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 .
Status of Claims
2. This action is responsive to the Preliminary Amendment filed on 09/22/2023.
Claims 1, 4, 13, 20, 23, 43, 53, 57-61, 63, 70, 91, 95, 100, 102, 118, & 120 are pending, and have been examined on the merits.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1, 13, 20, 43, & 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2012/0238901 to Augustine (“Augustine”) [made of record in Applicant’s 04/11/24 IDS].
5. Regarding claim 1, Augustine discloses a method for regulating a core body temperature of a living subject [e.g., ¶[0076]], the method comprising:
removably coupling a 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”)]; and
applying heat via the flexible heat exchange pad to the skin surface and underlying tissue of the living subject while the 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]].
6. Regarding claim 13, Augustine discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further discloses wherein the 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 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].
7. Regarding claim 20, Augustine discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further discloses wherein removably coupling the 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 flexible heat exchange pad to a contour of the skin surface [e.g., ¶[0049]].
8. Regarding claim 43, Augustine discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine further discloses wherein the flexible heat exchange pad [(100)] has 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] of the flexible heat exchange pad [(100)] faces toward the skin surface [(103)] when the flexible heat exchange pad is coupled to the skin surface [(103)] via the flexible adhesive composite laminate [¶’s [0052], [0068]], and
wherein the second surface [surface away from skin] of the flexible heat exchange pad faces away from the skin surface [(103)] 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”)] via the flexible adhesive composite laminate [¶[0068]],
wherein the flexible heat exchange pad comprises:
a flexible heater [heater (104)] defining the first surface of the flexible heat exchange pad and configured for generating heat [¶[0049]]; and
a flexible thermally-insulative layer defining the second surface of the flexible heat exchange pad [layer (110)] and configured for inhibiting heat transfer from the second surface of the flexible heat exchange pad [¶’s [0054]-[0055]].
9. Regarding claim 53, Augustine discloses all of the limitations of claim 43 for the reasons set forth in detail (above) in the Office Action.
Augustine further discloses 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].
Claim Rejections - 35 USC § 103
10. 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.
11. 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. DEPENDENT CLAIMS 4, 23, & 57-60 [which Depend from Independent Claim 1]
12. Claims 4 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of U.S. Patent Application Publication No. 2017/0231811 to Cubon ("Cubon").
13. Regarding claim 4, Augustine discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine discloses that the device may be used with a variety of body surface areas, including body surface areas that tend not to have excessively thick layers of subcutaneous fat [e.g., ¶[0079] (“areas such as the upper chest, side chest, neck, forehead or upper arm are generally chosen because these areas tend not to have excessively thick layers of subcutaneous fat. However, other body surface areas are also anticipated for core temperature measurement with this invention”)].
Augustine does not, however, explicitly disclose:
wherein the skin surface comprises at least a portion of a hand of the living subject.
Cubon, in a similar field of endeavor, teaches a self-regulating heater for maintaining normothermia, and teaches that the heater may conform to various body parts of a patient including, e.g., the hand [e.g., ¶’s [0026], [0027]; FIG. 3].
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 such that the device be used/placed on known, art-recognized skin surface locations known to aid in regulating core body temperature including, e.g., wherein the skin surface comprises at least a portion of a hand of the living subject, as taught by Cubon, since such a particular known heater placement was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Cubon), and one of ordinary skill in the art would have been capable of applying this known placement technique to the known method of Augustine, and the results [warming a subject to maintain normothermia] 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).
14. Regarding claim 23, Augustine discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Augustine does not, however, disclose:
wherein the living subject is under general anesthesia.
Cubon, in a similar field of endeavor, 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 ¶[0003] (“There is a threat to the patients of heat loss, and possibly hypothermia if core body temperature cannot be maintained. Hypothermia can pose an increased risk of surgical infection and other post-operative complications, such as impaired drug metabolism and immune functions”)].
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 modify Augustine 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 Cubon), and one of ordinary skill in the art would have been capable of applying this known warming technique to the known method of Augustine, 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).
15. Claims 57-60 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of U.S. Patent Application Publication No. 2018/0184908 to Meyerson et al. ("Meyerson") [made of record in Applicant’s 04/11/24 IDS].
16. Regarding claims 57 & 58, Augustine discloses all of the limitations of claim 53 for the reasons set forth in detail (above) in the Office Action.
Augustine further discloses controlling an electronic controller [controller (114) - ¶[0057]] based on feedback from a temperature sensor [e.g., ¶’s [0057], [0076], [0111]].
Augustine does not, however, appear to disclose controlling an electronic controller based on feedback from multiple sensors, and therefore fails to disclose the following emphasized limitations:
[claim 57] determining, via the feedback control temperature sensors, a plurality of temperature values; and
controlling, via an electronic controller, 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 plurality of temperature values.
[claim 58] wherein determining, via the feedback control temperature sensors, the plurality of temperature values comprises:
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.
Meyerson, in a similar field of endeavor, teaches a wearable patch for core temperature determination [e.g., Abstract; ¶[0032]]. Meyerson teaches that the 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 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 temperature sensor, a first temperature value, and determining, via a second 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 modify Augustine such that data/values from multiple temperature sensors be used to determine core body temperature and control the electronic controller [controller (114)] accordingly, or more particularly to include determining, via the feedback control temperature sensors, a plurality of temperature values, and controlling, via an electronic controller, 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 plurality of temperature values, and wherein determining, via the feedback control temperature sensors, the plurality of temperature values comprises: 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 temperature values, 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.
17. Regarding claim 59, the combination of Augustine and Meyerson teaches all of the limitations of claim 58 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 58) to include temperature measurements from multiple temperature sensors.
Augustine further teaches comparing a measured temperature value against a predetermined threshold and controlling, via the electronic controller, 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”)].
The combination of Augustine and Meyerson does not explicitly teach determining a greater of measured temperature values for comparison against the predetermined threshold, and therefore fails to teach:
wherein controlling, via the electronic controller, 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 plurality of temperature values comprises: 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 electronic controller, 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 a comparison of the greater temperature value and the predetermined maximum temperature setting.
However, it is the Examiner’s position that, 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 one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Augustine and Meyerson such that the highest/greatest measured temperature value be compared to 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.
18. Regarding claim 60, the combination of Augustine and Meyerson teaches all of the limitations of claim 58 for the reasons set forth in detail (above) in the Office Action.
Augustine was modified above (in the rejection of claim 58) to include temperature measurements from multiple temperature sensors, as taught by Meyerson.
Augustine further teaches comparing a measured temperature value against a predetermined threshold and controlling, via the electronic controller, 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”)].
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 and Meyerson such that wherein controlling, via the electronic controller, 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 plurality of temperature values comprises: 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 electronic controller, 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 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/Meyerson, 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).
II. INDEPENDENT CLAIM 61 [& DEPENDENT CLAIMS 63, 70]
19. Claims 61 & 63 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of Cubon.
20. Regarding claim 61, Augustine teaches a flexible heat exchange pad [sensor (100) including heater (104) - ¶[0049]] for regulating a core body temperature of a living subject [e.g., ¶[0076]], the flexible heat exchange pad comprising:
a flexible heater [heater (104)] defining a first surface [lower/bottom surface] 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]]…, and
a flexible thermally-insulative layer [layer (110)] defining an opposite second surface [surface away from skin] of the flexible heat exchange pad [¶’s [0052], [0054]] 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 the skin surface [(103)] 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”)] via the flexible adhesive composite laminate [¶[0068]].
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.
Cubon, in a similar field of endeavor, teaches a self-regulating heater for maintaining normothermia, and teaches that the heater may conform to various body parts of a patient including, e.g., the hand, & foot [e.g., ¶’s [0026], [0027]; FIG. 3].
Cubon further teaches that the heater has constitutive properties such that the flexible heater is self-regulating against heating above a predetermined temperature [Cubon teaches a positive temperature coefficient (PTC) heater that it designed to reach a steady-state temperature - see, e.g., ¶’s [0002], [0022] (“As the heating continues, the temperature of the material continues to rise until it exceeds a phase transformation temperature. As the material passes through the phase transformation temperature, the densely packed crystalline polymer matrix changes to an amorphous structure. The phase change is accompanied by an expansion of the polymer. As the conductive particles move apart from each other, most of them no longer conduct current and the resistance of the heater 10 increases sharply. The heater 10 will reach a designed steady state temperature and will draw reduced amperage to maintain the steady state temperature. The heater 10 will stay “warm”, remaining in this high resistance state as long as the power is applied. Removing the power source will reverse the phase transformation and allow the carbon chains to re-form as the polymer re-crystallizes. The heater resistance returns to its original value”)].
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 Cubon, 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 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).
21. Regarding claim 63, the combination of Augustine and Cubon teaches all of the limitations of claim 61 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein the predetermined temperature is less than or equal to 43°C [¶[0062]].
22. Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of Cubon, as applied to claim 61 above, and further in view of Meyerson.
23. Regarding claim 70, the combination of Augustine and Cubon teaches all of the limitations of claim 61 for the reasons set forth in detail (above) in the Office Action.
Augustine further teaches wherein the flexible heat exchange pad further comprises a plurality of feedback control temperature sensors [¶’s [0048], [0111]].
The combination of Augustine and Cubon does not, however, teach the following emphasized limitation:
wherein the flexible heat exchange pad further comprises a plurality of feedback control temperature sensors each comprising a resistance temperature detector.
Meyerson, in a similar field of endeavor, teaches a wearable patch for temperature determination [e.g., Abstract]. Meyerson teaches that the 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]].
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 Cubon such that the temperature sensors each comprise a resistance temperature detector, since such a modification amounts merely to the simple substitution of one known temperature sensor for another, yielding only predictable results [temperature measurement] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
II. INDEPENDENT CLAIM 91 [& DEPENDENT CLAIMS 95, 100, 102, 118, 120]
24. Claims 91, 95, 100, 118, & 120 are rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of Cubon.
25. 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 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]] 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]],…; and
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”)].
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:
and wherein the flexible heater has constitutive properties such that the flexible heater is self-regulating against heating above a predetermined temperature.
Cubon, in a similar field of endeavor, teaches a self-regulating heater for maintaining normothermia, and teaches that the heater may conform to various body parts of a patient including, e.g., the hand, & foot [e.g., ¶’s [0026], [0027]; FIG. 3].
Cubon further teaches that the heater has constitutive properties such that the flexible heater is self-regulating against heating above a predetermined temperature [Cubon teaches a positive temperature coefficient (PTC) heater that it designed to reach a steady-state temperature - see, e.g., ¶’s [0002], [0022] (“As the heating continues, the temperature of the material continues to rise until it exceeds a phase transformation temperature. As the material passes through the phase transformation temperature, the densely packed crystalline polymer matrix changes to an amorphous structure. The phase change is accompanied by an expansion of the polymer. As the conductive particles move apart from each other, most of them no longer conduct current and the resistance of the heater 10 increases sharply. The heater 10 will reach a designed steady state temperature and will draw reduced amperage to maintain the steady state temperature. The heater 10 will stay “warm”, remaining in this high resistance state as long as the power is applied. Removing the power source will reverse the phase transformation and allow the carbon chains to re-form as the polymer re-crystallizes. The heater resistance returns to its original value”)].
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 Cubon, 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 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).
26. Regarding claim 95, the combination of Augustine and Cubon 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 Cubon.
Cubon further teaches wherein the flexible heater comprises:
a bus bar extending along a periphery of the flexible heater [either of bus bars (20, 22) - ¶[[0018]; FIG. 1]; and
a plurality of heating elements [finger portions (40), (42) - ¶’s [0019], [0020]] extending inward from the bus bar [(20) or (22)]; FIG. 1].
27. Regarding claim 100, the combination of Augustine and Cubon 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 heat exchange pad further comprises a plurality of feedback control temperature sensors [e.g., ¶’s [0048], [0111]].
28. Regarding claim 118, the combination of Augustine and Cubon 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”)].
29. Regarding claim 120, the combination of Augustine and Cubon 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 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].
30. Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over Augustine in view of Cubon, as applied to claim 100 above, and further in view of U.S. Patent Application Publication No. 2014/0074086 to MacIntyre-Ellis al. ("MacIntyre-Ellis") [made of record in Applicant’s 04/11/24 IDS].
31. Regarding claim 102, the combination of Augustine and Cubon 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 and Cubon 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 and Cubon 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/Cubon, 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).
Conclusion
32. 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 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. 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/Examiner, Art Unit 3794