Ex Parte Crow et alDownload PDFPatent Trial and Appeal BoardNov 30, 201713299932 (P.T.A.B. Nov. 30, 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. 13/299,932 11/18/2011 Loren M. Crow 8150BSC0151 5021 121974 7590 12/04/2017 K AC VINSKY DAISAK BLUNI PLLC America's Cup Building 50 Doaks Lane Marblehead, MA 01945 EXAMINER WEHRHEIM, LINDSEY GAIL ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 12/04/2017 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): bbonneville @ kdbfirm .com docketing @ kdbfirm. com ndeane @ kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LOREN M. CROW, MARK L. JENSON, and SCOTT SMITH Appeal 2017-000808 Application 13/299,9321 Technology Center 3700 Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and KRISTI L. R. SAWERT Administrative Patent Judges. SAWERT, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims 1, 2, 7, 11, and 13—15. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Boston Scientific Scimed, Inc. as the real party in interest. Appeal Br. 3. Appeal 2017-000808 Application 13/299,932 STATEMENT OF THE CASE Claims 1, 2, 7, 11, and 13—15 are on appeal. Claims 1, 2, 7, 11, and 13—15 stand rejected as unpatentable under 35 U.S.C. § 103(a) for obviousness over Deem2 in view of Demarais.3 Final Act. 3. Claim 1 is representative of the subject matter on appeal. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 1 recites: 1. An apparatus, comprising: a catheter comprising a flexible shaft having a proximal end, a distal end, and a length sufficient to access a patient’s renal artery relative to a percutaneous access location; an electrode array provided at the distal end of the shaft and dimensioned for deployment within the renal artery, the electrode array comprising a plurality of spaced-apart electrodes configured to be positioned at a plurality of renal artery sites at or near a wall of the renal artery; and an external system configured to couple to the catheter and deliver stimulation energy selectively to the plurality of electrodes for eliciting a physiologic response from the patient but insufficient to ablate renal nerves, the external system further configured to deliver high-frequency electrical energy to electrodes at target renal artery sites that elicit the physiologic response for ablating renal nerves proximate the target sites, wherein the physiologic response comprises one or more of pain, tingling, and heat. Appeal Br. 14. 2 Mark Deem et al., WO 2006/041881 A2 (Apr. 20, 2006) (“Deem”). 3 Denise Demarais and Nicolas Zadno, U.S. Patent Publication No. 2007/0083239 Al (Apr. 12, 2007) (“Demarais”). 2 Appeal 2017-000808 Application 13/299,932 DISCUSSION Background The claimed invention is directed to an apparatus for detecting renal nerves and ablating those nerves. Spec. 1. The Specification states that the apparatus stimulates perivascular renal nerves to locate and target renal nerve sites to be ablated for treatment of hypertension. Spec. 3. Certain embodiments of the apparatus “utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target, and whether the target nerves have been ablated.” Id. An embodiment of the claimed apparatus is illustrated in Figure 5, reproduced here: Fig. 5 shows an embodiment for detecting and ablating renal nerves. Spec. 3. 3 Appeal 2017-000808 Application 13/299,932 As shown in Figure 5, the apparatus for detecting and ablating renal nerves includes a catheter 200 with a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient’s renal artery 12. Spec. 16. At the distal end of the shaft, a treatment apparatus 202 is centered within the renal artery by an expandable support structure 210. Id. The Specification states that the support structure may take the form of an expandable wire or mesh structure, or a balloon structure. Id. As claimed, the treatment apparatus is an electrode array comprising a plurality of spaced-apart electrodes. Appeal Br. 14 (claim 1); see also Spec. 20. The apparatus also comprises an external system 220 that may include a pad electrode 275 that can be placed on a portion of the patient’s skin proximate the renal arteries. Id. at 16—17. The Specification explains that the pad electrode 275 serves as an external electrode for the stimulation and ablation electrodes. Id. at 17. As claimed, the external system delivers stimulation energy selectively to the electrode array to elicit a physiologic response from the patient. Appeal Br. 14 (claim 1); see also Spec. 17. The stimulation is sufficient to elicit a physiologic response comprising one or more of pain, tingling, and heat, but insufficient to ablate the renal nerves. Id. The Specification explains that once the renal artery sites that elicit a physiologic response are targeted, the external system then may deliver high-frequency electrical energy to ablate the renal nerves proximate those target sites. Spec. 1. The Examiner rejected representative claim 1 for obviousness over Deem in view of Demarais. Final Act. 3—6. The Examiner relied on Deem to teach the elements of claim 1, including monitoring for a physiological response to renal stimulation. Id. at 3^4 (citing Deem || 29, 43, 44, 49, 87, 4 Appeal 2017-000808 Application 13/299,932 138). The Examiner acknowledged that Deem “does not explicitly state that the physiologic response comprises one or more of pain, tingling, and heat” as recited in claim 1. Id. at 3. For this teaching, the Examiner relied on Demarais, which the Examiner found discloses that it was known in the art that pulsed electric field renal neuromodulation can elicit pain “such that the stimulation energy does not ablate renal nerves/target tissue, then deliver modified energy to the same site that elicits the response.” Id. at 4 (citing Demarais H 14, 109). The Examiner reasoned: It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the features of Demarais in the invention of Deem, since such a modification would provide the predictable results of a means to effectively provide stimulation to the renal artery which affects target tissue but reduces/prevents damage to other cells in the stimulation environment as known in the art. Id. Analysis On appeal, the Board “reviews the obviousness rejection for error based upon the issues identified by appellant, and in light of the arguments and evidence produced thereon.” Ex parte Frye, 94 USPQ2d 1072, 1075—76 (BPAI 2010) (Precedential). The issues Appellants raise on appeal are (1) whether Deem teaches an apparatus configured to deliver stimulation energy selectively to a plurality of electrodes for eliciting a physiologic response from a patient, and (2) whether the Examiner properly relied on Demarais to show that it was known in the art that pulsed electric field renal neuromodulation can elicit a physiologic response such as pain. Appeal Br. 7—11. Upon review of the record, we find no reversible error in the 5 Appeal 2017-000808 Application 13/299,932 Examiner’s findings and conclusions, and thus affirm the Examiner’s rejection of claims 1, 2, 7, 11, and 13—15. (1) Appellants first argue that “Deem does not teach an apparatus configured to deliver stimulation energy selectively to a plurality of electrodes for eliciting a physiologic response from the patient, wherein the physiologic response comprises one or more of pain, tingling and heat, much less to further deliver high-frequency electrical energy to electrodes at target renal artery sites that elicit such a physiologic response for ablating renal nerves proximate the target sites.” Appeal Br. 7. Appellants appear to argue that Deem instead “describes a system that stimulates nerves such that renal blood flow is affected.” Id. (citing Deem 1138). We find that the preponderance of the evidence supports the Examiner’s finding that Deem discloses an apparatus configured to deliver stimulation energy to electrodes at target renal artery sites that elicit a physiologic response, and to deliver high-frequency electrical energy to electrodes at target renal artery sites to ablate the renal nerves proximate those sites. Ans. 7. Specifically, Deem teaches an apparatus for renal neuromodulation using pulsed electric fields. Deem (Abstract). In one embodiment, Deem’s apparatus “includes one or more electrodes that are configured to physically contact a target region of a renal vasculature for delivery of a pulsed electric field.” Deem 143; see also id. 1 87 (describing an electrode array within the renal artery for delivering pulsed electric charges). Deem explicitly teaches that “varying the pulsed electric field parameters will produce different effects on the nervous activity.” Id. 142. For example, some electrical pulses “may completely block or denervate the 6 Appeal 2017-000808 Application 13/299,932 target neural structures,” whereas other “neuromodulation produces a less- than-complete change in the level of renal nervous activity.” Id. Thus, like the claimed invention, Deem teaches an apparatus utilizing different levels of electrical energy delivered via electrodes to renal nerves—where at least one level of electrical energy results in ablation by, for example, irreversible electroporation, electrofusion, and/or inducement of apoptosis (i.e., cell death) in the nerve cells. Id. 1 87. We note that the Specification describes, and claim 1 recites, electrical energy as the ablation agent used to ablate the target renal artery sites. Spec. 17; Appeal Br. 14 (claim 1). And, as the Examiner points out, the Specification does not refer to “high-frequency” electrical energy in a way that would exclude the electrical pulses described in Deem. Ans. 7. Deem also explicitly teaches that the apparatus may “comprise detectors or other elements that facilitate identification of locations for treatment and/or that measure or confirm the success of treatment.” Id. 149. Specifically, Deem teaches that the apparatus “can be configured to also deliver stimulation waveforms and monitor physiological parameters known to respond to stimulation of the renal nerves.” Id. (emphases added). “Based on the results of the monitored parameters,” Deem continues, “the system can determine the location of renal nerves and/or whether denervation has occurred.” Id. (emphasis added). Thus, like the claimed invention, Deem teaches a stimulation pulse that results in a physiological response used to determine the location of renal nerves, where the electrical pulse does not ablate, but rather stimulates a physiological response. As the Examiner acknowledged, Deem does not explicitly teach that the physiological response comprises one or more of pain, tingling and heat. 7 Appeal 2017-000808 Application 13/299,932 Final Act. 3. But the Examiner relies on Demarais for teaching this feature. Id. Appellants’ arguments for reversal based on Deem’s failure to specifically teach pain, tingling, and heat, therefore, are unpersuasive. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”). (2) Next, Appellants challenge the Examiner’s reliance on Demarais to show that it was known in the art that pulsed electric field renal neuromodulation can elicit a physiologic response such as pain. Appeal Br. 7—12. At base, Appellants’ argument appears to be that Demarais teaches a device designed and utilized to reduce pain and/or muscle spasms, not one that is designed to deliver stimulation energy for eliciting a physiological response of pain, tingling, and/or heat. Id. at 7—8. This argument, however, mischaracterizes the Examiner’s reliance on Demarais. The Examiner did not rely on Demarais for teaching an apparatus for delivering stimulation energy; thus, whether Demarais’s apparatus decreases, rather than increases, pain is irrelevant. See, e.g., In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012) (“A reference must be considered for everything that it teaches, not simply the described invention . . . .”). The Examiner instead relied on Demarais for the teaching that a physiological response to electrical stimulation may be pain, tingling, and/or heat. Final Act. 3. We agree with the Examiner that Demarais teaches that subjecting the neural tissue of a patient to an electrical pulse causes physiological responses such as pain and/or muscle spasm. Demarais 1109. 8 Appeal 2017-000808 Application 13/299,932 Appellants fail to provide persuasive evidence or sound scientific reasoning rebutting the Examiner’s finding that a skilled artisan would recognize that electrical stimulus causes pain, as taught by Demarais. Appellants first criticize the Examiner’s characterization of the claim language “for eliciting a physiologic response” as an intended use. Appeal Br. 9. In this case, however, the Examiner found—and we agree—that Deem teaches a stimulation pulse that results in a physiological response used to determine the location of renal nerves. Final Act. 3^4; Deem 149. Thus, the Examiner’s characterization of the claim language is, at most, harmless. Next, Appellants appear to argue that the Examiner relied on an improper inherency theory because the electrical signals in Demarais do not necessarily cause pain in a patient. Appeal Br. 10 (citing Demarais 1109). And Appellants argue that Demarais does not teach or suggest the apparatus as claimed. Id. at 11. We disagree that the Examiner relied on inherency in rejecting the claims over Deem in view of Demarais, or that the Examiner misapprehended the teachings of Demarais. As explained above, the Examiner properly relied on Deem to teach the elements of claim 1, including an apparatus that delivers a stimulation pulse that results in a physiological response used to determine the location of renal nerves. Final Act. 3^4; Deem 149. Deem fails to explicitly state that those physiological responses include pain, tingling, and heat. Final Act. 3. Demarais, however, teaches that physiological responses to an electrical signal in a patient include pain and muscle spasms. Demarais 1109. Again, in our view, Appellants have failed to provide persuasive arguments or evidence that the ordinarily skilled artisan would not recognize that the physiological 9 Appeal 2017-000808 Application 13/299,932 responses to which Deem refers include pain and muscle spasms, as evidenced by Demarais. Thus, we are not persuaded that the Examiner made any reversible error in maintaining the rejection of the claims. SUMMARY We affirm the rejection of claims 1, 2, 7, 11, and 13—15 under 35 U.S.C. § 103. AFFIRMED 10 Copy with citationCopy as parenthetical citation