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 Amendment
The amendment to claim 1 in the response filed on 8/05/2026 is acknowledged.
Claims 1-11 remain pending in the application.
Response to Arguments
Although the amendment to claim 1 changes the scope of the claim such that the claim can be interpreted in a different light, the newly added recitation “the activating inducing a thermal grill illusion in the patient” fails to overcome the rejection of record of claim 1 over Popielarski in view of Chiurco. As such, Applicant's arguments filed on 08/05/2026 have been fully considered but they are not persuasive. Applicant argued that “Popielarski fails to disclose, teach, or even suggest that the applicator portion 3099 is configured to induce a thermal grill illusion in the patient wearing the wearable thermal modulation system 3000.” The Examiner disagrees with Applicant’s argument, because, in fact, Popielarski specifically discloses empirical data on thermal modulation in human subjects. In [0210], Popielarski discloses application of heat to human body in the range of 42 degrees C – 52 degrees C-- “[T]o demonstrate thermal nerve block in humans, wet-ice (0°C) was used with one embodiment of a thermal modulation system described herein that circulated heated or cooled distilled water through an occipital pad at about 2-12°C (cold) or about 42-52°C (hot). Each system was adjustable to 20 set-temperatures between these extremes of hot and cold. In some implementations, a commercially available heating pad (Theratherm™) was used to further increase the skin-contact pad temperature when needed. Thermal nerve block in difficult-to-treat adult subject population with severe headache, migraine with or without aura, or head and/or neck pain of any cause or diagnosis who have failed many other therapies including back fusion surgeries and implantable occipital stimulators was evaluated.” In their arguments, Applicants relied on [0042] of the instant specification that “[A]s described in the present application, "[the thermal grill illusion refers to a sensory illusion in which the interlacing of hot and cold elements causes a slightly painful sensation in a healthy subject without a noxious stimulus (i.e., the thermal grill illusion activates a region of the brain associated with noxious thermal stimuli to generate a pain sensation)." (Paragraph [0042]).” Further review of [0042] of the instant specification revealed that “The thermal grill illusion refers to a sensory illusion in which the interlacing of hot and cold elements causes a slightly painful sensation in a healthy subject without a noxious stimulus (i.e., the thermal grill illusion activates a region of the brain associated with noxious thermal stimuli to generate a pain sensation). In one or more embodiments, the thermal grill illusion can be achieved with very mild hot and cold temperatures, for example, in the range of approximately 50C to approximately 200C for the cooling elements 202 and in the range of approximately 38°C to approximately 50°C for the heating elements 203. In one embodiment, the thermal grill illusion can be achieved with temperatures in the range of approximately 15°C to approximately 20°C for the cooling elements 202 and approximately 38°C to approximately 440C for the heating elements 203. Throughout the present disclosure, the heating elements 203 are often described as hot, but in practice temperatures generated by the heating elements 203 would typically not exceed approximately 44C.” In that light, it appears that Popielarski’s therapeutic (heat and cold) treatments indeed induce a thermal grill illusion (thermal grill effect” since testing discussions in Popielarski, see [0205-0209] discuss warming to about 45 degrees C. Also, see claims 1 together with dependent claims 13-15, and method claims 27-30 where the temperature ranges are claimed. Moreover, [0230] specifically discussed maintaining nerve temperature below 45 degrees C, which makes the device configured to activate heating or cooling in the device (e.g. heating as high as 44.9 degrees C) and of course alternating between hot and cold too. Based on the above evidence it is the Examiner’s position that Popielarski discloses “the activating inducing a thermal grill illusion in the patient” as per the criteria set forth by Applicant’s own specification.
Therefore, the rejection of at least claim 1 over Popielarski in view of Chiurco still apply to the amended claim 1. Because claims 2-11 depend, either directly or indirectly, from independent claim 1, the rejections of claims 2-11 have been maintained as laid out below.
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 1-11 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 claim 1, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “thermal grill illusion” in claim 1 is used by the claim to mean “refers to a sensory illusion in which the interlacing of hot and cold elements causes a slightly painful sensation in a healthy subject without a noxious stimulus (i.e., the thermal grill illusion activates a region of the brain associated with noxious thermal stimuli to generate a pain sensation) [0042],” while the accepted meaning is “something that deceives by producing a false or misleading impression of reality; misapprehension; an instance of being deceived; a perception, as of visual stimuli optical illusion, that represents what is perceived in a way different from the way it is in reality.” (see dictionary.com). The term is indefinite because the specification does not clearly redefine the term. The way it is explained in the specification, it appears the illusion is involuntary which contradicts the accepted meaning of “illusion” which is a conscious perception by the subject. For purpose of compact prosecution, the Examiner is interpreting the term “thermal grill illusion” as –thermal grill effect--.
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 1-4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Popielarski WO 2021/127195 in view of Chiurco US 4860748.
Regarding claim 1, Popielarski discloses a method of treating a patient suffering from an over-active bladder or other urinary or bowel movement disorder (figs. 30A-34B, Popielarski discloses treatment of chronic disorders and diseases using cold/heat block of nerves [0055, 0057, 0186, 0188, 0192, 0229, 0230] and claim 46 were treatment of saphenous and tibial nerves are experimented and treated, tibial nerves are indirectly connected to the bowel and bladder and thermal stimulation of the tibial nerve are known to calm and reset the nerves controlling the bladder and the bowel), the method comprising placing at least one thermal device 3099, 3199, 3299 (of thermal applicators 3070,3170,3270) on an exterior portion of the patient's body proximate to the patient's saphenous [0075,0076,0077,0229] nerve and/or the patient's tibial nerve [0231] , see figs. 30A-34B, placed on ankle which includes the tibial and the saphenous nerves which are sensory nerves that originate in the thigh, run down the inner side of the knee, and continue along the shin to terminate around the inner side of the ankle and the arch of the foot), the at least one thermal device comprising device 3099, 3199, 3299 (of thermal applicators 3070,3170,3270) heating elements and cooling elements (Peltier and/or resistive thermal devices [0074,0077,0085,0116,0118,0121,0128,0144,0164,0185], and activating the heating elements and cooling elements (via TESS 110,3098) to stimulate the saphenous nerve and/or the tibial nerve to alleviate symptoms of the over- active bladder or the other urinary or bowel movement disorder (warming/cooling the tibial nerve will help calm and reset the bowels and bladder [0029,0231]), the activating inducing a thermal grill illusion in the patient (Popielarski discloses warming/cooling of the nerves to levels that induce a “thermal grill effect” and this is discussed in [0196-0123] on benefits of heating/cooling to specific temperature ranges and [0230] specifically discussed maintaining nerve temperature below 45 degrees C, which makes the device configured to activate heating or cooling in the device (e.g. heating as high as 44.9 degrees C since in [0042] ideal by Applicant is 44 degrees C, also See claims 1 together with dependent claims 13-15, and method claims 27-30 where the temperature ranges are claimed by Popielarski) and of course alternating between hot and cold).
Although Popielarski discloses the at least one thermal device and activating the at least one thermal device, Popielarski does not explicitly disclose the at least one thermal device comprising a plurality of heating elements and a plurality of cooling elements arranged in a thermal array, and activating the plurality of heating elements and the plurality of cooling elements.
Chiurco teaches an analogous method of placing at least one analogous thermal device 10,34 (figs. 4A-4B, col. 4, lines 10-42), on an exterior portion of a patient’s body (e.g. lower back) proximate to a patient’s saphenous nerve and/or a patient’s tibial nerve (if applied to the lower back, the tibial nerve originates in the lower back at L4-S3 and saphenous nerve originates in the lower back at L3-L4 so 34 is employed at the those locations as shown in figs. 4A-4B, also, the invention 10 can also be employed to relieve pain in other areas such as the heat, neck, joint, and the like—the ankle and the knee are both joints, col. 4, lines 10-68, and both tibial and saphenous nerves extend down to the knee, to the ankle, and to the feet), the at least one thermal device 34 comprising a plurality of heating elements 22A-22H and a plurality of cooling elements 22A-22H arranged in a thermal array (see figs. 4A-4B, each of 22A-22H can be made cold or hot depending on the sequence of heating and cooling pattern desired, col. 5, lines 27-65, in one configuration, 22A-22D may be cold and 22E-22H may be hot, see various sequences in col. 6, lines 1-60), and activating the plurality of heating elements 22A-22H and the plurality of cooling elements 22A-22H via 12,14, 16, 18,20,26A-26H (figs. 1, 2, 4C, col. 4, lines 10-68, col. 5, lines 1-64), for the purpose of producing providing a user with full control of selectively generating repeatable series of temperature change patterns or sequences on the skin to stimulate nerves so as to decrease pain and discomfort (col. 2, lines 36-40 et seq. col. 5, lines 1-11).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the at least one thermal device and the step of activating the heating and cooling elements in the method of treating a patient of Popielarski with the at least one thermal device 34 a plurality of heating elements and a plurality of cooling elements arranged in a thermal array, and activating the plurality of heating elements and the plurality of cooling elements as taught by Chiurco in order to have provided a method of treating a patient having an improved at least one thermal device that includes plurality of heating and cooling elements arranged in a thermal arrays such that activating the plurality of heating elements and the plurality of cooling elements provides a user with full control of selectively generating repeatable series of temperature change patterns or sequences on the skin to stimulate nerves so as to decrease pain and discomfort (Chiurco, col. 2, lines 36-40 et seq. col. 5, lines 1-11).
Regarding claim 2, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski further discloses the placing the at least one thermal device (thermal applicator) comprises wrapping the thermal device around at least a portion of the patient's calf (lower leg which includes the calf, [0146].
Regarding claim 3, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco further discloses the placing the at least one thermal device 34 comprises wrapping the thermal device around at least a portion of the patient's knee in that, since Chiurco teaches wrapping/employing the invention 10 to alleviate joint pain, it would have been obvious to one of ordinary skill in the art to have wrapped the thermal device around at least a portion of the patient’s knee which is a joint, in order to alleviate knee pain.
Regarding claim 3, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski further discloses the placing the at least one thermal device 3070,3099,3199,3299 comprises wrapping the thermal device around at least a portion of the patient's ankle (figs. 30A-34B).
Regarding claim 5, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski further discloses the placing the at least one thermal device 3070 comprises placing a first thermal device on the patient proximate to the saphenous nerve (fig. 30B, [0229]) and placing a second thermal device on the patient proximate to the tibial nerve (fig. 32A-32B, [0231]).
Regarding claim 6, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco further discloses the plurality of heating elements 22A-22H is a plurality of hot Peltier devices, and wherein the plurality of cooling elements 22A-22H is a plurality of cold Peltier devices (Peltier tiles that can be heated and cooled in different sequences), as taught by Chiurco (col. 4, lines 10-42).
Regarding claim 7, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski further discloses the heating elements is an electrical resistive heating element [0077], and Popielarski in view of Chiurco further discloses wherein the plurality of cooling elements is a plurality of cold Peltier devices (the Peltier tiles 22A-22H can selectively be used to cool if needed).
Therefore, in further view of Popelarski, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the plurality of heating elements of Popielarski in view of Chiurco to be or also include resistive heating elements while having a plurality of electrical resistive heating elements to be operated as cooling elements in order to allow conveyance by wired conduction of electrical energy and converted to thermal energy by resistive heaters that are thermally coupled to the thermal device in case a source of power is needed (as further taught by Popelarski, [0078,0116,0121]). Furthermore in regards to the recitation “plurality of resistive heating elements”, it would have been obvious to one skilled in the art to have duplicated the electrical resistive heating elements in order to have ensured supplying of electrical heat current to various areas within the thermal device since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). It also appears that Applicant has not placed any criticality on the plurality of heating elements (including that of resistive heating elements) since Applicant has also contemplated a single cooling element 202 and a single heating element 203 (page 11, line 16-20 in [0038]).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Popielarski WO 2021/127195 in view of Chiurco US 4860748 further in view of Moczygemba US 2017/0027053.
Regarding claim 8, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco do not disclose determining a temperature of at least one heating element of the plurality of heating elements; and automatically adjusting, based on the measured temperature, a current supplied to the plurality of heating elements to achieve a desired temperature.
Moczygemba teaches an analogous method that includes determining a temperature of at least one heating elements 401,402 via 477 (measuring the temperature of hot plates 210 and 220 [0039-0046] and automatically adjusting, based on measured temperature via 477, a current supplied to the plurality of heating elements to achieve a desired temperature via 490 [0047-0057] for the purpose of controlling the plurality of heating elements to provide individual control to provide heating at different zones of the at least one thermal device [0043-0044].
Therefore, it would have been obvious one of ordinary skill in the art at the time the invention was made to provide the method of treating a patient of Popielarski in view of Chiurco with the step of determining a temperature of at least one heating element of the plurality of heating elements; and automatically adjusting, based on the measured temperature, a current supplied to the plurality of heating elements to achieve a desired temperature as taught by Moczygemba in order to provide an improved method of treating a patient that allows controlling the plurality of heating elements to provide individual control to provide heating at different zones of the at least one thermal device (Moczygemba [0043-0044]).
Regarding claim 9, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco do not disclose determining a temperature of at least one cooling element of the plurality of cooling elements; and automatically adjusting, based on the measured temperature, a current supplied to the plurality of cooling elements to achieve a desired temperature.
Moczygemba teaches an analogous method that includes determining a temperature of at least one cooling elements 401,402 via 477 (measuring the temperature of hot plates 210 and 220 [0039-0046] and automatically adjusting, based on measured temperature via 477, a current supplied to the plurality of cooling elements to achieve a desired temperature via 490 [0047-0057] for the purpose of controlling the plurality of cooling elements to provide individual control to provide cooling at different zones of the at least one thermal device [0043-0044].
Therefore, it would have been obvious one of ordinary skill in the art at the time the invention was made to provide the method of treating a patient of Popielarski in view of Chiurco with the step of determining a temperature of at least one cooling element of the plurality of cooling elements; and automatically adjusting, based on the measured temperature, a current supplied to the plurality of cooling elements to achieve a desired temperature as taught by Moczygemba in order to provide an improved method of treating a patient that allows controlling the plurality of cooling elements to provide individual control to provide cooling or reduction of temperature at different zones of the at least one thermal device (Moczygemba [0043-0044]).
Regarding claim 10, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco does not expressly disclose periodically reversing a direction of a current applied to the plurality of hot Peltier devices and the plurality of cold Peltier devices, wherein the periodically reversing the direction of the current causes the plurality of hot Peltier devices to become cooling elements and causes the plurality of cold Peltier devices to become heating elements.
Moczygemba teaches periodically reversing a direction of a current applied to the plurality of hot Peltier devices and the plurality of cold Peltier devices (polarity of the current from power source 490 can be switched), wherein the periodically reversing the direction of the current causes the plurality of hot Peltier devices 210 to become cooling elements [0043] and causes the plurality of cold Peltier 220 devices to become heating elements 210 [0043], in order to provide independent control of zones when a user selectively wants to warm an area while simultaneously wanting to cool another area of the body [0043].
Therefore, it would have been obvious one of ordinary skill in the art at the time the invention was made to provide the method of treating a patient of Popielarski in view of Chiurco with the step of periodically reversing a direction of a current applied to the plurality of hot Peltier devices and the plurality of cold Peltier devices, wherein the periodically reversing the direction of the current causes the plurality of hot Peltier devices to become cooling elements and causes the plurality of cold Peltier devices to become heating elements as taught by Moczygemba to provide an improved method of treating a patient by providing independent control of zones when a user selectively wants to warm an area while simultaneously wanting to cool another area of the body [0043].
Regarding claim 11, Popielarski in view of Chiurco discloses the invention as discussed above. Popielarski in view of Chiurco in view of Moczygemba further discloses a length of time between the periodically reversing of the direction of the current to the plurality of hot Peltier devices and the plurality of cold Peltier devices (Moczygemba,[0050]), but does not expressly disclose the length of time is between approximately 15 seconds and approximately 10 minutes.
Chiruco further teaches switching between hot and cold for each Peltier tile with a delay of 30 to 60 seconds (col. 6, lines 7-64) allowing a length of time between temperature changes allowing the Peltier devices to be turned off so the thermal gradients are never reversed that often and for more than one minute as taught by Chiurco (col. 5, lines 45-51).
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.
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