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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 26, 2023 was considered by the examiner.
Drawings
The drawings are objected to because Figs. 6B-7A, 8A-9A, 10B, 11B-11C, 12A, 12C, 15A, 16B, 18A-18B, 21, and 23 contain photographs; however, photographs are not the only practicable medium to show the depicted elements, see 37 C.F.R. 1.84(b)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Claim 1 recites “[a] method of detecting a low frequency modulation in the insular cortex and the hippocampus of a subject, wherein said subject is diagnosed with, or suspected of having, an impaired inhibitory control disorder (ICD), the method comprising” in lines 1-3, which recites the preamble of the claim. The determination on whether a preamble carries patentable weight is made on a case-by-case basis in light of the facts of the case. Mere statements of intended use or purpose are not treated as claim limitations. However, if the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is “necessary to give life, meaning, and vitality” to the claim, then the claim preamble should be construed as if in the balance of the claim. Furthermore, any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See MPEP § 2111.02. In this case, the preamble describes how the electrodes are used with a particular subject, not limiting the scope or structure of the claim. Solely for the purposes of examination, the examiner is interpreting the preamble as mere statements of intended use or purpose. Furthermore, dependent claims 1-6, that describe limitations of the intended use of the electrodes, are also being interpreted as intended use. Therefore, the examiner interprets the intended use/conditions of the claims in such a manner that if prior art, under 35 U.S.C. § 102 and/or 103, is capable to perform the intended use/conditions/methods of the claims, as satisfying the scope of the limitations pertaining to the intended use/conditions, then the prior art thereby teaches the claims as a whole in the application.
Claim Objections
Claims 2-5 are objected to because of the following informalities:
claims 2-5 recite both “hertz” and “Hz”, only one should be used consistently throughout the claims;
claims 2-5 recite both “to” or a dash “-“ between ranges, only one should be used consistently throughout the claims;
in claim 3, line 2: “Hz” should be inserted after “3.5”;
in claim 4, line 2: “Hz” should be inserted after “0.1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-8 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.
Claim 1 recites the limitation “the insular cortex” in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to recite “an insular cortex” would overcome the present rejection. The claims is being read as such for the purpose of examination. Appropriate correction is required.
Claim 1 recites the limitation “the hippocampus” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to recite “a hippocampus” would overcome the present rejection. The claims is being read as such for the purpose of examination. Appropriate correction is required.
Claim 1 recites the term “suspected” in line 2 is a relative term which renders the claim indefinite. The term “suspected” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear to what degree a subject may be “suspected” of having an impaired inhibitory control disorder. This uncertainty renders claim 1 indefinite. For the purpose of examination, this term is not being given patentable weight. Appropriate correction is required.
Claims 2-8 are rejected by virtue of their dependence from claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding intended use claim interpretations and rejections under 35 U.S.C. § 112 above.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Halpern et al. (US Patent Application Publication 2020/0376273 – cited by Applicant), hereinafter Halpern, in view of Lozano (US Patent Application Publication 2008/0046013), hereinafter Lozano.
Regarding Claim 1, Halpern teaches a method of recording oscillatory frequencies in a brain of a subject and delivering an electrical stimulation to ameliorate or prevent an OCD symptom from occurring (see abstract). Halpern teaches a method of detecting a low frequency modulation (¶[0018]-[0020] oscillatory frequency may be detected from an inserted electrode in brain tissue, which may include low frequency brain wave activity, ¶[0032] changes may be measured in the form of low frequency modulation) in the insular cortex (¶[0016] and ¶[0018] different brain regions contemplated, include the insular cortex) and the hippocampus of a subject (¶[0016] different brain regions contemplated, include the hippocampus, ¶[0121] measurement in the hippocampus),
wherein said subject is diagnosed with, or suspected of having, an impaired inhibitory control disorder (ICD) (¶[0010]-[0014] the OCD definition relates to various compulsion disorders, including being eating disorder), the method comprising:
inserting at least one electrode into each the insular cortex (¶[0016] and ¶[0018] different brain regions contemplated, include the insular cortex, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the same device used to administer electrical stimulation can be used to record brain wave activity) and the hippocampus of the subject (¶[0016] and ¶[0018] different brain regions contemplated, include the hippocampus, ¶[0121] measurement in the hippocampus, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the same device used to administer electrical stimulation can be used to record brain wave activity); and
recording brain wave activity in the insular cortex (¶[0016] and ¶[0018] different brain regions contemplated, include the insular cortex, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the same device used to administer electrical stimulation can be used to record brain wave activity) and the hippocampus of the subject (¶[0016] and ¶[0018] different brain regions contemplated, include the hippocampus, ¶[0121] measurement in the hippocampus, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the same device used to administer electrical stimulation can be used to record brain wave activity).
Here, Halpern teaches that electrodes may be placed into various brain regions including the insular cortex and the hippocampus (see ¶[0016], ¶[0018], ¶[0037], and ¶[0047]).
Alternatively and/or additionally, Lozano teaches a method of treating a mood/anxiety disorder, such as eating disorders, by nerve tissue stimulation to one or more areas of the brain affecting hunger and satiety (see abstract; Figs. 1A-1B), in which electrodes may be inserted into particular brain sites, including the hippocampus and the insular cortex, and stimulation applied (see ¶[0015], ¶[0027], and ¶[0049]-[0050]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode placement to the hippocampus and the insular cortex for eating disorders of Lozano with the method of Halpern because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the stimulation applied to the brain would be dependent on the specific disorder the patient has or is suspected of having, and their medical history, so the medical professional would apply stimulation to brain sites based upon the specific patient, such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure and apply stimulation in the hippocampus and the insular cortex, dependent on the particular patient and their medical history.
Regarding Claim 2, Halpern in view of Lozano teaches the method of claim 1 as stated above. Halpern further teaches aid low frequency modulation comprises a modulation having a frequency between about 0 hertz - 8 hertz (¶[0092] the low frequency modulation may have a frequency between 0 hertz - 8 hertz).
Regarding Claim 3, Halpern in view of Lozano teaches the method of claim 1 as stated above. Halpern further teaches said low frequency modulation comprises a modulation having a frequency between about 3.5 to 7.5 Hz (¶[0092] the low frequency modulation may have a frequency between 0 hertz - 8 hertz). The 0 hertz - 8 hertz range of Halpern suggests the range of the present claim because 3.5 to 7.5 Hz falls within with the range of 0 hertz - 8 hertz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 4, Halpern in view of Lozano teaches the method of claim 1 as stated above. Halpern further teaches said low frequency modulation comprises a modulation having a frequency between about 0.1 - 4 Hz (¶[0092] the low frequency modulation may have a frequency between 0 hertz - 8 hertz). The 0 hertz - 8 hertz range of Halpern suggests the range of the present claim because 0.1 - 4 Hz falls within with the range of 0 hertz - 8 hertz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 5, Halpern in view of Lozano teaches the method of claim 1 as stated above. Halpern further teaches said low frequency modulation is an increase of a frequency between about 0 hertz - 8 hertz (¶[0092] the low frequency modulation may have a frequency between 0 hertz - 8 hertz) relative to a standard control (¶[0022]-[0023] the brain activity may show an increase compared to a baseline, ¶[0032] the low frequency modulation may have various increase in power compared to baseline low frequency power).
Regarding Claim 6, Halpern in view of Lozano teaches the method of claim 1 as stated above. Halpern further teaches the ICD comprises a disorder that is associated with a lack of impulse control, and wherein the ICD includes one or more of binge eating, substance abuse, sex addiction or compulsive sexuality, kleptomania, pyromania, trichotillomania, panic disorder, Intermittent Explosive Disorder, compulsive behaviors including gambling, night eating, loss of control eating, emotional or stress eating, compulsive eating, purge behaviors, or suicidal ideation/attempt (¶[0010]-[0014] the OCD definition relates to various compulsion disorders, including being eating disorder).
Regarding Claim 7, Halpern in view of Lozano teaches the method of claim 1 as stated above. The modified Halpern further teaches administering, in response to the low frequency modulation, a stimulation to the insular cortex (¶[0016] and ¶[0018] different brain regions contemplated, include the insular cortex, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the stimulation triggered by a biomarker, ¶[0035] the low frequency modulation is the biomarker) and the hippocampus of the subject (¶[0016] and ¶[0018] different brain regions contemplated, include the hippocampus, ¶[0121] measurement in the hippocampus, ¶[0037] electrical stimulation administered via precise electrode placement in the brain region of interest, ¶[0047] the stimulation triggered by a biomarker, ¶[0035] the low frequency modulation is the biomarker). See also Lozano ¶[0015], ¶[0027], and ¶[0049]-[0050], the electrodes may be inserted into particular brain sites, including the hippocampus and the insular cortex, and stimulation applied.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lozano and in view of Halpern (US Patent Application 2020/0030608), hereinafter Halpern ‘608.
Regarding Claim 1, Lozano teaches a method of treating a mood/anxiety disorder, such as eating disorders, by nerve tissue stimulation to one or more areas of the brain affecting hunger and satiety (see abstract; Figs. 1A-1B). Lozano teaches a method of stimulating in the insular cortex and the hippocampus of a subject (¶[0015], ¶[0027], and ¶[0049]-[0050] the electrodes may be implanted in certain locations in the brain, including the insular cortex and the hippocampus),
wherein said subject is diagnosed with, or suspected of having, an impaired inhibitory control disorder (ICD) (abstract and ¶[0007]-[0009] the invention for treating an eating disorder in a patient, which may include areas in the brain that affect hunger and satiety; palatability and aversion; hedonism; reward/addiction behavior; mood; anxiety; depression, taste and smell, ¶[0023] the disorder may include compulsive eating), the method comprising:
inserting at least one electrode into each the insular cortex and the hippocampus of the subject (¶[0015], ¶[0027], and ¶[0049]-[0050] the electrodes may be implanted in certain locations in the brain, including the insular cortex and the hippocampus); and
stimulating the brain in the insular cortex) and the hippocampus of the subject (¶[0015], ¶[0027], and ¶[0049]-[0050] the electrodes may be implanted in certain locations in the brain, including the insular cortex and the hippocampus, and appropriate stimulation applied).
Lozano contemplates a closed feedback system (see ¶[0049]), but does not specifically teach that the implanted electrodes are utilized to record brain wave activity.
Halpern ‘608 teaches methods, apparatus, and systems useful for ameliorating impulse control disorders using stimulation (see abstract), such as binge eating (see ¶[0003]-¶[0004] and ¶[0032]), in which implanted electrodes may be utilized to apply stimulation to the brain in response to biomarker trigger (see ¶[0055]-[0063]), and that the same electrodes utilized to provide stimulation may also record brain wave activity in the subject (see ¶[0063]), in which the activity measured would include low frequency brain wave activity (i.e., a control) and low frequency modulation that is an increase in power when compared to the control/baseline, as the biomarker (see ¶[0051]-[0055]), over the range of about 0 to 8 Hz (see ¶[0092]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode recording (i.e., such as in a closed-loop system) of Halpern ‘608 with the electrodes of the method of Lozano because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the closed-loop system would provide automatic stimulation, shortening time to treatment (see Halpern ‘608 ¶[0063]); and/or (3) the brain wave recordings would provide useful information (i.e., brain wave activity during symptoms compared to control/baseline) to a medical professional in order to develop the specific stimulation parameters for the subject and long-term treatment (i.e., effectiveness) of the treatment to the subject.
Regarding Claim 2, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. The modified Lozano further teaches aid low frequency modulation comprises a modulation having a frequency between about 0 hertz - 8 hertz (see Halpern ‘608 ¶[0092], the low frequency modulation may have a frequency between 0 hertz - 8 hertz).
Regarding Claim 3, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. The modified Lozano further teaches said low frequency modulation comprises a modulation having a frequency between about 3.5 to 7.5 Hz (see Halpern ‘608 ¶[0092], the low frequency modulation may have a frequency between 0 hertz - 8 hertz). The 0 hertz - 8 hertz range of Halpern suggests the range of the present claim because 3.5 to 7.5 Hz falls within with the range of 0 hertz - 8 hertz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 4, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. The modified Lozano further teaches said low frequency modulation comprises a modulation having a frequency between about 0.1 - 4 Hz (see Halpern ‘608 ¶[0092], the low frequency modulation may have a frequency between 0 hertz - 8 hertz). The 0 hertz - 8 hertz range of Halpern suggests the range of the present claim because 0.1 - 4 Hz falls within with the range of 0 hertz - 8 hertz. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 5, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. The modified Lozano further teaches said low frequency modulation is an increase of a frequency between about 0 hertz - 8 hertz (see Halpern ‘608 ¶[0092], the low frequency modulation may have a frequency between 0 hertz - 8 hertz) relative to a standard control (see Halpern ‘608 ¶[0051]-[0055], the low frequency modulation that is an increase in power when compared to the control/baseline).
Regarding Claim 6, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. Lozano further teaches the ICD comprises a disorder that is associated with a lack of impulse control, and wherein the ICD includes one or more of binge eating, substance abuse, sex addiction or compulsive sexuality, kleptomania, pyromania, trichotillomania, panic disorder, Intermittent Explosive Disorder, compulsive behaviors including gambling, night eating, loss of control eating, emotional or stress eating, compulsive eating, purge behaviors, or suicidal ideation/attempt (abstract and ¶[0007]-[0009] the invention for treating an eating disorder in a patient, which may include areas in the brain that affect hunger and satiety; palatability and aversion; hedonism; reward/addiction behavior; mood; anxiety; depression, taste and smell, ¶[0023] the disorder may include compulsive eating).
Regarding Claim 7, Lozano in view of Halpern ‘608 teaches the method of claim 1 as stated above. The modified Lozano further teaches administering, in response to the low frequency modulation, a stimulation to the insular cortex and the hippocampus of the subject (see Lozano ¶[0015], ¶[0027], and ¶[0049]-[0050], the electrodes may be implanted in certain locations in the brain, including the insular cortex and the hippocampus, and appropriate stimulation applied, the contemplated closed feedback system; see Halpern ‘608 ¶[0055]-[0063], the implanted electrodes may be utilized to apply stimulation to the brain and to record brain wave activity in the subject, such that a closed-loop feedback system is utilized, triggered by detection of biomarker, i.e., the low frequency modulation).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Halpern in view of Lozano as applied to claim 7 above, and in view of Poltorak (US Patent Application Publication 2020/0086078), hereinafter Poltorak.
Regarding Claim 8, Halpern in view of Lozano teaches the method of claim 7 as stated above. Halpern further teaches said stimulation is invasive and/or non-invasive (see ¶[0048] and ¶[0052]-[0053]); but the modified Halpern does not specifically teach that the stimulation is transcranial direct current stimulation (TDCS), transcranial magnetic stimulation (TMS), or low intensity ultrasound stimulation.
Poltorak teaches a method of transplanting a sleep state in a subject (see abstract), in which noninvasive neuromodulation technologies are contemplated (see ¶[0027] and ¶[0211]), including TDCS, TMS (see ¶[0211], ¶[0215]-[0218], and ¶[0340]-[0343]), and low intensity ultrasound stimulation (see ¶[0450]-[0451]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the TDCS, TMS, and/or low intensity ultrasound stimulation of Poltorak with the method of the modified Halpern because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the modified Halpern requires a neuromodulation stimulation and Poltorak teaches such stimulation modalities; and/or (3) the stimulation modality applied to the brain would be dependent on the specific disorder the patient has or is suspected of having, and their medical history, so the medical professional would apply the stimulation modality based upon the specific patient, such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention apply a stimulation modality of TDCS, TMS, and/or low intensity ultrasound stimulation, dependent on the particular patient and their medical history.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lozano in view of Halpern ‘608 as applied to claim 7 above, and in view of Poltorak.
Regarding Claim 8, Lozano in view of Halpern ‘608 teaches the method of claim 7 as stated above. The modified Lozano does not specifically teach that the stimulation may include transcranial direct current stimulation (TDCS), transcranial magnetic stimulation (TMS), or low intensity ultrasound stimulation.
Poltorak teaches a method of transplanting a sleep state in a subject (see abstract), in which noninvasive neuromodulation technologies are contemplated (see ¶[0027] and ¶[0211]), including TDCS, TMS (see ¶[0211], ¶[0215]-[0218], and ¶[0340]-[0343]), and low intensity ultrasound stimulation (see ¶[0450]-[0451]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the TDCS, TMS, and/or low intensity ultrasound stimulation of Poltorak with the method of the modified Lozano because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the modified Lozano requires a neuromodulation stimulation and Poltorak teaches such stimulation modalities; and/or (3) the stimulation modality applied to the brain would be dependent on the specific disorder the patient has or is suspected of having, and their medical history, so the medical professional would apply the stimulation modality based upon the specific patient, such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention apply a stimulation modality of TDCS, TMS, and/or low intensity ultrasound stimulation, even alongside the implanted electrode stimulation, dependent on the particular patient and their medical history.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rezai et al. (US Patent Application Publication 2005/0010262) teaches methods of affecting chronic pain by electrically and/or chemically stimulating target sites associated with chronic pain (see abstract), in which the target site may include the insular cortex and the hippocampus, and may be stimulated via an implanted stimulator (see ¶[0006] and ¶[0015]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791