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`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
`
`2942
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`TEMPLETON, MARINA DELANEY
`
`ART UNIT
`
`3794
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`02/15/2024
`
`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):
`
`LegalUSDocketing@mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-2,4-7 and 10-20 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`5a) Of the above claim(s) _ is/are withdrawn from consideration.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 and 10-20is/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.
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`) ) ) )
`
`Application Papers
`10)( The specification is objected to by the Examiner.
`11) The drawing(s) filed on 12/11/2019 is/are: a)[¥) 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)£) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Q) All
`1.1) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) 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 20240207
`
`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 09/25/2023.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)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.
`
`

`

`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.
`
`Continued Examination Under 37 CFR 1.114
`
`2.
`
`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. Applicant's
`
`submission filed on September 25", 2023 has been entered.
`
`Response to Amendment
`
`3.
`
`The amendmentfiled September 25", 2023 has been entered. Claims 1 & 15 are amended.
`
`Claims 3 & 8-9 are canceled. Claims 1-2, 4-7, & 10-20 remain pending.
`
`Response to Arguments
`
`4.
`
`Applicant’s arguments with respect to claims 1-2, 4-7, & 10-20 have been considered, and in
`
`light of the amendments the previous rejection has been withdrawn, however a new rejection is made
`
`in view of 35 U.S.C 103. The examiner notes that Applicant argues that the system of Utturkar is not
`
`determining a body heat score as in the current claims, rather Utturkar is measuring temperature so as
`
`to determine whether heat should be applied to maintain the body core temperature at a certain level,
`
`and that maintaining the core body temperatureis not the same as determining a body heat score and
`
`applying heat based upon whether a patientis likely to sweat. The examiner respectfully disagrees, the
`
`examiner is giving the limitation “body heat score” the broadest reasonable interpretation,it is the
`
`examiners position that “body heat score” can be interpreted as a number that represents the
`
`temperature of the body. Utturkar provides a teaching for determining one or more body temperature
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 3
`
`parameters based on one or more sensed and/or entered physiological inputs ([0010], [0012], [0015],
`
`[0023], & [0062]; e.g. weight, age, skin temperature, breathing rate, blood volume), based on the
`
`calculated temperature of the patient the system then applies heat to a patient so as to maintain the
`
`patient’s temperature at a set point in order to create a thermoneutral environment meaning thereis
`
`no heat loss and no heat gain ([0056]); therefore it is the examiners position that the system of Utturkar
`
`does determine a body heat score based on one or more physiological indicators and doestransfer heat
`
`to a patient based on whether the patientis likely to sweat, as the system heats the patient to a set
`
`point that has been established to create a thermoneutral environment (e.g. no net heat loss).
`
`Claim Rejections - 35 USC § 103
`
`5.
`
`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.
`
`6.
`
`Claims 1-2, 4-7, 10-13, 15, & 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Utturkar et al. (previously presented-US 20170156923 A1) in view of Augustine (US 5941907 A),
`
`hereinafter Utturkar in view of Augustine.
`
`Regardingclaim 1, Utturkar discloses a system, comprising: a heating device ([0025]; Figure 2—
`
`element 240), wherein the heating device is configured to transfer heat to a patient based on a body
`
`heat score that indicates whether the patientis likely to sweat ([0014], [0025], & [0056]; the heating
`
`system is controlled to maintain the body temperature to a setpoint to create a thermoneutral
`
`environment), the heating device comprising: a heater circuit configured to produce heat ([0025];
`
`Figure 2—element 200 & 240), the heater circuit thermally coupled to the patient ([0025]; Figure 2—
`
`element 240); a controller communicatively coupled to the heater circuit ([0018] & [0025]; Figure 2—
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 4
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`element 200 & 280), the controller comprising: one or more processors ([0018]; Figure 2—element
`
`204) configured to: receive one or more physiological indicators of the patient ([0010], [0020], [0023],
`
`& [0062]; Figure 2—element 226 & 228; the processing circuit communicates with user interface device
`
`226 & sensors 228; processing circuitry can receives input parametersof a patient, such as: skin
`
`temperature, blood temperature, breathing rate, blood volume, heart rate, weight, etc.), wherein the
`
`one or more physiological indicators determine a physiological score ([0010]-[0014], & [0056]-[0057];
`
`Figure 1—element 20; one or more body physiological parameters of a patient (e.g. body temperature,
`
`blood temperature, skin temperature) are determined based on the one or more input), wherein the
`
`physiologically indicators comprise entered physiological indicators from an input component([0015],
`
`[0020], [0022], [0057], [0062]; Figure 2—element 224 & 226; characterizing inputs can be entered by an
`
`operator) and measured physiological indicators from one or more sensors ([0015], [0020], [0022], &
`
`[0023]; Figure 2—element 228); determine the body heat score from one or more physiological scores
`
`([0010]-[0014], [0031]-[0049], & [0056]; the body temperature, skin temperature, etc. is determined
`
`based on the one or moreinputs); determine whether the body heat score meets a score threshold
`
`([0050]; Figure 1—element 30; controller determinesif body temperatureis less than or greater than
`
`setpoint temperature); direct the heater circuit to produce a first amount of heat based on whether
`
`the body heat score meets a score threshold ([0050]; Figure 1—element30; if body temperatureis less
`
`than the setpoint the system is controlled to increase emission of heat energy), wherein the heating
`
`device further comprises a heat transfer device ([0025] & [0060]; Figures 2-4—element 240).
`
`Utturkar does not disclose wherein the heat transfer device is a convective warming blanket.
`
`Augustine teaches a heating device ([Col. 4, lines 30-44]; Figure 1—elements 10 & 18)
`
`comprising a controller ([Col. 4, lines 30-44];Figure 1—element 18c) the heating device configured to
`
`maintain a patient’s temperature ([Col. 1, lines 37-54], [Col. 2, line 20-27], & [Col. 2, lines 30-35]),
`
`wherein the heating device further comprises a heat transfer device ([Col. 4, lines 30-44]; Figure 1—
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 5
`
`element 10), wherein the heattransfer device is a convective warmingblanket ([Col. 4, lines 30-44];
`
`Figure 1—element 10).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the convective heat transfer device, as disclosed by Utturkar, to
`
`include a convective warming blanket, as taught by Augustine, as both references and the claimed
`
`invention are directed toward heating systems for maintaining a patient’s temperature. As disclosed by
`
`Utturkar, the heating system is controlled to maintain the patient’s temperature at a desired
`
`temperature and the heating device can be provided by heated air circulated through the device using a
`
`blower ([0014] & [0060]). As disclosed by Augustine, the heating system is controlled to maintain the
`
`patient’s temperature, the heating device may be provided by an inflatable blanket such that the
`
`heating system convectively delivers heated air, the convective blanket provides a barrier device that
`
`maintains a patient temperature, while differentiating the surgical field from the remainder of the
`
`operating area ([Col. 2, lines 30-34] & [Col. 4, lines 30-44]). It would have been obvious to one of
`
`ordinaryskill in the art, before the effective filing date of the claimed invention, to modify the
`
`convective heat transfer device, as disclosed by Utturkar, to include a convective warming blanket, as
`
`taught by Augustine, as such a modification would producethe predictable result of providing a
`
`convective thermal transfer device that is capable of regulating a patient’s temperature, and would also
`
`provide a barrier device that maintains a patient temperature, while differentiating the surgical field
`
`from the remainder of the operating area.
`
`Regarding claim 2, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses one or more sensors removably attached to the patient and
`
`communicatively coupled to the one or more processors ([0018], [0022], & [0023]; Figure 2—element
`
`228), wherein the one or moresensors are configured to detect one or more physiological indicators
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 6
`
`of the patient ([0023]; Figure 2—element 228; skin temperature, blood temperature, weight, heart rate,
`
`blood flow, breathing, etc.); wherein the one or more processors are configured to: determine the
`
`body heat score of the patient from one or more physiological indicators received from the one or
`
`more sensors([0010]-[0015], [0031]-[0049], & [0056]; Figure 1—element 20).
`
`Regarding claim 4, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses wherein an entered physiological indicator is selected from a group
`
`consisting of: age, height, weight, BMI, gender, body fat percentage, and combinations thereof
`
`([0023], [0056], & [0063]; height, weight, age, etc.; the examiner notesthe rest are in the alternative).
`
`Regarding claim 5, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses wherein the entered physiological indicator is a physiological
`
`condition that is measured no more than 2 times per hour ([0023] & [0082]; a weight value may not be
`
`provided repetitively because the shifts are slower compared to other variables; values that are not
`
`provided repetitively can be obtained on a once per hour, once every two hours, or once every five
`
`hoursbasis).
`
`Regarding claim 6, Utturkar in view of Augustine disclose all of the limitations of claim 2, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processors are configured to: reduce an
`
`amountof heat directed onto the patient in responseto thefirst amount of heat being sufficient
`
`([0050], & [0051]-[0053]; Figures 6D & 6E; if temperature is determined to be greater than set point the
`
`emission of heat energy is decreased); and monitor one or moresensors for one or more physiological
`
`indicators from the patient ([0080]; the program can continuously obtain one or more sensor input
`
`from a sensor).
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 7
`
`Regarding claim 7, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processorsare configured to turn off the
`
`heater circuit in response to the score threshold being met ([0071]; when the temperatureis higher
`
`than the setpoint the powerlevel of the heater tapers off to zero).
`
`Regarding claim 10, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses wherein directing the heating circuit to produce thefirst 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
`
`([0071], [0072], & [0083]; Figure 6C-6E; the system determines a heater system power-level vs. time
`
`curve thatis fed into the heating element, temperature can be re-checked intermittently and compared
`
`to the predicted skin temperature at that time instant)
`
`Regarding claim 11, Utturkar in view of Augustine disclose all of the limitations of claim 10, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processorsare configured to: determine a
`
`second amountofheat to transfer to the patient if the body heat score does not meet the score
`
`threshold and the time condition is met; direct the heater circuit to produce a second amountof heat
`
`([0050] & [0051]; if temperature is determined to be less than the setpoint temperature the heating
`
`system is controlled to increase the emission of heat energy).
`
`Regardingclaim 12, Utturkar in view of Augustine disclose all of the limitations of claim 2, as
`
`described above.
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 8
`
`Utturkar further discloses wherein a physiological indicator measured from the sensor is
`
`measured morethan 2 times per hour ([0015], [0080], & [0082]; sensor input can be obtained
`
`repetitively and continuously).
`
`Regarding claim 13, Utturkar in view of Augustine disclose all of the limitations of claim 1, as
`
`described above.
`
`Utturkar further discloses wherein the body heatscore is an aggregate of one or more
`
`physiological scores ([0010]-[0014] & [0023]); and wherein one or more physiological scoresis
`
`determined by a dropin a blood pressure measurementover a period of time ([0015], [0023], & [0065;
`
`the one or more inputs can be repetitively obtained; a blood volume sensor can be used, blood volume
`
`can significantly impact a thermal conductivity between a patient’s skin and a patient’s core).
`
`Regardingclaim 15, Utturkar discloses a system, comprising: one or more sensors removably
`
`attached to a patient ([0015], [0020], [0022], & [0023]; Figure 2—element 228) and communicatively
`
`coupledto one or more processors([0018] & [0022]; Figure 2—element 204), wherein the one or more
`
`sensors are configured to detect one or more physiological indicators of the patient ([0010], [0020],
`
`[0023], & [0062]; Figure 2—element 228; sensors can be used to sense parametersof a patient, such as:
`
`skin temperature, blood temperature, breathing rate, blood volume, heart rate, weight, etc.); a heating
`
`device ([0025]; Figure 2—element 240), wherein the heating device is configured to transfer heat to
`
`the patient sufficient to increase a body heat contentof the patient ((0014], [0025], & [0056]; the
`
`heating system is controlled to maintain the body temperature to a setpoint to create a thermoneutral
`
`environment), the heating device comprising: a heater circuit configured to produce heat ([0025];
`
`Figure 2—element 200 & 240), the heater circuit thermally coupled to the patient ([0025]; Figures 2-
`
`4—element 240); a controller communicatively coupled to the one or moresensorsandthe heating
`
`device ([0018]-[0022]; Figure 2—element 200 & 280), the controller comprising: a memory ([0018];
`
`Figure 2—element 208); and one or more processors communicatively coupled to the memory ([0018]
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 9
`
`& [0022]; Figure 2—element 204) configured to: receive one or more physiological indicators of the
`
`patient ([0010], [0020], [0023], & [0062]; Figure 2—element 226 & 228; the processing circuit
`
`communicates with user interface device 226 & sensors 228; processing circuitry can receives input
`
`parametersof a patient, such as: skin temperature, blood temperature, breathing rate, blood volume,
`
`heart rate, weight, etc.), wherein the one or more physiological indicators determine a physiological
`
`score ([0010]-[0014], & [0056]-[0057]; Figure 1—element 20; one or more body physiological
`
`parametersof a patient (e.g. body temperature, blood temperature, skin temperature) are determined
`
`based on the one or moreinput), wherein the physiologically indicators comprise entered
`
`physiological indicators from an input component ((0015], [0020], [0022], [0057], [0062]; Figure 2—
`
`element 224 & 226; characterizing inputs can be entered by an operator) and measured physiological
`
`indicators from the one or more sensors ([0015], [0020], [0022], & [0023]; Figure 2—element 228);
`
`determine a first amountof heat to transfer to a patient ([0050]-[0053]; controller determines whether
`
`or not to increase emission of heat energy based on comparing temperature to a setpoint temperature)
`
`with a heat transfer device ([0025] & [0060]; Figures 2-4—element 240); direct the heater circuit to
`
`produce a first amountof heat; determine a body heat content of the patient from one or more
`
`physiological scores ([0010]-[0014], [0031]-[0049], & [0056]; the body temperature, skin temperature,
`
`etc. is determined based on the one or more inputs); and determine whether thefirst amountof heat
`
`is sufficient for the patient to increase body heat content without sweating ([0050]-[0053] & [0056]).
`
`Utturkar does not disclose wherein the heat transfer device is a convective warming blanket.
`
`Augustine teaches a heating device ([Col. 4, lines 30-44]; Figure 1—elements 10 & 18)
`
`comprising a controller ([Col. 4, lines 30-44];Figure 1—element 18c) the heating device configured to
`
`maintain a patient’s temperature ([Col. 1, lines 37-54], [Col. 2, line 20-27], & [Col. 2, lines 30-35]),
`
`wherein the heating device further comprises a heat transfer device ([Col. 4, lines 30-44]; Figure 1—
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 10
`
`element 10), wherein the heattransfer device is a convective warming blanket([Col. 4, lines 30-44];
`
`Figure 1—element 10).
`
`A person ofordinaryskill in the art, before the effective filing date of the claimed invention,
`
`would have been motivated to modify the convective heat transfer device, as disclosed by Utturkar, to
`
`include a convective warming blanket, as taught by Augustine, as both references and the claimed
`
`invention are directed toward heating systems for maintaining a patient’s temperature. As disclosed by
`
`Utturkar, the heating system is controlled to maintain the patient’s temperature at a desired
`
`temperature and the heating device can be provided by heated air circulated through the device using a
`
`blower ([0014] & [0060]). As disclosed by Augustine, the heating system is controlled to maintain the
`
`patient’s temperature, the heating device may be provided by an inflatable blanket such that the
`
`heating system convectively delivers heated air, the convective blanket provides a barrier device that
`
`maintains a patient temperature, while differentiating the surgical field from the remainder of the
`
`operating area ([Col. 2, lines 30-34] & [Col. 4, lines 30-44]). It would have been obvious to one of
`
`ordinaryskill in the art, before the effective filing date of the claimed invention, to modify the
`
`convective heat transfer device, as disclosed by Utturkar, to include a convective warming blanket, as
`
`taught by Augustine, as such a modification would producethe predictable result of providing a
`
`convective thermal transfer device that is capable of regulating a patient’s temperature, and would also
`
`provide a barrier device that maintains a patient temperature, while differentiating the surgical field
`
`from the remainder of the operating area.
`
`Regardingclaim 17, Utturkar in view of Augustine disclose all of the limitations of claim 15, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processors are configured to: reduce an
`
`amountof heat directed onto the patient in responseto thefirst amount of heat being sufficient
`
`([0050], & [0051]-[0053]; Figures 6D & 6E; if temperature is determined to be greater than set point the
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 11
`
`emission of heat energy is decreased); and monitor one or moresensors for one or more physiological
`
`indicators from the patient ([0080]; the program can continuously obtain one or more sensor input
`
`from a sensor).
`
`Regarding claim 18, Utturkar in view of Augustine disclose all of the limitations of claim 15, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processorsare configured to determine a
`
`body heat contentof the patient ([0010]-[0014], & [0030]; Figure 1—element30) by: receiving a first
`
`set of one or more physiological indicators from the one or more sensors 0010], [0020], [0023], &
`
`[0062]; Figure 2—element 226 & 228; the processing circuit communicates with user interface device
`
`226 & sensors 228; processing circuitry can receives input parameters of a patient, such as: skin
`
`temperature, blood temperature, breathing rate, blood volume, heart rate, weight, etc.); determining a
`
`first physiological score from the first set of one or more physiological indicators ([0010]-[0014],
`
`[0031]-[0049], & [0056]; the body temperature, skin temperature, etc. is determined based on the one
`
`or more inputs); determining a body heat score from one or more physiological scores ([0010]-[0014],
`
`[0031]-[0049], & [0056]; the body temperature, skin temperature, etc. is determined based on the one
`
`or moreinputs).
`
`Regardingclaim 19, Utturkar in view of Augustine disclose all of the limitations of claim 18, as
`
`described above.
`
`Utturkar further discloses wherein the one or more processors are configured to determine
`
`whether a first amount of heatis sufficient by determining whether a body heat score meets a score
`
`threshold ([0050]).
`
`Regarding claim 20, Utturkar in view of Augustine disclose all of the limitations of claim 15, as
`
`described above.
`
`

`

`Application/Control Number: 16/621,297
`Art Unit: 3794
`
`Page 12
`
`Utturkar further discloses wherein the one or more processorsare configured to turn off the
`
`heater circuit in response to the score threshold being met ([0071]; when the temperatureis higher
`
`than the setpoint the powerlevel of the heater can taper off to zero).
`
`7.
`
`Claims 14 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Utturkar in view of
`
`Augustine and Grahn etal. (previously presented-US 20050103353 A1), hereinafter Grahn.
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`Regardingclaim 14, Utturkar in view of Augustine disclose all of the limitations of claim 13, as
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`described above.
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`Utturkar does not disclose wherein one or more physiological scores is determined by a fingertip
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`to forearm temperature differential.
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`Grahn teaches a heating system, comprising: a heating device configured to produce heat
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`([0055]; Figure 1—element 6), a controller communicatively coupled to the heater circuit ([0055],
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`[0056], & [0057]; Figure 1—element 6), one or more processors ([0056]) configured to: receive one or
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`more physiological indicators of the patient ([0055], [0061], & [0061]; Figure 1—elements 10 & 11),
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`wherein one or more physiological scores is determined by a fingertip to forearm temperature
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`differential ([0037] & [0065]).
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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 heating system, as disclosed by Utturkar, to include heat
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`transfer sensing, as taught by Grahn, as both references and the claimed invention are directed toward
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`heater systems that supply heat to a patient based on monitored patient characteristics. As disclosed by
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`Grahn, vasoconstriction of blood flow within a body portion occurs below a certain measurable
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`temperature range, while vasodilation occurs at some point above that temperature range ([0070]); the
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`state of vasoconstriction or vasodilation can be determined by various methods and devices, such as by
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`monitoring blood flow in a particular body portion ([0034] & [0035]), measuring the body temperature
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`of a patient ([0040]), measuring the skin temperature of a patient ([0042]), or measuring the
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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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`temperaturedifference between a finger and corresponding forearm ([0037]); the methods of
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`determining vasodilation or vasoconstriction can include any combination of these approaches and
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`provide the advantage of enabling increased heat transfer from the bodyof a patient ([0043] & [0071))
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`and addressing the hysteresis phenomena ([0072]). It would have been obvious to one of ordinaryskill
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`in the art, before the effective filing date of the claimed invention, to modify the heating system, as
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`disclosed by Utturkar, to include the sensing, as taught by Grahn, as such a modification would enable
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`increased heat transfer from the body of the patient, and address the hysteresis phenomena.
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`Regarding claim 16, Utturkar in view of Augustine disclose all of the limitations of claim 15, as
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`described above.
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`Utturkar does not disclose wherein determining whether the first amount of heat is sufficient
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`comprises: determining whether vasodilation has occurred in the patient using the one or more
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`physiological indicators from the sensor.
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`Grahn teaches a heating system, comprising: one or more sensors configured to detect one or
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`more physiological indictors of a patient ([0055], [0061], & [0062]; Figure 1—element 10 & 11) a heating
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`device configured to produce heat ([0055]; Figure 1—element 6), a controller communicatively coupled
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`to the heater device ([0055], [0056], & [0057]; Figure 1—element6), one or more processors ([0056])
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`configured to: receive one or more physiological indicators of the patient ([0055], [0061], & [0062];
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`Figure 1—elements 10 & 11); determine the body heat score from one or more physiological indicators
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`([0007], [0034]-[0038], [0040]-[0043], [0061], & [0062]; the sensors are used to determine whether the
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`bodyis in a state of vasoconstriction or vasodilation), and determine whether the first amount of heatis
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`sufficient for the patient to increase body heat ([0075] & [0076]; Figure 5—elements “5-14”,”5-16", &
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`“5-18” the system determines/senses whether a body portion is in a state of vasoconstriction or
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`vasodilation, if the body portion is in a state vasoconstriction the interface temperatureis raised until
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`vasodilation is sensed), ) wherein determining whether the first amountof heatis sufficient comprises:
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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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`determining whether vasodilation has occurred in the patient using the one or more physiological
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`indicators from the sensor ([0042], [0075]-[0077]; Figure 5—element 5-2; once the bodyis in a state of
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`vasodilation the interface temperature is lowered).
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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 heating system, as disclosed by Utturkar, to include the
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`teachings of Grahn, as described above, as both references and the claimed invention are directed
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`toward devices that supply heat to a patient when a patient’s temperatureis less than a predetermined
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`threshold. As disclose by Grahn, the system determines whether a body portion is in a state of
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`vasoconstriction or vasodilation, if the body portion is in a state of vasoconstriction the system will apply
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`heat until vasodilation is sensed ([0075] & [0076]), vasoconstriction and vasodilation can be determined
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`by measuring skin temperature, such that a cold skin temperature indicates vasoconstriction and a
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`warm skin temperature indicated vasodilation ([0042]). As disclosed by Utturkar, the system monitors
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`the patient’s temperature, when the patient’s temperatureis less than the setpoint temperature the
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`system applies heat to the patient until the patient’s temperature reaches the setpoint temperature
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`([0050]). 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 threshold temperature, of Utturkar, to include the vasodilation
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`threshold temperature, as taught by Grahn, as such a modification would produce the predictable result
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`of raising a patient’s temperature from a cold condition to a warm condition.
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`Accordingly, claims 1-2, 4-7, & 10-20 are rejected.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the exam