Ex Parte Chalekian

Patent Trial and Appeal BoardNov 26, 2012

11592365 (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 2012-000887 Application 11/592,365 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 2012-000887 Application 11/592,365 2 Statement of the Case Background “The present invention is directed to a balloon configuration developed particularly for performing a side-wall opening enlargement procedure which has a substantially reduced likelihood of producing . . . inward displacement” (Spec. 2, ll. 12-14). The Claims Claims 1, 3, 4, 6-12, 16, 17, and 22 are on appeal. Claim 1 is representative and reads as follows: 1. A medical device balloon having a proximal end, a distal end, and a longitudinal axis, the balloon comprising: a first balloon portion at the proximal end of the balloon, the first balloon portion defining a first chamber and having a globular configuration with a maximum perpendicular dimension (D1) taken in a plane perpendicular to the longitudinal axis of the balloon and an axial length (D3) which is not more than about 20% greater than the maximum perpendicular dimension (D1), and an adjacent second balloon portion, the second balloon portion defining a second chamber and having a generally cylindrical body portion which has a diameter (D2) which is less than the first chamber diameter axial length (D3), wherein the first balloon portion is proximal of the second balloon portion, the first balloon portion defines the proximal end of the balloon, the second balloon portion defines the distal end of the balloon, and the first balloon portion has an inwardly inverted conical portion disposed at the proximal end of the balloon. The issue The Examiner rejected claims 1, 3, 4, 6-12, 16, 17, and 22 under 35 U.S.C. § 103(a) as obvious over Sanati1 and Jang2 (Ans. 5-8). 1 Sanati et al., US 2006/0265041 A1, published Nov. 23, 2006. Appeal 2012-000887 Application 11/592,365 3 The Examiner finds that: Sanati discloses a medical device balloon (22a,22b) having a longitudinal axis (20), the balloon comprising a first balloon portion (22b) at the proximal end of the balloon, the first balloon portion defining a first chamber (23b) and having a globular configuration with a maximum perpendicular dimension (D 1) (fig. 2) taken in a plane perpendicular to the longitudinal axis of the balloon and an axial length (D3) (length of chamber 23b) which is not more than about 20% greater than the maximum perpendicular dimension (D 1) (fig. 2), and an adjacent second balloon portion (22a), the second balloon portion defining a second chamber (23a) and having a generally cylindrical body portion which has a diameter (D2) (fig. 2) which is less than the first chamber diameter axial length (D3) (fig. 2), wherein the first balloon portion is proximal of the second balloon portion (note fig. 2), the first balloon portion has a proximal end that defines the proximal end of the balloon (note figure 2), the second balloon portion has a distal end that defines the distal end of the balloon (note figure 2). (Ans. 5). The Examiner acknowledges that “Sanati fails to explicitly disclose the first balloon portion has an inwardly inverted conical portion disposed at the proximal end of the balloon” (Ans. 5). The Examiner finds that “Jang discloses a balloon portion (16) having an inwardly inverted conical portion disposed at the proximal end of the balloon (note in fig. 11 the inwardly inverted portion positioned at the proximal end of conical balloon 16)” (Ans. 5-6). The Examiner finds it obvious to “modify the first balloon portion invention of Sanati with the inwardly inverted conical balloon portion 2 Jang, G., US 4,763,654, issued Aug. 16, 1988. Appeal 2012-000887 Application 11/592,365 4 configuration as taught by Jang. Doing so would provide a balloon attachment which eliminates dead space of the attachment site providing a shorter, more easily manipulated and safer balloon portion as taught by Jang” (Ans. 6). Appellant contends that “Jang discloses an inwardly inverted proximal end of a distal balloon portion, not the proximal balloon portion as recited by claim 1” (App. Br. 11). Appellant contends that “there is no teaching or suggestion from the references to provide an inwardly inverted portion at the proximal end of the proximal balloon where there is no contact between balloon surfaces” (Id. at 12). Appellant contends that: At most, the combination of Sanati and Jang suggests an alternative arrangement for the attachment interface between the proximal balloon portion and the distal balloon portion at the center of the dual chamber balloon. The combination of Sanati and Jang does not teach or suggest inwardly inverting a balloon at either “free” end of the dual chamber balloon, where the balloon portion is not in contact another balloon portion. (Id. at 12). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Sanati and Jang render claim 1 obvious? Findings of Fact The following findings of fact (“FF”) are supported by a preponderance of the evidence of record. Appeal 2012-000887 Application 11/592,365 5 1. 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). 2. 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). 3. 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 2012-000887 Application 11/592,365 6 4. 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). 5. 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. We agree with the Examiner that Jang teaches prolapse of the balloon at the central attachment site (FF 4-5) but the Examiner provides no reason to prolapse the proximal end of Jang’s proximal balloon Appeal 2012-000887 Application 11/592,365 7 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 would have found it ‘obvious to try’ any of these combinations” (Ans. 10). 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 Sanati nor Jang provide a reason for configuring the catheter so that “the first balloon portion has an inwardly inverted conical portion disposed at the proximal end of the balloon” as required by claim 1, 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.”). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Sanati and Jang render claim 1 obvious. Appeal 2012-000887 Application 11/592,365 8 SUMMARY In summary, we reverse the rejection of claims 1, 3, 4, 6-12, 16, 17, and 22 under 35 U.S.C. § 103(a) as obvious over Sanati and Jang. REVERSED lp