Ex Parte Stypulkowski

Patent Trial and Appeal BoardNov 14, 2012

11168752 (P.T.A.B. Nov. 14, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PAUL H. STYPULKOWSKI ____________ Appeal 2010-009163 Application 11/168,752 Technology Center 3700 ____________ Before KEN B. BARRETT, BENJAMIN D. M. WOOD, and RICHARD E. RICE, Administrative Patent Judges. RICE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is an appeal under 35 U.S.C. § 134 involving claims to a method of therapeutically treating stuttering via an implantable pump and a catheter. The Examiner has rejected claims 1-8 and 25-33 as obvious. Claims 9-24 have been withdrawn. We have jurisdiction under 35 U.S.C. § 6. We affirm. CLAIMED SUBJECT MATTER Claim 1, reproduced below, is representative of the claimed subject matter: Appeal 2010-009163 Application 11/168,752 2 Claim 1 recites: 1. A method of therapeutically treating stuttering via an implantable pump and a catheter having a proximal end coupled to the pump and a discharge portion for infusing therapeutic dosages of a least one drug, the method comprising: implanting the catheter so that the discharge portion lies adjacent to a predetermined site in the brain; sensing activity of a patient's speech- producing muscles; determining whether the sensed activity is indicative of stuttering; and operating the pump to discharge at least one drug capable of stimulating neurons in to the predetermined site in the brain by delivering at least one drug, in response to the indication of stuttering. REJECTIONS The following Examiner’s rejections are before us for review: 1. Claims 1-3, 5-8, 25-29, and 32-33 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Rise (US 6,227,203 B2, iss. May 8, 2001), Kiziltan ("Stuttering May Be a Type of Action Dystonia," Movement Disorders, Vol. 11, No. 3, pp. 278-282 (1996)), and Smith ("Spectral analyses of activity of laryngeal and orofacial muscles in stutterers," J. Neurology, Neurosurgery and Psychiatry, 56:1303-1311 (1993)). 2. Claim 4 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Rise, Kiziltan, Smith, and Rothenberg (US 4,909,261, iss. Mar. 20, 1990). Appeal 2010-009163 Application 11/168,752 3 3. Claims 30-31 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Rise, Kiziltan, Smith, and Kehoe (US 5,794,203, iss. Aug. 11, 1998). ANALYSIS The rejection of claims 1-3, 5-8, 25-29, and 32-33 With respect to independent claim 1, the Examiner found that Rise teaches a method of therapeutically treating abnormal involuntary movement disorders (“AIMs”), such as the disorder or symptom known as “dystonia.” Ans. 4, 13; Rise, abstract, col. 1, ll. 13-21, col. 2, ll. 37-45, col. 10, l. 35−col. 11, l. 11. Rise discloses implanting a catheter (tube 922A) coupled to an implantable pump (pump 10) to deliver one or more drugs to a portion of the brain and implanting a stimulation electrode (tube 922B) coupled to an implantable signal generator (signal generator 16) for therapeutically stimulating the brain. Rise, col. 2, ll. 37-45, fig. 9; see Ans. 4. The Examiner relied on Kiziltan as teaching that “stuttering is known to be one type of dystonia.” Ans. 13; see also id. at 4 (“Although stuttering is not explicitly taught [by Rise] as one of the [AIMs] disorders, it is a form of dystonia.”). The Examiner reasoned that “as Rise teaches [a] system [that] can be used to treat AIMs, which can include dystonia as one of the symptoms, and stuttering is taught to be a known type of dystonia, by using Rise to treat AIMs, the symptoms of AIMs, including dystonia in the form of stuttering could necessarily be treated.” Ans. 13. The Examiner found that Smith teaches sensing EMG activity of the laryngeal and orofacial muscles in order to detect whether a person is stuttering. Id. at 4-5. The Examiner determined that it would have been obvious to one having ordinary skill in the art at the time the invention was Appeal 2010-009163 Application 11/168,752 4 made to have modified the method of Rise to include placing a sensor on the person's laryngeal and orofacial muscles as taught by Smith in order to detect whether a person is stuttering. Id. at 5. Appellant argues that the Examiner has not provided an adequate rationale for the proposed combination because “the Examiner has provided absolutely no support in any of the cited references for the assertion that stuttering is a symptom of AIMs” (Reply Br. 5) and “the Examiner has failed to show any reason supported by the cited art as to why one skilled in the art would be motivated to attempt to use the Rise treatment for AIMs to treat stuttering” (id. at 6). Appellant further argues that that “the connection drawn by the Examiner between Kiziltan and Rise is tenuous at best.” App. Br. 11. Appellant argues that “Kiziltan postulates that stuttering may be a type of focal action dystonia,” but “does not suggest that stuttering is a symptom of AIMs or that focal action dystonia is a symptom of AIMs.” Reply Br. 6; see App. Br. 9-11. Appellant additionally argues that “Rise only mentions improper muscle tone (‘dystonia’) which is not the same condition as that which results in stuttering described by Kiziltan.” Reply Br 6. Appellant contends that Rise’s “discussion of improper muscle tone in no way suggests or implies stuttering.” Reply Br 5. Appellant also argues that “Smith does not offer any type of stuttering detection mechanism that could be reliably incorporated into a closed-loop embodiment of Rise.” App. Br. 13; Reply Br. 8. In particular, Appellant argues that Smith teaches detection of stuttering “through human judges” who analyze manually-selected portions of audio tape, and that Smith does not disclose “any biomarker or algorithm that could be incorporated into Rise to implement a closed-loop system to reliably detect stuttering.” App. Appeal 2010-009163 Application 11/168,752 5 Br. 13 (citing Smith at 1309, para. bridging cols. 1 and 2; 1310, col. 1, ll. 29- 36); Reply Br. 8, n. 14. Appellant additionally argues that “the apparent failure of Smith to identify any generalized reliable mechanism for detecting stuttering in a patient’s speech-producing muscles, as required by Claim 1, actually even further teaches away from modifying Rise to obtain the claimed invention.” App. Br. 14. Appellant also contends that “attempting to substitute the Smith manual intervention techniques into the Rise closed- loop sensor system would transform that system into an open-loop treatment” and “would render the Rise closed-loop system inoperable for its intended purpose, which Rise describes as providing closed-loop feedback that could be used to automatically determine the level of drug delivery and/or electrical stimulation necessary to alleviate the symptoms of the AIM disorder in an enhanced manner.” Reply Br. 8. The Supreme Court has admonished that rigid adherence to a “teaching, suggestion, motivation” test in assessing obviousness is not consistent with its precedent. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In order to establish a prima facie case that a claim is obvious based on teachings of multiple prior art references, the Examiner must nevertheless articulate some “reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir 2006). “Common sense has long been recognized to inform the analysis of obviousness if explained with sufficient reasoning.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328 (Fed. Cir. 2009). Use of common sense as some apparent reason for combining references “does not require a ‘specific hint or suggestion in a particular reference,’ only a reasoned explanation that avoids conclusory generalizations.” Perfect Web, Appeal 2010-009163 Application 11/168,752 6 587 F.3d at 1329 (quoting DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006)). Appellant has not persuaded us that the combined teachings of Kiziltan and Rise would not have suggested to one of ordinary skill in the art using Rise’s AIMs therapy to treat stuttering and the involuntary movements associated with stuttering. Kiziltan teaches that the similarities between the involuntary movements associated with stuttering and the involuntary movements associated with dystonia suggest that stuttering is a form of “segmental or focal action dystonia.” Kiziltan at 278, 281. Rise teaches a method of therapeutically treating or controlling involuntary movement disorders and their symptoms. Rise, col. 1, ll. 17-25; col. 2, ll. 37-45; col. 11, ll. 8-11. Rise’s broad description of AIMs disorders reasonably encompasses involuntary movements associated with segmental or focal action dystonia as taught by Kiziltan, regardless of whether “dystonia (improper muscle tone)” in Rise excludes action dystonia as Appellant contends. See Rise, col. 1 ll. 17-25 (broadly describing “a variety of movement and muscle control problems, like resting, postural, intention or action tremor, dystonia (improper muscle tone); spasticity (undesirable movements, or muscle co-construction); [and] dyskinesia (poorly executed movements) or involuntary movements like ballismus, choreiform movements and torticollis (inappropriate movements or limb control).” The Examiner thus reasonably concluded as a matter of common sense that together Kiziltan and Rise suggest a method of therapeutically treating stuttering. Ans. 4, 13. See Perfect Web, 587 F.3d at 1329 (quoting KSR, 550 U.S. at 418-21) (“the sources of information for a properly flexible obviousness inquiry [may] include … the ‘interrelated teachings of multiple Appeal 2010-009163 Application 11/168,752 7 patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill”). We determine that the Examiner’s combination of the teachings of Kiziltan and Rise is supported by adequate articulated reasoning with rational underpinning. Further, we do not perceive any error in the Examiner’s determination that it would have been obvious to one of ordinary skill in the art to have modified the method of Rise to include placing a sensor on the person's laryngeal and orofacial muscles as taught by Smith in order to detect whether a person is stuttering. In arguing that Smith fails to disclose any biomarker or algorithm that could be incorporated into Rise to implement a closed-loop system to reliably detect stuttering, Appellant quotes the following Smith statements: Dominant oscillations in the 5-15 Hz band appear to be part of a neuromuscular pattern that characterizes stuttering, but they are not a necessary condition for stuttering. Disfluencies clearly can occur in the absence of excessive oscillations; thus other aberrant patterns of neuromuscular activity also must contribute to the breakdowns in speech production that characterize stuttering. … The present data do not support a strong central hypothesis to account for oscillations across systems and subjects. In some cases, subjects had oscillations at different frequencies in different muscles. In other cases, oscillations could occur at a common frequency, but the oscillations were not correlated. App. Br. 13 (quoting Smith at 1309, cols. 1-2, 1310, col. 1). Appeal 2010-009163 Application 11/168,752 8 Appellant has not adequately explained why Smith’s correlation of stuttering and excessive laryngeal muscle oscillations, in the 5-15 Hz band, could not have been used reliably in Rise’s control system to detect stuttering. Smith suggests the desirability of the modification by teaching that “[d]ominant oscillations in the 5-15 Hz band appear to be part of a neuromuscular pattern that characterizes stuttering,” even while noting that not all stutterers show such oscillations. Smith at 1309. Appellant also has not explained why using Smith’s EMG sensor to detect stuttering in stutterers would have been any less reliable than using Rise’s EMG sensor to detect dystonia in AIMs patients. Nor has Appellant asserted that the proposed modification would have been beyond the capabilities of a person of ordinary skill in the art. The context for the second Smith statement, quoted above, is the text that immediately precedes it and reads as follows: Usually hypotheses about the source of neuromuscular oscillations attempt to distinguish the contribution of central and peripheral mechanisms. A strong central hypothesis to account for neuromuscular oscillations in stuttering would assert that a single source within the CNS generates the oscillations seen in various muscles within and across speech subsystems. Id. This discussion appears under the subheading “Potential Mechanisms Underlying Neuromuscular Oscillations In Stuttering,” and does not detract from Smith’s teaching that “[d]ominant oscillations in the 5-15 Hz band appear to be part of a neuromuscular pattern that characterizes stuttering, but they are not a necessary condition for stuttering.” Smith at 1309; see App. Br. 13. Appellant has not persuaded us that modifying Rise to incorporate Appeal 2010-009163 Application 11/168,752 9 Smith’s stuttering detection teachings would have rendered Rise unfit to implement a closed-loop control system to reliably detect stuttering. We sustain the rejection of claims 1-3, 5-8, 25-29, and 32-33.1 The rejection of claim 4 Claim 4 depends from claim 2, which in turn depends from claim 1. Appellant argues that Rothenberg does not cure the deficiencies in the rejection of claim 1. For the reasons discussed with respect to claim 1 supra, there are no deficiencies to cure and thus we sustain the rejection of claim 4. The rejection of claims 30-31 Claim 30 depends from claim 25, which in turn depends from claim 1. Claim 31 depends from claim 30. Appellant argues that Kehoe does not cure the deficiencies in the rejection of claim 1. For the reasons discussed with respect to claim 1 supra, there are no deficiencies to cure and thus we sustain the rejection of claims 30-31. SUMMARY We affirm the rejection of claims 1-8 and 25-33. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Klh 1 Separate patentability is not argued for dependent claims 2-3, 5-8, 25-29, or 32-33. App. Br. 7-14.