Ex Parte Cook et alDownload PDFPatent Trial and Appeal BoardMar 17, 201612389070 (P.T.A.B. Mar. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/389,070 02/19/2009 Brian Cook 28390 7590 03/21/2016 MEDTRONIC VASCULAR, INC IP LEGAL DEPARTMENT 3576 UNOCAL PLACE SANTA ROSA, CA 95403 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P28509 US 2577 EXAMINER DANG, ANH TIEU ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 03/21/2016 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): rs.vasciplegal@medtronic.com medtronic_cv_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRIAN COOK, JAMES MITCHELL, NATIVIDAD VASQUEZ, and GIANFRANCO PELLEGRINI Appeal2013-007788 Application 12/389,070 Technology Center 3700 Before WILLIAM A. CAPP, LEE L. STEPINA, and FREDERICK C. LANEY, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Brian Cook et al. (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner's decision rejecting claims 1 and 4--12. 1 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 1 Claims 2 and 3 have been canceled, and claims 13-20 have been withdrawn. Appeal Br. 18-21. Appeal2013-007788 Application 12/389,070 THE CLAIMED SUBJECT MATTER The claimed invention is directed to a retractable drug delivery system. Spec. 1 (Title). Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A system for treating a vascular condition, the system compnsmg: a catheter including an inner member and an outer member, the outer member being concentrically arranged and slideably disposed about the inner member; a retractable drug delivery device disposed around a distal end of the inner member extending through the retractable drug delivery device, the retractable drug delivery device comprising a plurality of scaffold struts and a plurality of transition struts extending from the plurality of scaffold struts, wherein the scaffold struts of the retractable drug delivery are configured to expand radially from the inner member forming an open passageway wherein the distal end of the scaffold struts are unattached to the inner member; an attachment, wherein proximal ends of the plurality of transition struts are secured to the attachment and wherein the attachment is formed integrally with the inner member; a coating disposed on at least a portion of an outer surface of the retractable drug delivery device; and in at least one therapeutic agent within the coating; wherein the inner member and the outer member are operable to collapse the retractable drug delivery device from an expanded configuration to a compressed configuration about the inner member within the outer member when the inner member is moved slideably relative to the outer member. Appeal Br. 17 (emphasis added). REFERENCES RELIED ON BY THE EXAMINER Kleshinski Mc Innes Kao Shum er US 6,939,361 Bl US 6,558,405 B 1 US 2006/0282149 Al US 2007 /0100422 Al 2 Sept. 6, 2005 May 6, 2003 Dec. 14, 2006 May 3, 2007 Appeal2013-007788 Application 12/389,070 THE REJECTIONS ON APPEAL (I) Claims 1, 6-10, and 12 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kleshinski and Kao. (II) Claims 4 and 5 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kleshinski, Kao, and Mclnnes. (III) Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kleshinski, Kao, and Schumer. ANALYSIS Rejection(!) The Examiner finds that "Kleshinski teaches a system for treating a vascular condition with a catheter comprising an inner member ( 11) and an outer member (34) concentrically arranged about the inner member (figure 3, column 5, lines 33-47) and slideably disposed about the inner member (figure 3, column 6, lines 1-13)." Final Act. 3--4 (emphasis omitted).2 The Examiner further finds that filter 10 of Kleshinski corresponds to a retractable drug delivery device. Final Act. 4. Additionally, the Examiner finds that Kleshinski teaches that the inner and outer members (11 and 34) "are operable to collapse the retractable drug delivery device from an expanded configuration where it is in the body to a compressed configuration about the inner member ( 11) when the inner member is slideably retracted into outer sheath (34) to remove the stent (column 6, lines 1-13)." Final Act. 4. Regarding claim interpretation in relation to the above-noted findings, the Examiner interprets claim 1 as requiring "the retractable drug delivery 2 Dated August 15, 2012. 3 Appeal2013-007788 Application 12/389,070 device to be collapse[ d] to a compressed configuration about the inner member 'when' the outer member is moved slideably relative to the outer member." Adv. Act. 2. The Examiner's position is that the last paragraph of claim 1 "does not require the retractable drug delivery device to be collapsible as a result of the slideable movement of the outer member over the inner member." Adv. Act. 2 (emphasis added). In an alternate approach, the Examiner finds that filter 10 of Kleshinski "is capable of being collapsed by the sliding movement between the inner member and the outer member regardless of whether the filter is made of shape memory." Ans. 3. In this regard, the Examiner states, "[t]herefore it would be within the skill of one of ordinary skill in the art at the time of the invention to understand that the device could also operate in the same manner as claimed in the instant invention." Ans. 3. Appellants argue: Kleshinski fails to disclose structure in which moving the inner member slideably relative to the outer member will collapse the retractable drug delivery device to a compressed configuration, i.e., the inner member and the outer member being operable to collapse the retractable drug delivery device when the inner member is moved slideably relative to the outer member as claimed. Appeal Br. 9. Rather, according to Appellants, Kleshinski causes filter 10 to collapse by cooling it. See Appeal Br. 8-1 O; see also Reply Br. 4. Appellants argue that claim 1 requires the retractable drug delivery device to collapse as a result of the movement of the inner member relative to the outer member. Appeal Br. 11-13. Therefore, according to Appellants the Examiner's finding that filter 10 ofKleshinski collapses at the same time as 4 Appeal2013-007788 Application 12/389,070 inner member ( 11) moves relative to outer member (34) does not satisfy the requirements of claim 1. Appeal Br. 11-13. Regarding the Examiner's alternate approach, that Kleshinski "is capable of being collapsed by the sliding movement between the inner member and the outer member regardless of whether the filter is made of shape memory" (Ans. 3), Appellants argue that Kleshinski provides no support for the Examiner's finding. Reply Br. 5. Rather, according to Appellants, Kleshinski discloses that "[i]n the operation of the filter 10, the stent with the mesh filter material is inserted in a collapsed condition into a delivery tube 34." Reply Br. 5. Appellants contend that "[t]rying to compress the Kleshinski stent 14 from an expanded configuration by pulling the stent 14 into the delivery tube 34 would apply significantly greater stress to the delivery tube 34 than the minor amount of stress exerted by the collapsed stent." Reply Br. 5. We agree with Appellants' interpretation of claim 1. The plain language of claim 1, that "the inner member and the outer member are operable to collapse the retractable drug delivery device from an expanded configuration to a compressed configuration," means that the inner member and outer member are configured to perform the action of causing the retractable drug delivery device to collapse. Thus, we also agree with Appellants that a relative movement between inner member 11 and outer member 34 occurring simultaneously with the collapse of filter 10 does not satisfy the above-noted limitation in claim 1. As for whether the arrangement disclosed by Kleshinski is capable of performing the action of collapsing filter 10 as a result of movement of the inner member 11 relative to the outer member 34, we agree with Appellants 5 Appeal2013-007788 Application 12/389,070 that Kleshinski discloses collapsing stent 14 (which is the frame of filter 10) only via cooling. For example, Kleshinski states, "[p]referably the stent is formed of the thermal shape memory material such as nitinol and may be collapsed by cooling the stent to a temperature below a transition temperature." Col. 6, 1. 3-6. Although Kleshinski states that this is the preferable method of collapsing stent 14 (and filter 10), Kleshinski does not further teach any other method collapsing these components. Moreover, the Examiner does not provide any persuasive explanation as to why this capability would be inherent in Kleshinski. Thus, the Examiner's finding that Kleshinski provides the capability to push outer member 34 over filter 10 to collapse it is not supported by a preponderance of the evidence. The Examiner does not propose to use the teachings of Kao in any way that would remedy the deficiencies in Kleshinski discussed above. Accordingly, we do not sustain the Examiner's rejection of claim 1 and claims 6-10 and 12 depending therefrom as unpatentable over Kleshinski and Kao. Rejections II and III The Examiner does not rely either of Mcinnes or Schumer in any way that would remedy the deficiencies discussed above with respect to Kleshinski and the rejection of independent claim 1. Accordingly, we do not sustain Rejections II and III. DECISION We reverse the Examiner's decision to reject claims 1 and 4--12. REVERSED 6 Copy with citationCopy as parenthetical citation