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 Arguments
Applicant does not explicitly address the objections to Claims 1 and 2. The objection to Claim 1 is withdrawn in view of the amendment. However, the objection to Claim 2 is maintained, as the claim still recites “[…] comprising; […] into the target body part […].”
Applicant does not explicitly address the rejection of Claims 1-2 under 35 U.S.C. 112(b). The previous rejections of Claims 1-2 under 35 U.S.C. 112(b) are withdrawn, however, Claims 1-2 are still rejected under 35 U.S.C. 112(b) for new reasons as below.
Applicant’s argument on Pages 1-2 regarding the rejection of Claims 1-2 under 35 U.S.C. 102(a)(1) as being anticipated by Ren has been fully considered but is not persuasive under new grounds of rejection as below.
Drawings
The drawings filed 27 February 2024 are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “infrasonic sound wave device, further comprising a calibration component” (Claim 2) and “a second device” (Claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
According to MPEP 714, the new (substitute) abstract provided in clean form filed 11 November 2025 cancels and replaces previous Abstract. See examiner-initialed Abstract.
The disclosure filed on 11 November 2025 is objected to because of the following informalities: the specification recites “pressures within 30mmHg of the diastolic blood pressure” in [0003] and “key value” in [0001] and [0010], the examiner suggests amending the disclosure to identify that the pressures within 30mmHg of the diastolic blood pressure is the key value. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: a pre-calibration model (Claims 1-2 and 4) and a display device (Claim 5).
The amendment filed 11 November 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
[0001], [0010], [0014]: “pre-calibration model”
[0010]: the device generates an alarm
[0026] and [0027]: infrasonic and low-audible spectrum (1Hz – 20kHz)
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: minor grammatical errors and language clarification. The claim should be amended to “[…] a device consisting of at least one or more infrasonic […] [[or emitters]] the muscle fascia compartment, wherein the method uses the [[recorded]] detected frequencies […] for a muscle fascia compartment pressure has been exceeded through [[the]] an empirical relationship […].” Appropriate correction is required.
Claim 2 is objected to because of the following informalities: minor errors in antecedent basis. The claim should be amended to “[…] one or more emitters […] sound waves in [[the]] an infrasonic and low-audible sound range […] [[the]] a target body part, a muscle fascia compartment, or a container […] in the target body part, the muscle fascia compartment, or the container; one or more receivers to detect and record [[the]] emitted frequencies that induced resonance in the muscle fascia compartment, [[or]] the target body part, or the container; and [[comprising]] a pre-calibration model and an infrasonic wave device […] or a cadaver [[limb]] muscle fascial compartment […] where [[the]] a hardness and an internal pressure of the muscle fascia compartment model or the cadaver muscle fascial compartment are known; [[the]] an empirical relationship […] induced resonance frequencies of the muscle fascia compartment model.” Appropriate correction is required.
Claim 3 is objected to because of the following informalities: minor grammatical errors. The claim should be amended to “[…] wherein the infrasonic device [[with emitters and receivers are encased in or attached to]] further comprises a cuff that is wrapped around an arm or leg to [[hold the emitters and receivers in place]] encase or attach to the emitters and receivers.” Appropriate correction is required.
Claim 4 is objected to because of the following informalities: minor errors in antecedent basis. The claim should be amended to “[…] in the muscle fascia compartments of [[the]] a patient’s contralateral arm or leg are used as a [[the]] known pressure model […] between the muscle fascia compartment pressure and the induced resonance frequencies.” Appropriate correction is required.
Claim 5 is objected to because of the following informalities: minor errors in antecedent basis. The claim should be amended to “[…] the emitter sound wave frequencies, the resonance frequencies of the muscle fascia components, or the pressure of the muscle fascia components.” Appropriate correction is required.
Claim 6 is objected to because of the following informalities: minor grammatical errors. The claim should be amended to “[…] wherein [[the emitters and receivers are]] the device is a wearable […]” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: minor errors in antecedent basis. The claim should be amended to “[…] applied to [[the]] a patient’s contralateral leg or arm [[for the purpose of]] to detect[[ing]] differences or changes between the [[two arms or legs]] contralateral leg or arm […].” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1 the limitation regarding emitter(s) that generate sounds waves in only (“device consisting of”) the infrasonic and low-audible sound range (1Hz-20kHz) is not taught by the original disclosure.
Regarding Claim 2, the limitation regarding emitter(s) that generate sounds waves in the infrasonic and low-audible sound range (1Hz-20kHz) is not taught by the original disclosure.
Regarding Claim 7, the limitation “a second similar device […] for the purposes of detecting differences or changes between the frequencies that induce resonance of muscle fascia compartments between the two arms or legs” is not taught by the original disclosure.
Explicitly stating in applicant remarks where the amendment of the claims has support in the original disclosure is appreciated. Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 1-7 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.
Regarding Claims 1-2, the limitation “infrasonic or low-audible spectrum (1 Hz-20kHz)” renders the claims indefinite. It is unclear if applicant intends to claim the specific range, and, if so, the range must be positively recited (i.e., “infrasonic or low-audible spectrum within 1 Hz to 20kHz”).
Further regarding Claim 1, the limitation “a device” (Lines 3 and 6) renders the claim indefinite. It is unclear whether the device claimed in both Lines 3 and 6 is intended to be the same device, or two separate devices. For purposes of applying prior art, it is interpreted that the device claimed in Lines 3 and 6 is the same (Fig. 3) and is a singular unit.
Further regarding Claim 2, the limitation “one of several states of resonance” renders the claim indefinite. It is unclear what applicant intends to claim by such a limitation, as “several states of resonance” is not taught by the disclosure, [0027] and [0010] merely broadly describe the limitation. For purposes of applying prior art, it is interpreted that the target body part, muscle fascia compartment, or the container must have at least some kind of resonance induced. Furthermore, the limitation “a pre-calibration model and a [sic] infrasonic sound wave device further comprising […]” renders the claim indefinite. It is unclear which limitation, or if both, comprise the calibration component and muscle fascia component model. For purposes of applying prior art, it is interpreted that the pre-calibration model comprises the calibration component and muscle fascia component model.
Additionally regarding Claim 2, the limitation “key value pressure (30mmHg)” renders the claim indefinite. It is unclear if applicant intends to claim the specific value, and, if so, the value must be positively recited (i.e., “a key value pressure of 30mmHg”).
Moreover, the limitation “when actual monitoring of the muscle fascia compartment in a patient, comparing the subject and the pressure pre-calibration model and the device can detect when the key value pressure has been exceeded” renders Claim 2 indefinite. It is unclear what element of the device is intended to carry out such a step, and further, there is no teaching of what “actual monitoring” comprises of.
Regarding Claim 7, the limitation “second similar device” renders the claim indefinite. It is unclear what the first similar device is, and what classifies the device as “similar,” as there is no standard of “similarity” taught by the original disclosure.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Avila et al. (US 20200405218) in view of Ren (CN 108685593).
Regarding Claim 1, Avila teaches a monitoring method of internal pressure of a muscle fascial compartments, ([0001] “The present invention relates to a […] method for determining a physiological parameter.”), comprising:
a) utilizing a device consisting of infrasonic or low-audible spectrum (1Hz-20kHz) sound wave emitter or emitters to induce resonance in a muscle fascia compartment ([0156] “The transmitter 102 preferably comprises a vibroacoustic unit such as a coin vibrator or a linear vibrator or a linear piston or any other suitable vibration inducing (i.e. vibration creating) unit. The transmitter 102 creates an acoustic signal by vibrating a portion of the user's body. The transmitter 102 is preferably arranged in contact with a portion of the user's body, e.g. a muscle or muscle group of the user,” [0158] “The vibrating unit of the transmitter 102 transmits an acoustic signal in the vibroacoustic frequency range of the audio/acoustic spectrum. Vibroacoustic frequency range is defined as an acoustic signal between 50 hertz and 500 hertz more preferably the frequency range is less than 250 hertz but greater than or equal to 50 hertz even more preferably the frequency ranges between 70 hertz and 350 hertz.”); and
b) utilizing a device consisting of microphone receivers that detect which frequency sound waves from the emitter or emitters induce resonance in the muscle fascia compartment ([0160] “The receiver 104 comprises an acoustic receiver such as for example a microphone. The receiver 104 is configured detect i.e. receive a reflected acoustic signal from a portion of the user's body. The reflected acoustic signal is the reflected component of the transmitted acoustic signal that reflects off the user's body, in particular off the muscles of the user.”).
While Avila does teach monitoring a muscle component utilizing resonated frequencies of a infrasonic or low-audible range, Avila does not explicitly teach wherein the method uses the recorded frequencies that induce resonance are utilized in a pre-calibration model to determine if a key value for muscle fascia compartment pressure has been exceeded through the empirical relationship between the muscle fascia compartment pressure and the induced resonant frequency.
In an analogous monitoring of muscle fascia room pressure, Ren teaches a monitoring method of internal pressure of a muscle fascial compartments, wherein the method uses the recorded frequencies that induce resonance are utilized in a pre-calibration model to determine if a key value for muscle fascia compartment pressure has been exceeded through the empirical relationship between the muscle fascia compartment pressure and the induced resonant frequency (Claim 1 “calculating the hardness of the fascia chamber model based on the deformation ratio of the fascia chamber model and the calibration component, and then deducing the fascia chamber model pressure through the empirical relationship between the fascia chamber pressure and the fascia chamber hardness, so as to obtain the pressure pre-calibration model; the pressure pre-calibration model has a pre-calibrated fascia chamber pressure key value; when the actual measurement of the fascia chamber pressure of the subject, comparing the subject and the pressure pre-calibration model of the fascia chamber compression deformation in the manual pressing process can detect the subject fascia chamber pressure.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Avila with Ren because the modification helps to avoid the patient to have complications with fascia ventricular syndrome, as taught by Ren in the Abstract, while utilizing the infrasonic wavelengths in Avila better penetrate the fascia to observe pressure and fluid dynamics.
Regarding Claim 2, Avila teaches a device for monitoring muscle fascia compartment pressure, ([0001] “The present invention relates to a device […] for determining a physiological parameter.”), comprising; [sic]
a) one or more emitters that generate sound waves in the infrasonic and low-audible sound range (1Hz-20kHz) directed into the target body part, muscle fascia compartment, or container to be monitored, to induce one of several states of resonance in the target ([0156] “The transmitter 102 preferably comprises a vibroacoustic unit such as a coin vibrator or a linear vibrator or a linear piston or any other suitable vibration inducing (i.e. vibration creating) unit. The transmitter 102 creates an acoustic signal by vibrating a portion of the user's body. The transmitter 102 is preferably arranged in contact with a portion of the user's body, e.g. a muscle or muscle group of the user,” [0158] “The vibrating unit of the transmitter 102 transmits an acoustic signal in the vibroacoustic frequency range of the audio/acoustic spectrum. Vibroacoustic frequency range is defined as an acoustic signal between 50 hertz and 500 hertz more preferably the frequency range is less than 250 hertz but greater than or equal to 50 hertz even more preferably the frequency ranges between 70 hertz and 350 hertz.”);
b) one or more receivers to detect and record the emitted frequencies that induced resonance in the muscle fascia compartment or target container ([0160] “The receiver 104 comprises an acoustic receiver such as for example a microphone. The receiver 104 is configured detect i.e. receive a reflected acoustic signal from a portion of the user's body. The reflected acoustic signal is the reflected component of the transmitted acoustic signal that reflects off the user's body, in particular off the muscles of the user.”); and
c) comprising a infrasonic sound wave device, ([0154] “transmitter 102”).
However, Avila does not explicitly teach comprising a pre-calibration model further comprising a calibration component and a muscle fascia compartment model or cadaver limb, wherein the hardness and internal pressure of the model or cadaver muscle fascial compartment are known (Abstract “he pre-calibration model in the method also can be pre-calibrated known hardness material, the rib chamber hardness and pre-calibrated known hardness of material comparison”); the empirical relationship between the induced resonance frequencies of the model and the known pressure are deduced for a key value pressure (30mmHg) (Abstract “pre-calibration of the fascia chamber pressure key value, for example, 30 mm mercury”); when the actual monitoring of the muscle fascia compartment in a patient, comparing the subject and the pressure pre-calibration model and the device can detect when the key value pressure has been exceeded (Claim 1 “calculating the hardness of the fascia chamber model based on the deformation ratio of the fascia chamber model and the calibration component, and then deducing the fascia chamber model pressure through the empirical relationship between the fascia chamber pressure and the fascia chamber hardness, so as to obtain the pressure pre-calibration model; the pressure pre-calibration model has a pre-calibrated fascia chamber pressure key value; when the actual measurement of the fascia chamber pressure of the subject, comparing the subject and the pressure pre-calibration model of the fascia chamber compression deformation in the manual pressing process can detect the subject fascia chamber pressure.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Avila with Ren because the modification helps to avoid the patient to have complications with fascia ventricular syndrome, as taught by Ren in the Abstract, while utilizing the infrasonic wavelengths in Avila better penetrate the fascia to observe pressure and fluid dynamics.
Regarding Claim 3, the modified device of Avila teaches all limitations of Claim 2, as discussed above. Furthermore, Avila teaches wherein the infrasonic device with emitters and receivers are encased in or attached to a cuff that is wrapped around an arm or leg to hold the emitters and receivers in place ([0152] “The device 100 can be worn on a portion of the user's body for example on an arm or a leg” and [0153] “The wearable device 100 comprises a transmitter 102 and a receiver 104”).
Regarding Claim 4, the modified method of Avila teaches all limitations of Claim 1, as discussed above. Furthermore, Ren teaches wherein the pre-calibration model utilizes detected induced resonant frequencies in the muscle fascia compartment of the patient’s contralateral arm or leg are used as the known pressure model to determine the empirical relationship between muscle fascia compartment pressure and induce resonance frequencies (Fig. 5, reproduced below, and Page 7 Paragraph 1 “Therefore, the fascia chamber pressure can be calculated from the hardness of the measuring fascia chamber. The empirical relationship between the hardness and pressure of the fascia chamber can be deduced from simultaneously measuring the pressure of the fascia chamber and the hardness of the fascia chamber.”).
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Fig. 5 of Ren
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Avila with Ren for the same reasons as Claim 1. Furthermore, when the patient’s own data is monitored and used to determine relationships, it may be best for monitoring concerning changes in the muscle fascia compartment.
Regarding Claim 5, the modified device of Avila teaches all limitations of Claim 1, as discussed above. Furthermore, Avila teaches a display device indicating either emitter sound wave frequencies, resonance frequencies of the muscle fascia compartments, or pressure of the muscle fascia compartments ([0147] “The mobile device 200 is configured to at least display the various physiological parameters” and [0191] “The mobile device 200 may be configured to extract raw signals from the wearable device 100 and display them.”).
Regarding Claim 6, the modified device of Avila teaches all limitations of Claim 2, as discussed above. Furthermore, Avila teaches wherein the emitters and receivers are a wearable device applied to an arm or leg ([0152] “The device 100 can be worn on a portion of the user's body for example on an arm or a leg” and [0153] “The wearable device 100 comprises a transmitter 102 and a receiver 104”).
Regarding Claim 7, the modified device of Avila teaches all limitations of Claim 2, as discussed above. Furthermore, Avila teaches wherein a second similar device may simultaneously be applied to the patient’s contralateral leg or arm for the purpose of detecting differences or changes between the frequencies that induce resonance of muscle fascia compartments between the two arms or legs, indicating a change in pressure ([0224] “The user may also access changes in muscular parameters for a plurality of muscle groups if a plurality of wearable devices are used, to indicate a change in each of the muscle groups.”).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795