DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 10 November 2025. Claims 1-17, 19-20 are now pending. The Examiner acknowledges the amendments to claims 1, 2, 4, 5, 11, 16, 19.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
-Claim 1 recites “wherein the bed and the canopy define an environment around the baby” in lines 3-4. Examiner recommends amending to –wherein the bed and the canopy are configured to define an environment around the baby—
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
- Claims 1 and 11 recites "temperature control device" which is a generic
placeholder. There is no sufficient structure for this limitation provided in the
claims. The function of this limitation is to heat and cool the environment. According to the specification the controller includes a heater or cooler [0031]
and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “the interior” in line 5. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “the temperature of the environment” in line 12. There is insufficient antecedent basis for this limitation in the claim.
-Claim 11 recites “the interior” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 6, 7, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Timme (WO 2013058799).
Regarding Claim 1, Timme teaches an incubator, [0002; “The subject matter described herein relates to automatically monitoring and controlling the rate of temperature change of in an incubator or warmer environment.”]
Comprising: a bed configured to receive a baby; [Fig. 1, element 10] and [0040; “infants that are well and ready to be moved from the incubator, are typically weaned from the warming system based on age and gestation.”]
a canopy positioned over the bed, [Fig. 1, element 15].
wherein the bed and the canopy define an environment around the baby; [0006; “The system can further include an environmental sensor module having one or more air temperature sensors. The one or more air temperature sensors can be configured to measure air temperature within the patient environment, which can be closed.”]
and wherein the environment is a closed bed mode with an internal volume defined by the interior of the bed and the canopy [0009 and 0024]—reference to the patient environment being closed,
a sensor configured to measure a temperature of the baby; [0004; “The system includes a sensor module having a skin temperature sensor and a skin temperature controller operatively coupled to the skin temperature sensor and to the heater.”]
a temperature control device configured to heat and cool the environment; [0021; “The system 5 can include a heating module 20 that can include one or more heating units to direct warming energy for different purposes such as a main air heater 25, a mattress heater 30, and/or a humidity heater 35 or other air warmer. The mattress heater 30 can provide heat to the patient by contact between the patient and the mattress 10 or coverings surrounding the mattress 10.”] and [0046]—discloses situations where the device can be set to cooling mode.
and a computing system configured to: obtain a first desired environmental temperature (DET) for the baby; [0040; “The skin temperature of the infant is monitored by the system for fluctuations of temperature outside of the acceptable range.”]
obtain a DET zone for the baby based upon the first DET; [Fig. 4, element 420].
control the temperature of the environment with the temperature control device during a first period time based upon the first DET, the DET zone, or both; [Fig. 4, element 425].
calculate a second DET for the baby after the temperature of the environment has been controlled during the first period of time; [Fig. 4, element 420b].
compare the second DET to the first DET, the DET zone, or both; [Fig. 4, element 435b].
and trigger an alarm in response to the comparison. [0026; “The system 5 can also include various indicators and/or alarms to indicate status of the device. For example, an alarm can sound when a sensed condition (e.g. skin temperature, air temperature, oxygen, humidity, CO2 etc.) is outside of a set range or limit. The indicator and/or alarm may be a visual indication, auditory indication, tactile indication, and the like.”]
Regarding Claim 4, Timme further teaches wherein the second DET is based upon the temperature of the baby measured after the temperature of the environment has been controlled during the first period of time [Fig. 4, element 435b] and [0037; “If the Goal Skin Temp has not been reached, the system will determine the next Skin Set-Point (420b), which is equal to the Skin Sp 1 + Step Temp Increase. The system Regulates Heating Module in Skin Mode ( 425b) for the defined Step Duration. The system monitor whether the Goal Skin Temp is reached (435b).”]
Regarding Claim 5, Timme further teaches wherein the computing system is further configured to control the temperature of the environment with the temperature control device during a second period of time based upon the second DET [Fig. 4, element 445b] and [0037; “If the Goal Skin Temp has been reached, Warm-up Mode will end and the system 5 can continue operating in Skin Mode ( 445b ). If the Goal Skin Temp has not been reached, the system will determine the next Skin Set-Point (420c).”]
Regarding Claim 6, Timme further teaches wherein the alarm is triggered in response to the second DET being outside of the DET zone [Fig. 5, element 545] and [0043; “If Level 1 Skin Temp lies outside the weaning abort deviation range, then the system 5 can End Weaning Mode (545) and/or an alarm can sound.”]
Regarding Claim 7, Timme further teaches wherein the alarm is triggered in response to the second DET being outside of the DET zone for more than a predetermined amount of time or by more than a predetermined temperature [0037; “The system automatically Regulates Heating Module in Skin Mode ( 425) for the defined Step Duration as described above.”] and [0036; “In some implementations, Step Duration can be at least about 2, 4, 6, 8, 10, 12, 15, 18, 20, 22, 25, 28, 30 or more minutes. In some implementations, Step Temp Increase can be between about 0.1°C to 1.0°C.”]
Regarding Claim 8, Timme further teaches wherein the alarm is triggered in response to a slope of the second DET deviating from a slope of the first DET by more than a predetermined amount [Fig. 5, element 514] and [0042; “FIG. 5 illustrates an example of a Weaning Mode operation. Upon start of the Weaning Mode 330, the system 5 can switch into Air Mode 310. Weaning Mode Begins (500) and a user is prompted to Set Goal Air Temp (505), Set Step Duration (510), Set Step Temp Decrease (515), Set Goal Skin Temp (512) and Set Weaning Abort Deviation (514).”] and [0043; “If Level 1 Skin Temp lies outside the weaning abort deviation range, then the system 5 can End Weaning Mode (545) and/or an alarm can sound…If Level 2 Skin Temp lies outside the deviation range, then the system 5 can End Weaning Mode (545b) and/or an alarm can sound.”]
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Gadgil (U.S. 20200179206).
Regarding Claim 2, Timme teaches the incubator of claim 1. Timme is silent on wherein the first DET is based upon a gestational age of the baby, a number of days of life of the baby, a weight of the baby, a health of the baby, or a combination thereof.
Gadgil teaches wherein the first DET is based at least partially upon a gestational age of the baby, a number of days of life of the baby, a weight of the baby, a health of the baby, or a combination thereof [0030; “The measured/monitored parameters may include heart rate, respiration rate, temperature, weight/weight gain, acceptance of oral feeds, sucking reflex, gestational age at time of weaning, and duration of time in the microenvironment at the time the patient was weaned off a microenvironment ( or within a given time duration of the patient being weaned off the microenvironment, such as within 24 hours before being weaned). The same measured/monitored parameters may be used to train weaning assistant 126 to calculate the comfort index; however, the measured/monitored parameters used to train for determining the comfort index may be obtained at any time over the course of the patient's stay in the NICU and/or microenvironment, and may be tagged with the microenvironment or ambient temperature at the time the parameters were obtained, for example.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to consider the parameters of neonates as outlined by Gadgil to use in calculations and decisions regarding weaning as suggested by Timme, as Timme discusses considerations involving age and gestation involved with weaning an infant from a warming incubator [0040] with Gadgil because Gadgil teaches incorporation of age, gestation, and physiological information such as temperature in calculating the described weaning index [0025].
Claim(s) 3, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Falk (U.S. 20150182406).
Regarding Claim 3, Timme teaches the incubator of claim 1. Timme is silent on wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold.
Falk teaches wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold, [0035; “Cooling devices 368, 370 allow the one or more heating devices 364, 366 to heat warming chamber 24 to an overall desired upper temperature, wherein cooling devices 368, 370 selectively and differently cool the individual temperature zone 36, 38 to different temperatures to accommodate
different temperature requirements for patients P1, P2.”]
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 included a set temperature range as suggested by Falk to vary the temperature ranges for different patients as suggested by Timme as Timme discusses monitoring skin temperature including fluctuations outside an acceptable range [0040] with Falk because Falk teaches the use of these thresholds to establish different zones to accompany multiple patients [0035].
Timme further teaches the first DET being defined between the upper and lower temperature thresholds [Fig. 4, elements 435 and 445]. In this embodiment the upper threshold is interpreted as the goal skin temperature and the lower threshold is interpreted as the subsequent skin-set-point that is determined if the goal skin temperature is not met.
Regarding Claim 16, Timme teaches a method, comprising: receiving or calculating a first desired environmental temperature (DET) for a baby in an incubator [0038]—reference to desired temperature for the baby;
receiving or calculating a DET zone for the baby based upon the first DET; [Fig. 4, element 420].
the first DET being defined between the upper and lower temperature thresholds; [Fig. 4, elements 435 and 445]. In this embodiment the upper threshold is interpreted as the goal skin temperature and the lower threshold is interpreted as the subsequent skin-set-point that is determined if the goal skin temperature is not met.
controlling a temperature of an environment in the incubator during a first period of time based upon the first DET, the DET zone, or both; [Fig. 4, element 425].
measuring a temperature of the baby after the temperature of the environment has been controlled during the first period of time; [Fig. 5, element 530b].
calculating a second DET for the baby after the temperature of the environment has been controlled during the first period of time, [Fig. 5, element 540b].
wherein the second DET is based upon the temperature of the baby measured after the temperature of the environment has been controlled during the first period of time; [Fig. 5, element 535b] and [0043; “After the Step Duration, the system 5 can Determine Level 2 Skin Temp (530b) and assess whether Level 2 Skin Temp is greater than the Goal Skin Temp minus the Weaning Abort Deviation (535b).”]
controlling the temperature of the environment during a second period of time based upon the second DET; [0043; “If Goal Air Temp is not achieved then the system 5 will Begin Level 2 (525b). The system 5 can automatically set the heating module 20 to the Level 1 Air Temp plus the Step Temp Decrease for the Step Duration to Begin Level 2 (525b).”]
comparing the second DET to the first DET, the DET zone, or both; [Fig. 4, element 435b].
detecting an event in response to the comparison; and triggering an alarm in response to the event [0043; “Thus, at any point during the Weaning Mode procedure if the patient skin temperature measured by the system falls outside the deviation range, the system 5 can End Weaning Mode (545) and/or an alarm can sound.”]
Timme is silent on wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold,
Falk teaches wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold, [0035; “Cooling devices 368, 370 allow the one or more heating devices 364, 366 to heat warming chamber 24 to an overall desired upper temperature, wherein cooling devices 368, 370 selectively and differently cool the individual temperature zone 36, 38 to different temperatures to accommodate
different temperature requirements for patients Pl, P2.”]
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 included programming temperature ranges as taught by Falk to accommodate different patients as suggest by Timme, as Timme discusses the use of acceptable temperature ranges [0040] with Falk because Falk teaches the use of these thresholds to establish different zones to accompany multiple patients [0035].
Regarding Claim 17, Timme further teaches wherein the event comprises the second DET being outside of the DET zone [Fig. 5, element 545] and [0043; “If Level 1 Skin Temp lies outside the weaning abort deviation range, then the system 5 can End Weaning Mode (545) and/or an alarm can sound.”]
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Goldberg (U.S. 6296606).
Regarding Claim 9, Timme is silent on wherein the alarm is triggered before the second DET exits the DET zone. Goldberg teaches wherein the alarm is triggered before the second DET exits the DET zone [Col 4, lines 57-65; “In one illustrated embodiment, the temperature sensor is configured to be coupled to the patient. The apparatus includes an alarm coupled to the controller. The controller generating an alarm signal if the output from the temperature sensor changes above or below a predetermined level from the preselected or desired temperature. The apparatus further includes an input device coupled to the controller to permit a caregiver to adjust the preselected temperature.”]
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 alert the device user as to the status of the device as taught by Goldberg, to incorporate alarm systems as taught by Timme to as Timme discusses the use of alarms to indicate status of the device [0026] with Goldberg because Goldberg teaches the use of alarms related to system errors and indicators and status warnings that alert the user when the device is ready for use [Col 18, lines 14-18].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Underwood (U.S. 20190000703).
Regarding Claim 10, Timme is silent on wherein the alarm is triggered in response to a slope of the second DET being greater than a first predetermined slope or less than a second predetermined slope. Underwood teaches wherein the alarm is triggered in response to a slope of the second DET being greater than a first predetermined slope or less than a second predetermined slope [Fig. 7, elements 140, 142, 143 and 144]. In this embodiment, the temperature differential is considered the slope of the second DET and the ideal differential range is considered the first predetermined slope.
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 use fluctuations in temperature to monitor the health status of the individual as taught by Underwood to use throughout continuous care of individuals as suggested by Timme, as Timme discusses the comparison of a skin temperature, goal skin temperature and weaning abort deviation variables and the use of these variables in subsequent steps to determine whether to continue adjusting parameters or to end weaning mode [0043] with Underwood because Underwood teaches the use of monitoring temperature differential to detect temperature stress [0015].
Claim(s) 11, 12, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Gadgil (U.S. 20200179206) and in further view of Falk (U.S. 20150182406).
Regarding Claim 11, Timme teaches an incubator, [0002; “The subject matter described herein relates to automatically monitoring and controlling the rate of temperature change of in an incubator or warmer environment.”]
comprising: a bed configured to receive a baby; [Fig. 1, element 10] and [0040; “infants that are well and ready to be moved from the incubator, are typically weaned from the warming system based on age and gestation.”]
a canopy positioned over the bed, [Fig. 1, element 15]
wherein the bed and the canopy define an environment around the baby; [0006; “The system can further include an environmental sensor module having one or more air temperature sensors. The one or more air temperature sensors can be configured to measure air temperature within the patient environment, which can be closed.”]
wherein the environment is a closed bed mode with an internal volume defined by the interior of the bed and the canopy [0009 and 0024]—reference to the patient environment being closed,
a first sensor configured to measure a temperature of the baby; [0004; “The system includes a sensor module having a skin temperature sensor and a skin temperature controller operatively coupled to the skin temperature sensor and to the heater.”]
a second sensor configured to measure a temperature of the environment; [0006; “The system can further include an environmental sensor module having one or more air temperature sensors. The one or more air temperature sensors can be configured to measure air temperature within the patient environment, which can be closed.”]
a temperature control device configured to modify heat and cool the environment; [0021; “The system 5 can include a heating module 20 that can include one or more heating units to direct warming energy for different purposes such as a main air heater 25, a mattress heater 30, and/or a humidity heater 35 or other air warmer. The mattress heater 30 can provide heat to the patient by contact between the patient and the mattress 10 or coverings surrounding the mattress 10.”] and [0046]—discloses situations where the device can be set to cooling mode.
Wherein the first DET decreases over time; [0042; “FIG. 5 illustrates an example of a Weaning Mode operation. Upon start of the Weaning Mode 330, the system 5 can switch into Air Mode 310. Weaning Mode Begins (500) and a user is prompted to Set Goal Air Temp (505), Set Step Duration (510), Set Step Temp Decrease (515), Set Goal Skin Temp (512) and Set Weaning Abort Deviation (514).”]
receive or calculate a DET zone for the baby based upon the first DET, [Fig. 4, element 420].
the first DET being defined between the upper and lower temperature thresholds; [Fig. 4, elements 435 and 445]. In this embodiment the upper threshold is interpreted as the goal skin temperature and the lower threshold is interpreted as the subsequent skin-set-point that is determined if the goal skin temperature is not met.
control the temperature of the environment with the temperature control device during a first period of time based upon the first DET, the DET zone, or both; [Fig. 4, element 425].
calculate a second DET for the baby after the temperature of the environment has been controlled during the first period of time, [Fig. 4, element 420b].
wherein the second DET is based upon the temperature of the baby measured after the temperature of the environment has been controlled during the first period of time; [Fig. 4, element 435b] and [0037; “If the Goal Skin Temp has not been reached, the system will determine the next Skin Set-Point (420b), which is equal to the Skin Sp 1 + Step Temp Increase. The system Regulates Heating Module in Skin Mode ( 425b) for the defined Step Duration. The system monitor whether the Goal Skin Temp is reached (435b).”]
control the temperature of the environment with the temperature control device during a second period of time based at least partially upon the second DET; [Fig. 4, element, [Fig. 4, element 445b] and [0037; “If the Goal Skin Temp has been reached, Warm-up Mode will end and the system 5 can continue operating in Skin Mode ( 445b ). If the Goal Skin Temp has not been reached, the system will determine the next Skin Set-Point (420c).”]
compare the second DET to the first DET, the DET zone, or both; [Fig. 4, element 435b].
detect an event in response to the comparison; and trigger an alarm in response to the event [0043; “Thus, at any point during the Weaning Mode procedure if the patient skin temperature measured by the system falls outside the deviation range, the system 5 can End Weaning Mode (545) and/or an alarm can sound.”]
Timme is silent on and a computing system configured to: receive or calculate a first desired environmental temperature (DET) for the baby based at least partially upon a gestational age of the baby, a number of days of life of the baby, a weight of the baby, and a health of the baby.
Gadgil teaches and a computing system configured to: receive or calculate a first desired environmental temperature (DET) for the baby based at least partially upon a gestational age of the baby, a number of days of life of the baby, a weight of the baby, and a health of the baby, [0030; “The measured/monitored parameters may include heart rate, respiration rate, temperature, weight/weight gain, acceptance of oral feeds, sucking reflex, gestational age at time of weaning, and duration of time in the microenvironment at the time the patient was weaned off a microenvironment ( or within a given time duration of the patient being weaned off the microenvironment, such as within 24 hours before being weaned). The same measured/monitored parameters may be used to train weaning assistant 126 to calculate the comfort index; however, the measured/monitored parameters used to train for determining the comfort index may be obtained at any time over the course of the patient's stay in the NICU and/or microenvironment, and may be tagged with the microenvironment or ambient temperature at the time the parameters were obtained, for example.”] In this embodiment, the weaning assistant is interpreted as the computing system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to consider the parameters of neonates as outlined by Gadgil to use in calculations and decisions regarding weaning as suggested by Timme, as Timme discusses considerations involving age and gestation involved with weaning an infant from a warming incubator [0040] with Gadgil because Gadgil teaches incorporation of age, gestation, and physiological information such as temperature in calculating the described weaning index [0025].
Timme and Gadgil are silent on wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold. Falk teaches wherein the DET zone comprises an upper temperature threshold and a lower temperature threshold, [0035; “Cooling devices 368, 370 allow the one or more heating devices 364, 366 to heat warming chamber 24 to an overall desired upper temperature, wherein cooling devices 368, 370 selectively and differently cool the individual temperature zone 36, 38 to different temperatures to accommodate
different temperature requirements for patients P1, P2.”]
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 included a set temperature range as suggested by Falk to vary the temperature ranges for different patients as suggested by Timme and Gadgil, as Timme discusses monitoring skin temperature including fluctuations outside an acceptable range [0040] and Gadgil which discloses patient temperature being within a range of patient set temperatures [0041] with Falk because Falk teaches the use of these thresholds to establish different zones to accompany multiple patients [0035].
Regarding Claim 12, Timme further teaches wherein the event comprises the second DET being outside of the DET zone [Fig. 5, element 545] and [0043; “If Level 1 Skin Temp lies outside the weaning abort deviation range, then the system 5 can End Weaning Mode (545) and/or an alarm can sound.”]
Regarding Claim 13, Timme further teaches wherein the event comprises the second DET being outside of the DET zone for more than a predetermined amount of time or by more than a predetermined temperature [0037; “The system automatically Regulates Heating Module in Skin Mode ( 425) for the defined Step Duration as described above.”] and [0036; “In some implementations, Step Duration can be at least about 2, 4, 6, 8, 10, 12, 15, 18, 20, 22, 25, 28, 30 or more minutes. In some implementations, Step Temp Increase can be between about 0.1°C to 1.0°C.”]
Regarding Claim 14, Timme further teaches wherein the event comprises a slope of the second DET deviating from a slope of the first DET by more than a predetermined amount [Fig. 5, element 514] and [0042; “FIG. 5 illustrates an example of a Weaning Mode operation. Upon start of the Weaning Mode 330, the system 5 can switch into Air Mode 310. Weaning Mode Begins (500) and a user is prompted to Set Goal Air Temp (505), Set Step Duration (510), Set Step Temp Decrease (515), Set Goal Skin Temp (512) and Set Weaning Abort Deviation (514).”] and [0043; “If Level 1 Skin Temp lies outside the weaning abort deviation range, then the system 5 can End Weaning Mode (545) and/or an alarm can sound…If Level 2 Skin Temp lies outside the deviation range, then the system 5 can End Weaning Mode (545b) and/or an alarm can sound.”]
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Gadgil (U.S. 20200179206) and in further view of Falk (U.S. 20150182406) and Goldberg (U.S. 6296606).
Regarding Claim 15, Timme, Gadgil and Falk teach the incubator of claim 14. Timme, Gadgil and Falk are silent on wherein the alarm is triggered before the second DET exits the DET zone.
Goldberg teaches wherein the alarm is triggered before the second DET exits the DET zone [Col 4, lines 57-65; “In one illustrated embodiment, the temperature sensor is configured to be coupled to the patient. The apparatus includes an alarm coupled to the controller. The controller generating an alarm signal if the output from the temperature sensor changes above or below a predetermined level from the preselected or desired temperature. The apparatus further includes an input device coupled to the controller to permit a caregiver to adjust the preselected temperature.”]
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 program the alarm as taught by Goldberg to indicate the status of the alarm as suggested by Timme, and Gadgil, and Falk, as Timme discusses the use of alarms to indicate status of the device [0026] and Gadgil which discloses the use of internal notifications to program the weaning assistant [0055] and Falk which discloses the use of alarms within the system [0038] with Goldberg because Goldberg teaches the use of alarms related to system errors and indicators and status warnings that alert the user when the device is ready for use [Col 18, lines 14-18].
Claim(s) 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timme (WO 2013058799) in view of Falk (U.S. 20150182406) and in further view of Gadgil (U.S. 20200179206).
Regarding Claim 19, Timme and Falk are silent on further comprising training a machine learning algorithm based upon the DET zone for the baby.
Gadgil teaches further comprising training a machine learning algorithm based upon the DET zone for the baby [0070; “the weaning index and/or comfort index may be determined with an AI-based module, such as weaning assistant 126, using a suitable machine learning algorithm.”]
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 use automation and training machine learning algorithms as taught by Gadgil to incorporate into programming and computerized components of the device as suggested by Timme, and Falk as Timme discusses the use of a computer program with the described invention [0030] and Falk which discloses the use of a controller to manage temperature zones [0014] with Gadgil because Gadgil teaches the use of patient data and outcomes to train the weaning assistant [0030].
Regarding Claim 20, Timme and Falk are silent on further comprising calculating a DET zone for a second baby. Gadgil teaches further comprising calculating a DET zone for a second baby [0055; “Further, the weaning assistant may re-tune the algorithm used to compute the weaning index/re-weight the patient parameters, such that those parameters are given a lower weight (which may result in a lower weaning index value being selected for those same parameters in the future). In this interpretation the second baby is interpreted to mean a later patient.
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 use a machine learning algorithm to for calculations as taught by Gadgil to determine a desired temperature range as suggested by Timme, and Falk as Timme discusses the use of a computer program with the described invention [0030] and Falk which discloses the use of a controller to manage temperature zones [0014] with Gadgil because Gadgil teaches the use of patient data and outcomes to train the weaning assistant [0030].
Response to Arguments
Applicant's arguments filed 10 November 2025 with respect to the specification
and abstract objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 10 November 2025 with respect to the claim objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 10 November 2025 with respect to the claim interpretations have been fully considered but they are not persuasive. “Temperature control device” is still a generic place holder despite the amendments to the functional language. Therefore, this limitation is still interpreted under 35 U.S.C. 112(f).
Applicant's arguments filed 10 November 2025 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 10 November 2025 with respect to the rejection of
claims 1, 4, 5, 6, 7, 8, under 35 U.S.C.102 have been fully considered however, new rejections are presented above in light of the amendments. The applicant contends that the prior art of reference Timme does not teach the environment is a closed bed mode with an internal volume defined by the interior of the bed and the canopy, however, the cited reference does teach a closed system and environment which is interpreted to be “a closed bed mode”, “internal volume”, and “interior.” Further reference to this teaching can be found in the prior art rejections under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103.
Applicant’s arguments filed 10 November 2025 with respect to the rejection of
claims 2, 3, 9-17, 19 and 20, under 35 U.S.C.103 have been fully considered however, new rejections are presented above in light of the amendments.
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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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791