Ex Parte MoffittDownload PDFPatent Trial and Appeal BoardDec 27, 201613855589 (P.T.A.B. Dec. 27, 2016) Copy Citation 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. BSNC-1-580.1 4700 EXAMINER STICE, PAULA J ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 13/855,589 04/02/2013 50638 7590 12/27/2016 Boston Scientific Neuromodulation Corp. c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 Michael A. Moffitt 12/27/2016 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 MICHAEL A. MOFFITT Appeal 2015-001348 Application 13/855,589 Technology Center 3700 Before LINDA E. HORNER, MITCHELL G. WEATHERLY, and ERIC C. JESCHKE, Administrative Patent Judges. JESCHKE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Michael A. Moffitt (“Appellant”) seeks review under 35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Final Office Action dated March 10, 2014 (“Final Act.”), and as further explained in the Advisory Action dated April 25, 2014 (“Adv. Act.”), rejecting claims 1, 2, and 4—16.1 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies Boston Scientific Neuromodulation Corporation as the real party in interest. Appeal Br. 2. Appeal 2015-001348 Application 13/855,589 BACKGROUND The disclosed subject matter “relate[s] to spinal cord stimulation.” Spec. 12. Claim 1, the sole independent claim, is reproduced below, with emphasis added: 1. A method for treating an ailment of a patient using at least one electrode implanted within a spinal column of the patient, the method comprising: increasing an activation threshold of a side- effect exhibiting neural structure relative to the activation threshold of a dorsal column (DC) nerve fiber of the patient; and applying electrical stimulation energy to the DC nerve fiber via the at least one electrode while the activation threshold of the neural structure is increased, thereby treating the ailment while minimizing stimulation of the neural structure, wherein the at least one electrode is implanted within the spinal column of the patient at a T4—T6 spinal nerve level, and wherein the ailment is lower back pain. REJECTIONS 1. Claims 1, 2, 4—12, 14, and 15 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Holsheimer (US 6,421,566 Bl, issued July 16, 2002) and Feler (US 2010/0030300 Al, published Feb. 4, 2010). 2. Claim 13 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Holsheimer, Feler, and Moffitt (US 7,742,810 B2, issued June 22, 2010). 2 Appeal 2015-001348 Application 13/855,589 3. Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Holsheimer, Feler, and Lee (US 2011/0009923 Al, published Jan. 13,2011). DISCUSSION Rejection 1 Independent claim 1 recites, inter alia, “wherein the at least one electrode is implanted within the spinal column of the patient at a T4—T6 spinal nerve level, and wherein the ailment is lower back pain.” Appeal Br. 8 (Claims App.). In rejecting claim 1, the Examiner relied on Holsheimer for various limitations, but stated: “Holsheimer only discloses the treatment of pain and is not specific to back pain or the stimulation of the T4, T5 and T6 vertebrae. Feler however teaches of stimulation to the T4, T5 and T6 in order to treat back pain.” Final Act. 4 (citing Feler || 3, 42, 62). According to the Examiner, it would have been obvious “to modify Holsheimer to include the treatment of back pain using the T4, T5 and T6 vertebrae stimulation, as taught by Feler, in order to effectively treat post laminectomy pain as well as pain from the lower back ... as disclosed by Feler.” Id. (citing Feler 13). Appellant argues that “although Feler discloses ah vertebral levels (C1-C7, Tl—T12, LI—L6 and SI—S5) at paragraph [0064], Feler makes no special mention of the T4—T6 level in the context of lower back pain.” Appeal Br. 4.2 Appellant also argues: 2 Feler discloses stimulating ah vertebral levels in paragraph 63, not paragraph 64. 3 Appeal 2015-001348 Application 13/855,589 Although it is clear that the device in Feler may be used on any spinal level, it is not relevant to the particular problem discussed in the present application (using neurostimulation on T4—T6 spinal level to treat lower back pain), and does not specially discuss the problems of neurostimulation specifically in the T4—T6 spinal nerve level. Id. at 4—5. In response, the Examiner states that Feler “clearly discloses that the implantable lead can be implanted in multiple spinal cord locations” and, after quoting paragraph 63 of Feler, the Examiner also states, “[i]t is clear from this recitation . . . that the electrode [s] can be and are implanted in the region claimed by Appellant, T4—T6.” Ans. 3^4. Here, the claimed range of vertebral levels T4—T6 is within the disclosed range of paragraph 63 of Feler, which lists all vertebral levels in the human back.3 In such a situation, an applicant can demonstrate nonobviousness by showing that the particular claimed range is critical, generally by demonstrating that the claimed range achieves unexpected results relative to the prior art range. See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). The Specification here provides evidence showing that the maximum probabilities of achieving beneficial “paresthesia” in the lower back of a 3 Paragraph 63 provides: “In preferred embodiments, the dorsal column of the spinal cord is stimulated; more particularly, any neuronal tissue of the dorsal column associated with any of the cervical vertebral segments (Cl, C2, C3, C4, C5, C6, Cl) and/or any tissue associated with any of the thoracic vertebral segments (Tl, T2, T3, T4, T5, T6, T7, T8, T9, T10, Til, 12) and/or any tissue associated with any of the lumbar vertebral segments (LI, L2, L3, L4, L5, L6) and/or any tissue associated with the sacral vertebral segments (SI, S2, S3, S4, S5).” 4 Appeal 2015-001348 Application 13/855,589 patient occurs via stimulation within the claimed T4—T6 range. See Spec. Ill (discussing Fig. 1, chart 1); see also id. 1 6 (discussing paresthesia). The Specification also discloses that, due to the thickness of the cerebrospinal fluid layer in that range, the probability of side effects is also at a maximum. See id. 111 (discussing Fig. 1, chart 2). According to the Specification, “[a]s a result, clinicians have traded off ineffective stimulation for patient comfort by stimulating the DC nerve fibers well outside of the optimum spinal level range of T4—T6.” Id. 112. The Specification also provides: “There, thus, remains a need to provide an SCS [i.e., spinal cord stimulation] regimen that provides relief for chronic lower back pain while minimizing the probability of side effects. The art remains unable to apply SCS in the most beneficial location.” Id. 114. Considering all the evidence and argument presented, we conclude that the evidence against obviousness outweighs the evidence for obviousness. In particular, the disclosures discussed above demonstrate the criticality of the claimed range within the broader disclosure of Feler and the unexpected nature of the results achieved using the claimed range in the context of the claimed method. See Appeal Br. 4 (arguing that Feler’s disclosure of treating lower back pain by stimulating T8—T12 “confirms the unsolved problem disclosed in the background of the invention that [it] is problematic to treat lower back pain by stimulating within the T4—T6 spinal nerve level range (see [Spec.] paragraph [0012])”). For these reasons, we do not sustain the rejection of claim 1, or the rejection of claims 2, 4—12, 14, and 15, which depend from claim 1. 5 Appeal 2015-001348 Application 13/855,589 Rejections 2 and 3 Claims 13 and 16 depend from claim 1. Appeal Br. 8—10 (Claims App.). The Examiner’s added reliance on Moffitt (regarding Rejection 2) and Lee (regarding Rejection 3) does not remedy the deficiencies in the combined teachings of Holsheimer and Feler, discussed above (see supra Rejection 1). Thus, for the same reasons discussed above, we do not sustain the rejection of claims 13 and 16. DECISION We REVERSE the decision to reject claims 1, 2, and 4—16 under 35 U.S.C. § 103(a). REVERSED 6 Copy with citationCopy as parenthetical citation