Jared Huston et al.

Patent Trials and Appeals Board

Jan 5, 2022

2021002790 (P.T.A.B. Jan. 5, 2022)

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. 11/318,075 12/22/2005 Jared M. Huston 10642-703.200 9722 66854 7590 01/05/2022 SHAY GLENN LLP 2929 CAMPUS DRIVE SUITE 225 SAN MATEO, CA 94403 EXAMINER D ABREU, MICHAEL JOSEPH ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 01/05/2022 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JARED M. HUSTON and KEVIN J. TRACEY Appeal 2021-002790 Application 11/318,075 Technology Center 3700 ____________ Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and RYAN H. FLAX, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The Examiner rejected 1-12 and 34-40 under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as The Feinstein Institutes for Medical Research. Appeal Br. 1-2. Appeal 2021-002790 Application 11/318,075 2 STATEMENT OF THE CASE The Examiner rejected claims 1-12 and 34-40 in the Final Office Action as follows: Claims 1-7, 34, 36, and 38-40 under 35 U.S.C. § 103(a) as obvious in view of Knudson et al. (US 7,167,750 B2, issued Jan. 23, 2007) (“Knudson”) and Boveja et al. (US 2005/0154425 A1, published July 14, 2005) (“Boveja”). Final Act. 3. Claims 8-12, 35, and 37 under 35 U.S.C. § 103(a) as obvious in view of Knudson, Boveja, and Whitehurst et al. (US 2003/0236557 A1, published Dec. 25, 2003) (“Whitehurst”). Final Act. 6. There are three independent claims on appeal, claims 1, 36, and 38. The claims are reproduced below (with emphasis added to highlight certain limitations in the claim): 1. A method for treating inflammation in a subject suffering from an inflammatory disorder, the method comprising stimulating, in the subject suffering from inflammation, the subject’s vagus nerve with an electrical signal to achieve an anti-inflammatory effect for treating the inflammation, wherein the signal current is from l mA to 100 mA, provided that the condition is not ileus, asthma or cystic fibrosis; and re- stimulating the vagus nerve after waiting for more than 24 hours and prior to the anti-inflammatory effect being abolished, wherein the anti-inflammatory effect for treating the inflammation persists for at least 24 hours after stimulation has ended. Appeal 2021-002790 Application 11/318,075 3 36. A method for treating inflammation in a subject suffering from an inflammatory disorder, the method comprising stimulating, in the subject suffering from inflammation, the subject’s vagus nerve with an electrical signal to achieve an anti-inflammatory effect for treating the inflammation, wherein the signal current is between 1 mA and 100 mA, the pulse width is between 0.1 ms and 5 ms, the signal frequency is from 0.1 Hz to 30 Hz, and the signal on-time is from 1 second to 120 seconds, provided that the condition is not ileus, asthma or cystic fibrosis; further comprising re-stimulating the vagus nerve after waiting greater than 24 hours and prior to the anti- inflammatory effect being abolished, wherein the anti- inflammatory effect for treating the inflammation persists for at least 24 hours after stimulation has ended. 38. A method for treating inflammation in a subject suffering from an inflammatory disorder, the method comprising stimulating, in a subject suffering from inflammation, the subject’s vagus nerve with an electrical signal to achieve an anti-inflammatory effect for treating the inflammation, wherein the signal current is between 1 mA and 100 mA applied to the vagus nerve for a signal on-time that is between 1 second and 120 seconds; further comprising re-stimulating the vagus nerve after 24 hours after the electrical signal has ended and prior to the anti-inflammatory effect being abolished, wherein the anti- inflammatory effect for treating the inflammation persists for up to three days-before restimulation, provided that the condition is not ileus, asthma or cystic fibrosis. See Appeal Br. at App’x A (emphases added). OBVIOUSNESS Rejection Each of the independent claims are directed to a “method for treating inflammation in a subject suffering from an inflammatory disorder.” The methods each comprise “stimulating, in the subject suffering from inflammation, the subject’s vagus nerve with an electrical signal to achieve Appeal 2021-002790 Application 11/318,075 4 an anti-inflammatory effect for treating the inflammation.” In all three independent claims, the signal current is l mA to 100 mA. Additional parameters for the signal are recited in claims 36 and 38. Each of the independent claims also comprise re-stimulating the vagus nerve after 24 hours and prior to the anti-inflammatory effect being abolished. Claims 1 and 36 require the anti-inflammatory effect to persist for at least 24 hours after stimulation has ended and claim 38 “for up to three days-before restimulation.” The Examiner found that Knudsen describes stimulating the vagus nerve to inhibit inflammation as required by the claim. Final Act. 3-4. The Examiner acknowledged that Knudsen does not disclose re-stimulating the vagal nerve after 24 hours as recited in each of the independent claims. Id. at 4. However, the Examiner found that Boveja describes treating a subject comprising stimulating the vagus nerve subject with an electrical signal to achieve a therapeutic effect and waiting up to 24 hours before re-stimulating the vagus nerve. Id. The Examiner found “it would have been an obvious design choice to one of ordinary skill in the art to have an off-time of greater than 24 hours prior to restimulating the vagus nerve . . . to yield the predictable results of providing treatment to a wide range of patients with different physiological attributes and further, treatment of a plurality of different inflammatory conditions.” Id. The Examiner also found that that the “off-time” between stimulations is a result-effective variable and obvious to optimize. Id. at 4-5. Persistence Appellant argues that “[p]rior to the work described in the Applicant’s disclosure, there was no suggestion or belief that stimulating the vagus nerve Appeal 2021-002790 Application 11/318,075 5 could result in such a long-lasting effect and that re-stimulating before a 24 hour period would not provide additional benefit.” Appeal Br. 6. Appellant argues there was no suggestion in Knudsen or Boveja of this persistent effect and that it was a “surprising” discovery. Id. at 8-10. This argument does not persuade us that the Examiner erred. Knudson describes treating inflammation with vagus nerve stimulation, a fact not disputed by Appellant. See Appeal Br. 6 (“Specifically, with respect to inflammation, Knudson teaches that vagal blocking can treat inflammation.”). Appellant describes this same vagal nerve stimulation as producing the long-lasting anti-inflammatory effect. Appellant has simply recognized an advantage of vagal nerve stimulation that was not described by Knudson. However, as explained In re Baxter Travenol Labs, 952 F.2d 388, 392 (Fed. Cir. 1991), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254, 132 USPQ 282, 283-84 (CCPA 1962).” (“Since the prior art bags plasticized with DEHP were inherently suppressing hemolysis, albeit unknown at the time of the Becker document, this hemolysis-suppressing function is not a basis for rebutting a prima facie finding of obviousness.”). Because vagal stimulation had been used in the prior art, recognizing that it inherently had a long-lasting anti-inflammatory effect when it had been used, is not a basis to distinguish the claims over Knudsen. Re-stimulation Each of the independent claims also comprise re-stimulating the vagus nerve after 24 hours and prior to the anti-inflammatory effect being abolished. The Examiner found reason to do so in Boveja which describes Appeal 2021-002790 Application 11/318,075 6 treating neuropsychiatric and cognitive disorders with vagus nerve stimulation. Appellant contends that the Examiner erred in finding that it would have been obvious to one of ordinary skill in the art to re-stimulate the vagus nerve after 2 hours. Appellant explains that Knudson discloses stimulating the vagus nerve multiple times a day for treatment, including for inflammation associated with Crohn’s disease, but does not describe re- stimulating the nerve after waiting for more than 24 hours. Appeal Br. 6-7. Appellant argues that Boveja uses vagus nerve stimulation for the treatment of neuropsychiatric disorders and cognitive impairment in a range of “10 Secs - 24 hours,” which is outside the claimed timing of more than 24 hours, required by each of the independent claims. Id. at 7. Appellant further argues that a person of ordinary skill in the art would “not look to Boveja’s method of treating neuropsychiatric and cognitive disorders to modify Knudson’s methods for treating GI disorders” because such person “would not expect that modifying stimulation parameters for treatment of GI disorders as taught by Knudson with stimulation parameters used for treating neuropsychiatric disorders as taught by Boveja (which are used in combination with magnetic pulses to the brain) would improve any aspect of treating the GI disorders.” Id. at 12. The issue is whether it would have been obvious to one of ordinary skill in the art to apply the vagus nerve stimulation parameters of an off-time of “10 Secs-24 hours” described by Boveja for neuropsychiatric disorders and cognitive impairments to treat inflammation as disclosed in Knudson. “An examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. Appeal 2021-002790 Application 11/318,075 7 2011). The Examiner did not meet this burden. The Examiner did not establish that the stimulation parameters listed in Table 1 of Boveja, which discloses an off-time between vagus nerve stimulation of “10 Secs-24 hours” (Id. ¶ 93), are for anything other than treating neuropsychiatric disorders and cognitive impairments. All of the independent claims in this appeal are directed to methods of treating inflammation. The methods require stimulating the vagus nerve in a subject “suffering from inflammation.” The Examiner did not provide evidence that a patient in need of treatment for a neuropsychiatric disorder or cognitive impairment would also suffer from inflammation. The patient populations receiving the vagus nerve stimulation in the rejected claims have therefore not been shown to be the same as those in Boveja. The Examiner did not establish that the skilled worker would have believed that the stimulation parameters used to treat neuropsychiatric and cognitive conditions would be effective for treating inflammation. As Appellant points out, Knudson discloses intermittent treatment over the day (Knudson 12:67-13:2) and a reversible vagal block in which normal nerve activity is restored once it is removed (Id. 13:61-67). The Examiner did not explain how any of the stimulation conditions disclosed in Knudson reasonably suggests to one of ordinary skill in the art re-stimulating the vagus nerve after waiting for more than 24 hours. While it might be obvious to optimize the parameters in Knudsen to treat inflammation, the Examiner did not guide us to sufficient evidence in this record of an off-time of 24 hours between stimulation and re-stimulation, when 24 hours at most was used in Boveja and for different disease indications. Appeal 2021-002790 Application 11/318,075 8 While Knudson also discloses that its “invention also applicable to treating other diseases such as neuropsychiatric disorders” (Knudson 5:51- 52), the Examiner did not explain how this statement would have given the skilled worker reason to adapt the stimulation conditions in Boveja to treat the disorders in Knudsen. Knudson makes this statement about the applicability of its invention with respect to using “vagal stimulation to improve vagal tone (similar in concept to improving cardiac electrical tone through cardiac pacing). Id. 5:45-48. The conditions described by Knudson to improve vagal tone is intermittent over the day (Id. 12:67-13:5; 13:14- 16). This disclosure in Knudsen is a suggestion to apply Knudsen’s pacing to treat neuropsychiatric disorders, not to use Boveja’s parameters to treat inflammation. The Examiner cited Whitehurst to meet various stimulation parameters and cytokine sensing recited in the dependent claims. Final Act. 6. The Examiner did not rely on Whitehurst to reach the limitation of re- stimulating the vagus nerve after more than 24 hours and prior to the anti- inflammatory effect being abolished. For the foregoing reasons, the obvious rejection of independent claims 1, 36, and 38 is reversed. All the dependent claims incorporate the limitations of the independent claims. The rejections of the dependent claims are reversed for the same reasons. Appeal 2021-002790 Application 11/318,075 9 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-7, 34, 36, 38-40 103 Knudson, Boveja 1-7, 34, 36, 38-40 8-12, 35, 37 103 Knudson, Boveja, Whitehurst 8-12, 35, 37 Overall Outcome 1-12, 34-40 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). REVERSED