13272074 (P.T.A.B. Apr. 26, 2016)

Ex Parte Khairkhahan et al

Patent Trial and Appeal BoardApr 26, 2016

13272074 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/272,074 10/12/2011 24473 7590 STEVEN M MITCHELL St. Jude Medical 645 Alman or A venue SUNNYVALE, CA 94085 04/28/2016 FIRST NAMED INVENTOR Alexander Khairkhahan 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. NANO-704.200 2116 EXAMINER FAIRCHILD, MALLIKA DIPAYAN ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 04/28/2016 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): traymer@sjm.com jnewell@sjm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEXANDER KHAIRKHAHAN and ALANKLENK Appeal2014-003293 Application 13/272,074 Technology Center 3700 Before NEALE. ABRAMS, LYNNE H. BROWNE, and GORDON D. KINDER, Administrative Patent Judges. BROWNE, Administrative Patent Judge. STATEMENT OF THE CASE Alexander Khairkhahan and Alan Klenk (Appellants) appeal under 3 5 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 13-18 and 24-- 27.1 We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 Claims 1-12 and 19-22 are withdrawn from consideration. Claim 23 was canceled in an Amendment filed with the Appeal Brief entered by the Examiner in a communication mailed to Appellants on October 23, 2013. Appeal2014-003293 Application 13/272,074 CLAIMED SUBJECT MATTER The claims are directed to delivery catheter systems and methods. Claim 13, reproduced below, is illustrative of the claimed subject matter: 13. A delivery catheter, comprising: a shaft configured to apply rotational torque to a leadless biostimulator; a lumen disposed within the shaft, the lumen sized and configured to receive a tether of the leadless biostimulator; and a tether lock disposed on or in a proximal handle of the delivery catheter and configured to engage the tether to hold the leadless biostimulator in contact with the delivery catheter. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Koblish Dahl Jacobson US 6,542,781 Bl Apr. 1, 2003 US 6,697,677 B2 Feb. 24, 2004 US 2007/0088418 Al Apr. 19, 2007 REJECTIONS2 I. Claims 13-18, 24, 25, and 27 stand rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Jacobson and Koblish. 3 II. Claim 26 stands rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Jacobson, Koblish, and Dahl. 2 The rejection of claim 23 is moot as claim 23 is canceled. See note 1. 3 The statement of the rejection in the Final Action is incomplete as it states that claims "13-" stand rejected. See Final Act. 3. We understand claims 13-18, 23-25, and 27 to stand rejected as unpatentable over Jacobson and Koblish. 2 Appeal2014-003293 Application 13/272,074 DISCUSSION Rejection I Appellants argue claims 13-18, 24, 25, and 27 together. Appeal Br. 5. We select independent claim 13 as the representative claim, and claims 14-- 18, 24, 25, and 27, stand or fall with claim 13. The Examiner finds that the combined teachings of Jacobson and Koblish disclose or suggest the limitations of claim 13. In particular the Examiner finds that Jacobson discloses "a lumen disposed within the shaft, the lumen configured to receive a tether of the leadless biostimulator (e.g. tether sty let 204 runs the length of the catheter shaft in a lumen, also seen in Fig. 4, 420)." Final Act. 3 (emphasis added). Contending that "the Jacobson 'sty let' is not a 'tether of the leadless biostimulator, "'Appellants argue that "[t]he Examiner has misconstrued Jacobson as it relates to claim 13." Appeal Br. 3--4; see also Reply Br. 2 (noting that the Examiner determines that Jacobson's stylet comprises a tether). Responding to this argument, the Examiner notes that "the tether couple of the biostimulator has not been positively recited, and the limitation is directed to the lumen capable of [receiving] a tether." Ans. 3. The Examiner is correct. Claim 13 requires a "lumen sized and configured to receive a tether of the leadless biostimulator," and does not require a tether. Appeal Br. 8 (emphasis added). Jacobson discloses a lumen sized and configured to receive a stylet 204. See, e.g., Jacobson, Fig. 2. The Examiner finds that a lumen sized and configured to receive a stylet is also sized and configured to receive a tether. See Final Act. 3. 3 Appeal2014-003293 Application 13/272,074 Appellants have not provided sufficient evidence or arguments to establish that this finding is in error. See, e.g., In re Schreiber, 128 F.3d 1473, 1477-78 (Fed. Cir. 1997) (claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function); see also In re Swinehart, 439 F.2d 210, 213(CCPA1971) ("[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on."). Contending that "Koblish is not in the same field of endeavor as Appellants' invention and is solving completely different problems than those addressed by Appellants' delivery catheter," Appellants argue that Koblish is "nonanalogous art and should play no part in the rejection of claim 13 underÂ§ 103 (a)." Appeal Br. 4; see also Reply Br. 2. Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In re Bigio, 381F.3d1320, 1325 (Fed. Cir. 2004) (citing In re Deminski, 796 F.2d 436, 442 (Fed.Cir.1986); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)). The Examiner finds that "Koblish is in the field of implantable medical stimulation devices, and is also particularly relevant in that Koblish teaches construction of a probe assembly for delivering the stimulation elements to their desired locations." Ans. 3--4. 4 Appeal2014-003293 Application 13/272,074 Koblish states, "The present invention relates generally to medical devices that support one or more diagnostic or therapeutic elements in contact with body tissue and, more particularly, to medical devices that support one or more diagnostic or therapeutic elements in contact with bodily orifices or the tissue surrounding such orifices." Koblish, 1: 10-15. Koblish describes a catheter 10 with a helically shaped distal member 16. Id. at 6:6, 12, 28-29. However, Koblish does not describe a medical implant. See id. at 1: 1-20: 17. Accordingly, the Examiner's finding that Koblish "is in the field of implantable medical stimulation devices" is in error. Ans. 3. However, this fact does not end our inquiry. The problems with which Appellants are concerned relate to the "features and methods for delivering a leadless cardiac pacemaker to tissue." Spec. i-f 2. Koblish is concerned with delivering diagnostic or therapeutic elements to tissue. See Koblish, 1: 10-15. Both the instant invention and Koblish use catheters with handles to deliver their respective diagnostic or therapeutic devices to tissue. See, e.g., Spec. i-f 43; Koblish, 6:6-11. Both are concerned with locking the delivery mechanism (tether in the instant invention, stylet in Koblish). See, e.g., Spec. i-f 30; Koblish, 9:51-55. Thus, Koblish is pertinent to the problem with which Appellants are concerned and is analogous art. Accordingly, Appellants' argument is unconvincing. In addition, Appellants argue that "the Examiner must provide a motivation for modifying the prior art to achieve the claimed invention." Appeal Br. 5; see also Reply Br. 2. This argument is foreclosed by KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007), in which the Court rejected the rigid requirement of a teaching or suggestion or motivation to combine known elements in order to show obviousness. KSR, 550 U.S. at 415. The 5 Appeal2014-003293 Application 13/272,074 Court noted that an obviousness analysis "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. Furthermore, the Examiner explicitly reasons that it would have been obvious "to modify the system as taught by Jacobson with use a set screw at a proximal portion of a handle since such a modification would provide the predictable results of managing the sty let and selectively preventing movement of the sty let during delivery." Final Act. 3--4. The Examiner "notes the set screw arrangement in the modified Jacobson invention would also engage the tether to hold the leadless biostimulator in contact with the delivery catheter since it would control the length of the sty let and rotation of the stylet." Id. at 4. Appellants do not explain why the Examiner's reasoning lacks rationale underpinnings, and thus, do not apprise us of error. For these reasons, we sustain the Examiner's decision rejecting claim 13, and claims 14--18, 24, 25, and 27, which fall therewith. Rejection II Appellants argue that "Dahl does nothing to remedy the deficiencies of Jacobson and Koblish with respect to the subject matter of claim 13. Thus, claim 26 is patentable over Jacobson, Koblish, and Dahl under Â§ 103(a)." Appeal Br. 5. As we find no deficiencies in Jacobson and Koblish, Appellants' argument is unconvincing as discussed supra. We sustain the Examiner's decision rejecting claim 26. 6 Appeal2014-003293 Application 13/272,074 DECISION The Examiner's rejections of claims 13-18 and 24--27 are AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 7