Ex Parte Osborne et alDownload PDFPatent Trial and Appeal BoardJan 14, 201511714579 (P.T.A.B. Jan. 14, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/714,579 03/06/2007 Thomas A. Osborne 8627-1668 4114 48004 7590 01/14/2015 BGL/Cook - Indianapolis BRINKS GILSON & LIONE CAPITAL CENTER, SUITE 1100 201 NORTH ILLINOIS STREET INDIANAPOLIS, IN 46204-4220 EXAMINER SZPIRA, JULIE ANN ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 01/14/2015 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte THOMAS A. OSBORNE and M. KEM HAWKINS __________ Appeal 2012–006981 Application 11/714,579 Technology Center 3700 __________ Before DONALD E. ADAMS, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a puncture resistant balloon catheter. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Cook Medical Technologies LLC (see App. Br. 2). Appeal 2012-006981 Application 11/714,579 2 Statement of the Case Background “Conventional balloon catheters may be used to maneuver through the fenestration of the stent graft and deploy a stent. However, conventional balloon catheters are prone to puncture during the delivery and deployment of the stent” (Spec. 1 ¶ 5). The Claims Claims 1–4, 6–12, and 15 are on appeal. Independent claim 1 is representative and reads as follows: 1. A puncture resistant balloon catheter comprising: a catheter comprising a shaft extending along a longitudinal axis of the catheter and an inflation lumen extending therethrough; a balloon formed from a polymeric material overlying the shaft of the catheter, the inflation lumen being in communication with the balloon to inflate the balloon; and a puncture resistant cover disposed over the balloon, the cover made of a metallic alloy having a thickness ranging from about 0.0001 inches to about 0.0020 inches and having a width extending along a working length of the balloon, the width being less than the working length and ranging from about 0.010 inches to about 0.040 inches, the cover extending circumferentially around the balloon along the working length thereof and covering substantially the entire outer surface of the balloon over the working length, the cover being fitted to a size and shape of an expanded state of the balloon and being adapted to be movable between a deflated state and an inflated state in response to inflation of the balloon, wherein the cover inhibits piercing of the balloon. Appeal 2012-006981 Application 11/714,579 3 The issue The Examiner rejected claims 1–4, 6–12, and 15 under 35 U.S.C. § 103(a) as obvious over Trotta2 and Andrews3 (Ans. 5–7). The Examiner finds that Trotta teaches “a puncture resistant balloon catheter comprising: a catheter (17) . . . a balloon (10) formed from a polymeric material . . . and a puncture resistant cover (20) disposed over the balloon, having a thickness ranging from about 0.0001 inches to about 0.0020 inches” (Ans. 5). The Examiner finds that Trotta teaches “the cover being fitted to a size and shape of an expanded state of the balloon and being adapted to be movable between a deflated state and an inflated state in response to inflation of the balloon, wherein the cover inhibits piercing of the balloon” (Ans. 5). The Examiner acknowledges that Trotta “fails to disclose the cover being made of a metallic alloy and having a width of about .010 to .040 inches” (Ans. 6). The Examiner finds that Andrews teaches “a cover made from a metallic alloy . . . disposed over the surface of a balloon . . . where the cover is . . . a sleeve” (Ans. 6). The Examiner finds it obvious to “reinforce the polymeric balloon of Trotta et al. with a metallic alloy cover, in view of the teachings of Andrews et al., to prevent axial movement and wall thinning of the balloon . . . which would prevent accidental puncture of the balloon” (Ans. 6). 2 Trotta et al., US 5,613,979, issued Mar. 25, 1997. 3 Andrews et al., US 6,156,254, issued Dec. 5, 2000. Appeal 2012-006981 Application 11/714,579 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Trotta and Andrews render the claims obvious? Findings of Fact 1. Figure 1 of Trotta is reproduced below: “FIG. 1 is an enlarged, fragmentary view, taken partly in longitudinal section, of the distal end of a balloon catheter” (Trotta, col. 3, ll. 59–61). 2. Trotta teaches that a “difficulty which is found with such biaxially oriented balloons is that, since they are typically very thin–walled, they can be easily punctured” (Trotta, col. 1, ll. 26–28). 3. Trotta teaches a solution is where “the inflatable balloon has an outer surface which is surrounded by an elastomeric sleeve. The sleeve is bonded typically throughout at least a majority of its area to the balloon outer surface, to provide pin hole and abrasion resistance” (Trotta, col. 1, ll. 59–63). 4. Trotta teaches that “[o]uter polyurethane layer may 20 have a thickness of, typically, 0.0005 to 0.002 inch, to provide abrasion and puncture resistance to the coextruded tubular structure 22 which comprises Appeal 2012-006981 Application 11/714,579 5 PET balloon 10 and polyurethane outer tubular layer 20” (Trotta, col. 4, ll. 33–37). 5. Trotta teaches that the “balloon catheter of this invention may carry an expansible stent about the outer surface of the elastomeric sleeve, so that the expansible stent may be expanded by the balloon into engagement with the wall of a blood vessel” (Trotta, col. 3, ll. 7–10). 6. Andrews teaches “the stent readily punctures the balloon before the stent can be properly placed. It is common to use two or three balloons to place the stent. The use of replacement balloons increases the time of the procedure during which time the arterial blood flow is restricted, thus increasing patient risk and trauma” (Andrews, col. 2, ll. 43–49). 7. Andrews teaches that the “fibre re–inforcement is formed integrally with the material of the wall of the balloon portion so that it moves with the wall as the balloon portion is inflated” (Andrews, col. 3, ll. 32–34). 8. Andrews teaches that “[h]owever, the fibres could be at an inner or an outer surface of the flexible wall material, as long as they are in some way bonded or affixed to the wall material so that they are substantially fixed with respect to the wall material and do not slide or move significantly with respect to the wall material” (Andrews, col. 3, ll. 37–42). 9. Andrews teaches that the “braiding can be made from any suitable material, notably a stainless steel or polymer fibre, ribbon or wire. Preferably, the material is one which possesses shape memory properties” (Andrews, col. 4, ll. 16–19). Appeal 2012-006981 Application 11/714,579 6 10. Andrews teaches that materials may include “medical grade stainless steel and polymers such as polyesters, notably PET or polyamides, for example those materials available under the Trade Mark Nitinol” (Andres, col. 4, ll. 40–43). 11. Andrews teaches that “the reinforcement may be configured so that limited radial stretching of the balloon may occur so that the reinforcement constructed from the inelastic fibres need not itself be inelastic” (Andrews, col. 3, ll. 50–54). Principles of Law “An examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai–Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 5–10; FF 1–10) and agree that claim 1 is obvious over Trotta and Andrews. We address Appellants’ arguments below. Appellants contend that “the properties of Trotta’s elastomeric sleeve are opposite of the properties of Applicants’ cover or coil, which is required Appeal 2012-006981 Application 11/714,579 7 to be metallic, and therefore, would be hard and have limited elasticity compared to Trotta’s elastomeric sleeve” (App. Br. 5). We find these arguments unpersuasive. Appellants fail to address the combination of Trotta and Andrews, instead arguing the references individually. Trotta teaches the problem of balloon punctures (FF 2) and a solution relying upon the use of elastomeric balloon cover (FF 3). Andrews also recognizes the puncture problem (FF 6), and suggests the use of metal braiding (FF 9) which may be located at “an outer surface of the flexible wall material, as long as they are in some way bonded or affixed to the wall material” (Andrews, col. 3, ll. 37–39; FF 8). We agree with the Examiner that “the substitution of the metal reinforcement of Andrews for the elastomeric reinforcement of Trotta is an obvious variation of a secondary structure designed to support a catheter balloon and prevent that balloon from being accidentally puncture” (Ans. 8). Appellants contend that “Andrews fails to fill the deficiencies of Trotta. Andrews discloses a fibre braiding reinforcement in a balloon” (App. Br. 5). Appellants contend that “Andrews only relates to a reinforcing structure” (Reply Br. 4). We are not persuaded because Andrews teaches both fibre braiding “formed integrally with the material of the wall of the balloon” as well as teaching that “the fibres could be at an . . . outer surface of the flexible wall material” (Andrews, col. 3, ll. 32–42; FF 7–8). This is consistent with the Examiner’s finding that “Andrews distinctly points out that the support structure can be overlaid on the balloon, as long as there is a means to adhere the support structure and the balloon to one another” (Ans. 9). We Appeal 2012-006981 Application 11/714,579 8 agree with the Examiner that Andrews is reasonably interpreted as suggesting placement of the fibre reinforcement over the balloon, not just inside the material of the balloon, which is also consistent with the covering sleeve of Trotta (FF 3). Appellants contend that “Andrews fails to disclose that the fibre reinforcement covers substantially the entire working length of the balloon” (App. Br. 5–6). We are not persuaded. As the Examiner notes and Appellants do not dispute, “Trotta discloses that the puncture resistant cover extends over the entire working length of the balloon” (Ans. 5, 9). Because the problem that both Trotta and Andrews address is the concern regarding punctures of the balloon during treatment (FF 2, 6), the ordinary artisan would have reasonably found it obvious to cover the entire working length of the balloon with the puncture resistant cover in order to prevent the undesirable punctures at an uncovered location, as Trotta teaches that the “balloon has an outer surface which is surrounded by an elastomeric sleeve” (Trotta, col. 1, ll. 59–61; FF 3). Appellants contend that “Trotta and the claimed inventions are directly opposite of each other: Trotta is fitted to the deflated state, and the claimed inventions are fitted to the expanded state” (Reply Br. 3). Appellants contend that “Applicants’ cover does not merely contract and expand with the balloon, it is ‘fitted’ to the balloon in its ‘expanded state’” (Reply Br. 2). We do not find these arguments persuasive. Just as claim 1 requires a cover “adapted to be movable between a deflated state and an inflated state Appeal 2012-006981 Application 11/714,579 9 in response to inflation of the balloon”, Trotta also teaches that the sleeve may move between a deflated and inflated state (FF 5). Similarly, Andrews teaches that “the reinforcement may be configured so that limited radial stretching of the balloon may occur so that the reinforcement constructed from the inelastic fibres need not itself be inelastic” (Andrews, col. 3, ll. 50– 54; FF 11). Thus, Andrews also teaches that the cover may be “adapted to be movable between a deflated state and an inflated state in response to inflation of the balloon” as required by claim 1. To the extent that Appellants are interpreting the claim limitation of “cover being fitted to a size and shape of an expanded state of the balloon” as a structural limitation, rather than an intended use recitation for the cover, after the Andrews cover composed of braided stainless steel (FF 9) has been expanded, the Andrews cover would reasonably render this structural limitation obvious when combined with Trotta. Conclusion of Law The evidence of record supports the Examiner’s conclusion that Trotta and Andrews render the claims obvious. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as being obvious over Trotta and Andrews. Pursuant to 37 C.F.R. § 41.37(c), claims 2–4, 6–12, and 15 fall with claim 1, as these claims were not argued separately. Appeal 2012-006981 Application 11/714,579 10 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED sl Copy with citationCopy as parenthetical citation