13792411 (P.T.A.B. Dec. 20, 2018)

Ex Parte Johnston et al

Patent Trial and Appeal BoardDec 20, 2018

13792411 (P.T.A.B. Dec. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/792,411 03/11/2013 Thomas M. Johnston 143331 7590 12/25/2018 Medtronic, Inc./RCS Shumaker 60 Middletown A venue Mailstop 54, Legal Dept. North Haven, CT 06473 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. H-KN-02739(1214-103US01) 5884 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 12/25/2018 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): rs. patents. two@medtronic.com covidien@ssiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS M. JOHNSTON and TY F AIRNENY Appeal2017-003163 Application 13/792,411 1 Technology Center 3700 Before CHARLES N. GREENHUT, MICHELLE R. OSINSKI, and NATHAN A. ENGELS, Administrative Patent Judges. ENGELS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. Â§ 134 from a rejection of claims 1, 2, 7-14, 18-21, and 24--26. Claims 5, 6, 17, 22, and 23 are withdrawn, and no other claims are pending. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. 1 Regarding the real party in interest, Appellants identify Medtronic plc as the ultimate parent company of Covidien LP, the assignee of record. Appeal Br. 3. Appeal2017-003163 Application 13/792,411 ILLUSTRATIVE CLAIM Claims 1, 14, and 24 are independent claims. Claims 1 and 24 are reproduced below as illustrative of the claimed subject matter: 1. A system comprising: a catheter including a wall having an inner surface and an outer surface, the inner surface defining a lumen, and the wall defining at least one side opening extending from the outer surface to the inner surface defining the lumen; and a stylet including: an elongate body defining a passage and at least one aperture in fluid communication with the passage; a first blocking dam secured to the elongate body proximal to the at least one aperture; and a second blocking dam secured to the elongate body distal to the at least one aperture, the at least one aperture including a plurality of apertures axially aligned with one another along a longitudinal axis of the elongate body, between the first and second blocking dams, wherein the stylet is movable within the lumen to a position in which the first and second blocking dams are, respectively, proximal and distal to the at least one side opening of the catheter and each of the first and second blocking dams is sealingly engaged with the inner surface of the catheter such that fluid introduced into the lumen, from the passage and through the at least one aperture of the stylet, is directed through the at least one side opening of the catheter. 24. A system comprising: a catheter including a wall having an inner surface and an outer surface, the inner surface defining a lumen, and the wall defining at least one side opening extending from the outer surface to the inner surface defining the lumen; and a stylet including: an elongate body defining a passage and at least one aperture in fluid communication with the passage; 2 Appeal2017-003163 Application 13/792,411 a first blocking dam secured to the elongate body proximal to the at least one aperture; and a second blocking dam secured to the elongate body distal to the at least one aperture, wherein the stylet is movable within the lumen to a position in which the first and second blocking dams are, respectively, proximal and distal to the at least one side opening of the catheter and each of the first and second blocking dams is sealingly engaged with the inner surface of the catheter such that fluid introduced into the lumen, from the passage and through the at least one aperture of the stylet, is directed through the at least one side opening of the catheter, and wherein a distance between an outer surface of the elongate body of the stylet and the inner surface of the wall of the catheter is uniform between the first blocking dam and the second blocking dam. THE REJECTIONS Claims 24 and 25 stand rejected under 35 U.S.C. Â§I02(b) as being anticipated by Hoffman et al. (US 8,814,847 B2; Aug. 26, 2014). Claims 1, 2, 8, 9, 11, 12, 14, 20, 21, and 24--26 stand rejected under 35 U.S.C. Â§ I03(a) as being unpatentable in view of Hoffman and Wang (US 5,425,723; June 20, 1995). Claims 7, 18, and 19 stand rejected under 35 U.S.C. Â§ I03(a) as being unpatentable in view of Hoffman, Wang, and Hiatt (US 2007/0213671 Al; Sept. 13, 2007). Claim 10 stands rejected under 35 U.S.C. Â§ I03(a) as being unpatentable in view of Hoffman, Wang, and Slater et al. (US 2005/010773 8 Al; May 19, 2005). Claim 13 stands rejected under 35 U.S.C. Â§ I03(a) as being unpatentable in view of Hoffman, Wang, and Schwab et al. (US 5,876,376; Mar. 2, 1999). 3 Appeal2017-003163 Application 13/792,411 Claims 24 and 25 stand rejected under 35 U.S.C. Â§ 103(a) as being unpatentable in view of Slater and Hoffman. ANALYSIS The Anticipation Rejection of Claims 24 and 25 Arguing the Examiner erred in finding that Hoffman anticipates independent claim 24, Appellants contend Hoffman does not disclose a catheter and sty let "wherein a distance between an outer surface of the elongate body of the stylet and the inner surface of the wall of the catheter is uniform between the first blocking dam and the second blocking dam," as claimed. Appeal Br. 6. Specifically, Appellants argue the distance between Hoffman's delivery catheter 11 and inner member 16 (cited as the claimed "sty let") is not uniform between Hoffman's first sealing member 21 and second sealing member 22. Id. The Examiner concludes that the disputed claim language can be interpreted in different ways, and, with reference to the version of Appellants' Figure 8 copied below with arrows added by the Examiner, the Examiner states that Appellants' Specification does not disclose a uniform distance between an outer surface of the sty let and the inner wall of the catheter between two blocking dams. Ans. 4--7. 4 Appeal2017-003163 Application 13/792,411 224 206 108 \\ 2!8 l , I \ l I 106 216 L Appellants' Figure 8 (arrows added by the Examiner (Ans. 6)) Appellants' Figure 8 depicts an elongate body 206 of stylet 200 within a lumen 108 of a catheter. As explained in the Specification, "the radial spacing between the elongate body 206 and the inner surface 110 is substantially uniform around the circumference of the pressure zone formed between the elongate body 206 and the inner surface 110 of the lumen." Spec. ,r 62. The stylet includes a series of apertures 216 between the first blocking dam 218 and the second blocking dams 220. Spec. ,r 66. As reflected by the arrows added by the Examiner to Figure 8 as shown above, the Examiner contends Appellants' Specification does not depict a uniform distance between the stylet and the catheter; according to the Examiner, Appellants' Figure 8 shows that the distance is longer where there are apertures 216. Ans. 5-7. Finding ambiguity in the claim language when read in light of Appellants Specification, the Examiner provides a second annotated version of Appellants Figure 8, copied below, explaining the Examiner's interpretation of the relevant distance is the distance between the outer edges of each blocking dam themselves. Ans. 6-8. 5 Appeal2017-003163 Application 13/792,411 : 224 208 108 l 218 1 ' \ ' i ' \ ~ / \ 226 f)24 .. Â·o- l -!J Â· '2?2 \ 220 ' / Â·Â·'""Â·Â· \ I ! f t \ / . i L Appellants' Figure 8 (arrows added by the Examiner (Ans. 7)) Interpreting the disputed limitation to claim the distance depicted by the arrows added by the Examiner within blocking dams 218 and 220 ( as opposed to the distance labeled "L" by Appellants), the Examiner finds Hoffman anticipates claim 24 with its Figure 3, which depicts a uniform distance at the blocking dams, but a tapering, non-uniform stylet between the blocking dams. Ans. 7-9. We agree with Appellants that the Examiner erred. Claim 24 recites a uniform surface between an outer surface of the elongate body, which does not include apertures 216, and the inner surface of the catheter. Appellants' Figure 8 depicts a uniform distance between blocking dams 218 and 220 consistent with the claim language and unaffected by apertures 216-- apertures 216 are not part of the outer surface of the elongate body from which the recited distance can be measured. Accordingly, contrary to the Examiner's interpretation, we agree with Appellants that the recited "between the first blocking dam and the second blocking dam" refers to the distance between the two blocking dams (e.g., between blocking dams 218 and 220 along the distance marked "L" in Appellants' Figure 8) such that the wherein clause requires a uniform distance between the stylet and the 6 Appeal2017-003163 Application 13/792,411 catheter between the blocking dams. Further, we agree with Appellants that Hoffman does not disclose the recited uniform distance between a first blocking dam and a second blocking dam. Accordingly, we do not sustain the Examiner's rejection of independent claim 24, nor the Examiner's rejection of dependent claim 25, which includes the same error. The Obviousness Rejections of Claims 1, 2, 7-14, 18-21, and 24-26 Regarding the rejections of claims 1, 2, 8, 9, 11, 12, 14, 20, 21, and 24--26 based on Hoffman in combination with Wang, Appellants argue that Hoffman and Wang are non-analogous art and that a person of ordinary skill would not have had reason to combine the references as suggested by the Examiner. Appeal Br. 9-15. According to Appellants, Hoffman describes a catheter for delivery of an implantable medical device, and Appellants argue Hoffman is not concerned with delivering therapeutic fluids, as taught by Wang. Appeal Br. 9-12. Because Hoffman is not concerned with delivering therapeutic fluids, Appellants argue the Examiner erred in concluding that a person of ordinary skill would have had reason to combine Hoffman and Wang to provide uniform fluid delivery as suggested by Wang. Appeal Br. 11-14. The Examiner broadly interprets Hoffman's field of invention and determines that it relates to catheters generally, as evidenced by the Patent Office's classification of Hoffman in United States Patent Classification system class 604/529, which is directed to catheters. Ans. 10-11. The Examiner also cites Hoffman's references to hydrating fluid to suggest that the reference teaches providing fluids to the vascular system. Ans. 11 ( citing Hoffman 9: 15-18). 7 Appeal2017-003163 Application 13/792,411 We disagree with the Examiner's findings regarding Hoffman's teachings of fluid delivery, and we agree with Appellants that the Examiner has not adequately supported the proposed combination of references. Hoffman teaches a catheter for delivery of an implantable medical device. Hoffman, Abstract. Hoffman explains that certain implantable medical devices must remain hydrated during the implantation period, and Hoffman states that a hydrating fluid can be contained "within the device-containing region" of the delivery catheter. E.g., Hoffman 2:24--40, 56-57, 3:4--7 ("the implantable medical device is an expandable medical device requiring or benefiting from maintenance of hydration of at least part of the implantable medical device"). Reading Hoffman's disclosures as a whole, however, although Hoffman describes a hydrating fluid that is expelled from the catheter, Hoffman does not teach delivery of therapeutic fluids, and the fluid expelled from Hoffman's catheter is incidental to the purpose of delivering an implantable medical device. Hoffman, 2:56-58 ("The device containing region contains the implantable medical device and a hydrating fluid."); 2:62---65 ("A flushing fluid is delivered to the device-containing region via the delivery lumen, so as to expel at least a portion of the hydrating fluid through the side port."); 3:4--7 ("In one embodiment, the implantable medical device is an expandable medical device requiring or benefiting from maintenance of hydration of at least part of the implantable medical device."); 9:52-10:3 (describing flushing hydrating fluid from the catheter with no mention of therapeutic benefits from the hydrating fluid). Indeed, Hoffman states that the purpose of the hydrating fluid is to maintain the medical device in a hydrated state. Hoffman 6: 13-16 ("The presence of first 8 Appeal2017-003163 Application 13/792,411 and second sealing member 21 and 22 maintains the hydrating fluid within the device-containing region so that the medical device is maintained in a hydrated state."). We find nothing in Hoffman to suggest a concern regarding uniform fluid delivery, as suggested by the Examiner. Because Hoffman is not concerned with uniform delivery of therapeutic fluids, we agree with Appellants that the Examiner erred in concluding that it would have been obvious "to provide the catheter of Hoffman with a plurality of axially aligned openings, as disclosed by Wang, in order to provide sufficiently voluminous, uniform, and diffuse flow rate through the catheter openings." Final Act. 7; see Ans. 12-13. Accordingly, we do not sustain the Examiner's rejection of claims 1, 2, 8, 9, 11, 12, 14, 20, 21, and 24--26 based on the combination of Hoffman and Wang. The same error in the combination of Hoffman and Wang is found in the Examiner's rejections of (i) claims 7, 18, and 19 based on the combined teaches of Hoffman Wang, and Hiatt; (ii) claim 10 based on Hoffman, Wang, and Slater; and (iii) 13 based on Hoffman, Wang, and Schwab, and we do not sustain the Examiner's rejections for the same reasons. The Obviousness Rejection of Claims 24 and 25 Appellants argue the Examiner erred in rejecting claims 24 and 25 as obvious based on the combination of Slater and Hoffman. Appeal Br. 17- 18. According to Appellants, unlike the device-delivery system of Hoffman, Slater discloses an occlusion and drug-delivery system, and a person of ordinary skill would not have had reason to modify Slater's system to add the blocking dams taught by Hoffman. Id. at 18-20. 9 Appeal2017-003163 Application 13/792,411 The Examiner determines that it would have been obvious to modify the sty let of Slater with the first and second blocking dams of Hoffman "in order to prevent leakage between the catheter and the stylet." Final Act. 16. The Examiner finds that Hoffman discloses that blocking dams are necessary to isolate fluid flow and that "Hoffman establishes why Slater's fluid seal 810 would have been inadequate" because Slater only seals the distal end of its stylet and fails to isolate its opening 812. Ans. 17-18. For reasons similar to those explained above, we agree with Appellants that the Examiner has not provided sufficient rationale to support the proposed combination of Slater and Hoffman. Hoffman teaches a delivery system for an implantable medical device and is not concerned with delivery of fluids. Slater, on the other hand, is directed to dispensing therapeutic fluids, and the Examiner has not established that Slater's device would have suffered from a leakage problem or that a person of ordinary skill would have had reason to modify Slater's device to include the first and second blocking dams from Hoffman "in order to prevent leakage between the catheter and the stylet." Final Act. 16. Accordingly, we do not sustain the Examiner's rejection of claims 24 and 25 based on the combination of Slater and Hoffman. DECISION We reverse the Examiner's rejection of claims 1, 2, 7-14, 18-21, and 24--26. REVERSED 10