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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 02, 2022 and June 03, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on November 02, 2022 are accepted.
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.
Claims 23-53 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 pre-AIA the applicant regards as the invention.
Claims 23 and 33 recite the step of detecting, with the physiological sensor, physiological data that renders the scope of the claims indefinite. There is a missing link between this step and the rest of the claims. It is unclear what role this detecting step plays in the recited method of inducing or maintaining a relaxed brain state of the user with the combination of the plurality of different energy types.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 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.
(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.
Claims 23-28, 30, 32-38, 40, 42-46 and 49-53 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chu et al., US 2019/0232047 A1, hereinafter Chu.
Claim 23. Chu teaches in FIG.20 a method, comprising:
securing a band of an attachment element of a wearable device about a head of a user to maintain the wearable device against physiological tissue of the user ([0569]: FIG.32A depicts one embodiment of a transcutaneous neuromodulation device 3200 that includes two separate ergonomic support components 3208; and [0570]: each ergonomic support component 3208 includes an elastomeric arm 3220 for comfortably engaging with a portion of a human subject, for example, the elastomeric arm is configured to hug or otherwise engage the subject’s ears; FIG.32D; and [0586]: the ergonomic support component 3300 comprises a linkage component formed to engage (e.g., wrap around) a body part of a subject (e.g., a head)),
the wearable device comprising a body including a flexible material layer ([0570]: each ergonomic support component 3208 includes an elastomeric arm 3220; and [0593]: FIGS.33I and 33J also depict an insulating or interface material 3330 (e.g., fabric) disposed on the housing 3338), a power source (506), a physiological sensor ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device); and), a processing unit (502; and FIG.6C: the controller board 1…n) ([0571]: a housing 3226 for supporting and/or enclosing at least one mechanical transducer. The housing may also support and/or enclose other components, such as at least one controller board, and at least one battery or other power source; FIG.34A) – either the elastomeric material or the fabric is considered the flexible material layer as claimed, and
a plurality of energy generator elements independently operable to convert electricity from the power source into a plurality of different energy types (FIG.6A: Transducers 1…n; FIG.6C: each transducer is paired with its own controller board 1…n; and [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal)),
at least one of the plurality of energy generator elements being disposed at least partially within the flexible material layer ([0571]: controller boards and batteries or other power source are not enclosed within or supported by the housing, but rather within other portions of the ergonomic support components 3208, for example within the elastomeric arms 3220; and [0572]:each housing 3326 comprises a window, adjacent to which the mechanical transducers are disposed, and which contacts skin of the subject when the ergonomic support components are worn. The window may include an be covered with insulating material and/or a tactile fabric so as to prevent direct contact between the transducer surface and skin of the subject);
detecting, with the physiological sensor, physiological data ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device and/or external to and in communication with the device)(e.g., a heart rate; e.g., a galvanic skin response; e.g., physical movement (e.g., recorded by an accelerometer) provided following their receipt of a round (e.g., a duration) of the transcutaneous mechanical stimulation provided by the stimulation device; and [0630]-[0654] list various physiological sensors);
causing, with the processing unit, the plurality of energy generator elements to output a combination of the plurality of different energy types toward the physiologic tissue; and inducing or maintaining a relaxed brain state of the user with the combination of the plurality of different energy types ([0080]: a method of treating anxiety and/or an anxiety related disorder in a subject by providing transcutaneous mechanical stimulation…via a stimulation device (e.g., a wearable device); [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal); and [0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21).
Claim 33. Chu teaches in FIG.20 a method, comprising:
obtaining a wearable device ([0569]: FIG.32A depicts one embodiment of a transcutaneous neuromodulation device 3200 that includes two separate ergonomic support components 3208) comprising
a body including a flexible material layer ([0570]: each ergonomic support component 3208 includes an elastomeric arm 3220; and [0593]: FIGS.33I and 33J also depict an insulating or interface material 3330 (e.g., fabric) disposed on the housing 3338), a power source (506), a physiological sensor ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device); and), a processing unit (502; and FIG.6C: the controller board 1…n) ([0571]: a housing 3226 for supporting and/or enclosing at least one mechanical transducer. The housing may also support and/or enclose other components, such as at least one controller board, and at least one battery or other power source; FIG.34A) – either the elastomeric material or the fabric is considered the flexible material layer as claimed,
an attachment element including a band ([0586]: the ergonomic support component 3300 comprises a linkage component formed to engage (e.g., wrap around) a body part of a subject (e.g., a head)), and
a plurality of energy generator elements independently operable to convert electricity from the power source into a plurality of different energy types (FIG.6A: Transducers 1…n; FIG.6C: each transducer is paired with its own controller board 1…n; and [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal)),
at least one of the plurality of energy generator elements being disposed at least partially within the flexible material layer ([0571]: controller boards and batteries or other power source are not enclosed within or supported by the housing, but rather within other portions of the ergonomic support components 3208, for example within the elastomeric arms 3220; and [0572]:each housing 3326 comprises a window, adjacent to which the mechanical transducers are disposed, and which contacts skin of the subject when the ergonomic support components are worn. The window may include an be covered with insulating material and/or a tactile fabric so as to prevent direct contact between the transducer surface and skin of the subject);
securing the band of the attachment element about a head of a user to maintain a skin facing surface of the body against physiological tissue of the user ([0569]: FIG.32A depicts one embodiment of a transcutaneous neuromodulation device 3200 that includes two separate ergonomic support components 3208; and [0570]: each ergonomic support component 3208 includes an elastomeric arm 3220 for comfortably engaging with a portion of a human subject, for example, the elastomeric arm is configured to hug or otherwise engage the subject’s ears; FIG.32D; and [0586]: the ergonomic support component 3300 comprises a linkage component formed to engage (e.g., wrap around) a body part of a subject (e.g., a head));
detecting, with the physiological sensor, physiological data ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device and/or external to and in communication with the device)(e.g., a heart rate; e.g., a galvanic skin response; e.g., physical movement (e.g., recorded by an accelerometer) provided following their receipt of a round (e.g., a duration) of the transcutaneous mechanical stimulation provided by the stimulation device; and [0630]-[0654] list various physiological sensors); and
causing, with the processing unit, the plurality of energy generator elements to output different combinations of the plurality of different energy types toward the physiologic tissue ([0080]: a method of treating anxiety and/or an anxiety related disorder in a subject by providing transcutaneous mechanical stimulation…via a stimulation device (e.g., a wearable device); [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal))
each different combination being configured to induce a different brain state of the user ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21; [0514]: other states in a subject can be produced by modifying a waveform to produce that state. For example, as shown in FIG.21, a focused state is associated with decreased theta waves, neutral alpha waves, increased beta waves, increased BP, and increased HRV; and [0515]: one or more of the characteristics, such as those shown in FIG.21, can be targeted in this manner, via monitoring of one or more corresponding physiological signals, to produce a desired state in a subject).
Claim 43. Chu teaches in FIG.20 a method, comprising:
providing a wearable device ([0569]: FIG.32A depicts one embodiment of a transcutaneous neuromodulation device 3200 that includes two separate ergonomic support components 3208) comprising
a body including a flexible material layer ([0570]: each ergonomic support component 3208 includes an elastomeric arm 3220; and [0593]: FIGS.33I and 33J also depict an insulating or interface material 3330 (e.g., fabric) disposed on the housing 3338), a power source (506), a physiological sensor ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device); and), a processing unit (502; and FIG.6C: the controller board 1…n) ([0571]: a housing 3226 for supporting and/or enclosing at least one mechanical transducer. The housing may also support and/or enclose other components, such as at least one controller board, and at least one battery or other power source; FIG.34A) – either the elastomeric material or the fabric is considered the flexible material layer as claimed,
an attachment element including a band ([0586]: the ergonomic support component 3300 comprises a linkage component formed to engage (e.g., wrap around) a body part of a subject (e.g., a head)), and
a plurality of energy generator elements independently operable to convert electricity from the power source into a plurality of different energy types (FIG.6A: Transducers 1…n; FIG.6C: each transducer is paired with its own controller board 1…n; and [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal)),
at least one of the plurality of energy generator elements being disposed at least partially within the flexible material layer ([0571]: controller boards and batteries or other power source are not enclosed within or supported by the housing, but rather within other portions of the ergonomic support components 3208, for example within the elastomeric arms 3220; and [0572]:each housing 3326 comprises a window, adjacent to which the mechanical transducers are disposed, and which contacts skin of the subject when the ergonomic support components are worn. The window may include an be covered with insulating material and/or a tactile fabric so as to prevent direct contact between the transducer surface and skin of the subject);
receiving a selection input from the user ([0510]: waveforms may be varied and controlled in an interactive fashion, for example by a user or in response to received feedback and physiological signals from the user);
securing the band of the attachment element about a head of a user to maintain a skin facing surface of the body against physiological tissue of the user ([0569]: FIG.32A depicts one embodiment of a transcutaneous neuromodulation device 3200 that includes two separate ergonomic support components 3208; and [0570]: each ergonomic support component 3208 includes an elastomeric arm 3220 for comfortably engaging with a portion of a human subject, for example, the elastomeric arm is configured to hug or otherwise engage the subject’s ears; FIG.32D; and [0586]: the ergonomic support component 3300 comprises a linkage component formed to engage (e.g., wrap around) a body part of a subject (e.g., a head));
causing, with the processing unit, responsive to the selection input ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21), the plurality of energy generator elements to output a combination of the plurality of different energy types toward the physiologic tissue during a period ([0080]: a method of treating anxiety and/or an anxiety related disorder in a subject by providing transcutaneous mechanical stimulation…via a stimulation device (e.g., a wearable device); [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal); and [0010]: the one or more controller boards modulate the waveform output to introduce particular signals that include active or inactive pulse durations and frequencies configured to accommodate particular mechanoreceptor recovery periods, adaption times, inactivation times, sensitization and desensitization times, or latencies),
the combination of the plurality of different energy types being operable to induce or maintain a brain state of the user during the period ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21); and
detecting, with the physiological sensor, physiological data during the period ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device and/or external to and in communication with the device)(e.g., a heart rate; e.g., a galvanic skin response; e.g., physical movement (e.g., recorded by an accelerometer) provided following their receipt of a round (e.g., a duration) of the transcutaneous mechanical stimulation provided by the stimulation device; and [0630]-[0654] list various physiological sensors).
Claims 24 and 34. Chu further teaches that
the plurality of energy generator elements include first energy generator elements including a mechanical actuator configured to convert the electricity from the power source into a mechanical movement recognizable by the physiological tissue of the user ([0005]: the approaches described herein utilize a stimulation device for generation and delivery of the mechanical vibrational waves).
Claims 25 and 35. Chu further teaches that
the first energy generator elements are disposed at least partially within the flexible material layer ([0571]: controller boards and batteries or other power source are not enclosed within or supported by the housing, but rather within other portions of the ergonomic support components 3208, for example within the elastomeric arms 3220; and [0572]:each housing 3326 comprises a window, adjacent to which the mechanical transducers are disposed, and which contacts skin of the subject when the ergonomic support components are worn. The window may include an be covered with insulating material and/or a tactile fabric so as to prevent direct contact between the transducer surface and skin of the subject).
Claims 26 and 36. Chu further teaches that
the plurality of energy generator elements include second energy generator elements including a pressure generator configured to convert the electricity from the power source into a pressure energy recognizable by the physiological tissue of the user ([0498]: the device can modulate the pressure of the transducer contact on the skin surface, thus allowing for control of the transmission of the mechanical stimulation into the body).
Claims 27 and 37. Chu further teaches that
the plurality of energy generator elements include a plurality of third energy generator elements including a heat generator configured to convert the electricity from the power source into a heat flux recognizable by the physiological tissue of the user ([0453]: mechanical stimulation results in soft buzzing and/or gentle warming sensation on the skin underneath the device).
Claims 28 and 38. Chu further teaches that
the physiological sensor is a heart sensor configured to detect heart signals when disposed adjacent to a blood vessel of the user ([0511]: a heart-rate monitor).
Claims 30 and 40. Chu further teaches that
the physiological sensor is a breath sensor configured to detect breath signals of a user ([0034]: a functional form of the waveform output is based on one or more recorded natural sounds (e.g., breathing)).
Claims 32 and 42. Chu further teaches
responsive to the detecting the physiological data ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21), the processing unit causes the plurality of energy generator elements to output the combination of the plurality of different energy types toward the physiologic tissue during a period ([0080]: a method of treating anxiety and/or an anxiety related disorder in a subject by providing transcutaneous mechanical stimulation…via a stimulation device (e.g., a wearable device); [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal); and [0010]: the one or more controller boards modulate the waveform output to introduce particular signals that include active or inactive pulse durations and frequencies configured to accommodate particular mechanoreceptor recovery periods, adaption times, inactivation times, sensitization and desensitization times, or latencies)
to induce or maintain the relaxed brain state of the user during the period ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21).
Claim 44. Chu further teaches that
the brain state comprises Theta waves in a range between 3 Hz and 8 Hz or Alpha waves in a range between 8 Hz to 12 Hz ([0032]: a frequency range matching an alpha brain wave frequency range; e.g., approximately 10 Hz; and [0402]: a frequency of the carrier wave corresponds to a frequency of a particular type of brain wave. For example, theta, alpha…brain waves have frequencies range from 4-8 Hz, 8-16 Hz…, respectively).
Claim 45. Chu further teaches
receiving a second selection input from the user ([0510]: waveforms may be varied and controlled in an interactive fashion, for example by a user or in response to received feedback and physiological signals from the user); and
causing, with the processing unit, responsive to the second selection input ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21),
the plurality of energy generator elements to output a second combination of the plurality of different energy types toward the physiologic tissue during a second period ([0080]: a method of treating anxiety and/or an anxiety related disorder in a subject by providing transcutaneous mechanical stimulation…via a stimulation device (e.g., a wearable device); [0028]: the device comprises a secondary stimulation device for proving one or more external stimulus/stimuli (e.g., visual stimulus, e.g., acoustic stimulus; e.g., limbic priming; e.g., a secondary tactile signal); and [0010]: the one or more controller boards modulate the waveform output to introduce particular signals that include active or inactive pulse durations and frequencies configured to accommodate particular mechanoreceptor recovery periods, adaption times, inactivation times, sensitization and desensitization times, or latencies),
the second combination of the plurality of different energy types being operable to induce or maintain a second brain state of the user during the second period ([0513]: to produce a relaxation state in a subject undergoing mechanical stimulation, physiological signals, such as various brain waves, BP, and HRV, can be monitored for the subject, and waveform characteristics can be modified to produce brain wave, BP, and HRV characteristics that are associated with the relaxation state, such as those shown in FIG.21; [0514]: other states in a subject can be produced by modifying a waveform to produce that state. For example, as shown in FIG.21, a focused state is associated with decreased theta waves, neutral alpha waves, increased beta waves, increased BP, and increased HRV; and [0515]: one or more of the characteristics, such as those shown in FIG.21, can be targeted in this manner, via monitoring of one or more corresponding physiological signals, to produce a desired state in a subject); and
detecting, with the physiological sensor, second physiological data during the second period ([0083]: biofeedback data recorded by one or more sensors (e.g., included within the device and/or external to and in communication with the device)(e.g., a heart rate; e.g., a galvanic skin response; e.g., physical movement (e.g., recorded by an accelerometer) provided following their receipt of a round (e.g., a duration) of the transcutaneous mechanical stimulation provided by the stimulation device; and [0630]-[0654] list various physiological sensors).
In regard to the steps being a second time repeat of what’s recited in claim 43, Chu teaches in [0022]: each mechanical transducer begins and/or ends producing mechanical vibration at a particular delay with respect to one or more other mechanical transducers are sequentially triggered, one after another…a first portion of the mechanical transducers outputs a different frequency mechanical vibration from a second portion of the mechanical transducers of the transducer array (e.g., wherein each mechanical transducer of the transducer array outputs a different frequency mechanical vibration. Hence, Chu teaches that different combination of the different energy types are controlled to be triggered to stimulate the brain to different states in response to the user input based on the physiological data.
Claim 46. Chu further teaches that
the brain state comprises one of Theta waves in a range between 3 Hz and 8 Hz or Alpha waves in a range between 8 Hz to 12 Hz ([0032]: a frequency range matching an alpha brain wave frequency range; e.g., approximately 10 Hz; and [0402]: a frequency of the carrier wave corresponds to a frequency of a particular type of brain wave. For example, theta, alpha…brain waves have frequencies range from 4-8 Hz, 8-16 Hz…, respectively); and
the second brain state comprises the other one of the Theta waves and the Alpha waves ([0022]: a first portion of the mechanical transducers outputs a different frequency mechanical vibration from a second portion of the mechanical transducers of the transducer array (e.g., wherein each mechanical transducer of the transducer array outputs a different frequency mechanical vibration).
Claim 49. Chu further teaches that
the physiological data comprises one or more of brainwave signals, heart signals, motion signals, and breath signals ([0630]: various biometric assessment that can be performed are listed below: [0635]-[0638]: brainwave signal measurement; [0643]-[0645]: heart rate measurement; [0649]-[0650]: movement measurement).
Claim 50. Chu further teaches
receiving the selection input from the user with a user interface in data communication with the processing unit ([0510]: waveforms may be varied and controlled in an interactive fashion, for example by a user (e.g., through an app in communication with the devices)).
Claim 51. Chu teaches that
the user interface comprises a display ([0598]: the processor 3602 can process instructions for execution within the computing device, including instructions stored in the memory or on the storage device to display graphical information for a GUI on an external input/output device; and [0603]: the mobile computing device includes a processor…an input/output device such as a display).
Claim 52. Chu further teaches that
the brain state comprises brain waves in a range between 3 Hz and 36 Hz ([0402]: theta, alpha, beta, gamma brain waves have frequencies ranging from 4-8 Hz, 8-16 Hz, 16-30 Hz, and 30-60 Hz, respectively).
Claim 53. Chu further teaches
training, with an optical interface, the user to induce or maintain the brain state responsive to the combination of the plurality of different energy types (FIG.20: the user is trained based on the output on the display (i.e., an optical interface) to provide feedback for adjusting the waveform in order to achieve the desired brain state).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Owen in view of Chu et al., US 2019/0232047 A1, hereinafter Chu, in view of Yoon et al., US 2015/0164352 A1, hereinafter Yoon.
Claims 29 and 39. Chu teaches all the limitations of claims 28 and 38, respectively, including a heart sensor ([0511]: a heart-rate monitor).
Chu does not teach detecting, with the heart sensor, a volumetric change in the blood vessel; and measuring, with the heart sensor, a heart rate of the user based on the volumetric change.
However, in an analogous heart rate measurement device field of endeavor, Yoon teaches
detecting, with the heart sensor, a volumetric change in the blood vessel; and measuring, with the heart sensor, a heart rate of the user based on the volumetric change ([0006]: PPG observes optical characteristics of bio tissues such as light reflectivity, absorptance and transmittance that show during volumetric change in blood vessel by using a light, and measures the heart rate using the change).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Chu employ such a feature “detecting, with the heart sensor, a volumetric change in the blood vessel; and measuring, with the heart sensor, a heart rate of the user based on the volumetric change” as taught in Visvanathan for the advantage of “providing a non-invasive method that is widely used due to enablement of measuring bio signals, advantageous because of miniaturized size and convenience in usage, and conductive to development of wearable life signal detection sensor”, as suggested in Yoon, [0006].
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Owen in view of Chu et al., US 2019/0232047 A1, hereinafter Chu.
Claim 47. Chu further teaches
calculating a differential between a target brain state and the brain state based on the physiological data; and causing the plurality of energy generator elements to output the combination of the plurality of different energy types at an intensity proportionate to the differential ([0511]: a waveform of the electronic drive signal is controlled based on the electronic response signal such that the mechanical wave delivered to the body location of the subject is modulated accordingly, reflecting the received feedback. Accordingly, the systems, methods, and devices described herein provide for adjustment and/or selection of a particular waveform, tailored to a particular subject, based on received feedback corresponding to subject biometrics; and FIG.21) – in order to adjust the waveform to tailor to a particular subject, it at least implicitly teaches that a difference is calculated, and based on which the output energy, i.e., the waveform, is adjusted accordingly.
In regard to the intensity being adjust to proportionate to the differential, since the intensity is adjusted based on the differential, there has to be a relationship between the intensity and the differential. However, whether it is a proportional, inverse proportional, or any other relationship, it depends on the type of targeted brain state and the physiological data. Hence it requires only routine experimentation for one of ordinary skill in the art to identify the relationship between the differential and the intensity based on the desired objective. It would have been obvious to one of ordinary skill in the at before the effective filing date of the claimed invention to adjust the intensity in proportionate to the differential through routine experimentation with reasonable expectation of success.
Claim 48. Chu further teaches
calculating a second differential between a second target brain state and the second brain state based on the second physiological data; and causing the plurality of energy generator elements to output the second combination of the plurality of different energy types at a second intensity proportionate to the second differential ([0511]: a waveform of the electronic drive signal is controlled based on the electronic response signal such that the mechanical wave delivered to the body location of the subject is modulated accordingly, reflecting the received feedback. Accordingly, the systems, methods, and devices described herein provide for adjustment and/or selection of a particular waveform, tailored to a particular subject, based n received feedback corresponding to subject biometrics; and FIG.21).
In regarding the recited parameters being a second set, as applied to claim 43, Chu teaches in [0022]: each mechanical transducer begins and/or ends producing mechanical vibration at a particular delay with respect to one or more other mechanical transducers are sequentially triggered, one after another…a first portion of the mechanical transducers outputs a different frequency mechanical vibration from a second portion of the mechanical transducers of the transducer array (e.g., wherein each mechanical transducer of the transducer array outputs a different frequency mechanical vibration. Hence, a second combination of energy can be controlled to be applied to the subject for reaching the second brain state. When assessing if the waveform needs to be adjusted based on physiological data, the second set of parameters are used or generated.
Further, in order to adjust the waveform to tailor to a particular subject, it at least implicitly teaches that a difference is calculated, and based on which the output energy, i.e., the waveform, is adjusted accordingly. In regard to the intensity being adjust to proportionate to the differential, since the intensity is adjusted based on the differential, there has to be a relationship between the intensity and the differential. However, whether it is a proportional, inverse proportional, or any other relationship, it depends on the type of targeted brain state and the physiological data. Hence it requires only routine experimentation for one of ordinary skill in the art to identify the relationship between the differential and the intensity based on the desired objective. It would have been obvious to one of ordinary skill in the at before the effective filing date of the claimed invention to adjust the intensity in proportionate to the differential through routine experimentation with reasonable expectation of success.
Allowable Subject Matter
Claims 31 and 41 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
The limitations recited in claims 31 and 41 in regard to the features of “measuring, with the breath sensor, breath signals responsive to an electricity activity of lungs of the user when the breath sensor is disposed adjacent to a blood vessel of the user based on a flow of blood through the blood vessel", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
The prior arts relevant to the claimed invention are cited below:
Reddy et al., US 2020/0337594 A1. This reference teaches in [0123]: in order to detect the exhaled breath biomarker VOCs…an array can be deployed with differentially-reactive customized ultra-sensitive gas sensors that convert VOC gas molecules into digital electrical signal patterns. However, as the sensor of Reddy is a gas sensor for detecting the breathing air, it cannot be reasonably combined with Chu for the sensor to be included in the body of the wearable device that is secured about the head of the user and maintained against the physiological tissue of the user.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798