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 .
Claim Objections
Claims 9, 12, and 20 are objected to because of the following informalities:
In claim 9, line 1, “generates” should read “generate”
In claim 12, line 1, “comprising a controller” should read “further comprising a controller”
In claim 20, line 1, “comprising determining” should read “further comprising determining”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“interface configured to obtain the plurality of measurements…” in claim 1, lines 4-5; equivalent structure in paras. 0024-0026. Therefore, in light of the specification, an “interface” is best understood as a plurality of electrodes, speakers, lights, display screens, or mechanical actuators with hardware/software components that are configured to provide sensory stimuli to a user, and equivalents thereof.
“controller” in claim 8, line 1; equivalent structure found in paras. 0006, 0033, and 0036. Therefore, in light of the specification, a controller is best understood as a device comprising processors configured to receive inputs and generate output signals, and equivalents thereof.
“interface configured to obtain a plurality of measurements…” in claim 11, lines 2-3; equivalent structure in paras. 0024-0026. Therefore, in light of the specification, an “interface” is best understood as a plurality of electrodes, speakers, lights, display screens, or mechanical actuators with hardware/software components that are configured to provide sensory stimuli to a user, and equivalents thereof.
“an interface…” in claim 17, lines 2-3; equivalent structure in paras. 0024-0026. Therefore, in light of the specification, an “interface” is best understood as a plurality of electrodes, speakers, lights, display screens, or mechanical actuators with hardware/software components that are configured to provide sensory stimuli to a user, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 5-6, 13-14, and 19-20 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 5 recites the limitation “the plurality of biomarkers comprises a ratio of band activities and shifts in frequency spectra of activity” in lines 2-3. It is unclear how a biomarker itself could comprise a ratio of band activities and shifts in frequency spectra of activity.
Claim 6 recites the limitation “a first target sleep profile” in line 2. It is unclear whether a “first target sleep profile” is synonymous to the previously recited “first target sleep profile” in claim 1,
line 9, or if the “first target sleep profile” in claim 6, line 2 is associated with a different technical feature entirely. For examination purposes, the “first target sleep profile” recited in claims 6 is being treated as the same technical feature as the “first target sleep profile” recited in claim 1.
Claim 13 recites the limitation “a plurality of biomarkers” in line 2. It is unclear if “a plurality of biomarkers” are intended to be positively required as part of the device or not.
Claim 19 recites “at least one target biomarker” in lines 1-2. It is unclear if “at least one target biomarker” is one of the plurality of “biomarkers” recited in claim 18, from which claim 19 depends, or a separate biomarker. For examination purposes, “at least one target biomarker” is being treated as one of the plurality of biomarkers recited in claim 18.
The term “similar” in claim 20 is a relative term which renders the claim indefinite. The term “similar” 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. Overall, it is unclear which metrics constitute “similar” metrics.
The dependent claim not specifically addressed above is rejected under 35 U.S.C. 112(b) as
indefinite due to its dependence from an indefinite claim.
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 (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 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, 11, 13-15, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laura Lapoint et al. (US 2016/0302718).
Regarding claim 1, Laura Lapoint et al. teaches a system (Abstract; Fig. 1, system 10) comprising:
a plurality of electrodes (Fig. 1, sensors 18) configured to be coupled to a brain of a user and configured to obtain a plurality of measurements from the brain of the user (para. 0020);
an interface (Fig. 1, user interface 24) configured to obtain the plurality of measurements from at least the plurality of electrodes (paras. 0024 and 0040-0041); and
a processing device (Fig. 1, processor 20) comprising one or more processors (paras. 0021-0023 and 0044; Fig. 1, control component 36) configured to generate a plurality of stimulus parameters (paras. 0033-0036) to effect a change in a band ratio based on a range of values associated with a ratio of slow wave activity to beta wave activity based (Fig. 1, brain activity component 30; paras. 0025-0026 and 0028-0030), at least in part, on a comparison of a first target sleep profile (para. 0027, wherein the “target sleep state/stage” is being construed as the “target sleep profile”) and a sleep profile (paras. 0020 and 0035, wherein the “current sleep state/stage” is being construed as the “sleep profile”) of the user (Fig. 1, comparison component 34; paras. 0005 and 0027-0032, wherein the comparison component 34 is configured to compare the current state of the subject 12 to the target sleep state);
wherein the first target sleep profile is based, at least in part, on the plurality of measurements (paras. 0024 and 0027, wherein the target component 32 is configured to determine target ranges for brain activity parameters and obtain target sleep state based on information from the subject’s pervious sleep sessions, information from a population of subject’s sleep sessions, and/or EEG readings received from the user interface 24).
Regarding claim 2, Laura Lapoint et al. teaches the system according to claim 1 as stated above wherein the one or more processors (Fig. 1, target component 32) are further configured to generate the first target sleep profile based, at least in part, on a plurality of biomarkers (Fig. 2; paras. 0025-0028, and 0031, wherein the characteristics of the EEG, which are defined by brainwaves (theta, beta, delta, gamma, etc.) and their associated frequency ranges, are being construed as “biomarkers”).
Regarding claim 3, Laura Lapoint et al. teaches the system according to claim 2 as stated above wherein the first target sleep profile is identified based, at least in part, on a plurality of sleep stages and the plurality of biomarkers (Fig. 2; paras. 0025-0028 and 0031).
Regarding claim 4, Laura Lapoint et al. teaches the system according to claim 3 as stated above wherein one or more biomarkers of the plurality of biomarkers identify each of the plurality of sleep stages (Fig. 2; paras. 0025-0028 and 0031).
Regarding claim 6, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Laura Lapoint et al. teaches the system according to claim 1 as stated above wherein the one or more processors are configured to generate a first target sleep profile for the user based, at least in part, on the plurality of measurements (paras. 0024, 0027, and 0047, wherein the target ranges are determined based on the EEG, which is determined by sensor 18 and received from the user interface 24).
Regarding claim 7, Laura Lapoint et al. teaches the system according to claim 1 as stated above wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition (para. 0025, “typical EEG characteristics during NREM sleep include a transition from alpha waves (e.g., about 8-12 Hz) to theta waves (e.g., about 4-7 Hz) for sleep stage N1”; paras. 0028 and 0035).
Regarding claim 8, Laura Lapoint et al. teaches the system according to claim 1 as stated above, further comprising a controller (Fig. 1, control component 36) configured to stimulate the brain of the user via the plurality of electrodes (para. 0019, wherein the sensory stimulator 16 may be a collection of electrodes on the scalp of the subject) and based on the plurality of stimulus parameters (paras. 0033-0035);
wherein the processing device is further configured to generate a second target sleep profile after stimulation of the brain of the user (paras. 0038, 0044, and 0048, where the process of determining a target sleep state, comparing the current/actual sleep state to the target sleep state, and providing sensory stimulation to the subject to guide the brain activity parameters of the subject into the target ranges may be repeated until the brain activity parameters of the subject are within the target ranges).
Regarding claim 9, Laura Lapoint et al. teaches the system according to claim 8 as stated above wherein the processing device is configured to generate a stimulus regimen (paras. 0035-0037, “sensory stimulation” and “timing of auditory tones”) that is configured to modify or shape the sleep profile of the user to match the first target sleep profile via the stimulation provided by the controller and the interface (see Claim 14; paras. 0005, 0033, 0038, and 0050, wherein the control component 36 and interface 24 are configured to control and adjust the delivered sensory stimulation to guide the brain activity parameters of the subject into the target ranges).
Regarding claim 11, Laura Lapoint et al. teaches a device (paras. 0039-0042, wherein the interface 24 may be integrated into the electronic storage 22 and the electronic storage 22 integrated with the processor 20 – this assembly is being construed as the “device”) comprising:
an interface (Fig. 1, user interface 24) configured to obtain a plurality of measurements from a plurality of electrodes (para. 0020; Fig. 1, sensor 18) configured to be coupled to a brain of a user (paras. 0024 and 0040-0041, wherein EEG readings from the sensor 18 may be displayed via the user interface 24);
a processing device (Fig. 1, processor 20) comprising one or more processors (paras. 0021-0023 and 0044) configured to:
generate a first target sleep profile for the user based (para. 0027, wherein the “target sleep state/stage” is being construed as the “target sleep profile”), at least in part, on:
the plurality of measurements (paras. 0024, 0027, and 0047, wherein the target ranges are determined based on the EEG, which is determined by sensor 18 and received from the user interface 24); and
a target band ratio based on a range of values associated with a ratio of target slow wave activity to target beta wave activity (Fig. 2, paras. 0025-0027 and 0028-0030, wherein each brainwave/EEG pattern is associated with a specific frequency range); and
generate a plurality of brain stimulus parameters based, at least in part, on a comparison of the first target sleep profile (para. 0027, wherein the “target sleep state/stage” is being construed as the “target sleep profile”) and a sleep profile (paras. 0020 and 0035, wherein the “current sleep state/stage” is being construed as the “sleep profile”) of the user (para. 0035, “The sensory stimulation is tailored by control component 36 to entrain the EEG in the frequency band(s) where discrepancies (e.g., including both deficits and/or excess) exist between the brain activity parameter range for the target sleep state and the brain activity parameters for the current sleep state”; paras. 0029 and 0032-0034, wherein the comparison component 34 is configured to compare the one or more brain activity parameters to the target ranges and the control component is configured to determine stimulation parameters and control the sensory stimulator 16), wherein the plurality of brain stimulus parameters effects an adjustment of a band ratio of the sleep profile to the target band ratio (paras. 0025-0026 and 0028-0030, wherein the target band ratio may be associated with beta waves (frequency range of 15-30 Hz), which are linked with a high level of alertness, this target frequency range may be communicated to the sensory stimulator 16 – see para. 0036 specifically).
Regarding claim 13, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Laura Lapoint et al. teaches the device according to claim 11 as stated above wherein the first target sleep profile is identified based, at least in part, on a plurality of sleep stages and a plurality of biomarkers (Fig. 2; paras. 0025-0028 and 0031).
Regarding claim 14, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Laura Lapoint et al. teaches the device according to claim 11 as stated above wherein one or more biomarkers of the plurality of biomarkers identify each of the plurality of sleep stages (Fig. 2; paras. 0025-0028 and 0031).
Regarding claim 15, Laura Lapoint et al. teaches the device according to claim 11 as stated above wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition (para. 0025, “typical EEG characteristics during NREM sleep include a transition from alpha waves (e.g., about 8-12 Hz) to theta waves (e.g., about 4-7 Hz) for sleep stage N1”; paras. 0028 and 0035).
Regarding claim 17, Laura Lapoint et al. teaches a method (Fig. 5, method 500; paras. 0006 and 0044) comprising:
receiving, via an interface and a plurality of electrodes coupled to a brain of a user, a plurality of measurements from the brain of the user (Fig. 5, operation 502; para. 0045; paras. 0020, 0024, and 0040-0041, wherein EEG readings from the sensor 18 may be received via the user interface 24;
generating, using one or more processors of a processing device, a first target sleep profile for the user based, at least in part, on the plurality of measurements (Fig. 5, operation 506; paras. 0046-0048); and
generating, using the one or more processors of the processing device, a plurality of brain stimulus parameters (Fig. 5, operation 510; paras. 0050; paras. 0018, 0034-0036) that adjusts a band ratio associated with the plurality of measurements to a target band ratio associated with the first target sleep profile (paras. 0025-0026 and 0028-0030, wherein the target band ratio may be associated with beta waves (frequency range of 15-30 Hz), which are linked with a high level of alertness, this frequency range may be communicated to the sensory stimulator 16 – see para. 0036 specifically) based, at least in part, on a comparison of the first target sleep profile and a sleep profile of the user (Fig. 5, operation 508; para. 0049; paras. 0020 and 0035, wherein the “current sleep state/stage” is being construed as the “sleep profile”; para. 0027, wherein the “target sleep state/stage” is being construed as the “target sleep profile”);
wherein the band ratio and the target band ratio are each based on a range of values associated with a ratio of slow wave activity and beta wave activity (Fig. 2, paras. 0025-0027 and 0028-0030, wherein each brainwave/EEG pattern is associated with specific frequency range), respectively.
Regarding claim 18, Laura Lapoint et al. teaches the method according to claim 17 as stated above wherein the first target sleep profile is identified based, at least in part on a plurality of sleep stages and biomarkers identifying each of the plurality of sleep stages (Fig. 2; paras. 0025-0028 and 0031).
Regarding claim 19, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Laura Lapoint et al. teaches the method according to claim 18 as stated above wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition (para. 0025, “typical EEG characteristics during NREM sleep include a transition from alpha waves (e.g., about 8-12 Hz) to theta waves (e.g., about 4-7 Hz) for sleep stage N1”; paras. 0028 and 0035).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laura Lapoint et al. in view of Pradeep (US 2019/0126033).
Regarding claim 5, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Laura Lapoint et al. teaches the system according to claim 2 as stated above. Laura Lapoint et al. further teaches wherein: the plurality of biomarkers comprises a ratio of band activities and shifts in frequency spectra of activity (Fig. 2; paras. 0025-0028 and 0030-0031); and the plurality of stimulus parameters comprises frequencies of stimulation (paras. 0034-0035). Laura Lapoint et al. fails to teach wherein the plurality of stimulus parameters comprises amplitudes of stimulation.
In the same field of endeavor, Pradeep teaches wherein the plurality of stimulus parameters comprises amplitudes of stimulation (para. 0180).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Laura Lapoint et al. with the stimulus parameters comprising amplitudes of stimulation of Pradeep. The stimuli may be generated from neural activity measurements and further adjusted to enhance the power of slow wave oscillations in the brain (Pradeep, paras. 0009 and 0179-0180).
Regarding claim 10, Laura Lapoint et al. teaches the system according to claim 1 as stated above. While Laura Lapoint et al. further teaches electrodes on the scalp (para. 0019) and wherein the plurality of stimulus parameters comprise a plurality of acoustic stimulus parameters (paras. 0034-0037), Laura Lapoint et al. fails to specifically teach electrical brain stimulus parameters.
In the same field of endeavor, Pradeep teaches electrical brain stimulus parameters (paras. 0042-0043 and 0180).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Laura Lapoint et al. with the electrical brain stimulus parameters of Pradeep. Electrical stimulation with specific parameters may be applied to the cortical tissue of the brain to improve slow wave and spindle synchrony, sleep quality, and memory consolidation (Pradeep, Abstract; paras. 0005, 0029, 0042-0043, and 0180).
Regarding claim 12, Laura Lapoint et al. teaches the device according to claim 11 as stated above. Laura Lapoint et al. further teaches a controller (Fig. 1, control component 36) but fails to specifically teach a controller comprising one or more processors configured to generate a control signal based on the plurality of brain stimulus parameters.
In the same field of endeavor, Pradeep teaches a controller comprising one or more processors configured to generate a control signal based on the plurality of brain stimulus parameters (paras. 0015, 0060-0062, and 0180; Claims 1-2).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Laura Lapoint et al. with the controller configured to generate a control signal of Pradeep. Based on the control signal, one or more electrical stimuli may be generated to increase slow wave oscillation power of the brain and/or alleviate pain, depression, and cognitive pain (Pradeep, paras. 0009 and 0069).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laura Lapoint et al. in view of Simons et al. (US 2019/0282812).
Regarding claim 16, Laura Lapoint et al. teaches the device according to claim 11 as stated above. Laura Lapoint et al. further teaches wherein the processing device is further configured to generate the first target sleep profile for the user (para. 0027, wherein the “target sleep state/stage” is being construed as the “target sleep profile”). Laura Lapoint et al. fails to teach wherein the first target sleep profile for the user is based, at least in part, on a percent of time that a transition from the first sleep stage to a second sleep stage of the user occurs with respect to a percent of total sleep time.
In the same field of endeavor, Simons et al. a percent of time that a transition from the first sleep stage to a second sleep stage of the user occurs with respect to a percent of total sleep time (Fig. 16, paras. 0090-0091; Table 3).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Laura Lapoint et al. with the percentages of sleep stages according to total sleep time of Simons et al. Understanding the proportion of time allocated to each sleep stage could enable the system to administer electrical stimulation at precise intervals within the user’s sleep cycle (Simons et al., paras. 0089-0091).
Claim(s) 20 as best understood in light of the rejections under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Laura Lapoint et al. in view of Garcia Molina et al. (US 2019/0254591).
Regarding claim 20, Laura Lapoint et al. teaches the method according to claim 17 as stated above. Laura Lapoint et al. further teaches determining the first target sleep profile based on an aggregation of previously measured data from numerous other users that have similar metrics as a plurality of user metrics (para. 0027). Laura Lapoint et al. fails to teach a plurality of biological metrics and a plurality of health metrics.
Garcia Molina et al. teaches an analogous method wherein an aggregation of previously measured data includes a plurality of biological metrics and a plurality of health metrics (paras. 0023, 0026, and 0055-0056).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Laura Lapoint et al. with the plurality of health and biological metrics of Garcia Molina et al. Using historical data from a pooled population with similar demographics and physiology allows the system to develop a more personalized prediction model, which can accurately forecast the user’s sleep stages or sleep stage transitions (Garcia Molina et al., paras. 0055-0057).
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.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 15-16, and 18 of U.S. Patent No. 12,042,606. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patent claims.
Instant Application
12,042,606
Claim 1. A system comprising:
a plurality of electrodes configured to be coupled to a brain of a user and configured to obtain a plurality of measurements from the brain of the user;
an interface configured to obtain the plurality of measurements from at least the plurality of electrodes; and
a processing device comprising one or more processors configured to generate a plurality of stimulus parameters to effect a change in a band ratio based on a range of values associated with a ratio of slow wave activity to beta wave activity based, at least in part, on a comparison of a first target sleep profile and a sleep profile of the user; wherein the first target sleep profile is based, at least in part, on the plurality of measurements.
Claim 1
Claim 2. The system of claim 1, wherein the one or more processors are further configured to generate the first target sleep profile based, at least in part, on a plurality of biomarkers.
Claim 1
Claim 3. The system of claim 2, wherein the first target sleep profile is identified based, at least in part, on a plurality of sleep stages and the plurality of biomarkers.
Claim 1
Claim 4. The system of claim 3, wherein one or more biomarkers of the plurality of biomarkers identify each of the plurality of sleep stages.
Claim 1
Claim 5. The system of claim 2, wherein: the plurality of biomarkers comprises a ratio of band activities and shifts in frequency spectra of activity; and the plurality of stimulus parameters comprises frequencies and amplitudes of stimulation.
Claim 2 & Claim 3
Claim 6. The system of claim 1, wherein the one or more processors are configured to generate a first target sleep profile for the user based, at least in part, on the plurality of measurements.
Claim 1
Claim 7. The system of claim 1, wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition.
Claim 1
Claim 8. The system of claim 1, further comprising a controller configured to stimulate the brain of the user via the plurality of electrodes and based on the plurality of stimulus parameters; wherein the processing device is further configured to generate a second target sleep profile after stimulation of the brain of the user.
Claim 4 & Claim 5
Claim 9. The system of claim 8, wherein the processing device is configured to generates a stimulus regimen that is configured to modify or shape the sleep profile of the user to match the first target sleep profile via the stimulation provided by the controller and the interface.
Claim 6
Claim 10. The system of claim 1, wherein the plurality of stimulus parameters comprise a plurality of electrical brain stimulus parameters.
Claim 1
Claim 11. A device comprising:
an interface configured to obtain a plurality of measurements from a plurality of electrodes configured to be coupled to a brain of a user;
a processing device comprising one or more processors configured to: generate a first target sleep profile for the user based, at least in part, on:
the plurality of measurements; and
a target band ratio based on a range of values associated with a ratio of target slow wave activity to target beta wave activity; and
generate a plurality of brain stimulus parameters based, at least in part, on a comparison of the first target sleep profile and a sleep profile of the user, wherein the plurality of brain stimulus parameters effects an adjustment of a band ratio of the sleep profile to the target band ratio.
Claim 15
Claim 12. The device of claim 11, comprising a controller comprising one or more processors configured to generate a control signal based on the plurality of brain stimulus parameters.
Claim 15
Claim 13. The device of claim 11, wherein the first target sleep profile is identified based, at least in part, on a plurality of sleep stages and a plurality of biomarkers.
Claim 15
Claim 14. The device of claim 13, wherein one or more biomarkers of the plurality of biomarkers identify each of the plurality of sleep stages.
Claim 15
Claim 15. The device of claim 11, wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition.
Claim 15
Claim 16. The device of claim 11, wherein the processing device is further configured to generate the first target sleep profile for the user based, at least in part, on a percent of time that a transition from a first sleep stage to a second sleep stage of the user occurs with respect to a percent of total sleep time.
Claim 16
Claim 17. A method comprising:
receiving, via an interface and a plurality of electrodes coupled to a brain of a user, a plurality of measurements from the brain of the user;
generating, using one or more processors of a processing device, a first target sleep profile for the user based, at least in part, on the plurality of measurements; and
generating, using the one or more processors of the processing device, a plurality of brain stimulus parameters that adjusts a band ratio associated with the plurality of measurements to a target band ratio associated with the first target sleep profile based, at least in part, on a comparison of the first target sleep profile and a sleep profile of the user;
wherein the band ratio and the target band ratio are each based on a range of values associated with a ratio of slow wave activity and beta wave activity, respectively.
Claim 18
Claim 18. The method of claim 17, wherein the first target sleep profile is identified based, at least in part on a plurality of sleep stages and biomarkers identifying each of the plurality of sleep stages.
Claim 18
Claim 19. The method of claim 18, wherein the first target sleep profile includes at least one target biomarker that corresponds with a sleep stage transition.
Claim 18
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grossman et al. (US 2019/0143073) teaches a neuromodulator that measures the endogenous electrical activity of the brain via electrodes and delivers electrical stimulation to a subject’s brain via external electrodes to modify a sleep state or accelerate a subject’s sleep onset. Tononi (US 2008/0081941) discloses an apparatus for promoting restorative sleep that provides a brain stimulator for periodic stimulation of brain at a frequency substantially less than five hertz to promote slow wave activity. Raniere (US 2006/0106275) discloses a device and method for monitoring a person’s sleep patterns through physiological characteristics and guiding the person through one or more desired sleep patterns via sensory stimuli.
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/B.R.L./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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