www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/621,297
`
`12/11/2019
`
`DANIEL P. DORAN
`
`79600US004/083749-0108
`
`2942
`
`200663
`
`7590
`
`09/03/2024
`
`Vorys-Solventum
`Vorys, Sater, Seymour and Pease LLP
`909 Fannin St.
`
`EXAMINER
`
`TEMPLETON, MARINA DELANEY
`
`HOUSTON,TX 77010
`
`3794
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/03/2024
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`IPDocketing @ Solventum.com
`VDocketHou @vorys.com
`vorys_docketing @cardinal-ip.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`16/621,297
`DORAN etal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`MARINA D TEMPLETON
`3794
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 05/23/2024.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1-2,4-7,10-14 and 16 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`CL] Claim(s)__is/are allowed.
`Claim(s) 1-2,4-7,10-14 and 16 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240814
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined under the first
`
`inventor to file provisions of the AIA.
`
`Response to Amendment
`
`2.
`
`The amendmentfiled May 23, 2024 has been entered. Claims 1-2, 4-7, 11-14, & 16 are
`
`amended. Claims 3, 8-9, 15, & 17-20 are canceled. Claims 1-2, 4-7, 10-14, & 16 remain pending.
`
`Response to Arguments
`
`3.
`
`Applicant’s arguments with respect to claims 1-2, 4-7, 10-14, & 16 have been considered but are
`
`moot because the new ground ofrejection does not rely on any reference applied in the prior rejection
`
`of record for any teaching or matter specifically challenged in the argument; as necessitate by
`
`amendment.
`
`Claim Rejections - 35 USC § 112
`
`4.
`
`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-AlA), 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.
`
`5.
`
`Claims 1-2, 4-7, 10-14, & 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA),
`
`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-AlA 35 U.S.C. 112, the
`
`applicant), regards as the invention.
`
`Claim 1 recites the limitation “and a timing component configured to: determine a duration of
`
`heat transfer from the heating device to the patient; and determine when the measured physiological
`
`indicator is received by the sensing component”(lines 25-29); First, the relationship between the timing
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 3
`
`componentand the other componentsof the device (e.g. the sensing component) is unclear, more
`
`specifically it is unclear how the timing component determines when the measured physiological
`
`indicator is received by the sensing componentas no relationship between the timing component and
`
`the sensing componentis recited; which renders the claim indefinite. Second,it is unclear as to if the
`
`timing component marks/determinesa specific time that data is received by the sensing componentor
`
`if the timing component determines a time for when data is received by the sensing component(e.g.
`
`sets an interval at which data is collected), similarly, it is unclear if the timing componentjust
`
`marks/determines the time/duration at which the heater was active or if the timing component
`
`determines a duration for the heating device to be activated; which renders the claim indefinite. For
`
`examination purposes the examiner is considering the timing componentto in communication with the
`
`sensing component, and the timing componentbeing configured to determine the point in time at
`
`which data was received by the sensor, and determine how long/the duration the heater was activated.
`
`Claims 2, 4-7, 10-14, & 16 are rejected by virtue of their dependency on independent claim 1.
`
`Claim Rejections - 35 USC § 103
`
`6.
`
`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 ordinaryskill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
`
`7.
`
`Claims 1-2, 4, 6-7, 10-13, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Luoma et al. (US 20190104776 A1) in view of Chakravarty et al. (WO 2016069551 A1; the examiner
`
`notesthatall citations made to the Chakravarty reference are made in reference to the attached foreign
`
`reference), Buller (US 20190029537 A1), and Koewler et al. (US 20090240312 A1) , hereinafter Luoma in
`
`view of Chakravarty, Buller, and Koewler.
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 4
`
`Regarding claim 1, Luoma discloses a system configured to transfer heat to a patient ([0022] &
`
`[0023]; Figure 1—element 3), the system comprising: a heating device ([0029]; Figure 3—element3),
`
`configuredto transfer heat to the patient based on a bodyheatscore that indicates whether the
`
`patientis likely to sweat ([0022], [0026], [0031]; the heating device is controlled to provide heating and
`
`cooling to maintain the body temperature in a safe zone, while maintain the overall comfort level of the
`
`user, thus limiting the possibility of heat exhaustion), the heating device comprising: a heater circuit
`
`configured to produce heat ([0026], [0029], [0031], & [0033]; Figure 3—elements 6 & 12); a controller
`
`communicatively coupled to the heater circuit, the controller comprising a processor ([0023], [0026], &
`
`[0035]; Figure 1 & 2—element4), comprising: a sensing componentconfigured to receive physiological
`
`indicators of the patient ([0024]-[0026]; Figure 2; data received by the sensors are relayed to the
`
`control unit), a measured physiological indicator from one or more sensors([0024] & [0025]; Figure 1 &
`
`2—element2; the system includes one or more sensors 2 that monitor physiological parameters such as
`
`skin temperature; heart rate; heart rate variability; blood pressure; activity level; breathing rate; muscle
`
`activity; body temperature; and heatflux); a scoring componentconfigured to: determine a
`
`physiological score from the physiological indicators ([0026]; the sensor data is transformed using an
`
`algorithm that determines the physiological strain index of the user); determine the body heat score
`
`from the physiological scores ([0026]; the algorithm uses real-time data obtained from the sensors to
`
`determine the strain the user is experiencing; the algorithm calculates a metric that represents feedback
`
`of the core temperature or an extrapolation of core temperature); determine whether the body heat
`
`score meets a score threshold indicating that the patientis likely to sweat; and direct the heater
`
`circuit to producea first amount of heat based on whether the body heat score meets the score
`
`threshold ([0026]; based on the strain index of the user, the heating device will be selectively and
`
`systematically controlled to provide cooling or heating to maintain the body temperature of the user in
`
`a safe zone; the examiner is considering the threshold to be “safe zone”, and it is the examiners position
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 5
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`that the controller would have to determine if the strain index meets a certain threshold/the safe zone
`
`to determine whether or not to provide heating or cooling to maintain the user within the safe zone).
`
`Luoma doesnot disclose the heating device comprising: a convective warming blanket; the
`
`heater circuit coupled with the convective warming blanket; wherein the physiological indicators
`
`comprise an entered physiological indicator from an input component; and a timing component
`
`configured to: determine a duration of heat transfer from the heating device to the patient; and
`
`determine when the measured physiological indicator is received by the sensing component.
`
`Chakravarty teaches a system configured to transfer heat to a patient ([0002]) comprising a
`
`heating device comprising: a convective warming blanket; the heater circuit coupled with the
`
`convective warming blanket ([0002]; the warming device can include one convective apparatus
`
`attached with a blanket).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the garment heating device, as disclosed by Luoma, to include a
`
`convective warming blanket, as taught by Chakravarty, as both references and the claimed invention are
`
`directed toward heating systems for controlling a user's body temperature. As disclosed by Luoma, the
`
`heating device can bein the form of a garment, wherein the heating device is configured to warm or
`
`cool a user ([0027], [0029], & [0031]). As disclosed by Chakravart, the heating device can be in the form
`
`of a blanket, pad, or garment, the heating device can include a convective apparatus attached to the
`
`heating device so as to distribute air through the heating device in order to warm or cool a user ([0002]
`
`& [0003]).
`
`It would have been obvious to one of ordinary skill in the art, before the effective filing date
`
`of the claimed invention, to modify the garment heating device, as disclosed by Luoma, to include a
`
`convective warming blanket, as taught by Chakravarty, as such a modification would provide for a
`
`knownalternative heating device in the art, and produce the predictable result of providing a heating
`
`device that is configured to warm or coolauser.
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 6
`
`Buller discloses a system for determining the risk of heatillnesses of a user using physiological
`
`indicators ([0003] & [0008]), wherein the physiological indicators comprise a measured physiological
`
`indicator ({0030]; Figure 1—element 104) and an entered physiological indicator from an input
`
`component([0010], [0028], & [0029]; Figure 1—element 102).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the physiological indicators, as disclosed by Luoma,to include an
`
`entered physiological indicator, as taught by Buller, as both references and the claimed invention are
`
`directed toward using physiological indicators to determine the heat strain of a user. As disclosed by
`
`Buller, the system can adjust for external factors that influence the physiological strain index, such as
`
`the user’s physical fitness, age, and weight, the processor can receive these external factors through an
`
`input device ([0028]). It would have been obvious to one of ordinary skill in the art, before the effective
`
`filing date of the claimed invention, to modify the physiological indicators, as disclosed by Luoma, to
`
`include an entered physiological indicator, as taught by Buller, as such a modification would allow for
`
`the system to adjust for external factors that influence the physiological strain index, such as the user’s
`
`physical fitness, age, and weight.
`
`Koewler discloses a system configured to transfer heat to a user to maintain a user’s
`
`temperature at a desired setpoint ([0006], [0007], & [0030]; Figure 1—element 10), the system
`
`comprising a controller ([0032]; Figure 1—element 26) comprising a sensing component configured to
`
`receive physiological indicators ([0032]; Figure 1—element 31) and a timing component([0040]; the
`
`controller comprises an internal timer) configured to: determine a duration of heat transfer from the
`
`heating device to the patient ([0040], [0045]-[0050]; Figure 3B—element 59; Figure 3B portrays the
`
`duration of heat transfer over time to the patient); and determine when the measuredphysiological
`
`indicator is received by the sensing component([0040], & [0045]-[0050]; Figure 3B—element61; Figure
`
`3B showsthe patients temperature measured over time).
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 7
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the controller, as disclosed by Luoma,to include the timing
`
`component, as taught by Koewler, as both references and the claimed invention are directed toward
`
`heating systems for regulating a user’s temperature. As disclosed by Koewler, the controller may
`
`comprise an internal timer such that the user’s temperature and the heater temperature may be shown
`
`over time, the internal timer also allows a user to select a desired time interval for varying the
`
`temperature gradient whichallowsfor a user-friendly system ([0030] & [0083]). It would have been
`
`obvious to one of ordinaryskill in the art, before the effective filing date of the claimed invention, to
`
`modify the controller, as disclosed by Luoma,to include the timing component, as taught by Koewler, as
`
`such a modification would allow for the sensed parameters of the user and the temperatureof the
`
`heater to be shownover time in order to provide additional feedback to a user and create a user-
`
`friendly experience.
`
`Regardingclaim 2, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
`
`limitations of claim 1, as described above.
`
`Luoma further discloses one or more sensors removably attachable to the patient and
`
`communicatively coupled to the processor, wherein the one or moresensorsare configured to detect
`
`at least the measured physiological indicator ([0024]-[0026]; Figure 1 & 2—element2).
`
`Regardingclaim 4, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
`
`limitations of claim 1, as described above.
`
`Buller further teaches wherein the entered physiological indicator is selected from the group
`
`consisting of: age, height, weight, BMI, gender, body fat percentage, and combinations thereof
`
`([0010], [0028], & [0029]; Figure 1—element 102).
`
`Regarding claim 6, Luoma in view of Chakravarty, Buller, and Koewlerdisclose all of the
`
`limitations of claim 1, as described above.
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 8
`
`Luoma doesnot discloses wherein the scoring componentof the processor is configured to
`
`direct the heater circuit to produce a second amountof heat, whichis less than the first amount of heat,
`
`based upon the body heat score meeting or exceeding the score threshold.
`
`Koewler further teaches a processor scoring componentconfigured to direct the heater circuit
`
`to producea first amount of heat based on whether the body heat score meets the score threshold
`
`([0006]-[0007] & [0046]-[0047]; Figure 3B—element 57, 59, & 61; the user’s temperature 611 is
`
`compared to a set point 57, if the user’s temperatureis less than the set point the system deliversa first
`
`amountof heat until the patient’s temperature reaches the set point), wherein the scoring component
`
`of the processoris configured to direct the heater circuit to produce a second amountof heat, which
`
`is less than the first amount of heat, based upon the body heat score meeting or exceeding the score
`
`threshold ([0007, [0008], [0048], & [0049]; Figure 3B—elements 57, 59, & 61; the patients temperature
`
`61 exceeds the setpoint 57 the heater system delivers a second amountof heat/cooling 59 until the
`
`patient’s temperature reaches the set point).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the controlling of the heater circuit, as disclosed by Luoma, to
`
`include the controlling of the heater circuit to produce a second amountofheat, less than the first
`
`amount of heat based on the body heat score meeting or exceeding the threshold, as taught by Koewler,
`
`as both references and the claimed invention are directed toward heating and cooling systems for
`
`controlling a user’s temperature to maintain a user’s temperature at a desired level. As disclosed by
`
`Koewler, the heating system may produce a second amountof heat thatis less than the first amount of
`
`heat if the user’s temperature exceed the desired temperature, the heating system quickly and
`
`efficiently drives a user’s temperature in a desired direction so as to effectively heat and cool the user to
`
`the desired temperature in a reasonable time, while reducing the occurrence and the magnitude of
`
`overshoot([0006]-[0008] & [0025]). It would have been obvious to one of ordinary skill in the art, before
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 9
`
`the effective filing date of the claimed invention, to modify the controlling of the heater circuit, as
`
`disclosed by Luoma,to include the controlling of the heater circuit to produce a second amountof heat,
`
`less than the first amount of heat based on the body heat score meeting or exceeding the threshold, as
`
`taught by Koewler, as such a modification would provide for a heating system quickly and efficiently
`
`drives a user’s temperature in a desired direction so as to effectively heat and cool the user to the
`
`desired temperature in a reasonable time, while reducing the occurrence and the magnitude of
`
`overshoot.
`
`Regardingclaim 7, Luoma in view of Chakravarty, Buller, and Koewlerdisclose all of the
`
`limitations of claim 1, as described above.
`
`Luoma doesnot disclose wherein the scoring componentof the processor is configured to turn
`
`off the heatercircuit in response to the body heat score meeting or exceeding the score threshold.
`
`Koewler further teaches a processor scoring componentconfigured to direct the heatercircuit
`
`to producea first amount of heat based on whether the body heat score meets the score threshold
`
`([0006]-[0007] & [0046]-[0047]; Figure 3B—element 57, 59, & 61; the user’s temperature 611 is
`
`compared to a set point 57, if the user’s temperatureis less than the set point the system deliversa first
`
`amountof heat until the patient’s temperature reaches the set point), wherein the scoring component
`
`of the processoris configured to turn off the heater circuit in response to the body heat score meeting
`
`or exceeding the score threshold ([0007] & [0047]; once the patient’s temperature has reached the
`
`setpoint temperature the controller discontinues further warming).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the controlling of the heater circuit, as disclosed by Luoma, to
`
`include the controlling of the heater circuit to turn off once the body heat score meets the score
`
`threshold, as taught by Koewler, as both references and the claimed invention are directed toward
`
`heating and cooling systems for maintaining a user’s temperatureat a desired level. As disclosed by
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 10
`
`Koewler, once the patient’s temperature has reached the target temperature the system can
`
`discontinue the warming or cooling of the heating device, so as to minimize the magnitude and
`
`occurrence of temperature overshoot and the concern for patient comfort ([0007] & [0018]). It would
`
`have been obvious to one ofordinaryskill in the art, before the effective filing date of the claimed
`
`invention, to modify the controlling of the heater circuit, as disclosed by Luoma, to include the
`
`controlling of the heater circuit to turn off once the body heat score meets the score threshold, as
`
`taught by Koewler, as such a modification would minimize the magnitude and occurrence of
`
`temperature overshootand the concern for patient comfort.
`
`Regardingclaims 10 & 11, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
`
`limitations of claim 1, as described above.
`
`Luoma doesnot disclose wherein directing the heating circuit to produce the first amount of
`
`heat comprises: determining heater circuit settings relating to the first amount of heat, wherein the
`
`heating circuit settings includes a time condition; and determining whether the time condition is met
`
`(claim 10), wherein the scoring component of the processor is configured to: determine a second
`
`amountof heat to transfer to the patient if the body heat score does not meet the score threshold and
`
`the time condition is met; and direct the heater circuit to produce the second amountof heat (claim 11).
`
`Koewler teaches a processor scoring componentconfigured to direct the heater circuit to
`
`producea first amount of heat based on whether the body heat score meets the score threshold
`
`([0006]-[0007] & [0046]-[0047]; Figure 3B—element 57, 59, & 61; the user’s temperature 611 is
`
`compared to a set point 57, if the user’s temperatureis less than the set point the system delivers a first
`
`amountof heat until the patient’s temperature reaches the set point), wherein directing the heating
`
`circuit to produce the first amount of heat comprises: determining heater circuit settings relating to
`
`the first amount of heat, wherein the heating circuit settings includes a time condition; and
`
`determining whether the time condition is met ([0023] & [0024]; the system delivers a first amount of
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 11
`
`heat for the patient’s temperature to reach the set point and system determines a predetermined
`
`period of time (i.e. 30 minutes) for delivering the first amount of heat in order for the patient’s
`
`temperature to meet the setpoint), wherein the scoring componentof the processor is configuredto:
`
`determine a second amountof heatto transfer to the patient if the body heat score does not meet
`
`the score threshold and the time condition is met; and direct the heater circuit to produce the second
`
`amountof heat ([0023] & [0024]; if predetermined period of time (i.e. 30 minutes) has elapsed and the
`
`setpoint is not reached, the controller causes the system to deliver a second amountof heat to the
`
`patient).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the controlling of the heater circuit, as disclosed by Luoma, to
`
`include the controlling of the heater circuit including determining a time condition related to the first
`
`amount of heat and determining and transferring a second amountof heat to transfer based on the
`
`time condition being met, as taught by Koewler, as both references and the claimed invention are
`
`directed toward heating and cooling systems for maintaining a user’s temperatureat a desired level. As
`
`disclosed by Koewler, if the user’s temperature does not meet the target temperature the heating
`
`system can deliver a first amount of heat for a predetermined time increment, if the time increment has
`
`past and the user’s temperaturestill does not meet the target temperature the heating system can
`
`deliver a second amountofheat, this feature provides for greater versatility in causing a user’s
`
`temperature to move upwardly or downwardly to reach the desired temperature, and this system
`
`efficiently and effectively warms or cools the user to the setpoint temperaturein a reasonable time,
`
`while reducing the occurrence and the magnitude of overshoot. ([0023]-[0025]). It would have been
`
`obvious to one of ordinaryskill in the art, before the effective filing date of the claimed invention, to
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`modify the controlling of the heater circuit, as disclosed by Luoma, to include the controlling of the
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`heatercircuit including determining a time condition related to the first amount of heat and
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`Application/Control Number: 16/621,297
`Art Unit: 3794
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`Page 12
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`determining and transferring a second amount of heat to transfer based on the time condition being
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`met, as taught by Koewler, as such a modification would provide for greater versatility in causing a
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`user’s temperature to move upwardly or downwardly to reach the desired temperature, efficiently and
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`effectively warming or cooling the user to the setpoint temperature in a reasonable time, and would
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`reduce the occurrence and the magnitude of overshoot.
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`Regardingclaim 12, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
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`limitations of claim 1, as described above.
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`Luoma doesnot explicitly disclose wherein the measured physiological indicator is measured
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`from the one or more sensors more than 2 times per hour.
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`Koewler further teaches a heating system configured to receive a measured physiological
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`indicator ([0032]; Figure 1—element 31), wherein the measuredphysiological indicator is measured
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`from the one or moresensors morethan 2 timesper hour ([0082]; the temperature can be sensed
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`continuously).
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`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
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`would have been motivated to modify the measuring of the physiological indicator, as disclosed by
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`Luoma, to include wherein the measured physiological indicator is measured from the one or more
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`sensors morethan 2 times per hour, as taught by Koewler, as both references and the claimed invention
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`are directed toward heating and cooling systems for maintaining a user’s temperature at a desired level.
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`As disclosed by Koewler, the temperature can be sensed continuously or intermittently, in order to
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`provide continuous information regarding the patient’s temperature ([0032] & [0082]). It would have
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`been obvious to one ofordinary skill in the art, before the effective filing date of the claimed invention,
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`to modify the measuring of the physiological indicator, as disclosed by Luoma, to include wherein the
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`measured physiological indicator is measured from the one or more sensors more than 2 times per
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`

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`Application/Control Number: 16/621,297
`Art Unit: 3794
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`Page 13
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`hour, as taught by Koewler, as such a modification would provide for continuous information regarding
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`the patient’s physiological parameters.
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`Regardingclaim 13, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
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`limitations of claim 1, as described above.
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`Luoma does not disclose wherein the physiological score is determined by multiple
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`measurements of the measured physiological indicator that indicate a drop in a blood pressure of the
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`patient over a period of time measured by the timing component.
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`Buller further teaches determining a physiological score ([0003] & [0008]), wherein the
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`physiological score is determined by multiple measurements of the measured physiological indicator
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`that indicate a drop in a blood pressure of the patient over a period of time measured by the timing
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`component([0035] & [0058]; the physiological strain index which indicates heat strain can be calculated
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`at variable times based on a change detected in one of the physiological signals like blood flow).
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`It would have been obvious to one of ordinary skill in the art, before the effective filing date of
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`the claimed invention, to modify the physiological indicator and the physiological score, as disclosed by
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`Luoma, to include wherein the physiological score is determined by multiple measurementsof the
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`measured physiological indicator that indicate a drop in a blood pressureof the patient over a period of
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`time, as taught by Buller, as both references and the claimed invention are directed toward determining
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`a physiological score to determine if a user or patient is experiencing heatillness. As disclosed by Buller,
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`the physiological strain index which indicates heat strain can be calculated at variable times based ona
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`change detected in one of the physiological signals like blood flow, the physiological strain index
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`provides for an improvedindication of the current physiological strain of the individual being monitored
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`([0034], [0035], & [0058]). It would have been obvious to one of ordinary skill in the art, before the
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`effective filing date of the claimed invention, to modify the physiological indicator and the physiological
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`score, as disclosed by Luoma,to include wherein the physiological score is determined by multiple
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`

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`Application/Control Number: 16/621,297
`Art Unit: 3794
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`Page 14
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`measurements of the measured physiological indicator that indicate a drop in a blood pressure of the
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`patient over a period of time, as taught by Buller, as such a modification would provide for a known
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`indicator that can be used to calculate the physiological score to indicated heat strain, and would
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`provide for an improved indication of the current physiological strain of the individual being monitored.
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`Regarding claim 16, Luoma in view of Chakravarty, Buller, and Koewler disclose all of the
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`l