- 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 - Sabinsa Corporation v. Franco CavaleriInstitutedPTAB · Jun 15, 2022 · PGR2022-00015 · APJ Susan L C Mitchell · PGR · Institution
Instituted PGR of claims 1–7 on all petition grounds; the Board found claims more likely than not indefinite because the claimed curcumin percentages lacked a clear measurement basis.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition and the cited evidence, we conclude that Petitioner has satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would comprise an individual with a Ph.D in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, or an M.S. or B.S. degree in pharmaceutical sciences, pharmaceutics, chemical engineering, or a related field, with an additional 3–5 years of practical experience in pharmaceutical or nutraceutical product development of characterization.” Pet. 17 (citing Ex. 1019 ¶ 94 (Dr. Amiji Declaration)). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’970 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“Petitioner asserts that the term “about” in relation to the percentages of curcumin I, II, and III in claims 2 and 5 of the ’970 patent “should be given its ordinary meaning of ‘approximately’ rather than a particular numerical range.” Pet. 18. On this record, we agree with Petitioner that “about” generally means “approximately,” but how much this term numerically affects the express boundaries for ranges set forth in the claims that the term “about” modifies is not clarified by the proposed construction. See Ortho-McNeil Pharmas., Inc. v. Caraco Pharma., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (“Although both parties and the district court seem to agree that the term “about” means “approximately,” the parties and the district court disagree over the numerical limits that that term imparts to the limitation “1:5” in this case.”).” slip op. at 10
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteInstituted
“We agree with Dr. Amiji’s analysis and determine, based on the present record, that Petitioner has established that it is more likely than not that claims 1–7 are indefinite. Claims 1–7 are unclear because these claims do not specify how the percentages of curcumin I, II, or III, are to be measured, but instead only provide raw percentages for each curcumin species. See Ex. 1001, 14:10–49. The Specification of the ’970 patent mentions a weight-by-volume measure for curcumin species for only Examples 6 through 8, but as Dr. Amiji testifies, these Examples are formulated as capsules with optional fillers that may be liquid including water. See id. at 13:15–19, 34–38. The remaining Examples 4 and 5 setting” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,945,970 - Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentablePTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision
The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedOther
“It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of 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 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16
Patent outcomesUS 10,561,659 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,561,659 - PTAB · Apr 25, 2022 · IPR2022-00193 · APJ John G New · IPR · Institution
Instituted IPR on claims 1–20 and all asserted grounds after finding a reasonable likelihood that Levi anticipates or renders obvious at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“prosthetic heart valve depicted in Figure 42 of Levi is necessarily a drafter’s error, we conclude that Petitioner has established a reasonable likelihood that it will prevail in demonstrating that Levi anticipates claims 1–8, 10–18, and 20 of the ’538 patent at trial. Furthermore, because we conclude that Petitioner is reasonably likely to prevail at trial in demonstrating that challenged claims 1–8, 10–18, and 20 are anticipated by Levi, we similarly find, and for the same reasons, that Petitioner has shown a reasonable likelihood of prevailing at trial in demonstrating that the challenged claims are obvious over Levi.14 See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (holding that “[i]t is well settled that ‘anticipation is the epitome of obviousness’” (quoting Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983))).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Other
“proceeding, weighs in favor of showing that Petitioner has a reasonable likelihood of prevailing at trial on these grounds. Specifically, we find that Petitioner has sufficiently shown that Levi alone anticipates or renders obvious the challenged claims.13 We are not persuaded, at this stage of the proceedings, that a person of skill in the art would recognize that the exemplary embodiment depicted in Figure 42 of Levi depicting the “fibrous network extend[ing] over at least two circumferentially extending rows of grids formed in the open cell configuration” is necessarily a drafter’s error. Nowhere in the disclosures of Levi do we discern a requirement that the upper edge of the outer skirt 18 is, or must be, attached via stitches to 13 Unlike the claims in the other related cases, the claims of the ’538 patent do not require the fibers to be “radially” or “outwardly” extending. See, e.g., IPR2021-01527, Paper 15, 31–37. Accordingly, on this record, we find that Petitioner has sufficiently shown that Levi’s outer skirt formed of a woven PET material satisfies the claim requirements of a “fibrous network.” Patent Owner does not dispute that Levi’s outer skirt satisfies this aspect of the claims. struts 24, such that only a single row of the frame gridwork is covered. Rather, Levi’s Specification employs the conditional language “can be,” stating that “each projection 164 can be sutured to the second rung II of struts 24 of the frame 12” and that “projections 164 can be folded over respective struts of rung II and secured with sutures 168.” Ex. 1008, col. 13, ll. 58–61. This disclosure does not prohibit the projections 164 of the outer skirt 16 from being stitched to struts 26 of rung III (see id. at Fig. 5), as is depicted in Levi’s Figure 42. We acknowledge that Levi indicates that Figures 42 and 43 each show views of the exemplary heart valve depicted in Figure 1 of Levi. See Ex. 1008, col. 5, ll. 12–13. But, again, there is nothing in the disclosures of Levi that requires the upper edge projections 164 of the outer skirt 18 be stitched to the struts 24, as depicted in Figure 43, and not to the struts 26, as depicted in Figure 42. It would be reasonable that a person of ordinary skill in the art would regard these to be minor variations of the same embodiment, rather than necessarily being a drafter’s error. We find that this is a reasonable inference at this stage particularly because stitching the outer skirt 18 to struts 26 such that it “extends over at least two circumferentially extending rows of grids formed in the open cell configuration” is plainly depicted in Figure 42, and is not expressly or implicitly contradicted or prohibited by any of the disclosures of Levi. See, e.g., Default Proof Credit Card System, Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 1300 (Fed. Cir. 2005) (Figure in specification accorded little probative weight when it appeared to contradict language of the claim). In this instance, we find based on the present record that the disclosures of the Specification and the language of the claims in Levi do not contradict, preclude, or render inoperative the device depicted in Figure 42, and we accord that Figure probative weight in accordance with what it plainly depicts, rather than merely dismiss that figure as a self-evident drafter’s error. See Duramed Pharms., Inc. v. Watson Lab’ys, Inc., 413 F. App’x 289, 294 (Fed. Cir. 2011) (“A reference … is prior art for all that it discloses”).” slip op. at 28
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Based on the present record, we find that Petitioner has satisfied the threshold standard set forth in Hulu to identify, with particularity, evidence sufficient to establish a reasonable likelihood that the Walther and Cribier references were publicly accessible before the priority date of the ’172 patent. As noted by Petitioner, each of the references are articles published in known journals with dates and other indicia of publication on the face of the references themselves. The Hulu decision specifically notes that “the indicia on the face of a reference, such as printed dates and stamps, are considered as part of the totality of the evidence” that should be taken into account. Hulu, Paper 29 at 17–18; see also id. at 19 (noting that “[t]he face of Dougherty bears a copyright date of 1990, a printing date of November 1992, and an ISBN date of 8/94” and the fact that the book was from “an established publisher”). We also take into account that journal articles, unlike, perhaps, other disputed publications, are “the type[s] of document[s] intended for public dissemination,” and that the Walther and Cribier references “bear[] no designations, such as ‘draft’ or ‘confidential,’ that might suggest that [they were] not intended for public distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018). Additionally, we have considered the declaration of Dr. Hall-Ellis and the supporting evidence cited therein as further evidence of public accessibility.18 We find that it was appropriate for Petitioner to submit this evidence with its Preliminary Reply. Indeed, the Hulu case recognizes that a petitioner may provide additional evidence “in a reply to a patent owner preliminary response,” and “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu Paper 29 at 14–15. Here, we determined that Petitioner satisfied the good cause requirement of 37 C.F.R. § 42.108(c) for submitting its Preliminary Reply with the Hall-Ellis declaration and other supporting evidence in order to respond to Patent Owner’s challenges to the printed publication status of Walther and Cribier. See related case IPR2021-01528, Ex. 1071, 13–14, ll. 23–24 (Transcript of teleconference call from February 14, 2022). Accordingly, in view of the totality of the evidence currently in the record, we find that Petitioner has established a reasonable likelihood that 18 Contrary to Patent Owner’s arguments, we are not of the view that a librarian declaration is always necessary to show public accessibility of a journal article, especially where the article itself bears credible indicia of publication.” slip op. at 57
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“Based on the present record, we determine that Petitioner has made a persuasive showing that a POSITA would have found it obvious to substitute the woven PET outer skirt taught by Levi with a fibrous material, such as the outer cloth taught by Walther or the compressible material taught by Spenser II, to arrive at a heart valve structure that meets the claimed structural requirements. We further determine that, on the present record, Petitioner has persuasively shown that a person of ordinary skill in the art would have been motivated to deliver such a modified device endovascularly, either using the transfemoral approach or through the common iliac artery, with a reasonable expectation of success. We find that the modification to Levi’s device proposed by Petitioner would entail the “simple substitution of one known element for another” to obtain predictable results. See KSR, 550 U.S. at 417. In this regard, we note that Walther’s outer cloth, Spenser II’s compressible material, and Levi’s outer skirt all serve similar functions of helping reduce paravalvular leakage for a prosthetic heart valve. Ex. 1007, 1; Ex. 1008, col. 14, ll. 7–9; Ex. 1011 ¶ 145. Walther and Spenser II provide an additional motivation to incorporate fibrous cloth materials as the outer layer insofar as they teach that the fibers may encourage blood coagulation and tissue ingrowth to further fill in the gaps and prevent leakage. Ex. 1007, 1; Ex. 1011 ¶ 145.” slip op. at 45
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,881,538 - Restem, LLC. v. Jadi Cell, LLCInstitutedPTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes 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, the Preliminary Response, 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 ’176 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
“Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited 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))).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionOther
“Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted
“the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,803,176 - Laboratoire Francais Du Fractionnement Et Des Biotechnologies S.A. v. Novo Nordisk Healthcare AGNo claims unpatentablePTAB · Apr 13, 2022 · IPR2017-00028 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–15 were not shown unpatentable under the remaining Tolo anticipation and Eibl ’023 combination grounds; Patent Owner’s motion to exclude was granted in part.
RulingsFinal written decision- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“We agree that a motion to exclude is not the appropriate vehicle for consideration of whether a party has improperly raised new arguments. Our Trial Practice Guide delineates between a motion to exclude and a motion to strike, indicating that a motion to strike is the preferred mechanism “[i]f a party believes that a brief filed by the opposing party raises new issues, is accompanied by belatedly presented evidence, or otherwise exceeds the proper scope of reply or sur-reply . . . .” See Trial Practice Guide Update 17 (Aug. 2018); Patent Trial and Appeal Board Consolidated Trial Practice Guide 80 (Nov. 2019).10 Although a motion to exclude is pre-authorized in the Scheduling Order, see Paper 64, 4 (Supplemental Scheduling Order), a motion to strike is not, and Patent Owner did not request prior authorization to file its motion to strike. Petitioner did, however, have an opportunity to respond and did so respond to Patent Owner’s contentions that the allegedly new evidence and argument exceeded the proper scope of a reply. See Paper 87, 3–8. Therefore, we find that Petitioner had an appropriate opportunity, of which it took advantage, to respond to Patent Owner’s arguments regarding the alleged new arguments and evidence. Accordingly, we determine that Petitioner is not prejudiced by our consideration of Patent Owner’s motion to exclude as, in effect, a motion to strike.” slip op. at 11
- Skill levelSkill level board ownDecided for patent owner
“Owner’s proposed levels of skill in the art to be somewhat deficient. Paper 53, 8. We found that Petitioner’s proposed skill level does not address the specific problems concerning the nanofiltration of FVIIa that is the subject of the ’762 patent at issue in this proceeding. Id. We also found, however, that we were unaware of any basis in the record for Patent Owner’s contention that the hypothetical skilled artisan must be a “team” of scientists and engineers with two different areas of “expertise.” Id. Nonetheless, based on our consideration of the record, we found that the skilled artisan would need skills and knowledge with respect to both the biochemistry of coagulation factors (particularly FVII/FVIIa) and separation/purification/processing techniques used in the biotechnology industry for such proteins (particularly nanofiltration). Id. We agreed with both Petitioner and Patent Owner that such skills and knowledge may be obtained through some combination of education and industry/laboratory experience, wherein a skilled artisan with a doctorate degree (Ph.D.) could have fewer years of experience than required for a skilled artisan with a Master’s or Bachelor’s degree. Id. In general, we found that the “ordinary skill” level of a scientist or engineer in this art is relatively high. Id. As explained by Dr. Chtourou, “[e]xtensive academic training and laboratory experience are necessary for producing recombinant coagulation proteins and removing viruses from compositions of such proteins.” Id. at 8–9 (citing Ex. 1010 ¶ 27). We further took into account that this level of skill is also reflected in the prior art of record, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and we found that the parties’ declarants in this proceeding meet the requirements for this skill level. Id. at 8–9. The parties have not challenged these findings and we see no reason to depart from them for our analysis in this Decision.” slip op. at 22
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“As we stated in our Final Written Decision, Petitioner offered constructions for the following claim terms: “cell culture supernatant” and “Factor VII polypeptides.” See Paper 53, 9 (citing Pet. 10–15). We noted that Patent Owner did not disagree with Petitioner’s proposed construction for “cell culture supernatant,” and asserts that “Factor VII [poly]peptide[]” is expressly defined in the Specification of the ’762 patent. PO Resp. 6; see also Paper 67, 4. We previously found that no explicit construction of any claim term was necessary to resolve the issues in this case. No new claim construction issues have been raised in this proceeding, and we again find no explicit construction of any claim term is necessary in this proceeding. 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 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“First, we begin with the unassailable fact that Tolo does not disclose expressly or inherently any particular concentration of FVII. See Ex. 1006, 7:25–34 (only mention of Factor VII in Tolo with no express statement concerning a concentration for FVII). In fact, we found in our Final Written Decision that: The record in this proceeding does not show persuasively that the skilled artisan would have reasonably expected that the same concentration disclosed in Example 3 of Tolo for IFN-α (0.04 mg/mL) could be successfully used for the nanofiltration of FVIIa. To the contrary, the evidence shows that IFN-α and FVIIa differ significantly in many respects, including molecular weight, size, and structure, such that the skilled [artisan] would not have necessarily considered them interchangeable in a nanofiltration process. Paper 53, 38 (citations omitted).” slip op. at 34
Patent outcomesUS 9,102,762 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 9,102,762 - PTAB · Apr 1, 2022 · IPR2021-01584 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted review of non-disclaimed claims 7 and 12 on all petition grounds, finding a reasonable likelihood of obviousness over Levi combined with Walther or Spenser II.
RulingsInstitution decision- Adverse judgmentAdverse judgmentOther
“(“Petitioner”) filed a Petition requesting inter partes review of claims 1–12 of U.S. Patent Number 10,857,011 B2 (Ex. 1001, “the ’011 patent”). Paper 1 (“Petition” or “Pet.”). Aortic Innovations LLC (“Patent Owner”) filed a Preliminary Response to the Petition. Paper 7 (“Prelim. Resp.”). Along with its Preliminary Response, Patent Owner filed a Statutory Disclaimer of claims 1–6 and 8–11 of the ’011 patent. Prelim. Resp. 1, 82–83; Ex. 2011. Pursuant to our authorization, Petitioner filed a Preliminary Reply and Patent Owner filed a Preliminary Sur-Reply addressing the prior art status of certain references relied upon in the Petition. Paper 10 (“Prelim. Reply”); Paper 12 (“Prelim. Sur-Reply”). In view of Patent Owner’s statutory disclaimer, we treat claims 1–6 and 8–11 as having never been part of the ’011 patent, such that Petitioner cannot seek inter partes review of those claims. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the original patent’ in section 253 to mean that the patent is treated as though the disclaimed claims never existed.”) (citing Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 1996)); 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”). And because no inter partes review will be instituted based on disclaimed claims, we do not consider claims 1–6 and 8–11 to be within the scope of this proceeding. Cf. General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution of inter partes review based on disclaimer of all challenged claims). We base our decision to institute on the remaining challenged claims that have not been disclaimed.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“likely to prevail on its Ground 5 and Ground 6 challenges (anticipation or obviousness based on Levi alone). However, we are persuaded that Petitioner has demonstrated a reasonable likelihood of prevailing with regard to at least independent claims 7 and 12 in view of its Ground 7 (Levi + Walther) and Ground 8 (Levi + Spenser II) challenges. We do not at this stage find it necessary to address the merits of Petitioner’s Ground 10–14 challenges relying upon the additional teachings of Spenser or Cribier ’321. Accordingly, we institute an inter partes review of all challenged claims of the ’172 patent, based on all of the grounds identified in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). We address the remaining grounds of the Petition below in a more cursory manner to provide some additional guidance for the parties during trial.” slip op. at 52
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“Having considered the arguments of record, we find that the Examiner materially erred during prosecution by failing to fully consider the prior art teachings regarding the claim requirement for a “sealing material.” Indeed, although Spenser II and Levi were presented to the Examiner, the Examiner did not issue any rejections during prosecution based on that prior art despite teachings that are closely related to the subject matter and claims of the ’011 patent. For example, we find that the Examiner erred by failing to address why Spenser II’s Figure 22 embodiment did not suggest the claimed “sealing material.” See, e.g., Ex. 1011 ¶ 145, Fig. 22 (Spenser II’s Figure 22 embodiment showing an outer layer of compressible material made of fabric or cloth that can reduce paravalvular leakage). We also find that the Examiner erred by failing to address whether the prior art taught or suggested the requirement that the valves be delivered endovascularly as recited in challenged claims 7 and 12. See, e.g., Ex. 1008, 2:1–5 (Levi discussing that the diameter of the crimped profile of the heart valve is an important design parameter to allow for transfemoral delivery). In view of this material error by the Examiner, we decline to deny institution under 35 U.S.C. § 325(d).” slip op. at 28
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“threshold standard set forth in Hulu to identify, with particularity, evidence sufficient to establish a reasonable likelihood that the Walther reference was publicly accessible before the priority date of the ’011 patent. As noted by Petitioner, Walther is an article published in a known journal with dates and other indicia of publication on the face of the reference itself. The Hulu decision specifically notes that “the indicia on the face of a reference, such as printed dated and stamps, are considered part of the totality of the evidence” that should be taken into account. Hulu, 17–18; see also id. at 19 (noting that “the face of Dougherty bears a copyright date of 1990, a printing date of November 1992, and an ISBN date of 8/94” and the fact that the book was from “an established publisher”). We also take into account that journal articles, unlike perhaps other disputed publications, are “the type[s] of document[s] intended for public dissemination,” and that the Walther reference “bears no designations, such as ‘draft’ or ‘confidential,’ that might suggest that it was not intended for public distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018). Additionally, we have considered the declaration of Dr. Hall-Ellis and the supporting evidence cited therein as further evidence of public accessibility.9 We find that it was appropriate for Petitioner to submit this evidence with its Preliminary Reply. Indeed, the Hulu case recognizes that a petitioner may provide additional evidence “in a reply to a patent owner preliminary response,” and “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu at 14–15. Here, we determined that Petitioner satisfied the good cause requirement of 37 C.F.R. § 42.108(c) for submitting its Preliminary Reply with the Hall-Ellis declaration and other supporting evidence in order to respond to Patent Owner’s challenge to the printed publication status of Walther. See Ex. 1071, 13:23–14:4 (Transcript of teleconference call from February 14, 2022). Accordingly, in view of the totality of the evidence currently in the record, we find that Petitioner has established a reasonable likelihood that both the Walther reference is a printed publication that was publicly accessible before the priority date of the ’011 patent.” slip op. at 30
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,857,011 - PTAB · Apr 1, 2022 · IPR2022-00034 · APJ John G New · IPR · Institution
The Board instituted IPR on all extant claims and grounds, finding a reasonable likelihood that claim 6 would have been obvious over Levi combined with Walther or Spenser II.
RulingsInstitution decision- Adverse judgmentAdverse judgmentOther
“Patent Owner’s Statutory Disclaimer On January 26, 2022, Patent Owner filed a statutory disclaimer of claims 1–5 and 7–12 of the ’846 patent with the U.S. Patent and Trademark Office. See Ex. 2011. In view of Patent Owner’s statutory disclaimer, we treat claims 1–5 and 7–12 as having never been part of the ’846 patent, such that Petitioner cannot seek inter partes review of those claims. See Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998) (holding that “[t]his court has interpreted the term ‘considered as part of the original patent’ in section 253 to mean that the patent is treated as though the disclaimed claims never existed”) (citing Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 1996)); 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims”). Grounds 8–10 set forth in the Petition, which are directed solely to disclaimed claim 10, are also hereby deemed moot. And because no inter partes review will be instituted based on disclaimed claims, we do not consider claims 1–5 and 7–12 to be within the scope of this proceeding. Cf. General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution of inter partes review in view of a statutory disclaimer of all challenged claims). We base our decision to institute on the remaining challenged claim 6 that has not been disclaimed.” slip op. at 2
- PTAB / AIA Trials › Real party in interest / privityOther
“Real Parties in Interest Petitioner identifies Edwards Lifesciences Corp. and Edwards Lifesciences LLC, as the real parties-in-interest. Pet. 111. Patent Owner identifies Aortic Innovations, LLC as the real party-in-interest. Paper 4, 1.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 ’846 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim Construction The Board applies the same claim construction standard that would be 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 given their ordinary and customary meaning” as understood by a person of 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 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. 23; see generally Prelim. Resp. Nor do we perceive a need to construe any claim terms of the ’846 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 11
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,966,846 - Ideavillage Products Corp. v. Koninklijke Philips N.VInstitution deniedPTAB · Mar 24, 2022 · PGR2021-00116 · APJ Ken B Barrett · PGR · Institution
The Board denied institution because eight grounds failed the threshold showing and the remaining lack-of-ornamentality ground was marginal, making trial inefficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Here, Petitioner advances nine challenges against the claim of the ’346 patent. Pet. 8. As discussed above, we determine that, on this record, Petitioner has not met its burden for institution under eight grounds—an on-sale bar ground, six obviousness grounds, and an indefiniteness ground. Additionally, we determine that the ninth ground— the challenge based on the alleged lack of ornamentality—is marginal, at 5 We acknowledge that SAS and Harmonic address inter partes reviews, but see no reason to interpret differently § 324(a), the statute governing post-grant reviews. 6 Available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sas-aia-trial. 7 Available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf best. Based on the particular facts of this proceeding, instituting a trial with respect to all grounds based on evidence and arguments directed only to the one ornamentality ground would not be an efficient use of the Board’s time and resources. Cf. Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 10–11 (PTAB Nov. 7, 2018) (informative); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7 (PTAB Jan. 24, 2019) (informative). Thus, we do not institute a post-grant review.” slip op. at 26
- Other 314aInstitution denied discretionary otherInstitution denied
“Under the Office Guidance, “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.” Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).6 When a petition fails to satisfy the “more likely than not” institution standard as to some challenges, the Board evaluates “all the challenges and determine[s] whether, in the interests of efficient administration of the Office and integrity of the patent system, the entire petition should be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide7 64 (Nov. 2019) (citing 37 C.F.R. §§ 316(b), 326(b)). Here, Petitioner advances nine challenges against the claim of the ’346 patent. Pet. 8. As discussed above, we determine that, on this record, Petitioner has not met its burden for institution under eight grounds—an on-sale bar ground, six obviousness grounds, and an indefiniteness ground. Additionally, we determine that the ninth ground— the challenge based on the alleged lack of ornamentality—is marginal, at 5 We acknowledge that SAS and Harmonic address inter partes reviews, but see no reason to interpret differently § 324(a), the statute governing post-grant reviews. 6 Available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sas-aia-trial. 7 Available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf best. Based on the particular facts of this proceeding, instituting a trial with respect to all grounds based on evidence and arguments directed only to the one ornamentality ground would not be an efficient use of the Board’s time and resources. Cf. Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 10–11 (PTAB Nov. 7, 2018) (informative); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7 (PTAB Jan. 24, 2019) (informative). Thus, we do not institute a post-grant review.” slip op. at 26
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The POSITA relating to the subject matter of the D’346 patent would possess [a] Bachelor’s degree in industrial design (or a related or equivalent field) and at least ten (10) years of research or work experience related to designing, developing, specifying, testing or analyzing multi-component consumer products (or supervising the same), with experience related to handheld consumer electronic products. Pet. 14. For purposes of this decision, we assume Petitioner is referring to the designer of ordinary skill in the art. See In re Nalbandian, 661 F.2d 1214, 1216 (CCPA 1981) (“In design cases we will consider the fictitious person identified in § 103 as ‘one of ordinary skill in the art’ to be the designer of ordinary capability who designs articles of the type presented in the application.”). Patent Owner has not filed a preliminary response and therefore, at this stage, does not disagree or propose a different definition of the designer of ordinary skill in the art. Based on the limited record in front of us, we determine that Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the designer of ordinary skill in the art.” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“incorrect standard, but also lacks credibility because it is internally inconsistent with other parts of his testimony. Mr. Fletcher testifies that it is his understanding that indefiniteness is viewed through the perspective of the ordinary observer, stating the following: I understand that an ordinary observer must be able to understand the scope of an invention with reasonable certainty. If not, a design is indefinite under 35 U.S.C. § 112. It is my understanding that errors and inconsistencies between drawings of a design patent can be indefinite, and thus invalid, if an ordinary observer cannot discern the overall appearance of the claimed design without resorting to conjecture or speculation. Ex. 1003 ¶ 27 (emphasis added). However, his opinions regarding indefiniteness all are in terms of the “POSITA.” Ex. 1003 ¶¶ 32–58; see, e.g., id. ¶ 32 (“The D’346 Patent is indefinite due to the inclusion of conflicting views, which would prevent a POSITA from understanding the claimed design as drawn. . . . A POSITA cannot discern from the D’346 Patent figures what design is actually being claimed.”). Casting further doubt on the reliability of his testimony, Mr. Fletcher does not articulate any definition for the POSITA, which is a necessary foundation for his opinions.4 Mr. Fletcher does not refer to the perspective of the ordinary observer (or even one skilled in the art, viewing the design as would an ordinary observer) in his opinions regarding indefiniteness (Ex. 1003 ¶¶ 32– 58), and we decline to assume his references to the unadorned “POSITA” implicitly encompass the perspective of the ordinary observer. Thus, Mr. Fletcher’s testimony regarding indefiniteness is unhelpful because it utilizes the incorrect perspective.” slip op. at 20
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips - PTAB · Mar 17, 2022 · IPR2021-01527 · APJ Christopher G Paulraj · IPR · Institution
The Board instituted review of non-disclaimed claims 8 and 13–17 on all petition grounds, finding a reasonable likelihood of obviousness over Levi combined with Walther or Spenser II.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte 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.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Based on the present record, we do not find that Levi alone teaches, or otherwise provides a motivation to incorporate, a sealing material with radially extending fibers. Accordingly, we are not persuaded that Petitioner is likely to prevail with regard to Grounds 6 and 7.” slip op. at 37
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Based on the present record, we find that Petitioner has satisfied the threshold standard set forth in Hulu to identify, with particularity, evidence sufficient to establish a reasonable likelihood that the Walther and Cribier references were publicly accessible before the priority date of the ’172 patent. As noted by Petitioner, each of the references are articles published in known journals with dates and other indicia of publication on the face of the references themselves. The Hulu decision specifically notes that “the indicia on the face of a reference, such as printed dated and stamps, are considered part of the totality of the evidence” that should be taken into account. Hulu, 17–18; see also id. at 19 (noting that “the face of Dougherty bears a copyright date of 1990, a printing date of November 1992, and an ISBN date of 8/94” and the fact that the book was from “an established publisher”). We also take into account that journal articles, unlike perhaps other disputed publications, are “the type[s] of document[s] intended for public dissemination,” and that the Walther and Cribier references “bear[] no designations, such as ‘draft’ or ‘confidential,’ that might suggest that [they were] not intended for public distribution.” See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1377 (Fed. Cir. 2018). Additionally, we have considered the declaration of Dr. Hall-Ellis and the supporting evidence cited therein as further evidence of public accessibility.9 We find that it was appropriate for Petitioner to submit this evidence with its Preliminary Reply. Indeed, the Hulu case recognizes that a petitioner may provide additional evidence “in a reply to a patent owner preliminary response,” and “if the patent owner challenges a reference’s status as a printed publication, a petitioner may submit a supporting declaration with its reply to further support its argument that a reference qualifies as a printed publication.” Hulu at 14–15. Here, we determined that Petitioner satisfied the good cause requirement of 37 C.F.R. § 42.108(c) for submitting its Preliminary Reply with the Hall-Ellis declaration and other supporting evidence in order to respond to Patent Owner’s challenges to the printed publication status of Walther and Cribier. See Ex. 1071, 13:23–14:4 (Transcript of teleconference call from February 14, 2022). Accordingly, in view of the totality of the evidence currently in the record, we find that Petitioner has established a reasonable likelihood that both the Walther and Cribier references are printed publications that were publicly accessible before the priority date of the ’172 patent.” slip op. at 29
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“We do not, however, find persuasive Petitioner’s contention that Levi’s disclosure of an outer skirt made of a woven PET fabric that “bulge[s] outwardly” from the frame meets the requirements of a sealing material with radially extending fibers. We understand the requirement for “radially extending,” in accordance with its plain and customary meaning, to mean that the tips of the fibers must extend in a generally outward direction from the frame as shown in the figures of the ’172 patent.11 See Ex. 1001, Figs. 8, 9, 11–14, 20. We agree with Patent Owner that nothing in Levi suggests that the “woven PET fabric” used to form the outer skirt expressly or inherently meets this requirement. We are not persuaded by Petitioner’s contention that the laser-cut woven PET disclosed for use in Levi’s outer skirt would necessarily exhibit the type of “hairiness” described for PET yarn used in other textile applications. Ex. 1028, 10. In this regard, we take into account the evidence cited by Patent Owner showing that the type of woven PET fibers utilized for cardiovascular applications are tightly wound and do not radially extend from the surface. Prelim. Resp. 53–54 (citing Ex. 2019, Fig. 1A; Ex. 2020, Fig. 8; Ex. 2021, Fig. 1.18A). Based on the present record, we do not find that Levi alone teaches, or otherwise provides a motivation to incorporate, a sealing material with radially extending fibers. Accordingly, we are not persuaded that Petitioner is likely to prevail with regard to Grounds 6 and 7.” slip op. at 36
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 10,792,172
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.