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 with traverse of Species A in the reply filed on 6/3/2026 is acknowledged. The traversal is on the ground(s) that the Examiner has not established there would be a serious search burden. This is not found persuasive because each mode of stimulation has a separate classification (as explicitly pointed out in the restriction) which is set forth in MPEP §808.02 as one of the ways of establishing burden (see (A) Separate classification thereof).
The requirement is still deemed proper and is therefore made FINAL.
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 1-20 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 recites “processor circuitry configured to cause the stimulation circuitry to output the neuromodulation signal to the nerve target as timed with an event, and in response, cause alteration to midbrain dopamine signals to the subject.” This is a computer-implemented functional limitation that provides stimulation to result in altering midbrain dopamine levels.
As noted in MPEP §2161.01, “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
In the instant application, Applicant has claimed the functional result of causing alteration to midbrain dopamine signals by applying a neuromodulation signal to a nerve target but has not set forth any particular parameters that result in said outcome or any algorithm in sufficient detail to describe how the specific neuromodulation signal parameters are generated to achieve said effect. Applicant refers to related Patent 11,752,339 as providing details on how the neuromodulation signals can be implemented (see par. [0040] of the specification) but the Patent does not provide any details regarding specifically tailoring a signal to alter midbrain dopamine levels as claimed. Applicant also broadly discloses that detected nerve signals can be used to generate synthetic neuromodulation signals (see par. [0052]) but the specification fails to describe any steps or algorithm detailing how the synthetic signal is created from a detected signal. In another embodiment, Applicant states a machine learning model can be used to create the stimulation signals by training it with known neuromodulation signals and known effects on the midbrain dopamine signals responsive to the known neuromodulation signals. However, the specification does not have any details regarding these “known neuromodulation signals” and does not provide any details regarding what midbrain dopamine effects are monitored, how they are obtained, what degree they change based on the signals, etc. Applicant has provided numerous examples of intended functional results of altering midbrain dopamine signals without sufficient details indicating what signals create these desired effects and/or how to even create these signals.
Claim 3 likewise claims the functional result of using a machine learning model to predict alteration of midbrain dopamine signals and to predict a condition improvement. The specification does not provide sufficient details on how these predictions are made and/or how the machine learning model is particularly trained to provide these predictions.
Claims 2 and 4-20 are rejected as inheriting the issues set forth with respect to Claim 1 above (claim 13 is the method from of Claim 1 and contains the same issues as Claim 1).
Claims 1-20 are further rejected under 35 USC 112a as reciting a broad genus without a description of a representative number of species describing the claimed genus.
Specifically, Claim 1 includes the following terms: “neuromodulation signal”; “nerve target”; and “an event”. While Applicant has elected the electrical stimulation embodiment, the Examiner notes the current scope of the term “neuromodulation signal” covers every possible type of neuromodulation signal. Applicant’s specification, in par. [0043] states : “The stimulation circuitry 506 can use known technologies to apply the neuromodulation signals to the subject 501, including electrical, electromechanical, optical, and acoustic technologies, among others. For example, the stimulation circuitry 506 can include various types of generators, such as but not limited to electrodes, light emitting diodes or other light-emitting devices, mechanical vibrators, radio-frequency transducers, electromagnets, and/or other mechanical or electromechanical components, which can be implemented on various devices, such as speakers, headphones, ear buds, chest straps, smart eye coverings (e.g., glasses, goggles) or virtual reality headsets, among others.” This description covers electrical, mechanical, optical and acoustic signals but broadens the disclosure out using the term “among others”. Thus, the signals could include, heat, cold, chemical, radiation, etc. There is a large variance among each of the possible types of signals that are encompassed by “neuromodulation signals” and Applicant has not provided a representative number of species (see MPEP §2163) to fully encapsulate the large variances in the broad genus of “neuromodulation signals”. To overcome the rejection with respect to this term, the Examiner suggests amending the claim to recite the particular type of neuromodulation signal. In light of the species elected, Applicant could amend the claim to recite electrical stimulation.
Regarding the term “nerve target”, the Examiner notes this term encompasses any possible nerve target within he body. This would include targets in the brain, spinal cord and any potential nerve throughout the body. Applicant’s specification states in par. [0044], “In some embodiments, the nerve target is a vagus nerve, such as a right-side vagus nerve. In other embodiments, the nerve target is a left-side vagus nerve, left-side and right-side (e.g., bilateral) vagus nerves, or other nerve targets and different delivery portals. In some embodiments, the target can be associated with or include a delivery portal (e.g., locations). For example, a portion of the ear or ears can be the delivery portal. As other examples, a part of the head, eye(s), and/or chest can be the delivery portal.” Applicant discloses various aspects of the vagus nerve, a portion of the ear, head, eyes and/or chest. Given the wide variance of nerve targets encompassed by the term “nerve target” (brain, spinal nerves, splanchnic nerve, pudendal nerve, femoral nerve, etc.), the Examiner notes Applicant has not provided a representative number of species to encompass the wide variability of this genus. To overcome this rejection, the Examiner suggests amending the claim to limit the nerve target to at least one of the targets disclosed in the specification.
In regards to the term “an event”, Applicant’s specification states in par. [0056], “In various embodiments, the event that the neuromodulation is timed to can include a physiological event and/or a behavioral event. Example physiological events include a respiratory event, a cardiac event, and physiological threshold associated thereof, which may be determined based on measures of biosignals. The behavioral event can be an endogenous behavioral event (e.g., self-initiated) or an exogenous behavioral event (e.g., external cues). Example endogenous behavioral events include consumption of food or liquid, movement or other motor actions (e.g., movement of the arms or limbs, grasping, exercise), learning a skill or improving on a skill, among others. Example exogenous behavioral event include external cues, such as environmental stimuli including visual, auditory, and other cures. A behavioral event can be measured using signals and/or data other than biosignals. In some embodiments, the event is a non-respiratory event.”
The “events” are therefore described as physiological events (respiratory event, cardiac event” and “behavioral events” (self-initiated events such as consumption of food or liquid, movement or other motor actions, learning a skill or improving a skill; and external cues such as visual stimuli, auditory stimuli or other cues). However, physiological events vary greatly from respiratory or cardiac events and can include brain injury, tremor, cancer, diabetes, spinal cord injury, stroke, etc. Behavioral or “self-initiated” events could include smoking, vaping, sleeping, driving, etc. and external cues could encompass haptic stimuli, electrical stimuli, heat, cold, etc. The term “event” is overly broad and each described category within the scope of “event” is also broad with great variances within each genus. Applicant’s specification does not provide a representative number of species for the broad genus “event”. The Examiner suggests amending the claim to recite at least one of the disclosed events described in the specification.
In summary, each of the terms “neuromodulation signal”; “nerve target”; and “an event” encompass a broad genus without a representative number of species in the specification to sufficiently describe such a broad genus. Additionally, when viewed as a combination of broad genii, the combination is an extremely broad genus that likewise does not have a representative number of species to encompass the broad scope of the claimed invention.
Claims 2-20 are rejected for inheriting the same issues from Claim 1.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 13 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102()(2) as being anticipated by Danielsson (2010/0069995).
Regarding Claims 1, 13 and 20, Danielsson discloses providing electrical stimulation (a neuromodulation signal) to a vagus nerve (a nerve target) in a timed relation to an event (particularly at some point in time after a stroke), wherein the electrical stimulation of the vagus nerve causes the midbrain to release dopamine (par. [0066, 0074]).
In regard to Claim 8, Danielsson discloses that a first stimulation pulse train can be applied at a point in time after a stroke and a second pulse train having different parameters can be applied in a timed relationship to an event (namely with respect to the OFF times of the first pulse train) to achieve a desired result (par. [0066, 0074]).
Claims 1 and 13 are rejected under 35 U.S.C. 102(a)(1) and 102()(2) as being anticipated by Cala Health, Inc (WO 2024/086209), herein Cala.
Regarding Claims 1 and 13, Cala discloses treating pain, inflammation, etc. (par. [0011]) by targeting the vagus nerve to produce a dopaminergic response that alters (upregulates/downregulates) the dopaminergic system thus producing an alteration of midbrain dopamine signals (par. [0051, 0057]).
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.
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.
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.
Claims 1, 2, 10, 13, 14 and 17 rejected under 35 U.S.C. 103 as being unpatentable over Connolly et al. (2017/0340881) in view of Cala Health, Inc (WO 2024/086209), herein Cala.
Regarding Claims 1 and 13, Connolly discloses constructing neuromodulation signals and applying them to a nerve target (such as a vagus nerve) in order to cause a similar effect as that of a drug without the need to actually apply the drug (par. [0049]). Connolly discloses that the stimulation can be applied in response to a patient indicated need (such as in response to pain for example, see par. [0087]; treating depression (par. [0050]) or inflammation as well on an as needed basis (par. [0052])). Connolly is silent regarding the specific effect being an alteration of midbrain dopamine signals. However, Cala, in the same field of endeavor of treating pain, inflammation, etc. (par. [0011]) discloses that targeting the vagus nerve produces a dopaminergic response that alters (upregulates/downregulates) the dopaminergic system thus producing an alteration of midbrain dopamine signals (par. [0051, 0057]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Connolly reference to include targeting the vagus nerve to alter dopamine expression in the midbrain, as taught and suggested by Cala, for the purpose of non-invasively treating pain or inflammation without the need for drug/pharmacological therapy.
In regard to Claims 2 ,14 and 17 Connolly discloses the processor as a depository of a plurality of neuromodulation signals that represent a processed nerve tissue signal as a sequence of at least one state corresponding to a set of state parameters and correlated with causing a particular effect (par. [0054], “The first component is a neuromodulatory signal generator system that stores a plurality of synthetic neuromodulatory signals. Each synthetic neuromodulatory signal stored in the neuromodulatory signal generator system represents at least one processed measured peripheral nerve tissue signal. As indicated below, the processed measured peripheral nerve tissue signal may be a signal derived from a neurogram. The neurogram may have been recorded from a subject that had been put into a particular condition to cause a desired effect...The recorded neurogram from the subject may be processed through a state machine, as discussed below, the form a sequence of one or more states represented by one or more state parameters.”). Paragraph, [0056] has a similar disclosure. The combination of Connolly and Cala provide for the specific condition/state to be the treatment of pain, inflammation, etc. by stimulating the vagus to alter dopamine expression in the midbrain, as set forth in the rejection of Claim 1.
In regard to Claim 10, Connolly discloses the stimulation is applied to manipulate an appetite (consumption) of a user (par. [0054]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cala Health, Inc (WO 2024/086209), herein Cala. Cala discloses providing stimulation immediately in response to a sensed condition (par. [0022]). Cala is silent regarding the particular time frame after the send condition but is understood to be as close to immediate as possible in order to provide effective therapy to a detected condition. It would have been obvious to one having ordinary skill in the art before the effective fling date to include a time frame after detection of an event in which to delivery therapy, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 3-7, 15, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Connolly et al. (2017/0340881) in view of Cala Health, Inc (WO 2024/086209), herein Cala, further in view of Howard (PGPUB 2020/0405204).
Regarding Claims 3-7, 15, 16 and 18, Connolly and Cala disclose electrically stimulating the vagus nerve to alter dopamine signals to treat conditions such as pain, inflammation, etc. Connolly further discloses the use of machine learning models and aiding the data processing steps (par. [0100-0101]) but fails to disclose using machine learning to predict outcomes and/or optimize stimulation to obtain desired outcomes. However, Howard, in the same field of endeavor of medical devices that affect dopamine levels in closed-loop stimulation systems (par. [0163, 0194]), discloses using machine learning algorithms trained on patient populations with known inputs and outputs (par. [0355, 0357, 0633]) for the purpose of quickly and accurately determining new insights for treatment (par. [0355]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Connolly and Cala combination to include training a machine learning model on known inputs and outputs of a desired brain state (such as dopamine levels), as taught and suggested by Howard, for the purpose of quickly and accurately determining new insights for treatment.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Connolly et al. (2017/0340881) in view of Cala Health, Inc (WO 2024/086209), herein Cala, further in view of Rosenbluth et al. (2019/0001129). Connolly and Cala disclose applying stimulation to a user in a closed-loop manner to alter dopamine signals in a patient to treat conditions such as pain, inflammation, etc. but fails to disclose sweeping through various parameters to find optimal stimulation parameters. However, in the same field of endeavor of a neurostimulator, Rosenbluth discloses sweeping through various stimulation parameters and receiving patient feedback for the purpose of optimizing stimulation to achieve a desired effect (par. [0143]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Connolly et al. (2017/0340881) in view of Cala Health, Inc (WO 2024/086209), herein Cala, further in view of Howard (PGPUB 2020/0405204) and Grund et al. (2023/0225800). Connolly and Cala disclose electrically stimulating the vagus nerve to alter dopamine signals to treat conditions such as pain, inflammation, etc. Connolly further discloses the use of machine learning models and aiding the data processing steps (par. [0100-0101]) but fails to disclose using machine learning to predict outcomes and/or optimize stimulation to obtain desired outcomes. However, Howard, in the same field of endeavor of medical devices that affect dopamine levels in closed-loop stimulation systems (par. [0163, 0194]), discloses using machine learning algorithms trained on patient populations with known inputs and outputs (par. [0355, 0357, 0633]) for the purpose of quickly and accurately determining new insights for treatment (par. [0355]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Connolly and Cala combination to include training a machine learning model on known inputs and outputs of a desired brain state (such as dopamine levels), as taught and suggested by Howard, for the purpose of quickly and accurately determining new insights for treatment.
Connolly, Cala and Howard fail to disclose using an autoencoder as a specific neural network that encodes data into a compressed state to form a latent or embedding space. However, Grund discloses encoding data measures as pre-images (a compressed state) into a latent space in order to provide similarity measures among the input data that can then be used to make predictive outcomes. This is a known equivalent to other machine learning architectures as also set forth by Grund (par. [0135-0139]). It would have bene obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Connolly, Cala and Howard to use an autoencoder model, as taught and suggested by Grund, as it is a known equivalent model for providing machine learning that would provide the predictable result of providing predictive outcomes based on data input.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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