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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 3/31/25; 4/3/24; 3/29/24 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 112(a)
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 14 and 18 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 10 is directed toward deep brain stimulation and claim 14 is directed toward external transcutaneous electrodes. The specification is silent as to how transcutaneous electrodes provide deep brain stimulation.
Claim Rejections - 35 USC § 112(d)
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 14 and 18 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. Claim 10 is directed toward deep brain stimulation and claim 14 is directed toward external transcutaneous electrodes. Claim 14 broadens the claim 10 and fails to further limit it. 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 § 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) 1-4, 6-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carroll (U.S. Pub. 2021/0138245) in view of Zhang et al. (U.S. Pat. 11/931,572 hereinafter “Zhang”).
Regarding claims 1, 10 and 15, Carroll discloses a deep brain stimulation system comprising at least four stimulation pairs of electrodes (see Figure 2 and paragraph 41; "a first circuit 120 is created between a first electrode 108a and a second electrode 108b a second circuit 122 is created between a third electrode 108c and a fourth electrode 108d a third circuit 124 is created between a fifth electrode 108e and a sixth electrode 108f a fourth circuit 126 is created between a seventh electrode 108g and an eighth electrode 108h; also see paragraph 55), each of the stimulation pairs of electrodes providing an electric stimulation at a respective carrier frequency, wherein a mean value between the carrier frequency of any first stimulation pair of electrodes and the carrier frequency of any second stimulation pair of electrodes defines a first mean carrier frequency (e.g. ¶¶56-57; [Regarding lines 16-21, which discusses that each first, second, third and fourth carrier signal has a specific first, second, third and fourth carrier frequency, respectively, it is noted that paragraphs 56 and 57 state that there is "a base frequency of about 15 kHz on the first channel", "a base frequency of about 10 kHz on the second channel", "a base frequency of about 20 kHz on the third channel", and "a base frequency of about 14.9 kHz on the fourth channel"]), a mean value between the carrier frequency of any third stimulation pair of electrodes and the carrier frequency of any fourth stimulation pair of electrodes defines a second mean carrier frequency, a difference between the first and second mean carrier frequencies is equal to or greater than 200 Hz (e.g. ¶¶42-43; ["Subsequently, interaction of the two resultant beat frequencies results in a combined beat signal proximate to and/or within the subject's spinal cord in the target area 128." And in paragraph 58, it teaches that based on the example base frequencies (which are above with respect to the rejection of lines 16-21), "interaction of the first beat signal 130 (having a beat frequency of about 5 kHz) and the second beat signal 132 (having a beat frequency of about 5.1 kHz) results in the combined beat signal 134 being about 100 Hz (5.1 kHz-5 kHz=100 Hz)."]). However, Carroll teaches implanted electrodes in the spinal cord, and a single signal generator (i.e., not one generator per electrode pair).
Zhang teaches a system and method for providing transcutaneous or subcutaneous temporal interference spinal cord stimulation (see Title) that also can be used for deep brain stimulation (e.g. Col. 6, ll. 21-31; Col. 18, ll. 52-55). "In one arrangement, an example method comprises applying at least two input waveforms to respective pairs of -electrodes affixed on the patient's skin or subcutaneously disposed
relative to the target neural tissue, wherein the frequencies of the input waveforms are configured such that they combine, when simultaneously applied, to generate a beat waveform having a beat frequency due to interference, wherein the beat frequency is of a value operative to impart a therapeutic effect to the target neural tissue" (see Abstract). "Example system 100A may include two or more input waveform sources 104A, 104B, each operative to energize a corresponding pair of electrodes 106A-1, 106A-2 and 106B-1, 106B-2, respectively, that may be placed, attached or otherwise affixed externally on the skin of a patient 102, or disposed subcutaneously, proximate to a target neural tissue of the patient 102" (see Col. 6, lines 35-41). In other words,
Zhang teaches deep brain stimulation via interference, which is the same as Carroll.
However, Zhang teaches that the electrodes can be used spinal stimulation, as Carroll also teaches, but also could be used for deep brain stimulation (see quote above from column 6), and also that dedicated waveform generators/sources can be used per pair of electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the electrodes for deep brain stimulation, as taught by Zhang, within the system and methods of Carroll because the same stimulation for spinal cords is used in deep brain stimulation (see Col. 6, ll. 21-31). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize one generator/source per pair of electrodes, as taught by Zhang, within the system and methods of Carroll because Zhang explicitly teaches that "although input current sources 122A/122B and 122A/122B are illustrated in FIG. 1B as four separate entities, they may be integrated in a single neuromodulator device or apparatus having a multi-channel output, wherein each channel may be configured to drive a corresponding electrode pair”, and is used for deep brain stimulation (see Col. 6, ll. 21-31; Col. 9, line 65 through Col. 10, line 3).
Regarding claims 2 and 19, meeting the limitations of claims 1 above, Carrol further discloses between four to a number (n) higher than four of stimulation pairs of electrodes, a difference between the carrier frequency of any first stimulation pair of electrodes and the carrier frequency of any second stimulation pair of electrodes defines a first envelope frequency, a difference between the carrier frequency of any third stimulation pair of electrodes and the carrier frequency of any fourth stimulation pair of electrodes defines a second envelope frequency (e.g. ¶¶56-57; [Regarding lines 16-21, which discusses that each first, second, third and fourth carrier signal has a specific first, second, third and fourth carrier frequency, respectively, it is noted that paragraphs 56 and 57 state that there is "a base frequency of about 15 kHz on the first channel", "a base frequency of about 10 kHz on the second channel", "a base frequency of about 20 kHz on the third channel", and "a base frequency of about 14.9 kHz on the fourth channel"]), a difference between the carrier frequency of any subsequent pth stimulation pair of electrodes, 4<p<n, and the carrier frequency of another subsequent qth stimulation pair of electrodes q=p+1 defines a subsequent rth envelope frequency, r=q/2 and values of the first, second, and any subsequent rth envelope frequencies are less than or equal to 500 Hz (e.g. ¶¶42-43; ["Subsequently, interaction of the two resultant beat frequencies results in a combined beat signal proximate to and/or within the subject's spinal cord in the target area 128." And in paragraph 58, it teaches that based on the example base frequencies (which are above with respect to the rejection of lines 16-21), "interaction of the first beat signal 130 (having a beat frequency of about 5 kHz) and the second beat signal 132 (having a beat frequency of about 5.1 kHz) results in the combined beat signal 134 being about 100 Hz (5.1 kHz-5 kHz=100 Hz)."]).
Regarding claims 3 and 4, meeting the limitations of claim 1 above, Carroll further discloses wherein the carrier frequencies of the stimulation pairs of electrodes are greater than 1000 Hz (e.g. see ¶73). it is noted that paragraphs 56 and 57 state that there is "a base frequency of about 15 kHz on the first channel", "a base frequency of about 10 kHz on the second channel", "a base frequency of about 20 kHz on the third channel", and "a base frequency of about 14.9 kHz on the fourth channel".
Therefore, the mean frequency used for the beat frequency of the combined first and second channels would be 12.5 kHz, while the mean frequency used for the beat frequency of the combined third and fourth channels would be 17.45 kHz. Therefore, the difference of these would be 4,950 Hz, or 4.95 kHz. However, it is noted that paragraphs 59-60 teach a multitude of the ranges that the first, second, third or fourth circuits/channels may utilize. Therefore, if the first channel utilizes 5 kHz while the second channel uses 10 kHz as stated earlier, then their mean frequency would be 7.5 kHz, and the difference of this the above stated third and fourth channels would be 9.95 kHz. Additionally, it is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144(II)(A)), and since a difference of 4.95 kHz is explicitly taught by a mere example of Carroll, while additionally disclosed ranges would be greater than 5 kHz, the conditions are generally taught by Carroll and Carroll therefore reads on claim 1. Also see paragraph 73.
Regarding claims 6, 11, 16 and 20, meeting the limitations of claims 1 and 10 above, Carroll further discloses that the phase of the envelopes is controlled, especially by using a predefined phase modulation (e.g. ¶70).
Regarding claims 7-8 and 12, meeting the limitations of claims 1 and 10 above, Zhang further discloses wherein the stimulation amplitude of the electrodes is comprised between 10 uA and 2500 uA (e.g. Col. 17, lines 1-8).
Regarding claim 9, Zhang further discloses one or more current sources, the one or more current sources being electrically connected to the pairs of electrodes (e.g. Col. 7, lines 1-5).
Regarding claim 13, meeting the limitations of claim 10 above, Carroll further discloses wherein the stimulation is biphasic, with bipolar pulses (e.g. ¶70).
Regarding claims 14 and 18, meeting the limitations of claim 1 above, Zhang further discloses the electrodes on the scalp is calculated based at least on a predefined simulation for the stimulation (e.g. Col. 5, lines 11-15; Col. 6, lines 21-31).
Allowable Subject Matter
Claims 5 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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