Ex Parte Krishnan et alDownload PDFBoard of Patent Appeals and InterferencesFeb 3, 201210731421 (B.P.A.I. Feb. 3, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte MOHAN KRISHNAN, ERIC HAMMILL, and REBECCA ARON __________ Appeal 2010-009092 Application 10/731,421 Technology Center 3700 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1, 5, 7, and 9-18.1 We have jurisdiction under 35 U.S.C. § 6(b). 1 Claims 2-4, 8, 19, and 20 are also pending, but stand withdrawn from consideration (App. Br. 4). Appeal 2010-009092 Application 10/731,421 2 STATEMENT OF THE CASE Claim 1 is representative of the claims on appeal, and reads as follows: 1. A lead comprising: a lead body extending from a proximal end to a distal end; and a ring electrode coupled to the lead body; wherein the lead body and the ring electrode each have an outer surface adapted to passively prevent formation of clots on the outer surfaces, wherein the outer surface of the lead body is adapted such that a layer of blood cells is formed on the outer surface when exposed to a bloodstream, and wherein the outer surface of the ring electrode includes a textured coating including titanium microspheres. The following grounds of rejection are before us for review: I. Claims 1, 5, 7, and 9-18 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Thorén2 and Helland3 (Ans. 3). II. Claims 1, 5, 7, and 9-18 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Thorén, Helland, and MacGregor4 (Ans. 6). We vacate Rejection I and affirm Rejection II. But as our reasoning differs from that of the Examiner, we designate our affirmance as a new ground of rejection. 2 Thorén, US 4,149,542, issued Apr. 17, 1979. 3 Helland et al., US 5,318,572, issued Jun. 7, 1994. 4 MacGregor, US 4,101,984, issued Jul. 25, 1978. Appeal 2010-009092 Application 10/731,421 3 ISSUE Does the preponderance of evidence of record support the Examiner’s conclusion that the combination of Thorén, Helland, and MacGregor renders obvious the claimed lead? FINDINGS OF FACT FF1. The Specification teaches that the invention “relates to the field of implantable leads, and more specifically to an endocardial lead” (Spec. 1). FF2. According to the Specification: Medical leads, such as cardiac leads, have a distal end having one or more electrodes and a proximal end having a terminal which is coupled to a pulse generator. Electrical therapy is delivered from the pulse generator to the heart via the electrode in order to manage cardiac rhythms. One type of therapy includes cardiac resynchronization therapy. This is typically done with the lead placed in the coronary veins. However, it can be difficult to implant leads in the coronary veins. Further, the therapy may work better with the electrical energy delivered directly to the lateral free wall of the heart. However, the concern with placing a lead in the left atrium or left ventricle is that the left atrium and ventricle pump blood directly to the brain and there is a risk of emboli and therefore stroke from an implanted device in the left chamber of the heart. (Id.) FF3. The Examiner’s finds that Thorén teaches “an endocardial lead with a lead body extending from proximal to a distal end” (Ans. 6). FF4. The Examiner finds further that “Thoren discloses a titanium ring electrode (e.g. side component 5) that is textured with pores to allow for Appeal 2010-009092 Application 10/731,421 4 tissue ingrowth and a distal tip electrode that is inert and thereby prevents clotting (e.g. Col. 2, line 24- Col. 3, line 52)” (id.). FF5. Thorén teaches that the “art is aware of endocardial electrodes comprised of an elongated electrical conductor encased or enveloped within an electrical insulator and having an electrode head or tip on the distal end of such conductor for transmitting stimulating impulses to the heart pursuant to the controlled application of an electrical current to the conductor” (Thorén, col. 1, ll. 11-17). FF6. The Examiner notes that “Thoren fails to . . . teach the use of titanium microspheres for texturing the ring electrode” (Ans. 5). FF7. The Examiner finds that “Helland teaches that it is known to use titanium microspheres between 75-100um to form a layer of blood cells around the lead body electrode as set forth in e.g., column 5, lines 62 -66; column 10, lines 19-20, Col. 6, line 16; for providing the predictable results of immobilizing and stabilizing the electrode and lead body upon implantation” (id.). FF8. The Examiner concludes: It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Thoren with use of a textured coating of titanium microspheres between 75-100um to form a layer of blood cells around the ring electrode and lead body for providing the predictable results of immobilizing and stabilizing the ring electrode and lead body upon implantation. (Ans. 5.) FF9. The Examiner finds that “MacGregor teaches that it is known to select the particle size and orientation of sphere particles on an electrode surface to Appeal 2010-009092 Application 10/731,421 5 provide the predictable results of promoting tissue ingrowth while at the same time preventing clot formation through formation of flattened endothelial-like cells which confer thromboresistance (e.g. Col. 2, line 59- Col. 3, line 22)” (id. at 6). FF10. Specifically, MacGregor teaches: It is well known that the introduction of foreign bodies into the blood stream, for example, the polished metal surfaces of artificial heart valves, tends to cause the formation of blood clots which may break loose and embolize to various parts of the body. Such thromboembolic problems have led to the administration of anticoagulants to patients with artificial heart valves. The effects of these anticoagulants on the blood clotting mechanism cause difficulties in stopping the flow of blood through even a minor flesh wound. In addition, flexible plastic conduits are used for vascular graft purposes and such surfaces also are thrombogenic. (MacGregor, col. 1, ll. 10-21.) FF11. MacGregor thus teaches: The present invention provides a heart valve which overcomes the prior art defects by providing the blood- engaging metallic parts in the form of a solid substrate having an adherent porous metallic surface coating which has a network of interconnected pores therein. It has been found that the rigid nature of the metal coating, the strength of the substrate-coating interface and the strength of the particle- particle bond in the coating provide excellent strength and wear resistance characteristics while nucleated cells circulating in the blood stream colonize onto the blood-engaging surface of the porous coating and subsequently differentiate into other cell types to form a thin, smooth, generally uniformly-thick, firmly attached tissue covering on the surface. The tissue covering is formed rapidly over about a one month period, does not appear to increase significantly in thickness thereafter, and includes Appeal 2010-009092 Application 10/731,421 6 flattened endothelial-like cells at the surface thereof. The tissue formation is not accompanied by thrombosis or embolish owing to its blood-compatible nature, and once the maximum thickness has been attained, the tissue covering is self- regenerating. (Id. at col. 1, ll. 43-64.) FF12. MacGregor also teaches that the “invention is not restricted to heart valves but is applicable to a wide variety of cardiovascular prosthetic devices or implants having blood engaging surfaces. In accordance with the invention, the blood engaging surface is porous in nature and has an interconnected network of pores in the subsurface thereof” (id. at col. 3, ll, 21-26). ANALYSIS Appellants argue that the combination as set forth by the Examiner does not teach or suggest that “the outer surface of the lead body is adapted such that a layer of blood cells is formed on the outer surface when exposed to a bloodstream” (App. Br. 10). We disagree. We conclude that it would have been obvious to the ordinary artisan to adapt an outer surface of the lead body such that a layer of blood cells is formed on the outer surface when exposed to a bloodstream, such as by using an adherent porous metallic surface coating which has a network of interconnected pores therein as taught by MacGregor. Thus, we agree with the Examiner that the combination of Thorén, Helland, and MacGregor renders obvious the subject matter of independent claims 1, 11, and 17. But as our reasoning differs from that of the Examiner, and in order Appeal 2010-009092 Application 10/731,421 7 to give Appellants an opportunity to respond, we designate our affirmance as a new ground of rejection. CONCLUSION OF LAW We conclude that the preponderance of evidence of record supports the Examiner’s conclusion that the combination of Thorén, Helland, and MacGregor renders obvious the claimed lead. We thus affirm the rejection of claims 1, 11, and 17 as being rendered obvious by the combination of Thorén, Helland, and MacGregor. As Appellants did not argue dependent claims 5, 7, 9, 10, 12-16, and 18 separately, we affirm the rejection as to those claims as well. 37 C.F.R. § 41.37(c)(1)(vii). TIME PERIOD FOR RESPONSE This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner…. Appeal 2010-009092 Application 10/731,421 8 (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record…. 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)(1)(iv)(2007). AFFIRMED; 37 C.F.R. § 41.50(b) cdc Copy with citationCopy as parenthetical citation