Ex Parte CullDownload PDFPatent Trial and Appeal BoardNov 7, 201612681731 (P.T.A.B. Nov. 7, 2016) 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. 12/681,731 11/03/2010 David L. Cull CDL-8-PCT-US 6408 22827 7590 11/07/2016 DORITY & MANNING, P.A. POST OFFICE BOX 1449 GREENVILLE, SC 29602-1449 EXAMINER BERDICHEVSKY, AARTI ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 11/07/2016 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 DAVID L. CULL1 Appeal 2014-006694 Application 12/681,731 Technology Center 3700 Before GEORGE R. HOSKINS, LEE L. STEPINA, and AMANDA F. WIEKER, Administrative Patent Judges. WIEKER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE David L. Cull (“Appellant”) appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1—20. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellant, the Real Party in Interest is CreatiVasc Medical, LLC. Br. 1. Appeal 2014-006694 Application 12/681,731 CLAIMED SUBJECT MATTER The claimed invention concerns “devices and methods to facilitate cannulation and prevent needle puncture bleeding of an arteriovenous fistula.” Spec. 3:4—6. Claim 1 is illustrative of the subject matter on appeal, and recites: 1. A device for locating an arteriovenous fistula and occluding an arteriovenous fistula needle puncture site, the device comprising: a body, the body formed from a self-sealing biocompatible material, the body having a semi-curved shape with two edges that extend along the length of the body, the body configured to conform to a contour of a portion of an arteriovenous fistula with the edges configured to be generally parallel to the length of an arteriovenous fistula, the edges providing a tactile clue when focal pressure is applied to skin above an arteriovenous fistula, the body providing a barrier to limit bleeding from a posterior portion of an arteriovenous fistula. Br. 8 (Claims App.). Independent claim 11 is a method claim and contains similar limitations. Id. at 9 (Claims App.). REJECTIONS The claims stand rejected as follows: I. Claims 1—12 and 15—20 under 35 U.S.C. § 103(a) as unpatentable over Vertenstein (US 5,167,629, iss. Dec. 1, 1992) and House (US 2006/0118236 Al, pub. June 8, 2006). II. Claims 13 and 14 under 35 U.S.C. § 103(a) as unpatentable over Vertenstein, House, and Berry (US 5,306,240, iss. Apr. 26, 1994). 2 Appeal 2014-006694 Application 12/681,731 ANALYSIS Rejection I— Claims 1—12 and 15—20 Appellant argues claims 1 and 11 as a group. Br. 3—6. We treat claim 1 as representative, and claim 11 stands or falls with claim 1. 37 C.F.R. §41.37(c)(l)(iv). The Examiner finds that Vertenstein teaches a device substantially as recited in claim 1 but fails to teach that the device’s body is formed from a self-sealing material. Final Act. 2—3; Ans. 2. The Examiner finds that House teaches an implantable device formed from a self-sealing biocompatible material with reinforcement. Final Act. 3. In light of these teachings, the Examiner concludes it would have been obvious to an ordinarily skilled artisan to replace the body material disclosed by Vertenstein with the self-sealing and reinforced material taught by House because “this material would provide a body that would be more resistant to fluid leakage following puncturing with a needle, and would be more flexible than simply metal alone” such as disclosed in Vertenstein. Id. at 3— 4 (citation omitted). Appellant contends that Vertenstein teaches away from the proposed combination because Vertenstein’s device is “designed strictly as a vein locator with metal walls designed to ‘protect[] any surrounding vital organs from injury during placement of an intravenous access catheter’ . . . and to prevent disassembly.” Br. 4—5 (citing Vertenstein 4:34—36, 4:53—54). In Appellant’s view, an ordinarily skilled artisan would not have substituted House’s self-sealing material for Vertenstein’s metal body “since such a 3 Appeal 2014-006694 Application 12/681,731 material would potentially allow the needle penetration that Vertenstein . . . aims to avoid.” Id. at 5. We are not persuaded by Appellant’s argument. Vertenstein discloses a vein locator that includes a U-shaped sleeve (10), adapted to surround a patient’s vein (7). Vertenstein 3:20—22, Figs. 4—5. Vertenstein specifies that the sleeve is formed from “a biocompatible metal,” but contemplates expressly that “other materials could be used.” Id. at 3:43—45. Therefore, we are not persuaded that a skilled artisan would have been discouraged or dissuaded from modifying Vertenstein’s device body to be formed from a different material, i.e., a self-sealing material as taught by House. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Additionally, we are unpersuaded that use of a self-sealing material may permit injury to vital organs, which Vertenstein aims to avoid. Br. 5. Vertenstein attributes the avoidance of injury to the “configuration of the sleeve’s walls 15,” not to the material employed. Vertenstein 4:34—38; see also Ans. 2. Appellant provides no persuasive evidence or technical reasoning to establish that organs would be injured if the material of Vertenstein’s device were changed, but its configuration remained the same. Indeed, Vertenstein discloses that it is the arrangement of protuberances (21) atop the sleeve, which may be felt through the patient’s skin to identify the vein’s location within the sidewalls (15) of the sleeve, which allows needle insertion into the vein and protects surrounding organs from injury. See Vertenstein 3:23— 4 Appeal 2014-006694 Application 12/681,731 30, 4:34—38. Vertenstein does not suggest that the metal material of the sleeve is necessary for performance of this function.2 Appellant also contends that House teaches away from the claimed invention because House’s device replaces an arteriovenous fistula, whereas the claimed device surrounds an arteriovenous fistula. Br. 5—6. We are unpersuaded by this argument, which attacks the references individually. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The Examiner’s rejection does not rely on House as teaching any structural features of the device. Final Act. 2—4. Rather, the rejection relies on Vertenstein’s disclosure of a device structure and House’s teaching of a self-sealing material. Id.', Ans. 3. Appellant’s argument does not address the combination of references as relied upon by the Examiner. Br. 5—6. Unpersuaded of error in the Examiner’s rejection of claim 1, we sustain the rejection of claim 1 and claim 11, which was grouped with claim 1. Appellant does not provide separate argument for claims 2—10, 12, or 15— 20, which depend from independent claims 1 or 11. Appeal Br. 6. Accordingly, we also sustain the rejection of those claims. Rejection II— Claims 13 and 14 The Examiner finds that Vertenstein and House render obvious the method of claim 11, but do not teach a tunneler as recited in claims 13 and 14. Final Act. 6. The Examiner finds that Berry teaches a tunneler and a method for implanting a subcutaneous vascular access graft, and concludes 2 Appellant’s argument that Vertenstein’s device is designed to “prevent disassembly” is also unpersuasive. Br. 5. This function is attributed to locking clip 30, not the material of the sleeve. Vertenstein 4:53—54. 5 Appeal 2014-006694 Application 12/681,731 that it would have been obvious to an ordinarily skilled artisan “to use a tunneler as taught by Berry to at least partially position the vein locating device of Vertenstein and House” with less trauma. Id. Appellant contends that Vertenstein teaches away from use of a tunneler as required by claims 13 and 14 because Vertenstein “requires a surgeon to squeeze the side walls of the device to nest the device to the ring,” which is “counter to the purpose of a tunneler, which seeks to avoid a larger surgical opening.” Br. 6—7. We are unpersuaded by this argument. Although the procedure disclosed by Vertenstein involves “squeezing] the side walls of the device,” (Vertenstein 4:40-42), Appellant does not identify any disclosure in Vertenstein that would discourage or discredit the modification proposed by the Examiner, in light of Berry’s teachings. See In re Gurley, 27 F.3d at 553 (“A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.”). Further, the reasoning articulated by the Examiner for the proposed modification—to avoid trauma—is supported by rational underpinnings. See Berry 2:28—32. Unpersuaded of error in the Examiner’s rejection of claims 13 and 14, we sustain the rejection. 6 Appeal 2014-006694 Application 12/681,731 DECISION The rejection of claims 1—20 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 7 Copy with citationCopy as parenthetical citation