Ex Parte DiLorenzoDownload PDFPatent Trial and Appeal BoardApr 11, 201311159842 (P.T.A.B. Apr. 11, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DANIEL JOHN DILORENZO __________ Appeal 2012-002829 Application 11/159,842 Technology Center 1600 __________ Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and STEPHEN WALSH, 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’s neurological or psychiatric disorder. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2012-002829 Application 11/159,842 2 Statement of the Case Background “The present invention relates generally to neurological disease and, more particularly, to intracranial stimulation for optimal control of movement disorders and other neurological disease” (Spec. 1 ¶ 0002). The Claims Claims 59-86 are on appeal. Claim 59 is representative and reads as follows: 59. A method of treating a patient’s neurological or psychiatric disorder, the method comprising: using a control module coupled to a first electrode and a second electrode to deliver electrical stimulation to a nervous system component through the first electrode and the second electrode to treat the patient’s neurological or psychiatric disorder, said first electrode and said second electrode being implanted in the patient’s body; monitoring impedance between the first electrode and the second electrode; automatically adjusting at least one parameter of the electrical stimulation to compensate for a monitored change of electrode impedance between the first electrode and the second electrode; and delivering a subsequent electrical stimulation with the at least one adjusted parameter to the nervous system component through the first electrode and the second electrode to treat the patient’s neurological or psychiatric disorder. The issues A. The Examiner rejected claims 59-86 under 35 U.S.C. § 103(a) as obvious over Combs 1 and Fischell 2 (Ans. 4-10). 1 Combs et al., U.S. Patent No. 5,957,861, issued Sep. 28, 1999. Appeal 2012-002829 Application 11/159,842 3 B. The Examiner rejected claims 59-61, 63-66, 72, 73, 75, 77-80, and 86 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 12, 17, 21, 23, and 24 of DiLorenzo 3 (Ans. 11). C. The Examiner rejected claims 59-86 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 49-56, 59-70, and 75-85 of U.S. Patent No. 7,209,787 (Ans. 11-12). A. 35 U.S.C. § 103(a) over Combs and Fischell The Examiner finds that Combs teaches “an implantable device for measuring impedance in patients with edema and to manage the disease, wherein the cause of said edema may be due to various diseases, such as heart failure or myocardial infarctions” (Ans. 5). The Examiner finds that Combs teaches that the implantable device comprises at least two electrodes between which the impedance will be measured and monitored (reads on step II)) wherein the data may be output to a physician and a means for delivering electrical impulses to a living body. The control module is able to deliver electrical impulses to the living body between the two electrodes (id.). The Examiner finds that Combs teaches “the device will give a stimulus if required wherein the measurements are made and stored in memory and acted upon a program stored in memory, wherein the program can initiate routines to change the behavior of an implanted device based on the stored values, such as calibration” (id. at 6). 2 Fischell et al., U.S. Patent No. 6,016,449, issued Jan. 18, 2000. 3 DiLorenzo, D., U.S. Patent No. 7,324,851 B1, issued Jan. 29, 2008. Appeal 2012-002829 Application 11/159,842 4 The Examiner finds that Fischell teaches “an implantable device comprising electrodes, which may be implanted deep within the brain tissue or close proximity to the brain and configured to deliver electrical stimulation to manage a patient’s neurological disorder” (Ans. 7). The Examiner finds it obvious to have combined the implantable device configured to deliver stimulation to manage a patient's neurological disorder and deliver the electrical stimulation to the nervous system component through a first and second electrode as taught by Fischell et al. with the implantable device as taught by Combs et al. This is because Combs et al., as stated above, at col. 3, 5, and 13 describe that the invention can be used in conjunction with traditional pacemaker systems and other implantable devices or may be incorporated into them wherein the device can be programmed to communicate and be modified automatically, i.e. automatically adjusting a parameter. (Id. at 8.) The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Combs and Fischell render claim 59 obvious? Findings of Fact 1. Combs teaches that the importance of “long term impedance measurement and noting changes therein is that it is an valuable clinical indicator of the health of the living body” (Combs, col. 1, ll. 22-24). 2. Combs teaches “implantable devices including but not limited to tissue stimulators having measurement capability for determining impedance measurements and is particularly well suited to measure long term edema variations within a living body” (Combs, col. 1, ll. 6-10). Appeal 2012-002829 Application 11/159,842 5 3. Combs teaches: an implantable apparatus for production of impedance measurement in a subcutaneous region of the living body having at least two electrically isolated electrodes, preferably but not necessarily on the outer surface of its housing and having within the housing an energy pulse delivery mechanism to deliver electrical pulses to living body and means for receiving electrical impulses on the surface of the housing so as to determine the impedance of the body between the two preferred or less preferred pair of electrodes. (Combs, col. 3, ll. 16-25.) 4. Combs teaches that: Additional triggers for storing data on measurements made at the time of a trigger signal could be automatic, based on regular measurements made by the implanted device. For example, if a doctor believes a 10% change in LTA over a two week period should invoke hospitalization, he could set such a trigger in the implanted device memory. The device then would incorporate an automatic process for checking the data against the automatic trigger values, and when the comparison indicated a trigger condition. (Combs, col. 11, ll. 8-15.) 5. Combs teaches that “calibration against stored reference values or setting up on new reference values is handled. If changes are required, say for example in the level of stimulus required to elicit useful sensor response, they are determined at the next step” (Combs, col. 12, ll. 32-36). 6. Combs teaches that “[a]lternative types of implantable devices may also be used to house this invention including for example, defibrillators, drug infusion devices, spinal cord stimulators or any other Appeal 2012-002829 Application 11/159,842 6 implantable device having the minimum external number of electrodes and being provided with an impedance stimulation and measurement circuit” (Combs, col. 5, ll. 20-25). 7. Fischell teaches “a multi-electrode array with sophisticated signal processing techniques to achieve reliable detection of the onset of a neurological event (such as an epileptic seizure or migraine headache)” (Fischell, col. 2, ll. 42-45). 8. Fischell teaches that the “invention also provides means for generating an ensemble of coordinated electrical stimuli designed to terminate the neurological event immediately upon (or even prior to) its onset. Thus, the present invention is a responsive detection and stimulation system for the early recognition and prompt treatment of a neurological event” (Fischell, col. 2, ll. 52-57). 9. Fischell teaches the “capability to program the functions and parameters of the system to enhance the detection of a neurological event and to optimize the system responses for stopping a neurological event such as an epileptic seizure” (Fischell, col. 4, ll. 32-36). Principles of Law “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Combs reasonably teaches the use of a control module for electrical stimulation by monitoring impedance between two electrodes and Appeal 2012-002829 Application 11/159,842 7 automatically adjusting the electrical stimulation based on the measured changes in impedance, and then stimulating using the electrodes (FF 1-6). Fischell teaches treatment of epilepsy using electrical stimulation and a programmable device (FF 7-9). However, we agree with Appellant that there “is nothing in Fischell, Combs, or any other reference cited by the Examiner to suggest that electrode impedance is either a precursor of an event such as an epileptic seizure or the epileptic seizure itself” (App. Br. 7). Without any evidence that the prior art was aware of a relationship between impedance and a neurological or psychiatric disorder, there is no reason to automatically adjust “at least one parameter of the electrical stimulation to compensate for a monitored change of electrode impedance” as required by independent claims 59 and 73. The Examiner finds that Fischell “teaches that his device can be used to detect whether a neurological event such as a seizure is ABOUT TO OCCUR (col. 7, lines 46-51), and teaches that this detection occurs through measurement of various electrical parameters” (Ans. 14). We are not persuaded. The Examiner’s general reliance on “electrical parameters” does not provide any specific reason or evidence that impedance between two electrodes was known to have any correlation or causative relationship with any psychiatric or neurological disorder. In particular for epilepsy, the Examiner has not established that the prior art recognized that an impedance measurement would provide any useful information regarding future epileptic incidents. Conclusion of Law Appeal 2012-002829 Application 11/159,842 8 The evidence of record does not support the Examiner’s conclusion that Combs and Fischell render claim 59 obvious. B. & C. Double Patenting We summarily affirm the obviousness-type double patenting rejections. See Manual of Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, that ground of rejection will be summarily sustained by the Board.”); See also In re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002) (in which the Board affirmed an uncontested rejection of claims under 35 U.S.C. 112, second paragraph, and on appeal the Federal Circuit affirmed the Board's decision and found that the appellant had waived his right to contest the indefiniteness rejection by not presenting arguments as to error in the rejection on appeal to the Board). SUMMARY In summary, we reverse the rejection of claims 59-86 under 35 U.S.C. § 103(a) as obvious over Combs and Fischell. We summarily affirm the rejection of claims 59-61, 63-66, 72, 73, 75, 77-80, and 86 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 12, 17, 21, 23, and 24 of DiLorenzo. We summarily affirm the rejection of claims 59-86 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 49-56, 59-70, and 75-85 of U.S. Patent No. 7,209,787. Appeal 2012-002829 Application 11/159,842 9 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation