Ex Parte Marquez

Patent Trial and Appeal BoardSep 21, 2012

10811565 (P.T.A.B. Sep. 21, 2012)

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. 10/811,565 03/29/2004 Salvador Marquez ECV-5783 1380 30452 7590 09/21/2012 EDWARDS LIFESCIENCES CORPORATION LEGAL DEPARTMENT ONE EDWARDS WAY IRVINE, CA 92614 EXAMINER PRONE, CHRISTOPHER D ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 09/21/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte SALVADOR MARQUEZ ________________ Appeal 2010-004897 Application 10/811,565 Technology Center 3700 ________________ Before JENNIFER D. BAHR, MICHAEL L. HOELTER and JOHN W. MORRISON, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-004897 Application 10/811,565 2 STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. § 134(a), from a final rejection of claims 1-18 (App. Br. 2). Claims 19-23 have been cancelled (App. Br. 2). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM and we designate the affirmance (see infra) as containing new grounds of rejection. THE CLAIMED SUBJECT MATTER The claimed subject matter pertains to “an internal support frame for a prosthetic heart valve and, more particularly, to a leaflet support frame that separates into cusps after implantation” (Spec. ¶ [0001]). Independent claim 1 is illustrative of the claims on appeal and is reproduced below: 1. A support frame for a flexible leaflet prosthetic heart valve, comprising: a plurality of cusps each sized and shaped to support a cusp of a flexible leaflet of the heart valve; and a plurality of commissures, one each between each adjacent pair of cusps, the commissures each having a point of weakness designed to fracture upon repeated relative movement of the cusps after implantation such that the cusps move substantially independently of each other, wherein the support frame exhibits a substantially continuous stiffness along the cusps and commissures similar to that resulting from the cusps and commissures being formed integrally. REFERENCES RELIED ON BY THE EXAMINER Klöckner WO 00/53356 A1 Sep. 14, 2000 Marquez US 6,736,845 B2 May 18, 2004 Appeal 2010-004897 Application 10/811,565 3 THE REJECTION ON APPEAL Claims 1-18 are rejected under 35 U.S.C. § 103 as being unpatentable over Marquez and Klöckner (Ans. 4). ANALYSIS Appellant presents separate arguments for both independent claim 1 and independent claim 11 (App. Br. 4-7). We address these claims separately infra. No separate arguments are presented with respect to dependent claims 2-10 and 12-18 which stand or fall with their respective independent claim. We affirm the Examiner’s rejection of claims 1 and 11; however, since the basis of our rationale differs from that of the Examiner, pursuant to our authority under 37 C.F.R. § 41.50(b), we designate this affirmance as a new ground of rejection in order to afford Appellant a full and fair opportunity to react to the thrust of the rejection. The Rejection of Claim 1 as being unpatentable over Marquez and Klöckner The Examiner relies primarily on Marquez for disclosing the limitations of claim 1 but relies on Klöckner for disclosing “a continuous homogeneous metal sheet [made] with dedicated thinner weak portions as break points” (Ans. 4). The Examiner finds that it would have been obvious “to combine the teaching of continuous homogeneous breakable connections as taught by Klöckner with the implant of Marquez in order to simplify production and reduce costs” (Ans. 4). Appellant contends that Marquez does not disclose a “frame (stent) having a substantially continuous stiffness along the cusps” nor does Marquez disclose commissures that are “designed to fracture upon repeated Appeal 2010-004897 Application 10/811,565 4 relative movement of the cusps after implantation” (App. Br. 5, see also Reply Br. 2). Appellant contends that Marquez “discloses flexible commissures,” that “[t]his is not a substantially continuous stiffness” and that Marquez discloses that the fragile bridge 90 disclosed therein is designed to dissolve in the body and not fracture upon repeated relative movement (App. Br. 5, Reply Br. 2). These contentions are not persuasive. Regarding the claim limitation of “substantially continuous stiffness,” the Examiner finds that Marquez employs the same material (i.e., nitinol, Ans. 4) that is preferred by Appellant because, as Appellant indicates, the frame “must be relatively stiff” (Spec. ¶ [0029]). Marquez also teaches that “[t]he holder includes structure for maintaining a relatively fixed shape of the flexible prosthetic heart valve during implantation” (Marquez 4:25-27). Further, while the Examiner relies on Klöckner, not Marquez, for disclosing “a continuous homogeneous metal” (Ans. 4), it is noted that Marquez also teaches that “the stent 70 is desirably formed of a single piece (such as seen in FIG. 20D)” (Marquez 9:10-12). In view of the teachings of Marquez and Klöckner, the Examiner finds that “[t]he claims only require a continuous stiffness which the combination discloses through its materials and configurations[,] not a specific degree of stiffness” (Ans. 5). Regarding the claim limitation of “a point of weakness designed to fracture upon repeated relative movement,” the Examiner relies on Klöckner for this teaching, not Marquez (see Ans. 4). Klöckner teaches a mesh “cut in such a manner that certain webs are connected to one another only very thinly, i.e., certain mesh nodes are constructed as designed breaking points” (Klöckner, pg. 3). In view of these teachings of Marquez and Klöckner, we Appeal 2010-004897 Application 10/811,565 5 are not persuaded the Examiner erred in finding that “[b]y utilizing the homogeneous frame comprising breaking points taught by Klöckner the frame of Marquez would have a continuous stiffness that will fracture upon movement after implantation” (Ans. 5). Appellant also contends that designing Marquez’s “commissures to fracture would be counter to the intent of the invention of Marquez” (App. Br. 6). This contention is not persuasive because Marquez teaches commissures that are designed to separate in the body (see App. Br. 5 and Marquez 10:25-34). Appellant does not present evidence that separation of Marquez’s device after implantation by fracturing instead of by dissolving would affect the operation of Marquez’s device. Appellant further contends that in view of Klöckner’s expanded metal mesh that is cut so as to have break points, “Applicants fail to see how such a structure ‘exhibits a substantially continuous stiffness along the cusps and commissures’” as claimed because “the ultrathin nodes of the metal mesh of Klöckner, et al. would seem to be substantially weaker than the surrounding mesh, and certainly not as stiff” (Reply Br. 3). Appellant does not explain how the claimed structure of “substantially continuous stiffness” having “a point of weakness designed to fracture” is different from the Examiner’s suggested combination which also teaches a structure of “substantially continuous stiffness” and also having “a point of weakness designed to fracture.” Accordingly, we are not persuaded by Appellant’s contention. Appellant further argues that “[t]here is no mention [in Klöckner] of providing break points that withstand ‘repeated relative movement’ before fracture” or that Klöckner’s “ultrathin break points fracture rather quickly” (Reply Br. 3). Claim 1 does not specify how many Appeal 2010-004897 Application 10/811,565 6 repeated movements are required nor does claim 1 specify how quickly the fracture is to occur. Further, Appellant does not present evidence that Klöckner’s break points are unable to withstand repeated relative movement. These arguments are not persuasive. Appellant also traverses the Examiner’s finding that Klöckner is “in the same field of endeavor” (Reply Br. 4; Ans. 4). In addressing this statement, the Examiner clarifies that “Klöckner is in the field of metal fabrication which would comprise bridging three curved metal portions as done in the current application” (Ans. 5). Appellant contends that “[t]his characterization is overbroad,” that the “natural consequence of such a broad field is that any metal-working technique may be imputed” and that “Applicants do not believe that such a broad collection of prior art is warranted” (Reply Br. 4). We note that Appellant’s stated Field of the Invention is a “support frame for a prosthetic heart valve” (Spec. ¶ [0001]). We agree with Appellant that the Examiner’s characterization of Klöckner being in the field of metal fabrication is not the same as being in the field of heart valve fabrication. However, the Examiner appears to have identified a common problem addressed by both Klöckner and Appellant, such common problem being the bridging of multiple portions (Ans. 5). Our reviewing court has provided instruction that a reference is analogous art if it either is in the field of the applicant’s endeavor or is reasonably pertinent to the particular problem with which the inventor was concerned. In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006). The Examiner’s rejection is based on Klöckner being in the field of Appellant’s endeavor but we believe, more correctly, that Klöckner is appropriate art for consideration because Klöckner is reasonably Appeal 2010-004897 Application 10/811,565 7 pertinent to the particular problem with which the inventor was concerned (i.e. bridging multiple portions). Our reviewing court has also provided instruction that “[m]ere reliance by the Board on the same type of rejection or the same prior art references relied upon by the examiner, alone, is insufficient to avoid a new ground of rejection where it propounds new facts and rationales to advance a rejection-none of which were previously raised by the Examiner.” In re Stepan, 2010-1261 (Fed. Cir. Oct. 5, 2011). In view of these instructions and to ensure Appellant has a full and fair opportunity to react to the thrust of the rejection, we designate Klöckner being analogous art as a new ground of rejection. Appellant further contends that “[s]ince Marquez, et al. do[es] not teach points of weakness, there is no motivation to look to any secondary reference to find one” (Reply Br. 5). Regarding the assertion that Marquez does not teach points of weakness, this contention is not persuasive as Marquez does indeed disclose attachment 90 that is designed to dissolve (Marquez 10:25-34, see also App. Br. 5). Furthermore, whether Marquez teaches a point of weakness or not, Appellant acknowledges that a person skilled in heart valve fabrication “would likely already be aware of the concept of frangible break points, even without the ‘help’ of Klöckner, et al.” (Reply Br. 5). Regarding the assertion that there is no motivation to look to a secondary reference, we note the Examiner finds motivation to combine Marquez and Klöckner based on the desire “to simplify production and reduce costs” (Ans. 4). There is no indication by Appellant that the Examiner’s stated motivation to combine these references is unreasonable. Accordingly, we are not persuaded by Appellant’s contention. Appeal 2010-004897 Application 10/811,565 8 In view of the record presented, we sustain the rejection of claims 1- 10 but designate a new ground of rejection to the effect that Klöckner is analogous art. The Rejection of Claim 11 as being unpatentable over Marquez and Klöckner Appellant’s arguments with respect to claim 11 mirror those discussed supra with respect to claim 1 and our analysis is similar. However, claim 11 requires the commissures and cusps be “formed integrally of a homogeneous material” and Appellant contends that Marquez “does not disclose a support frame of a continuous homogeneous material” (App. Br. 6). We note the Examiner relied on Klöckner for disclosing a continuous homogeneous material, not Marquez (Ans. 4) even though Marquez also teaches a single piece frame (see Marquez 9:10-12). Appellant’s contention is not persuasive. Appellant further reiterates the contention that Klöckner is not in the same field of endeavor “as heart valve fabrication” (App. Br. 7). For the reasons stated supra, we find that Klöckner is analogous art but designate this a new ground of rejection because the rationale relied upon was not previously raised by the Examiner. In view of the record presented, we sustain the rejection of claims 11- 18 but designate a new ground of rejection to the effect that Klöckner is analogous art. DECISION The rejection of claims 1-18 under 35 U.S.C. § 103(a) are affirmed. However, since our rationale relies on findings additional to those made by the Examiner, pursuant to our authority under 37 C.F.R. § 41.50(b), Appeal 2010-004897 Application 10/811,565 9 we designate this affirmance as containing new grounds of rejection in order to afford Appellant a fair opportunity to respond. 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the [E]xaminer, in which event the proceeding will be remanded to the [E]xaminer. . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record . . . Should Appellant elect to prosecute further before the Examiner pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If Appellant elects prosecution before the Examiner and this does not result in allowance of the application, abandonment or a second appeal, this case should be returned to the Patent Trial and Appeal Board for final action on the affirmed rejection, including any timely request for rehearing thereof. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). Appeal 2010-004897 Application 10/811,565 10 AFFIRMED; 37 C.F.R. § 41.50(b) JRG