2020002446 (P.T.A.B. Nov. 27, 2020)

THE UNIVERSITY OF IOWA RESEARCH FOUNDATION

Patent Trials and Appeals BoardNov 27, 2020

2020002446 (P.T.A.B. Nov. 27, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/377,086 08/06/2014 Benjamin Dickerhoff 2016-6062 5144 22476 7590 11/27/2020 HAUGEN LAW FIRM SUITE 1130 - TCF TOWER 121 SOUTH EIGHTH STREET MINNEAPOLIS, MN 55402 EXAMINER BOUTSIKARIS, SOCRATES L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 11/27/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): haugenmail@haugenlaw.com kschmidt@haugenlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BENJAMIN DICKERHOFF, ROBERT S. FARIVAR, MADHAVAN L. RAGHAVAN, and VIJAY KUMAR __________ Appeal 2020-002446 Application 14/377,086 Technology Center 3700 ____________ Before BIBHU R. MOHANTY, BRADLEY B. BAYAT, and MATTHEW S. MEYERS, Administrative Patent Judges. BAYAT, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision to reject claims 1–8 and 10–14, which constitute all pending claims in the application. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies “Medical 21, Inc.” as the real party in interest. Appeal Br. 3. Appeal 2020-002446 Application 14/377,086 2 STATEMENT OF THE CASE Appellant’s “invention relates generally to prosthetic assemblies (e.g., vascular) and, more particularly, but not by way of limitation, to heart valves.” Spec. ¶ 3. Sole Independent Claim 1. A vascular prosthetic assembly comprising: a frame; and a cellulose-based body coupled to the frame, wherein: the cellulose-based body includes regenerated cellulose from methylolcellulose; the frame is configured to be altered from an expanded configuration to a collapsed configuration; the frame is biased toward the expanded configuration; and the assembly is configured for placement within a catheter when the frame is in the collapsed configuration. Appeal Br. 12 (Claims App.). Rejections Claim 8 stands rejected under 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. Claims 1–8, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Case et al. (US 2007/0038295 A1, pub. Feb. 15, 2007) (“Case ’295”) and Kumar (US 2009/0222085 A1, pub. Sept. 3, 2009). Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Case, Kumar, Case et al. (US 2007/0100432 A1, pub. May 3, 2007) (“Case ’432”), and Hunt (US 2006/0265053 A1, pub. Nov. 23, 2006). Appeal 2020-002446 Application 14/377,086 3 Claim 14 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Case ’295, Kumar, and Bodin et al. (US 2010/0278893 A1, pub. Nov. 4, 2010) (“Bodin”). OPINION 35 U.S.C. § 112, first paragraph The Examiner finds that claim 8’s recitation “the plurality of leaflets are configured to move from an open configuration to a closed configuration, and are biased toward the open configuration” is not supported by Appellant’s original disclosure because “[t]he term ‘bias’ is not found in the specification.” Final Act. 2. According to the Examiner: While Paragraph [0044] appears to discuss the leaflets being configured to move from an open configuration to a closed configuration, nothing in this discussion would lead a person having ordinary skill in the art to conclude that this configuration is accomplished by way of a bias. Rather, Paragraph [0044] merely states that the leaflets can move from an open configuration to a closed configuration depending on the flow of blood. Accordingly, the specification as originally filed does not support leaflets biased toward the open configuration. Id. at 2–3; see also Ans. 4–5. Alleging error in the rejection, Appellant disagrees and cites paragraph 42 with Figures 3B and 3C of the Specification for support. Appeal Br. 5; Reply Br. 2–3. We are persuaded by Appellant’s argument that the contrasting embodiments described in paragraph 42 of the Specification provide sufficient detail such that one skilled in the art can reasonably conclude that the inventor had possession of the disputed claimed feature. Paragraph 42 provides that “leaflets 46 can be configured to move assembly 10 between an open and a closed configuration.” And in describing the embodiment Appeal 2020-002446 Application 14/377,086 4 shown in Figure 3B of the disclosure, paragraph 42 describes “the preferred configuration of assembly 10 is an open or semi-open configuration.” We agree that “[t]he recited ‘preferred configuration’ (with leaflets 46 open or semi-open) infers a bias as the preference of the assembly to attain the open configuration.” Reply Br. 2. Accordingly, we do not sustain the rejection of claim 8 as failing to comply with the written description requirement. 35 U.S.C. § 103(a) Claims 1–8, 10, and 11 In rejecting independent claim 1 as unpatentable over Case ̀ 295 and Kumar, the Examiner finds that Case `295 “discloses a vascular prosthetic assembly (Figures 5–6) comprising” all the structural limitations of Appellant’s vascular prosthetic assembly except for “the cellulose-based body including regenerated cellulose from methylolcellulose.” Final Act. 3 (citing Case ̀ 295 ¶¶ 29, 57, 58, 78, 130). To remedy this deficiency, the Examiner finds Kumar “teaches a vascular prosthetic assembly comprising a cellulose-based body . . . includ[ing] pure regenerated cellulose from methylolcellulose.” Id. According to the Examiner, Kumar’s cellulose-based body (like Applicant’s) is formed by casting a methylolcellulose solution in a mold, removing the solid methylolcellulose matrix from the mold and soaking it in water. Exposure to water regenerates cellulose from methylolcellulose. Kumar teaches cellulose-based prostheses in a variety of geometries such as, for example, heart valves (e.g., a valve and supporting stent) and blood vessels (hollow tubes). Id. at 3–4 (citing Kumar ¶¶ 7, 9, 11, 24, 41, 43, and 49). The Examiner determines that “it would have been obvious to one of ordinary skill in the Appeal 2020-002446 Application 14/377,086 5 art, at the time the invention was made, to substitute Case’s leaflets for Kumar’s cellulose-based leaflets comprising regenerated cellulose from methylolcellulose, as Kumar’s leaflets are highly versatile and uniquely suited to improve the design of effective cell-prosthesis (hybrid/bioengineered) composite-based implants, such as cardiovascular implants.” Id. at 4 (citing Kumar ¶¶ 9, 24). Appellant argues that Kumar’s cellulose-based body “is a surgically- implantable body not supported by or attached to a collapsible and expandable frame,” and, therefore, “those of ordinary skill would not look to Kumar ’085 for any teachings whatsoever of materials or structures useful in a percutaneously-deliverable apparatus.” Appeal Br. 6–7; see also id. at 9. We are not persuaded by Appellant’s argument. First, as the Examiner points out, “Appellant’s assertion that Kumar’s heart valve prosthesis is not collapsible is unsupported by the reference.” Ans. 6 (“In fact, Kumar’s characterization of the prosthesis as ‘pliable’ (Paragraph [0023]) directly cuts against Appellant’s assertion.”). Second, Case ’295 and Kumar are analogous art because both references are directed to the same field of invention and Appellant’s endeavor: valves for implantation within the human circulatory system. We agree with the Examiner that “the argument that Kumar is not collapsible and is so manifestly different from Case’s collapsible prosthesis that a person having ordinary skill would not look to Kumar is without merit.” Id. In sum, Appellant has not presented persuasive arguments or evidence to establish that a person of ordinary skill in the art would not look to Kumar. We also are unpersuaded by Appellant’s argument that the Examiner has not established a prima facie case of obviousness by “failing to explain Appeal 2020-002446 Application 14/377,086 6 or identify the motivation for those of ordinary skill in the art to review Kumar ̀ 085 reference for substitution into Case et al. ’295.” Reply Br. 3. Contrary to Appellant’s argument that the Examiner “fails to identify any teaching or suggestion” (id.) why an artisan would make the proposed modification, we find the Examiner presents articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. See Final Act. 4 (“Kumar’s leaflets are highly versatile and uniquely suited to improve the design of effective cell-prosthesis (hybrid/bioengineered) composite-based implants, such as cardiovascular implants (Paragraphs [0009], [0024]).”). Appellant presents a conclusory argument without articulating specific flaws in the Examiner’s rationale as supported by the teachings of Kumar, and, as such, we are not apprised of error in the rejection of record. Accordingly, we sustain the rejection of independent claim 1, and dependent claims 2–8, 10 and 11, which are not argued separately. Claims 12–14 We sustain the rejections of dependent claims 12–14 for the same reasons because Appellant relies on arguments presented above for independent claim 1 in traversing those rejections. See Appeal Br. 10. CONCLUSION The rejection of claim 8 under 35 U.S.C. § 112, first paragraph, is reversed. The rejections of claims 1–8 and 10–14 under 35 U.S.C. § 103(a) are affirmed. Appeal 2020-002446 Application 14/377,086 7 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 8 112 ¶ 1 Written Description 8 1–8, 10, 11 103(a) Case ’295, Kumar 1–8, 10, 11 12, 13 103(a) Case ’295, Kumar, Case ’432, Hunt 12, 13 14 103(a) Case ’295, Kumar, Bodin 14 Overall Outcome 1–8, 10–14 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED