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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s arguments with respect to claim(s) Nofzinger not teaching a single body thermal regulator have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to the combination of Nofzinger in view of Agarwal filed 24 September 2025 have been fully considered but they are not persuasive.
Applicant argues that there is no rationale for modifying Nofzinger to include a phase change material from Agarwal since Agarwal’s purpose is to solve a problem with increased therapeutic duration from disposable products. This is not found to be persuasive. It appears that Applicant is arguing that Agarwal is non-analogous art to Nofzinger as the problem to be solved in Agarwal is with respect to increased therapeutic duration from disposable products. However, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned. Agarwal is in the same field of Applicant’s endeavor (hypothermal therapy). Additionally, Agarwal discusses that the inclusion of phase change materials relieve temperature spikes that may result in discomfort to the user in addition to extended therapeutic benefit (Col. 1, lines 38-44).
In response to applicant's argument that Agarwal’s disclosure is limited to use of phase change materials in a sleeve, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues that the skilled artisan would have to engage in an unacceptable amount of picking and choosing, based on the disclosure of Nofzinger, to arrive at the claimed parameters such that it would not have been obvious, based on the broad disclosure of Nofzinger, to apply cooling at the newly-recited, specific combination of temperature and duration. This is not found to be persuasive. MPEP 2144.05(111)(D) discusses that one factor weighing against maintaining an obviousness rejection based on optimization of a variable disclosed in a range in the prior art is where an applicant establishes that the prior art disclosure of the variable is within a range that is so broad in light of the dissimilar characteristics of the members of the range as to not invite optimization by one of skill in the art. This is not the case in with respect to the Nofzinger reference as Applicant has not established that the prior art disclosure of Nofzinger’s variable is within a range that is so broad in light of the dissimilar characteristics of the members of the range. Additionally, it is noted that the fact that experimentation may be complex does not make it unacceptable or not routine.
Claim Objections
Claims 19 is objected to because of the following informalities: The claims recites “having thermal transfer region” and should recite --a thermal transfer region--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 6, 8, 10-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0054958 A1 to Nofzinger (Nofzinger) in view of US 2004/0059400 A1 to Lin (Lin).
Regarding claim 1, Nofzinger teaches a method of improving by non-invasively applying hypothermal therapy to a user’s forehead (title “Method and Apparatus of Noninvasive, Regional Brain Thermal Stimuli for the Treatment of Neurological Disorders”, [0023, 0027] and Fig. 1), comprising placing a thermal regulator (see for example Figs. 1-6) having a thermal transfer region (10) on the skin of a user on the forehead of the user (Fig. 1), the thermal regulator comprising at least one Peltier device operable to cool the skin on the forehead of the suer through the thermal transfer region ([0030] which states in part “The apparatus provides stimulation by any method that cools or warms and serves the functional goal of noninvasive, localized temperature control for the treatment of neurological disorders, including, but not limited to:…thermoelectric cooling or warming.” and [0067] which states in part “Still another method of cooling is thermoelectric cooling based on the Peltier Effect…”), the thermal transfer region being cooled to a set temperature between about 5°C to 37°C and preferable between about 10°C to 30°C (0080]), and maintaining the set temperature for a time period extending between about 20 and 150 minutes and preferably between about 30 to 60 minutes and may vary outside of these ranges according to the individual patient ([0081]). Nofzinger teaches that the noninvasive, regional brain cooling of the present invention can occur using any cooling method that also serves the functional goal of localized temperature control for the treatment of neurological disorders. By way of example, Nofzinger discusses cooling by pumping or flowing cooling fluids through the device, passing a cooled fluid directly over the skull or scalp of a patient, a chemical cooling reaction, or thermoelectric cooling based on the Peltier Effect ([0065, 0067]). However, Nofzinger is silent with respect to the set temperature being between about 14°C and about 30°C, the set time period extending from 30 minutes to 3 hours or specifically a single body thermal regulator.
Regarding the set temperature being between about 14°C and about 30°C, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the temperature between about 14°C and about 30°C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding the set time period extending from 30 minutes to 3 hours, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the time period extending from 30 minutes to 3 hours, since it has been held that where the optimum or workable ranges are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. This is especially true as Nofzinger teaches that the period may vary outside of these ranges according to the individual patient ([0081])
Regarding the single body thermal regulator, Lin teaches an analogous device to that of Nofzinger’s device for application to the forehead (Figs. 1-4). The device of Lin includes a thermal transfer region (fabric 26) on the skin of a user and comprises at least one Peltier device (Peltier effect-thermoelectric cooler 21) operable to cool the skin on the forehead of the user through the thermal transfer region ([0014 which states in part “a hollow body 10 which has a curve inside so as to contact a forehead of a patient and two securing bands 14 are connected to two ends of the body 10.” and [0015] which states “A Peltier effect-thermoelectric cooler 21 is received in the body 10 and a cooling surface of the cooler 21 is exposed to the inside of the body 10…”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a single body thermal regulator as taught by Lin to allow for a less restrictive device that does not inhibit free movement of the user. This is especially true given the teaching of Nofzinger of pre-sleep cooling by applying the device to the head within about 10 minutes to 4 hours, and preferably within about 30 minutes to an hour, of their anticipated bedtime ([0074]).
Regarding claim 2, the combination teaches the method of claim 1 as well as Lin teaching wherein the thermal transfer region is further cooled by at least one thermally conductive material (metal heat transferring plate 23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a single body thermal regulator as taught by Lin to allow for a less restrictive device that does not inhibit free movement of the user. This is especially true given the teaching of Nofzinger of pre-sleep cooling by applying the device to the head within about 10 minutes to 4 hours, and preferably within about 30 minutes to an hour, of their anticipated bedtime ([0074]).
Regarding claim 6, the combination teaches the method of claim 1 as well as wherein Nofzinger teaching the thermal transfer region is attached to a headgear (11), and wherein the headgear is removably securable to the heat of the user ([0060] which states in part “attachment can occur by placing straps around the ears of a patient, using one or two straps 22 which fit around the back of the head or skull of the patient, utilizing a chin strap 23, and/or using an adhesive to attach the device to the scalp of the patient or any other method of providing a wearable device.”).
Regarding claim 8, the combination teaches the method of claim 1 as well as Nofzinger teaching placing the thermal transfer region such that it cools the skin of the user over the frontal cortex ([0062] which states in part “where insomnia is addressed as a neurological disorder, the device is placed on the frontal area or more particularly placed over the forehead and temporal region of the patient’s skull…Such placement corresponds to those areas of the brain that have high levels of metabolism during sleep, i.e., the frontal and temporal cortex.”).
Regarding claim 10, the combination teaches the method of claim 1 as well as Nofzinger teaching wherein the thermal transfer region has a thermal conductivity (inherent in that there is thermal transfer), but not specifically wherein the thermal conductivity is greater than about 0.1 watts per meter kelvin. Itis asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nofzinger to have a thermal conductivity greater than about 0.1 watts per meter kelvin, since it has been held that discovering the optimum or workable value of a results effective variable involves only routine skill in the art.
Regarding claim 11, the combination teaches the method of claim 1 as well as Nofzinger teaching wherein the thermal transfer region does not contact the periorbital regions or the cheek regions of the face of the suer during use (Figs 1-4).
Regarding claim 12, the combination teaches the method of claim1 as well as Nofzinger teaching wherein the thermal transfer region does not contact the back of the head of the suer during use (Figs. 1-4).
Regarding claim 19, Nofzinger teaches a method of improving by non-invasively applying hypothermal therapy to a user’s forehead (title “Method and Apparatus of Noninvasive, Regional Brain Thermal Stimuli for the Treatment of Neurological Disorders’, [0023, 0027] and Fig. 1), comprising placing a thermal regulator (see for example Figs. 1-6) having a thermal transfer region (10) on the skin of a user on the forehead of the user (Fig. 1), the thermal transfer region being cooled to a set temperature between about 5°C to 37°C and preferable between about 10°C to 30°C ([0080]), and maintaining the set temperature for a time period extending between about 20 and 150 minutes and preferably between about 30 to 60 minutes and may vary outside of these ranges according to the individual patient ([0081]). Nofzinger teaches that the noninvasive, regional brain cooling of the present invention can occur using any cooling method that also serves the functional goal of localized temperature control for the treatment of neurological disorders. By way of example, Nofzinger discusses cooling by pumping or flowing cooling fluids through the device, passing a cooled fluid directly over the skull or scalp of a patient, a chemical cooling reaction, or thermoelectric cooling based on the Peltier Effect ([0065, 0067]). However, Nofzinger is silent respect to the set temperature being between about 14°C and about 30°C, the set time period extending from 30 minutes to 3 hours or specifically a single body thermal regulator comprising a cooled thermal conductive material.
Regarding the set temperature being between about 14°C and about 30°C, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the temperature between about 14°C and about 30°C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding the set time period extending from 30 minutes to 3 hours, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the time period extending from 30 minutes to 3 hours, since it has been held that where the optimum or workable ranges are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. This is especially true as Nofzinger teaches that the period may vary outside of these ranges according to the individual patient ([0081])
Regarding the single body thermal regulator, Lin teaches an analogous device to that of Nofzinger’s device for application to the forehead (Figs. 1-4). The device of Lin includes a thermal transfer region (fabric 26) on the skin of a user and comprises at least one Peltier device (Peltier effect-thermoelectric cooler 21) operable to cool the skin on the forehead of the user through the thermal transfer region ([0014 which states in part “a hollow body 10 which has a curve inside so as to contact a forehead of a patient and two securing bands 14 are connected to two ends of the body 10.” and [0015] which states “A Peltier effect-thermoelectric cooler 21 is received in the body 10 and a cooling surface of the cooler 21 is exposed to the inside of the body 10…”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a single body thermal regulator as taught by Lin to allow for a less restrictive device that does not inhibit free movement of the user. This is especially true given the teaching of Nofzinger of pre-sleep cooling by applying the device to the head within about 10 minutes to 4 hours, and preferably within about 30 minutes to an hour, of their anticipated bedtime ([0074]).
Claim(s) 2-5 and 13, 15-18 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nofzinger in view of Lin and US 6,881,219 B1 to Agarwal et al. (Agarwal).
Regarding claim 2, Nofzinger in view of Lin teaches the method of claim 1, but not wherein the at least one thermal transfer region is further cooled by at least one phase change material. Agarwal teaches a phase change material (56) incorporated into a flexible thermal therapy sleeve (50) thus extending the life of a thermal therapy system that is attributed to the use of at least one phase change material in cooperation with traditional thermal therapy techniques (Col. 3, line 12-Col. 4, line 17). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nofzinger to include the thermal therapy sleeve incorporating the phase change material of Agarwal to extend the life of the thermal therapy system and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claim 3, the combination teaches the method of claim 2, but not wherein the at least one phase change material has a phase transition between about 14oC and about 30oC. Agarwal states that that for a given thermal application, the desired therapeutic temperature may readily be attained by selection of the appropriate PCMs or combination of PCMs (Col. 4, lines 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected PCMs with desired transition temperatures in order to affect the desired therapeutic temperature and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claim 4, the combination teaches the method of claim 2, as well as Agarwal teaching a plurality of capsules, each encapsulating the at least one phase change material, wherein the capsules are arranged in a matrix of thermally conductive and conformable material (Col. 6, line 63-Col. 7, line 27). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the encapsulated capsules as taught by Agarwal so as to ensure that the PCM is contained and does not migrate to other regions (Col. 6, line 53-Col. 7, line 27).
Regarding claim 5, the combination teaches the method of claim 2 as well as Agarwal teaching wherein the at least one phase change material comprises a mixture of two or more different phase change materials. Agarwal states that that for a given thermal application, the desired therapeutic temperature may readily be attained by selection of the appropriate PCMs or combination of PCMs (Col. 4, lines 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected two or more PCMs with desired transition temperatures in order to affect the desired therapeutic temperature and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claims 13 and 21, Nofzinger teaches a method of improving by non-invasively applying hypothermal therapy to a user’s forehead (title “Method and Apparatus of Noninvasive, Regional Brain Thermal Stimuli for the Treatment of Neurological Disorders”, [0023, 0027] and Fig. 1), comprising placing a thermal regulator (see for example Figs. 1-6) having a thermal transfer region (10) on the skin of a user on the forehead of the user (Fig. 1), the thermal transfer region being cooled to a set temperature between about 5°C to 37°C and preferable between about 10°C to 30°C(0080]), and maintaining the set temperature for a time period extending between about 20 and 150 minutes and preferably between about 30 to 60 minutes and may vary outside of these ranges according to the individual patient ([0081]). Nofzinger teaches that the noninvasive, regional brain cooling of the present invention can occur using any cooling method that also serves the functional goal of localized temperature control for the treatment of neurological disorders. By way of example, Nofzinger discusses cooling by pumping or flowing cooling fluids through the device, passing a cooled fluid directly over the skull or scalp of a patient, a chemical cooling reaction, or thermoelectric cooling based on the Peltier Effect ([0065, 0067]). However, Nofzinger is silent with respect to the inclusion of a phase change material that is activated along with the at least one Peltier device and the set temperature being between about 14°C and about 30°C, the set time period extending from 30 minutes to 3 hours or specifically a single body thermal regulator.
Agarwal teaches a phase change material (56) incorporated into a flexible thermal therapy sleeve (50) thus extending the life of a thermal therapy system that is attributed to the use of at least one phase change material in cooperation with traditional thermal therapy techniques (Col. 3, line 12-Col. 4, line 17). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nofzinger to include the thermal therapy sleeve incorporating the phase change material of Agarwal to extend the life of the thermal therapy system and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding the set temperature being between about 14°C and about 30°C, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the temperature between about 14°C and about 30°C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding the set time period extending from 30 minutes to 3 hours, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have set the time period extending from 30 minutes to 3 hours, since it has been held that where the optimum or workable ranges are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. This is especially true as Nofzinger teaches that the period may vary outside of these ranges according to the individual patient ([0081])
Regarding the single body thermal regulator, Lin teaches an analogous device to that of Nofzinger’s device for application to the forehead (Figs. 1-4). The device of Lin includes a thermal transfer region (fabric 26) on the skin of a user and comprises at least one Peltier device (Peltier effect-thermoelectric cooler 21) operable to cool the skin on the forehead of the user through the thermal transfer region ([0014 which states in part “a hollow body 10 which has a curve inside so as to contact a forehead of a patient and two securing bands 14 are connected to two ends of the body 10.” and [0015] which states “A Peltier effect-thermoelectric cooler 21 is received in the body 10 and a cooling surface of the cooler 21 is exposed to the inside of the body 10…”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a single body thermal regulator as taught by Lin to allow for a less restrictive device that does not inhibit free movement of the user. This is especially true given the teaching of Nofzinger of pre-sleep cooling by applying the device to the head within about 10 minutes to 4 hours, and preferably within about 30 minutes to an hour, of their anticipated bedtime ([0074]).
Regarding claim 15, the combination teaches the method of claim 13, as well as Agarwal teaching a plurality of capsules, each encapsulating the at least one phase change material, wherein the capsules are arranged in a matrix of thermally conductive and conformable material (Col. 6, line 63-Col. 7, line 27). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the encapsulated capsules as taught by Agarwal so as to ensure that the PCM is contained and does not migrate to other regions (Col. 6, line 53-Col. 7, line 27).
Regarding claim 16, the combination teaches the method of claim 13 as well as Agarwal teaching wherein the at least one phase change material comprises a mixture of two or more different phase change materials. Agarwal states that that for a given thermal application, the desired therapeutic temperature may readily be attained by selection of the appropriate PCMs or combination of PCMs (Col. 4, lines 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected two or more PCMs with desired transition temperatures in order to affect the desired therapeutic temperature and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claim 17, the combination teaches the method of claim 13 as well as Nofzinger teaching wherein the thermal transfer region is attached to a headgear (11), and wherein the headgear is removably securable to the heat of the user ([0060] which states in part “attachment can occur by placing straps around the ears of a patient, using one or two straps 22 which fit around the back of the head or skull of the patient, utilizing a chin strap 23, and/or using an adhesive to attach the device to the scalp of the patient or any other method of providing a wearable device.”).
Regarding claim 18, the combination teaches the method of claim 17 as well as Nofzinger teaching wherein the headgear includes a strap ([0060] which states in part “attachment can occur by placing straps around the ears of a patient, using one or two straps 22 which fit around the back of the head or skull of the patient, utilizing a chin strap 23, and/or using an adhesive to attach the device to the scalp of the patient or any other method of providing a wearable device.”) configured to attach the headgear to the head of the user.
Regarding claim 22, Nofzinger in view of Lin teaches the method of claim 19, but not wherein the at least one thermal transfer region is further cooled by at least one phase change material. Agarwal teaches a phase change material (56) incorporated into a flexible thermal therapy sleeve (50) thus extending the life of a thermal therapy system that is attributed to the use of at least one phase change material in cooperation with traditional thermal therapy techniques (Col. 3, line 12-Col. 4, line 17). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nofzinger to include the thermal therapy sleeve incorporating the phase change material of Agarwal to extend the life of the thermal therapy system and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claim 23, the combination teaches the method of claim 22 as well as Agarwal teaching wherein the at least one phase change material comprises a mixture of two or more different phase change materials. Agarwal states that that for a given thermal application, the desired therapeutic temperature may readily be attained by selection of the appropriate PCMs or combination of PCMs (Col. 4, lines 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected two or more PCMs with desired transition temperatures in order to affect the desired therapeutic temperature and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Regarding claim 24, the combination teaches the method of claim 22, but not wherein the at least one phase change material has a phase transition between about 14oC and about 30oC. Agarwal states that that for a given thermal application, the desired therapeutic temperature may readily be attained by selection of the appropriate PCMs or combination of PCMs (Col. 4, lines 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected PCMs with desired transition temperatures in order to affect the desired therapeutic temperature and avoid temperature spikes that may result in discomfort to the user Col. 17, line 66-Col. 18, line 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jacobs (US 208/0046047 A1) teaches a hot and cold therapy device (title) incorporating a thermoelectric cell to enable therapeutic temperature to be applied to a body. The device of Jacobs is self-contained including a support adapted to surround a portion of the body of the user and securable to the body of the user to permit ambulatory use ([0008]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794