DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s Amendment filed May 6, 2026 (hereinafter “05/06/26 Amendment") has been entered, and fully considered. In the 05/06/26 Amendment:
claims 1, 13, 20, 57, 59, 60, 91, 100, & 120 were amended;
claims 4, 43, 53, 61, 63, & 70 were cancelled (claims 2, 3, 5-12, 14-19, 21-22, 24-42, 44-52, 54-56, 62, 64-69, & 71-90, 92-94, 96-99, 101, 103-117, & 119 were previously cancelled); &
claims 121-124 were newly added.
Therefore, claims 1, 13, 20, 23, 57-60, 91, 95, 100, 102, 118, and 120-124 are now pending in the application.
3. The 05/06/26 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the Non-Final Office Action mailed 01/07/2026 (“01/07/26 Action”).
4. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 103
5. 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
I. INDEPENDENT CLAIM 1 (& DEPENDENT CLAIMS 13, 20, 23, 57-60, & 124)
7. Claims 1, 13, 20, 23, 57-60, & 124 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2012/0238901 to Augustine (“Augustine”) in view of U.S. 2021/0236326 to Nardo et al. ("Nardo"), and further in view of U.S. 2018/0184908 to Meyerson et al. ("Meyerson") & U.S. 2023/0000667 to Patton et al. (“Patton”).
8. Regarding claim 1, Augustine teaches a method for regulating a core body temperature of a living subject [e.g., ¶[0076]], the method comprising:
removably coupling a first flexible heat exchange pad [sensor (100) including heater (104) - ¶[0049] (“The heater 104 may be made from electrically conductive metal foil, electrically conductive fabric, electrically conductive film, electrically conductive ink, electrically conductive wire or any other suitable low thermal mass heater construction. The heater 104, in certain embodiments of the invention, is flexible so that it can conform to the contours of the body surface”); see also ¶[0050]] to a skin surface… of the living subject [patient’s skin (103) - ¶[0048]] via a flexible adhesive composite laminate [adhesive layer (208) - see ¶[0068] (“an adhesive layer 208 may be made of a thin plastic film with "double-faced" adhesive, so that one face adheres to the skin and the other face adheres to the core temperature sensor 100. This can be a single piece of film with adhesive applied to both sides”)];
***
wherein the first… flexible heat exchange [pad] [(100)] [comprises]:
a first surface [lower/bottom surface facing skin] and a second surface [surface away from skin] disposed opposite one another [¶’s [0052], [0054]], wherein the first surface [lower/bottom surface] faces toward the skin surface [(103)], and wherein the second surface [surface away from skin] faces away from the skin surface [(103)];
a flexible heater [heater (104)] defining the first surface and configured for generating heat [¶[0049]];
a flexible thermally-insulative layer defining the second surface [layer (110)] and configured for inhibiting heat transfer from the second surface [¶’s [0054]-[0055]];
***
a plurality of feedback control temperature sensors [at least one temperature sensor (102) - ¶[0048] (interpreted as one or more); see also ¶[0111] describing a second sensor] disposed between the flexible heater [(104)] and the flexible thermally-insulative layer [(110)] [e.g., FIG. 3C];
removably coupling the first flexible heat exchange pad [(100)] to… a control module [controller (114) - ¶[0057]; FIG. 9] via a first cable [connector wiring (112) - ¶[0057]] extending between… the control module [(114)] and… the first flexible heat exchange pad [(100)];
***
applying heat via the first… flexible heat exchange [pad] [(100)] to the… skin [surface] and underlying [tissue] of the living subject while the first… flexible heat exchange [pad] [is] coupled to the… skin [surface] via the flexible adhesive composite laminate such that the applied heat regulates the core body temperature of the living subject [e.g., ¶’s [0021], [0062], [0075], [0076], [0079]].
A. MULTIPLE EXCHANGE PADS & CONNECTORS
Augustine does not explicitly teach the use of multiple flexible heat exchange pads, nor does Augustine teach the use of mating connectors to facilitate communication between the control module and the pad. As such, Augustine does not teach the following emphasized claim limitations:
removably coupling a second flexible heat exchange pad to a skin surface… of the living subject via a flexible adhesive composite laminate,
removably coupling the first flexible heat exchange pad to a first mating connector of a control module via a first cable extending between the first mating connector of the control module [(114)] and… the first flexible heat exchange pad [(100)];
removably coupling the second flexible heat exchange pad to a second mating connector of the control module via a second cable extending between the second mating connector of the control module and… the second flexible heat exchange pad;
applying heat via the first and second flexible heat exchange pads to the corresponding skin surfaces and underlying tissues of the living subject while the first and second flexible heat exchange pads are coupled to the corresponding skin surfaces via the flexible adhesive composite laminate such that the applied heat regulates the core body temperature of the living subject.
Nardo, in a similar field of endeavor, teaches a patient warming system comprising a control unit coupled to one or more warming devices [Abstract], and is concerned with the problems associated with, e.g., surgical patients that undergo surgery and require anesthesia, as they may be unable to regulate their core body temperature [e.g., ¶[0002]].
More particularly, Nardo teaches a modular patient warming system (100) comprising a control unit (200) electrically coupled to multiple warming devices (e.g., 300, 400, 500, 600) controllable by the control unit (200) to provide conductive heat transfer from the warming devices to the patient [e.g., ¶’s [0093], [0095] (“The patient warming system 100 is modular in that any one of (or combination of) the warming devices may be coupled to the control unit 200”); and ¶[0096] (“The control unit 200 may support individual and/or concurrent operation of multiple warming devices… concurrent operation may be performed with the coupled warming devices being controlled independently of one another. Adding, removing, or swapping a warming device may have no impact on the control of other warming devices”); FIG. 1].
Nardo further teaches the use of conventional wired connections between a control unit (200) and the various warming devices operably connected thereto [e.g., ¶[0112] (“The control unit 200 may further include one or more input/output (I/O) interface(s) 222. The I/O interface(s) 222 may be in the form of one or more electrical connectors and may connect the control unit 200 to one or more warming devices (e.g., underbody pad 300, over-body blanket 400, headrest 500, and/or under-body blanket 600). In some embodiments, the one or more electrical connectors include one or more universal sockets that can each be used to mate with a plug (connector) of any of the warming devices of the patient warming system 100”); FIG. 1].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Augustine to include at least a second flexible heat exchange pad to be removably coupled to a skin surface, since the use of multiple heat exchange pads would allow for scalability (including varied placement) based on, e.g., patient size, as well as desired clinical objectives and applications to ensure that a patient’s core body temperature is properly maintained. As modified to include at least a second flexible heat exchange pad, Augustine would be used to apply heat via the first and second flexible heat exchange pads to the corresponding skin surfaces and underlying tissues of the living subject while the first and second flexible heat exchange pads are coupled to the corresponding skin surfaces via the flexible adhesive composite laminate such that the applied heat regulates the core body temperature of the living subject.
Further, the use of the conventional mating connectors to facilitate communication between the control module and the pads would have likewise been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [the removable coupling of individual heat exchange pads to a control module] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. ELECTRONICS MODULE
The combination of Augustine and Nardo (as set forth above) does not explicitly teach that each pad includes an “electronics module.” As such, the combination of Augustine and Nardo does not explicitly teach the following emphasized claim limitations:
wherein the first and second flexible heat exchange pads each comprise:
an electronics module in operable communication with the flexible heater;
removably coupling the first flexible heat exchange pad to a first mating connector of a control module via a first cable extending between the first mating connector of the control module [(114)] and the electronics module of the first flexible heat exchange pad [(100)];
removably coupling the second flexible heat exchange pad to a second mating connector of the control module via a second cable extending between the second mating connector of the control module and the electronics module of the second flexible heat exchange pad;
Meyerson, in a similar field of endeavor, teaches a system comprising one or more wearable patches for core temperature determination [e.g., Abstract; ¶’s [0032]-[0033]]. More particularly, Meyerson teaches that each patch may comprise one or more sensors (18) [¶[0048]], that one or more of the sensors (18) may comprise a thermocouple, a thermistor, a thermometer, a resistance temperature detector (RTD), and/or any other like device useful in measuring temperature [¶[0049]], and that the various sensors (18) of the patch may be disposed at any location on or within the patch convenient for assisting in determining one or more temperatures of the patch, the skin surface on which the patch is disposed, and/or of an ambient environment in which the patch is being used [¶[0050]].
Meyerson further teaches that each patch (12) may include an electronics module [e.g., ¶[0040] (“Additionally, the patch 12 may include one or more transponders, transceivers, or other components configured to receive signals, power, or information from a remote source, such as a remote controller 20 or the like. Such components of the patch 12 may also include one or more devices configured to transmit signals, data, and/or other information to remote receivers… Further, although not shown in FIG. 1, it is understood that example patches 12 may also include one or more USB ports, communication terminals, or other like components configured to facilitate connecting the patch 12 to one or more computers, controllers 20, user interfaces 16, monitors, servers, routers, or other like monitoring devices via one or more cables, wires, leads, or other like connection devices”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine and Nardo such that each flexible heat exchange pad includes an electronics module in operable communication with the flexible heater, since such a modification would provide the benefit/advantage of enabling the sharing of signals, data, and/or other information relevant to treatment to other devices [e.g, remote patient devices (a smartphone, etc.)] in addition to transmissions to/from the control module.
C. HAND & FOOT
Finally, while Augustine teaches that the flexible heat exchange pad may be placed at various locations on a subject’s body [e.g., ¶’s [0079], [0080]], and Meyerson teaches that the patches may be removably attached to any skin surface of the subject to determine a core temperature of the subject [e.g., ¶’s [0034], [0057]], the combination of Augustine, Nardo, & Meyerson does not explicitly teach the following emphasized claim limitations:
removably coupling a first flexible heat exchange pad to a skin surface of a hand of the living subject via a flexible adhesive composite laminate; [and]
removably coupling a second flexible heat exchange pad to a skin surface of a foot of the living subject via a flexible adhesive composite laminate.
Patton, in a similar field of endeavor, relates to systems, devices, and methods for transferring heat via heating pads with shapes, profiles, conductive tracing patterns, and/or other parameters that facilitate efficient heat transfer [e.g., ¶[0004]].
Patton teaches that it was known that perioperative heat loss can occur predominantly via convective heat transfer, particularly through the palms of the hands, & soles of the feet [see ¶[0037]].
Accordingly, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, & Meyerson to place flexible heat exchange pads at the known locations [hands/feet] where perioperative heat loss is most likely to occur, since such a modification would provide an art-recognized effective location for both measuring, and applying heat to maintain, core body temperature.
9. Regarding claim 13, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein the first flexible heat exchange pad is coupled to the living subject solely by the flexible adhesive composite laminate such that no mechanical pressure is applied to the skin surface or the underlying tissue through the first flexible heat exchange pad [see ¶[0068]; Examiner notes that use of adhesive alone imparts no “mechanical pressure”; note also ¶[0080] which describes use of a strap (which would impart “mechanical” (physical) pressure) vs. adhesive; as well as ¶[0109] which describes inclusion of an additional piece (ring (206) needed to impart mechanical pressure against the skin].
10. Regarding claim 20, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein removably coupling the first flexible heat exchange pad to the skin surface of the living subject via the flexible adhesive composite laminate comprises conforming the flexible adhesive composite laminate and the first flexible heat exchange pad to a contour of the skin surface [e.g., ¶[0049]].
11. Regarding claim 23, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 23 further requires the limitation “wherein the living subject is under general anesthesia.”
Nardo further teaches that it is commonly established that patients undergoing surgery and under the influence of anesthesia are unable to regulate their core body temperature [see ¶[0002] (“Patient warming systems are used in various medical applications. For example, surgical patients that undergo surgery and require anesthesia may be warmed using a warming system, as they may be unable to regulate their core body temperature. The patients may be subject to detrimental heat loss if their core body temperature is not able to be maintained”)].
Given Augustine’s concern with regulating core body temperature, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, Meyerson, & Patton such that the device is used in known instances where the ability to regulate core body temperature is diminished or compromised, including, e.g., wherein the living subject is under general anesthesia, since such a particular known warming technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Nardo), and one of ordinary skill in the art would have been capable of applying this known warming technique to the known method of Augustine, Nardo, Meyerson, & Patton, and the results [warming a subject under general anesthesia to maintain core body temperature and avoid hypothermia] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
12. Regarding claim 57, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches controlling, via the control module [controller (114) - ¶[0057]], the heat applied via the first flexible heat exchange pad based on feedback from a plurality of temperature sensors [e.g., ¶’s [0057], [0076], [0111]].
Augustine was modified above (in the rejection of claim 1) to include multiple flexible heat exchange pads, as taught by Nardo. As such, as modified, the control module of Augustine would be used to control the heat applied via both the connected first and second flexible heat exchange pads to the skin surface of the hand and foot, respectively, and the underlying tissue of the living subject based at least in part on the plurality of temperature values.
13. Regarding claim 58, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 57 for the reasons set forth in detail (above) in the Office Action.
Meyerson further teaches that it was known to utilize multiple temperature sensors when determining core body temperature, including determining, via temperature sensors, a plurality of temperature values [¶’s [0037], [0059]], and determining via a first feedback control temperature sensor, a first temperature value, and determining, via a second feedback control temperature sensor, a second temperature value [¶’s [0037], [0054], [0059]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, Meyerson, & Patton such that data/values from multiple temperature sensors be used to determine core body temperature and control the controller [controller (114)] accordingly, or more particularly to include determining via a first feedback control temperature sensor, a first temperature value, and determining, via a second feedback control temperature sensor, a second temperature value, since the use of multiple sensor measurements would provide a more robust determination of core temperature, and also provide for redundancy in the event of a temperature sensor failure.
14. Regarding claim 59, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 58 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified (above) to include acquiring multiple temperature values.
Augustine further teaches comparing a measured temperature value against a predetermined maximum temperature setting and controlling, via the control module, the heat applied via the flexible heat exchange pad to the skin surface and the underlying tissue of the living subject based at least in part on the comparison [see, e.g., ¶[0062] (“The heater 104 continues to receive this power until the skin temperature sensor 102 senses a threshold temperature. The threshold temperature can be any desired temperature greater than core temperature. In some embodiments, the threshold temperature is 38° C., 40° C., 42° C., or other temperatures as discussed elsewhere herein. Once the skin temperature sensor 102 senses the threshold temperature, the controller 114 prompts the power source 116 to stop supplying power to the heater 104”)].
Nardo further teaches that it was known to use a highest temperature reported by any temperature sensor to control the heating element of a warming device [e.g., ¶[0148]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, Meyerson, & Patton to include determining a greater temperature value of the first temperature value and the second temperature value; comparing the greater temperature value and a predetermined maximum temperature setting; and controlling, via the control module, the heat applied via the first or second flexible heat exchange pad to the skin surface and the underlying tissue of the living subject based at least in part on a comparison of the greater temperature value and the predetermined maximum temperature setting, since, when measuring multiple temperature values, and when concerned with meeting/exceeding a predetermined temperature threshold as in Augustine, it would have been obvious (and logical) to utilize the highest (or greatest) measured temperature value for comparison against the predetermined temperature threshold to ensure that the threshold is not exceeded, since using a measured temperature value other than the highest/greatest measured temperature value would run the risk of exceeding the threshold.
15. Regarding claim 60, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 58 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified (above) to include acquiring multiple temperature values.
Augustine further teaches comparing a measured temperature value against a predetermined threshold and controlling, via the control module, the heat applied via the first or second flexible heat exchange pad to the skin surface and the underlying tissue of the living subject based at least in part on the comparison [see, e.g., ¶[0062] (“The heater 104 continues to receive this power until the skin temperature sensor 102 senses a threshold temperature. The threshold temperature can be any desired temperature greater than core temperature. In some embodiments, the threshold temperature is 38° C., 40° C., 42° C., or other temperatures as discussed elsewhere herein. Once the skin temperature sensor 102 senses the threshold temperature, the controller 114 prompts the power source 116 to stop supplying power to the heater 104”)].
Meyerson further teaches using a differential between first and second temperature values when determining core body temperature [e.g., ¶[0054]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, Meyerson, & Patton to include determining a differential between the first temperature value and the second temperature value; comparing the differential and a predetermined threshold limit; and controlling, via the control module, the heat applied via the first or second flexible heat exchange pad to the skin surface and the underlying tissue of the living subject based at least in part on a comparison of the differential and the predetermined threshold limit, since such a particular known comparison technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Meyerson), and one of ordinary skill in the art would have been capable of applying this known comparison technique to the known method of Augustine, Nardo, Meyerson, & Patton, and the results [ensuring that threshold is not exceed] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
16. Regarding claim 124, the combination of Augustine, Nardo, Meyerson, & Patton teaches all of the limitations of claim 57 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 1) to include multiple flexible heat exchange pads, as taught by Nardo.
Nardo further teaches wherein controlling the heat applied via the first flexible heat exchange pad is separate and independent from controlling the heat applied via the second flexible heat exchange pad [see Nardo, ¶[0096] (“The control unit 200 may support individual and/or concurrent operation of multiple warming devices. In some embodiments, concurrent operation may be performed with the coupled warming devices being controlled based on one or more common parameters (e.g., set point, on time, off time, etc.). In other embodiments, concurrent operation may be performed with the coupled warming devices being controlled independently of one another. Adding, removing, or swapping a warming device may have no impact on the control of other warming devices”)].
II. INDEPENDENT CLAIM 91 (& DEPENDENT CLAIMS 95, 100, 102, 118, & 120-123)
17. Claims 91, 95, 100, 118, & 120-123 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of Nardo, and further in view of Meyerson.
18. Regarding claim 91, Augustine teaches a heat exchange assembly for regulating a core body temperature of a living subject [e.g., ¶[0076]], the heat exchange assembly comprising:
a… first flexible heat exchange pad [sensor (100) including heater (104) - ¶[0049] (“The heater 104 may be made from electrically conductive metal foil, electrically conductive fabric, electrically conductive film, electrically conductive ink, electrically conductive wire or any other suitable low thermal mass heater construction. The heater 104, in certain embodiments of the invention, is flexible so that it can conform to the contours of the body surface”); see also ¶[0050]] configured to couple to a foot of the living subject [NOTE: Augustine teaches that the flexible heat exchange pad may be placed at various locations on a subject’s body (e.g., ¶’s [0079], [0080]) and is therefore capable of being coupled to a foot]…,
[the first]… flexible heat exchange [pad] [(100)] comprising:
a flexible heater [heater (104)] defining a first surface [lower/bottom surface facing skin] of the flexible heat exchange pad and configured for generating heat [¶[0049]], wherein the first surface [lower/bottom surface] of the flexible heat exchange pad is configured for facing toward a skin surface of the living subject [patient’s skin (103) - ¶[0048]] when the flexible heat exchange pad is coupled to the skin surface [¶’s [0052], [0068]]…;
a flexible thermally-insulative layer [layer (110)] defining an opposite second surface [surface away from skin] of the flexible heat exchange pad and configured for inhibiting heat transfer from the second surface of the flexible heat exchange pad [¶’s [0054]-[0055]], wherein the second surface [surface away from skin] of the flexible heat exchange pad is configured for facing away from when the flexible heat exchange pad is coupled to the skin surface [(103)] [see ¶[0054] (“a relatively thick layer of thermal insulation 110 is located over the heater's 104 second surface, on the side away from the skin”)]; and
***
a flexible adhesive composite laminate configured for removably coupling the flexible heat exchange pad to the skin surface [adhesive layer (208) - see ¶[0068] (“an adhesive layer 208 may be made of a thin plastic film with "double-faced" adhesive, so that one face adheres to the skin and the other face adheres to the core temperature sensor 100. This can be a single piece of film with adhesive applied to both sides”)], the flexible adhesive composite laminate comprising:
a flexible substrate [thin plastic film - ¶[0068]] having a first surface [facing the skin] and a second surface [facing the sensor] disposed opposite one another;
a first adhesive disposed on the first surface [facing the skin] of the flexible substrate [thin plastic film] and configured for removably adhering to the skin surface [¶[0068]]; and
a second adhesive disposed on the second surface [facing the sensor] of the flexible substrate [thin plastic film] and configured for removably adhering to the flexible heat exchange pad [¶[0068]], wherein the second adhesive is different from the first adhesive [see ¶[0070] (“In certain embodiments, the adhesive layer 208 is optimized by utilizing a different adhesive formulation on each face. For example, the adhesive on the face contacting the patient's skin is optimized for secure bonding to skin, yet must be detachable from the skin without damaging fragile skin. Since the heater 104 may cause localized sweating, certain moisture-tolerant adhesives including but not limited to hydrocolloids or hydrogels, are preferable on the face attached to the skin. Other adhesives are anticipated for the skin attachment face. Conversely, the adhesive on the face attached to the skin temperature sensor 102 may be formulated to securely bond to plastic film and yet be detachable without leaving a sticky adhesive residue or damaging the film layer of the core temperature sensor 100 when it is removed”)]; and
a control module [controller (114) - ¶[0057]; FIG. 9] comprising a housing [FIG. 9],… and controlling the operation of [the] connected heat exchange pad [e.g., ¶’s [0057], [0062]],
wherein the first flexible heat exchange pad [(100)] is coupled to the control module [(114)] via the first cable [connector wiring (112) - ¶[0057]]…
A. SELF-REGULATING FLEXIBLE HEATER
While Augustine teaches that the heater (104) may comprise a variety of heating means [e.g., ¶’s [0049], [0050]], Augustine does not explicitly teach:
wherein the flexible heater has constitutive properties such that the flexible heater is self-regulating against heating above a predetermined temperature.
Nardo, in a similar field of endeavor, teaches a patient warming system comprising a control unit coupled to one or more warming devices [Abstract], and is concerned with the problems associated with, e.g., surgical patients that undergo surgery and require anesthesia, as they may be unable to regulate their core body temperature [e.g., ¶[0002]].
More particularly, Nardo teaches a modular patient warming system (100) comprising a control unit (200) electrically coupled to multiple warming devices (e.g., 300, 400, 500, 600) controllable by the control unit (200) to provide conductive heat transfer from the warming devices to the patient [e.g., ¶’s [0093], [0095] (“The patient warming system 100 is modular in that any one of (or combination of) the warming devices may be coupled to the control unit 200”); and ¶[0096] (“The control unit 200 may support individual and/or concurrent operation of multiple warming devices… concurrent operation may be performed with the coupled warming devices being controlled independently of one another. Adding, removing, or swapping a warming device may have no impact on the control of other warming devices”); FIG. 1].
Nardo additionally teaches that the heating elements used in the patient warming system may comprise self-regulating positive temperature coefficient (PTC) heating elements [e.g., ¶[0118], ¶[0120] (“The resistive layer 116 is formed adjacent the electrically conductive layer 106 and is formed of a positive thermal coefficient (PTC) material, such as a PTC ink. The PTC material may be printed over the electrically conductive layer 106. The PTC material has a higher electrical resistance than the electrically conductive layer 106. The PTC material may be produced to achieve a predetermined threshold temperature at which the heating element 102 is self-regulating”); ¶[0121] (“In operation, the self-regulating characteristic for the heating element 102 is provided by way of the PTC effect that occurs when the heating element 102 is heated”); and ¶[0122] (“The PTC material therefore provides the heating element with a “self-regulating” temperature effect to limit the heating element from reaching a temperature above a predetermined value. The self-regulating temperature effect also helps to improve the thermal uniformity of the heating element”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Augustine to utilize a known, art-recognized heater, such as the PTC heater of Nardo, or, more particularly, wherein the flexible heater has constitutive properties such that the flexible heater is self-regulating against heating above a predetermined temperature, since use of a PTC material having a self-regulating temperature effect helps to improve the thermal uniformity of the heating element, as explicitly taught by Nardo. Still further, such a modification amounts merely to the simple substitution of one known heater for another, yielding only predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. MULTIPLE EXCHANGE PADS, CONNECTORS, & USER INTERFACE
Augustine does not explicitly teach the use of multiple flexible heat exchange pads, nor does Augustine teach the use of mating connectors to facilitate communication between the control module and the pads. Augustine also fails to teach that the control module includes a user interface for programming, monitoring, and controlling the operation of each connected heat exchange pad. As such, Augustine additionally fails to teach the following emphasized claim limitations:
a plurality of flexible heat exchange pads, including a first flexible heat exchange pad configured to couple to a foot of the living subject and a second flexible heat exchange pad configured to couple to a hand of the living subject,
a control module comprising a housing, a user interface for programming, monitoring, and controlling the operation of each connected heat exchange pad, a plurality of mating connectors, and a plurality of cables, including a first cable and a second cable each couplable to the plurality of mating connectors,
wherein the first flexible heat exchange pad is coupled to the control module via the first cable coupled between… the first flexible heat exchange pad and a first mating connector of the plurality of mating connectors, and
wherein the second flexible heat exchange pad is coupled to the control module via the second cable coupled between… the second flexible heat exchange pad and a second mating connector of the plurality of mating connectors.
Nardo further teaches that modular patient warming system (100) comprises a control unit (200) electrically coupled to multiple warming devices (e.g., 300, 400, 500, 600) controllable by the control unit (200) to provide conductive heat transfer from the warming devices to the patient [e.g., ¶’s [0093], [0095] (“The patient warming system 100 is modular in that any one of (or combination of) the warming devices may be coupled to the control unit 200”); and ¶[0096] (“The control unit 200 may support individual and/or concurrent operation of multiple warming devices… concurrent operation may be performed with the coupled warming devices being controlled independently of one another. Adding, removing, or swapping a warming device may have no impact on the control of other warming devices”); FIG. 1].
Nardo additionally teaches that the control unit (200) includes a user interface for programming, monitoring, and controlling the operation of each connected heat exchange pad [¶’s [0099], [0100], [0116], [0132], & [0150]; FIG. 3].
Nardo further teaches the use of conventional wired connections between a control unit (200) and the various warming devices operably connected thereto [e.g., ¶[0112] (“The control unit 200 may further include one or more input/output (I/O) interface(s) 222. The I/O interface(s) 222 may be in the form of one or more electrical connectors and may connect the control unit 200 to one or more warming devices (e.g., underbody pad 300, over-body blanket 400, headrest 500, and/or under-body blanket 600). In some embodiments, the one or more electrical connectors include one or more universal sockets that can each be used to mate with a plug (connector) of any of the warming devices of the patient warming system 100”); FIG. 1].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine and Nardo to include at least a second flexible heat exchange pad configured to couple to a hand of the living subject [Augustine teaches that the flexible heat exchange pad may be placed at various locations on a subject’s body (e.g., ¶’s [0079], [0080]) and is therefore capable of being coupled to a hand], since the use of multiple heat exchange pads would allow for scalability (including varied placement) based on, e.g., patient size, as well as desired clinical objectives and applications to ensure that a patient’s core body temperature is properly maintained.
As modified to include multiple heat exchange pads, it would have likewise been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine and Nardo to include a user interface for programming, monitoring, and controlling the operation of each connected heat exchange pad, since such a modification would provide the benefit/advantage of enabling a user to control, from a single interface, each of the connected heat exchange pads as well as to receive information about each of the connected heat exchange pads, including, e.g., temperatures, alarms and other informational messages, as explicitly taught by Nardo, thereby facilitating the procedure for a practitioner by providing a centralized control.
Finally, the use of the conventional mating connectors to facilitate communication between the control module and the pads would have likewise been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [the removable coupling of individual heat exchange pads to a control module] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. ELECTRONICS MODULE
The combination of Augustine and Nardo (as set forth above) does not explicitly teach that each pad includes an “electronics module.” As such, the combination of Augustine and Nardo does not explicitly teach the following emphasized claim limitations:
each of the plurality of flexible heat exchange pads comprising:
an electronics module in operable communication with the flexible heater;
wherein the first flexible heat exchange pad is coupled to the control module via the first cable coupled between the electronics module of the first flexible heat exchange pad and a first mating connector of the plurality of mating connectors, and
wherein the second flexible heat exchange pad is coupled to the control module via the second cable coupled between the electronics module of the second flexible heat exchange pad and a second mating connector of the plurality of mating connectors.
Meyerson, in a similar field of endeavor, teaches a system comprising one or more wearable patches for core temperature determination [e.g., Abstract; ¶’s [0032]-[0033]]. More particularly, Meyerson teaches that each patch may comprise one or more sensors (18) [¶[0048]], that one or more of the sensors (18) may comprise a thermocouple, a thermistor, a thermometer, a resistance temperature detector (RTD), and/or any other like device useful in measuring temperature [¶[0049]], and that the various sensors (18) of the patch may be disposed at any location on or within the patch convenient for assisting in determining one or more temperatures of the patch, the skin surface on which the patch is disposed, and/or of an ambient environment in which the patch is being used [¶[0050]].
Meyerson further teaches that each patch (12) may include an electronics module [e.g., ¶[0040] (“Additionally, the patch 12 may include one or more transponders, transceivers, or other components configured to receive signals, power, or information from a remote source, such as a remote controller 20 or the like. Such components of the patch 12 may also include one or more devices configured to transmit signals, data, and/or other information to remote receivers… Further, although not shown in FIG. 1, it is understood that example patches 12 may also include one or more USB ports, communication terminals, or other like components configured to facilitate connecting the patch 12 to one or more computers, controllers 20, user interfaces 16, monitors, servers, routers, or other like monitoring devices via one or more cables, wires, leads, or other like connection devices”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine and Nardo such that each flexible heat exchange pad includes an electronics module in operable communication with the flexible heater, since such a modification would provide the benefit/advantage of enabling the sharing of signals, data, and/or other information relevant to treatment to other devices [e.g, remote patient devices (a smartphone, etc.)] in addition to transmissions to/from the control module.
19. Regarding claim 95, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 91) to utilize the PTC heater of Nardo.
Nardo further teaches wherein the flexible heater comprises:
a bus bar extending along a periphery of the flexible heater [either of buses (108, 110) - ¶[0119]; FIG. 4A]; and
a plurality of heating elements [fingers (112, 114)] extending inward from the bus bar [see ¶[0119] (“The electrically conductive layer 106 includes electrical buses 108, 110 spaced relative to each other, and fingers 112, 114 that extend from the respective bus 108, 110 toward the other bus. The arrangement of the busses 108, 110 and fingers 112, 114 is merely exemplary and other arrangements may be suitable”); FIG. 4A].
20. Regarding claim 100, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 91) to include multiple flexible heat exchange pads. As modified, Augustine further teaches wherein each of the plurality of flexible heat exchange pads further comprises a plurality of feedback control temperature sensors [e.g., ¶’s [0048], [0111]].
21. Regarding claim 118, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein the flexible adhesive composite laminate further comprises: a first cover removably covering the first adhesive and the first surface of the flexible substrate and configured for being removed therefrom prior to adhering the first adhesive to the skin surface; and a second cover removably covering the second adhesive and the second surface of the flexible substrate and configured for being removed therefrom prior to adhering the second adhesive to the flexible heat exchange pad [see ¶[0070] (“the adhesive faces may each be covered with removable liners to prevent inadvertent adhesion prior to use”)].
22. Regarding claim 120, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein the first flexible heat exchange pad [(100)] has a first footprint, and wherein the flexible adhesive composite laminate [(208)] has a second footprint that is equal to or less than the first footprint [“equal to” - as clearly shown in, e.g, FIG. 3B wherein the left/right edges of (100) & (208) are aligned].
23. Regarding claim 121, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 91) to include multiple flexible heat exchange pads, as well as the conventional cables/connectors of Nardo, as well as the electronics module of Meyerson.
As such, Augustine, as modified, further teaches a third flexible heat exchange pad configured to couple to a second foot or a second hand of the living subject, the third flexible heat exchange pad being coupled to the control module via a third cable coupled between the electronics module of the third flexible heat exchange pad and a third mating connector of the plurality of mating connectors [Augustine teaches that the flexible heat exchange pad may be placed at various locations on a subject’s body (e.g., ¶’s [0079], [0080]); as such, an additional flexible heat exchange pad would be capable of being coupled to a second foot or a second hand of the living subject].
24. Regarding claim 122, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 91) to include the user interface of Nardo. Nardo further teaches wherein the user interface is configured to receive inputs to selectively and independently control operation of the first or second heat exchange pad [e.g., ¶’s [0096], [0099], [0100], [0132], [0150], [0154]; FIG. 3].
25. Regarding claim 123, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 91 for the reasons set forth in detail (above) in the Office Action.
Nardo further teaches wherein the control module is coupled to and supported by a support structure having a mobile base [see ¶[0171] (“As described above, and with continued reference to FIG. 3, the control unit includes a housing 250. With additional reference to FIGS. 25 and 26, a support apparatus 900 may be attached to (or form a part of) the housing 250. The support apparatus may be configured to attach the housing to either of a vertical shaft (e.g., a support structure such as an IV pole) or a horizontal shaft (e.g., a support structure, bed rail, and the like). It will be understood that the support apparatus can be secured to other suitable support structures having a vertical and/or horizontal structure for attachment”); FIGS. 3, 25, 26].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, & Meyerson such that the control module is coupled to and supported by a support structure having a mobile base [e.g., an IV pole, a bed rail, etc.] since such a modification would provide the benefit/advantage of enabling the control module and attached flexible heat exchange pads to move with the patient as, for example, the patient’s bed is wheeled into an operating room (when attached to a bed rail), and/or to allow a patient to use the bathroom (when attached to an IV pole) without having to disconnect each of the pads from the control module, thereby facilitating use for both the patient and a provider [nurse, surgeon, etc.].
26. Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Augustine, Nardo, & Meyerson, as applied to claim 100 above, and further in view of U.S. 2014/0074086 to MacIntyre-Ellis al. ("MacIntyre-Ellis").
27. Regarding claim 102, the combination of Augustine, Nardo, & Meyerson teaches all of the limitations of claim 100 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches that at least one temperature sensor (102) is disposed between the flexible heater [(104)] and the flexible thermally-insulative layer [(110)] [e.g., FIG. 3C].
The combination of Augustine, Nardo, & Meyerson does not, however, teach:
wherein the feedback control temperature sensors are coupled to a sensor strip.
MacIntyre-Ellis, in a similar field of endeavor, teaches personal warming systems that aid in the maintenance of patient normal thermia during the Perioperative experience [e.g., ¶[0013]].
MacIntyre-Ellis further teaches that it was known to mount, e.g., RTD sensors utilized for temperature measurement, on a ribbon cable or a flex circuit ribbon [e.g., ¶’s [0038], [0074]]
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine, Nardo, & Meyerson such that the feedback control temperature sensors are coupled to a sensor strip, since such a particular known sensor mounting technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by MacIntyre-Ellis), and one of ordinary skill in the art would have been capable of applying this known sensor mounting technique to the known device of Augustine, Nardo, & Meyerson, and the results would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
28. As noted above, the 05/06/26 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the Non-Final Office Action mailed 01/07/26 Action.
29. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Conclusion
30. 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 extension fee 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 date of this final action.
31. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. 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. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights