although some challenges of certain claims here may not be entirely persuasive at this point in the proceeding, concerning the majority of the challenged claims, as discussed above, we find Petitioner’s showing to be strong on the merits, as contrasted with Patent Owner’s weaker arguments on the merits at this stage. As discussed above, we find the preliminary record supports Petitioner’s assertions under Ground 1 that the claims would have been obvious over Arnold and do not find Patent Owner’s preliminary arguments over this ground persuasive. See supra Section II.D.1. Accordingly, we weigh this factor in favor of not exercising our discretion to deny institution. 3. Holistic Assessment of Factors Under Section 314(a) After analyzing the Fintiv factors with a holistic view of whether the efficiency and integrity of the system are best served by denying or instituting review, we determine that the factors, on balance, weigh in favor of not exercising discretion to deny institution here. Hence, we do not exercise our discretion under § 314(a) to deny institution.” slip op. at 44
- Obviousness (§103) › Motivation to combine / reasonable expectation of successOther
“We disagree with Patent Owner’s characterization of Petitioner’s asserted obviousness based on Arnold. Contrary to Patent Owner’s argument, Petitioner is not relying on the knowledge of an ordinary artisan to supply claim limitations missing from Arnold. Rather, Petitioner relies on the knowledge of an ordinary artisan to explain that an ordinary artisan would understand a particular teaching in Arnold to disclose a claim limitation. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (“[A] prior art reference must be ‘considered together with the knowledge of one of ordinary skill in the pertinent art.’” (quoting In re Samour, 571 F.2d 559, 562 (CCPA 1978)); In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (explaining that testimony from those skilled in the art may be used to explain the meaning of a reference). For example, Petitioner contends “[a]n ordinary artisan would have understood Arnold’s ‘road sign’ information presented on the ‘display system’ as being an output having an original format, as claimed.” Pet. 7 (citing Ex. 1003 ¶¶ 96–98, 133). Moreover, to the extent Petitioner is arguing an ordinary artisan would have understood Arnold discloses each and every claim limitation, “a disclosure that anticipates under § 102 also renders the claim invalid under § 103, for ‘anticipation is the epitome of obviousness.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792 (CCPA 1982)); see also Application of Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (“[T]his court has sanctioned the practice of nominally basing rejections on § 103 when, in fact, the actual ground of rejection is that the claims are anticipated by the prior art. The justification for this sanction is that a lack of novelty in the claimed subject matter, e.g., as evidenced by a complete disclosure of the invention in the prior art, is the ‘ultimate or epitome of obviousness.’” (citations and footnote omitted)).” slip op. at 31
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner also argues that Petitioner’s witness, Mr. Andrews, may not be credible because of some past relationship with Petitioner or its related companies. Prelim. Resp. 61–63. Mr. Andrews’s past relationship, without more, is not persuasive evidence that causes us to question Mr. Andrews’s credibility at this stage of the proceeding.” slip op. at 33
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,047,170 - Coloplast A/S. v. Pamarope Pty Ltd.InstitutedPTAB · Mar 4, 2022 · IPR2021-01437 · APJ Lynne H Browne · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 1–4, 6, 7, 9–14, 16, 17, 19, and 20 are unpatentable under either asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition and any response thereto shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition and all supporting evidence, we determine that Petitioner shows a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute inter partes review.” slip op. at 2
- BurdenInstituted
“deemed to not explicitly teach or render obvious adjusting the tension by moving the second portion through the aperture of the second anchor so that the central portion provides at least a sling-like support for the urethra between the first and second locations,” Benderev teaches such a technique. Pet. 16–17. In support of this assertion, the Petition provides multiple reasons in support of the proposed combination, including a desire a) towards “achieving proper support of the urethra,” b) to “allow a medical practitioner to tacitly determine whether the anchor was properly engaged in the implant location to provide adequate fixation of that anchor,” c) to “allow a medical practitioner to implant the anchors without interference from the attached sutures,” and d) recognition by a POSITA “that applying Bendrev’s tensioning technique would have led to predictable results without significantly altering or hindering the Neisz’s method of providing support for the urethra to treat female urinary incontinence.” Id. at 17–21 (citing Ex. 1003 ¶ 61). Accordingly, on this record, we find Petitioner has sufficiently shown that Neisz in combination with Benderev suggests and expectation of success.” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art at the time of the invention of the ’715 patent would have had a doctor of medicine (M.D.) in an area emphasizing female pelvic surgery, or an equivalent field, 1 Neisz et al., US Patent Application No. 2002/0161382 A1, published October 31, 2002 (Ex. 1004) (“Neisz”). 2 Benderev et al., US Patent No. 6,500,194 B2, issued December 31, 2002 (Ex. 1005) (“Benderev”). 3 Brenneman et al., International Patent Application Publication No. WO 98/19606, published May 14, 1998 (Ex. 1006) (“Brenneman”). 4 Kovac, US Patent No. 6,039,686, published March 21, 2000 (Ex. 1010) (“Kovac”). reconstructive surgery, or an equivalent field or a bachelor of science and/or an advanced degree in an academic area emphasizing biomedical engineering, bioengineering, mechanical engineering, medical device design, or an equivalent field. Pet. 9 (citing Ex. 1003 ¶¶ 41–43). For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art). We also find that Petitioner’s expert Dr. Erickson is qualified to opine on the issues in this proceeding from the perspective of one of ordinary skill in the art. Ex. 1011 (Dr. Erickson’s CV); see Kyocera Senco Indus. Tools Inc. v. Int'l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case . . . a witness must at least have ordinary skill in the art.”).” slip op. at 4
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits constructions for several claim limitations “as being consistent with the plain meaning of the terms.” Pet. 8. Except to the extent we explain how we interpret the claims in the analysis below, we decline to otherwise expressly construe any claim terms at this time. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) extent necessary to resolve the controversy); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs in the context of an inter partes review).” slip op. at 5
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 10,925,715 - PTAB · Feb 11, 2022 · IPR2021-01341 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–4 and 7–10, finding a reasonable likelihood of success on the Tan and Boies obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 23
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner also argues that Petitioner’s witness, Mr. Andrews, may not be credible because of some past relationship with Petitioner or its related companies. Prelim. Resp. 50–52. Patent Owner offers mere unsubstantiated allegations and cites no persuasive evidence that causes us to question Mr. Andrews’s credibility at this stage of the proceeding.” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts: An ordinary artisan would have been a person having, as of October 24, 2001, a Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Computer Engineering, or Computer Science, or an equivalent degree with at least two years of experience in electronic user interface systems and vehicle sensor systems or related technologies. Additional education may substitute for lesser work experience and vice-versa. (Ex.1003, ¶40.) Pet. 3 (citing Andrews Declaration). Patent Owner does not address the definition of the person of ordinary skill in the art, either to contest Petitioner’s proposal or to offer a different definition. See generally Prelim. Resp. For the purposes of this Institution Decision, we accept Petitioner’s unopposed, proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’994 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,713,994
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.