Ex Parte Galdonik et al

Patent Trial and Appeal BoardMay 3, 2018

13117452 (P.T.A.B. May. 3, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/117,452 05/27/2011 Jason A. Galdonik 62274 7590 05/04/2018 CHRISTENSEN, FONDER, DARDI & HERBERT PLLC 33 South Sixth Street Suite 3950 Minneapolis, MN 55402 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. 5101.01US02 7636 EXAMINER WEISBERG, AMY REGINA ART UNIT PAPER NUMBER 3731 MAILDATE DELIVERY MODE 05/04/2018 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 JASON A. GALDONIK, EDWARD ANDERSON, KA VITHA GANESAN, GREG BOLDENOW, JOHN KIRCHGESSNER, and GRAZYNA WLODARSKI Appeal2017-004458 Application 13/117,452 1 Technology Center 3700 Before DONALD E. ADAMS, ERIC B. GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. Â§ 134(a) involves claims 21--40 (App. Br. 3). Examiner entered rejections under 35 U.S.C. Â§ 102(b) and 35 U.S.C. Â§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b). We REVERSE. 1 Regarding the real party in interest, Appellants state that "[t]he present application is assigned to Medtronic, Inc.," and "Mivi Neuroscience, Inc. controls prosecution of the instant application" (App. Br. 3). Appeal2017-004458 Application 13/117,452 STATEMENT OF THE CASE Appellants' disclosure "relates to medical devices, such as fiber-based vascular devices, for less invasive medical procedures, such as embolic protection and/ or embolectomy procedures" (Spec. 1: 9-10). Claim 21 is representative and reproduced below: 21. A method of using an aspiration catheter in a thrombectomy procedure to treat an acute stroke condition, wherein the aspiration catheter comprises: a proximal portion, a connection port connected to the proximal portion, a distal segment wherein the distal segment comprises a single lumen, and a tube section connected between the distal segment and the proximal portion, wherein the distal segment consists of polymer forming a tubular element, metal wire reinforcement embedded in the polymer tubular element and extending around the tubular element and optionally one or more radiopaque marker bands, and has a constant outer diameter with a value that is from about 25 percent to about 95 percent of the average outer diameter of the tube section and comprises a distal opening at the distal end of the catheter, and wherein the catheter comprises a continuous lumen extending from the proximal portion through the tube section and the distal segment to the distal opening that provides fluid communication between the proximal portion and the distal opening, and the portion of the continuous lumen inside the distal segment has a smaller diameter relative to the diameter of the portion of the continuous lumen inside the tube section, the method comprising, tracking the aspiration catheter along a guide structure to place the distal segment of the catheter into a small blood vessel with the distal opening of the catheter close to thrombus deposits within the vessel, and applying suction through the proximal portion to effect aspiration at the distal opening of the catheter through the distal segment having an outer diameter with a value that is 2 Appeal2017-004458 Application 13/117,452 from about 2 5 percent to about 9 5 percent of the average outer diameter of the tube section to aspirate the thrombus deposits from the vessel, wherein the small blood vessel is an artery of the brain, such that aspiration of the thrombus deposit treat the acute stroke condition. (App. Br. 28 (emphasis added).) The claims stand rejected as follows: Claims 21, 23, 26, 27, 30-33, 35-37, and 40 stand rejected under 35 U.S.C. Â§ 102(b) as anticipated by von Hoffmann. 2 Claims 22 and 29 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Boldenow. 3 Claims 25 and 28 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Engelson. 4 Claims 24, 34, 38, and 39 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Ha. 5 Claim Interpretation: Appellants' claim 21, the only independent claim before this Panel for review, is reproduced above. Appellants' claim 21 begins by providing a description of a specific aspiration catheter for use in Appellants' claimed method. Specifically, the aspiration catheter comprises, inter alia, a proximal portion, a distal 2 von Hoffmann, US 7,309,334 B2, issued Dec. 18, 2007. 3 Boldenow et al., US 8,021,351 B2, issued Sept. 20, 2011. 4 Engelson et al., US 6,030,369, issued Feb. 29, 2000. 5 Ha et al., US 6,159,195, issued Dec. 12, 2000. 3 Appeal2017-004458 Application 13/117,452 segment, and a tube section connected between the distal segment and the proximal portion (see App. Br. 28). Appellants' claim 21 further defines the aspiration catheter's distal segment as having a constant outer diameter with a value that is from about 25 percent to about 95 percent of the average outer diameter of the tube section of the aspiration catheter (see id.). The method of Appellants' claim 21 then uses the aspiration catheter defined in the preceding clauses of the claim, i.e., an aspiration catheter that, inter alia, has a distal segment that has a constant outer diameter with a value that is from about 25 percent to about 95 percent of the average outer diameter of the tube section, to effect aspiration at the distal opening of the catheter through the distal segment by applying suction to the proximal portion of the aspiration catheter (see id.; see also App. Br. 14). Therefore, we are not persuaded by Examiner's assertions that: Appellants' claim 21 does not define the diameter of the distal segment during aspiration, Appellants' claim 21 does not define the outer diameter of the distal segment of the aspiration catheter during aspiration, or Appellants' Specification fails to provide written descriptive support for a suction diameter of the distal segment (see Final Act. 6 4; see also Ans. 6-8; cf App. Br. 14--16 and 17-18). To be complete, we recognize Examiner's assertion that Appellants' Specification does not provide written descriptive "support for a constant diameter distal segment during aspiration," but find no rejection before this Panel or citation of a disclosure in Appellants' Specification that supports Examiner's assertion (see Ans. 7 (emphasis removed)). Thus, Examiner's unsupported assertion is not persuasive. 6 Office Action mailed June 24, 2016. 4 Appeal2017-004458 Application 13/117,452 Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner's finding that von Hoffmann teaches Appellants' claimed invention? FACTUAL FINDINGS (FF) FF 1. von Hoffmann discloses a method for removing thromboembolic material from a carotid or cerebral artery ... compris[ing] the steps of[, inter alia,] providing a catheter having a proximal end, a distal end, an expandable distal section having a distal port, an aspiration lumen communicating with the port, and an axially movable support. ( von Hoffmann 3: 4--9.) FF 2. von Hoffmann's Figure 1 is reproduced below: FIG. I von Hoffmann's "FIG. 1 is a side elevational schematic view of an intracranial aspiration catheter in accordance with [ von Hoffmann' s] invention, with a distal segment [34] in a reduced [cross-sectional] profile configuration" (von Hoffmann 4: 28-31 (emphasis omitted); see also id. at 5: 42 ("adjustable diameter distal section 34") (emphasis omitted)). 5 Appeal2017-004458 Application 13/117,452 FF 3. von Hoffmann' s Figure 2 is reproduced below: f ;>frt / J(_.,, ...,, von Hoffmann's "FIG. 2 is a side elevational view as in FIG. 1, with the distal segment [34] in an enlarged cross-sectional configuration" ( von Hoffmann 4: 32-33) (emphasis omitted). FF 4. von Hoffmann discloses that Transluminal navigation [of its catheter] is accomplished with the distal section of the catheter in the first, reduced cross sectional configuration. This enables navigation of tortuous vasculature which a larger cross section may not be able to traverse .... [T]he cross section of the distal segment is enlarged after the catheter has been positioned ... [t]his allows a larger inside diameter aspiration lumen than would otherwise have been navigable to the treatment site. (von Hoffmann 12: 53-63.) ANALYSIS Examiner incorrectly interprets Appellants' claimed invention as comprising, inter alia, an aspiration catheter that does not comprise a "distal segment [that] has a constant diameter during aspiration" (Ans. 7 (emphasis removed); cf App. Br. 14--16 and 17-18). Based on this incorrect interpretation of Appellants' claimed invention Examiner finds that von Hoffmann, which discloses an aspiration catheter comprising a distal segment with a variable diameter, anticipates Appellants' claimed invention (see Ans. 7; see generally Final Act. 4; cf FF 1--4). We are not persuaded. 6 Appeal2017-004458 Application 13/117,452 As discussed above, Examiner failed to establish that the distal segment of the aspiration catheter set forth in the method of Appellants' claim 21 has a variable diameter such that it would read on von Hoffmann's method (see App. Br. 14--16 and 17-18). CONCLUSION The preponderance of evidence on this record fails to support Examiner's finding that von Hoffmann teaches Appellants' claimed invention. The rejection of claims 21, 23, 26, 2, 30-33, 35-37, and 40 under 35 U.S.C. Â§ 102(b) as being anticipated by von Hoffmann is reversed. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS We recognize Examiner's obviousness rejections and reliance on von Hoffmann in combination with Boldenow, Engelson, or Ha (see Final Act. 7-10). Examiner, however, failed to establish that any of Boldenow, Engelson, or Ha make up for the deficiency in von Hoffmann discussed above (see App. Br. 19 ("Boldenow does not make up for [this] deficienc[y ]"); id. at 25 ("Engelson does not make up for any deficiencies of von Hoffmann" and "Ha does not make up for [this] deficienc[y]")). Therefore, we reverse the obviousness rejections on this record. CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. 7 Appeal2017-004458 Application 13/117,452 The rejection of claims 22 and 29 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Boldenow is reversed. The rejection of claims 25 and 28 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Engelson is reversed. The rejection of claims 24, 34, 38, and 39 under 35 U.S.C. Â§ 103(a) as unpatentable over the combination of von Hoffmann and Ha is reversed. REVERSED 8