Ex Parte Stehr et alDownload PDFPatent Trial and Appeal BoardNov 7, 201311910503 (P.T.A.B. Nov. 7, 2013) Copy Citation 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. 11/910,503 10/02/2007 Richard E. Stehr 0B-046908US 6495 55714 7590 11/08/2013 ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION Kite & Key, LLC P.O. Box 315 Hamel, MN 55340-0315 EXAMINER BOSWORTH, KAMI A ART UNIT PAPER NUMBER 3767 MAIL DATE DELIVERY MODE 11/08/2013 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 RICHARD E. STEHR and XIAOPING GUO ____________ Appeal 2012-001909 Application 11/910,503 Technology Center 3700 ____________ Before DONALD E. ADAMS, LORA M. GREEN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 1-12 (App. Br. 4).2 Examiner entered rejections under 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The claims are directed to a splittable reinforced flexible tubular body for a catheter or sheath. Claims 1 and 9 are representative and are reproduced in the Claims Appendix of Appellants’ Brief. 1 The Real Party in Interest is St. Jude Medical, Atrial Fibrillation Division, Inc. (App. Br. 2.) 2 Pending “[c]laims 13-35 stand withdrawn from consideration” (App. Br. 4). Appeal 2012-001909 Application 11/910,503 2 Claims 1 and 2 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Morris.3 Claims 3, 4, and 8 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris and Bühler.4 Claims 5-7 and 9 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris, Bühler, and Potter.5 Claims 10-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris and Potter. Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Morris teaches Appellants’ claimed invention? FACTUAL FINDINGS (FF) FF 1. Morris’ “invention relates generally to an introducer system having a kink resistant sheath for the insertion of catheters and other instruments into the body and more particularly to an introducer system having a kink resistant splittable sheath used to introduce pacemaker leads into the venous system” (Morris, col. 1, ll. 5-9). 3 Morris, US 5,713,867, issued Feb. 3, 1998. 4 Bühler et al., US 4,402,685, issued Sept. 6, 1983. 5 Potter et al., US 2004/0267203 A1, published Dec. 30, 2004. Appeal 2012-001909 Application 11/910,503 3 FF 2. Morris’ Figures 16 and 19 are reproduced below: “FIG. 16 depicts a lead introducer system in accordance with one embodiment of [Morris’] … invention” (id. at col. 3, ll. 20-21). “FIG. 18 is a detailed cross-sectional view of the wall of the kink resistant sheath used in an introducer system of the [Morris’] … invention” (id. at ll. 24-26). FF 3. Morris teaches a sheath 61 having “a two-part construction with a tubular portion 71 having at least one reinforcing fiber 72 integral therewith,” wherein, as illustrated in FIG. 19, “a score line 63 [is] cut into both the sheath wall and the reinforcing fibers” to permit the sheath “to be longitudinally split apart along [the] score line” (id. at col. 5, ll. 32-34 and col. 6, ll. 13-18 (emphasis added); see generally Ans. 5 and 10-11). FF 4. Morris teaches that “[v]arious other equivalent means may … be used to accomplish splitting [the] sheath 61 along [the score] line 63 includ[ing] … providing a line of weakened wall” or constructing the entire wall “using material having the physical property of molecular orientation whereby a tear in the material runs readily only in a longitudinal direction along the length of [the] sheath 61” (id. at col. 6, ll. 20-28; see generally Ans. 5 and 10-11). Appeal 2012-001909 Application 11/910,503 4 ANALYSIS Claim 1 is drawn to a splittable reinforced flexible tubular body for a catheter or sheath, comprising, inter alia, a wall structure that includes (1) a reinforcement layer within the wall structure and (2) a separation line extending longitudinally along the wall structure and adapted to facilitate the splitting of the wall structure (Appellants’ Claim 1). Claim 1 also requires that the reinforcement layer is formed without introducing discontinuities thereto (id.). Examiner finds, inter alia, that Morris teaches a sheath that comprises a reinforcement layer, wherein the reinforcement layer is “formed without introducing discontinuities thereto” because Morris teaches that the sheath 61 can be split along a score line 63 “by either scoring the sheath [61] or by alternative means including providing a line of weakened wall or using specific materials to allow the splitting” (Ans. 5 and 10). We are not persuaded. Morris teaches that “a score line 63 [is] cut into both the sheath wall and the reinforcing fibers” to permit the sheath “to be longitudinally split apart along [the] score line” (FF 3). While Morris teaches that “[v]arious other equivalent means may … be used to accomplish splitting [the] sheath 61 along [the score] line 63,” Examiner failed to establish an evidentiary basis on this record to support a finding that Morris’ teaching of alternatives to cutting the sheath wall also make it unnecessary to cut into the reinforcing fiber (see FF 4; Cf. FF 3 (“a score line 63 [is] cut into both the sheath wall and the reinforcing fibers”); see also App. Br. 9 (“While Morris does teach a reinforcing layer …, Morris only discloses the introduction of discontinuities for splitting that layer”)). Appeal 2012-001909 Application 11/910,503 5 In the alternative, Examiner finds that while Morris’ reinforcing fiber is scored, as illustrated in Fig. 19, the “scores [63] are shorter in length than the diameter of fiber 72 and … [since] the scores do not completely cut through the fibers …, completely break or interrupt the individual fibers … the reinforcing member is … ‘formed without introducing discontinuities thereto’” (Ans. 11). In support of this assertion, Examiner finds that Appellants’ Specification fails to define the term “discontinuous” and “the broadest reasonable definition [of the term is, as set forth in the American Heritage Dictionary of the English Language,] … ‘marked by breaks or interruptions’” or, as set forth in Macmillan Dictionary, “not continuing without being stopped or interrupted” (Ans. 11). We are not persuaded. As Appellants explain “[a] scored reinforcing layer, even if the ‘scores do not completely cut through the fibers,’ necessarily has discontinuities introduced to it…. Put simply, a score is a discontinuity in the scored material” (Reply Br. 4-5). CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner’s finding that Morris teaches Appellants’ claimed invention. The rejection of claims 1 and 2 under 35 U.S.C. § 102(b) as being anticipated by Morris is reversed. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? Appeal 2012-001909 Application 11/910,503 6 FACTUAL FINDINGS (FF) FF 5. Examiner finds that Morris fails to suggest a “separation line [that] is a strip of first polymer material that is different from a second polymer material utilized to form the rest of the wall structure wherein a bond interface between the two materials creates a stress concentration that facilitates the splitting of the wall structure” and relies on Bühler to make up for this deficiency (Ans. 6-7 (emphasis added)). FF 6. Examiner finds that Morris fails to suggest a “separation line [that] is defined by a peel groove longitudinally extending along the wall structure” and relies on Potter to make up for this deficiency (id. at 8 (emphasis added)). FF 7. Examiner finds that the combination of Morris and Bühler fails to suggest a separation line, comprising two polymers, wherein “the first polymer material is more radiopaque” and relies on Potter to make up for this deficiency (id. at 7). FF 8. Examiner finds that Morris alone or in combination with Bühler fails to suggest a “reinforcement layer [that] is pre-stressed or pre-treated without being severed to fail [sic] along a longitudinal path that aligns with the separation line” (id. at 8 and 9). FF 9. Examiner relies on Potter to suggest a cannula comprising a radiopaque marker ring, wherein the radiopaque marker “may be grooved, scored, serrated, or provided with a sidewall having weakened or reduced material cross-sections … generally corresponding to the location of the score lines …, grooves, or other splitting means running along the longitudinal axis of the sheath” (see id.; Potter 4: ¶¶ [0044]-[0045]). Appeal 2012-001909 Application 11/910,503 7 ANALYSIS Claims 3-12 depend directly or indirectly from claim 1. Examiner failed to establish that Morris in combination with Bühler or Potter alone or in combination makes up for the deficiency in Morris discussed above (see App. Br. 10; Cf. FF 5-8). At best, Examiner finds that Potter suggests a pre- stressed or pre-treated radiopaque marker ring that is unsevered (see FF 8-9). Examiner failed to establish an evidentiary basis on this record to support Examiner’s characterization of the radiopaque marker ring as a reinforcement layer (see FF 8). Further, assuming arguendo that Potter’s radiopaque marker ring could be a reinforcement layer, Examiner failed to establish that it would have been prima facie obvious to use such a layer, as described by Potter, to replace Morris’ reinforcement layer (see Ans. 8-9). Instead, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to “include a pre-treated layer without being severed, as taught by Potter et al., for the purpose of aiding in splitting of the sheath” (Ans. 8 and 9). Examiner failed to explain why a person of ordinary skill in this art would have included an additional reinforcement layer to Morris’ structure, which already includes a reinforcement layer, to facilitate splitting of the sheath (see FF 3). “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). For the foregoing reasons, we are compelled to reverse the obviousness rejections on this record. Appeal 2012-001909 Application 11/910,503 8 CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 3, 4, and 8 under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris and Bühler is reversed. The rejection of claims 5-7 and 9 under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris, Bühler, and Potter is reversed. The rejection of claims 10-12 under 35 U.S.C. § 103(a) as unpatentable over the combination of Morris and Potter is reversed. REVERSED cdc Copy with citationCopy as parenthetical citation