DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed December 04, 2025 have been entered. Applicant’s amendments have overcome the Drawing objection, the Specification objection, the claim objection, and the 112(a) rejection previously set forth in the Non-Final Rejection mailed on 09/25/2025. Currently, claims 1, 11-12, and 20 have been amended, claim 10 has been newly cancelled, and claims 1-9, 11-18, and 20 are pending in the application.
Claim Objections
Claim 12 is objected to because of the following informalities: the phrase “comprising controlling the first heater is based on” is recommended to be further amended to remove the “is” after “heater”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Timme (W.O. Application No. 2013058799 A1), in view of Shaefer (U.S. Application No. 20170296378 A1), in view of Barker (U.S. Application No. 20130085609 A1), and further in view of Starr (U.S. Patent No. 10966615 B2).
Regarding independent claims 1 and 11, Timme discloses a medical device (5) and a method for controlling the medical device for warming a patient (pa. 0018), the medical device comprising:
a bed (10) configured to support the patient thereon (pa. 0021 & Fig. 1);
walls (15) that at least partially enclose the bed (pa. 0021);
a second heater (25) configured to produce heat for the patient when supported on the bed (pa. 0024), and being coupled to the bed so as to be moveable therewith (see Fig. 1, the heater is coupled to heating module 20 which is positioned on a stand 7 (pa. 0021), wherein the figure shows the stand is moveable via wheels);
a first temperature sensor (65) that detects an inside air temperature within the walls that at least partially enclose the bed (pa. 0024, 0033) and being coupled to the bed so as to be moveable therewith (see Fig. 1, the first temperature sensor is coupled to an environmental sensor module 60 which is coupled to one of the walls), wherein the second heater is controlled based on the inside air temperature (pa. 0024);
a controller (80) in communication with the first temperature sensor, wherein the controller produces a signal based on the inside air temperature from the first temperature sensor to adjust the inside air temperature within the walls that at least partially enclose the bed (pa. 0024).
However, Timme does not disclose a first heater controllable based on a room-based temperature sensor.
Shaefer, in the same field of endeavor, teaches a medical device (500) comprising a dual input thermostat (510) which includes an internal room temperature sensor (522) (i.e., a room-based temperature sensor that is different from the first temperature sensor and the second temperature sensor) (pa. 0065 & Fig. 5). The thermostat receives temperature inputs from both the internal room temperature sensor and/or a remote skin temperature sensor in order to instruct a connected HVAC system (532) (i.e. a first heater that is different from the second heater) to provide the temperature required to keep a person within a predetermined threshold (pa. 0065). Shaefer teaches controlling, or automatically adjusting the ambient air temperature to be within a threshold value (pa. 0071- 0072).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the room-based temperature sensor and the first heater to the medical device of Timme in order to provide additional temperature control of a room by taking into account additional input values of the ambient temperature of the room.
However, Timme/Schaefer combination do not teach the medical device being located in a room, nor a second temperature sensor that detects an ambient air temperature outside the walls that at least partially enclose the bed, nor the controller being in communication with the second temperature sensor and being configured to compare the ambient air temperature to a threshold and to produce a signal when the ambient air temperature is determined to be outside the threshold so as to assist in adjusting the ambient air temperature via the first heater to be within the threshold, wherein the signal is produced as an instruction to adjust the ambient temperature.
Barker, in the same field of endeavor, teaches a patient room (100) comprising a patient room environmental control system (150) (pa. 0107 & Fig. 1), wherein the control system is configured to control the ambient air temperature of the room and other air conditions or variables (via an HVAC unit 154, which is analogous to the first heater of Shaefer) by receiving temperature inputs from a second temperature sensor (152) (pa. 0111) that detects an ambient air temperature outside the walls of a partially enclosed bed (see Fig. 1), wherein the second temperature sensor is different from the first temperature sensor and the room-based temperature sensor. Furthermore, the second temperature sensor may have a wired or a wireless communication with the heating HVAC unit (pa. 0112- 0113).
Barker further teaches a controller (300) comprising a processor (204) and a memory (206) that stores a control routine (302) (analogous to the controller of Timme), wherein the control routine directs the operation of the systems operable within the environmental control system (i.e., the controller is in communication with the second temperature sensor) (pa. 0128 & Fig. 3A) based on a detected change of state (step 504 & Fig. 5). The state of change is a temperature indication generated by the second temperature sensor corresponding to the ambient air temperature within the patient’s room. If the second temperature sensor detects that the ambient air temperature within the patient room has changed, the detected temperature value is communicated from the second temperature sensor to the HVAC unit, wherein the sensed temperature is compared to a stored threshold value, the control routine automatically prompts an increase/decrease in the airflow and/or in the air temperature within the patient’s room in an attempt to drive the ambient air temperature to the threshold level (pa. 0144).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a patient room, a second temperature sensor, and a first heater to the medical device of Timme, as well as to have modified the functions of the controller of Timme to receive temperature inputs from the second temperature sensor of Barker in order to compare it to a threshold, for the purpose of providing an additional temperature input which further allows the first heater of the medical device of Timme to more efficiently maintain the patient under recommended temperatures.
However, Timme/Shaefer/Barker combination does not teach the second temperature sensor being coupled to the bed so as to be moveable into and out of the room therewith.
Starr, in the same field of endeavor, teaches an air temperature sensor that may be mounted on top of a sidewall of an infant holding area (302) such that it is movable with the bed (Col. 4, lines 18-21; Col. 8, lines 50-54 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the second temperature in a location that would allow it to move with the bed because any location of an air temperature sensor is acceptable since it would yield the same predictable results of measuring the ambient air temperature of the room.
Regarding claim 2, Timme/Shaefer/Barker/Starr combination discloses wherein the second heater is also controlled based on the signal produced by the controller (Timme, pa. 0024).
Regarding claims 3 and 13, Timme/Shaefer/Barker combination discloses the invention substantially as claimed in claims 1 and 11 discussed above.
However, they do not disclose wherein the heat provided by the second heater is also controlled as a function of a gestational age of the patient, a post-conceptual age of the patient, and a birth weight of the patient.
Starr, in the same field of endeavor, teaches an apparatus (100) for warming a patient, comprising a heating device (240) (analogous to the second heater of Timme) an air temperature sensor (228) (analogous to the first temperature sensor of Timme) mounted on a top of a sidewall of an infant holding area (302) (analogous to the bed and walls that at least partially enclose the bed of Timme) configured to sense the air temperature representative of the air temperatures in which the infant held within infant holding area is exposed is being exposed to (Col. 8, lines 50-65 & Fig. 3). Starr further teaches wherein the heat provided by the second heater is controlled as a function of a gestational age of the patient, a post-conceptual age of the patient, and a birth weight of the patient (Col. 7, lines 62-67 – Col. 8, lines 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat provided by the second heater of Timme to be controlled as function of patient parameters, as taught by Starr, in order to determine the appropriate amount of heat needed for each patient.
Regarding claims 4 and 14, Timme/Shaefer/Starr combination discloses further comprising a display device (23) in communication with the controller, wherein the display device displays the inside air temperature detected by the first temperature sensor (Timme, pa. 0027, 0028).
However, they do not disclose the display device displaying the ambient air temperature detected by the second temperature sensor.
Barker, in the same field of endeavor, teaches a user interface (400) which illustrates the ambient temperature value (416) detected by the second temperature sensor (152) (pa. 0145 & Fig. 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the display of Timme to incorporate images of the current/detected ambient air temperature for the purpose of providing additional temperature information that is useful to the user to properly warm a patient.
Regarding claims 5 and 15, Timme/Shaefer/Starr combination discloses further comprising a display device (23), wherein the signal from the controller causes the display device to produce a warning when the inside air temperature is below the threshold (Timme, pa. 0026).
However, they do not disclose producing a warning when the ambient air temperature is below the threshold.
Barker, in the same field of endeavor, teaches the control routine remains in an idle state until a change of state or a state event associated with an environmental condition within the patient room being monitored is detected (step 504) (pa. 0132 & Fig. 5). A change of state or a state event is a command (or a warning) that influences or alters the environmental within the patient’s room. For example, if the control routine detects a change of state (i.e., a decrease/increase in the ambient air temperature above or below the threshold), then the HVAC unit is prompted to increase/decrease airflow/air temperature within the room (pa. 0144).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display of Timme to include a warning when the ambient air temperature is below the threshold for the purpose of providing additional temperature information that is useful to the user to properly warm a patient.
Regarding claims 6 and 16, Timme/Shaefer/Barker/Starr combination discloses further comprising a speaker, and wherein the signal from the controller causes the speaker to produce an audible warning (Timme, pa. 0026).
Regarding claims 7 and 17, Timme/Schaefer/Starr combination discloses wherein the warning includes an indication to increase inside air temperature (Timme, pa. 0024, 0026).
However, they do not disclose wherein the indication causes an increase in the ambient temperature.
Barker, in the same field of endeavor, teaches if the control routine detects a change of state (i.e., a decrease/increase in the ambient air temperature above or below the threshold), then the HVAC unit is prompted to increase/decrease airflow/air temperature within the room (pa. 0144).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display of Timme to include a warning when the ambient air temperature is below the threshold for the purpose of providing additional temperature information that is useful to the user to properly warm a patient.
Regarding claims 8 and 18, Timme/Schaefer/Starr combination discloses the invention substantially as claimed in claims 1 and 11 discussed above.
However, they do not disclose wherein the controller is configured to communicate with an electronic medical record system, and wherein at least one of the ambient air temperature and the comparison of the ambient air temperature to the threshold is provided to the electronic medical record system.
Barker, in the same field of endeavor, teaches wherein the controller (via the processor 1004 and/or the memory 1006) is configured to communicate with an electronic medical record system (pa. 0091), and wherein at least one of the ambient air temperature and the comparison of the ambient air temperature to the threshold is provided to the electronic medical record system (pa. 0100, 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an electronic medical record for the purpose of allowing for time-efficient review of patient data, confirmation of review visitation, and enhanced decision support.
Regarding claim 9, Timme/Schaefer combination discloses wherein the bed is at least partially enclosed within walls (15), wherein the second heater provides the heat within the walls (Timme, pa. 0021-0022 & Fig. 1).
However, they do not disclose detecting the ambient air temperature outside the walls.
Barker, in the same field of endeavor, teaches the control system configured to control the ambient air temperature of the room (via an HVAC unit 154) via the second temperature sensor (152) (pa. 0111) that detects an ambient air temperature outside the walls of a partially enclosed bed (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a second temperature sensor and a first heater to the medical device of Timme for the purpose of allowing the medical device to maintain the patient under recommended temperatures.
However, Timme/Schaefer/Barker combination do not disclose a cover.
Starr, in the same field of endeavor, teaches the apparatus (100) comprising two embodiments of the infant holding area (302), the first one illustrating side walls (Fig. 3) (analogous to the embodiment of Timme) and the second illustrating side walls and a cover (Fig. 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the walls that partially enclosed the bed of Timme with the side walls and cover of Starr in order to minimize temperature fluctuations by reducing drafts and other unwanted external temperature changes.
Regarding claim 12, Timme/Starr combination discloses the invention substantially as claimed in claim 11 and discussed above.
However, they do not disclose controlling the first heater based on the second temperature sensor.
Schaefer teaches an embodiment in which multiple air temperature sensors can be connected with the single thermostat and the data aggregated to operate the thermostat and the HVAC system (pa. 0071).
Barker teaches the HVAC unit 154 (analogous to the first heater of Shaefer) which receiving temperature inputs from a second temperature sensor (152) (pa. 0111) that detects an ambient air temperature outside the walls of a partially enclosed bed (see Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the input of the second temperature sensor of Barker to control the output of the first hearer in order to provide for additional information that efficiently adjusts the ambient air temperature in the room to the correct temperature.
Regarding independent claim 20, Timme discloses a medical device (5) for an infant patient device (pa. 0018), the medical device comprising:
a bed (10) configured to support the patient thereon (pa. 0021 & Fig. 1);
a first temperature sensor (65) that detects an inside air temperature proximate the bed (pa. 0024), wherein the first temperature sensor is coupled to the bed so as to be moveable therewith (see Fig. 1, the first temperature sensor is coupled to an environmental sensor module 60 which is coupled to one of the walls);
a second heater (25) configured to produce heat for the patient when supported on the bed (pa. 0024), wherein the second heater is coupled to the bed so as to be moveable therewith (see Fig. 1, the heater is coupled to heating module 20 which is positioned on a stand 7 (pa. 0021), wherein the figure shows the stand is moveable via wheels); and
a controller (80) in communication with the second heater, the first temperature sensor (pa. 0024), wherein the controller controls the heat provided by the second heater based on the inside air temperature from the first temperature sensor (pa. 0024).
However, Timme does not disclose a first heater controllable based on a room-based temperature sensor, nor a controller in communication with the first heater.
Shaefer, in the same field of endeavor, teaches a medical device (500) comprising a dual input thermostat (510) which includes an internal room temperature sensor (522) (i.e., a room-based temperature sensor that is different from the first temperature sensor and the second temperature sensor) (pa. 0065 & Fig. 5). The thermostat receives temperature inputs from both the internal room temperature sensor and/or a remote skin temperature sensor in order to instruct a connected HVAC system (532) (i.e. a first heater that is different from the second heater) to provide the temperature required to keep a person within a predetermined threshold (pa. 0065). Shaefer teaches controlling, or automatically adjusting the ambient air temperature to be within a threshold value (pa. 0071- 0072).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the room-based temperature sensor and the first heater to the medical device of Timme in order to provide additional temperature control of a room by taking into account additional input values of the ambient temperature of the room.
However, Timme/Schaefer combination do not teach the medical device being located in a room, nor a second temperature sensor that detects an ambient air temperature away from the bed, nor the controller being in communication with the second temperature sensor and being configured to compare the ambient air temperature detected by the second temperature sensor to a threshold and to automatically control the first heater so as to change the ambient air temperature when below the threshold.
Barker, in the same field of endeavor, teaches a patient room (100) comprising a patient room environmental control system (150) (pa. 0107 & Fig. 1), wherein the control system is configured to control the ambient air temperature of the room and other air conditions or variables (via an HVAC unit 154, which is analogous to the first heater of Shaefer) by receiving temperature inputs from a second temperature sensor (152) (pa. 0111) that detects an ambient air temperature away from the bed (see Fig. 1), wherein the second temperature sensor is different from the first temperature sensor and the room-based temperature sensor. Furthermore, the second temperature sensor may have a wired or a wireless communication with the heating HVAC unit (pa. 0112- 0113).
Barker further teaches a controller (300) comprising a processor (204) and a memory (206) that stores a control routine (302) (analogous to the controller of Timme), wherein the control routine directs the operation of the systems operable within the environmental control system (i.e., the controller is in communication with the second temperature sensor) (pa. 0128 & Fig. 3A) based on a detected change of state (step 504 & Fig. 5). The state of change is a temperature indication generated by the second temperature sensor corresponding to the ambient air temperature within the patient’s room. If the second temperature sensor detects that the ambient air temperature within the patient room has changed, the detected temperature value is communicated from the second temperature sensor to the HVAC unit, wherein the sensed temperature is compared to a stored threshold value, the control routine automatically prompts an increase/decrease in the airflow and/or in the air temperature within the patient’s room in an attempt to drive the ambient air temperature to the threshold level (pa. 0144).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the patient room, a second temperature sensor, and a first heater to the medical device of Timme, as well as to have modified the functions of the controller of Timme to receive temperature inputs from the second temperature sensor of Barker in order to compare it to a threshold, for the purpose of allowing the medical device to maintain the patient under recommended temperatures.
However, Timme/Shaefer/Barker combination does not teach the second temperature sensor being coupled to the bed so as to be moveable into and out of the room therewith.
Starr, in the same field of endeavor, teaches an air temperature sensor that may be mounted on top of a sidewall of an infant holding area (302) such that it is movable with the bed (Col. 4, lines 18-21; Col. 8, lines 50-54 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the second temperature in a location that would allow it to move with the bed because any location of an air temperature sensor is acceptable since it would yield the same predictable results of measuring the ambient air temperature of the room.
Response to Arguments
Applicant’s arguments, see pages 9-11, filed 12/04/2025, with respect to the 103 rejection of claims 1, 11, and 20 under Timme, Schaefer, and Barker have been fully considered but are not persuasive.
With regards to independent claims 1, 11 and 20, Applicant argues that the Barker reference does not teach "the second temperature sensor being different than the first temperature sensor and different than the room-based temperature sensor". Specifically, Applicant contends that simply citing two references (Schaefer and Barker) wherein each discloses an air temperature sensor that controls an HVAC system doesn't mean one of ordinary skill in the art would have combined these parts of these systems together, particularly since neither Schaefer's nor Barker’s system need another temperature sensor, nor provide any suggestion for doing so, and there is no teaching or logical reason that these thermostats would behave differently. However, Examiner respectfully disagrees.
The claim language of all three independent claims state a first heater controllable based on a room-based temperature sensor; a second temperature sensor that detects an ambient air temperature outside the walls that at least partially enclose the bed, the second temperature sensor being different than the first temperature sensor and different than the room-based temperature sensor. The broadest reasonable interpretation of the claims is one temperature sensor which senses the air temperature in a room and whose feedback is utilized to control a heater, and an additional temperature sensor that detects essentially the same air temperature of the room; there is no claim language directed to or suggesting that the room-based temperature performs a task that is different/distinct from the second temperature sensor. The claim is broad and does not specify if there is difference between a room-based temperature and an ambient air temperature; it is silent on the specific difference between these two temperature sensors and does not distinguish how they would behave differently from each other. Therefore, as long as the combination of references is able to teach multiple air temperature sensors that detect room/ambient temperature of a room, not including the ambient air temperature found inside the bed confided by the walls, then the references meet the claim language.
Shaefer teaches a medical device (500) comprising a thermostat (510) that includes an internal room temperature sensor (522) (i.e., a room-based temperature sensor) (pa. 0065 & Fig. 5). The thermostat receives temperature inputs from the internal room temperature sensor in order to instruct an HVAC system (532) (i.e. a first heater) to provide the temperature required to keep a person within a predetermined threshold (pa. 0065). It would have been obvious to one of ordinary skill in the art to have added the room-based temperature sensor and the first heater to the medical device of Timme in order to provide additional temperature control of a room by taking into account additional input values of the ambient temperature of the room.
The Barker reference teaches a patient room (100) comprising a patient room environmental control system (150) (pa. 0107 & Fig. 1), wherein the control system is configured to control the ambient air temperature of the room via an HVAC unit (154) (which is analogous to the first heater of Shaefer) which receives input information from a second temperature sensor (152) (pa. 0111) that detects an ambient air temperature outside the walls of a partially enclosed bed (see Fig. 1). It would have been obvious to one of ordinary skill in the art to have added the second temperature sensor for the purpose of providing an additional temperature input which further allows the medical device of Timme to more efficiently maintain the patient under recommended temperatures.
In regards to Applicant’s argument of how both Shaefer and Barker’s temperature sensors have duplicate functions, and therefore one of ordinary skill in art would not have combined them, Examiner disagrees. As stated previously, the claim language of the independent claims are broad and not assign a separate function between the room-based temperature sensor and the second temperature sensor; Examiner is interpreting both sensors as essentially being duplicates of each other given they have the same functionality of detecting air temperature sensor of a room/not the air temperature inside the walls of the bed. Therefore, the rejection stated above simply combines these two references to provide the medical device with multiple temperature inputs that allow a heater to more accurately modify the temperature of the room. Hence, for the reasons set-forth above, the rejection based on the combination of Timme, Schaefer, and Barker is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794