Ex Parte Whitehurst et al

Patent Trials and Appeals BoardMay 23, 2013

12339639 - (D) (P.T.A.B. May. 23, 2013)

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. 12/339,639 12/19/2008 Todd K. Whitehurst 06-01612-02 7589 71422 7590 05/23/2013 VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION 2040 MAIN STREET, Suite 710 IRVINE, CA 92614 EXAMINER GETZOW, SCOTT M ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 05/23/2013 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte TODD K. WHITEHURST, RAFAEL CARBUNARU, KRISTEN N. JAAX, ANDREW DIGIORE, BRETT SCHLEICHER, and GREG BALDWIN __________ Appeal 2012-002810 Application 12/339,639 Technology Center 3700 __________ Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating a patient to avoid the negative side effect of seizures. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2012-002810 Application 12/339,639 2 Statement of the Case Background “While brain stimulation has proven to be quite effective in treating many different medical conditions, a number of negative side effects are often associated with the treatment. For example, brain stimulation may actually cause generalized seizures, which can be detrimental to a patient” (Spec. 2 ¶ 0003). The Specification teaches “[s]ystems for treating seizures caused by brain stimulation include a stimulator configured to generate at least one stimulus . . . to treat a medical condition” (Spec 3 ¶ 0005). The Claims Claims 11 and 31-38 are on appeal. Claim 11 is representative and reads as follows: 11. A method of treating a patient having a medical condition, comprising: applying at least one stimulus to a stimulation site within the brain of the patient in accordance with one or more stimulation parameters, thereby treating the medical condition; detecting an event indicative of one of an impending seizure caused by the at least one stimulus before the seizure actually occurs and an actual seizure caused by the at least one stimulus; and applying an asynchronous electrical stimulation pattern to a location of the brain to prevent the actual seizure from occurring or to treat the actual seizure. The issue The Examiner rejected claims 11 and 31-38 under 35 U.S.C. § 103(a) as obvious over Gliner1 and DiLorenzo2 (Ans. 4-5). 1 Gliner, B., US 2003/0074032 A1, published Apr. 17, 2003. 2 DiLorenzo, D., US 2005/0021104 A1, published Jan. 27, 2005. Appeal 2012-002810 Application 12/339,639 3 The Examiner finds “Gliner teaches applying a stimulus to a patient’s brain to treat a condition, and detecting a seizure caused by the stimulus” (Ans. 4). The Examiner finds that “Gliner teaches that the collateral activity (seizure caused by a stimulus) can be treated by applying electrical or magnetic stimuli to disrupt or desynchronize the collateral activity” (Ans. 4). The Examiner finds that “DiLorenzo teaches applying stimulation to a patient's brain in order to treat a seizure” (Ans. 4). The Examiner finds that DiLorenzo teaches “that the stimulation that can be used to treat the seizure disorder is asynchronous stimulation” (Ans. 4). The Examiner finds that to “use asynchronous stimulation to treat the seizure caused by a stimulus is considered to be obvious in that no unpredictable results would occur from using such asynchronous stimulation, and that DiLorenzo teaches that asynchronous stimulation is known to the skilled artisan to use to treat seizure disorder” (Ans. 4-5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the Gliner and DiLorenzo render claim 1 obvious? Findings of Fact 1. Gliner teaches “systems and methods for detecting and responding to collateral neural activity that may arise in association with or as a result of stimulation applied to a region of the cortex or other area of the brain” (Gliner 1 ¶ 0002). 2. Gliner teaches that “[c]ollateral neural activity may comprise seizure activity” (Gliner 2 ¶ 0020). Appeal 2012-002810 Application 12/339,639 4 3. Figure 4 of Gliner is reproduced below: “FIG. 4 is a flowchart of a neural stimulation process 400 responsive to collateral neural activity according to an embodiment of the invention” (Gliner 5 ¶ 0044). 4. Gliner teaches that “the process 400 begins with a stimulation operation 402 by initiating or continuing a neural stimulation procedure in which stimulation signals are delivered to one or more target neural populations within a patient 190 in accordance with a given set of stimulation signal parameters” (Gliner 5 ¶ 0044). 5. Gliner teaches that after “initiating the stimulation operation 402, the process 400 also includes a detection query 404 that determines whether collateral neural activity or evidence of such activity exists. The Appeal 2012-002810 Application 12/339,639 5 detection query 404 may be performed in a simultaneous or sequential manner relative to the stimulation operation 402” (Gliner 5 ¶ 0044). 6. Gliner teaches that if “the detection query 404 the process 400 determines that collateral neural activity exists, the process 400 halts the neural stimulation procedure in a termination operation 410, and generates and/or issues a notification signal indicative of such activity in a notification procedure 412” (Gliner 5 ¶ 0044). 7. Gliner teaches that “[t]reatment signals may alternatively or additionally be directed toward affecting or modulating a patient sensation such as pain; or eliminating or ameliorating the effects of neurodegenerative disorders, for example, involuntary movements and/or other symptoms associated with Parkinson’s disease” (Gliner 2-3 ¶ 0022). 8. Gliner teaches that the prior art teaches “an implantable device capable of detecting a neurological event, such as seizure activity, and generating a responsive electrical signal intended to terminate the detected event” (Gliner 2 ¶ 0011). 9. DiLorenzo teaches: 38. A system as in claim 37, wherein said neuromodulator array delivers a multiplicity of signals that are at least one of asynchronous, uncorrelated, non-identical, and unrelated by a multiplicative factor, unrelated by an additive factor, unrelated by any other function. 39. A system as in claim 37, wherein said neuromodulator array delivers a multiplicity of signals that are at least one of synchronous, correlated, identical, and related by a multiplicative factor, related by an additive factor, related by other function. (DiLorenzo 34, claims 38-39). Appeal 2012-002810 Application 12/339,639 6 10. DiLorenzo teaches a neural modulation system for use in treating disease which provides stimulus intensity that may be varied is disclosed. The stimulation may be at least one of activating, inhibitory, and a combination of activating and inhibitory and the disease is at least one of neurologic and psychiatric. For example, the neurologic disease may include Parkinson’s disease, Huntington’s disease, Parkinsonism, rigidity, hemiballism, choreoathetosis, dystonia, akinesia, bradykinesia, hyperkinesia, other movement disorder, epilepsy, or the seizure disorder. (DiLorenzo 2 ¶ 0023). Principles of Law In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the Supreme Court emphasized “an expansive and flexible approach” to the obviousness question, the Court also reaffirmed the importance of determining “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418. Thus, even post-KSR, “[o]bviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.” Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Instead, “[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Appeal 2012-002810 Application 12/339,639 7 Analysis Gliner reasonably suggests treating a patient with a medical condition (FF 1) by applying an electrical stimulus to a stimulation site in the patient’s brain (FF 4) and then detecting collateral neural activity including an impending seizure (FF 2, 3, 5), followed by acting to prevent the seizure by either stopping the procedure (FF 6) or terminating the seizure by applying an electrical stimulation (FF 8). The Examiner relies upon DiLorenzo to teach the use of asynchronous electrical stimulation to prevent or treat seizure (see Ans. 4-5). Appellants contend that “[t]here is no specific teaching here that asynchronous stimulation can be applied to the brain to treat a seizure disorder” (App. Br. 5). We conclude that Appellants have the better position. The only citation to asynchronous signals identified by the Examiner appears in claim 38 of DiLorenzo, while claim 39 suggests synchronous signals (FF 9). Even where DiLorenzo mentions seizure disorder in paragraph 23, DiLorenzo also lists a dozen other disorders and provides no connection between treatment with asynchronous signals and seizure disorder (FF 10). Nor has the Examiner provided evidence that such a connection would have been otherwise known by a person of ordinary skill in the art. Thus, the Examiner has provided no evidence of record that treatment with asynchronous signals would have any effect on a seizure, whether occurring as a separate disorder or during a treatment using electrical stimulation. In the absence of such evidence, there would have been no reason to incorporate these elements of DiLorenzo into the method of Gliner. Appeal 2012-002810 Application 12/339,639 8 Conclusion of Law The evidence of record does not support the Examiner’s conclusion that the Gliner and DiLorenzo render claim 1 obvious. SUMMARY In summary, we reverse the rejection of claims 11 and 31-38 under 35 U.S.C. § 103(a) as obvious over Gliner and DiLorenzo. REVERSED lp