Brain Electrophysiology Laboratory Company, LLC

Patent Trials and Appeals Board

Jan 21, 2022

2021004581 (P.T.A.B. Jan. 21, 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. 16/573,182 09/17/2019 Don M. Tucker P 1332.49005 1048 30615 7590 01/21/2022 BIRDWELL & JANKE, LLP 900 SW Fifth Avenue SUITE 1820 PORTLAND, OR 97204 EXAMINER PORTER, JR, GARY A ART UNIT PAPER NUMBER 3792 MAIL DATE DELIVERY MODE 01/21/2022 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 DON M. TUCKER and PHAN LUU ____________ Appeal 2021-004581 Application 16/573,182 Technology Center 3700 ____________ Before KENNETH G. SCHOPFER, AMEE A. SHAH, and ROBERT J. SILVERMAN, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1-20, which are all the claims pending in this application.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Brain Electrophysiology Laboratory, LLC. Appeal Br. 2. 2 Claims 13-15 have been withdrawn. Appeal 2021-004581 Application 16/573,182 2 CLAIMED SUBJECT MATTER The Appellant’s invention “relates to transcranial electrical stimulation (‘TES’) of the brain, and more particularly to a method and system that uses TES for stimulating the neurophysiology of sleep, including deep, or ‘slow wave,’ sleep.” Spec. 1. Claims 1 and 8 are the independent claims on appeal. Claim 1 is illustrative of the subject matter on appeal and is reproduced below (with added bracketed notations for reference): 1. A system for stimulating slow wave sleep in a person, comprising: [(a)] at least one pair of first electrodes; [(b)] a headband structure adapted for first placing the electrodes of each pair of first electrodes on the person’s head in positions that allow for primarily stimulating the person’s orbitofrontal cortex and at least one of the person’s temporal lobes therewith; and [(c)] a TES controller having a user interface enabling a user of the TES controller to configure the TES controller with stimulation parameters for controlling the at least one pair of first electrodes so that one of the electrodes of each pair of first electrodes functions as an anode and the other of each pair of fast electrodes functions as a cathode for passing respective currents through the electrodes of each pair of first electrodes so as to stimulate selected portions of the brain, wherein the TES controller is configured with stimulation parameters suitable for primarily stimulating the person’s orbitofrontal cortex and at least one of the person’s temporal lobes. Appeal Br. Claims App. Appeal 2021-004581 Application 16/573,182 3 REFERENCES The prior art references relied upon by the Examiner are: Name Reference Date Palermo et al. (“Palermo”) US 7,949,403 B2 May 24, 2011 Simons et al. (“Simons”) US 2019/0282812 A1 Sept. 19, 2019 Charlesworth et al. (“Charlesworth”) US 2017/0197081 A1 July 13, 2017 Intan Technologies Inc., “Intan Stimulation/Recording Controller User Guide,” Feb. 6, 2000 (“Intan”) REJECTIONS Claims 1-16 stand rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. Claim 1 stands rejected under 35 U.S.C. § 102(a)(1) and (a)(2) as being anticipated by Intan. Claims 1, 7, 8, and 12-14 stand rejected under 35 U.S.C. § 102(a)(1) and (a)(2) as being anticipated by Charlesworth. Claims 1, 5, 7, 8, 12-14, 18, and 20 stand rejected under 35 U.S.C. § 103 as being unpatentable over Simons and Charlesworth. Claims 2-4, 6, 9-11, 15-17, and 19 stand rejected under 35 U.S.C. § 103 as being unpatentable over Simons, Charlesworth, and Palermo. OPINION 35 U.S.C. § 112(a) - Enablement The Examiner rejects claims 1-16 on the basis that the limitation of “controlling stimulation ‘so as to result in primarily stimulating the person’s orbitofrontal cortex and at least one of the person’s temporal lobes’,” as recited in independent claims 1 and 8, is “not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with Appeal 2021-004581 Application 16/573,182 4 which it is most nearly connected, to make and/or use the invention.” Final Act. 8. Specifically, the Examiner finds that “there are no other guidance or working examples of how this result is achieved and the state of the art,” such as that disclosed in prior art, and when considering the possible infinite combinations of number of electrodes used in addition to stimulus intensity, duty cycle, frequency, etc. that must be considered to create a stimulus regimen, it would appear to place an undue burden on and require undue experimentation by one skilled in the art to attempt to recreate the claimed invention if applying electrical current through the claimed electrode placement is not enough to achieve the claimed result. Id. at 9. The Appellant contends that the rejection of claims 1 and 8 is in error because “[t]he application correctly states that it is important, for the purpose of optimizing stimulation of the claimed brain locations, to have at least one electrode on the forehead, and at least one other electrode on one of the mastoid areas of the neck” (Appeal Br. 6 (citing Spec. 3), and that “[t]o provide the additional information needed to provide the optimization described . . . [above], the application discloses the brain locations to be stimulated” in providing “[t]he ‘orbitofrontal cortex and at least one of the temporal lobes’” (Appeal Br. 6). See also id. at 7. Claim 1 recites an apparatus comprising the structure of a pair of electrodes, a headband adapted to place the electrodes on a person’s head “in positions that allow for primarily stimulating the person’s orbitofrontal cortex and at least one of the person’s temporal lobes therewith,” and a TES controller “configured with stimulation parameters suitable for primarily stimulating the person’s orbitofrontal cortex and at least one of the person’s temporal lobes” and having a user interface. Appeal Br., Claims App. The Appeal 2021-004581 Application 16/573,182 5 placement allowing for stimulating the specific areas with the recited headband is a functional recitation regarding a purpose of the electrode positions and does not affect the claimed structure of the headband. See Final Act. 11. Similarly, the stimulation parameters suitable for stimulating certain areas is a functional recitation regarding the purpose of the parameters and does not change the structure of the parameters of the TES controller. See id. The claim does not require specific areas or locations for placement of the electrodes but merely requires that the electrodes be placed such that they are capable of stimulating the person’s orbitofrontal cortex and one temporal lobe, separately or together, and that the controller be capable of stimulating those areas. The Specification discusses enhancing sleep “by electrically stimulating the temporal lobes and the orbitofrontal cortex of the brain” (Spec. 6; see also id. at 3) by a TES controller controlling electrodes (id. at 7) and provides an example placement to “optimize stimulation of the appropriate brain regions” of one of the pair of electrodes on the forehead and the other electrode of the pair on the neck (id. at 3, 8). Thus, there is sufficient description to enable one skilled in the art to make or use the apparatus with a headband with electrodes capable of stimulating the regions claimed and a controller capable of controlling those electrodes for the purpose of stimulating particular regions. Therefore, we do not sustain the Examiner’s rejection of independent claims 1 and 8 as failing the enablement requirement of 35 U.S.C. § 112(a). We also do not sustain the rejection as it pertains to the dependent claims 2-7 and 9-16, as they were not rejected separately. Appeal 2021-004581 Application 16/573,182 6 35 U.S.C. § 102 - Anticipation Intan We agree with the Appellant’s contention that the Examiner’s rejection of claim 1 as anticipated by Intan is in error because the Examiner has not shown how Intan discloses the structural element of the headband as claimed. See Appeal Br. 8. The Examiner makes no specific findings regarding how Intan discloses the claimed headband. See Final Act. 10-11. Rather, the Examiner appears to rely on Intan solely for disclosing the TES controller configured to control electrodes to stimulate portions of the scalp. See id.; see also Ans. 16. And, we do not readily see where Intan discusses a headband or headband-type structure. Therefore, we do not sustain the Examiner’s rejection of claim 1 as under 35 U.S.C. § 102 as anticipated by Intan. Charlesworth The Appellant contends that the Examiner’s rejection of independent claims 1 and 8 as anticipated by Charlesworth is in error because “Charlesworth doesn’t even claim to stimulate sleep.” Appeal Br. 9; see also Reply Br. 6-8. This argument is not persuasive first because “for stimulating slow sleep wave sleep in a person,” as recited in the preambles of claims 1 and 8, merely provides a context in which the invention may be used and does not limit the claim. See Boehringer Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). The preamble adds no limitations on the structure recited in claim 1, and the steps of the method of claim 8 would perform in the same way regardless of whether the stimulation is for cognitive effect or for sleep. See Rowe v. Appeal 2021-004581 Application 16/573,182 7 Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001) (holding that the preamble language, stating that method was “for reducing hematologic toxicity,” did not further limit the claim; “The steps of the . . . method are performed in the same way regardless whether or not the patient experiences a reduction in hematologic toxicity, and the language of the claim itself strongly suggests the independence of the preamble from the body of the claim.”). The Appellant does not contest the Examiner’s findings that Charlesworth discloses the system comprising a pair of electrodes, a headband adapted to position the electrodes, and a TES controller having a user interface. This argument is also not persuasive because Charlesworth discloses that one use of the TES system causes a cognitive effect of sleep. Charlesworth ¶ 23. Specifically, Charlesworth discloses using TES based on parameters adapted to cause a cognitive effect. See id. ¶ 24. The nature or class of the cognitive effects depends in part on the positioning of electrodes to a person’s body. Id. ¶ 22. One such class of cognitive effects “includes those associated with relaxation and a calm mental state, for example: a state of calm . . .; a care-free state of mind; a mental state free of worry; induction of sleep; a slowing of the passage of time; [and] enhanced physiological, emotional, or and/or muscular relaxation,” and others. Id. ¶ 23. Thus, the Examiner’s findings that Charlesworth discloses a system and method for stimulating sleep (Final Act. 12; Ans. ¶ 17) is supported. Appeal 2021-004581 Application 16/573,182 8 To the extent the Appellant argues that Charlesworth does not disclose the specific electrode positions for stimulating sleep as claimed (see Appeal Br. 6, 9-10; Reply Br. 6-8, 10-11), we are not persuaded of Examiner error by this argument. As discussed above with respect to the rejection under 35 U.S.C. § 112, the claims do not require specific positions for the electrodes; rather, the claims merely require that the electrodes be placed such that they are capable of stimulating the orbitofrontal cortex and temporal lobe. Charlesworth discusses that the electrodes can be positioned in a way to effect a desired result, and that the result can be to stimulate a cognitive effect of sleep. See supra. Charlesworth further discloses that these positions can be on the head and neck (Charlesworth ¶¶ 22, 24), for example the first electrode on the head or neck and the second electrode on the head or neck (id. ¶ 24). Although the drawings may not be to scale (Appeal Br. 6, 9; Reply Br. 6), one of ordinary skill in the art would understand Figures 2E-2H, and in particular Figure 2G, to show that the electrodes can be placed on the forehead and neck, as described in the written disclosure of Charlesworth and similar to the Appellant’s example described in the Specification. See supra. To the extent the Appellant argues that Charlesworth does not teach “primarily” stimulating the brain locations claimed (Reply Br. 8; see also Appeal Br. 10), we note that as discussed above, the claims only require that the controller and controlling be capable of stimulating those areas. Charlesworth’s TES control module is capable of stimulating specific areas based on electrode positions and parameters. See Charlesworth ¶ 20-22, 24, 50. We further note that the claims do not recite what the term “primarily” means; that is, the claims do not differentiate between primarily stimulating Appeal 2021-004581 Application 16/573,182 9 certain areas and simply stimulating the claimed areas, i.e., the degree to which the areas need to be stimulated to be primarily stimulated over other areas. Thus, we sustain the Examiner’s rejection of independent claims 1 and 8 under 35 U.S.C. § 102 as anticipated by Charlesworth. We also sustain the rejection of dependent claims 7 and 12-14 under this same ground as the Appellant provides no separate argument regarding these claims. 35 U.S.C. § 103 - Obviousness The Examiner finds that Simons teaches the apparatus of claim 1 comprising a pair of electrodes, a headband, and a TES controller as claimed, and the method of claim 8 comprising the steps of providing, placing, and controlling the electrodes, but does not teach the TES controller having a user interface. See Final Act. 13. The Examiner relies on Charlesworth to remedy this deficiency, determining that it would have been obvious to “modify the device in the Simons reference to include a stimulator with a user interface, as taught and suggested by Charlesworth, for the purpose of providing ease of access and use to the stimulator while reducing overall hardware costs of the stimulation device.” Id. at 13-14. The Appellant contends that the Examiner’s rejection of independent claims 1 and 8 as obvious over Simons in view of Charlesworth is in error because “merely positioning the electrodes generally as shown in Simons and Charlesworth is not a sufficient condition for stimulating sleep at all, let alone for optimally or ‘primarily’ stimulating sleep as required by the claims.” Appeal Br. 10; see also id. at 6, Reply Br. 8-9. This argument is not persuasive for the reasons provided with respect to the 35 U.S.C. § 102 Appeal 2021-004581 Application 16/573,182 10 rejection as anticipated by Charlesworth. That is, the argument is unpersuasive because “for stimulating slow sleep wave sleep in a person,” as recited in the preambles of claims 1 and 8, does not limit the claims, and the Appellant does not contest the Examiner’s findings that Simons discloses the system comprising a pair of electrodes, a headband adapted to position the electrodes, and a TES controller. It is also unpersuasive because the Examiner’s finding that Simons discloses a system and method for stimulating sleep (Final Act. 13) is supported. Simons teaches a system for delivering targeted electrical stimulations that can enhance sleep such as by improving or prolonging a person’s time in deep sleep. Simons ¶ 35. The argument is also unpersuasive as it pertains to Charlesworth. See Appeal Br. 10. The Appellant does not contest the Examiner’s finding that Charlesworth teaches a TES controller having a user interface. And, the Appellant admits that the Appellant “has never claimed that it is special for a TES ‘computing system’ to have a user interface, and [the Appellant] is not claiming to have made any improvements to TES user interfaces.” Id. To the extent the Appellant argues that Simons does not disclose the specific electrode positions for stimulating sleep as claimed (see Appeal Br. 6, 9-10; Reply Br. 6-8, 10-11), we are not persuaded of Examiner error by this argument. As discussed above, the claims do not require specific positions for the electrodes; rather, the claims merely require that the electrodes be placed such that they are capable of stimulating the orbitofrontal cortex and temporal lobe. Simons discusses that the electrodes can be positioned in a variety of positions including on the forehead and behind the ears, i.e., upper neck. See Simons ¶ 37. Although the drawings may not be to scale (Appeal Br. 6, 9; Reply Br. 6), one of ordinary skill in Appeal 2021-004581 Application 16/573,182 11 the art would understand Simons’s Figures 1 and 19A, in particular Fig. 19A, to show that the neurostimulation electrodes can be placed on the forehead and neck, as described in the written disclosure of Simons and similar to the Appellant’s example described in the Specification. To the extent the Appellant argues that Simons does not teach “primarily” stimulating the brain locations claimed (Reply Br. 8; see also Appeal Br. 10), we note that as discussed above, the claims only require that the controller and controlling be capable of stimulating those areas. Simons’s TES system is capable of stimulating specific areas based on electrode positions and parameters. See supra. We further note that the claim does not recite what the term “primarily” means; that is, the claim does not differentiate between primarily stimulating certain areas and simply stimulating the claimed areas, i.e., the degree to which the areas need to be stimulated to be primarily stimulated. Thus, we sustain the Examiner’s rejection of independent claims 1 and 8 under 35 U.S.C. § 103 as obvious over Simons and Charlesworth. We also sustain the Examiner’s rejections under 35 U.S.C. § 103 of dependent claims 2-7 and 9-20, for which the Appellant provides no separate argument. CONCLUSION The Examiner’s decision to reject claims 1-20 is affirmed. In summary: Claim(s) Rejected 35 U.S.C. § References/ Basis Affirmed Reversed 1-16 112(a) Enablement 1-16 Appeal 2021-004581 Application 16/573,182 12 Claim(s) Rejected 35 U.S.C. § References/ Basis Affirmed Reversed 1 102(a)(1) 102(a)(2) Intan 1 1, 7, 8, 12-14 102(a)(1) 102(a)(2) Charlesworth 1, 7, 8, 12-14 1, 5, 7, 8, 12-14, 18, 20 103 Simons, Charlesworth 1, 5, 7, 8, 12-14, 18, 20 2-4, 6, 9-11, 15-17, 19 Simons, Charlesworth, Palermo 2-4, 6, 9-11, 15-17, 19 Overall Outcome 1-20 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). AFFIRMED