BIOINDUCTION LIMITED

Patent Trials and Appeals BoardOct 22, 2020

2019006287 (P.T.A.B. Oct. 22, 2020)

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. 15/040,563 02/10/2016 NIKUNJ PATEL 72095-0009 3940 20915 7590 10/22/2020 MCGARRY BAIR PC 7412 Panners Lane NE Rockford, MI 49341 EXAMINER EVANISKO, GEORGE ROBERT ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 10/22/2020 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): patents@mcgarrybair.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NIKUNJ PATEL and IVOR STEPHEN GILLBE Appeal 2019-006287 Application 15/040,563 Technology Center 3700 Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and KENNETH G. SCHOPFER, Administrative Patent Judges. HOFFMANN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s rejection of claims 2, 4–7, 11, 13–17, 26, and 27. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appellant’s invention is directed to treating diseases through deep brain stimulation. See Spec., Title, Abstract. Independent claims 2 and 26 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies “Bioinduction Limited” as the real party in interest. Appeal Br. 2. Appeal 2019-006287 Application 15/040,563 2 are the independent claims on appeal. Below, we reproduce claim 2, with additional formatting, as illustrative of the appealed claims. 2. A method of treating Alzheimer’s Disease and/or Multiple Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or vascular brain disorders where there is small vessel compromise in a subject in need thereof, said subject having previously been diagnosed as suffering from Alzheimer’s Disease and/or Multiple Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or vascular brain disorders where there is small vessel compromise, the method comprising applying a neuromodulation signal to the lPAG or vlPAG of the subject having Alzheimer’s Disease and/or Multiple Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or vascular brain disorders where there is small vessel compromise, wherein the neuromodulation signal has a frequency within the range of 5 to 50 Hz. REJECTIONS AND PRIOR ART The Examiner rejects the claims as follows: I. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 112(a) as unsupported by an enabling disclosure; II. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 112(b) as indefinite; and III. Claims 2, 4–7, 11, 13–17, 26, and 27 under 35 U.S.C. § 103 as unpatentable based on Jaax et al. (US 8,515,541 B1, issued Aug. 20, 2013) (“Jaax”).2 2 We combine the obviousness rejections relative to the Non-Final Office Action. Also, throughout prosecution, the Examiner repeatedly refers to this reference as “Jaxx.” Appeal 2019-006287 Application 15/040,563 3 ANALYSIS Rejections I and II—Rejections under 35 U.S.C. §§ 112(a) and 112(b) Initially, we note that the Examiner rejects all of the claims under §§ 112(a) and 112(b), based on the Examiner’s determination that Appellant’s claims, not Specification, lack something critical or essential. Non-Final Action mailed Oct. 19, 2018 (“Non-Final Action”), at 2–4. Thus, we may fully agree, for example, with Professor Julian F.R. Patton that “[d]efining the precise stimulation variables is critical and varies depending on the brain region and the type of structure being stimulated[,] . . . [ and that Appellant’s] application does this,” and yet still sustain both rejections because Appellant’s claims do not recite at least one such critical variable. Declaration of Professor Julian F.R. Patton dated Oct. 1, 2018, ¶ (6)(ii). We may sustain the rejections even if Appellant’s Specification describes the unclaimed critical variable.3 In this case, the evidence that adequately supports the Examiner’s rejections under §§ 112(a) and 112(b) is Professor Patton’s explanation: Defining the precise stimulation variables is critical and varies depending on the brain region and the type of structure being stimulated . . . . [Appellant’s] application [defines these variables] . . . . For example, optimal stimulation parameters to excite grey matter may differ from white matter. Electrical polarity must also be considered and may preferentially activate one pathway but not another. The incorrect stimulation frequency and/or stimulation intensity can cause damage. All told, the selection of specified stimulation parameters is brain region 3 The Examiner finds that at least paragraph 90 of Appellant’s Specification describes treatment polarity, which the Examiner determines is a critical variable missing from Appellant’s claims, as discussed in further detail below. See Non-Final Action 5. Appeal 2019-006287 Application 15/040,563 4 specific and may even be brain sub-region specific and will be critical for effective long-term activation of a central neural structure. Patel’s application is unequivocal about this. Id. (emphases added). Based on the professor’s explanation, at least the electric polarity is critical to claim 2’s method of treating disease. Notwithstanding Appellant’s arguments (see Appeal Br. 6–9), because claim 2 itself does not recite a critical feature, the Examiner may reject the claim as unsupported by an enabling disclosure under 35 U.S.C. § 112(a) (see In re Mayhew, 527 F.2d 1229, 1233 (CCPA 1976)). Also despite Appellant’s arguments to the contrary (see Appeal Br. 9–11), because claim 2 does not recite a critical feature, the Examiner may reject the claim as incomplete, and, therefore, indefinite under 35 U.S.C. § 112(b) (see In re Collier, 397 F.2d 1003, 1006 (CCPA 1968)). Accordingly, we sustain the § 112 rejections of claim 2. Appellant does not argue separately any of claims 4–7, 11, 13–17, and 27 that depend from independent claim 2.4 Appellant’s arguments regarding claim 26 are the same in substance as Appellant’s arguments for claim 2, and claim 26 does not recite the critical feature of electric polarity. Consequently, because we sustain the § 112 rejections of claim 2, we also sustain the § 112 rejections of claims 4–7, 11, 13–17, 26, and 27. 4 Although Appellant states that “[c]laim 27 depends from claim 26” (Appeal Br. 10), based on our review of the record, it appears that claim 27 depends from claim 2 (see, e.g., id. at Claims App.; see also Submission filed Oct. 1, 2018, at 4 (“27. (New) The method according to claim 2 . . . .”)). Appeal 2019-006287 Application 15/040,563 5 Rejection III—Rejection under 35 U.S.C. § 103 The Examiner purports to reject each of the claims as “unpatentable over Ja[a]x.” Non-Final Action 5; see also id. at 5–9. Over these pages in the Non-Final Office Action, the only reference that the Examiner discusses is Jaax. Id. In the Response to Arguments section, as well as a Response to Amendment section, of the Office Action, however, the Examiner appears to rely on at least four other references—“WO 2007/007058 to Green,” “Green [US] 2014/0039450,” “Bruinstroop [US] 2007/0191903,” and “De Ridder,” which is US Publication no. US 2006/0004422 A1. Non-Final Action 10– 11; see also Answer 7–8. Thus, it is not clear to us on what basis the Examiner actually rejects the claims. Regardless, the Examiner does not support adequately in the Non- Final Office Action, and the Answer, that it would have been obvious to modify Jaax, based on these other references, to provide a method of treating disease comprising applying a neuromodulation signal to the lateral periaqueductal gray (“lPAG”) or ventrolateral periaqueductal gray (“vlPAG”) of a subject having Alzheimer’s Disease and/or Multiple Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or vascular brain disorders where there is small vessel compromise, wherein the neuromodulation signal has a frequency within the range of 5 to 50 Hz, as claimed. In the Answer, for example, the Examiner explains what each of the five above-identified references discloses, and then determines that “[i]t would [have] be[en] ‘obvious to try’ the finite number of identified areas of the PAG to find the right location and obvious to try a limited number of stimulation frequencies under 100 Hz.” Answer 8. As we state above, the Examiner does not support adequately this determination. There are too Appeal 2019-006287 Application 15/040,563 6 many differences between Jaax and claim 2’s method, and among the references themselves, for us to agree with the Examiner’s determination. For example, although the Examiner states that “[i]t is well known and common knowledge in the art to apply stimulation to the vlPAG or IPAG and use a frequency within the range of 5–50 Hz,” the Examiner does not rely on Jaax to disclose either of the claimed specific area of stimulation or the claimed frequency. Id. at 7. Instead, the Examiner appears to rely on the other references to disclose stimulation of various areas of the brain, and various stimulation frequencies, and determines that because Jaax shows some kind of brain stimulation and some frequency, “[i]t would [have] be[en] ‘obvious to try’ the finite number of identified areas of the PAG to find the right location and obvious to try a limited number of stimulation frequencies under 100 Hz” to thereby arrive at the claimed invention. Id. at 8. Without further explanation from the Examiner, however, this is inadequate to support the rejection. CONCLUSION We AFFIRM the Examiner’s §§ 112(a) and 112(b) rejections. We REVERSE the Examiner’s § 103 rejection. Appeal 2019-006287 Application 15/040,563 7 In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2, 4–7, 11, 13–17, 26, 27 112(a) Enablement 2, 4–7, 11, 13–17, 26, 27 2, 4–7, 11, 13–17, 26, 27 112(b) Indefiniteness 2, 4–7, 11, 13–17, 26, 27 2, 4–7, 11, 13–17, 26, 27 103 Jaax 2, 4–7, 11, 13–17, 26, 27 Overall Outcome 2, 4–7, 11, 13–17, 26, 27 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2018). AFFIRMED