CARDIAC PACEMAKERS, INC.Download PDFPatent Trials and Appeals BoardSep 2, 20212021001059 (P.T.A.B. Sep. 2, 2021) 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. 14/919,233 10/21/2015 Benjamin J. Haasl 1001.3628101 1407 11050 7590 09/02/2021 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER HERBERMANN, ERICH G. ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 09/02/2021 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte BENJAMIN J. HAASL and BRIAN L. SCHMIDT 1 ________________ Appeal 2021-001059 Application 14/919,233 Technology Center 3700 ________________ Before BIBHU R. MOHANTY, BRADLEY W. BAUMEISTER, and ROBERT J. SILVERMAN, Administrative Patent Judges. BAUMEISTER, Administrative Patent Judge. DECISION ON APPEAL Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1, 10, and 21–38, which constitute all claims pending in this application. Appeal Br. 2–3. We have jurisdiction under 35 U.S.C. § 6(b). The Board conducts a limited de novo review of the appealed rejections for error based upon the issues identified by Appellant, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential). We reverse. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Cardiac Pacemakers, Inc. as the real party in interest. Appeal Brief (“Appeal Br.”), at 4, filed August 24, 2020. Appeal 2021-001059 Application 14/919,233 2 CLAIMED SUBJECT MATTER Appellant describes the present invention as follows: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The distal holding section may be structured to have portions that flex and bend while allowing the implantable device to be recaptured within the distal holding section. Spec. Abstr. Independent claim 1, reproduced below, illustrates the subject matter of the appealed claims: 1. A delivery device for delivering an implantable leadless pacing device, the delivery device comprising: a proximal section having an outer diameter; a distal holding section extending distally of a distal end of the proximal section, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device and the distal holding section having an outer diameter greater than the outer diameter of the proximal section; wherein the distal holding section comprises a braided reinforcing element covered by a polymeric body; wherein a proximalmost end of the braided reinforcing element is disposed within the distal holding section. STATEMENT OF THE REJECTIONS Claims 1, 10, 21, 23, 24, 28, 29, 31, 32, 36, and 37 stand rejected under 35 U.S.C. § 103 as being unpatentable over the combined teachings of Steingisser (US 2013/0103047 A1; published Apr. 25, 2013) and Appeal 2021-001059 Application 14/919,233 3 Ju (US 6,217,566 B1; issued Apr. 17, 2001). Final Action (“Final Act.”), at 2–10, mailed April 2, 2020. Claims 22, 30, and 38 stand rejected under 35 U.S.C. § 103 as being unpatentable over the combined teachings of Steingisser, Ju, and Kellerman (US 2013/0123827 A1; published May 16, 2013). Final Act. 10–12. Claims 25–27 and 33–35 stand rejected under 35 U.S.C. § 103 as being unpatentable over the combined teachings of Steingisser, Ju, and Levine (US 6,726,700 B1; issued Apr. 27, 2004). Final Act. 12–14. DETERMINATIONS AND CONTENTIONS The Examiner finds that Steingisser discloses most of the limitations of independent claim 1, but does not disclose the claim language, “wherein the distal holding section comprises a braided reinforcing element covered by a polymeric body” or that “[the] proximalmost end of the braided reinforcing element is disposed within the distal holding section.” Final Act. 2–3. The Examiner finds that Ju teaches that it was known to have a braided reinforcing element covered in a polymeric body in the distal section of a catheter. Id. at 3 (citing Ju col. 1, ll. 50–60; Fig. 2). The Examiner further determines that it would have been obvious to have modified the device of Steingisser to have the braided reinforcing layer covered in the polymeric body . . . in the distal segment (located inside the distal section 235 of Steingisser) of the device in view of Ju to improve the kink resistance of the distal holding section. Id. (citing Ju col. 1, ll. 50–60) (emphasis added). Appellant argues various reasons for why no reasonable basis exists to modify the distal-most portion 235 of Steingisser’s device with the teachings of Ju to arrive at Appellant’s invention, as claimed. Appeal Br. 9–15. For Appeal 2021-001059 Application 14/919,233 4 example, Appellant argues one of ordinary skill would understand that the distal-most portion 235 of Steingisser would not be subject to kinking during either advancement or withdrawal of the outer tube. Id. Appellant then argues that because the Examiner has not established that the distal-most portion 235 would be subject to kinking, the Examiner has not established a sufficient reason to add the braid of Ju to the device of Steingisser. Id. at 14. In the Examiner’s Answer mailed October 2, 2020 (“Ans.”), the Examiner reiterates that the purpose for the modification is to “provide extra radial support to prevent the distal portion [of Steingisser] from kinking when forces are applied to the distal end when maneuvering the tool through the body.” Ans. 5. The Examiner responds to Appellant’s arguments, “[t]here is no mention in Steingisser to support the claim that the device[,] as described[,] has a distal-most portion that is resistant to kinking in any way.” Id. at 6. The Examiner reasons without providing support, “the distal end is subject to compression both during insertion and during withdrawal.” Id. at 8. ANALYSIS In order to modify Steingisser’s distal-most portion 235, the Examiner relies on Ju’s teaching of providing a braided reinforcing element 120 in the “most distal section” 102 of Ju’s catheter 100. Final Act. 3 (citing Ju’s distal section 102; Fig. 2). But Ju’s most distal section 102 does not sufficiently correspond to Steingisser’s distal-most portion 235. Steingisser describes its distal-most portion 235 as being an enlarged distal end of the outer tube 230—the distal end in which an implantable device 100 is loaded. Steingisser ¶¶ 19, 22; Fig. 2A. This distal-most Appeal 2021-001059 Application 14/919,233 5 portion 235 has a length of approximately 3 cm to contain device 100. Steingisser ¶ 19. In contrast, Ju’s most distal section 102 is an elongated section of catheter 100 that is the same outer diameter as the proximal section 104 and joint region 106. Ju Fig. 1; col. 1, ll. 15–17 (“the catheter assembly uses long conical joints between component tubular members to provide smooth and strong transitions between those members.”); id. at col. 2, ll. 19–21 (“The invention utilizes the concept of combining one or more polymeric tubes with a metallic braid comprising ribbons of a super-elastic alloy.”). Ju sets forth examples where the distal section has braid lengths of 14.5 cm and 22.5 cm. Id. at col. 14, ll. 1–2. These exemplary braid lengths of Ju’s distal section are five to seven times longer than the 3 cm length of Steingisser’s distal-most portion 235. Moreover, Ju’s most distal section 102 does not constitute the distal end of Ju’s catheter. Ju’s distal section 102 is proximal of the catheter’s radio opaque marker 108 and unlabeled tip. Ju Fig. 1. As such, Ju’s most distal section 102 appears to correspond more closely to Steingisser’s flexible elongate outer tube 230 than it does to Steingisser’s shorter-length and larger-diameter distal-most portion 235. On this record, then, the Examiner does not provide sufficient evidence or factual basis to support the determination that one of ordinary skill in the art would have expected Steingisser’s distal-most portion 235 to be prone to kinking. As such, the Examiner has not established that it would have been obvious to modify Steingisser’s distal-most portion 235 so as to include a braided reinforcing element covered by a polymeric body, as recited by claim 1. Appeal 2021-001059 Application 14/919,233 6 The initial burden is on the Examiner to support the Examiner’s findings by a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988). Only when the Examiner sets forth a prima facie case does the burden shift to Appellant to rebut the Examiner’s evidence. In re Sullivan, 498 F.3d 1345, 1351 (Fed. Cir. 2007). Because the Examiner has not met the initial showing, Appellant has no burden to show that Steingisser’s distal-most portion 235 is resistant to kinking. See Ans. 6 (wherein the Examiner determines that Appellant has not shown Steingisser’s distal-most portion to be resistant to kinking). For the foregoing reasons, Appellant has persuaded us of error in the Examiner’s obviousness rejection of independent claim 1. Accordingly, we reverse the Examiner’s rejection of that claim and of claims 10, 21, 23, 24, 28, 29, 31, 32, 36, and 37, which either depend from claim 1 or otherwise include similar claim language.2 Regarding the further rejections of claims 22, 25–27, 30, 33–35, and 38, the Examiner does not rely on either of the additionally cited references, Kellerman and Levine, to cure the deficiency of the obviousness rejection 2 We only address the narrow question of whether the Examiner has established that it would have been obvious to modify Steingisser’s distal- most portion 235, as proposed, for the specific purpose of preventing kinking. Because that was the sole stated basis for modifying Steingisser, we do not address any other potential reasons for why one would have been motivated to make an enlarged distal-most portion of a leadless-pacing delivery device, as claimed, flexible. See Frye, 94 USPQ2d at 1075 (The Board conducts a limited de novo review of the appealed rejections for error based upon the issues identified by Appellant, and in light of the arguments and evidence produced thereon.). Appeal 2021-001059 Application 14/919,233 7 explained above. Final Act. 10–14. We, therefore, reverse the obviousness rejections of these claims for the reasons set forth in relation to claim 1. DECISION SUMMARY In summary: REVERSED Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1, 10, 21, 23, 24, 28, 29, 31, 32, 36, 37 103 Steingisser, Ju 1, 10, 21, 23, 24, 28, 29, 31, 32, 36, 37 22, 30, 38 103 Steingisser, Ju, Kellerman 22, 30, 38 25–27, 33–35 103 Steingisser, Ju, Levine 25–27, 33–35 Overall Outcome 1, 10, 21–38 Copy with citationCopy as parenthetical citation