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
Claim 5 is objected to because of the following informalities: in lines 1-2, “each of the two or more electrodes are at a fixed distance relative to each other electrode” should be “each of the two or more electrodes are at a fixed distance relative to each other”. Appropriate correction is required.
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.
Claim 14, 17 and 20-21 are 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.
Claims 14 and 21 recite the limitation “the hand-held device of claim 1 comprising a plurality of electrodes” in lines 1-2. However, it is unclear if this plurality of electrodes is the same plurality of electrodes already recited in claim 1 or a new distinct plurality of electrodes. For purposes of examination, this limitation will be read as “the hand-held device of claim 1”.
Claim 17 recites the limitation "the placing and/or the adjusting" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation will be read as “a placing and/or an adjusting of the hand-held device”.
Claim 20 recites the limitation "the indication" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation will be read as “an indication”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 10-12, 14-15, 18-20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being taught by WO 2014059431 A2 (Coleman et al.).
Regarding Claim 1, Coleman teaches a hand-held device (e.g., of a size able to be held in a person’s hand) for electrophysiology data recording from a subject (see para. 0006), comprising:
a flexible substrate (see para. 0007, “the substrate can be formed of a mechanically flexible material”) having a plurality of electrodes (e.g., [102], [103], and [104]; see Fig. 3B) mounted onto an external surface of the substrate (see para. 0006);
and circuitry configured to acquire and process electrophysiology data signals recorded from the subject by the electrodes and for communicating the recorded electrophysiology data signals to a remote device (see para. 0007, "the electrical circuit can include a transmitter unit on the substrate in electrical communication with the signal processing circuit to transmit the amplified physiological signals to at least one of a data processing unit or a remote computer system").
Regarding Claim 2, Coleman teaches the flexible substrate comprises an electrically insulating material (see para. 0006).
Regarding Claim 3, Coleman teaches the flexible substrate comprises a reverse surface lined with an electrically insulating lining (see para. 0058).
Regarding Claim 5, Coleman teaches each of the two or more electrodes are at a fixed distance relative to each other on the external surface of the substrate (see para. 00103).
Regarding Claim 10, Coleman teaches the electrophysiological data is EEG (see para. 0042).
Regarding Claim 11, Coleman teaches the electrodes are arranged in an x x y matrix, wherein x and y are, independently, integers from 1 to 10 (e.g., they can be arranged in a linear 1 1 3 matrix; see para 0007 and Fig. 3B).
Regarding Claim 12, Coleman teaches a system comprising a remote device (e.g., a remote computer) including a user interface, the user interface configured for receiving input data and for generating a subject condition related indication (e.g., a cognitive-sensory condition related indication) based on the input data and on the electrophysiological signals recorded by the electrodes (see para. 0008, “a remote computer in communication with the local computer via a communication network or link to receive the initial physiological signal data from the local computer and to process the initial physiological signal data to generate the information set including one or more quantitative values associated with the cognitive-sensory profile category.”).
Regarding Claim 14, Coleman teaches a method for recording an EEG of a subject using the hand-held device of claim 1 (see para. 0009), comprising:
contacting the plurality of electrodes with the subject's scalp, resulting in electrically conductive contact between the subject's scalp and at least two electrodes (see para. 0075);
and recording EEG signals (see para. 0075).
Regarding Claim 15, Coleman teaches obtaining an automatically generated indication related to a condition of the subject, the indication at least partially based on the recorded EEG signals (see e.g. para. 0008).
Regarding Claim 18, Coleman teaches setting the electrodes in a bipolar montage (see para. 0009 and para. 00105).
Regarding Claim 19, Coleman teaches one of the plurality of electrodes is used as a reference and ground (see para. 0009 and para. 00105).
Regarding Claim 20, Coleman teaches an indication (e.g., mismatch negativity) related to a condition of the subject is generated by determining patterns in the recorded EEG signals using feature extraction techniques and comparing the patterns to pre-established EEG patterns known to be associated with physiological and/or pathophysiological conditions (see Figs. 15-16; see also para. 00137, “Mismatch negativity (MMN) is an ERP modulation that can be correlated with a wide range of neurological and neuropsychiatric disorders.”).
Regarding Claim 22, Coleman teaches a hand-held device (e.g., of a size able to be held in a person’s hand) for recording of electrophysiological data from a subject, comprising:
a flexible substrate (see para. 0007, “the substrate can be formed of a mechanically flexible material”), the substrate forming a substantially fixed 3-dimensional shape (e.g., the hemispherical shape of Fig. 3A or the shape as seen in Fig. 4A-4B);
at least three electrodes (e.g., [102], [103], and [104]; see Fig. 3B), each electrode mounted on an external surface of the flexible substrate (see para. 0006);
and circuitry for activating the electrodes to record electrophysiology related signals from a subject and for communicating the recorded signals to a remote device (see para. 0007, "the electrical circuit can include a transmitter unit on the substrate in electrical communication with the signal processing circuit to transmit the amplified physiological signals to at least one of a data processing unit or a remote computer system").
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) 1, 4, 6, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20240252088 A1 (Phillips) in view of WO 2014059431 A2 (Coleman et al.).
Regarding Claims 1 and 4, Phillips teaches a hand-held device [301] (see Fig. 3) for electrophysiology data recording from a subject (see Abstract), comprising:
a plurality of electrodes (e.g., [209], [210], [211], and [212]; see Fig. 2C);
circuitry configured to acquire and process electrophysiology data signals recorded from the subject by the electrodes and for communicating the recorded electrophysiology data signals to a remote device (see para. 0051 and para. 0053; see also Fig. 9);
wherein the circuitry includes an analog to digital converter (see para. 0051), an amplifier [904], and a communication module [908] (see para 0053).
Phillips does not explicitly teach that the plurality of electrodes is mounted on a flexible substrate.
Coleman teaches a flexible substrate (see para. 0007, “the substrate can be formed of a mechanically flexible material”) having a plurality of electrodes (e.g., [102], [103], and [104]; see Fig. 3B) mounted onto an external surface of the substrate (see para. 0006);
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Phillips in view of Coleman to further provide for the plurality of electrodes to be mounted on a flexible substrate. Doing so would allow for the electrodes to better conform to the shape of a subject’s scalp.
Regarding Claim 6, Phillips teaches the electrodes are dry electrodes, each electrode comprising a plurality of pins long enough for contacting the subject's scalp through hair (see para. 0035, “Dry electrodes comprise short pins, which allow them to penetrate the hair volume and provide solid contact between the tip of the pin and the scalp”).
Regarding Claim 13, Phillips teaches a stimulation module for applying electrical stimulation to the subject (see para. 0061, “the treatment device provides brain stimulation using transcranial electrical stimulation”). Phillips does not teach a kit comprising two hand-held devices according to claim 1 or that the treatment module is specifically included as part of the hand-held device. However, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Phillips to provide a kit comprising two of the hand-held devices and at least one of them further comprising such a stimulation module. With regards to having a kit comprising two of the hand-held devices, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (see St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.). As for having the stimulation module be part of the hand-held device, it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see Howard v. Detroit Stove Works, 150 U.S. 164 (1893)).
Regarding Claim 14, Phillips teaches a method for recording an EEG of a subject using a hand-held device, comprising:
contacting the plurality of electrodes with the subject's scalp, resulting in electrically conductive contact between the subject's scalp and at least two electrodes (see para. 0004);
and recording EEG signals (see para. 0004).
Regarding Claim 16, Phillips teaches adjusting a position of the hand-held device, relative to the subject's head, to reposition at least some of the plurality of electrodes on the scalp (see para. 0054-0055).
Regarding Claim 17, Phillips teaches the hand-held device is in communication with a user interface and a placing and/or adjusting of the hand-held device is according to instructions provided by the user interface (see para. 0055, “Visual cues are provided via the external device to guide the user to the desired brain region”).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2014059431 A2 (Coleman et al.) in view of US 20240180436 A1 (Dagher et al).
Regarding Claim 7, Coleman does not explicitly teach the circuitry comprises a controller programmed to control recording by the electrodes based on input received from a remote device. However, Dagher teaches a controller programmed to control recording by the electrodes based on input received from a remote device (see para. 0026). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Coleman in view of Dagher to further provide for such a controller. Doing so would allow a user to remotely operate the starting of the data recording process.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2014059431 A2 (Coleman et al.) in view of EP 3651638 B1 (Raudins et al).
Regarding Claim 8, Coleman does not explicitly teach one or more optical markers positioned on the external surface, the optical markers detectable by the remote device. However, Raudins teaches optimal markers positioned on an external surface and detectable by a remote device (see para. 0019, “markers visible to the camera may be printed on the electrode array and recognized via image processing”). It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify Coleman in view of Raudins to further provide for optimal markers positioned on the external surface of the substrate and detectable by the remote device. Doing so would facilitate better positioning of the electrodes, as recognized by Raudins (see para. 0021).
Claim(s) 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014059431 A2 (Coleman et al.) in view of US 20210208680 A1 (Tadi et al.).
Regarding Claim 9, Coleman does not explicitly teach one or more near-infrared spectroscopy sensors on the external surface of the substrate. However, Tadi teaches near-infrared spectroscopy sensors on a similar device (see para. 0034). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Coleman in view of Tadi to further include near-infrared spectroscopy sensors on the external surface of the substrate. Doing so would allow for measuring the blood oxygen levels of the brain tissue, as recognized by Tadi (see para. 0034).
Regarding Claim 21, Coleman teaches applying stimulation to a subject and using the hand-held device, recording a response to the stimulation via the plurality of electrodes (see e.g., para. 00102). Coleman does not explicitly teach that the stimulation can be electrical stimulation to an affected limb. However, Tadi teaches applying an electrical stimulation to an affected limb (see para. 0096). It would have been obvious for a person having ordinary skill in the art to modify the teachings of Coleman in view of Tadi to further include applying an electrical stimulation to an affected limb. Doing so would allow for tracking the response of limbs to said electric stimuli for diagnostic purposes.
Conclusion
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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