Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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.
Claims 2-8, 16-17, 18-23 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunbar et al. US 2006/0195168 A1.
Dunbar teaches:
2. (New) A device for manipulating a temperature of a surface, the device comprising:
at least one temperature adjustment device constructed and arranged to be disposed adjacent to a user's skin; [Figs. 3-4 and para. 0039, “The heating device portably delivers a therapeutic dose of heat to the skin to reduce accommodation of thermal nerve receptors and includes a portable heat delivery element, a power source and a microprocessor control unit.”]
a first sensor configured to sense a first parameter; [para. 0049, “The programming unit 400 can monitor process parameters via sensors (not shown) placed proximate to the heating device 100 and adjust the temperature based on the process parameters.”]
a second sensor configured to sense a second parameter; [para. 0049, “The programming unit 400 can monitor process parameters via sensors (not shown) placed proximate to the heating device 100 and adjust the temperature based on the process parameters.” (Emphasis added.)]and
at least one processor [unit 400] in electrical communication with the at least one temperature adjustment device [heating device 100], [para. 0049, “The programming unit 400 can include any processor, microprocessor, hand-held microcomputer, integrated circuit, Programmable Logic Controller, Distributed Control System, and the like.”] the at least one processor configured to:
control the at least one temperature adjustment device to generate a thermal profile adjacent to the surface; [para. 0062; Temperature profiles Figs. 13-18]
receive a first signal from the first sensor and a second signal from the second sensor; [para. 0059, “The sensing element 160 can include a temperature sensor, a transmissivity sensor, a bio-resistance sensor, an ultrasound sensor, and optical sensor, an infrared sensor, or any other desired sensor. In one example, the sensing element 160 can be a temperature sensor configured to measure the temperature of the first heat exchanging surface of the heating element and/or the temperature of the skin of the subject (not shown). Examples of suitable temperature sensors include thermocouples, resistance temperature devices, thermistors (e.g., neutron-transmutation-doped germanium thermistors), and infrared radiation temperature sensors. In another example, the sensing element 160 can be an ultrasound sensor. In yet another example, the sensing element can be an optical or infrared sensor. The sensing element 160 can be in electrical communication with the processing unit, for example, a direct wired connection and/or a wireless connection.” And para. 0049, “The programming unit 400 can monitor process parameters via sensors (not shown) placed proximate to the heating device 100 and adjust the temperature based on the process parameters.” (Emphasis added, plural.)] and
control the at least one temperature adjustment device to modify the thermal profile based at least in part on the first parameter and/or the second parameter [para. 0049, “The programming unit 400 can monitor process parameters via sensors (not shown) placed proximate to the heating device 100 and adjust the temperature based on the process parameters.”]
Dunbar teaches:
3. (New) The device of claim 2, wherein the at least one temperature adjustment device comprises at least one thermoelectric element. [para. 0046, “As shown in FIGS. 1A and 1B, the heating element or pad 100 is electrically connected to the power source 200.”]
Dunbar teaches:
4. (New) The device of claim 2, wherein the thermal profile is a cooling thermal profile. [Fig. 13 - ramp down portion is cooling]
Dunbar teaches:
5. (New) The device of claim 2, wherein the thermal profile is a heating thermal profile. [Fig. 13 ramp up and hold, which repeats]
Dunbar teaches:
6. (New) The device of claim 2, wherein the thermal profile comprises an alternating thermal profile. [Fig. 13 total heat cycle repeats]
Dunbar teaches:
7. (New) The device of claim 3, wherein the at least one thermoelectric element is configured to be disposed adjacent to a neck, chest, sternum, stomach, or wrist of the user when worn. [CLM 18, “The user-controllable therapeutic heating device of claim 11 wherein the thermal elements are contained by an elastomeric band configured to fit a knee, an ankle, a foot, an elbow, a wrist, a joint, a shoulder, a neck and/or a head.”]
Dunbar teaches:
8. (New) The device of claim 2, wherein the thermal profile is configured to modify one or more selected from a group of vasoconstriction, vasodilation, respiration rate, heart rate, skin temperature, sweating, and shivering [Fig. 15, para. 0029-0031, “FIG. 15 is a graph of energy applied versus time illustrating the energy applied to the system and the resultant skin temperature wherein the bars represent energy delivered and the line indicates the skin temperature in accordance with an embodiment of the invention.”].
Dunbar teaches:
16. (New) The device of claim 2, wherein the device is configured to be worn. [para. 0039, “Additionally, the portable heat delivery element may be contained within a housing and the housing may be adaptable to be worn proximate to the skin of a user.”]
Dunbar teaches:
17. (New) The device of claim 2, wherein an absolute difference between an average temperature during the thermal profile and an initial temperature of the user's skin is less than or equal to 10 °C. [para. 0040, “According to another aspect, the control unit also includes at least one of a predetermined variable heat cycle, the variable heat cycle having at least a ramp-up phase, a steady heat phase, a ramp-down phase and a soak heat phase, wherein the temperature differential between the steady heat phase and the soak heat phase is less than 5.degree. C., and wherein the soak heat phase is greater than basal body temperature.”]
Regarding method claims 13-23 and 31, these method claims recite the steps for executing the functions corresponding to apparatus claims above and are rejected on the same grounds and rationale as claims above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-15 and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dunbar et al. US 2006/0195168 A1 in view of Lofy et al. US 2016/0030234 A1.
Dunbar does not teach the following limitation, however, Lofy teaches:
9. (New) The device of claim 3,
wherein the thermal profile includes one or more setpoint temperatures configured to modify a sympathetic response of the user, [para. 0004, “For example, heating can be used to treat hypothermia, chills and/or any other condition or ailment. “] and
wherein the one or more setpoint temperatures are determined by the at least one processor based on a temperature applied to the user's skin from the at least one thermoelectric element during a time period. [para. 0007; heats or cools for selective time periods and para. 0113]
It would have been obvious to a person having ordinary skill in the art before the time of filing to combine the teachings of Lofy with those of Dunbar. A person having ordinary skill in the art would have been motivated to combine the teachings because Lofy teaches that heating or cooling the skin for specific time periods can be an effective treatment for medical treatments affecting nervous system. (See para. 0004).
Lofy teaches:
10. (New) The device of claim 9, wherein the time period is selected from at least one of a time period prior to receiving a signal, a time period during which the signal is received, and a time period after receiving the signal. [para. 0119, “The control unit 750 can include a processing unit that if configured, based on the inputs it receives, to modify operation of the system based on a particular operational mode or scheme that has been selected based on the inputs and/or via the operator interface 740.”]
Lofy teaches:
11. (New) The device of claim 2, wherein the first sensor and the second sensor are separately selected from the group consisting of temperature sensors, physiological/biometric sensors, accelerometers, and environmental sensors. [para. 0117, “The subject sensors 730 sense or measure one or more physical conditions, physiological responses, or other parameters of the subject and output signals indicative of the sensed or measured parameters. In various embodiments, the subject sensors 730 can include one or more of the sensors 200, for example temperature sensors, heat flux sensors, humidity sensors, condensation/moisture sensors, pressure sensors, motion sensors, heart rate sensors, blood-oxygen sensors, galvanic (skin conductance) sensors, and any other type of subject sensor, as desired or required.”]
Dunbar teaches:
12. (New) The device of claim 11, wherein the first sensor is a temperature sensor, and the first parameter is a temperature. [temrpeature sensor - sensing element 160, para. 0059]
Lofy teaches:
13. (New) The device of claim 12, wherein the at least one processor is configured to operate in accordance with a feedback loop to prevent undesired heating or cooling of the device and/or to maintain a temperature at a surface of the at least one temperature adjustment device within a preferred range. [para. 0120, “As discussed in greater detail herein, the control system 700 can be configured to operate based on a closed-loop scheme using input from one or more feedback mechanisms (e.g., sensors 720, 730, operator interface 740, and/or other data, etc.).”]
Dunbar teaches:
14. (New) The device of claim 12, wherein the at least one processor is configured to adjust the thermal profile based at least in part on a sensed temperature. [para. 0049, “The programming unit 400 can monitor process parameters via sensors (not shown) placed proximate to the heating device 100 and adjust the temperature based on the process parameters. Process parameters include but are not limited to the temperature of the heating device, the duration of the cycle, the ramp-up or ramp-down phase duration, the hold or soak phase duration, the duration of the pattern (in which multiple cycles can continuously or intermittently run), the duration, sequence and pattern of the thermal zones, and the like.”]
Lofy teaches:
15. (New) The device of claim 13, wherein the second sensor is an accelerometer and the second parameter is acceleration, and wherein the at least one processor is configured to control the at least one temperature adjustment device to generate the thermal profile based at least in part on a sensed acceleration. [para. 0123, “As discussed in greater detail herein, one or more other parameters can also be considered by the control unit 750 in the regulation of the thermal conditioning system 710. For example, the thermal conditioning control system 700 can include a motion sensor (e.g., accelerometer) as one of the subject sensors 730. In such systems, if the thermal conditioning control system 700 detects little to no subject motion, which may indicate that the thermal conditioning system 710 has been removed by the subject or that the subject has fallen asleep or has otherwise become unconscious, the control unit 750 can operate the thermal conditioning devices (e.g., thermoelectric devices, other cooling or heating devices, etc.) at a lower level to reduce the amount of thermal conditioning or can discontinue operation of the thermal conditioning system 710. In this way, the control unit 750 can protect the subject against potentially harmful excessive thermal conditioning. In some embodiments, the control unit 750 can restore operation of one or more devices of the thermal conditioning system 710 a previous operating level or to a higher level once the motion detector detects some subject movement or other activity that suggests the subject is awake and alert.”]
Regarding method claims 24-30, these method claims recite the steps for executing the functions recited in apparatus claims above and are rejected on the same grounds and rationale as corresponding claims above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY COLLINS whose telephone number is (571)270-0473. The examiner can normally be reached Monday - Friday 1-930PM EST.
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/GARY COLLINS/Primary Examiner, Art Unit 2115
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