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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 and 19-22 in the reply filed on 10/16/2025 is acknowledged.
Claims 15-18 and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/26/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16365676, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The usage of random pulse intervals, EEG variability patterns, and alpha spindle events are not disclosed in the prior-filed application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/26/2023 is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1-14 and 21-22 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 recites the limitation “for a time sufficient to create stochastic resonance in the mammal and modulate said brain activity” in lines 2-3. This limitation is unclear because the claim attempts to define the limitation based on a result to be achieved while not defining what is involved in determining the time bounds to create the result.
Claims 2-3 and 11-14 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 4 recites the limitation “for a time sufficient to modulate said brain activity” in line 4. This limitation is unclear because the claim attempts to define the limitation based on a result to be achieved while not defining what is involved in determining the time bounds to create the result.
Claims 5-7 inherit the deficiencies of claim 4 and are likewise rejected.
Claim 5 is unclear. The claim appears to further limit the random pulse intervals using an undefined step not recited in the preceding claims and its result. It is not clear if the undefined, unrecited step is meant to be part of the claimed method. It is also not clear what is involved in obtaining the claimed result.
Claims 6-7 inherit the deficiencies of claim 5 and are likewise rejected.
Claim 8 recites the limitation “for a time sufficient to modulate said brain activity” in line 8. This limitation is unclear because the claim attempts to define the limitation based on a result to be achieved while not defining what is involved in determining the time bounds to create the result.
Claim 9 inherits the deficiencies of claim 8 and is likewise rejected.
Claim 10 recites the limitation “for a time sufficient to reduce addiction symptoms” in line 9. This limitation is unclear because the claim attempts to define the limitation based on a result to be achieved while not defining what is involved in determining the time bounds to create the result.
Claim 21 is unclear. The claim appears to further limit the random pulse intervals using an undefined step not recited in the preceding claims and its result. It is not clear if the undefined, unrecited step is meant to be part of the claimed method. It is also not clear what is involved in obtaining the claimed result (the random magnetic pulses that produce a stochastic resonance).
Claim 22 inherits the deficiencies of claim 21 and is likewise rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0175589 (Wingeier).
In regards to claims 1-4, Wingeier discloses a method and system for providing electrical stimulation to a user (title and abstract; paragraphs 16-141). Wingeier discloses a method of modulating a brain activity of a mammal (see paragraphs 16-56 state the process of modulating brain activity and paragraph 59 states that the user can be a human (a type of mammal)):
subjecting the mammal to transcranial magnetic stimulation (TMS) (paragraphs 16-56 describe the electrical stimulation of the mammal with TMS being one of the ways to provide the stimulation (paragraph 29)) having random pulse intervals (paragraph 32 describes waveforms that use random pulse durations; figures 2B-D).
Wingeier discloses in paragraphs 33-50 describes modulating the stimulation signals based on received EEG signals from the user (deriving the pulse intervals from the EEG data), which requires administering EEG to the user, which meets the EEG limitations of claims 3 and 4.
Due to the 112 issue of the claim with regards to “a time sufficient to create stochastic resonance in the mammal and modulate said brain activity”, Wingeier would currently meet the limitations of the claims.
In regards to claim 14, Wingeier discloses the limitations of claim 1. In addition, paragraphs 19, 59, 80-81 disclose the various uses of the device and method which include treatments to improve neural plasticity of stroke patients, improve neurological states of user for memory function, focus, attention, and motor ability. These would meet the memory impairment ADHD, improving athletic performance, and stroke limitations of the claim.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0175589 (Wingeier) as applied to claim 1 above, and further in view of US 2019/0082990 (Poltorak).
In regards to claim 11, Wingeier discloses the limitations of claim 1, but does not state that the TMS stimulation is below the motor threshold of the mammal. In a related area, Poltorak discloses a method and apparatus for neuroenhancement (title and abstract). Poltorak states in paragraph 173 and 291 shows TMS being performed as single pulses or as pairs of pulses separated by a variable time interval in a repetitive manner (rTMS). Paragraphs 619-635 show the use of TMS on a mammalian subject (note that the subjects used in the reference are human brain entrainment subjects). Poltorak also discloses in paragraphs 173, 176, and 290 that in another study subthreshold stimulation is used modify the susceptibility of cells to depolarization and induces a polarity shift in neuronal excitability. Thus, it would have been obvious to one of ordinary skill in the art before the claimed invention was filed to modify the method of Wingeier to use sub-threshold stimulation in the mammal as taught by Poltorak to modify the susceptibility of cells to depolarization.
In regards to claims 12-13, Wingeier and Poltorak disclose the limitations of claim 11. Poltorak discloses subthreshold stimulation, which covers the range below motor threshold. While Poltorak does not explicitly state the claimed ranges, Applicant has not disclosed the criticality of the claimed range. It would be obvious to one of ordinary skill in the art to arrive at the claimed range before the filing date of the invention because it is the normal desire to scientist and artisans to improve upon what is already generally known to determine an optimum combination of percentages (MPEP 2144.05 — optimization of ranges).
Allowable Subject Matter
Claims 19-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 19, the prior art of record does not teach or suggest a method, as claimed by Applicant, that includes the following combination of steps:
analyzing an EEG data set to identify alpha spindle events resulting in an EEG signal pattern,
using the EEG signal pattern to program a TMS apparatus to deliver magnetic stimulation (TMS) having random pulse intervals and
subjecting the patient to random transcranial magnetic stimulation from said programmed TMS apparatus.
Claim 20 is dependent on allowed matter from claim 19 and would be allowable.
Conclusion
The examiner notes that, though no art has been applied against claims 5-10 and 21-22 at this time, they are not presently allowable. The question of prior art will be revisited upon resolution of the numerous issues noted above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791