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 .
This action is in response to the filing on 1/5/2024. Since the initial filing, no claims have been added, amended or cancelled. Thus, claims 1-20 are pending in the application.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claim 1 line 7: add “a” before “breathing apparatus”
Claim 13 line 5: add “a” before “breathing apparatus”
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.
Claim(s) 1, 10-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vicario (US 2021/0236757).
In regards to claim 1, Vicario discloses respiratory monitoring system (apparatus 300) comprising: a first valve (active valve used to sample from multiple lines and direct to chamber, paragraph 71 line 11-14); a mixing chamber having an input port fluidically coupled to the first multi-way valve (combined chambers 314a and 314b, paragraph 74); an oxygen sensor coupled to the mixing chamber (oxygen sensor 320, paragraph 74); an inhalation input-sampling flow line fluidically coupled at a first end to the first multi- way valve and to fluidically couple at a second end to an inhalation line that is fluidically coupled to breathing apparatus for a subject (sampling line 316a from inhalation line from ventilator 302, paragraph 67 and 70); and an exhalation input-sampling flow line fluidically coupled at a first end to the first multi- way valve and to fluidically couple at a second end to an exhalation line that is fluidically coupled to the breathing apparatus for the subject (sampling line 316b from exhalation line from patient 304, paragraph 68 and 70).
While Vicario does not explicitly disclose wherein the first valve is a multi-way valve and is configured to switch coupling of the input port of the mixing chamber between a first configuration where the input port is fluidically coupled to the inhalation input-sampling flow line and a second configuration where input port is fluidically coupled to the exhalation input-sampling flow line, it does describe an active valve (paragraph 71 line 11-14) which samples inhalation and exhalation in a proportional fashion (paragraph 71) which requires linkage to both inhalation and exhalation lines (paragraph 71 line 5-11) and being capable of switching between multiple pathways as needed (paragraph 70 and 71). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vicario wherein the first valve is a multi-way valve and is configured to switch coupling of the input port of the mixing chamber between a first configuration where the input port is fluidically coupled to the inhalation input-sampling flow line and a second configuration where input port is fluidically coupled to the exhalation input-sampling flow line as this is a known structural and functional need for proportional sampling.
In regards to claim 10, Vicario teaches the device of claim 1 and Vicario further teaches further comprising: a system controller (determining module 312 and gas concentration system 310) communicatively coupled to the oxygen sensor (paragraph 66-68 and 73) and configured to: determine a first concentration of oxygen in the inhalation line based at least in part on a first signal received from the oxygen sensor detecting gas received in the mixing chamber by way of the inhalation input-sampling flow line; determine a second concentration of oxygen in the exhalation line based at least in part on a second signal received from the oxygen sensor detecting gas received in the mixing chamber by way of the exhalation input-sampling flow line; and compute a value relevant to the health of the subject based at least in part on a difference between the first concentration of oxygen and the second concentration of oxygen (paragraph 66-68 and 73-74).
In regards to claim 11, Vicario teaches the device of claim 10 and Vicario further teaches wherein the value is a volume rate of oxygen consumed by the subject (paragraph 76 line 11-19).
In regards to claim 13, Vicario discloses a method of respiratory monitoring with a respiratory monitoring system, the method comprising: receiving inhalation gas for a subject in a mixing chamber (combined chambers 314a and 314b), wherein the inhalation gas is sampled from an inhalation line of the respiratory monitoring system and the inhalation line connects to breathing apparatus used by the subject (sampling line 316a from inhalation line from ventilator 302, paragraph 67 and 70); detecting a first concentration of oxygen in the mixing chamber with an oxygen sensor (oxygen sensor 320, paragraph 74); with a valve (active valve samples multiple lines, paragraph 71 line 11-14), coupling of an input port of the mixing chamber from being fluidically coupled to the inhalation line to being fluidically coupled to an exhalation line of the respiratory monitoring system (sampling line 316a from inhalation line and sampling line 316b from exhalation line, paragraph 70); receiving exhalation gas from the subject in the mixing chamber (combined chambers 314a and 314b, paragraph 74), wherein the exhalation gas is sampled from the exhalation line and the exhalation line is coupled to the breathing apparatus (sampling line 316b from exhalation line from patient 304, paragraph 68 and 70); detecting a second concentration of oxygen in the mixing chamber with the oxygen sensor (oxygen sensor 320, paragraph 74); and computing a value relevant to health of the subject based at least in part on a difference between the first concentration of oxygen and the second concentration of oxygen (paragraph 76 line 11-19).
While Vicario does not explicitly disclose wherein the valve is a multi-way valve and where the coupling is changed with the valve, during a first interval of time, receiving inhalation gas for a subject in a mixing chamber, detecting a first concentration of oxygen in the mixing chamber with an oxygen sensor during the first interval of time; during a second interval of time, receiving exhalation gas from the subject in the mixing chamber; detecting a second concentration of oxygen in the mixing chamber with the oxygen sensor during the second interval of time, it does teach wherein the valve switches sampling between lines and multiple pathways (paragraph 70 and 71) and wherein gas is received in the mixing chamber over periods of time (paragraph 75 line 1-3 and paragraph 76 line 16-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vicario wherein during a first interval of time, receiving inhalation gas for a subject in a mixing chamber, detecting a first concentration of oxygen in the mixing chamber with an oxygen sensor during the first interval of time; during a second interval of time, receiving exhalation gas from the subject in the mixing chamber; detecting a second concentration of oxygen in the mixing chamber with the oxygen sensor during the second interval of time as this would allow the device to sample at the appropriate moment in the breath cycle and determine differences in oxygen concentrations at different moments in said cycle (paragraph 73).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vicario (US 2021/0236757) in view of O’Brien (US 2021/0076979).
In regards to claim 4, Vicario teaches the device of claim 1 and Vicario further teaches further comprising: a carbon dioxide sensor coupled to the mixing chamber to measure a concentration of carbon dioxide in gas contained in the mixing chamber (paragraph 77).
Vicario does not disclose a relative humidity sensor coupled to the mixing chamber to measure a water vapor content of the gas contained in the mixing chamber; and a temperature sensor coupled to the mixing chamber to measure a temperature of the gas contained in the mixing chamber.
However, O’Brien teaches wherein a mixing chamber (mixing chamber 130) contains a relative humidity sensor coupled to the mixing chamber to measure a water vapor content of the gas contained in the mixing chamber; and a temperature sensor coupled to the mixing chamber to measure a temperature of the gas contained in the mixing chamber (paragraph 121).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vicario to have a relative humidity sensor coupled to the mixing chamber to measure a water vapor content of the gas contained in the mixing chamber; and a temperature sensor coupled to the mixing chamber to measure a temperature of the gas contained in the mixing chamber as taught by O’Brien as these are known sensors to place within mixing chambers to acquire relevant information.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vicario (US 2021/0236757) in view of McClung (US 2020/0022618).
In regards to claim 12, Vicario teaches the device of claim 1.
While Vicario teaches that the mixing chamber might be relatively small (paragraph 76), Vicario does not teach wherein the mixing chamber has a volume no larger than 50 mL.
However, McClung teaches wherein the mixing chamber has a volume no larger than 50 mL (mixing chamber shrunk to 30 mL, paragraph 75 line 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vicario wherein the mixing chamber has a volume no larger than 50 mL as taught by McClung as this would provide a smaller and more compact apparatus (Vicario: paragraph 76 line 1-3).
Allowable Subject Matter
Claims 2-3, 5-9 and 14-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claim 2, closest prior art Vicario does not teach a second multi-way valve fluidically coupled to an output port of the mixing chamber; a first output flow line fluidically coupled at a first end to the second multi-way valve and to fluidically couple at a second end to the inhalation line; and a second output flow line fluidically coupled at a first end to the second multi-way valve and to fluidically couple at a second end to the exhalation line. While Vicario implies some return of gases from mixing chamber (sampling port 318a of inhalation gas connector 306 and sampling port 318b of exhalation gas connector 308 have inlets and outlets which are linked to chambers 314a and 314b, paragraph 72), it is non explicit and no structural or functional elements are described. Addition of further multi-way valves would require undue modification and require improper hindsight reasoning.
In regards to claim 3, while allowable based on dependency from claim 2, further contains the limitations wherein the first multi-way valve is a four- way valve and the second multi-way valve is a three-way valve which Vicario does not teach. Further, altering Vicario to include such valves would require undue modification and require hindsight reasoning.
In regards to claim 5, while closest prior art Vicario teaches an embodiment wherein the mixing chamber is a first mixing chamber, the oxygen sensor is a first oxygen sensor, and the input port is a first input port, the respiratory monitoring system further comprising: a second mixing chamber having a second input port fluidically coupled to the first multi- way valve; and a second oxygen sensor coupled to the second mixing chamber (see Fig 4 and accompanying disclosure), it does not teach wherein the first multi-way valve is further configured to switch coupling of the first input port between the first configuration where the first input port is fluidically coupled to the inhalation input-sampling flow line and the second input port is fluidically coupled to the exhalation input-sampling flow line and a second configuration where first input port is fluidically coupled to the exhalation input-sampling flow line and the second input port is fluidically coupled to the inhalation input-sampling flow line and would not reasonably be able to accommodate such alteration, nor would such be reasonable without hindsight reasoning.
In regards to claim 6, while prior art McClung does teach a passive method of sampling from exhalation (paragraph 81), it specifically describes a system meant to be valveless. As Vicario establishes a valve which participates in the sampling, there would be no reasonable motivation for applying a passive, valveless, structure to a valves system.
In regards to claim 14, while closest prior art Vicario does not explicitly teach teaches further comprising: coupling an output port of the mixing chamber to the inhalation line; providing a portion of the inhalation gas received in the mixing chamber to the inhalation line; coupling the output port of the mixing chamber to the exhalation line; and providing a portion of the exhalation gas received in the mixing chamber to the exhalation line, Vicario implies some return of gases from mixing chamber (sampling port 318a of inhalation gas connector 306 and sampling port 318b of exhalation gas connector 308 have inlets and outlets which are linked to chambers 314a and 314b, paragraph 72) but fails to teach any structural or functional elements related to such, nor does it have any teaching regarding timing. Modification to accommodate the functional elements of the claimed method would require hindsight reasoning.
For these reasons, claims 2, 6 and 14 as well as further dependent claims 3, 7-9 and 15-20 are allowable over the prior art of record.
Conclusion
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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