DETAILED ACTION
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.
Claim 5 is 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. It is unclear if the limitations in parenthesis are positively claimed and, therefore, required by the claim. It is also unclear how a longer entrainment or a shorter relaxation period would indicate greater efficacy.
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) 1-4, 6-9, and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers (PG Pub. 2015/0374538).
Rogers discloses a device (see headset 18) for administering thermal stimulation to an ear canal of a subject, comprising:
an earpiece (see earpieces 12a and 12b) configured to be at least partially insertable into the ear canal of the subject (see Fig. 19 and par. 322);
a thermoelectric device (see TEDs 13a and 13b; Fig. 1) thermally coupled to the earpiece and configured to heat and/or cool the earpiece to thereby heat and/or cool the ear canal of the subject (par. 122, 275); and
a controller (see controller 11) associated with the thermoelectric device (see Fig. 1), the controller comprising a processor and memory storing non-transitory computer-readable instructions (see par. 136) that, when executed by the processor, cause the processor to administer a selected treatment plan comprising administering a caloric vestibular stimulation (CVS) stimulus to the ear canal of the subject during a first treatment interval (see par. 9 and 139),
wherein the selected treatment plan is effective to produce a durable improvement in at least one symptom of a condition for a time of at least 1 week following cessation of the administering of the CVS stimulus (see par. 481-482).
Regarding Claim 2, Rogers discloses wherein the memory of the controller stores non-transitory computer-readable instructions (see par. 25) that when executed by the processor cause the processor to perform an optimization protocol to modify the CVS stimulus of the selected treatment plan to be administered to the subject (see par. 12 and 38), wherein the instructions are configured to cause the processor to perform the optimization protocol prior to the first treatment interval of the selected treatment plan (see par. 242), or during a rest interval of the selected treatment plan between the first treatment interval and a second treatment interval of the selected treatment plan (see par. 101 and 545).
Regarding Claim 3, Rogers discloses wherein the instructions that cause the processor to perform the optimization protocol comprise instructions that cause the processor to perform operations comprising:
(a) administering a first CVS stimulus to the subject and detecting a time to entrainment (Te) of at least one physiological oscillatory pattern in the subject to the stimulus (see 12 minutes; par. 498);
(b) ceasing the administering of the first CVS stimulus and detecting a time to relaxation (Tr) of the at least one physiological oscillatory pattern in the subject from the entrainment (see 2-3 minutes; par. 497); and
(c) selecting a CVS stimulus for administering to the subject based on the detected Te and the detected Tr, wherein a longer Tr and/or a shorter Tr, as compared to predetermined standard values for Te and Tr, or as compared to detected Tr and Tr values for other CVS stimuli administered to the subject, indicates a greater efficacy of the first CVS stimulus for at least one symptom in the subject (see par. 182); and
(d) modifying a CVS stimulus of the selected treatment plan based on the selected CVS stimulus (see par. 183). The examiner considers time to entrainment is the same as a patient’s reaction time (see par. 103, 182, 233) and time to relaxation is the same as stability of treatment (see par. 103, 182, and 233).
Regarding Claim 4, see rejection of similarly worded Claim 3 above. Rogers discloses sequentially administering a plurality of different CVS stimuli and selecting one based on the Te and Tr values (see par. 11, 103 and 241).
Regarding Claim 6, Rogers discloses wherein the memory stores further non-transitory computer- readable instructions (see par. 165), that when executed by the processor, cause the processor to perform operations comprising:
generating a database of the plurality of different CVS stimuli sequentially administered to the subject (see par. 108); and
storing a respective efficacy score in the database for each of the plurality of different CVS stimuli sequentially administered to the subject, wherein the efficacy scores are based on the detected Tre and/or Tr values (see pain score; par. 107),
wherein the selecting of the CVS stimulus for administering to the subject is based on the respective efficacy score (see par. 10 and 11).
Regarding Claim 7, Rogers discloses wherein the controller is further configured to administer the modified CVS stimulus to the subject at least once (see par. 298 and 303).
Regarding Claims 8 and 9, Rogers discloses the modified CVS stimulus can be administered during the first or second treatment interval (see par. 210 and 327).
Regarding Claim 15, see rejection of similarly worded Claim 3 above. Rogers further discloses a monitoring device configured to monitor a physiological oscillatory pattern for a duration of time after administering the CVS stimulus during the first treatment interval (see EEG; par. 375),
wherein the controller is configured to commence a second treatment interval of the selected treatment plan based on parameters of the physiological oscillatory pattern diverging from target values (see desired efficacy; par. 375).
Regarding Claims 16-17, Rogers discloses wherein the condition is a neurodegenerative or neurological disease or a headache (see par. 354 and 362).
Regarding Claim 18, Rogers discloses the symptom is a non-motor symptom of the condition (see par. 98).
Regarding Claim 19, see rejection of similarly worded Claim 1 above. Rogers further discloses a monitoring device configured to monitor a biomarker as a proxy for a physiological oscillatory pattern for a duration of time after administering the CVS stimulus during the first treatment interval (see HRV; par. 521),
wherein the controller is configured to commence a second treatment interval of the selected treatment plan based on parameters of the biomarker proxy diverging from target values (see low HRV; par. 521).
Regarding Claim 20, Rogers discloses wherein the monitoring device comprises a pulse rate monitor, wherein the biomarker is heart rate varability (HRV), and wherein the physiological oscillatory pattern comprises cerebrovascular blood flow velocity (CBF,) oscillations (see par. 510 and 518).
Allowable Subject Matter
Claims 10-14 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. Rogers does not disclose applying an exogenous stimulus for resetting the pattern. Nor does he disclose cross frequency coupling.
Conclusion
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/N.P/Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner
Art Unit 3792