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 04/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 (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 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.
Claim(s) 1-8, 10-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nofzinger (US Patent No 20170252534).
Regarding claim 1, Nofzinger teaches a system for cooling a person (apparatus for delivery of regional cooling or warming, [0020]), comprising: a pump (see in which there is a major thermal regulator component which includes a pump, [0101]); a heat exchanger in fluid communication with the pump (the thermal regulator unit may include a heat exchanger which operates with fluid, [0101]); a bladder configured to be placed on a person (see in which there is a fluid reservoir which is in connection to the thermal applicator to be placed on the user, seen as the equivalent bladder, [0101]), the bladder being in fluid communication with the heat exchanger (thermal regulator in communication with the thermal applicator, [0101]); a thermometer is located with respect to the pump (one or more thermistors may be used to measure the temperature of the fluid in the circulating circuit near the pump, [0108]), the heat exchanger and the bladder to measure a temperature of fluid passing through at least one of the pump, the heat exchanger and the bladder (see [0108], in which the thermistors measure and control the fluid cycling through the circulating circuit which is connected to the pump element); a heart rate variability (HRV) sensor (the system may have feedback sensors consisting of heart rate variability, [0186]); and a controller in electrical communication with the thermometer, the HRV sensor and the heat exchanger, the controller configured to control power delivered to or flow through the heat exchanger based on signals received from the HRV sensor (see from [0185]-[0186], in which there is a feedback controller in communication with the thermistors and the thermal transfer components as to adjust the thermal transfer applied to the applicator via the transfer components and pump components as to achieve the desired physiological effect. The controller may have feedback control based on the HRV sensed).
Regarding claim 2, Nofzinger teaches the system of claim 1, wherein the controller is configured to determine whether a measured HRV is outside a predetermined range defined by a lower threshold and an upper threshold (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate if it raises or drops by 10-35%, see also [0381], for some of the specific range changes measured).
Regarding claim 3, Nofzinger teaches the system of claim 2, wherein the controller is further configured to determine whether the measured HRV is below a minimum threshold while or after determining the measured HRV is outside the predetermined range and below the lower threshold (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate if it drops by 10-35%, see also [0381], for some of the specific range changes measured).
Regarding claim 4, Nofzinger teaches the system of claim 3 further comprising an alarm in electrical communication the controller, and the controller is further configured to set off the alarm upon determining the measured HRV is outside the predetermined range and below the minimum threshold (see from [0370], in which the methods after being executed by the processor may cause the control to perform any of the following steps including displaying, communicating, or alerting the user of variables such as timing, frequency or intensity of the measured HRV).
Regarding claim 5, Nofzinger teaches the system of claim 3, wherein the controller is further configured to control the heat exchanger to further cool fluid entering the bladder upon determining the measured HRV is below the lower threshold (see from [0366], see in which the applicator may be cooled by the cooling fluid to ramp down the temperature upon determination that the HRV has dropped more than 10%).
Regarding claim 6, Nofzinger teaches the system of claim 2, wherein the controller is further configured to determine whether the measured HRV is above a maximum threshold while or after determining the measured HRV is outside the predetermined range and above the upper threshold (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate by 10-35%, see also [0381], for some of the specific range changes measured which includes but is not limited to an increase in the measured HRV by 10-35%, indicating the HRV is above a max threshold).
Regarding claim 7, Nofzinger teaches the system of claim 6 further comprising an alarm in electrical communication the controller, and the controller is further configured to set off the alarm upon determining the measured HRV is outside the predetermined range and above the maximum threshold (see from [0370], in which the methods after being executed by the processor may cause the control to perform any of the following steps including displaying, communicating, or alerting the user of variables such as timing, frequency or intensity of the measured HRV).
Regarding claim 8, Nofzinger teaches the system of claim 6, wherein the controller is further configured to control the heat exchanger to warm fluid entering the bladder upon determining the measured HRV is above the upper threshold (see from [0111], in which thermal fluid is circulated through the thermal applicator through the fluid delivery hoses as a way to heat the user and perform as a heat exchanger when the sensed feedback is greater than the upper threshold).
Regarding claim 10, Nofzinger teaches a method for cooling a person (apparatus for delivery of regional cooling or warming, [0020]), comprising: pumping fluid (see in which there is a major thermal regulator component which includes a pump, [0101]) through a heat exchanger (the thermal regulator unit may include a heat exchanger which operates with fluid, [0101]) to a bladder placed on a person (see in which there is a fluid reservoir which is in connection to the thermal applicator to be placed on the user, seen as the equivalent bladder, [0101]); removing heat from the fluid as the fluid passes through the heat exchanger (see [0027], cooling units may have heat sinks to remove heat from the thermal fluid); measuring a temperature of the fluid passing through at least one of the heat exchanger and the bladder (one or more thermistors may be used to measure the temperature of the fluid in the circulating circuit near the pump, [0108], in which the thermistors measure and control the fluid cycling through the circulating circuit which is connected to the pump element); monitoring the person's HRV with an HRV sensor in communication with a controller (the system may have feedback sensors consisting of heart rate variability, [0186]); and controlling at least one of power delivered to the heat exchanger and flow of fluid through the heat exchanger based on signals received from the HRV sensor (see from [0185]-[0186], in which there is a feedback controller in communication with the thermistors and the thermal transfer components as to adjust the thermal transfer applied to the applicator via the transfer components and pump components as to achieve the desired physiological effect. The controller may have feedback control based on the HRV sensed).
Regarding claim 11, Nofzinger teaches the method of claim 10, further comprising determining whether a measured HRV is outside a predetermined range defined by a lower threshold and an upper threshold (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate if it raises or drops by 10-35%, see also [0381], for some of the specific range changes measured).
Regarding claim 12, Nofzinger teaches the method of claim 11, further comprising determining whether the measured HRV is below a minimum threshold while or after determining whether the measured HRV is outside the predetermined range (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate if it drops by 10-35%, see also [0381], for some of the specific range changes measured).
Regarding claim 13, Nofzinger teaches the method of claim 12, further comprising setting off an alarm upon determining the measured HRV is below the minimum threshold (see from [0370], in which the methods after being executed by the processor may cause the control to perform any of the following steps including displaying, communicating, or alerting the user of variables such as timing, frequency or intensity of the measured HRV).
Regarding claim 14, Nofzinger teaches the method of claim 12, further comprising controlling the heat exchanger to further cool fluid entering the bladder upon determining the measured HRV is below the lower threshold (see from [0366], see in which the applicator may be cooled by the cooling fluid to ramp down the temperature upon determination that the HRV has dropped more than 10%).
Regarding claim 15, Nofzinger teaches the method of claim 11, further comprising determining whether the measured HRV is above a maximum threshold while or after determining whether the measured HRV is outside the predetermined range (see [0366] in which the temperature applicator may be controlled based on the measured heart rate, for example the processor may measure and monitor the heart rate to identify a change in the initial heart rate by 10-35%, see also [0381], for some of the specific range changes measured which includes but is not limited to an increase in the measured HRV by 10-35%, indicating the HRV is above a max threshold).
Regarding claim 16, Nofzinger teaches the method of claim 15, further comprising setting off an alarm upon determining the measured HRV is above the maximum threshold (see from [0370], in which the methods after being executed by the processor may cause the control to perform any of the following steps including displaying, communicating, or alerting the user of variables such as timing, frequency or intensity of the measured HRV).
Regarding claim 17, Nofzinger teaches the method of claim 15, further comprising controlling the heat exchanger to warm fluid entering the bladder upon determining the measured HRV is above the upper threshold of the predetermined range (see from [0111], in which thermal fluid is circulated through the thermal applicator through the fluid delivery hoses as a way to heat the user and perform as a heat exchanger when the sensed feedback is greater than the upper threshold).
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) 9, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nofzinger (US Patent No 20170252534) in view of Edelman (US Patent No 20130245729).
Regarding claims 9 and 18, Nofzinger teaches the system of claims 6 and 15, wherein the controller is further configured to control at least one of power delivered to the heat exchanger, an operating state of the valve and a flow rate of the pump to warm fluid entering the bladder upon determining the measured HRV is above the upper threshold (see from [0185]-[0186], in which there is a feedback controller in communication with the thermistors and the thermal transfer components as to adjust the thermal transfer or power output applied to the applicator via the transfer components and pump components as to achieve the desired physiological effect. The controller may have feedback control based on the HRV sensed).
Nofzinger does not teach further comprising a valve configured to open to allow fluid to bypass the heat exchanger.
However, the analogous cold therapy system taught by Edelman does teach a valve configured to open to allow fluid to bypass the heat exchanger (see from Edelman, [0013], in which there is a controllable valve configuration which allows the fluid to either travel in-line through the heat exchanger or to bypass the heat exchanger dependent on the configuration).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the heating and cooling system taught by Nofzinger, to contain the heat exchanger bypass valve taught by Edelman as it is another way to adjustably control the thermal fluid temperature as well as allowing for a quicker delivery of the thermal fluid to the applicator when the extra heat exchanger is not needed for treatment, as disclosed by Edelman, [0013].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights