Ex Parte Mahapatra et alDownload PDFPatent Trial and Appeal BoardSep 21, 201812530938 (P.T.A.B. Sep. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/530,938 09/11/2009 144465 7590 09/25/2018 Tanner IP, PLLC 13057 Champlain Drive Manassas, VA 20112 FIRST NAMED INVENTOR Srijoy Mahapatra 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. 503-110 5600 EXAMINER VAHDAT, KHADIJEHA ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 09/25/2018 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): dan@tannerip.com james@tannerip.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SRIJOY MAHAPATRA and GEORGE T. GILLIES 1 Appeal2017-006028 Application 12/530,938 Technology Center 3700 Before TA WEN CHANG, JOHN E. SCHNEIDER, and RY ANH. FLAX, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an ablation catheter, which have been rejected as obvious and as indefinite. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. STATEMENT OF THE CASE "Cardiac arrhythmias are frequently treated with electrophysiology procedures and ablation." Spec. 1. Most cardiac ablations are done endocardially although the target area is epicardial. Spec. 1-2. Endocardial 1 Appellants identify the Real Party in Interest as University of Virginia Patent Foundation. Appeal Br. 3. Appeal2017-006028 Application 12/530,938 ablation to treat tissue on the outside of the heart poses several risks including strokes. Spec. 2. While epicardial ablation techniques are known, adoption of these techniques has been limited by the lack of catheters and sheaths. Id. The Specification describes an epicardial ablation catheter. Claims 1, 3-8, 13-28, and 31-99 are on appeal. Claim 1 is illustrative and reads as follows: 1. An ablation catheter system for ablation of epicardial tissue of a heart of a subject, said ablation catheter system compnsmg: an ablation catheter, said ablation catheter comprising a distal end, a proximal end, and a longitudinal wall there between; a plurality of electrodes in communication with said ablation catheter; a catheter steering mechanism configured to orient said ablation catheter about the heart; a catheter control device, wherein said catheter control device is configured to manipulate said catheter steering mechanism; one or more distal irrigation apertures at said distal end of said ablation catheter, said distal irrigation apertures in communication with one or more irrigation lumens extending longitudinally toward said proximal end of said ablation catheter; one or more distal suction apertures at said distal end of the ablation catheter, said distal suction apertures in communication with one or more suction lumens extending longitudinally toward said proximal end of said ablation catheter; a sheath, said sheath comprising a distal end, a proximal end, and a longitudinal wall there between, and wherein said sheath is adapted for receiving said ablation catheter therein; a sheath steering mechanism configured to orient said sheath about the heart; and 2 Appeal2017-006028 Application 12/530,938 a sheath control device, wherein said sheath control device is configured to manipulate said sheath steering mechanism; wherein, said plurality of electrodes comprise at least one of: an anode and a cathode, a plurality of electrodes arranged in a circumferential array around said distal end of said ablation catheter, and a plurality of electrodes longitudinally separated on said distal end of said ablation catheter, and wherein, at least one of said one or more distal irrigation apertures or said one or more distal suction apertures comprises a plurality of apertures arranged in a circumferential array around the distal end of the ablation catheter. The claims stand rejected as follows: Claims 1, 5-8, 31---68 have been rejected under 35 U.S.C. § 112, second paragraph as indefinite. Claims 58 and 59 have been rejected under 35 U.S.C. § 112, fourth paragraph as being in improper dependent form. Claims 1, 5-8, 13, 14, 21-24, 31, 32, 43-2, and 65---68 have been rejected under 35 U.S.C. § I03(a) as unpatentable over Gaiser2 in view of Jahns. 3 Claims 15-20 have been rejected under 35 U.S.C. § I03(a) as unpatentable over Gaiser in view of Jahns in further view of Quaichon. 4 2 Gaiser et al., US 6,200,315 Bl, issued Mar. 13, 2001 ("Gaiser"). 3 Jahns et al., US 2002/0002372 Al, published Jan 3. 2002 ("Jahns"). 4 Quaichon et al., US 5,395,348, issued Mar. 7, 1995 ("Quaichon"). 3 Appeal2017-006028 Application 12/530,938 Claims 25-28 have been rejected under 35 U.S.C. § I03(a) as unpatentable over Gaiser in view of Jahns in further view of Chin. 5 Claims 33--42, 63, and 64 have been rejected under 35 U.S.C. § I03(a) as unpatentable over Gaiser in view of Jahns in further view of Stewart. 6 THE REJECTIONS UNDER SECTION 112 As a preliminary matter, we must address the issue raised by Appellants as to whether the rejections under section 112 are properly before us. As Appellants point out, in the Advisory action the Examiner stated that, "with respect to the arguments directed to the 112 rejections, the arguments as found to be persuasive and the 112 rejections have been withdrawn." Advisory Action mailed May 12, 2016 at 3. Appellants, relying on this representation, did not address the 112 rejections in their brief. See Appeal Br. 5. In the Answer, the Examiner revised this statement indicating that the withdrawal only applied to the rejection relating to a plurality of electrodes and not the remaining 112 rejections. Ans. 2-3. Appellants contend that the Examiner's reinstatement of the 112 rejections is improper in that it constitutes a new rejection that requires the Director's approval. Reply Br. 2-3. Appellants point out that the Examiner did not seek the Director's approval therefore the 112 rejections are improper and should not be addressed in this appeal. Id. 5 Chin et al., US 2006/0271032 Al, published Nov. 30, 2006 ("Chin"). 6 Stewart et al., US 2005/0273006 Al, published Dec. 8, 2005 ("Stewart"). 4 Appeal2017-006028 Application 12/530,938 While we appreciate the issue raised by Appellants, whether a new rejection was improperly included in the Answer is not an issue that we have jurisdiction to consider. Instead, such matters are properly addressed by a petition to the Director under 37 C.F.R. § 2.146. On the record before us, Appellants do not appear to have filed such a petition. We consider the issue to have been waived by Appellants. For purposes of judicial economy, we treat the reinstated 112 rejections to be new grounds of rejection under 37 C.F.R. § 41.49 (a)(2). When the Examiner issues a new rejection in the Examiner's Answer, Appellants have two options: reopen prosecution or maintain the appeal and substantively address the new grounds of rejection. 37 C.F.R. §§ 41.39 (b )(1) and (2). In the present appeal, Appellants have maintained the appeal and have presented substantive arguments relating to the 112 rejections. Reply Br. 3--4. Therefore, we have jurisdiction to address the rejections under 35 U.S.C. § 112. Indefiniteness Issue The issue with respect to this rejection is whether the Examiner has properly found the claims to be indefinite, The Examiner finds the term "wherein, at least one of said one or more distal irrigation apertures or said one or more distal suction apertures comprises a plurality of apertures arranged in a circumferential array around the distal end of the ablation catheter" to be indefinite in that it is unclear how many apertures are required to meet the limitation and whether it is the 5 Appeal2017-006028 Application 12/530,938 suction of irrigation apertures which must be arranged in a circumferential pattern. Ans. 3--4. Appellants contend that the term is not indefinite. Reply Br. 3. Appellants argue that the term means that when one irrigation aperture is present, there is a plurality of suction apertures present and vice versa. Id. Appellants argue that the term also allows for the possibility that there are a plurality of both types of apertures. Id. We find that Appellants have the better argument. The plain language of the claim term requires that when there is a single irrigation aperture, there must be a plurality of suction apertures and when there in only one suction aperture, there must be a plurality of irrigation apertures. Thus, the claim term is not indefinite. Improper Dependent Claims The Examiner has rejected claims 58 and 59 as improper dependent claims in that they do not further limit claim 1. The Examiner finds that, because claim 1 calls for a plurality of apertures that can be suction or irrigation apertures, it is unclear how the limitations of claims 58 and 59 further limit claim 1. Ans. 4--5. Appellants contend that the claims are proper in that they further limit claim 1. Reply Br. 4. Appellants contend that claim 1 does not require either a plurality of suction apertures or a plurality of irrigation apertures, since it encompasses embodiments comprising either a single irrigation aperture with a plurality of suction apertures or a single suction aperture with a plurality of irrigation apertures. Id. Appellants argue that claim 58 limits claim 1 to the situation where a plurality of irrigation apertures are 6 Appeal2017-006028 Application 12/530,938 present and claim 59 limits claim 1 to a situation where a plurality of suction apertures are present. Id. Again, we find that Appellants have the better argument. Claim 1 addresses an endoscope where there can be either a plurality of irrigation apertures or a plurality of suction apertures. Appeal Br. 13 (Claims App'x). Claim 5 8 further limits claim 1 to an endoscope that has a plurality of irrigation apertures and claim 59 further limits claim 1 to an endoscope that has a plurality of suction apertures. Accordingly, claims 58 and 59 further limit the scope of claim 1 and are proper dependent claims. OBVIOUSNESS Issue Each of the rejections under 35 U.S.C. § 103(a) are based on the teachings of Gaiser combined with Jahns. Appellants have only presented substantive arguments with respect to this combination of references. Appeal Br. 5-12. With respect to the remaining rejections, Appellants contend that the additional references do not address the deficiencies of the combination of Gaiser and Jahns. Id. at 12. Therefore we shall treat all the rejections under 35 U.S.C. § 103(a) together. The issue with respect to these rejection is whether a preponderance of the evidence supports the Examiner's conclusion that the subject matter of the claims would have been obvious over Gaiser combined with Jahns. The Examiner finds that Gaiser teaches an epicardial ablation catheter which includes all of the elements of claim 1 with the exception of one of more irrigation apertures and one or more suction apertures at the distal end of the catheter in communication with one or more irrigation or suction 7 Appeal2017-006028 Application 12/530,938 lmnens. Final Act. 8-11. The Examiner finds that Jahns teaches an epicardial ablation catheter having one or more irrigation apertures and one or more suction apertures at the distal end of the catheter. Id. at 11. The Examiner concludes: Id. It would have been obvious to one having ordinary skill in the art at the time of the invention to make use of a plurality of irrigation openings and a plurality of suction apertures at the distal end of the device arranged in a circumferential array around the distal end of the ablation catheter (as Jahns shows the plurality of apertures in Fig. 2 being positioned in a circumferential arrangement around the distal end if the catheter) in order to not only hold the device against the tissue firmly during the cardiac ablation procedure, but also to irrigate the ablation site to cool the area, create deeper lesions or prevent the electrodes from sticking to the tissue which would cause char or bum as Jahns teaches in [0051]. Appellants contend that Jahns does not teach or suggest a plurality of irrigation or suction apertures arranged in a circumferential array around the distal end of the ablation catheter. Appeal Br. 8. Appellants argue that Jahns teaches the use of suction ports arranged linearly. Id. Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). 8 Appeal2017-006028 Application 12/530,938 "It is axiomatic that, in proceedings before the PTO, claims in an application are to be given their broadest reasonable interpretation consistent with the specification and that claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) (citation omitted). "Proper claim construction ... demands interpretation of the entire claim in context, not a single element in isolation." ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003) (citing Hockerson- Halberstadt v. Converse, Inc., 183 F.3d at 1369 (Fed. Cir. 1999)). Analysis We have considered the parties' arguments and find that Appellants have the better argument. While Jahns discloses the use of a plurality of suction apertures at the distal end of the ablation catheter, as shown in Figure 2 of Jahns, reproduced below, the apertures, 54, are arranged linearly, not circumferentially. FIG. 2 '.JG .·· ... :· .. : .... l.: ... ,· .. ,./,.,,,, ., !,.:-.:: ... ::O'.,;,,,.,,cs,,--~,~,.,::-,-·i·.,i,~~s~:~."1~;ri#A,:it:~tlJtltt:~1~.J. , ,,,.~fl\titt~w·rtttriiM:t:-Jht. . ~ 2&£&l*YB>' 7 : :;,: / / J.Z ,i ,$) ; ! Figure 2 of Jahns shows a suction assisted ablation device. 9 Appeal2017-006028 Application 12/530,938 The Examiner argues that the broadest reasonable interpretation of the term circuniferential means lying around the edge or periphery of an object. Ans. 7-8. The Examiner contend that the apertures disclosed in Jahns lie in a circumferential array around the distal end of the catheter. Ans. 8. We are not persuaded. We agree with Appellants that the Examiner's interpretation of the term circumferential is not supported by the Specification and the wording of the claim 1 as a whole. Appeal Br. 9-10, Reply Br. 4. As Appellants point out, the term at issue is circuniferential array around the distal end of the catheter, not simple the term circumferential. Appeal Br. 9-10. This is not inconsistent with the Examiner's definition of circumferential, which is lying around the edge. Id. at 10. In addition, this interpretation is supported by the drawings ad Specification of the present application. As shown in Figures 5C and 5D of the instant application, reproduced below, the apertures are arranged about the tip of the catheter. 10 Appeal2017-006028 Application 12/530,938 ·l~ :, .. FIG, 5C Figures 5C and 5D of the Specification show apertures arranged about the tip of a catheter. The Specification's drawings reinforce a claim construction that the apertures must be arranged around the tip of the catheter. As shown above in Figure 2 of Jahns, the apertures do not lie around the tip of the catheter, but lie along one side of the catheter. The Examiner has not persuasively shown why one skilled in the art would modify the linear arrangement on one side of the catheter of Jahns to form a circumferential arrangement around the distal end of the catheter as required by claim 1. We conclude that a preponderance of the evidence does not support the Examiner's conclusion that the subject matter of the claims would have been obvious over Gaiser combined with Jahns. 11 Appeal2017-006028 Application 12/530,938 SUMMARY We reverse the rejections under 35 U.S.C. § 112. We reverse the rejections under 35 U.S.C. § 103(a). REVERSED 12 Copy with citationCopy as parenthetical citation