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 .
Acknowledgments
In the reply, filed on May 12, 2026, Applicant amended claims 1, 5-6, 9-17, and 19-20.
In the non-final rejection of February 20, 2026, Examiner noted that the information disclosure statement filed February 24, 2023, fails to comply with 37 CFR 1.98(a)(2). Applicant submitted a copy of the indicated foreign patent document. Concern is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 9, 11, 15-16, and 20. Applicant amended claims 1, 9, 11, 15-16, and 20. Objection is withdrawn.
Examiner rejected claims 15-20 under 35 U.S.C. 112(b). Applicant amended claims 15-16 and 20. Rejection is withdrawn.
Claim Objections
Claims 1, 11, 15-16, and 20 are objected to because of the following informalities:
In regards to claim 1, line 19, “the first and second parameters” should be changed to “the first parameter and the second parameter”.
In regards to claim 1, line 25, “the temperature” should be changed to “a temperature”.
In regards to claim 11, line 13, “the first and second parameters” should be changed to “the first parameter and the second parameter”.
In regards to claim 15, line 8, “the other ambient temperature” should be changed to “the another ambient temperature”.
In regards to claim 16, line 15, “the first and second parameters” should be changed to “the first parameter and the second parameter”.
In regards to claim 20, line 9, “the other ambient temperature” should be changed to “the another ambient temperature”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, lines 13-26 recite: “calculate, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter; calculate, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter; and adjust, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range”; however, such is new matter not described in the Specification. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 11, lines 7-20 recite: “calculating, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter; calculating, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter; and adjusting, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range”; however, such is new matter not described in the Specification. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
In regards to claim 13, lines 2-4 recite: “wherein the calculating the first parameter comprises adjusting the first relationship to account for the reduced heat loss”; however, such is new matter not described in the Specification.
In regards to claim 15, lines 4-8 recite: the method further comprises, “using a third temperature sensor, measuring another ambient temperature external to the pump; and the calculating the second parameter comprises adjusting the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature”; however, such is new matter not described in the Specification.
In regards to claim 16, lines 9-23 recite: “calculate, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter; calculate, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter; and adjust, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range”; however, such is new matter not described in the Specification. Claims 17-20 are rejected by virtue of being dependent upon claim 16.
In regards to claim 20, lines 5-6 recite: “receive a third output from a third temperature sensor indicating another ambient temperature external to the pump”; however, such is new matter not described in the Specification.
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 1-20 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.
In regards to claim 1, line 14 recites “temperatures of the heater”. Claim 1, line 9 previously recites “a temperature of the heater”. It is unclear whether the two recitations are related or different. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 17 recites “ambient temperatures”. Claim 1, line 8 previously recites “an ambient temperature”. It is unclear whether the two recitations are related or different. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 17 recites “temperatures of the heater”. Claim 1, line 9 previously recites “a temperature of the heater” and line 14 previously recites “temperatures of the heater”. It is unclear whether the three recitations are related or different. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 25 recites “the temperature of the fluid”. Claim 1, line 14 previously recites “temperatures of the fluid”. It is unclear whether the two recitations are related or different. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 11, line 8 recites “temperatures of the heater”. Claim 11, line 4 previously recites “a temperature of the heater”. It is unclear whether the two recitations are related or different. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
In regards to claim 11, line 8 recites “temperatures of the fluid”. Claim 11, line 1 previously recites “a temperature of a fluid”. It is unclear whether the two recitations are related or different. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
In regards to claim 11, line 11 recites “ambient temperatures”. Claim 11, line 3 previously recites “an ambient temperature”. It is unclear whether the two recitations are related or different. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
In regards to claim 11, lines 11-12 recite “temperatures of the heater”. Claim 11, line 4 previously recites “a temperature of the heater” and line 8 previously recites “temperatures of the heater”. It is unclear whether the three recitations are related or different. Claims 12-15 are rejected by virtue of being dependent upon claim 11.
In regards to claim 16, line 10 recites “temperatures of the heater”. Claim 16, lines 7-8 previously recite “a temperature of a heater”. It is unclear whether the two recitations are related or different. Claims 17-20 are rejected by virtue of being dependent upon claim 16.
In regards to claim 16, line 10 recites “temperatures of the fluid”. Claim 16, line 1 previously recites “a temperature of a fluid”. It is unclear whether the two recitations are related or different. Claims 17-20 are rejected by virtue of being dependent upon claim 16.
In regards to claim 16, line 13 recites “ambient temperatures”. Claim 16, lines 5-6 previously recite “an ambient temperature”. It is unclear whether the two recitations are related or different. Claims 17-20 are rejected by virtue of being dependent upon claim 16.
In regards to claim 16, lines 13 recites “temperatures of the heater”. Claim 16, lines 7-8 previously recite “a temperature of the heater” and line 10 previously recites “temperatures of the heater”. It is unclear whether the three recitations are related or different. Claims 17-20 are rejected by virtue of being dependent upon claim 16.
Claim Rejections - 35 USC § 102
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.
Claims 11, 14, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma (CN 107362418).
In regards to claim 11, Ma teaches a method of controlling a temperature of fluid used in a medical procedure (temperature of transfusion medicine liquid keep upper to make human body comfortable temperature), the method comprising:
using a first temperature sensor (41), measuring an ambient temperature (detecting the room temperature… through the ambient temperature sensor 41)
using a second temperature sensor (42), measuring a temperature of a heater (3) used to heat the fluid (transfusion medicine liquid) in a container (bottle) (detecting… heating temperature through.. the heating temperature sensor 42)
using a processor (4):
calculating, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter (control operation of the heater 3 through detecting… heating temperature through… the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
calculating, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature)
adjusting, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature… control operation of the heater 3 through detecting the room temperature and heating temperature through the ambient temperature sensor 41 and the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
In regards to claim 14, Ma teaches wherein the one or more operating parameters of the heater comprises switching the heater on and off for intervals (the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature).
In regards to claim 16, Ma teaches a control apparatus (Figure 1, temperature controller 4) for controlling a temperature of a fluid supplied to a medical instrument during a medical procedure (temperature of transfusion medicine liquid keep upper to make human body comfortable temperature), the control apparatus comprising:
a processor (4) comprising hardware (4), the processor being configured to:
receive a first output from a first temperature sensor indicating an ambient temperature (the temperature controller 4 comprises a detection chamber temperature of the ambient temperature sensor 41)
receive a second output from a second temperature sensor indicating a temperature of a heater configured to heat the fluid contained in a container (the temperature controller 4 comprises… detecting the heating temperature of the heating temperature sensor 42)
calculate, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter (control operation of the heater 3 through detecting… heating temperature through… the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
calculate, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature)
adjust, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature… control operation of the heater 3 through detecting the room temperature and heating temperature through the ambient temperature sensor 41 and the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
In regards to claim 19, Ma teaches wherein the one or more operating parameters of the heater comprises switching the heater on and off for intervals (the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature).
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, and further in view of Faries et al (US 2013/0197437).
In regards to claim 1, Ma teaches a medical fluid temperature management system (Figure 1) for a medical procedure, the medical fluid temperature management system comprising:
a container (bottle) configured to contain fluid (transfusion medicine liquid) for supply to a medical instrument
a heater (3) located externally to the container and configured to heat the fluid in the container
a first temperature sensor (41) configured to detect an ambient temperature
a second temperature sensor (42) configured to detect a temperature of the heater
a processor (4) comprising hardware (4), the processor being in communication with the first temperature sensor and with the second temperature sensor and the processor being configured to:
calculate, based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter (control operation of the heater 3 through detecting… heating temperature through… the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
calculate, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature)
adjust, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature… control operation of the heater 3 through detecting the room temperature and heating temperature through the ambient temperature sensor 41 and the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature)
Ma is silent about a pump operable to withdraw the fluid from the container and supply the fluid to the medical instrument. Faries et al teaches a medical fluid temperature management system (Figures 1A-2B, 3B) comprising a pump (inflatable bellows or bladder; a manual pump (e.g., bulb); a pump) operable to withdraw the fluid from the container and supply the fluid to the medical instrument. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Ma, with a pump, as taught by Faries et al, as such will enhance infusion by applying pressure to the container to achieve a desired solution flow or infusion rate (paragraph [0036]).
In regards to claim 2, in the modified system of Ma and Faries et al, Ma teaches wherein the heater is configured to contact one or more of a base and a side surface of the container (Figure 1).
In regards to claim 3, in the modified system of Ma and Faries et al, Ma teaches a support (1) on which the container is removably received, wherein the heater is located in the support (Figure 1).
In regards to claim 4, in the modified system of Ma and Faries et al, Ma teaches wherein the support defines an insulated (insulated) enclosure (1) for receiving the container.
In regards to claim 5, in the modified system of Ma and Faries et al, Ma teaches wherein the insulated enclosure is shaped and dimensioned to form a close fit with the container (Figure 1).
In regards to claim 6, in the modified system of Ma and Faries et al, Ma is silent about wherein at least a part of the insulated enclosure is formed of a resilient material. Faries et al teaches wherein at least a part of an enclosure (115) is formed of a resilient material (paragraph [0035]: The cover 115 may be flexible). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify at least a part of the insulated enclosure, of the modified system of Ma and Faries et al, to be formed of a resilient material, as taught by Faries et al, as such will enclose (wrap around) at least a portion of the container to secure it within the enclosure by conforming to the container (paragraph [0035]).
In regards to claim 7, in the modified system of Ma and Faries et al, Ma teaches wherein the heater comprises wire (3).
In regards to claim 8, in the modified system of Ma and Faries et al, Ma is silent about wherein the first temperature sensor is located externally of the pump. Faries et al teaches wherein a first temperature sensor (340B) is located externally of the pump (Figures 1A-1C, 3B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first temperature sensor, of the modified system of Ma and Faries et al, to be located externally of the pump, as taught by Faries et al, as such will allow for measuring the ambient temperature (e.g., the surface temperature or the air temperature) (paragraph [0057]) and will enhance infusion by applying pressure to the container to achieve a desired solution flow or infusion rate (paragraph [0036]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ma and Faries et al, as applied to claim 1 above, and further in view of Briggs et al (US 6,503,221).
In regards to claim 9, in the modified system of Ma and Faries et al, Ma is silent about wherein the first temperature sensor is located internally of the pump and detects the ambient temperature within the pump, and the second relationship is adjusted in accordance with a third relationship between the ambient temperature within the pump and another ambient temperature external to the pump. Briggs et al teaches a medical fluid temperature management system (Figures 1-12) wherein a first temperature sensor (472) is located internally of a pump (50) and detects an ambient temperature within the pump (column 16, line 64). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first temperature sensor, of the modified system of Ma and Faries et al, to be located internally of the pump and detect the ambient temperature within the pump, as taught by Briggs et al, as such will allow for adjusting the pump operating speed to provide a more accurate flow control (column 13, lines 64-67, to column 14, line 1).
Briggs et al is silent about the second relationship is adjusted in accordance with a third relationship between the ambient temperature within the pump and another ambient temperature external to the pump. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second relationship, of the modified system of Ma, Faries et al, and Briggs et al, to be adjusted in accordance with a third relationship between the ambient temperature within the pump and another ambient temperature external to the pump, as such will allow for maintaining the fluid within the temperature range based on temperatures of the pump and of the environment outside of the system determining the operating parameters of the heater.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ma and Faries et al, as applied to claim 1 above, and further in view of Bakke (US 6,035,102).
In regards to claim 10, in the modified system of Ma and Faries et al, Ma is silent about wherein the temperature range is 370C±30C. Bakke teaches a medical fluid temperature management system (Figures 1-4) wherein a temperature range is about 35 to 40 degrees C (column 1, lines 17-19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature range, of the modified system of Ma and Faries et al, to be about 35 to 40 degrees C, as taught by Bakke, as such is physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health (column 1, lines 17-24).
Bakke anticipates 370C+30C (40 degrees C); however, Bakke does not anticipate 370C-30C, which is equal to 340C, as Bakke teaches 35 degrees C. Applicant’s Specification (page 5, lines 6-9) recites: As normal body temperature is approximately 37° C., the predetermined temperature range can be a few degrees either side of this, for example it may be 37±3° C. Thus, other than surrounding normal body temperature, which is taught by Bakke, Applicant does not provide any criticality for the temperature range specifically being 37±3° C. Thus, before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the temperature range, of the modified system of Ma, Faries et al, and Bakke, to be 37±3° C, as Applicant has not disclosed that such a temperature range provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the temperature range being about 35 to 40 degrees C, as taught by Bakke, as a person having ordinary skill in the art would have known how to select the temperature range in order to deliver the fluid at physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health.
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied to claims 11 and 16 above, and further in view of Bakke.
In regards to claim 12, Ma is silent about wherein the temperature range is 370C±30C. Bakke teaches a method of controlling a temperature of fluid used in a medical procedure, wherein a temperature range is about 35 to 40 degrees C (column 1, lines 17-19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature range, of the method of Ma, to be about 35 to 40 degrees C, as taught by Bakke, as such is physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health (column 1, lines 17-24).
Bakke anticipates 370C+30C (40 degrees C); however, Bakke does not anticipate 370C-30C, which is equal to 340C, as Bakke teaches 35 degrees C. Applicant’s Specification (page 5, lines 6-9) recites: As normal body temperature is approximately 37° C., the predetermined temperature range can be a few degrees either side of this, for example it may be 37±3° C. Thus, other than surrounding normal body temperature, which is taught by Bakke, Applicant does not provide any criticality for the temperature range specifically being 37±3° C. Thus, before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the temperature range, of the modified method of Ma and Bakke, to be 37±3° C, as Applicant has not disclosed that such a temperature range provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the temperature range being about 35 to 40 degrees C, as taught by Bakke, as a person having ordinary skill in the art would have known how to select the temperature range in order to deliver the fluid at physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health.
In regards to claim 17, Ma is silent about wherein the temperature range is 370C±30C. Bakke teaches a control apparatus (Figures 1-4, temperature controller 22) for controlling a temperature of a fluid supplied to a medical instrument during a medical procedure, wherein a temperature range is about 35 to 40 degrees C (column 1, lines 17-19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature range, of the apparatus of Ma, to be about 35 to 40 degrees C, as taught by Bakke, as such is physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health (column 1, lines 17-24).
Bakke anticipates 370C+30C (40 degrees C); however, Bakke does not anticipate 370C-30C, which is equal to 340C, as Bakke teaches 35 degrees C. Applicant’s Specification (page 5, lines 6-9) recites: As normal body temperature is approximately 37° C., the predetermined temperature range can be a few degrees either side of this, for example it may be 37±3° C. Thus, other than surrounding normal body temperature, which is taught by Bakke, Applicant does not provide any criticality for the temperature range specifically being 37±3° C. Thus, before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the temperature range, of the modified apparatus of Ma and Bakke, to be 37±3° C, as Applicant has not disclosed that such a temperature range provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the temperature range being about 35 to 40 degrees C, as taught by Bakke, as a person having ordinary skill in the art would have known how to select the temperature range in order to deliver the fluid at physiologic temperature for transfusion, wherein infusion of cold liquids at high flow rates can cause cardiac arrhythmias, cardiac arrest and death, and even at low flow rates it is desirable to warm intravenous liquids for delivery to the patient, especially if the patient is an infant or child, has cardiac disease or is otherwise of fragile health.
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied to claims 11 and 16 above.
In regards to claim 13, Ma teaches placing the container in an insulated (insulated) enclosure (1) to reduce heat loss from the container (it can through the heating cavity 2 is directly sleeved on the dropping-bottle). However, Ma is silent about wherein the calculating the first parameter comprises adjusting the first relationship to account for the reduced heat loss. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the calculating the first parameter, of the method of Ma, to comprise adjusting the first relationship to account for the reduced heat loss, as such would save energy of a power supply and the heater as the heater would not have to heat as much to maintain the fluid within the predetermined temperature range due to the insulated enclosure reducing heat loss.
In regards to claim 18, Ma teaches the container being insulated (insulated) to reduce heat loss from the container. However, Ma is silent about wherein the processor is further configured to adjust the one or more operating parameters based on a reduced heat loss from the container resulting from the container being insulated. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor, of the apparatus of Ma, to be configured to adjust the one or more operating parameters based on a reduced heat loss from the container resulting from the container being insulated, as such would save energy of a power supply and the heater as the heater would not have to heat as much to maintain the fluid within the predetermined temperature range due to the insulated container reducing heat loss.
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied to claims 11 and 16 above, and further in view of Briggs et al and Faries et al.
In regards to claim 15, Ma is silent about wherein the ambient temperature is within a pump; the method further comprises, using a third temperature sensor, measuring another ambient temperature external to the pump; and the calculating the second parameter comprises adjusting the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature. Briggs et al teaches a method of controlling a temperature of fluid used in a medical procedure, wherein an ambient temperature within a pump (50) (column 16, line 64). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ambient temperature, of the method of Ma, to be within a pump, as taught by Briggs et al, as such will provide a more accurate flow control (column 13, lines 64-67, to column 14, line 1).
Faries et al teaches a method of controlling a temperature of fluid used in a medical procedure, wherein the method further comprises, using a third temperature sensor (340B), measuring another ambient temperature external to a pump (inflatable bellows or bladder; a manual pump (e.g., bulb); a pump) (Figures 1A-1C, 3B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Ma and Briggs et al, to comprise using a third temperature sensor, measuring another ambient temperature external to the pump, as taught by Faries et al, as such will allow for measuring the ambient temperature (e.g., the surface temperature or the air temperature) (paragraph [0057]) and will enhance infusion by applying pressure to the container to achieve a desired solution flow or infusion rate (paragraph [0036]).
Briggs et al and Faries et al are silent about the calculating the second parameter comprises adjusting the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the calculating the second parameter, of the modified method of Ma, Briggs et al, and Faries et al, to comprise adjusting the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature, as such will allow for maintaining the fluid within the temperature range based on temperatures of the pump and of the environment outside of the system determining the operating parameters of the heater.
In regards to claim 20, Ma is silent about wherein the ambient temperature is within a pump; the process is further configured to: receive a third output from a third temperature sensor indicating another ambient temperature external to the pump; adjust the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature. Briggs et al teaches a control apparatus (Figures 1-12) for controlling a temperature of a fluid supplied to a medical instrument during a medical procedure, wherein an ambient temperature is within a pump (50) (column 16, line 64). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ambient temperature, of the apparatus of Ma, to be within a pump, as taught by Briggs et al, as such will provide a more accurate flow control (column 13, lines 64-67, to column 14, line 1).
Faries et al teaches a control apparatus (Figures 1A-2B, 3B) for controlling a temperature of a fluid supplied to a medical instrument during a medical procedure, wherein a processor (30) is further configured to receive a third output from a third temperature sensor (340B) indicating another ambient temperature external to a pump (inflatable bellows or bladder; a manual pump (e.g., bulb); a pump) (Figures 1A-1C, 3B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor, of the modified apparatus of Ma and Briggs et al, to be configured to receive a third output from a third temperature sensor indicating another ambient temperature external to the pump, as taught by Faries et al, as such will allow for measuring the ambient temperature (e.g., the surface temperature or the air temperature) (paragraph [0057]) and will enhance infusion by applying pressure to the container to achieve a desired solution flow or infusion rate (paragraph [0036]).
Briggs et al and Faries et al are silent about adjust the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor, of the modified apparatus of Ma, Briggs et al, and Faries et al, to adjust the second relationship in accordance with a third relationship between the ambient temperature and the other ambient temperature, as such will allow for maintaining the fluid within the temperature range based on temperatures of the pump and of the environment outside of the system determining the operating parameters of the heater.
Response to Arguments
Applicant's arguments filed May 12, 2026, have been fully considered but they are not persuasive:
In regards to claims 1, 11, and 16, Applicant argued: The cited references do not disclose, teach, or suggest the above limitations. For example, the Office relies on MA as disclosing the first relationship… However, MA does not disclose "calculat[ing], based on the temperature of the heater and using a first relationship between temperatures of the heater and temperatures of the fluid in the container, a first parameter." At no point in MA is there any consideration that the temperature of the heater and the temperature of the fluid may differ from one another. Instead, MA simply controls the heater based on the room temperature and, optionally, the temperature adjustment knob (Remarks, pages 9-10). Examiner disagrees. Ma teaches calculate, based on the temperature of the heater (3) and using a first relationship between temperatures of the heater and temperatures of the fluid (transfusion medicine liquid) in the container (bottle), a first parameter (control operation of the heater 3 through detecting… heating temperature through… the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature), calculate, based on the ambient temperature and the temperature of the heater and using a second relationship between ambient temperatures and temperatures of the heater, a second parameter (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature), and adjust, based on the first and second parameters, one or more operating parameters of the heater to maintain the temperature of the fluid in the container within a temperature range (the temperature controller 4 controls the heater 3 according to the detected room temperature and heating temperature; For example, the temperature controller 4 can control the heater 3 the heating temperature is lower than the room temperature working, and stops working when the heating temperature reaches or higher than room temperature… control operation of the heater 3 through detecting the room temperature and heating temperature through the ambient temperature sensor 41 and the heating temperature sensor 42, time the temperature of the transfusion medicine liquid keep upper to make human body comfortable temperature).
Conclusion
THIS ACTION IS MADE FINAL. 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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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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