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 .
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 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.
Status of Claims
Claims 1-24 are pending and under consideration for patentability; claims 1, 3, 4, 6-10, 12, and 14-24 have been amended.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 15 January 2025 has been acknowledged and considered by the Examiner.
The Examiner notes that the IDS dated 15 January 2025 numbers 241 pages and contains over 6,200 entries. Applicant should note that the large number of references in the attached IDS have been considered by the Examiner in the same manner as other documents in Office search files are considered while conducting a search of prior art. Please see MPEP 609.05(b). Applicant is requested to direct the Examiner to any references in the IDS which may be of particular relevance to the presently claimed invention in response to this Office Action.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19 and amended claims 20-24) in the reply filed on 14 October 2025 is acknowledged.
Applicant’s amendments to claims 20-24 has rendered moot the previous Restriction/Election Requirement, and the restriction requirement is hereby withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-24 are rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility.
A deficiency under the utility prong of 35 U.S.C. 101 also creates a deficiency under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
The claimed invention of a method of brain entrainment comprising extracting a dominant brainwave frequency from a donor and stimulating a subject with the donor’s dominant brainwave frequency in order to assist the subject in achieving the same desired brain state as the donor lacks any specific, substantial, and credible utility.
Applicant has not provided any description in the disclosure or any other evidence of record in the form of test data, affidavits, or scientific publications, to establish the credibility of the claimed invention. To the contrary, Applicant’s own admitted prior art and Applicant’s own Specification speak to the theoretical, speculative, and outright incredibility of the claimed invention. Applicant repeatedly refers to the claimed invention in vague and theoretical terms, as highlighted below, without any evidence that the claimed method actually works or has ever worked in any environment.
[0040]: “Theoretical studies have explored phenomena such as propagation of activity in spatially structured networks and formation of patterned activity in neural fields, by means of traveling waves”
[0158]: “The entrainment hypothesis, suggests the possibility of inducing a particular oscillation frequency in the brain using an external oscillatory force (e.g., rTMS, but also tACS). … Because of the variety of experimental protocols for brain stimulation, limits on descriptions of the actual protocols employed, and limited controls, consistency of reported studies is lacking, and extrapolability is limited. Thus, while there is some consensus in various aspects of the effects of extra cranial brain stimulation, the results achieved have a degree of uncertainty dependent on details of implementation. …feedback control might be effective to control implementation of the stimulation for a given purpose; however, prior studies that employ feedback control are lacking.”
[0983]: “The concept of brain states has also been referred to as “mental states”. (Poltorak 2019) There is poor consensus about what mental states are and the nature of their relationship with the brain. According to identity theory, mental states are identical with brain states (Payne 2021). Others disagree (Chalmers 1995).”
[0994]: “neither recording nor stimulation techniques have access to all physiological processes that (at least in theory) contribute to a brain state.”
Applicant also fails to disclose enough information about the invention to make its usefulness immediately apparent to those familiar with the technological field of the invention.
Further documentary evidence supporting the Examiner’s rejection based on lack of utility is provided by Applicant’s own prior art (Poltorak, Front Hum Neurosci. 2021Sep 22:15:710003), which was published in the “Hypothesis and Theory” section of the journal and discusses the speculative and theoretical nature of Applicant’s work. The Examiner respectfully highlights the following sections from the Frontiers in Human Neuroscience publication.
p.2: The complexity of neural activity suggests that the reduction of brain states to an oscillatory signal of a single frequency can be expected to fail to capture the full complexity of brain states. Indeed, the conventional focus on individual oscillations and frequency bands as signatures of brain states is limiting…We hypothesize that taking into account the rich temporal structure of brain activity beyond a single (dominant) frequency in the spectrum should enable more effective brain entrainment through stimulation.
pp. 2-3: To be sure, brain waves are not identical with brain states and may not contain all information encoded in brain states. Measurements of brain waves, of course, are subject to all the limitations (such as noise or signal averaging across vast numbers of neurons) of the instruments being utilized, and loss of information is inevitable. However, we posit a bilateral correlation between brain waves and brain states….We hypothesize that specific spatiotemporal patterns of neural activity in the brain that are correlated with particular brain states can also cause these brain states…we posit a causal relationship that can be experimentally investigated.
p. 5: The complexity of identifying and transplanting brain states should not be underestimated. … It is not immediately obvious which is the correct level to be acquiring and transplanting patterns that would affect changes in behavior (that is, mental states)… More research is needed to better understand the representation patterns of specific cognitive states.
p. 5: these findings provide the basis for our hypothesis that brain states can be “transplanted” (transferred)…theoretical considerations suggest that this hypothesis is plausible and deserves experimental verification
Based at least on the above passages, it is clear that Applicant describes his own work as being at the theoretical, hypothetical stage and lacking experimental verification. As a result, it is also clear that the work, being at the theoretical stage with no experimental verification, is not operative.
An invention that is “inoperative” (i.e., it does not operate to produce the results claimed by the patent applicant) is not a “useful” invention in the meaning of the patent law. See, e.g., Newman v. Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989); In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968) (“An inoperative invention, of course, does not satisfy the requirement of 35 U.S.C. 101 that an invention be useful.”) In the instant case, not only does the claimed invention lack perfection or perform crudely, but Applicant provides no evidence of even a small degree of utility. As argued further herein, even the first step of extracting a dominant brainwave frequency that is responsible for a desired brain state has not been proven to be possible. Therefore, the more complex subsequent steps of stimulating a subject with that dominant brainwave frequency in order to achieve the same brain state as the donor is simply not possible. Applicant has provided no evidence that the claimed method operates to produce the claimed results.
Therefore, Applicant’s invention is wholly inconsistent with contemporary knowledge in the art, and Applicant has not disclosed a specific and substantial utility for the invention. On the record before the Examiner, the invention does not have a known or readily apparent well-established utility.
Claims 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a credible asserted utility or a well-established utility.
As described at length in the section above, Applicant has not provided any evidence that the claimed invention is anything more than theoretical, hypothetical, and speculative. Applicant also has not provided any evidence that the claimed method of transferring a brain state from one user to an other is scientifically possible.
Claims 1-24 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. To be sure, providing simulation to a subject with similar parameters as those derived from a donor is enabled, and has been for decades. But, identifying and extracting a dominant brainwave frequency that is responsible for a donor’s brain state is not enabled. Providing stimulation based on that donor’s dominant brainwave frequency to a subject in order to induce, in the subject, the same brain state as the donor is not enabled. Stimulation currents do not carry emotions and cannot transfer emotions from a donor to a recipient, and to suggest otherwise renders the pending claims non-enabling. A more detailed discussion of the rejection under 35 U.S.C. 112(a) is provided below.
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 1-24 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Because the invention as claimed does not have utility, a person skilled in the art would not be able to use the invention as claimed, and as such, the claims are defective under 35 U.S.C. 112(a). Please see MPEP 2107.01-IV (“If the application fails as a matter of fact to satisfy 35 U.S.C. § 101, then the application also fails as a matter of law to enable one of ordinary skill in the art to use the invention under 35 U.S.C. § 112.” In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993)).
The nature of the invention is drawn to a method of brain entrainment comprising extracting, from a donor, a dominant brainwave frequency corresponding to a desired brain state, detecting an endogenous dominant brainwave frequency from a subject desirous of the brain state that the donor has, and stimulating the subject in order to change the endogenous dominant brainwave frequency to the extracted dominant brainwave frequency in order to allow the subject to achieve the same brain state as the donor. Stated in another way, the claimed invention purports to induce an emotional state in a subject simply by stimulating the subject with a frequency similar to that obtained from a donor.
However, the relationship between a brain state and a dominant brainwave frequency has not been established and therefore has no degree of causality. For example, one cannot probe something so subjective as a brain state in a donor and definitively extract a brainwave frequency that can be said to be responsible for that brain state. Similarly, one cannot stimulate a subject with the extracted dominant brainwave frequency and definitely induce that same brain state in the subject. If such a concept was possible, it would mean that there would be a “happy” dominant brainwave frequency that could be used to stimulate everyone in the world and make them happy. For as wonderful as this may seem, it is, of course, scientifically not possible.
As discussed in the section above, Applicant’s own specification describes the invention in broad, theoretical terms and does not include any concrete evidence of entraining a subject by stimulating the subject’s brain with an external stimulus based on a donor’s brain state. The method steps may be performed to a small extent (a brainwave frequency can be detected and extracted, and a subject can be stimulated with that same frequency). However, ensuring that the extracted dominant brainwave frequency is responsible for a desired brain state is not possible. Achieving the result of transplanting a brain state from a donor to a subject cannot be completed. The concept of transplanting or transferring a desired brain state (a waking state, relaxation state, and/or emotional state) from one user to another is theoretical at best and has no credible scientific evidence of working with any degree of predictability.
Applicant’s claimed method does not appear to be accepted by the scientific community at large, and the current state of the art does not provide any proof of Applicant’s theories. Applicant’s Specification provides no examples of how this method may work with any degree of reliability or even whether the claimed method would work at all. Applicant also provides no examples of the claimed method working in any model (small animal, large animal, human, or in vitro). One key question to ask is this - can one stimulate a subject with a particular dominant brainwave frequency to induce a particular brain state? The answer, based on the accepted current state of the art of the scientific community as stated by the Applicant himself, is that such a stimulation cannot be performed in any predictable manner. Even before the stimulation occurs, Applicant would need to establish that the dominant brainwave frequency that corresponds to a particular brain state can be reliably identified and extracted. However, due to the complexities of the human brain and the current scientific constraints, there has not been any proposed method that can reliably and precisely determine the brain patterns responsible for a particular brain state.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” The Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. The Examiner lists some of the Wands factors below and briefly addresses why the instant application is not in compliance with the enablement requirement of 35 U.S.C. 112(a) based on the Wands factors.
(A) The breadth of the claims. The claims are directed towards assisting a subject in achieving a desired brain state, with examples of the desired brain state being a sleeping state, a waking state, a relaxation state, a state of hyper-focus, a state of flow, a state of altered consciousness, a meditative state, and an emotional state. However, the specification does not describe how to extract the dominant brainwave frequencies associated with any of these states, which dominant brainwave frequencies are correlated with each of these states, how to achieve any of these states in a subject, or even what the quantifiable differences are in each of these states. Applicant also does not clarify the scope of each of these states - for example, what is considered a “state of flow” and what emotions are covered by “an emotional state.” The Examiner respectfully submits that the breadth of the claims is unpredictably wide, and, as will become clear based on the analysis below, the wide breadth of enablement is not commensurate in scope with the claims.
(B) The nature of the invention. As described above, the invention pertains to inducing an emotional state in a subject by stimulating the subject with a frequency similar to that obtained from a donor. Applicant’s Specification does not describe how a dominant brainwave frequency may be identified and extracted from a donor in any predictable manner, nor does Applicant provide any evidence that stimulating a subject with the same dominant brainwave frequency will reliably induce the same emotional state as that of the donor.
(C) The state of the prior art. The prior art, including Applicant’s own prior art, describes the claimed invention in hypothetical, theoretical, and speculative terms. The prior art does not provide any evidence that the method described by Applicant could work, much less work consistently and reliably. The prior art and Applicant’s Specification both speak to the contrary, highlighting the complexity of the human brain, the limitations of current scientific knowledge, and the lack of evidence linking a dominant brainwave frequency to a desired brain state. For example, Sandberg writes that “brain emulation is currently only a theoretical technology…vulnerable to speculation, “handwaving” and untestable claims…it is important to emphasize the long‐term and speculative nature of many aspects of this roadmap, which in any case is to be regarded only as a first draft - to be updated, refined, and corrected as better information becomes available…difficulties and uncertainties inherent in this type of work” (Sandberg, A. & Bostrom, N. (2008): Whole Brain Emulation: A Roadmap, Technical Report #2008‐3, Future of Humanity Institute, Oxford University, p.6). In terms of imaging the donor’s brain in order to detect and extract a dominant brainwave frequency, Sandberg offers the following advice, “at present, electron microscopy appears to be the only scanning method that has the right resolution to reach synaptic connectivity, but it is limited in what chemical state information it can reveal” (ibid., p. 25). Bamford similarly writes that “"whole brain emulation", "mind uploading" and "substrate-independent minds" have been used informally in recent years to describe a set of related ideas regarding hypothetical possibilities for transferring or emulating the functioning of a human’s brain or "mind" on a synthetic substrate…it should be clear from the outset that these ideas require a great deal of speculation and rest on some difficult-to-define concepts” (Bamford, S., A Framework for Approaches to Transfer of a Mind’s Substrate. International Journal of Machine Consciousness Vol. 4, No. 1 (2012) 23-34). These references speak to one of the critical limitations in Applicant’s claims which renders the claims non-enabling, in particular that it is not possible to scan the brain state within a donor’s mind completely, and therefore there is no way to transfer the donor’s brain state to another subject.
(D) The level of one of ordinary skill. A person skilled in the neurostimulation arts readily would be able to provide stimulation to a subject in order to induce an evoked response or capture event. However, based on all of the evidence of record, including Applicant’s own work, the skilled artisan would not be able to positively identify a particular dominant brainwave frequency as being responsible for a desired brain state, and the skilled artisan would not be able to provide that same stimulation to a subject in order to induce the same brain state in the subject. Applicant seems to agree, when stating “there is poor consensus about what mental states are and the nature of their relationship with the brain” ([0983]) and “neither recording nor stimulation techniques have access to all physiological processes that (at least in theory) contribute to a brain state” ([0994]).
(E) The level of predictability in the art. As described above, no evidence has been provided to indicate that the skilled artisan can predicably induce a desired brain state in a subject simply by stimulating that subject with a frequency extracted from a donor. Due to the inherent physiological differences between different people, including the brain states that different people experience and the extent to which these brain states are experienced in response to a particular event, there currently exists no way to predictably transplant a desired brain state.
(F) The amount of direction provided by the inventor. Inventor’s theoretical conjectures provide no direction as to how the method can be reliably executed, how the dominant brainwave frequency can be accurately identified and extracted, and how this extracted dominant brainwave frequency can transfer a brain state from a donor to a subject.
(G) The existence of working examples. Applicant has not provided any working examples of the described method. To the contrary, Applicant freely admits that one would not expect to be able to extrapolate whatever little guidance is provided across the entire scope of the claims ([0158]: “because of the variety of experimental protocols for brain stimulation, limits on descriptions of the actual protocols employed, and limited controls, consistency of reported studies is lacking, and extrapolability is limited”).
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Due to the large amount of unknown factors and lack of guidance provided by Applicant, there remain numerous and substantial hurdles that must be overcome if this technology is to work with any degree of accuracy and predictability. These substantial hurdles represent undue experimentation.
Therefore, based on the specific findings of fact, supporting evidence, and conclusions drawn based on these findings of fact, the Examiner respectfully submits that the claims are not in compliance with the enablement requirement of 35 U.S.C. 112(a).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796