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 .
Response to Amendment
Claims 10-13 and 21-36 are currently pending. Claims 26-30 remain withdrawn. Claims 10 and 31 have been amended.
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 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fedorov et al. (“Restoration of vision after optic nerve lesions with noninvasive transorbital alternating current stimulation: a clinical observational study” – previously cited).
Regarding claim 10, Federov et al. teaches a method of treating a brain condition of a subject, the method comprising:
applying, to an ocular region of the subject via one or more electrodes, a brain-condition affecting treatment to the subject (page 191, Stimulation protocol, 1st paragraph; “four active multichannel stimulation electrodes were placed at the upper eyelids (two for each eye) with eyes closed”), the brain-condition affecting treatment including:
supplying an electrical signal via a direct conduction path from the ocular region of the subject through an optical nerve to a brain of the subject, the electrical signal in the form of at least one of a transcranial direct current stimulation (tDCS) or a transcranial alternating current stimulation (tACS) (page 191; Stimulation protocol, 1st paragraph; “rtACS was applied” The eyelids are in the “ocular region of the subject.” One of ordinary skill would understand that in order to stimulate the brain with electrodes placed on the eyelids, the stimulation current would go through the optic nerve to reach the brain.).
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.
Claims 11-13, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Federov et al. in view of Shapira et al. ‘787 (US Pub No. 2008/0200787 – previously cited).
Regarding claim 11, Federov et al. all of the elements of the current invention as mentioned above except for measuring, via at least some of the one or more electrodes, an ocular-brain region bioimpedance of the subject over a treatment time of the brain-condition affecting treatment; and
assessing, via one or more processors of a computing device, an efficacy of the brain-condition affecting treatment based on changes in the ocular-brain region bioimpedance over the treatment time.
Shapira et al. ‘787 teaches measuring an ocular-brain region bioimpedance of the subject over a treatment time of the brain-condition affecting treatment ([0010], [0024]); and
assessing, via one or more processors of a computing device, an efficacy of the brain-condition affecting treatment based on changes in the ocular-brain region bioimpedance over the treatment time ([0163]; “impedance measurements are dependent on blood volume”, [0047]; “to monitor the blood flow in the brain of a patient with a medical condition likely to lead to loss of blood flow to the brain”, [0003]; “data regarding quantity of blood flow in the brain and the changes in flow rate may be vastly important in evaluating the risk of injury to the brain tissue and the efficacy of treatment”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Federov et al. to include measuring an ocular-brain region bioimpedance of the subject over a treatment time of the brain-condition affecting treatment; and assessing an efficacy of the brain-condition affecting treatment based on changes in the ocular-brain region bioimpedance over the treatment time as Shapira et al. ‘787 teaches that this will aid in evaluating the risk of injury to the brain tissue and the efficacy of treatment ([0003]).
Regarding claim 12, Federov et al. in view of Shapira et al. ‘787 teaches all of the elements of the current invention as mentioned above except for wherein measuring the ocular-brain region bioimpedance of the subject over the treatment time of the brain-condition affecting treatment comprises:
providing, via at a subset of the at least some of the one or more electrodes, a measurement electrical signal to an ocular region of the subject through one or more electrodes placed on an outer surface of the subject at the ocular region of the subject;
detecting, via a remainder of the at least some of the one or more electrodes, the measurement electrical signal over a conduction path of the subject, that conduction path including the ocular region and at least a portion of a brain region; and
determining, via the one or more processors of the computing device, the ocular-brain region bioimpedance from the detected measurement electrical signal.
Shapira et al. ‘787 teaches wherein measuring the ocular-brain region bioimpedance of the subject over the treatment time of the brain-condition affecting treatment comprises:
providing, via at a subset of the at least some of the one or more electrodes, a measurement electrical signal to an ocular region of the subject through one or more electrodes placed on an outer surface of the subject at the ocular region of the subject ([0168]; “…electrodes 114 are placed on the temples…”);
detecting, via a remainder of the at least some of the one or more electrodes, the measurement electrical signal over a conduction path of the subject, that conduction path including the ocular region and at least a portion of a brain region ([0168]-[0169]; “voltage-measuring electrodes 114, or current-carrying electrodes 108 and 110, or both, are placed on the temples”); and
determining, via the one or more processors of the computing device, the ocular-brain region bioimpedance from the detected measurement electrical signal ([0010]; “the impedance of the head is measured by passing current through the head and measuring the associated voltage by electrodes”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the measuring the ocular-brain region bioimpedance of the subject over the treatment time of the brain-condition affecting treatment of Federov et al. in view of Shapira et al. ‘787 to include providing a measurement electrical signal to an ocular region of the subject through one or more electrodes placed on an outer surface of the subject at the ocular region of the subject; detecting the measurement electrical signal over a conduction path of the subject, that conduction path including the ocular region and at least a portion of a brain region; and determining the ocular-brain region bioimpedance from the detected measurement electrical signal as Shapira et al. ‘787 teaches this will aid in reducing the errors ([0010]).
Regarding claim 13, Federov et al. in view of Shapira et al. ‘787 teaches all of the elements of the current invention as mentioned above except for wherein assessing the efficacy of the brain-condition affecting treatment based on changes in the ocular-brain region bioimpedance over the treatment time comprises:
determining, via the one or more processors of the computing device, a brain health indicator from the bioimpedance information, wherein the brain health indicator indicates at least one of changes (i) in cerebral blood volume (CBV), (ii) cerebral autoregulation (CAR), (iii) intracranial pressure (ICP), (iv) cerebral perfusion pressure (CPP), (v) a perfusion reactivity index (PRx), (vi) cerebral blood flow (CBF), (vii) blood pressure, and (viii) ventilation; and
assessing, via the one or more processors of the computing device, the brain health indicator to determine if the brain health indicator has an acceptable brain health indicator value or an unacceptable brain health indicator value.
Shapira et al. ‘787 teaches determining, via the one or more processors of the computing device, a brain health indicator from the bioimpedance information, wherein the brain health indicator indicates at least one of changes (i) in cerebral blood volume (CBV), (ii) cerebral autoregulation (CAR), (iii) intracranial pressure (ICP), (iv) cerebral perfusion pressure (CPP), (v) a perfusion reactivity index (PRx), (vi) cerebral blood flow (CBF), (vii) blood pressure, and (viii) ventilation ([0003], [0047]; “cerebral blood flow”); and
assessing, via the one or more processors of the computing device, the brain health indicator to determine if the brain health indicator has an acceptable brain health indicator value or an unacceptable brain health indicator value ([0003]; “There is a need to measure cerebral blood flow during several medical events and procedures, because any disturbance to the flow of blood to the brain may cause an injury to the function of the brain cells, and even death of brain cells if the disturbance is prolonged.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assessing the efficacy of the brain-condition affecting treatment based on changes in the ocular-brain region bioimpedance over the treatment time of Federov et al. in view of Shapira et al. ‘787 to include determining a brain health indicator from the bioimpedance information, wherein the brain health indicator indicates at least one of changes (i) in cerebral blood volume (CBV), (ii) cerebral autoregulation (CAR), (iii) intracranial pressure (ICP), (iv) cerebral perfusion pressure (CPP), (v) a perfusion reactivity index (PRx), (vi) cerebral blood flow (CBF), (vii) blood pressure, and (viii) ventilation; and assessing the brain health indicator to determine if the brain health indicator has an acceptable brain health indicator value or an unacceptable brain health indicator value as Shapira et al. ‘787 teaches that this will aid in increasing cerebral blood flow and preventing permanent damage to the brain ([0003]).
Regarding claims 31 and 32, Federov et al., as modified by Shapira et al. ‘787, teaches an apparatus for treating a brain condition of a subject as claim 31 is analogous to the subject matter of claims 10-12.
Claims 21, 22, 24, and 25 are rejected under 35 U.S.C. 103 as being obvious over Federov et al. in view of in view of Willis ‘698 (US Pub No. 2010/0189698 – previously cited).
Regarding claim 21, Federov et al. teaches all of the elements of the current invention as mentioned above except for wherein the brain-condition affecting treatment further comprises: providing, via a photonic stimulation stage associated with the one or more electrodes, photonic stimulation to the brain through the ocular region for at least one of providing a therapy to the subject or obtaining diagnostic information on the subject.
Willis ‘698 teaches combination therapies of increasing dopamine function in the retina by flashing light into the retina and providing electrical stimulation to the brain ([0140], [0144]-[0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Federov et al. to include providing photonic stimulation to the brain through the ocular region for at least one of providing a therapy to the subject or obtaining diagnostic information on the subject as Willis ‘698 teaches that combining prior art elements (electrical brain stimulation and applying a brain-condition affecting treatment to the ocular region of the subject) according to known methods would yield the predictable result of providing treatment or prophylaxis of a neurological or neurophsychiatric disorder (Title, Abstract, [0001]).
Regarding claim 22, Federov et al. in view of Willis ‘698 teaches all of the elements of the current invention as mentioned above except for wherein the providing the photonic stimulation for providing the therapy to the subject includes: providing at least one of red light, blue light, or infrared light to the ocular region of the subject.
Willis ‘698 teaches a broad spectrum white light may be used, although blue and green spectrum may also be used ([0140]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the photonic stimulation for providing the therapy to the subject of Federov et al. in view of Willis ‘698 to include providing at least one of red light, blue light, or infrared light to the ocular region of the subject as Willis ‘698 teaches that any light within the broad spectrum may be used as each light would aid in increasing dopamine in the retina ([0140]).
Regarding claim 24, Federov et al. in view of Willis ‘698 teaches all of the elements of the current invention as mentioned above except for wherein the providing the photonic stimulation occurs during the supplying the electrical signal.
Willis ‘698 teaches combination therapies of increasing dopamine function in the retina by flashing light into the retina and providing electrical stimulation to the brain at the same time ([0140], [0144]-[0149]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Federov et al. in view of Willis ‘698 to include wherein the providing the photonic stimulation occurs during the supplying the electrical signal as Willis ‘698 teaches that combining prior art elements (electrical brain stimulation and applying a brain-condition affecting treatment to the ocular region of the subject) according to known methods would yield the predictable result of treating of a neurological or neurophsychiatric disorder (Title, Abstract, [0001]).
Regarding claim 25, Federov et al. in view of Willis ‘698 teaches all of the elements of the current invention as mentioned above except for wherein the providing the photonic stimulation does not during the supplying the electrical signal.
Willis ‘698 teaches different combination therapies of increasing dopamine function in the retina by flashing light into the retina and providing electrical stimulation to the brain ([0140], [0144]-[0149]). [0144]-[0149] shows that the administration of the agents may not include both the flashing light therapy and providing of the electrical stimulation to the brain.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Federov et al. in view of Willis ‘698 to include wherein the providing the photonic stimulation does not during with the supplying the electrical signal as Willis ‘698 teaches that combining prior art elements (electrical brain stimulation and applying a brain-condition affecting treatment to the ocular region of the subject) according to known methods would yield the predictable result of treating of a neurological or neurophsychiatric disorder (Title, Abstract, [0001]).
Claim 23 is rejected under 35 U.S.C. 103 as being obvious over Federov et al. in view of in view of Willis ‘698 further in view of Wagner et al. ‘734 (US Pub No. 2011/0245734 – previously cited).
Regarding claim 23, Federov et al. in view of Willis ‘698 teaches all of the elements of the current invention as mentioned above except for wherein the providing the photonic stimulation for obtaining the diagnostic information includes: determining, via the one or more processors of the computing device, a brain health indicator based on changes in an ocular-brain region bioimpedance of the subject due to the providing, via the photonic stimulation stage, the photonic stimulation.
Wagner et al. ‘734 teaches wherein the providing the photonic stimulation for obtaining the diagnostic information includes: determining, via the one or more processors of the computing device, a brain health indicator based on changes in an ocular-brain region bioimpedance of the subject due to the providing, via the photonic stimulation stage, the photonic stimulation ([0075]; “biofeedback measures can be used to track the effect of stimulation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the providing of the photonic stimulation for obtaining the diagnostic information of Federov et al. in view of Willis ‘698 to include determining, via the one or more processors of the computing device, a brain health indicator based on changes in an ocular-brain region bioimpedance of the subject due to the providing, via the photonic stimulation stage, the photonic stimulation as Wagner et al. ‘734 teaches this is will aid in providing a closed loop system of controlled stimulation ([0075]).
Allowable Subject Matter
Claims 33-36 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant argues that Federov et al. does not teach “supplying an electrical signal via a direct conduction path from the ocular region of the subject through an optical nerve to a brain of the subject” because the stimulation electrodes of Federov et al. are placed on the upper eyelids and the reference electrode is placed on the wrist of the right hand. Although Federov et al. does teach this, it is noted that the Applicant fails to provide how the reference electrode of the current application is being placed and how this differs from Federov et al. Furthermore, the disclosure of the current application is silent to any reference electrode and merely recites that impedance electrodes are placed around the eyelids.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reference electrode) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant also argues that Federov et al. does not teach direct path from the ocular region through the optical nerve to the brain. Examiner respectfully disagrees. The stimulation electrodes of Federov et al. are placed on the eyelids of the subject. When the electrodes apply rtACS on the subject, Brain-stim is used to provide the stimulation. The eyelids are in the “ocular region of the subject.” One of ordinary skill would understand that in order to stimulate the brain with electrodes placed on the eyelids, the stimulation current would go through the optic nerve to reach the brain. As such, Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791