Ex Parte Christian et alDownload PDFPatent Trial and Appeal BoardJun 12, 201712597840 (P.T.A.B. Jun. 12, 2017) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/597,840 04/13/2010 Steven C. Christian 0B-053703US 3145 55962 7590 Wiley Rein LLP Patent Administration 1776 K Street, NW Washington, DC 20006 06/14/2017 EXAMINER CARDINAL, ERIN M ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 06/14/2017 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): ptodocket @ wileyrein. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN C. CHRISTIAN, HARRY A. PURYEAR, JAMES V. KAUPHUSMAN, and WILLIAM M. SUTTON Appeal 2016-000035 Application 12/597,8401 Technology Center 3700 Before STEFAN STAICOVICI, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Steven C. Christian et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 17—21, 24—27, 30-33, and 37.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 According to Appellants, St. Jude Medical, Atrial Fibrillation Division, Inc. is the real party in interest. Br. 2 (filed Jan. 20, 2015). 2 Claims 1—6, 22, 23, 28, and 29 are canceled and claims 34—36 are withdrawn. Appellants’ Amendment 2-4 (filed July 2, 2014); Br. 4. Appeal 2016-000035 Application 12/597,840 SUMMARY OF DECISION We AFFIRM. INVENTION Appellants’ invention relates “to positioning and retaining a reference electrode of a localization system employed in navigating a medical device through a patient.” Spec., para. 2. Claims 17, 21, and 25 are independent. Claim 17 is illustrative of the claimed invention and reads as follows: 17. A catheter for anchoring an electrode in a lumen, the catheter comprising: an elongate catheter body configured for introduction over a guidewire and including a central axis and a flexible anchor segment, the flexible anchor segment configured to be movable between a deployed configuration, wherein the flexible anchor segment is deviated from the central axis of the catheter body into a uniform corkscrew shape to engage a tissue surface of the lumen such that relative movement between the catheter body and the lumen is inhibited without completely occluding the lumen, and an undeployed configuration, wherein the flexible anchor segment is generally collinear with the central axis of the catheter body to introduce the catheter into the lumen; and an ablation electrode on the catheter body within the flexible anchor segment, wherein the flexible anchor segment is biased into the deployed configuration. 2 Appeal 2016-000035 Application 12/597,840 REJECTIONS The following rejections are before us for review: (I) The Examiner rejected claims 17—20, 25—27, and 32 under 35 U.S.C. § 102(b) as anticipated by Scheiner et al. (US 2003/0195603 Al, pub. Oct. 16, 2003) (“Scheiner”). (II) The Examiner rejected claims 17—21, 24—26, 31, and 37 under 35 U.S.C. § 102(b) as anticipated by Deem et al. (US 2005/0288730 Al, pub. Dec. 29, 2005) (“Deem”). (III) The Examiner rejected claims 21, 24, 30, 31, 33, and 37 under 35 U.S.C. § 103(a) as unpatentable over Scheiner and Deem. (IV) The Examiner rejected claims 27, 30, and 32 under 35 U.S.C. § 103(a) as unpatentable over Deem. ANALYSIS The Anticipation Rejection Based Upon Scheiner The Examiner finds that Scheiner discloses all of the limitations of independent claims 17 and 25 including ablation electrodes, because Schemer’s sensing and pacing electrodes “are capable of being used for [both] mapping and ablation.” Final Act. 2—3 (citing Scheiner, paras. 51—55, 61, 69 and Fig. 1A). Appellants argue that the Examiner “does not offer any evidentiary support” that Schemer’s electrodes are capable of being used for ablation. Br. 9. According to Appellants, ablation and non-ablation electrodes are not interchangeable because “there are structural differences, both in the electrode itself and in the surrounding device, between a pacing and/or 3 Appeal 2016-000035 Application 12/597,840 sensing electrode as disclosed in Schemer and an ablation electrode as claimed.” Id. (citing the Declaration of Jeff Schweitzer submitted on July 2, 2014 (“Schweitzer Declaration”)). The Examiner responds that even though the Scheiner electrode is for sensing or pacing, it “is also inherently capable of being used for delivering ablation energy, as evidenced by Deem.” Ans. 2 (emphasis added). According to the Examiner, because Deem teaches that an electrode is equally capable of modulating, blocking, and ablating, Deem evidences “that the Scheiner electrode is inherently capable of being used for ablating.” Ans. 4 (citing Deem, paras. 40-42) (emphasis added). The Examiner thus, takes the position that as the electrodes of Scheiner are capable of providing a stimulating current, they are also “inherently capable of providing current for ablation.” Id (emphasis added). “It is well settled that a prior art reference may anticipate when the claim limitations not expressly found in that reference are nonetheless inherent in it. Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002) (citations and internal quotation marks omitted). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578, 581 (Fed. Cir. 1991)). In this case, the Examiner’s rejection relies on Deem for the proposition that Schemer’s electrodes are inherently capable of ablation. See Ans. 4 (citing Deem, paras. 40-42). Although the Examiner correctly points out that the electrodes of Scheiner 4 Appeal 2016-000035 Application 12/597,840 can provide a stimulating current, this in no way demonstrates that Sacheiner’s electrodes are capable of providing a current for ablation, as the Examiner contends. Just because the electrodes of Scheiner are sensing/pacing electrodes, it does not necessarily mean that they can also ablate tissue. Even though we appreciate Deem’s electrodes could be used so that structures could be “modulated, blocked or ablated,” Deem’s conductive coil or slotted tube is not the pacing electrode disclosed by Scheiner, and the Examiner does not proffer any evidence to show that Deem’s electrode is the same as the electrode described by Scheiner. See Deem, para. 85; Scheiner, paras. 57, 69 and Figs. 4C, 6D. For example, we note that the pacing system of Scheiner uses a battery powered pulse generator that is implanted in the patient, whereas the pulsed electric field generator 100 of Deem is located external to the patient. Compare Scheiner, para. 4 with Deem, para. 85, Fig. 4. Hence, just because Deem’s electrodes are configured to perform modulation or ablation does not mean that the electrodes of Scheiner are necessarily capable of ablation, as the Examiner contends. The Examiner’s finding that Schemer’s electrode is necessarily capable of being used as an ablation electrode is mere speculation based on an unfounded assumption that the electrode of the Scheiner would necessarily provide an ablation current and hence, function as an ablation electrode. Therefore, for the foregoing reasons, we do not sustain the rejection of claims 17—20, 25—27, and 32 as anticipated by Scheiner. 5 Appeal 2016-000035 Application 12/597,840 The Anticipation Rejection Based Upon Deem Claims 17, 19—21, 24^26, 31, and 37 The Examiner finds that Deem discloses each of the limitations of independent claims 17, 21, and 25. Final Act. 3 (citing Deem, paras. 38, 40, 41, and 87; Figs. 4, 5). Appellants argue that the anchor segment of Deem is not configured for “inhibiting relative movement between the catheter and the vessel,” because the Deem catheter is “brought into contact with an interior wall of the artery (Deem at | [0087]), which is not the same as inhibiting relative movement.” Br. 9. The Examiner responds that the anchor of Deem inhibits relative motion, because Deem discloses “that the device is ‘stabilized within the vessel’ before energy delivery [] by pressing the catheter in contact with the lumen.” Ans. 5 (citing Deem, paras. 40 and 87). We do not find Appellants’ arguments to be persuasive, because as the Examiner correctly finds, Deem discloses that the catheter “is stabilized within the vessel (e.g., braced against the vessel wall).” Deem, para. 40. Appellants do not explain adequately why a catheter that is “stabilized” and “braced” within the vessel would not inhibit movement relative to the vessel, as well. Accordingly, Appellants do not apprise us of error in the Examiner’s findings. We thus, sustain the rejection of claims 17, 19—21, 24—26, 31, and 37 as anticipated by Deem. 6 Appeal 2016-000035 Application 12/597,840 Claim 18 Appellants assert that Deem does not disclose “a guidewire configured to cause the flexible anchor segment to assume the undeployed configuration when the elongate catheter body is introduced thereover,” as recited in claim 18, because “Deem merely discloses a catheter that can be advanced over a guidewire.” Br. 9-10 (citing Deem, para. 38). The Examiner responds that Deem discloses that “guidewire delivery is used instead of or in conjunction with sheath delivery ... to achieve the deployed configuration . . . and the delivery mechanism (the guidewire and/or sheath) holds the device in the undeployed configuration for delivery.” Ans. 5 (citing Deem, paras. 38, 43, 87, and 88). We agree with the Examiner that Deem discloses that a guidewire is used to achieve the deployed configuration and holds the device in the undeployed configuration. Specifically, Deem discloses that the catheter may be positioned “in a low profile configuration within sheath 150” and then be expanded via a pull wire to contact the interior of a vessel wall. Deem, para. 87. Appellants do not explain adequately why a guidewire that causes the catheter to be in a low profile configuration before being deployed is not a guidewire configured as required by claim 18. Thus, Appellants’ arguments do not apprise us of Examiner error. Accordingly, for the foregoing reasons, we also sustain the rejection of claim 18 as anticipated by Deem. 7 Appeal 2016-000035 Application 12/597,840 The Obviousness Rejection Based Upon Scheiner and Deem Claims 21, 24, 30, 31, and 33 Claim 21 recites, in relevant part, “conducting an ablation procedure using the electrode on the catheter as an ablation electrode.” Br. 13 (Claims App.). The Examiner finds that although Scheiner fails to disclose an ablation step, nonetheless Deem discloses an anchored helix catheter including electrodes that provide both stimulation to modulate or block activity and to ablate tissue. Final Act. 4 (citing Scheiner, para. 51; Deem, paras, 40, 41, Fig. 4). The Examiner concludes that it would have been obvious for a person of ordinary skill in the art “to use the Scheiner device [with the electrodes of Deem] for ablation in addition to the disclosed pacing, as predictable results would ensue.” Id. Appellants reiterate that Scheiner does not use ablation electrodes, and that the structural differences discussed in the Schweitzer Declaration, “would defeat any motivation to modify the device of Scheiner as suggested by the Examiner to utilize ablating electrodes as disclosed in Deem.” Br. 10. The Examiner responds that because Deem discloses that electrodes of a device can be used for pacing (neuromodulation) and ablation, “Deem provide(s) the necessary motivation to use the device [of Scheiner] for ablation procedures, including any necessary device modifications (such as larger wire alleged to be required, or a connection to a source of ablation energy).” Ans. 6 (citing Deem, paras. 40-42). We do not find Appellants’ arguments to be persuasive, because although the electrodes of Scheiner are not inherently ablation electrodes, nor inherently capable of conducting an ablation procedure, for the reasons 8 Appeal 2016-000035 Application 12/597,840 discussed, supra, Appellants do not explain adequately why the electrodes of Scheiner could not be modified, according to the disclosure of Deem, to conduct an ablation procedure in addition to the pacing procedure. We appreciate that there are structural differences in the electrodes of Scheiner and Deem, but the Examiner’s modification of Schemer’s electrodes, according to Deem, takes these differences into account. See Ans. 6. Thus, we agree with the Examiner that based on the disclosure of Deem, a person of ordinary skill in the art would know what size electrode and what amount of energy to use to conduct an ablation procedure, using an electrode that is configured to conduct ablation. See Deem, paras. 40 and 41. In conclusion, for the foregoing reasons, Appellants do not apprise us of error in the Examiner’s conclusion of obviousness. Accordingly, we sustain the rejection of claims 21, 24, 30, 31, and 33 as unpatentable over Scheiner and Deem. Claim 3 7 Claim 37 recites, in relevant part, “wherein the ablation electrode is electrically coupled to a wire configured to transmit ablative energy therethrough.” Br. 15 (Claims App.). Appellants argue that because the electrodes of Scheiner are not ablation electrodes, and due to the structural differences between the electrodes of Scheiner and Deem, “one skilled in the art would not have modified the device of Scheiner to couple the electrodes to wire configured to transmit ablative energy.” Br. 11. As discussed, supra, the Examiner’s modification of Schemer’s electrodes, according to Deem, takes the structural differences into account, 9 Appeal 2016-000035 Application 12/597,840 including the size of the wire and “a connection to a source of ablation energy.” Ans. 6. Furthermore, because the electrode of Deem is configured to perform both modulation (pacing) and ablation, the Examiner has a solid basis for concluding that a modification to the Scheiner electrode and wire would predictably work in the same manner. See Final Act. 4. As such, Appellants’ arguments that the device of Scheiner would not have been modified based on the teachings of Deem to couple the electrodes to a wire configured to transmit ablative energy are unpersuasive. Accordingly, for the foregoing reasons, we likewise sustain the rejection of claim 37 as unpatentable over Scheiner and Deem. The Obviousness Rejection Based Upon Deem Appellants do not present separate arguments for the patentability of claims 27, 30, and 32 other than those presented for the rejection of claims 17, 21, and 25 in Rejection II. Br. 11. Accordingly, for the reasons discussed supra, we do not find Appellants’ arguments persuasive. Thus, for the same reasons, we sustain the rejection of claims 27, 30, and 32, as unpatentable over Deem. SUMMARY The Examiner’s decision to reject under 35 U.S.C. § 102(b) claims 17—20, 25—27, and 32 as anticipated by Scheiner is reversed. The Examiner’s decision to reject under 35 U.S.C. § 102(b) claims 17—21, 24—26, 31, and 37 as anticipated by Deem is affirmed. The Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 21, 24, 30, 31, 33, and 37 as unpatentable over Scheiner and Deem is affirmed. 10 Appeal 2016-000035 Application 12/597,840 The Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 27, 30, and 32 as unpatentable over Deem is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 11 Copy with citationCopy as parenthetical citation