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 13 is objected to because of the following informalities: Line 7 of claim 13 states “said measuring and monitoring unit”. However, a measuring and monitoring unit has not been introduced in claim 12 which claim 13 depends from. Examiner suggests rephrasing to “a measuring and monitoring unit”. Appropriate correction is required.
Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
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 2 is 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 claim 2, line 8 of claim 2 states “to control the same to at least make them”. However, it is unclear what “same” and “them” refer to. The use of “them” implies multiple components tighten and/or loosen the tourniquet cuff, but it is unclear exactly what components are being limited. For examination purposes, the examiner interprets “same” to be the pressure unit and “them” to also be the pressure unit as that is what is performing the tightening action.
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.
Claims 1-10, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marcus (US 20200360027 A1).
Regarding claim 1, Marcus teaches a blood flow restriction system (see paragraph 0049), for performing a blood flow restriction exercise regimen, comprising: a tourniquet cuff or band (Fig. 6 cuff 10) configured and arranged to be placed around a limb, proximally to a target muscle to be exercised (paragraph 0102 "FIG. 5 shows the embodiment of FIGS. 1 to 4 in use as training cuffs 10 to build and strengthen muscle, in this case, the upper arms 30, 32 by lifting dumbbells 60, 62"), tightened so as to apply a specific pressure to said limb to restrict arterial blood flow into the limb during a blood flow restriction exercise regimen (see paragraph 0114), and a measuring and monitoring unit to measure and monitor a physiological variable affected by the restricted arterial blood flow (the plurality of measuring devices disclosed in paragraphs 0052-0056), in order to guide safety and performance parameters of the blood flow restriction exercise regimen (paragraph 0108 discusses how the parameters are used to create a user profile to establish safety for a user during restriction training), wherein said measuring and monitoring unit is made and arranged to measure and monitor microvascular blood flow (see paragraphs 0073-0077 that teach using NIRS to monitor blood flow which is known to monitor microvascular blood flow according to page 7 paragraphs 2-4 of the instant application’s specification) within at least said target muscle (paragraph 0027 teaches using the device for muscle strengthening and Fig. 5 shows cuff 10 on the user’s biceps), in order to guide said safety and performance parameters of the blood flow restriction exercise regimen according at least to hemodynamic criteria (see paragraphs 0079-0082 that teach that the cuff pressure is a parameter that is based on the LOP and LOP is calculated using blood flow measurements which is a hemodynamic criteria).
Regarding claim 2, Marcus teaches the system of claim 1.
Marcus further teaches wherein the system further comprises: a pressure unit (Fig. 4 air pump 14) operatively connected to said tourniquet cuff to at least tightening the same to said specific pressure to restrict arterial blood flow into the limb during said blood flow restriction exercise regimen (see paragraph 0100); and a control unit (Fig. 4 controller 18) configured and arranged to control at least one parameter of said blood flow restriction exercise regimen (paragraph 0106 where the parameter is the pressure that is being maintained on the user’s limb), wherein said control unit is operatively connected to said pressure unit to control the same to at least make them at least one of tighten and loosen the tourniquet cuff according to said at least one parameter of the blood flow restriction exercise regimen (see paragraph 0106).
Regarding claim 3, Marcus teaches the system of claim 1.
Marcus further teaches wherein said measuring and monitoring unit is made and arranged to measure and monitor microvascular blood flow (paragraphs 0073-0077 teach using NIRS to monitor blood flow which is known to monitor microvascular blood flow according to page 7 paragraphs 2-4 of the instant application’s specification) within at least said target muscle (paragraph 0027 teaches using the device for muscle strengthening and Fig. 5 shows cuff 10 on the user’s biceps), at least one of: at least during part of the blood flow restriction exercise regimen (paragraph 0114; the Doppler ultrasound is continuous and thus will constantly provide data to the controller throughout the regimen) and at least prior and after the blood flow restriction exercise regimen.
Regarding claim 4, Marcus teaches the system of claim 2.
Marcus further teaches wherein said measuring and monitoring unit is operatively connected to said control unit (paragraph 0110 “The controller automatically maintains the arterial occluding cuff pressure measured by the pressure sensor by inflating or deflating the cuff in response to the Doppler signal”), wherein the control unit implements a closed-loop arrangement using as feedback the measured values received from the measuring and monitoring unit to determine at least one value for said at least one parameter of the blood flow restriction exercise regimen, according at least to said hemodynamic criteria (paragraphs 0073-0084 discuss how the blood flow is monitored and then used to determine LOP which influences the blood flow restriction parameters, such as the desired pressure), and to automatically control the pressure unit to at least one of tighten and loosen the tourniquet cuff according to said at least one determined value of the at least one parameter of the blood flow restriction exercise regimen (see paragraph 0084).
Regarding claim 5, Marcus teaches the system of claim 2.
Marcus further teaches wherein the measuring and monitoring unit is configured to one of: provide the measured values to a user interface (paragraph 0052 teaches how the blood flow data can be coupled with a smartphone app; One reasonably skilled in the art would expect the smartphone app coupled with collecting blood flow would provide the user with the measured values) so that the user can determine at least one value for said at least one parameter of the blood flow restriction exercise regimen (paragraph 0082-0083 teaches the user determining the range of pressures of the cuff which is a parameter of the regimen), according at least to said hemodynamic criteria (see paragraphs 0079-0082 that teach that the cuff pressure is a parameter that is based on the LOP and LOP is calculated using blood flow measurements which is a hemodynamic criteria); and determine the at least one value for the said at least one parameter of the blood flow restriction exercise regimen (paragraph 0082-0083 teaches the user determining the range of pressures of the cuff which is a parameter of the regimen), according at least to the hemodynamic criteria (see paragraphs 0079-0082 that teach that the cuff pressure is a parameter that is based on the LOP and LOP is calculated using blood flow measurements which is a hemodynamic criteria), and provide the determined at least one value to the user interface (claim 10; Fig. 5 the pressure value is shown on the interface 50); and wherein the control unit comprises an input device for said user to provide the control unit with said at least one determined value of the at least one parameter (see paragraph 0105 where the user can provide the cuff pressure which is a parameter via the smartphone), to make the control unit to control the pressure unit to at least one of tighten and loosen the tourniquet cuff according to said at least one determined value of the at least one parameter of the blood flow restriction exercise regimen (see paragraph 0106 where the cuff pressure is the parameter).
Regarding claim 6, Marcus teaches the system of claim 1.
Marcus further teaches wherein said measuring and monitoring unit uses a non-invasive technique to quantitatively measure and monitor the microvascular blood flow within at least the target muscle (see paragraph 0052-0056 which discuss the different techniques that are known to be non-invasive and quantitative).
Regarding claim 7, Marcus teaches the system of claim 6.
Marcus further teaches wherein said non-invasive technique is a non-invasive optical technique (NIRS is known to be a non-invasive optical technique according to page 7 paragraph 4 of the instant application’s specification).
Regarding claim 8, Marcus teaches the system of claim 7.
Marcus further teaches wherein said non-invasive optical technique includes at least one light speckle based hemodynamics measurement technique (NIRS includes speckle based hemodynamics according to page 7 paragraph 4 of the instant application’s specification).
Regarding claim 9, Marcus teaches the system of claim 1.
Marcus further teaches wherein said measuring and monitoring unit is also made and arranged to measure and monitor at least one of the following further physiological variables: blood oxygen saturation, blood volume, blood flow, oxygen extraction fraction and metabolic rate of oxygen consumption (see paragraph 0052), in order to guide said safety and performance parameters of the blood flow restriction exercise regimen according to said hemodynamic criteria and also according to a further criteria related to said at least one further physiological variable (see paragraph 0137).
Regarding claim 10, Marcus teaches the system of claim 2.
Marcus further teaches wherein the control unit is configured to control the pressure unit to at least one of tighten and loosen the tourniquet cuff according to a plurality of determined values for said at least one parameter (see paragraph 0112), from measured values provided by the measuring and monitoring unit following a modulation process for a user in a personalized manner (see paragraph 0137).
Regarding claim 12, Marcus teaches a method for performing a blood flow restriction exercise regimen, comprising the following steps: placing a tourniquet cuff or band around a limb, proximally to a target muscle to be exercised (see paragraph 0028), tightened so as to apply a specific pressure to said limb to restrict arterial blood flow into the limb during a blood flow restriction exercise regimen (see paragraphs 0031-0035); and measuring and monitoring a physiological variable affected by the restricted arterial blood flow, in order to guide safety and performance parameters of the blood flow restriction exercise regimen (see paragraphs 0030 and 0037); wherein said step of measuring and monitoring a physiological variable comprises measuring and monitoring microvascular blood flow within at least said target muscle (see paragraphs 0051-0056, where NIRS is a technique to measure and monitor microvascular blood flow according to page 7 paragraph 4 of the present invention specification), in order to guide said safety and performance parameters of the blood flow restriction exercise regimen according at least to hemodynamic criteria (paragraphs 0079-0081).
Regarding claim 13, Marcus teaches the method of claim 12.
Marcus further teaches wherein the method comprises implementing said steps with a blood flow restriction system, for performing a blood flow restriction exercise regimen (see paragraph 0027), comprising: a tourniquet cuff or band configured and arranged to be placed around a limb, proximally to a target muscle to be exercised (Fig. 6 cuff 10), tightened so as to apply a specific pressure to said limb to restrict arterial blood flow into the limb during a blood flow restriction exercise regimen (see paragraphs 0105-0107); and said measuring and monitoring unit to measure and monitor a physiological variable affected by the restricted arterial blood flow (the plurality of measuring devices disclosed in paragraphs 0052-0056), in order to guide safety and performance parameters of the blood flow restriction exercise regimen (see paragraphs 0079-0081); wherein said measuring and monitoring unit is made and arranged to measure and monitor microvascular blood flow (see paragraphs 0051-0056, where NIRS is a technique to measure and monitor microvascular blood flow according to page 7 paragraph 4 of the present invention specification) within at least said target muscle (paragraph 0027 teaches using the device for muscle strengthening and Fig. 5 shows cuff 10 on the user’s biceps), in order to guide said safety and performance parameters of the blood flow restriction exercise regimen according at least to hemodynamic criteria (see paragraphs 0079-0082 that teach that the cuff pressure is a parameter that is based on the LOP and LOP is calculated using blood flow measurements which is a hemodynamic criteria).
Regarding claim 14, Marcus teaches the method of claim 13.
Marcus further teaches a computer program product, comprising a tangible medium and, stored therein, a computer program including code instructions that implement part of those steps (see paragraph 0099; One skilled in the art would reasonably expect that some sort of program or code is required to remotely operate the cuff) of the method of claim 13 referring to at least measure and monitor a physiological variable affected by the restricted arterial blood flow, when executed on processors of at least the measuring and monitoring unit of the system (see paragraph 0108).
Regarding claim 15, Marcus teaches the method of claim 13.
Marcus further teaches when using the blood flow restriction system that further comprises: a pressure unit (Fig. 4 air pump 14) operatively connected to said tourniquet cuff to at least tightening the same to said specific pressure to restrict arterial blood flow into the limb during said blood flow restriction exercise regimen (see paragraph 0100); and a control unit (Fig. 4 controller 18) configured and arranged to control at least one parameter of said blood flow restriction exercise regimen (paragraph 0106 where the parameter is the pressure that is being maintained on the user’s limb), wherein said control unit is operatively connected to said pressure unit to control the same to at least make them at least one of tighten and loosen the tourniquet cuff according to said at least one parameter of the blood flow restriction exercise regimen (see paragraph 0106), which steps are carried out by the control unit to at least control said at least one parameter of the blood flow restriction exercise regimen (see paragraph 0018 where the predetermined pressure is a parameter of the exercise regimen), and to control the pressure unit to at least one of tighten and loosen the tourniquet cuff according to said at least one parameter of the blood flow restriction exercise regimen (see paragraph 0035).
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 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Marcus (US 20200360027 A1) in view of Houck (US 20210338090 A1).
Regarding claim 11, Marcus teaches the system of claim 1.
Marcus further teaches wherein the measuring and monitoring unit comprises at least one wearable or portable probe (see paragraph 0047 that mentions a pulse oximeter that can be used in conjunction with a Doppler ultrasound) adapted to be removably attached (One skilled in the art would reasonably expect a pulse oximeter to be removable) to the target muscle with a position and orientation that allows the same to take measurements within the target muscle (see paragraph 0048).
Marcus is silent wherein the probe specifically takes measurements of microvascular blood flow.
However, Houck teaches a wearable or portable probe (Fig. 1A where 102 is an optical sensor device; One skilled in the art would reasonably expect that a sensor device is portable) adapted to be removably attached to the target muscle (Fig. 1A shows the sensor proximate to the subject 104) with a position and orientation that takes measurements of microvascular blood flow within the target muscle (claim 7).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Marcus to include a probe to specifically measure microvascular blood flow. Measuring microvascular blood flow provides health insights at a unique depth range of the human body, which can be a better parameter for monitoring the user’s health during cuff operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKHIL A JAYAN whose telephone number is (571)272-6099. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 5712729034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AKHIL ADAI JAYAN/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785