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 Status
Applicant’s amendments in the response filed on 7/01/2025 has been considered by the Examiner. Currently, claims 1, 3-14, and 16-26 are pending, claims 1 and 13 have been amended, and claims 2 and 15 are canceled. A complete action on the merits of claims 1, 3-14, and 16-26 follows below.
Information Disclosure Statement
The information disclosure (IDS) submitted on 7/01/2025 has been considered by the examiner.
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, 3-14, and 16-26 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.
Claims 1 and 13 recite the limitation “a second layer…with independent freedom of motion from the first layer” and “a third layer …with independent freedom of motion from the first layer and the second layer.” While Applicant has support for separate layers in the Specification [0041], it is silent about the layers having freedom of motion.
Therefore, the claimed subject matter was not described in the specification in such a way as to reasonably convey one of ordinary skill in the art that the inventor at the time the application was filed had possession of the claimed invention.
All claims not specifically mentioned above are necessarily rejected due to their dependency on a rejected 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, 3-14, and 16-26 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 pre-AIA the applicant regards as the invention.
Claims 1 and 13 recite the limitation “a second layer…with independent freedom of motion from the first layer” and “a third layer …with independent freedom of motion from the first layer and the second layer.” It is the position of the Examiner that it is unclear how the three separate layers can be stacked into the retention device and have independent freedom of motion from each other. Prior art has been applied below as best understood.
All claims not specifically mentioned above are necessarily rejected due to their dependency on a rejected 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, 3-10, 13-14, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Patz (Patent No. 5,800,490), in view of Limon (2018/0142924), D’Ambrosio (Pub. No. 2010/0312318), Paulson (Pub. No. 2017/0049614), Smith (Pub. No 2005/0075593) and in further view of Vergara (2018/0098903).
Regarding claim 1, Patz teaches a wearable personal cooling and heating system for placement at a body region of a user (A modular device with an injury pack holder is shown for providing cooling and/or heating therapy to an injury; [Abstract]), comprising:
a retention mechanism defining a lumen in a first configuration, the retention mechanism comprising (injury pack holder 10 having a generally tubular shape with first and second ends configured to receive a body part):
a first layer comprising a first material comprising a stretchable fabric, the first layer defining a set of apertures (outer shell 20 includes module openings 55a and 55b…An outer shell 20 is manufactured form a flexible material. The outer shell 20 can be manufactured from a variety of materials…the outer shell 20 can be made from Lycra or similar material or a combination of materials having similar properties Col 1 lines 32-38)
a second layer separate with independent freedom of motion from the first layer, the second layer comprising a second material different than the first material, the second layer disposed underneath the first layer (inner shell 22 is sewn to the inside of the outershell …it is the position of the Examiner that the shells are separate because they are sewn together and when unstitched they have independent freedom of motion); and
a third layer separate with independent freedom of motion from the first layer and the second layer, positioned directly in contact with the body region of the user (gel pack 95 is separate from the inner and outer shells), wherein the first, second, and third layers are arranged in a stacked configuration (outer shell 20, inner shell 22, and gel pack 95 are arrange in a stacked configuration because when the user inserts thermoelectric assembly 75 into the module opening 55a the thermoelectric assembly 75 protrudes from the outer shell 22 and the gel pack 95 is in contact with the injured area. This stretches a mesh 60 that is between the third layer/gel pack and inner and outer shells; Col. 10 lines 54-60);
a temperature modulation subsystem (thermoelectric assembly 75) attached to the retention mechanism, the temperature modulation subsystem at least partially arranged through the aperture (module opening 55b), wherein in the first configuration each of the temperature modulation subsystem is arranged at a nonzero angle with respect to a central axis of the lumen (modular opening 55b is at a nonzero angle with the central axis of the tubular opening 15/16 that receives a body part), each of the plurality of temperature modulation subsystems comprising:
a thermoelectrical module (includes plate 80 and Peltier device 85);
a heat sink in direct contact with the thermoelectric module (the heat sink includes a radiator 120 having a radiator first surface 122 and a radiator second surface 124. Between the radiator first surface and second surface are a plurality of fins 127, Figs. 6, 8. The radiator second surface 124 is affixed to warm first surface 81 of first plate 80; Col. 6 lines 45-55);
a shield defining a shield cavity, wherein the shield encloses the heat sink within the shield cavity (The cover 140 is a four sided container with a partial top, an intake surface 141, with a plurality of holes through to promote the flow of air to the fan 110 and an intake opening 142 centrally located in the intake surface 141, FIGS. 9 & 10; Col. 9 lines 53-60);
a fan (fan 110; Col. 10 lines 15-20); and
a control module retrained by the retention mechanism, wherein the control module is communicatively coupled to the temperature modulation subsystem (control circuit 152 in electrical communication with battery pack 99; thermistor 104 is a strong function of the temperature of plate 88 and is part of a control circuit 152 which modulates the power applied to the Peltier device 85; Col. 8, lines 1-3) and wherein each of the temperature modulation subsystem is operable between a cooling mode and a heating mode by the control module (Col. 6 lines 16-25),
wherein the third layer extends past a footprint of the temperature modulation subsystem (Fig. 11 the gel pack extends past a perimeter of the thermoelectric module system col. 6 lines 61-67).
Patz is silent about specifically teaching the third layer disposed underneath the second layer and wherein the second layer is located between the first and third layer.
However, Limon teaches a device within the same field of invention (vest apparatus system with a cooling subsystem) comprising a first layer (Examiner interprets the first layer to be 122. Alternatively, the first layer can be interpreted to be the entirety of 118 and 122. These layers include an aperture to receive a TEM, Fig. 6 ), a second layer (inner layer 120 which is in direct contact with first layer 122, Fig. 6), a third layer (the entirety of coolant bladder 136 which includes cooling disbursement element 114 and element 124..bladder 136 is attached to inner layer 120 [0055]), wherein the third layer is underneath the second layer and wherein the second layer is located between , and in direct contact with, both the first and third layer (layer 120 is in direct contact with 122 and bladder 136, Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gel pack of Patz in view of Limon such that it extends underneath the second layer and the second layer is in direct contact with both the first and third layer since Limon provides the TEM module may be in heat transferring communication between the cooling disbursement element and the heat dissipation element [0055] and it is well known when the cooling disbursement element or coolant bladder extends to a length such that it is underneath the second layer, it would provide for an increased surface area for heat transfer.
Patz does not teach a second material different than the first material; the second material comprises silicone.
However, D’Ambrosio teaches a device within the same field of invention (thermal therapy device comprising a thermoelectric module) wherein a layer of the thermal therapy device comprises silicone material [0046].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the second layer in Patz such that they are different and the second material comprises silicone in view of D’Ambrosio since it would allow for a more conformal contact with the body and improves heat transport.
Patz is silent about specifically teaching the third layer comprising a third material different than the first material and the second material, the third material comprising a thermally-conductive fabric.
However, Paulson teaches a device within the same field of invention (thermal therapy) wherein its gel pack comprises thermally conductive layer ([0042] The gel pack 40 is preferably inserted within the fabric cover prior to engagement within the treatment cavity 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gel pack casing/third layer such that its material is different than the first and second layers and is a thermally conductive fabric since Paulson provides that it provides a more comfortable transmission of heat or cold than the plastic pouch defining the gel pack [0042].
Patz does not teach a plurality of temperature modulation subsystems at least partially arranged through the set of apertures and wherein the third layer extends past a footprint of each of the set of temperature modulation subsystems.
However, Smith teaches a device within the same field of invention (A self-contained heating and cooling orthopedic brace is described. The heating and cooling elements in the pad typically utilized the Peltier effect; [Abstract]) comprising a plurality of temperature modulation subsystems ([0059] brace 100 includes pockets 120 and the pads 200 are located within the pockets).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a plurality of temperature modulation subsystems and to further modify the apertures in Patz such that the plurality of temperature modulation subsystems are arranged through the set of apertures in order to treat above and below the knee.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third layer in Patz such that it extends past the footprint of each of the set of temperature modulation subsystems for the purposes of uniformly delivering therapy to the treatment area.
Patz does not teach a thermally conductive interference layer arranged between the thermoelectrical module and the second layer.
However, Vergara teaches a substrate cover having a high thermal conductance attached to one or more TECs [0051].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a thermally conductive interface layer arranged between the thermoelectrical module and the second layer since Vergara provides for high thermal conductance and therefore, would deliver therapy more effectively to the treatment area in Patz.
Regarding claim 3, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz teaches wherein each of the plurality of temperature modulation subsystems is attached to the second layer (the second layer 22 indirectly attaches to the temperature modulation subsystem by receiving the temperature modulation subsystem and further securing the temperature modulation subsystems to the device via strap attachments 65.
Regarding claim 4, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz provides that the first layer includes a 2-way stretch fabric, but is silent about specifically teaching the first layer comprising a 4-way stretch fabric and the third layer comprises a 2-way stretch fabric.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first layer and the third layer such that it comprises a 4-way fabric and 2 –way fabric respectively since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, Patz in view of Limon, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz provides for a thermoelectrical module but is silent about specifically teaching the thermoelectrical module comprises a TEC1-12702 thermoelectric module.
It is the position of the Examiner that it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide for a TEC1-12702 thermoelectrical module since it is well known and widely used in the art of thermoelectric modules for thermal therapy purposes, and providing thermal therapy with a TEC1-12702 thermoelectrical module would be within the level of ordinary skill in the art.
Regarding claim 6, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Vergara provides wherein the thermally conductive layer comprises a graphite sheet ([0051]).
Regarding claim 7, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz teaches wherein the retention mechanism further comprises a rigid base layered underneath each of the set of thermally conductive interface layers (plate 88).
Regarding claim 8, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz teaches the rigid base comprises a copper plate (col. 6 line 67), but does not teach aluminum. However, Vergara provides aluminum can be used in a thermoelectric device [0051].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rigid copper base in Patz so that it is aluminum since Vergara teaches it provides for high thermal conductance.
Regarding claim 9, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz teaches wherein the control module is configured to modulate the temperature modulation subsystem between the cooling mode and the heating mode according to a predetermined pattern (heat/cool switch 102 and temperature adjustment dial 103 mounted to the battery housing 105; Col 9 lines 34-40).
Regarding claim 10, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 9 as previously rejected above. Patz teaches wherein the predetermined pattern is selected by the user at a client application executing on a mobile device in communication with the control module (a user can access the temperature adjustment dial 103 on the battery housing).
Regarding claim 23, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 1 as previously rejected above. Patz teaches wherein the thermoelectrical module is in thermal contact with the third layer (the TEM is in thermal contact with the gel pack; Col. 7 lines 10-12).
Regarding claim 13, Patz teaches a wearable personal cooling and heating system for placement at a body region of a user (A modular device with an injury pack holder is shown for providing cooling and/or heating therapy to an injury; [Abstract]), comprising:
a retention mechanism defining a lumen in a first configuration, the retention mechanism comprising (injury pack holder 10 having a generally tubular shape with first and second ends configured to receive a body part):
a first layer comprising a first material comprising a stretchable fabric, the first layer defining a set of apertures (outer shell 20 includes module openings 55a and 55b… An outer shell 20 is manufactured form a flexible material. The outer shell 20 can be manufactured from a variety of materials…the outer shell 20 can be made from Lycra or similar material or a combination of materials having similar properties Col 1 lines 32-38)
a second layer separate with independent freedom of motion from the first layer, the second layer comprising a second material different than the first material, the second layer disposed underneath the first layer (inner shell 22 is sewn to the inside of the outershell …it is the position of the Examiner that the shells are separate because they are sewn together and when unstitched they have independent freedom of motion); and
a third layer separate with independent freedom of motion from the first layer and the second layer, positioned directly in contact with the body region of the user (gel pack 95 is separate from the inner and outer shells), wherein the first, second, and third layers are arranged in a stacked configuration (outer shell 20, inner shell 22, and gel pack 95 are arrange in a stacked configuration because when the user inserts thermoelectric assembly 75 into the module opening 55a the thermoelectric assembly 75 protrudes from the outer shell 22 and the gel pack 95 is in contact with the injured area. This stretches a mesh 60 that is between the third layer/gel pack and inner and outer shells; Col. 10 lines 54-60);
a temperature modulation subsystem (thermoelectric assembly 75) attached to the retention mechanism, the temperature modulation subsystem at least partially arranged through the aperture (module opening 55b), wherein in the first configuration each of the temperature modulation subsystem is arranged at a nonzero angle with respect to a central axis of the lumen (modular opening 55b is at a nonzero angle with the central axis of the tubular opening 15/16 that receives a body part), each of the plurality of temperature modulation subsystems comprising:
a thermoelectrical module (includes plate 80 and Peltier device 85);
a heat sink in direct contact with the thermoelectric module (the heat sink includes a radiator 120 having a radiator first surface 122 and a radiator second surface 124. Between the radiator first surface and second surface are a plurality of fins 127, Figs. 6, 8. The radiator second surface 124 is affixed to warm first surface 81 of first plate 80; Col. 6 lines 45-55);
a control module retrain by the retention mechanism, wherein the control module is communicatively coupled to the temperature modulation subsystem (control circuit 152 in electrical communication with battery pack 99; thermistor 104 is a strong function of the temperature of plate 88 and is part of a control circuit 152 which modulates the power applied to the Peltier device 85; Col. 8, lines 1-3) and wherein each of the temperature modulation subsystem is operable between a cooling mode and a heating mode by the control module (Col. 6 lines 16-25).
Patz is silent about specifically teaching the third layer disposed underneath the second layer and wherein the second layer is located between, and in direct contact with , both the first and third layer.
However, Limon teaches a device within the same field of invention (vest apparatus system with a cooling subsystem) comprising a first layer (Examiner interprets the first layer to be 122. Alternatively, the first layer can be interpreted to be the entirety of 118 and 122. These layers include an aperture to receive a TEM, Fig. 6 ), a second layer (inner layer 120 which is in direct contact with first layer 122, Fig. 6), a third layer (the entirety of coolant bladder 136 which includes cooling disbursement element 114 and element 124..bladder 136 is attached to inner layer 120 [0055]), wherein the third layer is underneath the second layer and wherein the second layer is located between , and in direct contact with, both the first and third layer (layer 120 is in direct contact with 122 and bladder 136, Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gel pack of Patz in view of Limon such that it extends underneath the second layer and the second layer is in direct contact with both the first and third layer since Limon provides the TEM module may be in heat transferring communication between the cooling disbursement element and the heat dissipation element [0055] and it is well known when the cooling disbursement element or coolant bladder extends to a length such that it is underneath the second layer, it would provide for an increased surface area for heat transfer.
Patz does not teach a second material different than the first material; the second material comprises silicone.
However, D’Ambrosio teaches a device within the same field of invention (thermal therapy device comprising a thermoelectric module) wherein a layer of the thermal therapy device comprises silicone material [0046].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the second layer in Patz such that they are different and the second material comprises silicone in view of D’Ambrosio since it would allow for a more conformal contact with the body and improves heat transport.
Patz is silent about specifically teaching the third layer comprising a third material different than the first material and the second material, the third material comprising a thermally-conductive fabric.
However, Paulson teaches a device within the same field of invention (thermal therapy) wherein its gel pack comprises thermally conductive layer ([0042] The gel pack 40 is preferably inserted within the fabric cover prior to engagement within the treatment cavity 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gel pack casing/third layer such that its material is different than the first and second layers and is a thermally conductive fabric since Paulson provides that it provides a more comfortable transmission of heat or cold than the plastic pouch defining the gel pack [0042].
Patz does not teach a plurality of temperature modulation subsystems at least partially arranged through the set of apertures and wherein the third layer extends past a footprint of each of the set of temperature modulation subsystems.
However, Smith teaches a device within the same field of invention (A self-contained heating and cooling orthopedic brace is described. The heating and cooling elements in the pad typically utilized the Peltier effect; [Abstract]) comprising a plurality of temperature modulation subsystems ([0059] brace 100 includes pockets 120 and the pads 200 are located within the pockets ).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a plurality of temperature modulation subsystem and to further modify the apertures in Patz such that the plurality of temperature modulation subsystems are arranged through the set of apertures in order to treat above and below the knee.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the third layer in Patz such that it extends past the footprint of each of the set of temperature modulation subsystems for the purposes of uniformly delivering therapy to the treatment area.
Patz does not teach a thermally conductive interference layer arranged between the thermoelectrical module and the second layer.
However, Vergara teaches a substrate cover having a high thermal conductance attached to one or more TECs [0051].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a thermally conductive interface layer arranged between the thermoelectrical module and the second layer since Vergara provides it provides for high thermal conductance and therefore, would deliver therapy more effectively to the treatment area in Patz.
Regarding claim 14, Patz in view of Limon, D’Ambrosio, Paulson, Smith and in further view of Vergara teaches the limitations of claim 13. Patz teaches wherein the third layer extends past a footprint of the temperature modulation subsystem (Fig. 11 the gel pack extends past a perimeter of the thermoelectric module system col. 6 lines 61-67).
Claim 16 recites the same limitations of claim 3 as previously rejected above.
Claim 17 recites the same limitations of claim 4 as previously rejected above.
Claim 18 recites the same limitations of claim 6 as previously rejected above.
Claim 19 recites the same limitations of claim 7 as previously rejected above.
Claim 20 recites the same limitations of claim 8 as previously rejected above.
Claim 21-22 recites the same limitations of claim 9-10 previously rejected above.
Claim 24 recites the same limitations of claim 23 as previously rejected above.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Patz (Patent No. 5,800,490) in view of Limon (2018/0142924) , D’Ambrosio (Pub. No. 2010/0312318), Paulson (Pub. No. 2017/0049614), Smith (Pub. No 2005/0075593), Vergara (2018/0098903), and in further view of Smith (Pub. No 2015/0101788).
Regarding claim 11, Patz in view of Limon, D’Ambrosio, Paulson, Smith’593 and Vergara teaches the limitations of claim 1 as previously rejected above. Patz generally provides for a central aperture in which other apertures are arranged around the central aperture (55a and 55c surround central aperture 55b). Smith ‘593 provides for a central aperture (106) in which thermoelectrical modules within apertures are arranged around the central aperture.
The combination does not teach the apertures are circumferentially arranged around the central apertures.
However, Smith '788 teaches a device within the same field of invention (The present disclosure relates to a device that includes one or more thermoelectric materials, or other suitable thermal adjustment apparatus (es), placed near a surface, such as the skin of a user; [0027]) wherein the device may include 2 or more, 3 or more, 4 or more, 5 or more, 10 or more, etc. such thermoelectric materials; 110A-D, Fig. 2. The thermoelectric materials may be arranged in any appropriate pattern along the surface of the device, for example, aligned along a row, arranged in a grid-like formation, positioned in an irregular pattern, arranged to form a particular shape (e.g., ellipse, circular, quadrilateral, hexagonal, etc.), or may be configured in another appropriate way; [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to provide for a plurality of temperature modulation subsystems to generate thermal pulses in a suitable manner as taught by Smith ‘593 and depending on a user’s needs as taught by Patz.
Regarding claim 12, Patz in view of Limon, D’Ambrosio, Paulson, Smith’593, Vergara, and Smith ‘788 teaches the limitations of claim 11 as previously rejected above. The combination is silent about specifically teaching wherein the set of apertures comprises a pentagonal array.
However, Smith ‘593 teaches the array can comprise a hexagonal array and therefore, it would have been obvious to one of ordinary skill in the art to provide for pentagonal array or whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ. In the instant application Applicant has not disclosed any criticality for the claimed array shape of the plurality of temperature modulation subsystems.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Patz (Patent No. 5,800,490) , in view of Limon (2018/0142924) , D’Ambrosio (Pub. No. 2010/0312318), Paulson (Pub. No. 2017/0049614), Smith (Pub. No 2005/0075593), Vergara (2018/0098903), and in further view of Williams (5,415,624).
Regarding claim 25, Patz in view of Limon, D’Ambrosio, Paulson, Smith, and Vergara teaches the limitations of claim 1 as previously rejected above. While Patz provides the first layer is flexible (outer layer 20 made of Lycra), it does not specifically teach wherein the first layer comprises a 4-way stretch fabric.
However, Williams teaches a device within the same field of invention (thermal therapy) comprising a brace, the brace includes a typical elasticized material body portion construction… pocket material is a four-way stretch nylon (LYCRA) spandex or the like material (Col. 2 lines 25-27).
Therefore, it would have been obvious to one of ordinary skill in the art such that the flexible first layer Patz is a four way stretch fabric for the purposes of comfort and conformance (Col. 2 lines 25-27). In addition, it is well known in the art that Lycra can be a four way stretch fabric.
Claim 26 recites the same limitations of claim 25 as previously rejected above.
Response to Arguments
Applicant’s arguments filed on 7/01/2025 has been considered by the Examiner; however, they were not persuasive.
It is the position of the Examiner that the combination of references in the previous rejection discussed how the first, second , and third materials were different from each other. Applicant discusses a new limitation whereby the first layer compared to the second and the third layer compared to the first and second layers have “independent freedom of motion.” It is the position of the Examiner that there is no support for such limitation in the specification as discussed in the 112(a) rejection above and it is unclear how the three layers can be stacked in a retention mechanism while having freedom of motion with respect to each layer as discussed in the 112(b) rejection above.
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 YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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, Joanne M. Hoffman can be reached at (303) 297-4276. 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.
/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
Prosecution Insights