11473874 (B.P.A.I. Jan. 31, 2012)

Ex Parte McCarthy

Board of Patent Appeals and InterferencesJan 31, 2012

11473874 (B.P.A.I. Jan. 31, 2012)

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. 11/473,874 06/23/2006 Patrick M. McCarthy CCF-6963NP 9232 26294 7590 01/31/2012 TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P. 1300 EAST NINTH STREET, SUITE 1700 CLEVELAND, OH 44114 EXAMINER PELLEGRINO, BRIAN E ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 01/31/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte PATRICK M. MCCARTHY ____________ Appeal 2010-001071 Application 11/473,874 Technology Center 3700 ____________ Before LINDA E. HORNER, JOHN C. KERINS, and KEN B. BARRETT, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Patrick M. McCarthy (Appellant) seeks our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1, 2, 4, 6, 8, 9, and 11 under 35 U.S.C. § 103(a) as unpatentable over Agathos (WO 97/00651; pub. Jan. 9, 1997) and Kaidash (US 4,576,605; iss. Mar. 18, 1986). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. Appeal 2010-001071 Application 11/473,874 2 THE INVENTION Appellant’s claimed invention is “directed to an apparatus for implantation in the annulus of a tricuspid valve.” Spec. 1, ll. 7-8. Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An apparatus for implantation in the annulus of a tricuspid valve, the annulus having an anterior annulus aspect, a posterior annulus aspect, and an atrioventricular (AV) node located adjacent the anterior annulus aspect, the apparatus comprising: an ovoid main body portion having an inner layer and an outer layer, the inner layer being an expandable support member and the outer layer being a biocompatible covering; the main body portion including an anterior body segment adapted for placement adjacent the anterior annulus aspect, a posterior body segment located opposite the anterior body portion and adapted for placement adjacent the posterior annulus aspect, and oppositely disposed left and right side body segments extending between the anterior and posterior body segments; at least two valve leaflets secured within the main body portion and coaptable to permit unidirectional flow of blood; and a cushioned section attached to the outer layer of the main body portion, the cushioned section having a first thickness and the main body portion having a second thickness which is less than the first thickness, the cushioned section coextending with only a portion of the main body portion and adapted for placement adjacent the AV node. ISSUE The issue presented by this appeal is whether the Examiner provided an adequate articulation of a reason based on rational underpinnings to Appeal 2010-001071 Application 11/473,874 3 explain why one of ordinary skill in the art would have been led to add the elastic disc segment of Kaidash to the tricuspid valve prosthesis of Agathos. ANALYSIS The Examiner determined that Agathos discloses the apparatus for implantation in the annulus of a tricuspid valve as called for in claim 1 except for the claimed cushioned section and that Kaidash discloses a cardiac valve apparatus with an elastic disc segment that can be placed over a zone of calcinosis and can be considered a cushion. Ans. 3. The Examiner determined that “it would have been obvious to one of ordinary skill in the art to use a cushioned segment as taught by Kaidash et al. with the prosthetic valve of Agathos such that it aids in reducing any more calcinosis effects from occurring.” Id. As to independent method claim 8, the Examiner determined that calcinosis tends to occurs “in nodular regions” and determined that one of ordinary skill would have been motivated to place the “cushioned” section of the modified Agathos apparatus adjacent the AV node in the procedure of repairing a tricuspid valve disclosed by Agathos. Ans. 4. The Examiner stated that “[t]his would reduce the chances of calcium deposits around the AV node, which is an area of high incidence for calcinosis.” Id. Kaidash discloses “a cardiac valve prosthesis that may be used for remedying valvular afflictions accompanied by calcinosis, and to isolate the latter.” Col. 1, ll. 8-10. Kaidash’s prosthesis includes a suturing collar 4 having a groove extending along the entire outer circumference and a disc segment 6 made of an elastic material mounted in the groove and angularly Appeal 2010-001071 Application 11/473,874 4 adjustable about an axis extending at right angles to the plane of the suturing collar. Col. 1, ll. 38-43; col. 2, ll. 16-29; fig. 1. Kaidash discloses that “the segment 6 can be disposed within the zone of calcinosis” and that by “fixing the disc segment 6 in the desired position, by using the elasticity of the material of the segment 6, the segment is deformed so as to place it over the calcinosis.” Col. 2, ll. 49-50; 53-56. Kaidash discloses that “[t]he advantage of the cardiac valve prosthesis according to the invention resides in the fact that it provides for the possibility of isolating the calcinosis without removing it during the process of implantation of the cardiac valve prosthesis, owing to the covering of the calcinosis by the disc segment.” Col. 1, ll. 46-50. Kaidash discloses that “[t]he use of the invention eliminates the appearance of paravalvular fistulae, improves reliability of operation and reduces operation time.” Col. 2, ll. 60-62. The Examiner failed to adequately explain, or support by reference to the prior art, the reasoning that using the elastic disc segment of Kaidash on the prosthetic valve of Agathos would reduce the chances of calcium deposits around the AV node. Kaidash appears to use the elastic disc segment to cover or isolate the calcinosis (discussion of Kaidash supra and Affidavit Under 37 CFR § 1.132 of Patrick M. McCarthy, paras. 6, 8, and 9). Kaidash does not disclose that use of the elastic disc segment to isolate the calcinosis will reduce or prevent further calcinosis from occurring. For this reason, we cannot sustain the Examiner’s rejection of claims 1, 2, 4, 6, 8, 9, and 11 under 35 U.S.C. § 103(a) as unpatentable over Agathos and Kaidash. Appeal 2010-001071 Application 11/473,874 5 CONCLUSION The Examiner did not provide an adequate articulation of a reason based on rational underpinnings to explain why one of ordinary skill in the art would have been led to add the elastic disc segment of Kaidash to the tricuspid valve prosthesis of Agathos. DECISION The decision of the Examiner to reject claims 1, 2, 4, 6, 8, 9, and 11 is REVERSED. REVERSED nlk