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
This application discloses and claims subject matter disclosed in prior Application No. 17/735, 599 now US 11413425 B2. Accordingly, this application appears to constitute a continuation as also evidenced in page 1 lines 4-10 of instant application specification as-filed. However, Examiner notes inconsistency in priority disclosed in page 1 lines 4-10 of instant application specification as-filed claiming priority to 17/735, 599 which is NOT listed in Application Data Sheet dated 08/15/2022. Examiner suggests a corrected ADS to cure the inconsistency.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
The listing of references in the specification such as on page 1 line 24-page 2 line 20, page 101 lines 12-page 121 line 10 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Restriction/Election
Applicant’s election with traverse of claims drawn to Group I and Species B in the reply filed on 05/18/2026 is acknowledged. The grounds for traversal appear moot at this time as in response to Requirement for Restriction dated 01/21/2026, Applicant amended all claims such that all claims 1-20 in claim set dated 05/18/2026 currently presented for examination are all drawn to a Group I system and Species B and thus, Requirement for Restriction/Election as raised in 01/21/2026 is not applicable to system claims 1-20 dated 05/18/2026 currently presented for examination.
Consequently, all claims 1-20 as currently presented are being examined on the merits.
Drawings
Figure 11-13 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated as evidenced in instant applications specification as-filed page 85 lines 24-26. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 disclosure is objected to because of the following informalities:
“…A device, system, and method for facilitating a sleep cycle in a subject suing a peri COVID vaccination period…” in abstract needs to be corrected. A suggested correction is -- A device, system, and method for facilitating a sleep cycle in a subject [[suing]] during a peri COVID vaccination period --.
“in a=n EEG feedback” in page 62 line 16 needs to be corrected. A suggested correction is –in [[a=n]] an EEG feedback--.
“Therefore, the series of states may differ in the implementation of these distinct goals, even if the endpoints are identical, i.e., the optimal algorithm to achieve state B from state A, may be different from the optimal algorithm to exist state A, and end up at state B” in page 74 line 24 needs to be corrected. A suggested correction is -- Therefore, the series of states may differ in the implementation of these distinct goals, even if the endpoints are identical, i.e., the optimal algorithm to achieve state B from state A, may be different from the optimal algorithm to [[exist]] exit state A, and end up at state B--.
Similar issues were noted in page 62 line 9, page 63 line 27, page 67 line 21, page 68 line 9, page 71 line 5, page 75 line 21, page 88 line 30, page 94 line 10.
The corresponding patent number i.e. US 11413425 B2 for U.S. Application Ser. No. 17/735, 599 in page 1 line 4 needs to be added.
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 Objections
Following claims are objected to because of the following informalities:
Claim 1 “adaptively progress dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern; to thereby brainwaves of the subject with the associated brainwave pattern corresponding to the series of sleep stages, to thereby induce the desired sleep cycle pattern in the person” needs to be corrected. A suggested correction is -- adaptively progress dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle patternentraining brainwaves of the subject with the associated brainwave pattern corresponding to the series of sleep stagesinducing the desired sleep cycle pattern in the person—to avoid intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 ).
Claim 15 “a stimulator, configured to generate a signal at an output port adapted to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective sleep stage, to thereby induce the desired sleep cycle pattern in the person” needs to be corrected. A suggested correction is -- a stimulator, configured to generate a signal at an output port adapted and configured to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective sleep stageinducing the desired sleep cycle pattern in the person —to avoid intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 ).
Claim 20 “generate at least one of an audio or optical stimulation pattern adapted to entrain brainwaves in the brain of the subject with the associated brainwave pattern, dependent on the desired sleep cycle pattern and being adaptive to the determined current stage of sleep of the subject, to thereby induce the desired sleep cycle pattern in the subject; and a stimulator, having an output port, the stimulator being configured to generate a signal at the output port adapted to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective distinct sleep stage, to thereby induce the desired sleep cycle pattern in the person” needs to be corrected. A suggested correction is --generate at least one of an audio or optical stimulation pattern adapted and configured to entrain brainwaves in the brain of the subject with the associated brainwave pattern, dependent on the desired sleep cycle pattern and being adaptive to the determined current stage of sleep of the subject, inducing the desired sleep cycle pattern in the subject; and a stimulator, having an output port, the stimulator being configured to generate a signal at the output port adapted and configured to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective distinct sleep stageinducing the desired sleep cycle pattern in the person-- to avoid intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 ).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in line 13 recites “the person”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claim 1 line 13 “the person” is the same as, different than or in addition to “subject” in claim 1 line 5 and if different in what way the two differ.
Claim 15 in line 13 recites “the person”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claim 15 line 13 “the person” is the same as, different than or in addition to “subject” in claim 15 line 6 and if different in what way the two differ.
Claim 20 in line 18 recites “the person”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claim 20 line 18 “the person” is the same as, different than or in addition to “subject” in claim 20 line 5 and if different in what way the two differ.
Claim 12 in line 2 recites “person” which renders this claim unclear. More specifically, it is unclear as to whether claim 12 line 2 “a person” is the same as, different than or in addition to “person” in claim 1 line 13 and if different in what way the two differ.
Claim 13 in line 2 recites “sensor” which renders this claim unclear. More specifically, it is unclear as to whether claim 13 line 2 “sensor” is the same as, different than or in addition to “sensor” recited in claim 1 line 5 and if different in what way the two differ.
Claim 3 recites the term “audio stimulus lacking infrasonic frequencies” which renders the claim unclear. More specifically, it is unclear as to what frequencies the audio stimulus actually contains. Additionally, the claim scope is rendered unclear the group comprising " audio stimulus lacking infrasonic frequencies " does not have definite and discernable boundaries. Therefore, claim 3 is rendered indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Examiner suggests positively reciting what frequencies the audio stimulus actually contains.
Claim 7 recites “the stimulation pattern representing a second respective sleep stage according to the desired sleep cycle pattern lacks a melody” which renders this claim unclear. More specifically, it is unclear as to what the content of stimulation pattern representing a second respective sleep stage according to the desired sleep cycle pattern actually is. Additionally, the claim scope is rendered unclear the group comprising "stimulation pattern … lacks a melody " does not have definite and discernable boundaries. Therefore, claim 7 is rendered indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Examiner suggests positively reciting what the stimulation pattern representing a second respective sleep stage according to the desired sleep cycle pattern actually contains.
Claims 1 in line 9, claim 8 in line 2 recite the limitation "the defined desired sleep cycle pattern". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 in line 9 recites “the defined desired sleep cycle pattern”. There is insufficient antecedent basis for this limitation in the claim.
Each of claim 1 and claim 15 recite “defined desired sleep cycle pattern” which renders this claim unclear. More specifically, as recited, none of the structures in respective claims are recited as actually performing the defining of the desired sleep cycle pattern.
Claim 1 recites “adaptively progress dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern; to thereby brainwaves of the subject with the associated brainwave pattern corresponding to the series of sleep stages” which renders this claim unclear. More specifically, it is unclear as to system adaptively progresses…to thereby what of the brainwaves of the subject. Additionally, it is unclear as to system adaptively progresses towards what end i.e. to thereby what the brainwaves of the subject.
Claim 15 recites “adaptively progressing dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern” which renders this claim unclear. More specifically, it is unclear as to system is adaptively progressing toward what or what end dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern.
Claim 17 recites “the sensor signal determines a respiratory pattern” which renders this claim unclear. More specifically, in light of the specification which is also silent on this subject-matter, it is unclear as to how a mere signal can “determine” a respirator pattern by itself in light of base claim 15 which is also silent on this subject-matter.
Dependent claims 2-14 and 16-19 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-14 and 16-19 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification page 1 line 19-23, page 38 lines 17-19, page 94, page 95, page 100.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Examined claims 1-6, 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11413425 B2 (U.S. Patent Application No. 17/375599, hereinafter referred to as “Poltorak-5”).
As per examined independent Claim 1, claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower SARS-CoV-2 related sleep of a person species and thus anticipates the more generic or broader claim 1 now pending.
As per examined Claim 2, claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 2 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 3, claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 3 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 4, claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 4 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 5, claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 5 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 6, claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 14 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 6 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 9, claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 13 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 9 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 10, claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 14 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 10 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 11, claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 15 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 11 now pending and for similar reasons provided for claim 1 now pending.
As per examined independent Claim 15, claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower SARS-CoV-2 related sleep of a person species and thus anticipates the more generic or broader claim 15 now pending.
As per examined Claim 16, claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 16 now pending and for similar reasons provided for claim 15 now pending.
As per examined Claim 17, claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 13 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 17 now pending and for similar reasons provided for claim 15 now pending.
As per examined Claim 18, claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 15 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 18 now pending and for similar reasons provided for claim 15 now pending.
As per examined Claim 19, claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 19 now pending and for similar reasons provided for claim 15 now pending.
As per examined independent Claim 20, claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower SARS-CoV-2 related sleep of a person species and thus anticipates the more generic or broader claim 20 now pending.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of Poltorak-5 in view of Morishima et al.(Pub. No.: US 20170319817 A1, hereinafter referred to as "Morishima").
As per examined dependent Claim 7, claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus reads on the more generic or broader claim 7 now pending and for similar reasons provided for claim 1 now pending except for the melody limitation i.e. wherein the stimulation pattern representing a first respective sleep stage according to the desired sleep cycle pattern comprises a melody, and the stimulation pattern representing a second respective sleep stage according to the desired sleep cycle pattern lacks a melody which is disclosed by Morishima (Morishima in at least [0040-0041], [0085] discloses sound stimulus which broadly would encompass well-knowns sounds such as the recited “melody”. [0041] “sound source 28 may play a piece of music that is compatible with the biorhythms acquired by the acquirer 22”[0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”;).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the claim 11 device of Poltorak-5 by further using melodic stimulators as disclosed by Morishima in order to use auditory appealing sensory stimuli (Morishima, [0041], [0085]).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of Poltorak-5 in view of Opp MR. (Cytokines and sleep. Sleep Med Rev. 2005 Oct;9(5):355-64, hereinafter referred to as “Opp”).
As per examined dependent Claim 8, claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 11 to Poltorak-5. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus reads on the more generic or broader claim 8 now pending and for similar reasons provided for claim 1 now pending except for the vaccination feature i.e. vaccinating the subject after achieving the defined desired sleep cycle pattern which is made obvious by Opp (Opp, abstract, page 360, col. 2 ).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the claim 11 device of Poltorak-5 by further vaccinating the subject after achieving the desired sleep cycle pattern as disclosed by Opp as healthy sleep-wake behavior enhances recovery from immune challenge triggered by vaccination(Opp, abstract, page 360, col. 2).
Examined claims 1, 2, 4, 11-16, 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11786694 B2 (U.S. Patent Application No. 16/883541, hereinafter referred to as “Poltorak-1”).
As per examined independent Claim 1, claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower waveforms derived from brainwaves of at least one sleeping donor species and thus anticipates the more generic or broader claim 1 now pending.
As per examined Claim 2, claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 2 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 4, claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 4 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 11, claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 11 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 12, claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 12 now pending.
As per examined Claim 13, claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 13 now pending and for similar reasons provided for claim 1 now pending.
As per examined Claim 14, claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 14 now pending and for similar reasons provided for claim 1 now pending.
As per examined independent Claim 15, claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower waveforms derived from brainwaves of at least one sleeping donor species and thus anticipates the more generic or broader claim 15 now pending.
As per examined Claim 16, claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 16 now pending and for similar reasons provided for claim 15 now pending.
As per examined Claim 18, claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 18 now pending and for similar reasons provided for claim 15 now pending.
As per examined Claim 19, claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over patented claim 19 to Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower species and thus anticipates the more generic or broader claim 19 now pending and for similar reasons provided for claim 15 now pending.
As per examined independent Claim 20, claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of Poltorak-1. Although the claim at issue is not identical, it is not patentably distinct from each other because the patented claim is drawn to narrower waveforms derived from brainwaves of at least one sleeping donor species and thus anticipates the more generic or broader claim 20 now pending.
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 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 1-3, 5-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Morishima.
As per independent Claim 1, Morishima discloses a system for improving sleep (Morishima in at least fig. 1-2, 6-8 abstract, [0001], [0004-0005], [0017], [0021-0030], [0045-0052], [0069-0076], [0083-0084], [0090-0092], [0094], [0098], [0101-0102], [0104] for example discloses relevant subject-matter. More specifically, Morishima in at least fig. 1, 2, 6-7, [0004-0005], [0070], [0101] for example discloses a system for improving sleep. See at least Morishima [0004] “a sleep guidance device that improves sleep quality and sleep satisfaction”;), comprising:
a memory (Morishima, fig. 1, [0026], [0056-0057], [0078]. [0026] “sleep depth estimator 24 has a memory”) configured to store a desired sleep cycle pattern comprising a series of sleep stages, each respective sleep stage having an associated brainwave pattern (Morishima in at least fig. 1, 2, 7, [0026], [0056-0057], [0078]. [0026], [0026] “The sleep depth estimator 24 has a memory, and based on detection results of the sensors 11, 12 and 13, estimates whether a current sleep depth of the human subject E corresponds to non-REM sleep, REM sleep, or wakefulness… A total of six stages are used for estimating sleep depths”; [0057] “characteristics obtained by the sleep depths of the human subject E estimated from the detection results of the sensors 11, 12 and 13 being sequentially stored in the memory”; [0078] “sleep depths being stored in the memory of the sleep depth estimator 24; and from the characteristics of the sleep depths stored in the database 30”);
a sensor configured to monitor a current sleep stage of a subject (Morishima in at least fig. 1-2, [0017-0018], [0083]. See at least [0017] “an electrode of the sensor 11, and the sensor 11 detects brain waves (.alpha. wave, .beta. wave, .delta. wave, .theta. wave, etc.) of the human subject); and
a stimulator (fig. 1, fig. 6, [0024], [0085]), under control of an automated processor (fig. 1, [0021]), configured to present a stimulation pattern to the subject representing a respective sleep stage according to the desired sleep cycle pattern (Morishima in at least fig. 1, 2, 6-7, [0024], [0085], [0092], [0101-0102]. See Morishima at least [0024] “a sleep guidance process executed by the CPU of the sleep guidance device 20.. CPU acquires biorhythms (a brain wave, a pulse wave, respiration, heartbeat, etc.) of the human subject … from the sensors 11, 12 and 13 (S1), and estimates sleep depths of the human subject … from the acquired biorhythms of the human subject …(S2). Next, the CPU controls the sound source 28 to play a sound in accordance with the acquired biorhythms and a current sleep depth among the estimated sleep depths”; [0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”;), and adaptively progress dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern; to thereby brainwaves of the subject with the associated brainwave pattern corresponding to the series of sleep stages, to thereby induce the desired sleep cycle pattern in the person (Morishima in at least fig. 1, 2, 6-7, [0017], [0021], [0070-0071], [0073-0077], [0085], [0092], [0101-0102]. See at least Morishima [0017] “human subject E has attached thereto an electrode of the sensor 11, and the sensor 11 detects brain waves (.alpha. wave, .beta. wave, .delta. wave, .theta. wave, etc.) of the human subject E.”; [0021] “sleep guidance device 20 serves to estimate sleep depths of the human subject … by processing the detected signals of the sensors 11, 12 and 13. The sleep guidance device 20 also serves to control a sound source such that, in accordance with the biorhythms of the human subject… and the estimated sleep depths, the sound source plays a sound to be heard by the human subject”; [0071] “Sensors 11A, 12A and 13A detect biorhythms of the human subject E, whereas sensors 11B, 12B and 13B detect biorhythms of the human subject F”; [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”).
As per dependent Claim 2, Morishima further discloses system wherein the stimulation pattern comprises an audio stimulus (Morishima in at least fig. 1, 6, [0021] [0021] “sleep guidance device 20 also serves to control a sound source such that, in accordance with the biorhythms of the human subject… and the estimated sleep depths, the sound source plays a sound to be heard by the human subject”;”), wherein the stimulation pattern for a respective sleep stage is distinct from the associated brainwave pattern for the respective sleep stage (Morishima in at least fig. 6-7, [0021], [0076], [0101-0102]. [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“).
As per dependent Claim 3, Morishima further discloses system wherein the stimulation pattern comprises an audio stimulus lacking infrasonic frequencies (Morishima in at least [0021] “The sleep guidance device 20 also serves to control a sound source such that, in accordance with the biorhythms of the human subject… and the estimated sleep depths, the sound souce plays a sound to be heard by the human subject”;).
As per dependent Claim 5, Morishima further discloses system wherein the stimulation pattern comprises isochronic tones (Morishima in at least [0040-0041], [0085] discloses sound stimulus which broadly would encompass well-knowns sounds such as the recited “isochronic tones”. Examiner also notes that the Applicants in instant application specification discloses use of isochronic tones stimulation pattern as well-known prior art. See specification disclosure of the following prior art: Fujioka, T., Trainor, L. J., Large, E. W., and Ross, B. (2012). Internalized timing of isochronous sounds is represented in neuromagnetic beta oscillations. J. Neurosci. 32, 1791-1802. doi: 10.1523/JNEUROSCI.4107-11.2012 ; Horr, Ninja K., Maria Wimber, and Massimiliano Di Luca. “Perceived time and temporal structure: Neural entrainment to isochronous stimulation increases duration estimates.” Neuroimage 132 (2016): 148-156; www.livingflow.net/isochronic-tones-work/;).
As per dependent Claim 6, Morishima further discloses system wherein the stimulation pattern comprises a visual stimulus with optical pulses (Morishima in at least [0092] for example discloses use of visual stimulus wherein the stimulation pattern is presented as at least one of an optical signal and a near-infrared signal to the person. See at least [0092] “When ambient light is used as a stimulus, lighting may be arranged proximate to the human subject E. A color and luminance of the lighting can be varied… lighting may be caused to flash on and off, on an as-needed basis”).
As per dependent Claim 7, Morishima further discloses system wherein the stimulation pattern representing a first respective sleep stage according to the desired sleep cycle pattern comprises a melody (Morishima in at least [0040-0041], [0085] discloses sound stimulus which broadly would encompass well-knowns sounds such as the recited “melody”. [0041] “sound source 28 may play a piece of music that is compatible with the biorhythms acquired by the acquirer 22”[0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”;), and the stimulation pattern representing a second respective sleep stage according to the desired sleep cycle pattern lacks a melody ([0041] “waveform data of nature sounds or instrumental sounds”; [0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”;).
As per dependent Claim 8, Morishima further discloses system further comprising vaccinating the subject after achieving the defined desired sleep cycle pattern (This well-known subject-matter is admitted as prior art by Applicants as also evidenced in specification as-filed page 1 lines 19-23, page 2 lines 10, line 17-27, page 29 lines 26-page 30 line 28).
As per dependent Claim 9, Morishima further discloses system wherein the current sleep stage of the subject is determined based on a respiratory pattern (See Morishima at least [0024] “a sleep guidance process executed by the CPU of the sleep guidance device 20.. CPU acquires biorhythms (a brain wave, a pulse wave, respiration, heartbeat, etc.) of the human subject … from the sensors 11, 12 and 13 (S1), and estimates sleep depths of the human subject … from the acquired biorhythms of the human subject …(S2). Next, the CPU controls the sound source 28 to play a sound in accordance with the acquired biorhythms and a current sleep depth among the estimated sleep depths”;).
As per dependent Claim 10, Morishima further discloses system wherein the stimulation pattern comprises infrared illumination of the subject (See Morishima in at least [0092] “When ambient light is used as a stimulus, lighting may be arranged proximate to the human subject E. A color and luminance of the lighting can be varied… lighting may be caused to flash on and off, on an as-needed basis”).
As per dependent Claim 11, Morishima further discloses system wherein the automated processor is part of a smartphone, tablet or wearable device (Morishima in at least fig. 1, [0021] “20”. See Morishima [0021] “sleep guidance device 20 may be a portable terminal or a personal computer”), the stimulation pattern defined by an app executing on the smartphone, tablet or wearable device (Morishima, fig. 1-2, [0021], [0094], [0104]. [0021] “The sleep guidance device 20 may be a portable terminal or a personal computer, for example. Functional blocks (described later) are realized by a central processing unit (CPU) (not shown) of the sleep guidance device 20 executing a pre-installed program…sleep guidance device 20 is illustrated as a personal computer, but the sleep guidance device 20 may instead be provided inside the pillow, for example”) and the monitoring is performed by at least one sensor within the smartphone, tablet or wearable device (Morishima at least [0016] “the system 1 includes sensors 11, 12 and 13, a loudspeaker 14, and the sleep guidance device 20. The system 1 aims to improve sleep quality, etc., and in turn lead to better sleep satisfaction by causing a sound that is output from the loudspeaker 14 to be heard or perceived by a human subject”; [0017] “sensor 11 detects brain waves (α wave, β wave, δ wave, θ wave, etc.) of the human subject E. The left wrist of the human subject E has attached thereto the sensor 12, and the sensor 12 detects pressure changes in the radial artery, i.e., a pulse wave, for example. Since a pulse wave is synchronous with a heartbeat, the sensor 12 indirectly detects a heartbeat. Inside a pillow there is provided the sensor 13 for detecting pressure changes and/or acceleration, so that the sensor 13 detects respiration, heartbeat and so on from body motion of the human subject E.”;[0083] “a brain wave, a pulse wave, respiration, etc., of the human subject E during sleep is detected to estimate sleep depths, and a simple sensor (e.g., an acceleration sensor serving to detect body motion) is additionally employed for the detection at the same time”).
As per dependent Claim 12, Morishima further discloses system wherein the associated brainwave patterns are each derived from brainwave recordings of person different from the subject (Morishima in at least fig. 7, [0076], [0101]. See at least Morishima [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”; [0101] “sleep guidance device … may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have either mutually equivalent phases or mutually reversed phases.”).
As per dependent Claim 13, Morishima further discloses system wherein sensor is configured to determine an awakening of the subject (see Morishima fig. 7 “wakefulness”), and the automated processor is further configured to subsequently restart the desired sleep cycle pattern selectively in dependence on the determined awakening (Morishima in at least fig. 7, [0076], [0101]. See at least Morishima [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E”).
As per dependent Claim 14, Morishima further discloses system wherein the automated processor is further configured to use differences between the brainwaves of the subject and the associated brainwave pattern corresponding to the respective sleep stage to adaptively define the stimulation pattern to improve brain entrainment (Morishima in at least fig. 7, [0076], [0101]. See at least Morishima [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“).
As per independent Claim 15, Morishima discloses a system for improving sleep (Morishima in at least fig. 1-2, 6-8 abstract, [0001], [0004-0005], [0017], [0021-0030], [0045-0052], [0069-0076], [0083-0084], [0090-0092], [0094], [0098], [0101-0102], [0104] for example discloses relevant subject-matter. More specifically, Morishima in at least fig. 1, 2, 6-7, [0004-0005], [0070], [0101] for example discloses a system for improving sleep. See at least Morishima [0004] “a sleep guidance device that improves sleep quality and sleep satisfaction”;), comprising:
a memory (Morishima in at least fig. 1, [0026], [0056-0057], [0078]. [0026] “sleep depth estimator 24 has a memory”) configured to store a desired sleep cycle pattern comprising a series of sleep stages, each respective sleep stage having an associated brainwave pattern (Morishima in at least fig. 1, 2, 7, [0026], [0056-0057], [0078]. [0026], “The sleep depth estimator 24 has a memory, and based on detection results of the sensors 11, 12 and 13, estimates whether a current sleep depth of the human subject E corresponds to non-REM sleep, REM sleep, or wakefulness… A total of six stages are used for estimating sleep depths”; [0057] “characteristics obtained by the sleep depths of the human subject E estimated from the detection results of the sensors 11, 12 and 13 being sequentially stored in the memory”; [0078] “sleep depths being stored in the memory of the sleep depth estimator 24; and from the characteristics of the sleep depths stored in the database 30”);
an input port configured to receive a sensor signal for monitoring a current sleep stage of a subject (Morishima in at least fig. 1-2, [0026]. [0026] “The sleep depth estimator 24 has a memory, and based on detection results of the sensors 11, 12 and 13, estimates whether a current sleep depth of the human subject E corresponds to non-REM sleep, REM sleep, or wakefulness”;);
at least one automated processor (fig. 1, [0021]), configured to define a stimulation pattern representing a respective sleep stage according to the desired sleep cycle pattern (Morishima in at least fig. 1, 2, 6-7, [0024], [0085], [0092], [0101-0102]. See Morishima at least [0024] “a sleep guidance process executed by the CPU of the sleep guidance device 20.. CPU acquires biorhythms (a brain wave, a pulse wave, respiration, heartbeat, etc.) of the human subject … from the sensors 11, 12 and 13 (S1), and estimates sleep depths of the human subject … from the acquired biorhythms of the human subject …(S2). Next, the CPU controls the sound source 28 to play a sound in accordance with the acquired biorhythms and a current sleep depth among the estimated sleep depths”; [0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”;), adaptively progressing dependent on the monitored current sleep stage of the subject and the defined desired sleep cycle pattern (Morishima in at least fig. 1, 2, 6-7, [0017], [0021], [0070-0071], [0073-0077], [0085], [0092], [0101-0102]. See at least Morishima [0017] “human subject E has attached thereto an electrode of the sensor 11, and the sensor 11 detects brain waves (.alpha. wave, .beta. wave, .delta. wave, .theta. wave, etc.) of the human subject E.”; [0021] “sleep guidance device 20 serves to estimate sleep depths of the human subject … by processing the detected signals of the sensors 11, 12 and 13. The sleep guidance device 20 also serves to control a sound source such that, in accordance with the biorhythms of the human subject… and the estimated sleep depths, the sound source plays a sound to be heard by the human subject”; [0071] “Sensors 11A, 12A and 13A detect biorhythms of the human subject E, whereas sensors 11B, 12B and 13B detect biorhythms of the human subject F”; [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”); and
a stimulator (Morishima in at least fig. 1, fig. 6, [0024], [0085]), configured to generate a signal at an output port (see fig. 1-2) adapted to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective sleep stage, to thereby induce the desired sleep cycle pattern in the person (Morishima in at least fig. 7, [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”; [0077] “As a result of such control, the sleep depths (a time waveform thereof) for the human subject F indicated by the broken line change so as to approach the sleep depths (a time waveform thereof) for the human subject E indicated by the solid line. … disturbance of sleep … can be minimized”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“).
As per dependent Claim 16, Morishima further discloses system wherein the stimulation pattern comprises at least one of biaural beats, isochronic tones, and a visual stimulus with optical pulses (Morishima in at least [0092] for example discloses use of visual stimulus wherein the stimulation pattern is presented as at least one of an optical signal and a near-infrared signal to the person. See at least [0092] “When ambient light is used as a stimulus, lighting may be arranged proximate to the human subject E. A color and luminance of the lighting can be varied… lighting may be caused to flash on and off, on an as-needed basis”).
As per dependent Claim 17, Morishima further discloses system wherein the sensor signal determines a respiratory pattern (Morishima in at least fig. 1, 2, 6-7, [0024]. See Morishima at least [0024] “a sleep guidance process executed by the CPU of the sleep guidance device 20.. CPU acquires biorhythms (a brain wave, a pulse wave, respiration, heartbeat, etc.) of the human subject … from the sensors 11, 12 and 13 (S1), and estimates sleep depths of the human subject … from the acquired biorhythms of the human subject …(S2). Next, the CPU controls the sound source 28 to play a sound in accordance with the acquired biorhythms and a current sleep depth among the estimated sleep depths”).
As per dependent Claim 18, Morishima further discloses system wherein the at least one automated processor is part of a smartphone, tablet or wearable device (Morishima in at least fig. 1, [0021] “20”. See Morishima [0021] “sleep guidance device 20 may be a portable terminal or a personal computer”), the stimulation pattern defined by an app executing on the smartphone, tablet or wearable device (Morishima, fig. 1-2, [0021], [0094], [0104]. [0021] “The sleep guidance device 20 may be a portable terminal or a personal computer, for example. Functional blocks (described later) are realized by a central processing unit (CPU) (not shown) of the sleep guidance device 20 executing a pre-installed program…sleep guidance device 20 is illustrated as a personal computer, but the sleep guidance device 20 may instead be provided inside the pillow, for example”) and the monitoring is performed by at least one sensor within the smartphone, tablet or wearable device (Morishima at least [0016] “the system 1 includes sensors 11, 12 and 13, a loudspeaker 14, and the sleep guidance device 20. The system 1 aims to improve sleep quality, etc., and in turn lead to better sleep satisfaction by causing a sound that is output from the loudspeaker 14 to be heard or perceived by a human subject”; [0017] “sensor 11 detects brain waves (α wave, β wave, δ wave, θ wave, etc.) of the human subject E. The left wrist of the human subject E has attached thereto the sensor 12, and the sensor 12 detects pressure changes in the radial artery, i.e., a pulse wave, for example. Since a pulse wave is synchronous with a heartbeat, the sensor 12 indirectly detects a heartbeat. Inside a pillow there is provided the sensor 13 for detecting pressure changes and/or acceleration, so that the sensor 13 detects respiration, heartbeat and so on from body motion of the human subject E.”;[0083] “a brain wave, a pulse wave, respiration, etc., of the human subject E during sleep is detected to estimate sleep depths, and a simple sensor (e.g., an acceleration sensor serving to detect body motion) is additionally employed for the detection at the same time”).
As per dependent Claim 19, Morishima further discloses system wherein the at least one automated processor is further configured to use differences between the brainwaves of the subject and the associated brainwave pattern corresponding to the respective sleep stage to adaptively define the stimulation pattern to improve brain entrainment (Morishima in at least fig. 7, [0076], [0101]. See at least Morishima [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“).
As per independent Claim 20, Morishima discloses a system improving sleep in a subject (Morishima in at least fig. 1-2, 6-8 abstract, [0001], [0004-0005], [0017], [0021-0030], [0045-0052], [0069-0076], [0083-0084], [0090-0092], [0094], [0098], [0101-0102], [0104] for example discloses relevant subject-matter. More specifically, Morishima in at least fig. 1, 2, 6-7, [0004-0005], [0070], [0101] for example discloses a system for improving sleep. See at least Morishima [0004] “a sleep guidance device that improves sleep quality and sleep satisfaction”;),), comprising:
a memory (Morishima, fig. 1, [0026], [0056-0057], [0078]. [0026] “sleep depth estimator 24 has a memory”) configured to store a series of distinct sleep stages, each respective distinct sleep stage having an associated characteristic brainwave pattern (Morishima in at least fig. 1, 2, 7, [0026], [0056-0057], [0078]. [0026], “The sleep depth estimator 24 has a memory, and based on detection results of the sensors 11, 12 and 13, estimates whether a current sleep depth of the human subject E corresponds to non-REM sleep, REM sleep, or wakefulness… A total of six stages are used for estimating sleep depths”; [0057] “characteristics obtained by the sleep depths of the human subject E estimated from the detection results of the sensors 11, 12 and 13 being sequentially stored in the memory”; [0078] “sleep depths being stored in the memory of the sleep depth estimator 24; and from the characteristics of the sleep depths stored in the database 30”);
an input port configured to receive a sensor signal for monitoring a current stage of sleep of a subject (Morishima in at least fig. 1-2, [0026]. [0026] “The sleep depth estimator 24 has a memory, and based on detection results of the sensors 11, 12 and 13, estimates whether a current sleep depth of the human subject E corresponds to non-REM sleep, REM sleep, or wakefulness”);
at least one automated processor, configured to: define a desired sleep cycle pattern comprising a series of the distinct sleep stages, each respective distinct sleep stage having the associated brainwave pattern (Morishima in at least fig. 1, 2, 6-7, [0024], [0085], [0092], [0101-0102]. See Morishima at least [0024] “a sleep guidance process executed by the CPU of the sleep guidance device 20.. CPU acquires biorhythms (a brain wave, a pulse wave, respiration, heartbeat, etc.) of the human subject … from the sensors 11, 12 and 13 (S1), and estimates sleep depths of the human subject … from the acquired biorhythms of the human subject …(S2). Next, the CPU controls the sound source 28 to play a sound in accordance with the acquired biorhythms and a current sleep depth among the estimated sleep depths”; [0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“); and
generate at least one of an audio or optical stimulation pattern adapted to entrain brainwaves in the brain of the subject with the associated brainwave pattern, dependent on the desired sleep cycle pattern and being adaptive to the determined current stage of sleep of the subject, to thereby induce the desired sleep cycle pattern in the subject (Morishima in at least fig. 7, [0076], [0085], [0092], [0101]. See at least Morishima [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E”; [0085] “a sound is given as an example of stimuli, but stimuli that appeal to other sensory organs may also be used. For example, … ambient light (visual stimulus)…or vibration (tactile stimulus), or other relevant stimuli may be used alone, or two or more of the above stimuli including sound may be used in appropriate combination, so as to guide a sleep depth to a desired sleep depth.”; [0092] “When ambient light is used as a stimulus, lighting may be arranged proximate to the human subject E. A color and luminance of the lighting can be varied… lighting may be caused to flash on and off, on an as-needed basis” [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“); and
a stimulator (Morishima in at least fig. 1, fig. 6, [0024], [0085]), having an output port (Morishima in at least fig. 1-2), the stimulator being configured to generate a signal at the output port adapted to entrain brainwaves of the subject with the associated brainwave pattern corresponding to the respective distinct sleep stage, to thereby induce the desired sleep cycle pattern in the person (Morishima in at least fig. 7, [0076] “The sound source controller 26 controls the sound source 28 associated with the human subject F such that the sleep depths of the human subject F will have the characteristics of the sleep depths estimated for the human subject E, i.e., so that phases of the sleep depths of the human subject F are equivalent to phases of the sleep depths of the human subject E.”; [0077] “As a result of such control, the sleep depths (a time waveform thereof) for the human subject F indicated by the broken line change so as to approach the sleep depths (a time waveform thereof) for the human subject E indicated by the solid line. … disturbance of sleep … can be minimized”; [0101] “The sleep guidance device according to the aforementioned aspect may have a configuration in which the acquirer further acquires a biorhythm of another human subject differing from the human subject, and the sleep depth estimator estimates the sleep depths of the human subject from the biorhythm of the human subject acquired by the acquirer, and estimates sleep depths of the other human subject from a biorhythm of the other human subject acquired by the acquirer, and the stimulus controller controls the stimulus imparter such that time changes in the sleep depths estimated for the human subject and time changes in the sleep depths estimated for the other human subject have …mutually equivalent phases“).
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 of this title, 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Morishima in view of Monroe (Pub. No.: US 5356368 A, hereinafter referred to as “Monroe”).
As per dependent Claim 4, Morishima discloses system according to claim 1 (see claim 1)
Morishima does not explicitly disclose biaural beat feature.
However, in an analogous system for improving sleep field of endeavor, Monroe discloses a system for improving sleep (Monroe in at least abstract, col. 1 lines 13-17 “inducing desired states of consciousness, including different levels of sleep, in human beings, using a technique known as frequency following response (FFR),”) wherein the stimulation pattern comprises biaural beats (Monroe col. 2 lines 60-65 “EEGs for a number of individuals in different states of consciousness are sampled, and EEG waveforms for the group of individuals, corresponding to each identifiable state of consciousness, are combined. A binaural beat then is generated using the combined EEGs. Examiner notes that the Applicants in instant application specification discloses use of biaural beats stimulation pattern as well-known prior art. See specification disclosure of the following prior art: “A binaural beat is an auditory illusion perceived when two different pure-tone sine waves, both with frequencies lower than 1500 Hz, with less than a 40 Hz difference between them, are presented to a listener dichotically (one through each ear). en.wikipedia.org/wiki/Beat_(acoustics)#Binaural_beats. … Binaural beats are widely used in brain stimulation”; Padmanabhan, R., A. J. Hildreth, and D. Laws. “A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery.” Anaesthesia 60.9 (2005): 874-877; Kalyan, Ritu, and Bipan Kaushal. “Binaural Entrainment and Its Effects on Memory.” (2016); Lefournour, Joseph, Ramaswamy Palaniappan, and Ian V. McLoughlin. “Inter-hemispheric at spectral power analyses of binaural beat effects on the brain.” Matters 2.9 (2016): e201607000001; Palaniappan, Ramaswamy, Somnuk Phon-Amnuaisuk, and Chikkannan Eswaran. “On the binaural brain entrainment indicating lower heart rate variability.” Int. J. Cardiol 190 (2015): 262-263; Atwater, F. H. (2001). Binaural beats and the regulation of arousal levels. Proceedings of the TANS, 11; Hink, R. F., Kodera, K., Yamada, O., Kaga, K., & Suzuki, J. (1980). Binaural interaction of a beating frequency-following response. Audiology, 19(1), 36-43;).
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 stimulation pattern used in the system for improving sleep as taught by Morishima, with the biaural beats stimulation pattern, as taught by Monroe. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of applying biaural beat entrainment principles to induce/guide the brain of the subject towards desired sleep state (Monroe, abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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