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 Interpretation
The examiner called Mr. E Jonas Jarvholm (Reg. No. 69,289) on 01/15/2025 and conducted a very brief interview in order correct claims 9 and 34. Mr. Jarvholm indicated that claim 9 depends directly from claim 1 and claim 34 depends directly from claim 30.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “electromagnetic shielding” (of claim 6) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-4, 7, 9, 11, 13-16, 18, 22-23, 25-26, 30, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aharonovitch et al. (U.S. Patent Application Publication 2020/0139112).
Regarding claims 1, and 15, Aharonovitch et al. disclose an apparatus comprising:
a power source (comprising: 1) “a power supply unit and power regulator 10,” and/or 2) “battery 30,” see [0092]-[0093] and figures 3-5, and other alternate/equivalent counterparts in other embodiments);
a control system (“microcontroller 11 comprising one or more CPUs (processor cores) along with memory and programmable input/output peripherals,” see [0093] and figures 3-5, and other alternate/equivalent counterparts in other embodiments);
a plurality of electrodes (comprising the plurality of: 1) “stimulation electrodes 16,” and 2) “brain function monitor electrodes 21,” see [0094]-[0095] and figures 3-5, and other alternate/equivalent counterparts in other embodiments);
a wearable support (see [0101] for example) for the electrodes;
a number of electrical conductors (the “independent lines” in “a series of independent lines come out from the D2A 12 to specific drivers 13 via a surge protection 14 to the connectors 15 for the stimulation electrodes 16,” see [0094] and figure 3, and other alternate/equivalent counterparts in other embodiments) electrically connecting the electrodes to the control system and/or to the power source;
wherein the control system is configured to:
calibrate the brain stimulator apparatus to determine a baseline profile (interpreted as the user’s/patient’s measured or sensed brain activity at the time of the brain at that time) of the user's neural activity, based at least in part on electrode data determined via the plurality of electrodes,
wherein calibrating the brain stimulator apparatus comprises:
sensing electrical activity of a brain of the user, using the number of electrodes, over a sensing time window (since it happens in specific steps, e.g., 801, also see [0003]) that is associated with at least one activity state (steps 801 and 802, see [0181] and figure 9); and
storing sensor data that is associated with the sensed electrical activity (step 803, see [0181] and figure 9);
determine a treatment electrical stimulation pattern (step 804 in figure 9), based at least in part on the sensor data and other data that is associated with a known neurological condition, using a machine learning model ([0215]),
the treatment electrical simulation pattern comprising:
a current profile for each electrode, the current profile being indicative of a current to be applied to each electrode (see [0111]–[0125]) over a treatment time window (since it happens in specific steps, e.g., 805, also see [0003]); and/or
a voltage profile for each electrode, the voltage profile being indicative of a voltage to be applied to each electrode (see [0125]) over the treatment time window (since it happens in specific steps, e.g., 805, also see [0003]); and
control application of a voltage to the electrodes in accordance with an electrical stimulation pattern, via the electrical conductors, in response to a treatment requirement indication ([0011], [0097], [0108] for example), to, when worn, produce electric current through the wearer's head to induce stimulation of one or more neurons in the wearer's brain (see [0028] and figures 9-11).
Regarding claim 2, Aharonovitch et al. disclose the claimed invention including wherein the control system is configured to control application of a current ([0111]-[0125]) to the electrodes via the electrical conductors, wherein the current applied stimulates one or more neurons in the wearer's brain.
Regarding claim 3, Aharonovitch et al. disclose the claimed invention including wherein the electrodes are distributed across the brain stimulator to target one or more
specific areas of the brain and/or one or more specific conditions or desired effects in the
brain (see figures 2 and 11).
Regarding claim 4, Aharonovitch et al. disclose the claimed invention including wherein the electrodes are positioned evenly across the brain stimulator to target
preferred areas of the brain, targeting left and right sides of the brain (see figures 2 and 11).
Regarding claim 7, Aharonovitch et al. disclose the claimed invention including “one or more of the electrodes comprise a plurality of needles, the plurality of needles being configured to be inserted into or to contact a wearer's scalp for direct application of at least one electrical signal to the wearer.” (see [0138]-[0143] and figure 8).
Regarding claim 9, Aharonovitch et al. disclose the claimed invention including “wherein the brain stimulator apparatus includes a structure to conform to a wearer's head shape, and the structure is made of a flexible fabric, reticulated structure or another solid material” (see [0138]-[0143] and figure 8).
Regarding claim 11, Aharonovitch et al. disclose the claimed invention including “wherein the apparatus is attached to or attachable to headgear, wherein the each of the plurality of electrodes and the control system are configured to be connected to the headgear such that movement of the headgear causes corresponding movement of each of the plurality of electrodes and the control system” (see [0028]).
Regarding claims 13-14, Aharonovitch et al. disclose the claimed invention including:
1) “wherein the power source includes an electrical charge storage device, a battery and/or capacitive storage device, wherein the electrical charge storage device is attached or attachable to the brain stimulator apparatus and/or to the headgear” (see [0080] and figure 3),
2) “wherein the charge storage device is rechargeable” (see [0080]).
Regarding claim 16, Aharonovitch et al. disclose the claimed invention including wherein the apparatus includes wireless communication capability (see [0026], [0059], [0080], and [0096]-[0097] for example).
Regarding claim 18, Aharonovitch et al. disclose the claimed invention including
wherein the apparatus is arranged and configured to communicate with a mobile device, wherein the mobile device controls and monitors the voltage applied to the wearer via the electrodes (see [0016], [0033] and claim 77 for example).
Regarding claim 22, Aharonovitch et al. disclose the claimed invention including wherein the voltage applied by the control system is pulsed or constant over a period of time (see [0111] – where “constant/alternating” current translates to constant or pulsing (alternating) voltage).
Regarding claim 23, Aharonovitch et al. disclose a method comprising:
bringing a plurality of electrodes onto or into contact with a scalp of a wearer of the wearable brain stimulator (see [0173]);
conducting an assessment of the wearer's brain activity in at least a region of the brain using the electrodes (1) steps 801-802 in figure 9, or 2) step 902 in figure 10 for example), wherein conducting the assessment of the wearer's brain activity comprises determining electrode data that is associated with at least one activity state, via the plurality of electrodes (“sensing electrodes 21” and “sensing electrode unit 203,” see [0095], [0108] and figures 3-5);
calibrating the wearable brain stimulator (since it happens in specific steps, e.g., 801, also see [0003]) to determine a baseline profile of the user's neural activity (interpreted as the user’s/patient’s measured or sensed brain activity at the time of the brain at that time), based at least in part on the assessment;
determining a treatment electrical stimulation pattern (step 804 in figure 9), based at least in part on the electrode data and other data that is associated with a known neurological condition, using a machine learning model ([0215]),
the treatment electrical stimulation pattern comprising:
a current profile for each electrode, the current profile being indicative of a current to be applied to each electrode (see [0111]–[0125]) over a treatment time window (since it happens in specific steps, e.g., 805, also see [0003]); and/or
a voltage profile for each electrode, the voltage profile being indicative of a voltage to be applied to each electrode (see [0125] – additionally when an electrode or a set of electrodes deliver electrical stimulations to tissue there inherently is current and voltage) over the treatment time window (since it happens in specific steps, e.g., 805, also see [0003]); and
applying a voltage through the electrodes to stimulate the brain, the voltage being determined based at least in part on the treatment electrical stimulation pattern (steps 804 and 805 in figure 9).
Regarding claim 25, Aharonovitch et al. disclose the claimed invention including the treatment electrical stimulation pattern is programmed into the control system (“microcontroller 11 comprising one or more CPUs (processor cores) along with memory and programmable input/output peripherals,” see [0093], [0160], and [0162] and figures 3-5) of the apparatus.
Regarding claim 26, Aharonovitch et al. disclose the claimed invention including the brain stimulator apparatus control system is operated or influenced by a mobile device (see [0016], [0033] and claim 77 for example), wherein monitoring and/or adjustment of the voltage is controlled via the mobile device or controlled through the control system (see [0011], [0013], [0015], [0125], and [0180]-[0182]), and wherein the control system monitors and/or adjust the voltage, to avoid over stimulation (figures 8-9, also see [0005] and [0054]).
Regarding claim 30, Aharonovitch et al. disclose an apparatus comprising:
a plurality of non-invasive electrodes (comprising the plurality of: 1) “stimulation electrodes 16,” and 2) “brain function monitor electrodes 21,” see [0094]-[0095] and figures 3-5, and other alternate/equivalent counterparts in other embodiments) that are configured to be electrically connected to a head of a user of the brain stimulator apparatus;
a wearable support ([0028]) configured to be connected to the electrodes;
a control system (“microcontroller 11 comprising one or more CPUs (processor cores) along with memory and programmable input/output peripherals,” see [0093] and figures 3-5, and other alternate/equivalent counterparts in other embodiments); and
a number of electrical conductors (the “independent lines” in “a series of independent lines come out from the D2A 12 to specific drivers 13 via a surge protection 14 to the connectors 15 for the stimulation electrodes 16,” see [0094] and figure 3, and other alternate/equivalent counterparts in other embodiments) electrically connecting the electrodes to the control system,
the control system comprising:
at least one processor (recall from above “microcontroller 11 comprising one or more CPUs (processor cores) along with memory and programmable input/output peripherals,” see [0093] and figures 3-5, and other alternate/equivalent counterparts in other embodiments); and
memory storing program instructions ([0093]) accessible by the at least one processor and configured to cause the at least one processor to:
calibrate the brain stimulator apparatus to determine a baseline profile (interpreted as the user’s/patient’s measured or sensed brain activity at the time of the brain at that time) of the user's neural activity, based at least in part on electrode data determined via the plurality of electrodes, wherein calibrating the brain stimulator apparatus comprises:
sensing electrical activity of a brain of the user, using the plurality of electrodes, over a sensing time window (since it
happens in specific steps, e.g., 801, also see [0003]) that is associated with at least one activity state (steps 801 and 802, see [0181] and figure 9, step 902 in figure 10, also see [0205], [0208], and [0231]); and
storing sensor data that is associated with the sensed electrical activity in the memory (step 803, see [0181] and figure 9, and/or step 904, see [0182] and figure 10);
determine a treatment electrical stimulation pattern (step 804 in figure 9, and/or step 905 in figure 10), based at least in part on the sensor data and other data that is associated with a known neurological condition, using a machine learning model ([0215]), the treatment electrical simulation pattern comprising:
a current profile for each electrode, the current profile being indicative of a current to be applied to each electrode (see [0111]–[0125]) over a treatment time window (since it happens in specific steps, e.g., 805, also see [0003]); and/or
a voltage profile for each electrode, the voltage profile being indicative of a voltage to be applied to each electrode (see [0125]) over the treatment time window (since it happens in specific steps, e.g., 805, also see [0003]) ; and
apply an electrical output to each of the plurality of electrodes, in response to a treatment requirement indication (1) steps 804 and 805, or 2) steps 905 and 906), based at least in part on the treatment electrical stimulation pattern, over the treatment time window (up to the end of that step).
Regarding claim 34, Aharonovitch et al. disclose the claimed invention including the at least one activity state is a resting state, a reading state, a walking state or a
talking state (see [0205], and [0208]). Additionally, claim 34 recites a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971). A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Aharonovitch et al. (U.S. Patent Application Publication 2020/0139112) as applied to claim 1 above, and further in view of Icenbice, Jr. (U.S. Patent 3,851,651).
Regarding claim 5, Aharonovitch et al. show the invention above
but fail to explicitly recite “the brain stimulator apparatus has electrically insulating material between the electrodes, wherein the electrical insulating material isolates the electrodes from each other to prevent electrical interference.”
It is extremely well known in the electrical stimulation arts to electrically insulate electrodes, as an example, like Aharonovitch et al., Icenbice, Jr. discloses a device for electrically stimulating the head (i.e., face) with a plurality of electrodes and teach placing an electrically insulating material (“electrically insulative body 28,” see col. 3:1-7 and figure 2) between the electrodes (“electrodes 29 and 30,” see col. 3:1-7 and figure 2) in order to provide a known and workable manner of delivering electrical stimulation to the patient/user when using multiple electrodes.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Aharonovitch et al., as taught by Icenbice, Jr., to place an electrically insulating material between the electrodes in order to provide a known and workable manner of delivering electrical stimulation to the patient/user when using multiple electrodes.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Aharonovitch et al. (U.S. Patent Application Publication 2020/0139112) as applied to claim 1 above, and further in view of Harris et al. (U.S. Patent Application Publication 2008/0027515).
Regarding claim 6, Aharonovitch et al. show the invention above
but fail to explicitly recite “the apparatus includes electromagnetic shielding to prevent or restrict external interference from one or more external electromagnetic fields (EMF).”
Like Aharonovitch et al., Harris et al. disclose a device for electrically stimulating the brain and teach providing the device with “a conductive electromagnetic interference shield (EMI) that is configured to shield the electronic components,” (see [0095]) in order to provide the device with a known and workable manner of providing some protection from EMI/EMF.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Aharonovitch et al., as taught by Harris et al., to provide the device with “a conductive electromagnetic interference shield (EMI) that is configured to shield the electronic components” in order to provide the device with a known and workable manner of providing some protection from EMI/EMF.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792