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 .
Specification
The abstract of the disclosure is objected to because of the presence of a reference number to a figure in line 1 (reference number 50). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 6-11 are objected to because of the following informalities:
Claims 1 and 6-11 contain reference numbers to figure elements when they should be removed from the claims. Appropriate correction is required.
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(s) 1-4 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. (hereinafter ‘Berman’, U.S. PGPub No. 2016/0235983) in view of Arendash et al. (hereinafter ‘Arendash’, U.S. PGPub No. 2020/0346028).
In regards to claim 1, Berman discloses a head device comprising an array of one or more body tissue radiofrequency applicators configured for emitting an electromagnetic signal, said array of one or more body tissue radiofrequency applicators being combined with an array of one or more LEDs configured for emitting red and/or near-infrared signals, wherein said one or more body tissue radiofrequency applicators and of one or more LEDs are embedded within said head device, wherein said head device is configured to fit an head of a subject, and wherein said combined arrays of one or more body tissue radio frequency applicators and of one or more LEDs are positioned such that they are adjacent to said head when the head device is worn by the subject (Figs. 1-3, [0039]: "Referring now to FIG. 1, a block diagram illustrates components of a system that is useful for administering trans-cranial directed energy to a skull 102A a subject 102. The directed energy may be administered via a directed energy emission device 101 secured proximate to a surface of a subject's skull 102A. The directed energy emission device 101 will include multiple energy portals 113. In some implementations, the energy portals 113 may include a light emitting diode capable of emitting infrared light with a wavelength of between 450 nanometers and 1500 nanometers.", [0040]: "The source of directed energy 112 may include, for example, an electromagnetic coil that converts electrical current into a desired wavelength of electromagnetic field and/or a light emitting diode (LED) producing a specific wavelength or band of wavelengths of light (e.g. visible, infrared, near infrared).", [0055]: "The remediation process may be achieved by delivering a sequence of neuromodulating stimuli, e.g., near infrared light, radio band electromagnetic frequencies and low level, variable frequency, electromagnetic energy.", see [0049]: "...and (g) combinational transducers capable of delivering any combination of types of directed energy.").
However, Berman does not disclose the specific frequencies of electromagnetic signals ranging from 30 to 3000 MHz.
Arendash teaches a transcranial electromagnetic treatment system which uses electromagnetic emission with a frequency in a range of 1 MHz to 430 THz ([0047]: "In another example, the TEMT system includes a first emitter in electrical contact with a scalp of a patient. The system also includes a controller to cause the first emitter to emit a signal with a frequency between 1 MHz and 430 THz."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use electromagnetic emission in a frequency ranging from 30 to 3000 MHz, as taught by Arendash, as doing so allows the system to target specific peptides in nerve cells that are presumed to cause neurological diseases such as Alzheimer’s ([0018]: "Alzheimer's Disease (AD) is a neuro-degenerative disease which affects millions of lives and for which no pharmaceutical cure or treatment has been found. Where pharmaceutical solutions have failed, the innovative medical system as described herein, which uses transcranial electromagnetic treatment (TEMT), provides a solution. The system shows unique potential to slow and/or potentially even reverse the effects of AD.", [0019]: "The system of the present specification is the only technology under clinical development that targets both presumed causes of AD—the build-up of small β-amyloid (Aβ) oligomers and tau oligomers within nerve cells. A wide spectrum of pre-clinical studies show that the TEMT system has beneficial cognitive impact linked to disaggregation of toxic protein oligomers (especially Aβ) and brain mitochondrial enhancement in Alzheimer's animal models.").
In regards to claim 2, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Arendash further teaches that the frequency of said electromagnetic signal is in a range of 30-300 MH 30-200 MHz, 40-250 MHz, 50-200 MHz, 50-150 MHz, 100-150MHz, 60-100MHz, 50-70 MHz, 60-65 MHz, 400-1500 MHz, 500-1300 MHz, 800-1100 MHz, 850-950 MHz, 800-930 MHz, 850-915 MHz, or 910-920 MHz ([0047]: "In another example, the TEMT system includes a first emitter in electrical contact with a scalp of a patient. The system also includes a controller to cause the first emitter to emit a signal with a frequency between 1 MHz and 430 THz."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use electromagnetic emission in a frequency ranging from 30 to 3000 MHz, as taught by Arendash, as doing so allows the system to target specific peptides in nerve cells that are presumed to cause neurological diseases such as Alzheimer’s ([0018]: "Alzheimer's Disease (AD) is a neuro-degenerative disease which affects millions of lives and for which no pharmaceutical cure or treatment has been found. Where pharmaceutical solutions have failed, the innovative medical system as described herein, which uses transcranial electromagnetic treatment (TEMT), provides a solution. The system shows unique potential to slow and/or potentially even reverse the effects of AD.", [0019]: "The system of the present specification is the only technology under clinical development that targets both presumed causes of AD—the build-up of small β-amyloid (Aβ) oligomers and tau oligomers within nerve cells. A wide spectrum of pre-clinical studies show that the TEMT system has beneficial cognitive impact linked to disaggregation of toxic protein oligomers (especially Aβ) and brain mitochondrial enhancement in Alzheimer's animal models.").
In regards to claim 3, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that the electromagnetic signal is pulsed ([0040]: "Directed energy may be any suitable form of energy capable of being applied to effect a desired biological response according to the present invention, including but not limited to...electromagnetic fields (static or pulsed)…").
Arendash further teaches that the repetition rate of said pulsed electromagnetic signal is between 40-100 Hz, 100-200 Hz, or around 40 Hz, 100Hz, or 200Hz ([0089]: " In some examples, the TEMT is applied in an Industrial, Scientific, Medical (ISM) band of radio frequencies. As a particular example, the emitters (FIG. 2, 220) may emit at a frequency of between 1 MHz to 3 GHz, having a pulse repetition rate of 10 Hz to 300 Hz and a duty cycle of between 1% and 100%", see claim 6). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use pulsed electromagnetic signal with a repetition rate which is between 40-100 Hz, 100-200 Hz, or around 40 Hz, 100Hz, or 200Hz, as taught by Arendash, as doing so allows for optimal treatment dependent on a wide range of individual subject differences and needs ([0091]: "In some examples, a patient's response to the TEMT may be determined and treatment parameters may be altered during a subsequent TEMT based on such a response. For example, as indicated earlier due to any number of reasons, different patients may respond differently to TEMT with different treatment parameters...The parameters that may be adjusted are wide and include for example frequency, pulse rate, duration, modality, and power level.").
In regards to claim 4, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that red signals have a wavelength in a range of from 620 to 680 nm and said near-infrared signals have a wavelength in a range of from 800 to 1100 nm ([0049]: "By way of non-limiting example, energy portals may include one or more of: (a) a plurality of light emitting diodes capable of emitting light with a wavelength of between 450 nanometers and 1500 nanometers…").
In regards to claim 12, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that the device is a medical or wellness head device ([0006]: "Disclosed is an apparatus for providing therapeutic administration of directed energy to a subject. In some implementations, the directed energy apparatus may be employed to administer a predetermined directed energy therapy to the cranium of the target subject, such as may be desirable to treat any of a variety of cognitive or other neurological disorders or conditions (e.g. dementia, Alzheimer's, PTSD, TBI, CTE, PTSD, etc. . . . ).").
In regards to claim 13, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that the device is a non-invasive brain stimulation head device ([0002]: "The present disclosure relates to apparatus for non-invasive inducement of biological responses via administration of directed energy. More specifically, the present disclosure describes focused administration of directed energy to targeted areas of the cranium, for specific periods of time in order to achieve a desired biological response.").
In regards to claim 14, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that the device is an intelligent wearable cap comprising multiple neurological sensors, processing units, and wireless communication modules ([0056]: "Treatment is provided noninvasively using a skull strap, skull cap, helmet-like device or other mechanism to secure a delivery portal of directed energy proximate to an area of treatment.", [0065]: "According to some embodiments, the apparatus disclosed herein may include software and hardware for acquisition of 19-channels of low impedance EEG and delivery of pulsed or continuous NIR stimulation and pulsed RF band stimulation based on the measured EEG's dominant frequency activity, which is called Neuro-Gen neurofeedback (NGN).", [0007]: "Additionally, the apparatus may include a controller which may be in logical communication with the source of electromagnetic radiation. Further, the controller may be operative to cause the source of electromagnetic radiation to provide specific frequencies of electromagnetic energy to at least some of the energy portals. Furthermore, the controller may include a processor and a digital data storage.", [0048]: "As with previous examples, the apparatus may be in communication with a controller (not shown), either via a wired or wireless connection.").
In regards to claim 15, Berman/Arendash combination discloses the invention substantially as described above in claim 14.
Berman further discloses that the neurological sensors comprise electroencephalogram (EEG) electrodes, near-infrared spectroscopy sensors, or magnetometers ([0044]: "In some implementations, the biometric measurement device 36 may include an elecroencephalography (EEG, whether standard or quantitative/QEEG) apparatus, an electromyography (EMG) apparatus, a thermometer, an electrodermography (EDG) apparatus, a photoplethysmography (PPG) apparatus, an electrocardiogram (ECG) apparatus, a pneumography apparatus, a capnography apparatus, a rheonocephalography (REG) apparatus, and/or a hemoencephalography (HEG) apparatus.").
In regards to claim 16, Berman/Arendash combination discloses the invention substantially as described above in claim 14.
Berman further discloses that the wireless communication modules comprise Bluetooth, Wi-Fi, or 5G connectivity for real-time data transmission to external devices for real-time analysis ([0119]: "n input device 866, including alphanumeric and other keys, or modes of input, such as, for example, a microphone and a radio frequency device such as Bluetooth, may be coupled to bus 852 for communicating information and command selections to processor 854.").
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Arendash and in further view of Wang (U.S. PGPub No. 2022/0054856).
In regards to claim 5, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
Berman further discloses that the red signals and near-infrared signals are pulsed ([0065]: "According to some embodiments, the apparatus disclosed herein may include software and hardware for acquisition of 19-channels of low impedance EEG and delivery of pulsed or continuous NIR stimulation…").
However, Berman/Arendash combination does not disclose that the red signals and near-infrared signals are pulsed with the same or a different repetition rate ranging from 10 Hz to 100 Hz, or from 10-60 Hz, around 20 Hz, or around 40 Hz.
Wang teaches a non-invasive brain stimulation system which uses red signals and near-infrared signals are pulsed with the same or a different repetition rate around 40 Hz ([0079]: "In one study, a volunteer receives electrical pulse from electrodes attached to the skin surface on top of the skull at non-acupuncture sites, red light/NIR pulse (630 nm and 850 nm) radiation and vibration stimulation to the skin on top of skull all at a frequency between 35-45 Hz with power level the volunteer feels comfort for 0.5-1 hour daily.").
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use red signals and near-infrared signals are pulsed with the same or a different repetition rate around 40 Hz, as taught by Wang, as doing so promotes memory and cognitive activity ([0079]: "Different stimulation has the same frequency and the onset of the 35-45 Hz pulse in different stimulation are aligned to the same time point. The volunteer feels improved memory, sleep quality and cognitive activity.").
Claim(s) 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Arendash and in further view of Sverdlov et al. (hereinafter ‘Sverdlov’, U.S. PGPub No. 2021/0205634).
In regards to claim 6, Berman/Arendash combination describes the invention substantially as described above in claim 1.
The claim further recites nothing more than a PCB with wires connecting the radiofrequency applicators. The claim limitations of being “divided into at least two sections or into two halves”, each half or section comprising “a wire or PCB having a first and a second end”, “a central connector”, and a first or second “conductor structure” amount to nothing more than generic structural elements that a person of ordinary skill in the art would be able to use for a head device as described in claim 1. According to of the specification of the application, the use of splitting the applicators among two halves is to allow the device to optimally fit the head of a plurality of anatomy types, depending on the subject ([76]: “The arrangement of these sections or halves (70) may be symmetrical or asymmetrical, depending on the application requirements and the anatomical body tissue region being targeted. The dimensions, curvature, and structural topology of the BTRFA (50) are adaptable to different tissue regions, allowing for precise targeting of RF energy.”). Therefore, as long as prior art shows the use of wires and PCBs connected to an applicator, for the function of being able to fit a variety of subjects’ anatomical types, the claim limitations are met.
Sverdlov teaches a head device which provides transcranial treatment for neurological conditions which uses a PCB and wiring to connect to the applicators ([0070]: "Shown in FIG. 7 is an LED 202 mounted on a first side of a printed circuit board 200 which can have connectors 208 for wiring to the main circuit panel 270 shown in FIG. 12."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a wire or PCB for the applicator, as taught by Sverdlov, as doing so allows for the device to fit a variety of subject anatomies ([0070]: "Moreover, different classes of patient (e.g., patients of different ages) can have different cranial thicknesses. As a result, different transmission power (and penetration) may be necessary as a function of patient age.").
In regards to claim 7, the claim recites nothing more than making a wire continuous across the connectors of the device that are a matter of choice which a person of ordinary skill in the art would have found obvious, with an absence of persuasive evidence that such a particular configuration of the claimed wire being connected to the inner coaxial or first conductor structure extend unbroken and preferably along a straight line across the central connector structure from one half to the other half and wherein the ends of the wires being connected to the outer coaxial or second conductor structure do not extend unbroken across the central connector structure from one half to the other half but preferably form an interrupted straight line was significant (see MPEP 2144.04 V(E), In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963)). Sverdlov teaches a head device which provides transcranial treatment for neurological conditions which uses a PCB and wiring to connect to the applicators ([0070]: "Shown in FIG. 7 is an LED 202 mounted on a first side of a printed circuit board 200 which can have connectors 208 for wiring to the main circuit panel 270 shown in FIG. 12."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a wire or PCB for the applicator, as taught by Sverdlov, as doing so allows for the device to fit a variety of subject anatomies ([0070]: "Moreover, different classes of patient (e.g., patients of different ages) can have different cranial thicknesses. As a result, different transmission power (and penetration) may be necessary as a function of patient age.").
In regards to claims 8 and 9, the claims recite nothing more than a simple rearrangement of parts, the parts in this case being the wires and their configuration on the device that are a matter of choice, which a person of ordinary skill in the art would have found obvious, with an absence of persuasive evidence that such a particular configuration of the claimed wires being “fully crisscrossed forming a X- shaped structure., as recited in claim 8, or “wires being connected to the inner coaxial or first conductor structure extend unbroken along a -Y-shaped line from one half to the another half, the ends of the wires or PCBs being connected to the outer coaxial or second conductor structure end at the outer coaxial or second conductor structure thereby forming a Y-shaped structure or line that is interrupted by the central connector structure.”, as recited in claim 9 (see MPEP 2144.04 VI(C), In re Japiske, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). Sverdlov teaches a head device which provides transcranial treatment for neurological conditions which uses a PCB and wiring to connect to the applicators ([0070]: "Shown in FIG. 7 is an LED 202 mounted on a first side of a printed circuit board 200 which can have connectors 208 for wiring to the main circuit panel 270 shown in FIG. 12."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a wire or PCB for the applicator, as taught by Sverdlov, as doing so allows for the device to fit a variety of subject anatomies ([0070]: "Moreover, different classes of patient (e.g., patients of different ages) can have different cranial thicknesses. As a result, different transmission power (and penetration) may be necessary as a function of patient age.").
In regards to claim 10, the claims recite nothing more than a simple change in shape of the sections of the radiofrequency applicators that are a matter of choice for where the applicator may be arranged to have a bowtie configuration, a bowtie complex butterfly configuration, or a fully compact meandered configuration which a person of ordinary skill in the art would have found obvious, with an absence of persuasive evidence that such a particular configuration of the claimed applicator arrangement was significant (see MPEP 2144.04 IV(B), In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Sverdlov teaches a head device which provides transcranial treatment for neurological conditions which uses a PCB and wiring to connect to the applicators ([0070]: "Shown in FIG. 7 is an LED 202 mounted on a first side of a printed circuit board 200 which can have connectors 208 for wiring to the main circuit panel 270 shown in FIG. 12."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a wire or PCB for the applicator, as taught by Sverdlov, as doing so allows for the device to fit a variety of subject anatomies ([0070]: "Moreover, different classes of patient (e.g., patients of different ages) can have different cranial thicknesses. As a result, different transmission power (and penetration) may be necessary as a function of patient age.").
In regards to claim 11, Berman/Arendash combination discloses the invention substantially as described above in claim 1.
However, Berman/Arendash combination does not disclose that one or more body tissue radiofrequency applicators are made of wire or PCB, curved flexible PCB, or flexy PCB.
Sverdlov teaches a head device which provides transcranial treatment for neurological conditions which uses a PCB and wiring for the applicators ([0070]: "Shown in FIG. 7 is an LED 202 mounted on a first side of a printed circuit board 200 which can have connectors 208 for wiring to the main circuit panel 270 shown in FIG. 12."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a wire or PCB for the applicator, as taught by Sverdlov, as doing so allows for the device to fit a variety of subject anatomies ([0070]: "Moreover, different classes of patient (e.g., patients of different ages) can have different cranial thicknesses. As a result, different transmission power (and penetration) may be necessary as a function of patient age.").
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Arendash and in further view of Chowdhury et al. (hereinafter ‘Chowdhury’, U.S. PGPub No. 2022/0051039).
In regards to claim 17, Berman/Arendash combination discloses the invention substantially as described above in claim 14.
Berman further discloses the processing units are able to provide real-time feedback of brainwave patterns ([0088]: "The logical communication may include a data feed that is continuous without artificial delay (real time), that is transmitted periodically, or that is transmitted upon command.").
However, Berman/Arendash combination does not disclose using a machine learning algorithm for analyzing brainwave patterns.
Chowdhury teaches using a machine learning, neural network algorithm to analyze brainwave EEGs of a subject ([0027]: "Unique biomarkers are extracted from the recorded EEG response (e.g., as periodogram data points corresponding to different frequencies observed in the brain waves, which can be used to identify a person). A novel signal processing approach uses neural network-based architecture to analyze the EEG response and identify the subject."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the body tissue applicator system to use a machine learning algorithm for analyzing brainwave patterns, as taught by Chowdhury, as doing so would provide rapid implementation of an analysis method which provides high accuracy and precision and may analyze a plurality of features from the EEGs ([0027]: "This signal processing architecture can be readily implemented on hardware and provides high accuracy, precision, and recall.", [0068]: "The process continues at operation 810, with analyzing the plurality of feature points (e.g., with a neural network) to identify the human subject.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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