DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed December 17, 2025 has been entered. Claims 1, 19, 30-31 have been amended. Claim 16 states it is “currently amended” but there are no amendments made to this claim. Claims 3-8, 10-11, 21-29 are canceled. Currently, claims 1-2, 9, 12-20 and 30-32 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 1-4, filed December 17, 2025, with respect to the rejection(s) of claim(s) 1-2, 9, 12-20 and 30-32 under 35 U.S.C. 103have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Badran et al. (US 2022/0296889) and Bansal et al. (US 2023/0031262).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9, 12-20 and 30-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite the limitation, “wherein the at least one motor learning task is first performed at least 10 days after occurrence of a demyelination event in the subject”. The phrase, “a demyelination event” is considered a broad genus claim but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The specification provides examples of demyelination diseases, disorders and conditions that could be treated using the claimed method ([0048]) but do not recite all demyelination events that are in existence. Through the recitation of “a demyelination event”, applicant is attempting to claim other demyelination diseases, disorders and conditions not currently recited by and supported by the specification.
Claims 9, 12-20 is rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim 30 is rejected to for the same reasons as claim 1.
Claims 31-32 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 30.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 9, 12-20 and 30-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite the limitation, “wherein the at least one motor learning task is first performed at least 10 days after occurrence of a demyelination event in the subject”. This limitation by itself is indefinite because the metes and bounds of the claim cannot be interpreted so as to understand how to avoid infringement. Looking at the demyelination diseases, disorders and conditions recited in paragraph [0048] as an example, a traumatic brain injury or concussion as an occurrence of a demyelination event comprises a measurable point in time to start counting the at least 10 days, but for longer term events such as Amyotrophic lateral sclerosis (ALS), Alzheimer’s, Parkinson’s or Huntington’s disease, it would be unclear at what point of time for those events to consider as “a demyelination event” and to determine when to start the counting of the at least 10 days.
Claim 2 recites the limitation “wherein the motor learning task is performed after the subject has suffered a demyelination event comprising a traumatic brain injury (TBI) or concussion” in lines 1-2. However claim 1 now recites “wherein the at least one motor learning task is first performed at least 10 days after occurrence of a demyelination event in the subject”. There is insufficient antecedent basis for this limitation in the claim. If applicant is intending the demyelination event in claim 2 to reference the demyelination event of claim 1, then claim 2 should be amended to recite, “wherein the demyelination event comprises a traumatic brain injury (TBI) or concussion”.
Claims 9, 12-20 is rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim 30 is rejected to for the same reasons as claim 1.
Claim 31 recites the limitation "the TBI, the accident, or the concussion in the subject" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claims 31-32 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 30.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 9, 12-20 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pruitt et al. (“Vagus Nerve Stimulation Delivered with Motor Training Enhances Recovery of Function after Traumatic Brain Injury.” J Neurotrauma. 2016 May 1;33(9):871-9) in view of Badran et al. (US 2022/0296889) and Bansal et al. (US 2023/0031262).
Regarding claims 1-2 and 17-18, Pruitt et al. discloses a method for treating a demyelination disease, disorder or condition in a subject (“traumatic brain injury”, as categorized by applicant’s own specification in [0043] of the published application), the method comprising: stimulating a vagus nerve of the subject; having the subject perform at least one motor learning task; and causing the stimulation to occur before, at the same time as, or after the subject performs the motor learning task (“Here we have tested the hypothesis that vagus nerve stimulation (VNS) paired with physical rehabilitation could enhance functional recovery after TBI.” p. 871, Abstract; “receive VNS paired with successful trials during rehabilitative training (VNS + Rehab)” p. 872 Behavioral training).
Pruitt et al. discloses stimulating the vagus nerve invasively (“They were then implanted with a vagus nerve cuff” p. 872 Behavioral training) and does not expressly disclose the stimulating the vagus nerve of the subject is non-invasively and from a site external to the body, wherein the site comprises a neck region of the subject. Badran et al. teaches an equivalent alternative of providing invasive vagus nerve stimulation ([0004]) is transcutaneous vagus nerve stimulation ([0006]) where the stimulation site is at the neck area 112 of the subject 108 ([0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pruitt et al. to substitute and try transcutaneous vagus nerve stimulation at the neck region of the subject as taught by Badran et al. as it is a known equivalent to invasive vagus nerve stimulation, thus providing a “noninvasive, simple, and rapid translation of cervically implanted VNS findings” 9[0006]), such a modification being reasonably predictable.
Pruitt et al. discloses wherein the at least one motor learning task is performed at least 9 days after occurrence of a demyelination event in the subject (fig. 1 describes 1 week rest + 2 days baseline before rehabilitative therapy +/- VNS) but does not expressly disclose wherein the at least one motor learning task is performed at least 10 days after occurrence of a demyelination event in the subject. Bansal et al. teaches that after a traumatic brain injury, it is known in the art to rest from a range of a couple of weeks to a couple of months as the initial treatment before starting physical therapy (regarded as motor learning tasks) ([0068]). It would have been a matter of routine optimization to select “at least 10 days” as the waiting period after the occurrence of the demyelination event in the subject to perform the at least one motor learning task as Bansal et al. teaches a resting period of a couple of weeks is known in the art and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, Pruitt et al. discloses wherein at least one motor learning task comprises at least one of a fine motor skill or a gross motor skill (“Animals were trained to pull on the handle with 120g of force” p. 872, Behavioral training).
Regarding claim 12, Pruitt et al. discloses wherein the stimulating the vagus nerve in the subject comprises electrical stimulation (p. 872, Stimulation parameters).
Regarding claim 13, Pruitt et al. discloses wherein the electrical stimulation comprises using about 0.05 to about 100 milliamperes or about 0.5 to about 20 milliamperes electrical current (p. 872 Stimulation parameters).
Regarding claim 14, Pruitt et al. discloses wherein the electrical stimulation comprises about 1 microsecond (µs) to about 1 millisecond (ms) or about 10 to about 100 microsecond (µs) electrical pulses (p. 872 Stimulation parameters).
Regarding claim 15, Pruitt et al. discloses wherein the electrical stimulation comprises a frequency of about 0.3 to about 3000 Hz or about 3 to about 300 Hz (p. 872 Stimulation parameters).
Regarding claim 16, Pruitt et al. discloses administering a pharmaceutical composition to the subject (“4 mg Rimadyl” p. 872 Surgical procedures). The limitation, “and reducing progression of, and/or reducing demyelination in a subject” is regarded as a “whereby” clause that is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Regarding claim 19, Pruitt et al. in view of Bansal et al. disclose wherein the at least one motor learning task is performed at least 14 days after occurrence of the TBI, accident, or concussion of the patient (see claim 1).
Regarding claim 20, Pruitt et al. discloses wherein performing the at least one motor learning task comprises performing at least one motor learning task multiple times per day, twice per day, daily, every other day, a couple times a week or other pre-determined regimen (“Animals underwent training for two 30-min sessions per day 5 days per week, with at least 2 h between sessions” p. 872 Behavioral training).
Regarding claim 30, Pruitt et al. discloses a method for treating a demyelination disease, disorder or condition in a subject (“traumatic brain injury”, as categorized by applicant’s own specification in [0043] of the published application), the method comprising: stimulating a vagus nerve of the subject; having the subject perform at least one motor learning task; and actuating the vagus nerve stimulation using control logic to deliver the stimulation (“stimulator” p. 872, Stimulation parameters) before, at the same time as, or after the subject performs the motor learning task (“Here we have tested the hypothesis that vagus nerve stimulation (VNS) paired with physical rehabilitation could enhance functional recovery after TBI.” p. 871, Abstract; “receive VNS paired with successful trials during rehabilitative training (VNS + Rehab)” p. 872 Behavioral training).
Pruitt et al. discloses stimulating the vagus nerve invasively (“They were then implanted with a vagus nerve cuff” p. 872 Behavioral training) and does not expressly disclose the stimulating the vagus nerve of the subject is non-invasively and from a site external to the body, wherein the site comprises a neck region of the subject. Badran et al. teaches an equivalent alternative of providing invasive vagus nerve stimulation ([0004]) is transcutaneous vagus nerve stimulation ([0006]) where the stimulation site is at the neck area 112 of the subject 108 ([0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pruitt et al. to substitute and try transcutaneous vagus nerve stimulation at the neck region of the subject as taught by Badran et al. as it is a known equivalent to invasive vagus nerve stimulation, thus providing a “noninvasive, simple, and rapid translation of cervically implanted VNS findings” 9[0006]), such a modification being reasonably predictable.
Pruitt et al. discloses wherein the at least one motor learning task is performed at least 9 days after occurrence of a demyelination event in the subject (fig. 1 describes 1 week rest + 2 days baseline before rehabilitative therapy +/- VNS) but does not expressly disclose wherein the at least one motor learning task is performed at least 10 days after occurrence of a demyelination event in the subject. Bansal et al. teaches that after a traumatic brain injury, it is known in the art to rest from a range of a couple of weeks to a couple of months as the initial treatment before starting physical therapy (regarded as motor learning tasks) ([0068]). It would have been a matter of routine optimization to select “at least 10 days” as the waiting period after the occurrence of the demyelination event in the subject to perform the at least one motor learning task as Bansal et al. teaches a resting period of a couple of weeks is known in the art and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 31, Pruitt et al. in view of Bansal et al. disclose wherein the at least one motor learning task is performed at least 14 days after occurrence of the TBI, accident, or concussion of the patient (see claim 30).
Regarding claim 32, Pruitt et al. discloses wherein performing the at least one motor learning task comprises performing at least one motor learning task multiple times per day, twice per day, daily, every other day, a couple times a week or other pre-determined regimen (“Animals underwent training for two 30-min sessions per day 5 days per week, with at least 2 h between sessions” p. 872 Behavioral training).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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