Ex Parte Whitehurst et al

Patent Trial and Appeal BoardOct 31, 2012

11192750 (P.T.A.B. Oct. 31, 2012)

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. 11/192,750 07/29/2005 Todd K. Whitehurst 05-00595-02 6885 71422 7590 10/31/2012 VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION 2040 MAIN STREET, Suite 710 IRVINE, CA 92614 EXAMINER LAVERT, NICOLE F ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 10/31/2012 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, JAMES P. MCGIVERN, and RAFAEL CARBUNARU __________ Appeal 2012-000211 Application 11/192,750 Technology Center 3700 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L. McCOLLUM, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating obesity, which the Examiner has rejected as anticipated or obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification states that “[i]mplantable stimulators are used to treat a variety of patient medical conditions. Such stimulators include a microminiature implantable electrical stimulator, referred to herein as a Appeal 2012-000211 Application 11/192,750 2 microstimulator.” (Spec. 1, ¶ 3.) The Specification discloses that “patients with obesity . . . may be significantly aided by a microstimulator 100 placed in the lower esophageal sphincter (LES) 240 that allows them to open and close the LES 240 at will, i.e., to open it when eating and to close it otherwise. Benefits include the promotion of normal metabolism, weight control, and prevention of diabetes.” (Id. at 31, ¶ 105.) Claims 1, 6-9, 12, 13, 18-21, and 29-38 are on appeal. Claim 1 is representative and reads as follows: 1. A method for treating a patient suffering from obesity, comprising: providing at least one stimulator coupled to at least two electrodes implanted within the patient; using at least one external appliance to transmit stimulation parameters; generating stimulation pulses with the at least one stimulator in accordance with the stimulation parameters; and delivering the stimulation pulses via the at least two electrodes to a lower esophageal sphincter of the patient, wherein the at least one stimulator is operated, such that the lower esophageal sphincter is opened when the patient is eating and closed when the patient is not eating. Claims 13 and 31, the only other independent claims, also require stimulating the LES, “wherein the at least one stimulator is operated, such that the lower esophageal sphincter is opened when the patient is eating and closed when the patient is not eating” (Appeal Br. 9-10 (Claims Appendix)). The Examiner has rejected claims 1, 6, 7, 12, 13, 18, 19, 29-33, and 38 under 35 U.S.C. § 102(b) as anticipated by Flesler1 (Answer 4) and has rejected claims 8, 9, 20, 21, and 34-37 under 35 U.S.C. § 103(a) as obvious 1 Flesler et al, US 2002/0161414, Oct. 31, 2002. Appeal 2012-000211 Application 11/192,750 3 based on Flesler and Lowell2 (Answer 6). The same issue is dispositive for both rejections. The Examiner finds that Flesler discloses treating obesity using “electrodes applied in the vicinity of the lower-esophageal sphincter” (Answer 5) and applying stimulation “such that the lower esophageal sphincter is opened and closed when the patient is not eating” (id.). As support, the Examiner points to “the disclosed application of enhancement signal(s) via the control unit to the electrodes that induces constriction of the stomach at times when the patient should not be eating by way of limiting the foods [sic] ability to vacate the esophageal region of the stomach” (id.). Appellants argue that “Flesler discloses the opposite of the claimed invention–i.e., stimulating the patient when the patient is eating, and not stimulating the patient when the patient is not eating (see paragraph [0098])” (Appeal Br. 5). We agree with Appellants that the Examiner has not shown that Flesler discloses treating obesity by stimulating the lower esophageal sphincter (LES) in the manner required by the claims on appeal; specifically, stimulating the LES “such that the lower esophageal sphincter is opened when the patient is eating and closed when the patient is not eating” (claim 1). Flesler discloses a method of treating obesity by applying electrodes to the gastrointestinal (GI) tract and applying signals to modulate contraction of muscles in the GI tract (Flesler 1, ¶ 12). If the signal is applied to the stomach muscles, for example, the effect can be “to cause a narrowing of the 2 Lowell, US 4,628,928, Dec. 16, 1986. Appeal 2012-000211 Application 11/192,750 4 stomach analogous to that produced mechanically by [ ] gastric bands” (id. at 1, ¶ 14). Flesler discloses that its apparatus can also include “a second set of one or more electrodes, adapted to be applied to one or more respective sites in a vicinity of the lower esophageal sphincter . . . to apply a signal to the sphincter, configured such that application thereof increases a contraction force generated by the sphincter” (id. at 3, ¶ 40). Flesler discloses that the signal can be applied “so as to induce constriction of stomach 20 at times when the patient should not be eating, or when the patient’s eating should be minimized” (id. at 6, ¶ 98). Flesler discloses that “[a]lternatively or additionally, the enhancement signal is (a) applied during one or more meals during the day, so as to reduce the patient’s appetite during those meals, and (b) removed during the remainder of the day, so as to prevent counterproductive remodeling of the stomach” (id.). Flesler discloses that “the control unit may generate an enhancement signal which causes a contraction of the corpus of the stomach at the beginning of a meal” (id. at 6, ¶ 100), which causes an accumulation of food that, “in turn, increases intra-gastric pressure” (id.). “If it is determined that a patient has intermittent gastro-esophageal reflux episodes in response to the increased intra-gastric pressure, then it is preferable to additionally apply the enhancement signal to the lower esophageal sphincter, so as to increase the contraction force thereof and reduce or eliminate the reflux” (id.). Thus, Flesler discloses that its method can include electrodes that stimulate the lower esophageal sphincter (LES) but discloses that such stimulation is used to reduce or eliminate gastro-esophageal reflux caused by Appeal 2012-000211 Application 11/192,750 5 increasing intra-gastric pressure that results from contracting the stomach at the beginning of a meal. In other words, Flesler describes LES stimulation as an optional addition to the embodiment of its method in which the stomach is stimulated to contract during meals. Doing so would contract (close) the LES when the patient is eating, rather than opening the LES while the patient is eating, as required by the claims. The Examiner points to Flesler’s disclosure that stimulation can be applied at times when the patient is not eating (Answer 8, citing Flesler’s ¶¶ 15-17). Those disclosures, however, refer to contraction of the stomach, and do not address stimulation of the LES. Because the Examiner has not persuasively shown that Flesler expressly or inherently discloses all of the limitations of the claimed methods, we reverse the rejection under 35 U.S.C. § 102(b). With regard to the rejection based on 35 U.S.C. § 103(a), the Examiner relies on her finding that Flesler discloses the method defined by each of the independent claims, and concludes that Lowell would have made it obvious to add a drug pump to Flesler’s system (Answer 7). The Examiner therefore has not shown that Lowell makes up for the deficiency of Flesler discussed above, and we reverse the rejection under 35 U.S.C. § 103(a) for the same reason. Appeal 2012-000211 Application 11/192,750 6 SUMMARY We reverse the rejection of claims 1, 6, 7, 12, 13, 18, 19, 29-33, and 38 as anticipated by Flesler, and the rejection of claims 8, 9, 20, 21, and 34- 37 as obvious based on Flesler and Lowell. REVERSED lp