Ex Parte OllivierDownload PDFPatent Trial and Appeal BoardFeb 27, 201712834385 (P.T.A.B. Feb. 27, 2017) 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. 12/834,385 07/12/2010 Jean-Francois Ollivier 104292-0129 8391 22428 7590 03/01 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER FAIRCHILD, MALLIKA DIPAYAN ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 03/01/2017 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEAN-FRANCOIS OLLIVIER Appeal 2015-002449 Application 12/834,385 Technology Center 3700 Before: LISA M. GUIJT, JEFFREY A. STEPHENS, and BRENT M. DOUGAL, Administrative Patent Judges. DOUGAL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134 from a final rejection of claims 1—15. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2015-002449 Application 12/834,385 CLAIMED SUBJECT MATTER The claims are directed to a coronary venous pacing lead and anchoring screw system. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A system implantable in a coronary venous system, for stimulating a left heart chamber by a generator of an active implantable medical device, comprising: a stimulation lead having a distal end, a proximal end and a lead body having a sheath of a deformable material, said stimulation lead having a lead head at the distal end, with at least one stimulation electrode adapted to come into contact with a region facing an epicardial wall of a target vein of a patient’s coronary network, and said stimulation lead having at the proximal end means for coupling to the generator of the active implantable medical device, and a removable guide catheter comprising a hollow tube having a proximal end and a distal end, both ends being open and having a lumen for receiving the stimulation lead for movement translationally within the guide catheter between a retracted position and a deployed position, at the retracted position the lead head being positioned at the guide catheter lumen distal end, and at the deployed position the lead head with the at least one stimulation electrode extending from said catheter lumen distal end, wherein the hollow tube of the guide catheter is elastically deformable and relatively more rigid than the sheath of the lead body, wherein the stimulation lead is a screw lead, having an anchoring screw axially extending along the lead head configured to penetrate the patient’s epicardial tissue in response to a screw motion imparted to the lead head; wherein the sheath of the lead body is not pre-shaped at the distal end of the stimulation lead, and wherein the hollow tube of the guide catheter is a single pre-shaped tube with, in the absence of a stress, first and second curvatures inscribed in two separate surfaces, said first and second curvatures self-orienting the distal end of the guide 2 Appeal 2015-002449 Application 12/834,385 catheter tube in the target vein with the lead head in the retracted position, and configured to maintain the axis of the anchoring screw towards the epicardial wall of the target vein during a combined motion of screwing and moving the lead head to the deployed position. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Altman US 5,658,327 Voda US 5,868,700 Ollivier US 6,385,492 B1 Williams US 6,408,214 B1 REJECTIONS I. Claims 1—3, 5—7, 14, and 15 are rejected under 35 U.S.C. §103 (a) as being unpatentable over Ollivier and Williams. II. Claims 4, 8, and 10—13 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Ollivier, Williams, and Altman. III. Claims 1, 3, and 9 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Voda and Williams. Aug. 19, 1997 Feb. 9, 1999 May 7, 2002 June 18, 2002 OPINION Rejection I All of the claims subject to Rejection I are argued together. Appeal Br. 4—9. We select claim 1, the sole independent claim, as representative. See 37 C.F.R. § 41.37(c)(l)(iv). The Examiner finds that among other things, Ollivier teaches a guide catheter and that Williams teaches a stimulation electrode with a screw lead 3 Appeal 2015-002449 Application 12/834,385 introduced through two catheters. Final Act. 5, 9-10. It is also stated that “[t]he examiner is . . . generally applying the concept of a pre-bent unitary catheter to a catheter/lead configuration.” Id. at 5. Thus, rather than relying on two catheters to introduce the lead, as in Williams, the Examiner determines that it would be obvious to use a pre-bent unitary catheter as taught by Ollivier to introduce a screw lead, as in Williams. Id. at 5, 10-11. Appellant argues that Ollivier does not teach the claimed guide catheter. Appeal Br. 5. Rather, Appellant explains, Ollivier teaches a self- orienting and self-guiding probe, stating that “[a] probe is simply not a guide catheter.” Id.', see also Reply Br. 8. Appellant acknowledges that “Ollivier is capable of receiving a stylet,” but argues that a stylet is not the same as a lead and that the probe “is not used as a guide” for the stylet. Appeal Br. 5. Rather, the stylet 36 is used to change the curvature of the probe. Id. at 6 (citing Ollivier, col. 4:13—23). Though one embodiment of Ollivier’s stylet is used to change the curvature of the probe, Ollivier also teaches “a stylet and reinforcing tube” (Final Act. 10; see also Ans. 5 (citing Ollivier, col. 5:32—36)) with “variable rigidity” (Ollivier, col. 5:46) so that it can be advanced into the probe after the probe “has been introduced into the sinus” {Id. at col. 5:25). The probe of Ollivier is used as a guide for the “stylet and reinforcing tube” and further used as a guide so that when the first stylet is removed “an angioplasty stylet can be introduced into the central cavity of the probe body through the reinforcement tube 68 (thus avoiding any dislodgement of the probe).” Id. at col. 6:8—10. The angioplasty stylet can then be advanced to a collateral vein selected by the surgeon. Id. at col. 6:12—13. Thereafter, the probe can be 4 Appeal 2015-002449 Application 12/834,385 advanced over the angioplasty stylet to the collateral vein. Id. at col. 6:13— 17. Ollivier’s probe is used as a guide for the stylet and reinforcing tube and for the angioplasty stylet. Thus, Appellant’s argument that Ollivier’s probe is not used as a guide catheter and that “[a] probe is simply not a guide catheter” is unconvincing. Appeal Br. 5; see also Reply Br. 8. For these same reasons, Appellant’s argument that using Ollivier’s probe as a guide catheter “would change the principle of operation of the invention of Ollivier,” is also unconvincing. Appeal Br. 8. Appellant also argues that modifying the probe of Ollivier to receive a lead would render the probe unsatisfactory for its intended purpose. Id. The rejection, however, does not rely on Ollivier for the probe or stimulation lead of the probe. As discussed above, Ollivier is relied on for teaching a guide catheter and Williams is relied on for the stimulation electrode (i.e. the probe). Final Act. 5, 9—10. The Examiner determines that one of skill in the art would understand that the pre-bent unitary catheter of Ollivier could be used in place of the two-catheter system of Williams. Id. at 5, 10-11. Further, as discussed above, using Ollivier as a guide catheter is consistent with the teachings of Ollivier and would not render it unsatisfactory for its intended purpose. For these reasons we are not informed of error in the Examiner’s rejection. Rejection II Claim 12 depends from claim 1 and adds “wherein the anchoring screw comprises an end portion that is configured to penetrate the patient’s 5 Appeal 2015-002449 Application 12/834,385 epicardial tissue and a tip active electrically conductive region extending through an electrically isolated intermediary part.” The Examiner finds that silicone rods 410 of Altman are the claimed “electrically isolated intermediary part.” Final Act. 15. The Examiner also determines that “it would have been obvious ... to further modify the system of Ollivier in view of Williams to include [Altman’s] electrically isolated intermediary part of silicone ... in order to provide the predictable results of controlling the amount of electric charge delivered to the tissue.” Id. Appellant argues “that Altman does not teach or suggest wherein the anchoring screw comprises a tip active electrically conductive region extending through an electrically isolated intermediary part, as required by Claim 12.” Appeal Br. 11 (emphasis added). Appellant further argues: The Examiner . . . asserts that Altman “clearly shows that there are two separate rods 410 that enclose coil conductors 420 that extend to the fixation helix 140.” [But,] . . . the silicone rods of Altman [] do not disclose that the anchoring screw extends through an electrically isolated intermediary part. As the Examiner states, the rods 410 extend to the fixation helix. Reply Br. 12. Though the Examiner has shown that Altman teaches “an electrically isolated intermediary part” (i.e. silicone rods 410), it has not been established that the combination of prior art references teach or suggest “the anchoring screw comprises a tip active electrically conductive region extending through an electrically isolated intermediary part” as required by claim 12. For these reasons we do not sustain the Examiner’s rejection of claim 12, or claim 13 which depends therefrom. 6 Appeal 2015-002449 Application 12/834,385 Appellant relies on the arguments concerning claim 1 to overcome the rejection of claims 4, 8, 10, and 11. Appeal Br. 9—10. Thus, we are not informed of error in the Examiner’s rejection of claims 4, 8, 10, and 11 for the same reasons discussed previously with respect to claim 1. Rejection III All of the claims subject to Rejection III are argued together. Appeal Br. 11—13. We select claim 1 as representative. See 37 C.F.R. § 41.37(c)(l)(vii). The Examiner finds that Voda teaches the claimed guide catheter and that “the catheter is to be used for introducing other elements such as other catheters into the coronary system.” Final Act. 7 and 16—17. The Examiner finds that Williams teaches the claimed stimulation lead. Final Act. 17—18. Finally, the Examiner determines that the combination of the guide catheter and stimulation lead would be obvious. Id. at 18. Appellant argues that Voda fails “to show, particularly, a guide catheter configured to maintain the axis of the anchoring screw towards the epicardial wall,” as required by claim 1. Appeal Br. 12; see also Reply Br. 13. Rather, Appellant states, “Voda teaches that it is important that the distal end of a catheter be aligned with the target vein or artery, and be positioned coaxially therein.” Appeal Br. 12 (citing Voda, col.2:52—59); see also Reply Br. 14. The Examiner responds that “the combination of Voda in view of Williams teaches the limitation that the curvatures of the catheter configured to maintain the axis at its distal end towards the epicardial wall.” Ans. 10. This is because “Williams teaches that the screw is imbedded in the cardiac 7 Appeal 2015-002449 Application 12/834,385 tissue (i.e. epicardial wall) and Voda teaches that the first and second curvatures maintain the axis of the distal end of the lead.” Id. Appellant’s argument focuses solely on Voda, while the rejection relies on the combination of Voda and Williams. Appellant’s argument does not address what is taught or suggested by the combination of Voda and Williams. See In re Keller, 642 F.2d413, 425 (CCPA 1981) (citations omitted) (explaining that obviousness must be considered in light of “what the combined teachings of the references would have suggested to those of ordinary skill in the art”). For this reason, we are not informed of error in the Examiner’s rejection. Appellant also argues that “[mjodifying the guide catheter of Voda . . . [to] maintain the axis of the anchoring screw towards the epicardial wall would clearly render Voda unsatisfactory for its intended purpose.” Appeal Br. 13. Appellant also states that Voda’s “emphasis made on [coaxially aligning the distal end of the catheter with the target vein or artery] teaches away from a guide catheter having curvatures to maintain the axis of the anchoring screw towards the epicardial wall.” Id. Though Voda does discuss a prior art catheter that can cause misalignment with the ostium (Voda, col.2:52—59), Appellant has not identified anything in Voda that would limit the intended purpose to this one example. In fact, Appellant provides neither support nor explanation for either assertion. Voda appears to be more concerned with precise control of the end of the catheter, as opposed to just coaxial alignment with a vein. Voda states that the “invention relates generally to catheters adapted to be inserted into the cardiovascular system . . . and, more particularly, to a preshaped 8 Appeal 2015-002449 Application 12/834,385 catheter. . . for providing more precise access to the right main coronary artery of the cardiovascular system.” Voda, col. 1:14-20 (see also id. at col. 7:46—53 discussing desire for more precise control and maneuverability of the catheter). As such, we are not informed of error in the Examiner’s rejection. DECISION The Examiner’s rejections of claims 1—11, 14, and 15 are affirmed. The Examiner’s rejection of claims 12 and 13 is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 9 Copy with citationCopy as parenthetical citation