Ex Parte Aron et al

Patent Trial and Appeal BoardMar 28, 2014

12686035 (P.T.A.B. Mar. 28, 2014)

MOD PTOL-90A (Rev.06/08) APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. 12686035 01/12/2010 Rebecca Aron 387521 EXAMINER FAEGRE BAKER DANIELS LLP PATENT DOCKETING-INTELLECTUAL PROPERTY (32469) 220 WELLS FARGO CENTER 90 SOUTH SEVENTH STREET MINNEAPOLIS, MN 55402-3901 HELLER, TAMMIE ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 03-28-2014 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. UNITED STATES DEPARTMENT OF COMMERCE U.S. Patent and Trademark Office Address : COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov UNITED STATES PATENT AND TRADEMARK OFFICE _____________________________________________________________________________________ MOD PTOL-90A (Rev.06/08) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte REBECCA ARON, MOHAN KRISHNAN, and KEVIN ELY __________ Appeal 2012-003544 Application 12/686,035 Technology Center 3700 __________ Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1 and 4-20. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation (App. Br. 3). Appeal 2012-003544 Application 12/686,035 2 STATEMENT OF THE CASE Claims 1 and 15, the only independent claims, read as follows: 1. A method comprising: wrapping a first piece of porous polyethylene material around a first portion of a lead assembly under tension and controlling size of pores in the polyethylene by adjusting the tension applied during wrapping, such that the first piece of porous polyethylene has a first section having tissue ingrowth allowing pores and a second section having tissue-inhibiting pores; and fusing a first portion of the first piece of porous polyethylene material to a second portion of the first piece of porous polyethylene material. 15. The method comprising: wrapping a first section of porous polyethylene material around a first portion of a lead assembly, and the first section has tissue ingrowth allowing pores; and wrapping a second section of porous polyethylene material around a second portion of the lead assembly, the second section having tissue ingrowth inhibiting pores, and the first section is at a different longitudinal location than the second section. Issue The Examiner has rejected claims 1, 4-11, and 15-20 under 35 U.S.C. § 103(a) as obvious over the combination of Sridharan2 and Carson3 (Ans. 4- 9). The Examiner has also rejected claims 12-14 under 35 U.S.C. § 103(a) in view of Sridharan, Carson, and Bhat4 (Ans. 9). Because the same issue is 2 Sridharan, US 7,195,638 B1, issued Mar. 27, 2007. 3 Carson, US 5,931,862, issued Aug. 3, 1999. 4 Bhat, US 6,645,135 B1, issued Nov. 11, 2003. Appeal 2012-003544 Application 12/686,035 3 dispositive for both rejections, we will consider them together. We focus our initial analysis on claim 1. The issue presented is: Has the Examiner established that the preponderance of the evidence supports the conclusion that the cited references would have made obvious the modification of Sridharan’s method for making a catheter balloon by wrapping the porous polyethylene to control the “size of pores in the polyethylene . . . such that the . . . porous polyethylene has a first section having tissue ingrowth allowing pores and a second section having tissue-inhibiting pores” as required by claim 1? Findings of Fact FF1. The Examiner finds that “Sridharan discloses a catheter lead 10 having a porous polymeric cover 33 formed by wrapping a first piece of porous material 40 around a first portion of the assembly” and fusing first and second portions of the first piece of porous polyethylene material (Ans. 4-5). FF2. The Examiner finds that “Sridharan discloses that the material 40 may be porous polyethylene” (id. at 5). FF3. The Examiner finds that “Sridharan further discloses that the porous polyethylene material 40 may be wrapped under tension” (id.). FF4. The Examiner finds that “Sridharan’s disclosure of stretching the polyethylene results in the controlling of the size of the pores in the polyethylene” (id.). FF5. Sridharan discloses an “expandable medical device [that] is an inflatable balloon for a catheter . . . [to] be used on a variety of suitable balloon catheters including coronary and peripheral dilatation catheters, stent Appeal 2012-003544 Application 12/686,035 4 delivery catheters, drug delivery catheters and the like” (Sridharan, col. 2, ll. 55-59). FF6. Sridharan discloses a method of making an expandable medical device in which a sheet of porous polymeric material is wrapped, typically on a mandrel, to form a tube having a seam formed by adjacent edges of the sheet . . . [wherein the] tube is heated . . . to fuse the longitudinal edges of the wrapped sheet together, to form a tubular body having a fused seam. (Id. at 4, ll. 13-24). FF7. The Examiner finds that Sridharan does not disclose that the “porous polyethylene has a first . . . [section] having tissue ingrowth allowing pores and a second section having tissue-inhibiting pores” (Ans. 5). FF8. The Examiner finds that Carson discloses a lead assembly with a coating having “an outer surface with relatively small pores to inhibit tissue ingrowth and an inner layer with larger pores which would be suitable to allow tissue ingrowth” (id.). FF9. Carson discloses that “the inner layers of tubular covering 10 may have larger pores, which would allow more saline within the material, thereby increasing conductivity” (Carson, col. 5, ll. 25-27). FF10. The Examiner concludes that it would have been obvious to one having ordinary skill in the art to modify the Sridharan method to control pore size so that “the first section of porous material has tissue ingrowth allowing pores and the second section of porous material has tissue ingrowth inhibiting pores, as taught by Carson, in order to allow for body fluids to wet the surface while controlling tissue ingrowth” (Ans. 5). Appeal 2012-003544 Application 12/686,035 5 Analysis Appellants argue that “[t]here is nothing in Sridharan and Carson that suggests modification of Sridharan using [the] Carson porous polyethylene material” (App. Br. 13). Appellants further argue that “Sridharan describes a catheter balloon that may be used to deliver a stent during angioplasty surgery” (id.). Appellants argue that there “would be no reason that tissue ingrowth into the balloon would be desired, and such ingrowth could actually be detrimental, because it would make the balloon catheter difficult to remove and/or may cause tissue damage upon removal” (id.). Appellants argue that while the Examiner reasons that “Sridharan should have tissue ingrowth allowing pores ‘in order to allow for body fluids to wet the surface’ as in the lead of Carson,” that “there is no teaching or suggestion that the surface of the balloon of Sridharan is desired to be ‘wet’ since the balloon does not have to be conductive as does the lead in Carson” (id. at 14). The Examiner responds that “surface wetting is not necessarily limited to wetting in the sense of enabling a lead to be conductive” (Ans. 12). According to the Examiner, “the catheter of Sridharan is desired to be ‘wet’ to facilitate easy insertion and navigation through a human body” (id.). We agree with Appellants that the Examiner has not adequately explained how the cited references would have made obvious the method of claim 1. Sridharan discloses an expandable medical device, e.g. an inflatable balloon for a catheter, that is made of porous polyethylene, and that is formed by wrapping the porous polyethylene around a mandrel (FFs 5 and 6). Carson discloses a medical lead which is wrapped in a tubular Appeal 2012-003544 Application 12/686,035 6 covering (FF 8). Carson discloses that pore size in the outer layer is chosen to inhibit tissue growth, but that inner layers of the tubular covering may have larger pores to allow more saline within the material and increase conductivity (FF 9). The Examiner reasons that it would have been obvious to modify the Sridharan invention to have both tissue ingrowth allowing pores and tissue ingrowth inhibiting pores, as taught by Carson, in order to allow for body fluids to wet the surface. We conclude that the Examiner has not explained why one of skill in the art would have wanted a balloon catheter with ingrowth-allowing and ingrowth-inhibiting pores because the balloon is not left in the body. Cf. Carson, col. 5, ll. 29-32 (“pore sizes . . . so that tissue ingrowth is properly controlled upon chronic placement in the body”). Additionally, the Examiner has not pointed to any evidence or provided any scientific reasoning to suggest that the wetting of a catheter balloon, which is used to compress a stenosis to allow for improved blood flow after deflation and removal from the patient, is advantageous. Thus, we conclude that the Examiner has not adequately explained how the cited references would have made obvious the method of claim 1. Thus, we reverse the rejection of independent claim 1, and dependent claims 4-11 as being obvious in view of Sridharan and Carson. Independent claim 15, which is set forth above, is directed to a method comprising wrapping a first and second sections of porous polyethylene material around first and second portions of a lead assembly such that “the first section has tissue ingrowth allowing pores and . . . the second section . . . [has] tissue ingrowth inhibiting pores.” Appeal 2012-003544 Application 12/686,035 7 Thus, for the reasons discussed above, we reverse the rejection of independent claim 15 and dependent claims 16-20 as being obvious in view of Sridharan and Carson. With regard to the rejection of claims 12-14 under 35 U.S.C. § 103(a) over the combination of Sridharan, Carson, and Bhat, we also reverse that rejection. Claims 12-14 depend from claim 1, directly or indirectly, and the Examiner relies on Bhat only to supply dependent claim limitations. Conclusion of Law The preponderance of the evidence does not support the conclusion that the cited references would have made obvious the modification of Sridharan’s method for making a catheter balloon by wrapping the porous polyethylene to control the “size of pores in the polyethylene . . . such that the first piece of porous polyethylene has a first section having tissue ingrowth allowing pores and a second section having tissue-inhibiting pores” as required by claim 1. SUMMARY We reverse the rejection of claims 1 and 4-20 under 35 U.S.C. § 103(a). REVERSED dm