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 filed February 23, 2026 has been entered and the references cited therein have been considered by the examiner.
Response and Amendment Filed
Applicant’s response and amendment, filed February 23, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed August 19, 2025) is as follows:
The objections to the drawings under 37 CFR 1.83(a) and 37 CFR 1.84(p)(5) have been overcome and the drawing corrections submitted with the February 23, 2026 response are approved.
The objection to the specification has been overcome by amendments to the specification.
The 35 USC 112(a) rejection of claims 2-4 is hereby withdrawn.
The 35 USC 112(b) rejection of claims 14-20 has been overcome by amendments to claim 14.
The 35 USC 102(a)(2) rejection of claims 1, 5, 6 and 10 as being anticipated by Harsy (U.S. Patent No. 7,959,657) is hereby withdrawn.
The 35 USC 103 rejection of claim 13 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) is hereby withdrawn.
The 35 USC 103 rejection of claims 7-9, 11 and 12 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Caruso et al. (U.S. Patent Application Publication No. 2021/0106459) is hereby withdrawn.
The 35 USC 103 rejection of claims 14-20 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Karasahin (U.S. Patent Application Publication No. 2017/0224520) is hereby withdrawn.
The following new grounds of rejection are set forth:
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 22 and 28 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.
Newly filed claim 22 recites “a thermally reflective layer on a side of the body-contacting heat exchanger away from the user’s body.” The examiner cannot find a description of this thermally reflective layer in the specification or a depiction in the drawings. Similarly, newly filed claim 28 recites “a temperature sensor on the body-contacting heat exchanger, wherein the controller maintains a temperature band at the body contacting heat exchanger responsive to the temperature sensor.” The examiner cannot find a description of this temperature sensor or its attachment/connection to the controller in the specification or a depiction in the drawings. Accordingly, these recitations constitute new matter.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, 6, 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Mongold (FR 3134512).
In regard to claims 1 and 5, Harsy teaches a thermal therapeutic apparatus comprised of an enclosure 246 that houses a fluid reservoir 258, a pump 262, a thermo electric module (TEM) 266 a heat sink 270 and a fan 268 (see Fig. 17 and col. 12, lines 7-13). Collectively they constitute a liquid-to-ambient-air heat exchanger. A body worn pad 254 is coupled to the enclosure 246 via conduit hoses 252 which constitute a first conduit (inlet) and a second conduit (outlet) (see Fig. 17). Figure 17 shows that the body worn pad 254 is a conformable bladder defining a serpentine portion of a liquid flow path. A second portion enclosure 248 is coupled to the first enclosure 246 and houses a controller 274, a power supply 276 and a battery 282 (see Fig. 17 and col. 12, lines 15-22). Harsy teaches that the TEM module removes heat on cold plate manifold 264 via the Peltier effect (see Fig. 17 and col. 8, lines 61-65). Harsy also teaches employing four TEM modules (see col. 9, lines 3-9). Harsy also teaches that the heat sinks 128 are finned (see col. 9, lines 60-61). Figure 17 shows that the TEM module 266 is adjacent the fluid reservoir 258 and in thermal communication with the liquid flow path and the heat sink 270 is adjacent the TEM module 266 with the TEM module 266 being disposed between the fluid reservoir 258 and the heat sink 270. Harsy also teach that the device is adapted to deliver programmable set point temperatures for both heat therapy and cold therapy in one therapeutic session where various set point temperatures and time intervals are entered into the apparatus 34 (see col. 7, lines 14-23). Harsy is silent as to the body worn pad 254 having a stress-relief aperture on an edge of the bladder and another aperture surrounded on all sides by the bladder and configured to receive a joint of a user. However, Mongold teaches an orthopedic device in the form of a pocket 1 where the pocket 1 has a plurality of slots 4 (stress-relief apertures) on the edge of the pocket 1 and a center light 15 (an aperture surrounded on all sided by the pocket 1 and configured to receive the joint of the user (see Figs. 1-7 and the attached translation). Mongold thus demonstrates that providing an orthopedic device with stress-relief apertures on the edge and a central aperture to receive a joint is well known in the art for the purpose of properly conforming the device to the joint of a user for effective therapy. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the body worn pad 254 of Harsy with the stress-relief and central apertures, as disclosed by Mongold, in order to properly conform the device to the joint of a user for effective therapy. In regard to claims 6 and 10, Harsy teaches a variety of garments attached to the body that incorporate the body worn pad 254 and thus position the body worn pad 254 adjacent to a user’s body such as a knee brace (see Figs. 1-3). In regard to claim 13, see col. 9, lines 1-18 and col. 10, lines 1-20 of Harsy. Harsy is not specific as to the periodic cycle, duty cycle or phase of the TEM modules. However, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the controller of Harsy to operate the device such that the TEM modules are driven on a periodic cycle with less than 100% duty cycle and out of phase with respect to each other, as this type of programming is within the capabilities of a controller.
Claim(s) 7-9, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Mongold (FR 3134512) and further in view of Caruso et al. (U.S. Patent Application Publication No. 2021/0106459).
In regard to claims 7-9, 11 and 12, Harsy is silent as to a plurality of body pads 254, a winch to hold the body pad 254 against the user’s body, or forming the body pads 254 as a vest, ankle brace or head band/hat. It is noted, however, the Harsy does teach a variety of embodiments of the body pad 254, as is seen in Figures 1-3. Caruso et al. teach a similar thermal therapeutic device having various embodiments, such as a leg brace 162, a facial pad 163, a head-mounted display 164, an equine pad 166 (vest) and a canine pad 167 (either a vest or having more than one component -- see Figs. 1 and 14A-14C). Figures 1 and 14A-14C also show winches (straps) to hold the device on the user. Caruso et al. thus demonstrate that forming thermal therapeutic devices in different shapes for different body parts and using straps to hold the device against the body are well known in the art in order to provide effective therapy. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the body pad 254 of Harsy in a vest, ankle brace or head band/hat shape, provide attachment straps and provide more than one body pad, in the manner disclosed by Caruso et al. in order to provide effective therapy.
Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Mongold (FR 3134512) and further in view of Karasahin (U.S. Patent Application Publication No. 2017/0224520).
In regard to claims 14-20, Harsy is silent as to an array of needles on the body pad 254 for transdermal delivery of a material or to sample a fluid. However, Karasahin et al. teach a splint 361, for example, that is shaped to conform to different parts of the body (see Figs. 36-37). The splint 361 is provided with modular or embedded probes (effectors) and equipment strategically positioned to stimulate or deliver other therapies 363, 364 (see para. 0114). Karasahin also discloses that the splint 611 can provide heat or cold therapy (see Fig. 61 and paras. 0137-139). Karasahin also teaches incorporating a pre-installed needle 652 or microneedles for injection or infusion of pharmaceutical substances where a microcomputer controls the delivery of the pharmaceutical substance (see Fig. 65 and paras. 0140-142). This broad disclosure would incorporate the use of stem cell derivatives, blood plasma and fibrin as they are broadly pharmaceutical compositions. Karasahin thus demonstrates that thermal therapeutic devices for placement on the body having needles or microneedles to effectuate delivery of a pharmaceutical substance are well known in the art. Karasahin also teaches that use of sensors to sample or analyze various bodily outputs is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Harsy with the sensors and needles/microneedles of Karasahin in order to enhance the therapeutic capabilities of the device and provide the administration of pharmaceutical substances as well as sense biometric parameters. With further respect to claim 20, Karasahin discloses the use of various lotions, creams, ointments, liniments, liposomes, powders, pastes, gels, hydrogels, etc. that when used in conjunction with a microneedle array would result in the hydrogel being adjacent at least some of the needles (see para. 0140).
Claim(s) 21-25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Tian et al. (U.S. Patent Application Publication No. 2020/0289361).
In regard to claims 21, 23, 25 and 27, Harsy teaches a thermal therapeutic apparatus comprised of an enclosure 246 that houses a fluid reservoir 258, a pump 262, a thermo electric module (TEM) 266 a heat sink 270 and a fan 268 (see Fig. 17 and col. 12, lines 7-13). Collectively they constitute a liquid-to-ambient-air heat exchanger. A body worn pad 254 is coupled to the enclosure 246 via conduit hoses 252 which constitute a first conduit (inlet) and a second conduit (outlet) (see Fig. 17). Figure 17 shows that the body worn pad 254 is a conformable bladder defining a serpentine portion of a liquid flow path. A second portion enclosure 248 is coupled to the first enclosure 246 and houses a controller 274, a power supply 276 and a battery 282 (see Fig. 17 and col. 12, lines 15-22). Harsy teaches that the TEM module removes heat on cold plate manifold 264 via the Peltier effect (see Fig. 17 and col. 8, lines 61-65). Harsy also teaches employing four TEM modules (see col. 9, lines 3-9). Harsy also teaches that the heat sinks 128 are finned (see col. 9, lines 60-61). Figure 17 shows that the TEM module 266 is adjacent the fluid reservoir 258 and in thermal communication with the liquid flow path and the heat sink 270 is adjacent the TEM module 266 with the TEM module 266 being disposed between the fluid reservoir 258 and the heat sink 270. Harsy also teach that the device is adapted to deliver programmable set point temperatures for both heat therapy and cold therapy in one therapeutic session where various set point temperatures and time intervals are entered into the apparatus 34 (see col. 7, lines 14-23). Harsy is silent as to an actuator disposed on a side of the body worn pad 254 away from the user’s body where the actuator comprises at least one air bladder, a conduit placing the actuator in fluid communication with a compressor and a controller operatively coupled to the compressor. Harsy does teach a personal computing device 36 that is coupled via a cable 38 to the apparatus 34 where the computing device 36 provides instructions to the apparatus 34 (see col. 7, lines 11-29 and Fig. 4). However, Tian et al. teach an integrated cold therapy-compression assembly 10 having a treatment pad 16 that includes a bladder 46 that mounts to a user where the bladder 46 includes a compressant compartment 52 and a coolant compartment 54 (see Figs. 5 and 6 and para. 0049). The coolant compartment 54 is positioned immediately next to the user’s body and the compressant compartment 52 overlays the coolant compartment more distal from the user’s body (see para. 0051). The assembly 10 may be activated to selectively cycle the compressant into and out of the compressant compartment 52 (see para. 0051). A compressant in/out line 40 connects the treatment pad 16 to a compressant pump 80 in the reservoir lid 22 (see paras. 0044, 0047 and 0055 and Figs. 7-9). A compressant solenoid 88 powers the compressant pump 80 and the solenoid 88 is controlled by a printed circuit board (PCB) 104 (also housed in reservoir lid 22) that has a microprocessor (see para. 0055). Tian et al. thus demonstrate that it is well known in the art to provide a device that has both cooling and compression functions with actuator disposed on a side of the body worn pad away from the user’s body where the actuator comprises at least one air bladder, a conduit placing the actuator in fluid communication with a compressor and a controller operatively coupled to the compressor in the interest of providing integrated cold therapy-compression therapy (see para. 0042 of Tian et al.). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Harsy with the compressant compartment 52, compressant in/out line 40, compressor pump 80, solenoid 88 and PCB 104, in the manner disclosed by Tian et al., in order to provide integrated cold therapy-compression therapy. In regard to claim 22, see Fig. 5 of Tian et al. In regard to claim 24, see col. 9, lines 1-18 and col. 10, lines 1-20 of Harsy. Harsy is not specific as to the periodic cycle, duty cycle or phase of the TEM modules. However, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the controller of Harsy to operate the device such that the TEM modules are driven on a periodic cycle with less than 100% duty cycle and out of phase with respect to each other, as this type of programming is within the capabilities of a controller. With further respect to claim 25, Figure 2 of Tian et al. shows that the treatment pad 16 is arranged about an axis of rotation of a joint and teaches that when pressurized, the compression compartment 52 presses the coolant compartment 54 against the user’s body (see para. 0051) but yet the treatment pad 16 is pliable even when a treatment fluid resides in one or both of the fluid compartments 52, 54 (see para. 0050). With further respect to claim 27, Tian et al. teach retention straps 48 to bias the treatment pad 16 against the user’s body (see Fig. 2).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Tian et al. (U.S. Patent Application Publication No. 2020/0289361) and further in view of Caruso et al. (U.S. Patent Application Publication No. 2021/0106459).
In regard to claim 26, Harsy is silent as to forming the body pad 254 as an ankle brace. It is noted, however, the Harsy does teach a variety of embodiments of the body pad 254, as is seen in Figures 1-3. Caruso et al. teach a similar thermal therapeutic device having various embodiments, such as a leg brace 162, a facial pad 163, a head-mounted display 164, an equine pad 166 (vest) and a canine pad 167 (either a vest or having more than one component -- see Figs. 1 and 14A-14C). Caruso et al. thus demonstrate that forming thermal therapeutic devices in different shapes for different body parts is well known in the art in order to provide effective therapy. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to form the body pad 254 of Harsy in an ankle brace, in the manner disclosed by Caruso et al., in order to provide effective therapy.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harsy (U.S. Patent No. 7,959,657) in view of Tian et al. (U.S. Patent Application Publication No. 2020/0289361) in view of Gengrinovitch et al. (U.S. Patent Application Publication No. 2022/0331135).
In regard to claim 28, Harsy teaches that the device is adapted to deliver programmable set point temperatures for both heat therapy and cold therapy in one therapeutic session where various set point temperatures and time intervals are entered into the apparatus 34 (see col. 7, lines 14-23). Harsy also teaches a temperature sensor 317 within the pump 122 (see col. 1, lines 1-20). Gengrinovitch et al. teach a similar orthopedic brace having a temperature sensor 162 on the brace (see Fig. 2A). Gengrinovitch et al. thus demonstrate that having a temperature sensor on an orthopedic brace is well known in the art to provide a more accurate indication of the temperature inside the brace (see para. 0218). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the brace of Harsy with a temperature sensor on the brace, in the manner disclosed by Gengrinovitch et al., to provide a more accurate indication of the temperature inside the brace.
Allowable Subject Matter
Claims 2-4 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794