DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of Claims 1-7 and 9-11 by Garth Janke dated 7/16/25 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 5, the use of the metric does not change the system of claim 4, does not add any structural aspects to what is already claimed in claim 4, nor does it have a clear connection to any structural aspects found in claim 4.
In claim 6, the shape of the electrical field and the effects of such shape does not change the system of claim 4, does not add any structural aspects to what is already claimed in claim 4, nor does it have a clear connection to any structural aspects found in claim 4.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 6 is 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. Inverse modeling of scalp potentials is not described in the Specification.
Claim 9 is 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. A predefined safety envelope is not described in the Specification. Claim 12 is similarly rejected for “seizure risk thresholds”.
Claim 4 limitations “localization system”, “stimulation unit”, “feedback system”, and “control unit” all invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claim is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
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, 4-5 and 11 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.
Regarding claims 1, 4 and 11, the parentheses render the claim indefinite because it is unclear whether the limitations inside the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 is rejected because it is unclear what is meant by “synchronization metrics”, as this is not mentioned in claim 4, nor is it tied to anything in claim 4.
Claim 11 recites the limitation "the same stimulation hardware" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 limitations “localization system”, “stimulation unit”, “feedback system”, and “control unit” all invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “localization system”, “stimulation unit”, “feedback system”, and “control unit” in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abouelsoud et al. (PG Pub. 2023/0241403).
Regarding Claim 1, Abouelsoud discloses a method of cortical neuromodulation comprising the steps of:
delivering transcranial electrical stimulation to a targeted subset of cortical columns oriented perpendicularly to the scalp (see par. 84; Fig. 20 and 23),
measuring and modeling the electrical field distribution in relation to the columnar orientation of the cortex (see par. 66, 72, and 79),
synchronizing the induced electrical field with endogenous oscillatory activity in the functional (e.g., gamma or spindle) frequency range (see 0-100 Hz; par. 64 and 69-70)
and computing the degree of synchronization as a quantitative metric of effective modulation of excitatory-inhibitory (E-I) balance in the stimulated cortical networks (see coherence; par. 31).
Regarding Claim 2, Abouelsoud discloses wherein said synchronization targets gamma oscillations in the range of 30-80 Hz for therapeutic modulation in Alzheimer's Disease (see par. 34, 82).
Regarding Claim 3, Abouelsoud discloses wherein said synchronization targets sleep spindle activity in the 9-16 Hz range to enhance deep sleep-associated neural plasticity (see par. 10, 25, and 33).
Regarding Claim 4, Abouelsoud also discloses
a high-resolution EEG source localization system for measuring columnar cortical orientation (see par. 75),
an electrical stimulation unit capable of delivering time-locked waveforms at functional (e.g., gamma or spindle) frequencies (see phase-locked; par. 70),
a feedback system that quantifies synchronization between induced and endogenous oscillations (see par. 70), and
a control unit that modulates stimulation amplitude, phase, and frequency to maintain synchronization within a safe E-I balance (see par. 74).
Regarding Claim 5, Abouelsoud discloses wherein synchronization metrics are used to optimize stimulation in real time and avoid both under-synchronization and over-synchronization (see par. 70 and 79).
Regarding Claim 6, Abouelsoud discloses wherein the induced electrical field is shaped to align with the anatomical orientation of targeted cortical columns using inverse modeling of scalp potentials and brain conductivity profiles (see par. 39 and 64).
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.
Claim(s) 7 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abouelsoud et al. (PG Pub. 2023/0241403) in view of Echauz et al. (PG Pub. 2002/0103512).
Regarding Claim 7, Abouelsoud discloses epilepsy (see par. 29), but does not elaborate on monitoring and adjustment of stimulation relating to seizures. Echauz discloses a similar system with continuous monitoring of electrical and neural activity to detect subclinical epileptiform discharges (see par. 91 and 164),
dynamic adjustment of stimulation parameters to prevent seizure onset (see par. 93 and 96),
and maintaining stimulation within a critical regime of neural synchrony, defined as enhanced coherence without super-critical excitatory entrainment (see par. 96). It would have been obvious to one of ordinary skill in the art at the time of the invention to prevent seizures using Abouelsoud’s system because Echauz teaches neural synchronization is a good indicator in predicting seizures (see par. 196) and can be used to prevent them (see claim 127).
Regarding Claim 9, Echauz further discloses wherein neural synchrony is computed using real-time EEG phase- locking value (PLV) or coherence metrics (see par. 104), and stimulation is halted or reduced if the synchrony exceeds a predefined safety envelope (see par. 94). It would have been obvious to one of ordinary skill in the art at the time of the invention to stop or decrease stimulation when synchrony exceeds a safety envelope because Echauz teaches it is preferable to cause little or minimal disruption of normal activity when the probability of seizure onset is low (see par. 97).
Regarding Claim 10, Echauz discloses wherein the induced oscillatory stimulation is constrained to cortical regions with low susceptibility to seizure propagation, as determined by individual neurophysiological and anatomical markers (see par. 97). It would have been obvious to one of ordinary skill in the art at the time of the invention to stop or decrease stimulation when synchrony exceeds a safety envelope because Echauz teaches it is preferable to cause little or minimal disruption of normal activity when the probability of seizure onset is low (see par. 97).
Regarding Claim 11, Echauz discloses wherein synchronization to beneficial oscillations (gamma during waking, spindle during sleep) is achieved using the same stimulation hardware, adapted in frequency and waveform phase-locking profiles, with safety constraints enabled via the E-I balance quantification algorithm (see par. 116, 139, and 293). It would have been obvious to one of ordinary skill in the art at the time of the invention to adapt the waveforms to different conditions because Echauz teaches the adaptations will respond to internal and external changes and evolve over time to accomplish the desired optimal equilibrium point where the seizure frequency reaches zero with less invasive and minimal stimulation (see par. 107 and 108).
Regarding Claim 12, both Abouelsoud (see par. 84) and Echauz (see par. 294) disclose a non-transitory computer-readable medium storing instructions that control modulation as described in Claims 1, 4, and 7 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Venturino et al. (PG Pub. 2023/0095907) induces synchronized gamma oscillations to address Alzheimer’s (see par. 60, 70, and 132).
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/N.P/Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792