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 .
Response to Amendment
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The amendment filed 10/16/2024 has been entered. Claims 10-17 and 23-32 remain pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites “selecting between larger magnitude thermal profiles and smaller magnitude thermal profiles.” It is unclear what “magnitude” refers to as it relates to temperature. The magnitude is the size of something. So, it is unclear how the limitation is referring to the size of the temperature e.g. whether “larger magnitude” means a higher temperature or a longer temperature profile (being bigger in “size” by being a longer duration of time). If the magnitude refers to the temperature, does the larger magnitude mean a sustained higher temperature or is one instance of higher temperature enough. For the purposes of examination, the limitation will be interpreted as “selecting between different thermal profiles”.
Claim Rejections - 35 USC § 103
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.
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 10, 17, 23, 24, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995).
Regarding claim 10, Garetz teaches a method of operating a haptic actuator for treating thermal dysregulation of a user (see abstract), the method comprising:
detecting a presence of a thermal dysregulation event in the user (see paragraph 21, the microprocessor compares the sensor readings to preset conditions to determine if a hot flash has commenced, a hot flash is a thermal dysregulation event), wherein detecting the presence of a thermal dysregulation event in the user is based on at least one input from a sensor (see paragraphs 20-21, temperature and/or humidity sensors used as input to detect hot flashes) and one or more activation parameters (see paragraph 21, the activation parameter is the preset conditions indicating hot flash that triggers activation of the actuator), wherein the sensor is selected from a group of a temperature sensor, a skin conductance sensor, and a heart rate sensor (see paragraph 20, a temperature sensor is used); and
activating the haptic actuator to provide cooling thermal sensations to the user to provide symptom relief, as perceived by the user, for thermal dysregulation event of the user (see paragraphs 22-23, the cooling vest 20 is used to relieve hot flash symptoms experienced by the user).
Garetz does not teach after the treatment is completed, obtaining an input from the user regarding the perceived symptom relief; and updating one or more operating parameters of the haptic actuator for subsequent operation of the haptic actuator based at least in part on the input.
However, Leung teaches an analogous thermal regulation system and method for providing relief to a user (see abstract and fig. 1) comprising, after the treatment is completed, obtaining an input from the user regarding the perceived symptom relief (see fig. 7c and paragraph 52, the user inputs a post-treatment pain score); and updating one or more operating parameters of the haptic actuator for subsequent operation of the haptic actuator based at least in part on the input (see paragraph 52 and 54, the user inputs a post-treatment pain score that is then used to “provide updated treatment plans and settings”).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Garetz to include the step of obtaining input from the user after treatment is completed and updating the operating parameters based on the user input, as taught by Leung, for the purpose of adjusting the settings to provide appropriate treatment and to avoid the need for the user to visit with a healthcare provider in order to update their treatment program (see paragraph 54 of Leung).
Regarding claim 17, Garetz further teaches wherein the thermal sensations are applied to a chest or neck of the user (see paragraph 23 and Fig. 1, vest 20 covers the user’s chest and applies cooling to the chest area).
Regarding claim 23, Garetz, as modified, further teaches wherein updating the one or more operating parameters of the haptic actuator includes changing an initial setting for the one or more operating parameters based at least in part on the input (see Leung paragraphs 52-54, when the user saves the input, the next time the program is run, its initial settings are adjusted to updated parameters based on the user’s previous input).
Regarding claim 24, Garetz further teaches wherein the initial setting for the one or more operating parameters is based on a condition of the user (see paragraphs 23-24, the settings of the cooling vest or pad are set to reduce the symptoms of a hot flash).
Regarding claim 27, Garetz, as modified, further teaches wherein the input from the user is a manual adjustment of the one or more operating parameters (see paragraphs 28-32, the user manually adjusts the parameters using buttons. As modified, Garetz would allow manual adjustment).
Regarding claim 32, Garetz, as modified, further teaches the haptic actuator prompting the user to provide the input regarding the sufficiency of the perceived symptom relief (see Leung fig. 7c and paragraphs 52-54, the user is prompted to input their pain level after the treatment to see how well the treatment provided relief.).
Claims 28-29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995) as applied to claim 10 above and further in view of Thomas (US PGPub 20180193185).
Regarding claim 28, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein updating the one or more operating parameters includes updating a pulse intensity of a thermal profile.
H However, Thomas teaches an analogous thermal regulation device (abstract and fig. 1) wherein the updating the one or more operating parameters includes updating a pulse intensity of a thermal profile (See figs. 5A-5E and paragraphs 28-30, the user can select different profiles. Applicant defines “pulse intensity” as the delta between maximum and minimum applied stimuli. In this case, temperature is applied. Thomas teaches applying different thermal profiles, including one with different ‘pulse intensity;. E.g. compare fig. 5E and fig. 5B.).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the operation of the system of Garetz to have the updated operating parameters to include updating a pulse intensity of a thermal profile, as taught by Thomas, so that the user can select a profile that gives them the most relief and is tailored to their needs.
Regarding claim 29, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein updating the one or more operating parameters includes selecting between more larger magnitude thermal profiles and smaller magnitude thermal profiles.
However, Thomas teaches an analogous thermal regulation device (abstract and fig. 1) wherein the one or more operating parameters can be updated (see paragraphs 29-30) wherein updating the one or more operating parameters includes selecting between larger magnitude thermal profiles and smaller magnitude thermal profiles (see above 12b rejection explaining this limitation is being interpreted as “selecting between different thermal profiles.” See figs. 5A-5E and paragraphs 28-30, the user can select different profiles).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Garetz to allow the use to select different profiles so that the user can select a profile that gives them the most relief and is tailored to their needs.
Regarding claim 30, Garetz, as modified, further teaches wherein updating the one or more operating parameters includes updating at least one selected from a waveform shape, a rate of change, a pulse intensity, a power profile, a duration of operation, a rest duration between pulses, and a frequency (see Garetz paragraph 24 and Thomas paragraphs 28-32 and Figs. 5A, the user can adjust the profile by adjusting the waveform shape, the rate of change, the power profile, and duration of operation. In modifying the operation of Garetz, the user can select profiles by changing these parameters.).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995) as applied to claim 10 above and further in view of Connor (US PGPub 20150320588).
Regarding claim 11, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein the sensor is the skin conductance sensor and the at least one input is a skin conductance value, and wherein detecting the presence of the thermal dysregulation event in the user includes detecting a skin conductance value that is greater than a threshold skin conductance for a threshold amount of time.
However, Connor teaches an analogous method for treating hot flashes (see abstract) wherein a sensor is used to detect hot flashes (see paragraph 485) wherein the sensor is the skin conductance sensor (paragraph 485, “wearable sensor can be a sternal skin conductance sensor) and the at least one input is a skin conductance value (paragraph 485, skin conductance is measured by the skin conductance sensor and used as input), and wherein detecting the presence of a thermal dysregulation event in the user includes detecting a skin conductance value that is greater than a threshold skin conductance for a threshold amount of time (see paragraph 485, an increase in skin conductance greater than a selected amount and which occurs in less than a selected period of time can be associated with a hot flash, or thermal dysregulation event.).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the sensor of Garetz to be a skin conductance sensor, as taught by Connor, because Connor teaches that skin conductance can be used to detect hot flashes and that it is an alternative to a temperature sensor (see paragraphs 484-485).
Regarding claim 12, Garetz, as modified by Connor, further teaches wherein the skin conductance sensor is a sternal skin conductance sensor (see Connor paragraph 485, Connor teaches a sternal skin conductance sensor specifically).
Regarding claim 13, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein the sensor is the skin conductance sensor and the at least one input is a skin conductance value.
However, Connor teaches an analogous method for treating hot flashes (see abstract) wherein a sensor is used to detect hot flashes (see paragraph 485) wherein the sensor is the skin conductance sensor (paragraph 485, “wearable sensor can be a sternal skin conductance sensor) and the at least one input is a skin conductance value.
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the sensor of Garetz to be a skin conductance sensor, as taught by Connor, because Connor teaches that skin conductance can be used to detect hot flashes and that it is an alternative to a temperature sensor (see paragraphs 484-485).
Regarding claim 14, Garetz, as modified by Connor, further teaches wherein the skin conductance sensor is a sternal skin conductance sensor (see Connor paragraph 485, Connor teaches a sternal skin conductance sensor specifically).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995) as applied to claim 10 above and further in view of Olson et al. (US PGPub 20120089063).
Regarding claim 15, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach recording information relative to the activation of the haptic actuator to create an event log associated with the thermal dysregulation event, wherein the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling sessions in a day.
However, Olson teaches a method of treating a medical condition (see abstract) wherein the method includes recording information relative to the activation of the actuator to create an event log associated with the disorder, wherein the information includes at least one selected from a group of a timestamp of the session, a duration of the session, and a selected intensity of the session, and number of sessions in a day (see paragraph 116, the memory registers the treatment sessions conducted, including the time and duration of each session, the pressure intensity of the session, and the number of sessions).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the method of Garetz to record information relative to the activation of the haptic actuator to create an event log associated with the hot flashes wherein the information includes at least one selected from a group of a timestamp of the session, a duration of the session, and a selected intensity of the session, as taught by Olson, for the purpose of logging data of clinical relevance to the caregiver to monitor and supervise an individual’s usage of the device (see paragraph 116). Creating an event log of the activation of the actuator allows the user and doctor to monitor how treatment is going and review the data to improve treatment of hot flashes. The modified Garetz teaches that the information includes at least one selected from a group of a timestamp of a cooling session, a duration of a cooling session, a selected intensity of a cooling session, and a number of cooling session in a day (see paragraph 24 of Garetz, Garetz applies cooling during a treatment session and so, as modified by Olson, the data is data associated with cooling such as duration, time, and intensity of cooling).
Regarding claim 16, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach transmitting the information to a remotely located database that includes the event log associated with the thermal dysregulation event of the user.
However, Olson teaches a method of treating a medical condition (see abstract) wherein the method includes transmitting treatment information to a remotely located database that includes the event log associated with the user (see paragraph 116, the data can be downloaded to an external device).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the modified method of Garetz to include the step of transmitting treatment information to a remotely located database, as taught by Olson, for the purpose of allowing the information to be reviewed by a caregiver (see paragraph 116).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995) as applied to claim 10 above and further in view of Zambotti (EP 3591659).
Regarding claim 25, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein the initial setting for the one or more operating parameters is determined by settings that have been determined to provide an adequate degree of symptom relief in a population of user's having a same condition as the user.
However, Zambotti teaches an analogous method of treating hot flashes (abstract) wherein the system determines mitigation strategies based on treatments that have been determined to provide an adequate degree of symptom relief in a population of user's having a same condition as the user (see Fig. 4 and paragraph 104, the menopausal management system analyzes information from a population of users to find mitigation strategies that are successful. The information can be used to treat the user).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Garetz to have an initial setting for the one or more operating parameters is determined by settings that have been determined to provide an adequate degree of symptom relief in a population of user's having a same condition as the user because Zambotti teaches that data from similar populations of users can be used to determine a treatment that is more likely to provide relief to future users.
Claims 26 are rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Leung et al. (US PGPub 20160015995) as applied to claim 10 above and further in view of Callister et al. (US PGPub 20060122673).
Regarding claim 26, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein the haptic actuator identifies the condition of a particular user prior to a first operation.
However, Callister teaches an analogous method of regulating a person’s body temperature (see abstract) using an actuator (see fig. 1) wherein the actuator identifies the condition of a particular user prior to a first operation (see paragraph 64, “based on the sensed temperatures and conditions, the control unit may direct the heating or cooling.” The controller first identifies a condition, either hypothermia or hyperthermia, before its first cooling or heating operation).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the haptic actuator of Garetz to first identify the condition of a particular user prior to a first operation, as taught by Callister, so that the actuator knows how to operate to treat the user.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Garetz (US PGPub 20100204764) in view of Thomas et al. (US PGPub 20180193185) as applied to claim 10 above and further in view of Luoma et al. (WO 2017/106973).
Regarding claim 28, Garetz teaches all previous elements of the claim as stated above. Garetz does not teach wherein the thermal sensations are applied to wrist of the user.
However, Luoma teaches an analogous thermal regulation device (abstract) wherein the thermal sensations are applied to wrist of the user (see paragraph 27 “Pulse points are found at the wrists, neck, insides of the elbows and knees, tops of the feet, insides of the ankles, and inner thighs. Therefore, thermoelectric elements (6) provided in zones encompassing these pulse points can be activated to quickly bring down the internal body temperature of the user.”).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the device of Garetz to apply thermal sensation to the wrist of the user because Luoma teaches that placing thermoelectrical elements on pulse points in the wrists can quickly bring down the internal body temperature of the user.
Response to Arguments
Applicant’s arguments with respect to claim 10 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 amendment to include the user inputting perceived symptom relief after treatment is concluded overcomes the Garetz and Thomas references, but Leung is now used to teach this limitation as stated above. Leung teaches a method for providing relief to the user and asking the user after treatment how well the treatment provided relief and updates the operating parameters based on that input.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hochman (US PGPub 20090030366) which receives user feedback after treatment; Rogers (US PGPub 20150374538) which uses patient feedback data.
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/S.G./
Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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