Ex Parte Miesel et alDownload PDFPatent Trial and Appeal BoardNov 7, 201311691423 (P.T.A.B. Nov. 7, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KEITH A. MIESEL, KENNETH T. HERUTH, and GREGORY F. MOLNAR1 __________ Appeal 2011-012508 Application 11/691,423 Technology Center 3700 __________ Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method, system, and computer-readable storage medium. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the real party in interest as Medtronic, Inc. (App. Br. 3.) Appeal 2011-012508 Application 11/691,423 2 STATEMENT OF THE CASE Claims 1-19, 21-24, and 31-33 are on appeal (App. Br. 3).2 Claim 1 is illustrative and reads as follows: 1. A method comprising: delivering to a patient, from an implantable medical device, at least one of a movement disorder therapy, Parkinson’s disease therapy, epilepsy therapy, tremor therapy, or deep brain stimulation; monitoring gait of the patient based on a signal generated by an implantable sensor that varies as a function of patient activity; and detecting a gait freeze event based on the signal. Claims 1-19, 21-24, and 31-33 stand rejected under 35 U.S.C. § 103(a) as obvious over Nieuwboer et al. (WO 2005/020866 A1, Mar. 10, 2005) in view of Baru Fassio et al. (US 2005/0010265 A1, Jan. 13, 2005) (Ans. 5). The Examiner relies on Nieuwboer for disclosing a method and system comprising delivering a therapy from a medical device to a patient to treat a movement disorder . . . ; monitoring gait of the patient based on a signal generated by a sensor that varies as a function of patient activity . . . ; and detecting a gait freeze event based on the signal with a processor. (Id.) The Examiner acknowledges that “Nieuwboer fails to disclose that the movement disorder therapy is delivered from an implantable medical device or the sensor is implantable” (id.). The Examiner relies on Baru Fassio for teaching “a fully implantable nerve signal sensing and stimulation device that delivers to a patient a movement disorder therapy from an implantable medical device and 2 Claims 25-30 are also pending but have been withdrawn from consideration (App. Br. 3). Appeal 2011-012508 Application 11/691,423 3 monitors a physiological signal from the patient via an implantable sensor” (id.). The Examiner finds that Baru Fassio “teaches that an implantable system is desirable in order to overcome difficulties with electrode placement or movement, pain and discomfort associated with external skin electrodes and frequent malfunctions associated with mechanical switches and external cables” (id.). The Examiner concludes: [I]t would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Nieuwboer such that the movement disorder therapy and monitoring gait of the patient are carried out by a fully implantable device, as taught by Baru Fassio, in order to ensure appropriate electrode placement, limit patient pain and discomfort, and eliminate problems associated with external cable malfunctions. (Id.) FINDINGS OF FACT 1. Nieuwboer discloses: A device and method for improving the walk of people suffering from movement disorders are described. These disorders include freezing gait, start hesitation, festination and some difficulties with getting up from a chair or out of bed and are typically seen in Parkinson’s disease suffers. The device includes a pulsed signal producing means (12) for producing pulsed signals and a frequency controlling means (16) for altering the frequency of the signals produced. The device also includes more than one output means (18) for transferring the signal to at least one sensory device (20). The method includes providing a series of regular pulsed sensory signals which act as a series of cues, to a person suffering from a movement disorder, to move in response to the cues. (Nieuwboer, Abstract.) Appeal 2011-012508 Application 11/691,423 4 2. Nieuwboer also discloses: By providing a device from which may be selected more than one pulsed signal, the advantage is provided that since different users respond better to one sensory stimulation, i.e. auditory, visual or tactile signals, a single unit can be provided which allows the user to experiment and find which stimulation works most effectively for them. Alternatively, it may be the case that a user finds that under certain conditions one form of stimulation is more effective than another, or that one form of stimulation may be unsuitable. For example, it is clear that in a noisy environment an audible signal may be inappropriate. Furthermore, some users may find the use of two simultaneous forms of stimulation provides the most effective assistance in overcoming movement disorders. (Id. at 3.) 3. In addition, Nieuwboer discloses that the “device may further comprise activity monitoring means for monitoring the movement of the person using the device” and “recording means for recording a signal from said activity monitoring means and/or the frequency of said pulsed signal and/or the or each sensory device used” (id. at 4-5). 4. Nieuwboer discloses that “[b]y the use of ambulatory monitoring and by recording data such as pulse frequency and output means selected, it is possible to analyse these data and determine what frequency and output devices are most effective for each user” (id. at 5). 5. Nieuwboer also discloses that the tactile signal may be provided by a vibrating device, the audio signal may be provided by an ear piece, and the visual signal may be provided by a light emitting diode (id. at 6). 6. In particular, Nieuwboer Figures 1 and 2 depict “a device 10 for improving the walk of a person suffering from movement disorders hav[ing] Appeal 2011-012508 Application 11/691,423 5 a pulsed signal producing means 12 which produces a pulsed signal,” “a frequency controlling means which is operated using buttons 16a and 16b,” “a number of outputs, 18a, 18b and 18c, from which it is possible to transfer the signal . . . to one or more sensory devices 20a, 20b and 20c,” a switch 22 for controlling which sensory device is to be used, and a switch 28 for turning the device on and off (id. at 7-8). 7. In addition, Nieuwboer discloses that the “device may also include a motion sensor . . . which is able to detect the movement of the person using the device. The data provided by the motion sensor . . . may be transferred through data output 32 using a cable, such as that shown at 34, to a computer for analysis.” (Id. at 8.) 8. Nieuwboer also discloses that “the signal producing means 12 may be in the form of a wrist-worn control device with the operating buttons locating thereon. . . . The output devices could be connected to the control device by wires but could alternatively be connected via wireless connection.” (Id. at 9.) 9. Baru Fassio discloses: Currently available, the FES [functional electrical stimulation] systems for treating foot drop have been either totally external to the body or partially implanted with certain components implanted and other components external to the body. The totally external stimulation systems typically consist of stimulation electrodes that are placed on the skin over the area below the knee where the common peroneal nerve courses quite superficially, as well as a battery power source, a sensor . . . and the stimulation control circuitry. Problems with totally external stimulation systems have included . . . difficulties with electrode placement, variable results because of electrode movement or changes to skin conductance, [and] pain or Appeal 2011-012508 Application 11/691,423 6 discomfort caused by the skin stimulation. . . . Frequent malfunctions and breakdowns of mechanical switches and external cables are also common. (Baru Fassio, ¶ [0007].) PRINCIPLES OF LAW A claim “composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The relevant question is “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. If a proposed modification would render the prior art being modified “inoperable for its intended purpose,” then there is no suggestion to make the proposed modification. In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984). “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citation omitted). ANALYSIS Nieuwboer discloses a “device and method for improving the walk of people suffering from movement disorders . . . includ[ing] freezing gait” (Finding of Fact (FF) 1). Nieuwboer’s “method includes providing a series of regular pulsed sensory signals which act as a series of cues, to a person suffering from a movement disorder, to move in response to the cues” (id.). In addition, Nieuwboer discloses that its “device may further comprise Appeal 2011-012508 Application 11/691,423 7 activity monitoring means for monitoring the movement of the person using the device” (FF 3; see also FF 7). However, it is undisputed that Nieuwboer does not disclose that its device is implantable (Ans. 5). In addition, we agree with Appellants that the Examiner has not adequately explained why one of ordinary skill in the art would have modified Nieuwboer’s device to make it implantable. The Examiner concludes that it would have been obvious “to modify the method of Nieuwboer such that the movement disorder therapy . . . [is] carried out by a fully implantable device, as taught by Baru Fassio, in order to ensure appropriate electrode placement, limit patient pain and discomfort, and eliminate problems associated with external cable malfunctions” (id.). We are not persuaded. First, with regard to ensuring appropriate electrode placement, we agree with Appellants that this rationale for modification of Nieuwboer is inadequate (App. Br. 6-7). As noted by Appellants, “the device of Nieuwboer does not include electrodes for [providing electrical] stimulation” (id. at 6).3 Even if we interpret the term electrode to encompass a vibratory electrode, we agree with Appellants that the Examiner has not pointed to any teaching in Nieuwboer of a vibratory electrode (Reply Br. 8). Instead, Nieuwboer discloses that the tactile signal may be provided by a 3 As noted by Appellants (App. Br. 8), Nieuwboer discloses that “devices which have been used in an attempt to assist persons overcoming a freezing gait include the use of electric stimulating pulses applied to the leg muscles thereby stimulating the person to take a step forward” (Nieuwboer 2). However, it is undisputed that Nieuwboer’s device does not include electrodes for providing electrical stimulation (Ans. 8). Appeal 2011-012508 Application 11/691,423 8 vibrating device (FF 5). In addition, the Examiner has not adequately explained why the concerns associated with the placement of electrical stimulation electrodes, as disclosed in Baru Fassio (FF 9), would have been applicable to a vibrating device intended to provide a tactile signal. Moreover, even if it would have been obvious to implant Nieuwboer’s vibrating device, which the Examiner has not shown,4 this would not explain why it would have been obvious to use “a fully implantable device,” as alleged by the Examiner (Ans. 5). We also agree with Appellants that the rationale regarding limiting patient pain and discomfort is inadequate (App. Br. 6). Baru Fassio discloses that “[p]roblems with totally external stimulation systems have included . . . pain or discomfort caused by the skin stimulation” (FF 9). However, given that Nieuwboer’s device does not include electrodes for providing electrical stimulation, we conclude that this rationale is not applicable to Nieuwboer’s device. The Examiner also argues that the “motivation to combine would be application to the motion sensory electrodes disclosed by Nieuwboer, as it would be desirable to ensure appropriate placement of the sensor at all times, thus ensuring that the sensed motion signal is accurate” (Ans. 9). However, this rationale does not address Appellants’ argument that the Examiner has 4 We note that the Examiner has, in the Examiner’s Answer, provided some evidence that it was “known in the art that auditory and tactile stimulation may be applied by implantable, and even implanted, devices” (Ans. 10-11). However, the question before us is whether the Examiner has set forth a prima facie case that Nieuwboer and Baru Fassio suggest the present claims. Appeal 2011-012508 Application 11/691,423 9 not set forth a prima facie case that it would have been obvious to modify Nieuwboer’s therapy device to be implantable. With regard to the rationale regarding eliminating problems associated with external cable malfunctions, Appellants do not dispute that modifying a device to be fully implantable would eliminate such problems (see App. Br. 8-9). However, Nieuwboer discloses a device having buttons 16a and 16b for controlling the frequency at which the device is operated, a switch 22 for controlling which sensory device is to be used, and a switch 28 for turning the device on and off (FF 6). In addition, Nieuwboer describes why being able to adjust these features is important (FF 2). We conclude that the Examiner has not adequately addressed Appellants’ argument that modifying Nieuwboer’s device to be fully implantable would render the device unsatisfactory for its intended purpose (App. Br. 9). In response to Appellants’ argument, the Examiner notes that the claim merely requires that the device is “implantable,” not that it is implanted (Ans. 9-10). However, it is undisputed that one of ordinary skill in the art would not consider a device that has buttons and switches for adjusting various parameters to be an implantable medical device (Ans. 5; Reply Br. 9). In addition, the Examiner finds that, with many implantable devices, the stimulation parameters are tested and selected prior to permanent implantation (Ans. 10). We note initially that the Examiner has not relied on any evidence to support this position. In addition, although Nieuwboer does teach “allow[ing] the user to experiment and find which stimulation works most effectively for them” (FF 2), Nieuwboer does not suggest then utilizing Appeal 2011-012508 Application 11/691,423 10 only that form and degree of stimulation. On the contrary, Nieuwboer discloses that “it may be the case that a user finds that under certain conditions one form of stimulation is more effective than another, or that one form of stimulation may be unsuitable” (id.). Thus, we agree with Appellants that the intended purpose of Nieuwboer’s device is to provide a user suffering from movement disorders with options for cuing the user to move and that the Examiner has not adequately explained how a fully implantable device would be suitable for Nieuwboer’s intended purpose. CONCLUSION The Examiner has not set forth a prima facie case of obviousness. We therefore reverse the obviousness rejection. REVERSED cdc Copy with citationCopy as parenthetical citation