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 .
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 1-12 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 claim(s) contains 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.
In claim 1, practicing the reasonable scope of the claim limitation drawn to providing electrode pairs that “enable electrical stimulation to be applied to the brain while bypassing the brain stem” requires undue experimentation. It is the examiner’s understanding that the body’s sensory and motor nerves pass through the brain stem from the spinal cord to the brain, and the head and neck’s sensory and motor nerves pass through the brain stem via the cranial nerves to the brain, with the exceptions of the optic and olfactory nerves. As all embodiments disclosed by Applicant apply electrodes to the neck, head, hands, feet and spine areas of the body, it does not appear that any embodiments apply signals directly to the optic or olfactory nerves, and therefore do not bypass the brain stem (see, e.g., US 2019/0247662 to Poltroak at par. 0027). Applying the In re Wands factors below, the examiner maintains that practicing the reasonable scope of these claims would require undue (unlimited) experimentation.
(A) The breadth of the claims is high, requiring electrodes that “enable” stimulation to be applied to the brain while bypassing the brain stem, but the electrodes do not appear to be disclosed as having any sort of structural features to provide this effect and the disclosed placements of the electrodes do not appear to make this effect possible;
(B) The nature of the invention is such that there does not appear to be any sort of structure to provide this effect, if it is even possible;
(C) The state of the prior art appears to recognize the human anatomical relationship that stimulating surfaces of the body will not bypass the brain stem (see Poltroak above);
(D) The level of one of ordinary skill would recognize human nervous system anatomy and the impossibility of providing this effect;
(E) The level of predictability in the art would indicate known human nervous system anatomy would not provide this effect;
(F) The amount of direction provided by the inventor is low, lacking any sort of “special” structural features of surface electrodes that can bypass the brainstem and stimulate the brain;
(G) The existence of working examples is lacking -- the disclosure describes a conventional stimulator, but does not describe how to provide the “bypassing” function or confirmation that the system actually produces this effect; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure is infinite due to the only ability of providing this effect is the direct stimulation of the optic nerves or olfactory nerves, which is not feasible with surface electrodes such as those described in the disclosure.
The remaining claims are rejected by virtue of their dependency.
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 1-12 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.
In regards to claim 1, the limitation drawn to electrode pairs that “enable electrical stimulation to be applied to the brain while bypassing the brain stem” is vague. It is unclear what particular structure of electrode pairs is required or implied by this limitation. The disclosure does not appear to provide any details as to any particular structure differentiating these electrode pairs from convention electrodes with the ability to be placed on a patient as desired. Accordingly, for prior art purposes, the examiner is considering the structure required by this limitation is electrode pairs capable of being placed in the neck and head or arm/feet/spine areas of a patient on the right and left halves of the body.
In regards to claims 3 and 6, it is unclear what structure is required or implied in the apparatus claim by the limitation “electrode pairs are arranged in advance.” This appears to be a method step recited in an apparatus claim, rendering it unclear whether this is a structural limitation, intended use, or carries no weight. The examiner is considering the claim to require an apparatus being capable of the recited placements if the user so desires.
In regards to claims 4 and 7, it is unclear what structure is required or implied in the apparatus claim by the limitation “a current value…is set.” This appears to be a method step recited in an apparatus claim, rendering it unclear whether this is a structural limitation (i.e., includes a controller set/programmed to provide a current in that range), intended use (i.e., has a controller capable of being set to those values), or carries no weight (i.e., is a method step in an apparatus claim). The examiner is considering the claim to require an apparatus being capable of being set to the recited current if the user so desires.
In regards to claims 8-11, similar to claims 4 and 7 above, it is unclear what structure is required or implied by the “is set”/”are set” limitations. This appears to be a method step recited in an apparatus claim, rendering it unclear whether this is a structural limitation (i.e., includes a controller set/programmed to provide a parameters in that range), intended use (i.e., has a controller capable of being set to those values), or carries no weight (i.e., is a method step in an apparatus claim). The examiner is considering the claim to require an apparatus being capable of being set to the recited parameters if the user so desires.
The remaining claims are rejected by virtue of their dependency.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In regards to claim 1, “electrode pairs removably attached to a living body” recites the connection to the living body (human organism), and so requires a human organism to meet the limitations of the claims, which is ineligible subject matter. It is respectfully suggested to recite electrode pairs configured to be or adapted to be removably attached to a living body, and such language would obviate this rejection.
The remaining claims are rejected by virtue of their dependency.
Allowable Subject Matter
Claims 1-12 avoid the prior art due to the enablement rejection set forth above (i.e., one of ordinary skill in the art could not practice the reasonable scope of this invention without undue experimentation). The closest prior art is to Yamakawa et al. (US 2016/0067493). Although Yamakawa appears to textually describe the essential structural features of the claimed invention and textually describes stimulating the brain while bypassing the brain stem, the examiner maintains that the claims are not currently anticipated because the functionality recited in the claims has not been rendered enabled by the current record. The prior art will be re-evaluated should Applicant be able to make a showing on the record that the claims are enabled. See MPEP 2121.01.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee et al. (US 2025/0177746) is another teaching of stimulating left and right sides of the body for brain stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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