Ex Parte Chalekian

Patent Trial and Appeal BoardNov 26, 2012

11592691 (P.T.A.B. Nov. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte AARON CHALEKIAN __________ Appeal 2012-002176 Application 11/592,691 Technology Center 3700 __________ Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a medical balloon device. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2012-002176 Application 11/592,691 2 Statement of the Case Background “The invention of the present application pertains, in various aspects, to methods of deploying stent assemblies at bifurcations, to catheter/stent assemblies and to two-stent assemblies useful for placement at bifurcation sites” (Spec. 2, ll. 6-8). The Claims Claims 7-13 and 15-17 are on appeal. Claim 7 is representative and reads as follows: 7. An assembly comprising: a first stent having a longitudinal axis, a tubular wall and a side branch opening, and a catheter assembly extending through the side branch projection of the first stent, the catheter assembly comprising: a catheter shaft, a balloon mounted on the catheter shaft, the balloon having two adjacent independently inflatable chambers, the balloon having a proximal balloon portion that defines a first of said chambers having a globular configuration when inflated, and a distal balloon portion that defines a second of said chambers disposed distally of the first chamber, the second chamber having a generally cylindrical configuration, and a second stent, the second stent having a tubular body which includes a main body portion, and, a plurality of finger- like projections the second stent mounted over the balloon such that the finger like projections are disposed over a portion of the first chamber and the main body portion is disposed over the second chamber, wherein the side branch opening in the first stent includes a tubular projection extending at an angle to the longitudinal axis from a portion of the tubular wall, the tubular projection overlapping with a portion of the second stent main body portion, and the proximal balloon portion has a proximal end attached to the catheter shaft in everted form. Appeal 2012-002176 Application 11/592,691 3 The issue The Examiner rejected claims 7-13 and 15-17 under 35 U.S.C. § 103(a) as obvious over Vardi, 1 Sanati 2 and Jang 3 (Ans. 5-8). The Examiner finds that “Vardi discloses a first stent (40) having a tubular wall with a longitudinal axis (fig. 7), and a side branch opening (16), a second stent (15) having tubular body which includes a main body portion (fig. 6g), a plurality of finger-like projections (18)” (Ans. 5). The Examiner finds that: Sanati discloses a stent delivery catheter assembly (10) capable of extending through the side branch projection of a first stent, the catheter assembly comprising a catheter shaft (12), a balloon (22a,22b) mounted on the catheter shaft (12 note fig. 1), the balloon having two adjacent independently inflatable chambers (23a,23b). (Id. at 5-6.) The Examiner acknowledges that Vardi and Sanati do not teach “the proximal balloon portion has a proximal end attached to the catheter shaft in everted form” (id. at 6). The Examiner finds that “Jang discloses a balloon portion (16) having a proximal end attached to a catheter (12) in everted form (fig. 11).” (Id.). The Examiner finds it obvious to “to modify the proximal balloon portion invention of Sanati with the everted balloon configuration as taught by Jang. Doing so would provide a catheter with a balloon portion which is shorter, more easily manipulated and safer as taught by Jang” (id.). 1 Vardi et al., US 6,835,203 B1, issued Dec. 28, 2004. 2 Sanati et al., US 2006/0265041 A1, published Nov. 23, 2006. 3 Jang, G., US 4,763,654, issued Aug. 16, 1988. Appeal 2012-002176 Application 11/592,691 4 Appellant contends that “Sanati and Jang merely teach an everted portion at the juncture where the proximal balloon and distal balloon meet” (App. Br. 18). Appellant contends that “[t]here is no teaching or suggestion from Sanati or Verdi (or in the earlier cited Jang) that everting the proximal end of the proximal balloon portion would result in a suitable balloon” (id. at 19). The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that Vardi, Sanati and Jang render claim 7 obvious? Findings of Fact The following findings of fact (“FF”) are supported by a preponderance of the evidence of record. 1. Figure 7 of Vardi is reproduced below: “FIG. 7 is a schematic depiction of the main stent with optional expandable portion, prior to balloon expansion of the expandable portion” (Vardi, col. 5, ll. 59-61). Appeal 2012-002176 Application 11/592,691 5 2. Figure 2 of Sanati is reproduced below: Figure 2 shows “an exemplary embodiment of a balloon apparatus 10 for delivering a stent or other prosthesis 40, e.g., into an ostium or other bifurcation between a main lumen and a branch lumen” (Sanati 2 ¶ 0024). 3. Sanati teaches that the “catheter 12 may include inflation lumens 18b, 18c that extend from respective side ports 32b, 32c in the handle 30 through the catheter 12 to openings 34b, 34c on the distal end 16. Each opening 34b, 34c communicates within an interior 23a, 23b of a respective balloon 22a, 22b” (Sanati 3 ¶ 0028). 4. Figure 11 of Jang is reproduced below: “FIG. 11 is a close-up view of the central attachment site of a catheter . . . with the balloons in cross-section” (Jang, col. 8, ll. 25-27). Appeal 2012-002176 Application 11/592,691 6 5. Jang teaches that it is preferred that the first balloon 16 is prolapsed over substantially all of the central attachment site 34 so that the prolapsed portion 40 is directly adjacent to, or even in contact with, the second balloon 20. This prolapse design eliminates the dead space of the central attachment site 34, providing a shorter, more easily manipulated and safer balloon portion of the catheter 10. (Jang, col. 16, ll. 1-9.) 6. Jang teaches that in “accordance with one advantageous embodiment of the tandem balloon design, the effective length of the catheter occupied by the two balloons may be shortened by prolapsing one of the balloons, as discussed in connection with FIG. 7” (Jang, col. 15, ll. 52-55). Principles of Law “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima face case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). To establish a prima facie case of obviousness, the examiner must find “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis This is a very close case, where we view the evidence of record as almost in equipoise. Claim 7 requires, however, that “the proximal balloon portion has a proximal end attached to the catheter shaft in everted form.” We agree with the Examiner that Jang teaches prolapse of the balloon at the Appeal 2012-002176 Application 11/592,691 7 central attachment site (FF 5-6), but the Examiner provides no reason to prolapse the proximal end of Jang‟s proximal balloon, rather than, or in addition to, the prolapse at the center attachment point. The Examiner provides no example, prior art reference or other showing of a prolapse of the proximal end of a proximal balloon. Instead, the Examiner finds that “there is only a finite number of configurations in which a balloon can be attached to a catheter . . . . Thus, one of ordinary skill in the art at the time of invention would have found it „obvious to try‟ any of these combinations” (Ans. 11). We are not persuaded by the Examiner‟s argument. While the Examiner correctly notes that a balloon may be attached with or without an eversion at each end, balloons may also be welded, tethered, crimped, clipped, or adhered to the catheter, each attachment mode possibly resulting in slightly different configurations of attached balloons. Since neither Vardi, Sanati nor Jang provide a reason for configuring the catheter so that “the proximal balloon portion has a proximal end attached to the catheter shaft in everted form” as required by claim 7, we are compelled to reverse this rejection. See KSR, 550 U.S. at 418 (There must be “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.”). Because claims 8-13 and 15-17 each depend, directly or indirectly, on independent claim 7, we reverse the rejection of these dependent claims as well. Conclusion of Law Appeal 2012-002176 Application 11/592,691 8 The evidence of record does not support the Examiner‟s conclusion that Vardi, Sanati and Jang render claim 7 obvious. SUMMARY In summary, we reverse the rejection of claims 7-13 and 15-17 under 35 U.S.C. § 103(a) as obvious over Vardi, Sanati and Jang. REVERSED cdc