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 .
Preliminary Amendment
Preliminary Amendment dated 06/15/2023has been formally entered and claims 1-20 submitted with Preliminary Amendment dated 06/15/2023 are being examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
“***” in page 9, 11-12, 14 needs to deleted or the relevance explained.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 20 line 2 “a wearable device” needs to be corrected. A suggested correction is – the [[a]] wearable device– in light of its antecedent in claim 1 line 1“A wearable device”.
Claim 1 line 5 “plurality of arms” needs to be corrected. A suggested correction is – the plurality of arms – in light of its antecedent in claim 1 line 4“a plurality of arms”.
Each of claims 8-9, 17-18 include numerous acronyms/abbreviations. At least first occurrence of each acronym/abbreviation should be spelled out in full.
Claim 19 include reference characters which are enclosed within parentheses. The use of reference characters is considered as having no effect on the scope of the claims. Since the reference characters are not afforded patentable weight, the reference characters enclosed within parentheses should be deleted from the claims.
Claim 9 and claim 18 “a range of about 0.10÷50.00 Hz” needs to be corrected. A suggested correction is --a range of about 0.10[[÷]]-50.00 Hz--.
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 1 recites the limitation “the acquisition”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 in line 7 recites the limitation “the fluctuation”. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 in line 10 recites “said arms” which renders this claim unclear. More specifically, it is unclear as to claim 1 line 10 “said arms” is referencing which of the preceding instances of the arm(s) i.e. claim 1 lines 4-5 “plurality of arms”, claim 1 line 6 “a pair of temporal arms” and/or “a pair of median arms”.
Each of claim 3-4 recites “one or more of said arms” which renders this claim unclear. More specifically, it is unclear as to claim 3-4 “one or more of said arms” is referencing which of the preceding instances of the arm(s) i.e. claim 1 lines 4-5 “plurality of arms”, claim 1 line 6 “a pair of temporal arms” and/or “a pair of median arms”.
Claim 5 in line 3 recites “the arm” which renders this claim unclear. More specifically, it is unclear as to claim 5 line 3 “the arm” is referencing which of the preceding instances of the arm(s) i.e. claim 5 line 2 “temporal arms”, claim 1 lines 4-5 “plurality of arms”, claim 1 line 6 “a pair of temporal arms” and/or “a pair of median arms”.
Claim 6 recites “said arms” which renders this claim unclear. More specifically, it is unclear as to claim 6 “said arms” is referencing which of the preceding instances of the arm(s) i.e. claim 1 lines 4-5 “plurality of arms”, claim 1 line 6 “a pair of temporal arms” and/or “a pair of median arms”.
Claim 12 recites “said arms” which renders this claim unclear. More specifically, it is unclear as to claim 12 “said arms” is referencing which of the preceding instances of the arm(s) i.e. claim 1 lines 4-5 “plurality of arms”, claim 1 line 6 “a pair of temporal arms” and/or “a pair of median arms”.
Claim 13 in line 5 recites the limitation " said acquired electroencephalographic signals ". There is insufficient antecedent basis for this limitation in the claim.
Each of claims 8-9, 17-18 recite the term “about” which renders the claim unclear. The term " about" here in each of claims 8-9, 17-18 is a relative range term which renders the claim indefinite. The term " about" is not defined by the claim with respect to the boundary i.e. unclear as to whether the term “about” refers herein to a value of +/-0.25% of the defined measure; or the term “about” refers herein to a value of +/-0.10% of the defined measure or some other value or percentage. Additionally, the specification does not provide a standard for ascertaining the requisite degree/range, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 in lines 9-10 recite “a plurality of acquisition and stimulation electrodes” which renders this claim unclear. More specifically, it is unclear as to [a] whether plurality/grouping of electrodes has first subgroup of electrodes with acquisition functionality and a second subgroup of electrodes with stimulation functionality; [b1] whether each electrode has the both acquisition and stimulation functionalities i.e. both “acquisition” and “stimulation” functionality qualifiers apply to each electrode; and [b2] if each electrode has the both acquisition and stimulation functionalities are the functionalities mutually exclusive or simultaneous. In the interest of furthering prosecution, claim 1 lines 9-10 recite “a plurality of acquisition and stimulation electrodes” is being reasonably interpreted as in [a] plurality/grouping of electrodes has first subgroup of electrodes with acquisition functionality and a second subgroup of electrodes with stimulation functionality.
Each of claims 10 and 19 recite the limitation “…in particular a tablet or smart phone..." The use of the word “in particular” in the claim language renders the claim indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention since it raises a "broader limitation followed by narrow limitation" indefiniteness type issue. Still more particularly, it is not clear whether you have to have a “mobile device” to meet the claim or whether you have to have the narrower “a tablet or smart phone” that follows the word "in particular".
Each of claims 3-5, 7, 16 recite limitation(s) proceeding the term “optionally”. The use of the word “optionally” in the claim language renders the claim indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention since it raises a "broader limitation followed by narrow limitation" indefiniteness type issue. Still more particularly, it is not clear whether you have to have a broader limitation to meet the claim or whether you have to have the narrower limitation that follows the word " optionally". For example with respect to claim 3, it is not clear whether you have to have a “means for adjusting its sagittal extension” to meet the claim or whether you have to have the narrower “means of a wheel-shaped manipulation element” that follows the word "optionally".
Claim 11 recites “means for acquiring an electroencephalic signal and/or means for electroencephalic stimulation” which renders this claim unclear in light of claim 1 lines 1-3. More specifically, first, 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."). Consequently, a broad yet reasonable interpretation of the limitation “means for acquiring an electroencephalic signal and/or means for electroencephalic stimulation” would encompasses [a] -- means for acquiring an electroencephalic signal -- or [b] -- means for electroencephalic stimulation—or [c] -- means for acquiring an electroencephalic signal and means for electroencephalic stimulation--. Using interpretation as in [a] or [b], it is unclear as to how just one of means for acquiring an electroencephalic signal or means for electroencephalic stimulation actually is able to perform acquisition of electroencephalographic signals and brain electrostimulation to induce falling asleep-in a person wearing it.
Claim 13 in lines 5-6 recites “… said acquired electroencephalographic signals” which renders this claim unclear in light of claim 13 line 4 which recites “acquisition unit of electroencephalographic signals of said subject” i.e. pre-existing stored/storage of electroencephalographic signals of said subject. More specifically, it is unclear as what structure actually performs the acquiring of electroencephalographic signals of the subject in this context. Consequently, claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structures/steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps/structures are: structure that actually acquires the electroencephalographic signals of the subject for downstream processing.
Dependent claims 2-12 and 14-20 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 2-12 and 14-20 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation – 35 U.S.C 112
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. More specifically, the following terms are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
Claims that invoke 35 U.S.C 112 (f)
Means term
Specification Support in instant application specification as-filed dated 06/15/2023
3, 4
“means for adjusting”
At least Figure 2C “40”, page 13 lines 1-3
3
“means of a wheel-shaped manipulation”
At least Figure 2C “40”, page 13 lines 1-3
11
“means for acquiring an electroencephalic signal”
At least Figure 1 “101”, page 6 lines 25-27
11
“means for electroencephalic stimulation”
At least Figure 1 “103”, page 7 lines 5-8
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 Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed dated 06/15/2023 pages 4-6, 14.
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.").
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kwan; Pui Tong (Pub. No.: US 20190030336 A1, hereinafter referred to as "Kwan").
As per independent Claim 1, Kwan discloses a wearable device for the acquisition of electroencephalographic signals and brain electrostimulation configured to induce desired mental states in a person wearing it (Kwan in at least abstract, fig. 1-13, [0001], [0024], [0034-0053], [0055-0084], [0086] for example discloses relevant subject-matter. More specifically, Kwan in at least abstract, fig. 1, fig. 4-6, fig. 9-10, fig. 12, [0001], [0035] for example discloses wearable device (see fig. 4-5) for the acquisition of electroencephalographic signals and brain electrostimulation configured to induce desired mental states in a person wearing it. See at least Kwan abstract “a transcranial electrical stimulation (TES) system …TES signals are generated and output to user in terms of sessions… electrical signals' frequencies, amplitudes and phase angles are varying during the time of application …kinds of variations in parameters such as frequencies, amplitudes and phase angles are tailor-made to the needs of improvement required in several brain disorders caused or related neurological disorders symptoms. With the help of the wearing design, the brain can be stimulated in dedicated positions such that the TES signals are continuously monitored by the unit”; [0001] “portable composite waveform Transcranial Electrical Stimulation (hereinafter called TES) system”), comprising:
a main body substantially in the form of a helmet, having a plurality of arms each adapted to extend sagittally on the scalp, which plurality of arms includes at least a pair of temporal arms and a pair of median arms frontally connected (Kwan in at least fig. 1, fig. 4-6, fig. 12, [0047], [0062], [0064-0065] for example discloses a main body substantially in the form of a helmet as seen in fig. 4-5, having a plurality of arms each adapted to extend sagittally on the scalp as seen in fig. 4-5, which plurality of arms includes at least a pair of temporal arms 1, 2 and a pair of median arms 3-8 frontally connected as seen in fig. 1 and fig. 4-5. See at least Kwan [0047] “TES system. In which, the electrical stimulation signals are output to the recipient via a delicate electrical probes system having 4+4 electrodes resided on the left and right side of the headset. The eight positions are relative to the brain's functional 3D spatial regions, namely, Cerebellum, Frontal and Temporal Lobe”; [0062] “electrical stimulation signals are output to the recipient via a delicate electrical probes system (FIG. 1) in which electrodes are resided into relevant positions. A total of eight individual electrodes are equipped in the headset as shown (FIG. 2: Front View, FIG. 3: Back View). When the headset is put onto the head as shown in FIG. 4 and FIG. 5, the probes system's structural design is made such that the orientations of the electrodes' contacts are located at the relative spatial distribution of brain's functional regions as shown in FIG. 6.”; [0065] “Multi-channels of electrical stimulation and flexible selection of electrode pairs are available. Depending on the needs, users can program the device to stimulate more than one region of brain intermittently by means of commutated pairs of electrodes within chosen probes via programming. Different combination of stimulating output electrodes (channels/electrode pairs) can be programmed”); and
a local control unit, configured to receive acquisition and stimulation commands from a remote unit and to operate a plurality of acquisition and stimulation electrodes arranged, or configured to be arranged, on said arms (Kwan in at least fig. 9-10, 12, [0024], [0047], [0062], [0064-0065], [0082] for example discloses a local control unit/electronics circuitry compartment, configured to receive acquisition and stimulation commands from a remote unit/remote control and to operate a plurality of acquisition and stimulation electrodes arranged, or configured to be arranged, on said arms. See at least Kwan [0082] “electronic circuitry is embodied into a detachable compartment … Inside which it houses all the main functional units including Microprocessor, Memories, Power Management, Impedance Tracking System, Digital to Analog, Outputs Control, Micro-USB or USB-C Interface, Remote Control and a Rechargeable Battery Cell. The compartment is connected to the Probe system via two pairs of connections located in the inner sides of compartment and the main functional unit relative position. Output TES signals are sent out from the compartment's contacts to the electrodes ends inside the Probe system (FIG. 10).”).
Kwan does not necessarily require induce falling asleep-in a person wearing it feature in the applied embodiment.
However, Kwan discloses alternate embodiments that disclose a wearable device for the acquisition of electroencephalographic signals and brain electrostimulation configured to induce falling asleep-in a person wearing it (Kwan in at least abstract, fig. 1, fig. 4-5, fig. 12, [0018], [0035] discloses wearable device for the acquisition of electroencephalographic signals and brain electrostimulation configured to induce falling asleep-in a person wearing it. See at least d1 [0018] “micro-current was used to stimulate the brain. The main result of the experiment was to generate hypnotic effect, and later the experiment was further applied to control anxiety, insomnia, depression and pain… further applied to Transcutaneous Electrical Nerve Stimulators (TENS) and other related devices”).
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 wearable device for the acquisition of electroencephalographic signals and brain electrostimulation configured to induce desired mental states in a person wearing it as taught by Kwan, by extending application to induce falling asleep-in a person wearing it, as also taught by Kwan. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending benefits to treat/alleviate sleep disorders such as insomnia (Kwan in [0018]).
As per dependent Claim 2, Kwan as a whole further discloses device wherein said local control unit is arranged at a front housing of said main body (Kwan in at least fig. 9-10, 12, [0077], [0082] for example discloses local control unit/electronics circuitry compartment is arranged at a front housing of said main body. See at least Kwan [0082] “electronic circuitry is embodied into a detachable compartment … Inside which it houses all the main functional units including Microprocessor, Memories, Power Management, Impedance Tracking System, Digital to Analog, Outputs Control, Micro-USB or USB-C Interface, Remote Control and a Rechargeable Battery Cell. The compartment is connected to the Probe system via two pairs of connections located in the inner sides of compartment and the main functional unit relative position. Output TES signals are sent out from the compartment's contacts to the electrodes ends inside the Probe system (FIG. 10).”).
As per dependent Claim 3, Kwan as a whole further discloses device wherein one or more of said arms comprises means for adjusting its sagittal extension, optionally operable by means of a wheel-shaped manipulation element (Kwan in at least fig. 9-10, [0064], [0077], [0082] for example discloses one or more of said arms comprises means for adjusting its sagittal extension. See at Kwan [0064] “probes system's structural design …allows us to access and contact onto the targeted functional region of the brain (see FIG. 6)...users can rotate and adjust the probes system in their favorable positions (FIG. 7). There is a strong stainless steel embedded inside the headband that provides an inwards spring back bending force when users put on the device…to ensure a secure mounting, support and right positioning of probes system”).
As per dependent Claim 4, Kwan as a whole further discloses device wherein one or more of said arms comprises means for adjusting the relative trans-cranial position, optionally configured to allow rotation about a frontal axis (Kwan in at least fig. 9-10, [0064], [0077], [0082] for example discloses one or more of said arms comprises means for adjusting the relative trans-cranial position. See at Kwan [0064] “probes system's structural design …allows us to access and contact onto the targeted functional region of the brain (see FIG. 6)...users can rotate and adjust the probes system in their favorable positions (FIG. 7). There is a strong stainless steel embedded inside the headband that provides an inwards spring back bending force when users put on the device…to ensure a secure mounting, support and right positioning of probes system” ).
As per dependent Claim 5, Kwan as a whole further discloses device wherein one or both of the temporal arms have a mastoid branch extending substantially orthogonal to a longitudinal direction of prevailing development of the arm, which branch is optionally configured to support one or more reference electrodes (Kwan in at least fig. 1, 4-5 for example discloses one or both of the temporal arms have a mastoid branch extending substantially orthogonal to a longitudinal direction of prevailing development of the arm).
As per dependent Claim 6, Kwan as a whole further discloses device wherein said arms have a free rear longitudinal end (Kwan in at least fig. 9-10, 12, [0062]. [0064], [0077], [0082] for example discloses said arms have a free rear longitudinal end).
As per dependent Claim 7, Kwan as a whole further discloses device wherein said local control unit is configured to perform an alternating current transcranial stimulation (tACS) optionally based upon signals consisting of sine waves, and optionally with variable current intensity and/or frequency (Kwan in at least [0035-0036] for example discloses said local control unit is configured to perform an alternating current transcranial stimulation (tACS) optionally based upon signals consisting of sine waves, and optionally with variable current intensity and/or frequency. See at least Kwan [0035]” TES system device in which its working principle is by means of transmitting electrical stimulation signals in the form of a composite waveform such that the recipient can experience electrical stimulation signals in terms of amplitudes, frequencies (both in the high range and low range) and phase angles variations”; [0036] “composite waveform can be an offset type AC signals or differential AC signals” ).
As per dependent Claim 8, Kwan as a whole further discloses device wherein said current intensity varies in a range of about 0.1-5 mA (Kwan in at least [0045] for example discloses current intensity varies in a range of about 0.1-5 mA. See at least Kwan [0045] “device contains an impedance measurement unit. Real-time measurements will be taken … measured values are acquired and feedback to the micro-processor for adjustment such that the output amplitude of DC equivalent is ensured to be under control. By means of voltage control corrections, the outcome TES electrical signals' voltage and current are always controlled below a safety magnitude of voltage at 35V and current at 10 mA.”).
As per dependent Claim 9, Kwan as a whole further discloses device wherein said frequency is variable in a range of about 0.10÷50.00 Hz (Kwan in at least [0037] for example discloses frequency is variable in a range of about 0.10-50.00 Hz. See at least Kwan [0037] “oscillation frequencies of signals applied and can be adjusted to the extent of 40 kHz in the high side and down to 0.001 Hz in the low side… employing a stimulation profile within ONE stimulation session that possess all required variations of amplitudes, frequencies & phase angles. The kind of waveform (as shown in FIG. 13A) can be a guided envelop of low frequencies (as shown in FIGS. 13B and 13C) with numerous high frequencies super-imposed onto the envelope.”).
As per dependent Claim 10, Kwan as a whole further discloses device wherein said local control unit is configured for communication with a mobile device, in particular a tablet or a smart phone (Kwan in at least fig. 9-10, fig. 12, [0083] for example discloses local control unit is configured for communication with a mobile device. See at least Kwan [0083] “Aside from the main unit of the device, it accompanies with a remote-control unit for handling the operation of the device when users are wearing it on their heads. The remote-control unit communicates with the main unit via 2.4 GHz wireless, Bluetooth, or infra-red wireless protocol. User's menu for selection of profile is shown inside the LCD display. The remote-control is also powered up by another set of rechargeable battery.”).
As per dependent Claim 11, Kwan as a whole further discloses device comprising means for acquiring an electroencephalic signal and/or means for electroencephalic stimulation (Kwan in at least fig. 1, fig. 12, [0024], [0062], [0077], for example discloses means for acquiring an electroencephalic signal and/or means for electroencephalic stimulation/TES. See at least Kwan [0077] “electrical probes system of portable TES device … equipped with four pairs of electrodes” ).
As per dependent Claim 12, Kwan as a whole further discloses device comprising housings for said acquisition and/or stimulation electrodes positioned on said arms at frontal, central and parietal scalp areas (Kwan in at least fig. 9-10 [0062], [0061], [0077], [0082] for example discloses housings for said acquisition and/or stimulation electrodes positioned on said arms at frontal, central and parietal scalp areas. See at Kwan [0064] “probes system's structural design …allows us to access and contact onto the targeted functional region of the brain (see FIG. 6)...users can rotate and adjust the probes system in their favorable positions (FIG. 7). There is a strong stainless steel embedded inside the headband that provides an inwards spring back bending force when users put on the device…to ensure a secure mounting, support and right positioning of probes system”).
As per dependent Claim 20, Kwan as a whole further discloses a system of brain electrostimulation (Kwan in at least fig. 12, [0058]), comprising a wearable device (Kwan in at least fig. 1, 4-6, [0047-0053]) according to claim 1 (see claim 1).
Claims 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Poltorak; Alexander (Pub. No.: US 20200086078 A1, hereinafter referred to as "Poltorak").
As per independent Claim 13, Poltorak discloses a system of brain electrostimulation configured to induce the falling asleep of a recipient subject, which system comprises, in operational data communication with each other (Poltorak in at least fig. 1-7, 9-10, abstract, [0003], [0122], [0340-0341], [0432-0433], [0344], [0823-0833], [0946-0947], [1006], [1074] for example discloses relevant subject-matter. More specifically, Poltorak in at least [0833], [0946-0947], [1006] for example discloses system of brain electrostimulation ( [0432-0433], [0833]) configured to induce the falling asleep of a recipient subject ([1006]) which system comprises, in operational data communication with each other. See at least Poltorak, fig. 1, [0003] “neuromodulation and neuroenhancement… systems and methods for improving sleep states in humans or animals”; [0432] “Transcranial Alternative Current Stimulation (tACS): Transcranial alternating current stimulation (tACS) is a noninvasive means by which alternating electrical current applied through the skin and skull entrains in a frequency-specific fashion the neural oscillations of the underlying brain.”; [0833] “One strategy to enhance deep sleep non-pharmacologically is to stimulate the brain with … electrical currents… based on artificial and synthetic stimulation paradigms”, [1006] “provide a method of inducing sleep in a second subject comprising: recording brain activity patterns of a first subject (donor) who is asleep; and inducing sleep in the second subject (recipient) by replicating the brain activity patterns of the donor in the recipient.”; [0947]” Mental states may be induced in a subject non-invasively via …transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tDAS) or HD-tACS”):
an acquisition unit of electroencephalographic signals of donor subject(Poltorak in at least fig.1, [0828], [0946-0947] for example discloses an acquisition unit of electroencephalographic signals of said subject. See at least Poltorak [0828] “EEG recordings of brainwaves are obtained”;);
a processing unit of said acquired electroencephalographic signals from donor, configured to output personalized electroencephalic stimulation signals for recipient subject (Poltorak in at least fig. 1, [0828], [0946-0947] for example discloses a processing unit of said acquired electroencephalographic signals from donor, configured to output personalized electroencephalic stimulation signals for recipient subject. See at least [0828] “EEG recordings of brainwaves are obtained and pre-processed … during various stages of sleep…The EEG recordings are analyzed to identify statistically significant waveform components correlated with specific sleep stages. A model (e.g., a linear multivariate model) is developed for the coefficients of the components of the EEG, based on sleep stage/wakefulness status; and the statistical significance of the model is measured. Stimulation protocols are developed that can provide safe and effective neurostimulation to induce desired sleep stage”; [0946] “general-purpose computer may be used for the processing of the information, a microprocessor, a FPGA, an ASIC, a system-on-a-chip, or a specialized system, which employs a customized configuration to efficiently achieve the information transformations required.”;); and
a stimulation unit, configured to control one or more stimulation electrodes, applied at least at the frontal, central, parietal and temporal regions of the scalp of the recipient subject, according to said stimulation signals (Poltorak in at least fig. 1, [0122], [0828], [0833], [0946-0947] for example discloses a stimulation unit, configured to control one or more stimulation electrodes, applied at least at the frontal, central, parietal and temporal regions of the scalp of the recipient subject, according to said stimulation signals. See at least Poltorak [0122] “EEG signals may be captured and analyzed by a mobile device, often referred as “brain wearables”. There are a variety of “brain wearables” readily available on the market today. EEGs can be obtained with a non-invasive method where the aggregate oscillations of brain electric potentials are recorded with numerous electrodes attached to the scalp of a person”; [0946] “apparatuses for acquiring the brain activity information from the source, processing the brain activity information to reveal a target brain activity state and a set of stimuli, which seek to achieve that state in a recipient, and generating stimuli for the recipient to achieve and maintain the target brain activity state over a period of time and potential state transitions. The generated stimuli may be feedback controlled.”; [0947]” Mental states may be induced in a subject non-invasively via …transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tDAS) or HD-tACS”).
Poltorak does not necessarily require both donor and recipient be the same subject i.e. brain electrostimulation to induce the falling asleep of a subject when subject suffers from sleep disorders using the subject’s own healthy sleep state acquired brainwave signals feature in the applied embodiment.
However, Poltorak discloses alternate embodiments that disclose where the donor and the recipient are the same subject (Poltorak in at least [1074] for example discloses where the donor and the recipient are the same subject. See at least Poltorak [1074] “a donor and a recipient are the same subject at different times… the stimulation signal may be a minimally processed recording of the same subject at an earlier time”).
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 system of brain electrostimulation configured to induce the falling asleep of a subject as taught by Poltorak, using the subject’s own health sleep state acquired brainwave signals, as also taught by Poltorak. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving a tACS that is modulated with indigenous brainwaves recorded from the subject during healthy sleep to replicate the desired healthy sleep in the same subject during times that subject suffers from sleep issues (Poltorak, [1074], [0826]).
As per dependent Claim 14, Poltorak as a whole further discloses system wherein said processing unit is configured to identify an instant, or a time interval, of falling asleep of the subject (Poltorak in at least [0828], [1074] for example discloses processing unit is configured to identify an instant, or a time interval, of falling asleep of the subject. See at least Poltorak [0828] “EEG recordings of brainwaves are obtained and pre-processed from … subjects during various stages of sleep…EEG recordings are analyzed to identify statistically significant waveform components correlated with specific sleep stages. A model (e.g., a linear multivariate model) is developed for the coefficients of the components of the EEG, based on sleep stage/wakefulness status;”; [1074] “a donor and a recipient are the same subject at different times”).
As per dependent Claim 15, Poltorak as a whole further discloses system wherein said processing unit is configured to identify an instant, or a time interval, of falling asleep of the subject based upon one or more of the following parameters: spectral power density of one or more of the electroencephalographic signals acquired by said acquisition unit; coherence, that is the degree of similarity between the electroencephalographic oscillatory signals acquired at different brain areas; entropy, that is the degree of complexity and predictability of the fluctuations in a time series defined by the acquired electroencephalographic signals (Poltorak in at least [0132], [0823], [0828], [1074] for example discloses wherein said processing unit is configured to identify an instant, or a time interval, of falling asleep of the subject based upon one or more of the following parameters: spectral power density of one or more of the electroencephalographic signals acquired by said acquisition unit; coherence, that is the degree of similarity between the electroencephalographic oscillatory signals acquired at different brain areas; entropy, that is the degree of complexity and predictability of the fluctuations in a time series defined by the acquired electroencephalographic signals. See at least Poltorak [0132] “EEG-based functional connectivity…: correlation, coherence and phase synchronization indices between each pair of EEG electrodes”).
As per dependent Claim 16, Poltorak as a whole further discloses system wherein said stimulation unit is configured to perform transcranial alternating current stimulation (tACS), optionally based upon signals made of sine waves, and optionally with variable current intensity and/or frequency (Poltorak in at least [0432], [0947] for example discloses stimulation unit is configured to perform transcranial alternating current stimulation (tACS). POLTORAK in at least [0432] “Transcranial Alternative Current Stimulation (tACS): Transcranial alternating current stimulation (tACS) is a noninvasive means by which alternating electrical current applied through the skin and skull entrains in a frequency-specific fashion the neural oscillations of the underlying brain.”; [0947]” Mental states may be induced in a subject non-invasively via …transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tDAS) or HD-tACS”).
As per dependent Claim 17, Poltorak as a whole further discloses system wherein said current intensity varies in a range of about 0.1-5 mA (Poltorak in at least [0344] for example discloses current intensity varies in a range of about 0.1-5 mA. See at least Poltorak [0344] “mild electrical shock (usually, a 2-milliamp current) is used to depolarize the neuronal membranes, making the cells more excitable and responsive to inputs… tDCS appears to bring about the flow state. The movements of the subjects become more … calm”).
As per dependent Claim 18, Poltorak as a whole further discloses system wherein said frequency is variable in a range of about 0.10÷50.00 Hz(Poltorak in at least [0826], [1074] for example discloses frequency is variable in a range of about 0.10-50.00 Hz. See at least Poltorak [0826] “non-pharmacological approaches to promoting sleep is neuromodulation via … transcranial electric stimulation (TES)… tACS modulated with indigenous brainwaves recorded from a …sleeping donor can be used to replicated a desired sleep stage of a healthy donor in another subject.”; [1074] “a donor and a recipient are the same subject at different times”).
As per dependent Claim 19, Poltorak as a whole further discloses system which is configured for communication with a mobile device, in particular a tablet or smart phone (Poltorak in at least [0122] for example discloses system configured for communication with a mobile device. see at least Poltorak [0122] “EEG signals may be captured and analyzed by a mobile device, often referred as “brain wearables”. There are a variety of “brain wearables” readily available on the market today. EEGs can be obtained with a non-invasive method where the aggregate oscillations of brain electric potentials are recorded with numerous electrodes attached to the scalp of a person.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims. US 20190021657, US 20150343196, US 10092753, US 20200139112, US 20210236806, US 6463328, US 20220134106, US 20200368491, US 10918862, US 20120296390, US 20200155061, US 20190001133, and US 20160074657 for disclosing portable/wearable adaptive transcranial electrical stimulation devices with stimulation based on neurofeedback from scalp electrodes that render treatment such as alleviating sleep disorders to the subject similar to that disclosed.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791