Ex Parte Kugler et al

Patent Trial and Appeal BoardNov 29, 2018

13079179 (P.T.A.B. Nov. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/079, 179 04/04/2011 11050 7590 12/03/2018 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 FIRST NAMED INVENTOR Chad J. Kugler 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 1001.3053102 9229 EXAMINER OSINSKI, BRADLEY JAMES ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 12/03/2018 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHAD J. KUGLER and ROBERT E. ATKINSON 1 Appeal2018-002667 Application 13/079, 179 Technology Center 3700 Before JOHN C. KERINS, LEE L. STEPINA, and RICHARD H. MARSCHALL, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. Â§ 134 from the Examiner's decision to reject claims 34--41 and 52-71. 2 We have jurisdiction under 35 U.S.C. Â§ 6(b). We REVERSE. 1 The Appeal Brief indicates that Bridgepoint Medical, Incorporated, is the real party in interest. Appeal Br. 3. 2 Claims 1-33 and 42-51 have been cancelled. Appeal Br. 20--21 (Claims App.). Appeal 2018-002667 Application 13/079, 179 CLAIMED SUBJECT MATTER The claims are directed to an intravascular device having an exposed balloon. Appeal Br. 20-21, 23 (Claims App.). Claim 34, reproduced below, is illustrative of the claimed subject matter: 34. An intravascular device for treating a blood vessel having a vascular wall, the vascular wall defining a vascular lumen, the intravascular device including: an elongate member defining a lumen extending distally to a distal opening; and a balloon located on a distal end region of the elongate member, the balloon having a proximal end and a distal end; wherein an exterior surface of the elongate member is exposed between the proximal end of the balloon and the distal end of the balloon; wherein the balloon is configured to be inflated in the vascular wall in opposing directions from the elongate member to orient the distal opening toward the vascular lumen. Id. at 20 ( emphases added). REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Deaton Makower '542 Makower '280 Flaherty US 6,565,583 Bl US 2003/0236542 Al US 2004/0059280 Al US 6,726,677 Bl REJECTIONS May 20, 2003 Dec. 25, 2003 Mar. 25, 2004 Apr. 27, 2004 (I) Claims 34--41 and 52-71 are rejected under 35 U.S.C. Â§ 112, first paragraph, as failing to comply with the written description requirement. 2 Appeal 2018-002667 Application 13/079, 179 (II) Claims 34--41 and 52---68 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Flaherty, Makower '542, and Deaton. (III) Claims 69--71 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Flaherty, Deaton, Makower '542, and Makower '280. OPINION Rejection (I); Written Description The Examiner finds that the recitation of "an exterior surface of the elongate member [ ] exposed between the proximal and distal ends of the balloon" in independent claim 34 is not supported by the original disclosure. Final Act. 4. The Examiner makes similar findings with respect to independent claims 52 and 62. Id. at 4--5. The Examiner determines that the Specification does not describe this feature, Figures 12A-12D do not support this feature because they may be interpreted as cross-sectional views, and there is no evidence that Figures 12A-12D were intended to depict a side view of the claimed device. 3 Id. at 14--16. The Examiner notes that the Specification uses the term "schematic illustrations" to describe Figures 12A-12D. Id. at 15-16 (citing Spec. ,r 22). Appellants contend that Figures 12A-12D support the claim limitation at issue because a person of ordinary skill in the art would understand that these Figures depict a side view (rather than a cross-sectional view) of the claimed device inasmuch as, in Figure 12D, only a portion of stylet 1230 is shown, not its entire length as would be depicted in a cross-sectional view. Appeal Br. 7-8. Appellants also point to Figures 3-5, 7 A-7D, 9A, and 9B 3 If Figures 12A-12D depict side views of the device, then Figures 12B-12D depict an exposed surface of catheter 1220. 3 Appeal 2018-002667 Application 13/079, 179 as depicting an intravascular device in a side view rather than a cross- sectional view and assert that this depiction is consistent with how Figures 12A-12D depict the device, namely, in a side view rather than a cross- sectional view. Id. at 9-10. In response, the Examiner finds that the Specification provides no indication as to how Figures 12A-12D are to be interpreted, much less that they are to be interpreted as depicting a side view, as asserted by Appellants. Ans. 12-13. Although we appreciate the Examiner's position that the Specification lacks any explanation as to whether Figures 12A-12D depict a side view of the claimed device or a cross-sectional view, in light of the depiction of stylet 1230 in Figure 12D and guide wire 1210 in Figures 12B and 12C, we agree with Appellants that Figures 12A-12D depict the device in side view. 4 In this regard, we understand Figures 12A-12D to provide a view of the device inside a blood vessel similar to the depiction in Figure 7 A, where the device inside the blood vessel is depicted in side view. Given that Figures 12A-12D are side views of the device, we agree with Appellants that these Figures support the requirement in claims 34, 52, and 62 that the elongate member/ catheter shaft be exposed between the proximal and distal ends of the balloon. Accordingly, we do not sustain the rejection of claims 34, 52, and 62 and their associated dependent claims as failing to comply with the written description requirement. 4 Despite the reference to "schematic illustrations" describing Figures 12A- 12D in paragraph 22 of the Specification, these drawings include aspects of a side view, and the exposed nature of the elongate member would be discemable to a person of ordinary skill in the art. 4 Appeal 2018-002667 Application 13/079, 179 Rejection (II); Flaherty, Makower '542, and Deaton The Examiner finds that Flaherty discloses many of the elements required by independent claim 34, including a balloon configured to be inflated to orient a distal opening toward a vascular lumen. Final Act. 5---6. Appellants contend that Flaherty fails to disclose this limitation because "[i]nflating the balloon of Flaherty does not appear to have any effect upon (e.g., does not change) the orientation of the alleged distal opening 144 (see also FIG. 6B vs. FIG. 6C) and in fact, inflating the balloon is meant to provide support and maintain a position of the device of Flaherty." Appeal Br. 15. Appellants assert that any orientation of the opening taught by Flaherty is achieved by rotation of an elongate shaft, not the inflation of a balloon. Id. In response, the Examiner states: As Applicant has not specifically disclosed in the specification what causes the orientation of the distal opening, the examiner has had to make an educated guess based upon the figures. The examiner's best guess was that due to the inner wall 1204 being thinner than the outer wall 1206, a balloon which is inflated will cause the inner wall 1204 to deform a greater amount than the outer wall 1206, such that the distal open will orient toward the lumen 1208. Flaherty possesses a balloon which inflates equally on opposite sides (figs 5A-5 C) such that it is capable of operating as claimed. If this assumption is not how Applicant's invention operates, then the claims do not appear enabled. Ans. 14 (emphases added). Thus, based upon Appellants' Figures, the Examiner determines that a balloon that inflates equally on opposite sides qualifies as a balloon that is configured to orient a distal opening toward a vascular lumen as recited in claim 34. 5 Appeal 2018-002667 Application 13/079, 179 Appellants argue that "a balloon that is radially equally inflated on opposite sides would not necessarily result in orienting a distal opening toward a vascular lumen (i.e., the orienting of a distal opening toward a vascular lumen when a balloon is inflated would not be inherent in view of Flaherty and Makower)." Reply Br. 7. A preponderance of the evidence does not support the Examiner's finding that a balloon that inflates equally on two sides qualifies as one that is configured to perform the "orient" function recited in claim 34. The Examiner's reasoning is based on an assumption that "the inner wall 1204 [is] thinner than the outer wall 1206." Ans. 14. However, even assuming for the purpose of argument that the Examiner's finding regarding the relative thicknesses of walls 1204 and 1206 is correct, the Examiner does not direct our attention to any evidence that inner wall 1204 provides less resistance to deflection than does outer wall 1206. Further, as Appellants point out (Reply Br. 6-7), Flaherty does not disclose performing an "orient" function as recited in claim 34 via inflation of a balloon, and, indeed, discloses merely stabilizing Flaherty's disclosed device via the balloon. See Flaherty, 10: 14--17 ("[I]nflation of the balloon 132 stabilizes the catheter 130, and facilitates operation of the tissue penetrating element 134. That is, the balloon 132 contacts the wall of blood vessel, and fills the lumen therein."). Thus, the Examiner's finding that Flaherty's balloon is configured to perform the "orient" function recited in claim 34 (Final Act. 5) is based on unsupported speculation. The Examiner relies on Makower '542 and Deaton, respectively, to disclose (i) a balloon that is capable of being inflated within a vascular wall and (ii) an elongate member that is exposed between the ends of the balloon. 6 Appeal 2018-002667 Application 13/079, 179 Final Act. 6-7. Thus, the Examiner's use of these references fails to remedy the deficiencies discussed above regarding Flaherty. Accordingly, we do not sustain the rejection of claim 34 and claims 35--41 depending therefrom as unpatentable over Flaherty, Makower '542, and Deaton. Independent claims 52 and 62 recite limitations substantially similar to those discussed above regarding claim 34. See Appeal Br. 20-21, 23 (Claims App.). Accordingly, for the reasons discussed above, we do not sustain the rejection of claims 52, 62, and associated dependent claims 53---61 and 63-71, as unpatentable over Flaherty, Makower '542, and Deaton. Rejection (III) The Examiner's use of Makower '280 does not remedy the deficiency discussed above regarding Rejection (II). See Final Act. 12-13. Accordingly, we do not sustain the rejection of claims 69-71 as unpatentable over Flaherty, Makower '542, Deaton, and Makower '280. DECISION The Examiner's rejection of claims 34--41 and 52-71 is reversed. REVERSED 7