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 .
Claim Status
Claims 1-16 are pending and under examination.
Response to Amendment
The amendments to the claims, received 02/06/2026, have overcome the claim objection(s) set forth in Non-Final Rejection mailed on 11/07/2025. Therefore, the claim objection(s) have been withdrawn.
Applicant’s amendments to the claims have overcome the 112(b) rejection(s) previously set forth in the Non-Final Office Action. However, based on the claim amendments, new 112(b) rejections have been set forth.
Based on the amended claims and remarks, the previous prior art rejection over Mochizuki has been modified to address the amended claims (see below).
The double patenting rejection over co-pending application 18/975,055 has been modified and maintained to address the amended claims.
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 11-16 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 pre-AIA the applicant regards as the invention.
Claim 11 lines 21-26 have been amended to recite “thereby the measuring chamber is purged from the gas sample … with the sensor, measuring at least one of an indicator of a concentration of the substance in the gas sample located in the measuring chamber and an indicator of an amount of the substance in the gas sample located in the measuring chamber”. It is unclear how the sensor is measuring a concentration/amount of the gas sample “in the measuring chamber” if the gas sample was previously purged from the measuring chamber. Claims 12-16 are also rejected by their dependency from claim 11.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mochizuki et al. (US 2014/0165698; already of record – hereinafter “Mochizuki”), and further in view of Ben-Yosef et al. (US 2007/0293780; already of record – hereinafter “Yosef”).
Regarding claim 1, Mochizuki teach an analyzer for analyzing a gas sample delivered by a subject for a predetermined substance (Mochizuki; fig. 1, #1, [0106]), the analyzer comprises:
an input unit configured to input or receive the gas sample (Mochizuki; figs. 1-2, #21, #30, [0106-0107]);
a measuring chamber (Mochizuki; fig. 6, #15a, [0113]), the analyzer being configured to at least temporarily provide an input fluid connection (Mochizuki; fig. 6, #21/22, [0113]) between the input unit and the measuring chamber (Mochizuki; fig. 6);
a sensor configured to measure at least one of an indicator of an amount of the substance in the gas sample located in the measuring chamber and an indicator of a concentration of the substance in the gas sample located in the measuring chamber (Mochizuki; fig. 6, #15, [0106, 0113]);
a suction chamber unit configured to be selectively transferred into a minimum volume state or a maximum volume state (Mochizuki; fig. 6, #17, “air barrel 17 … can be expanded and contracted”; [0113]), the analyzer being configured to at least temporarily provide a suction fluid connection (Mochizuki; fig. 6, #23, [0113]) between the suction chamber unit and the measuring chamber (Mochizuki; fig. 6);
a drive unit (Mochizuki; fig. 6, #18, [0113]) configured to selectively transfer the suction chamber unit into the minimum volume state or into the maximum volume state, the drive unit being mechanically coupled to the suction chamber unit (Mochizuki; fig. 6, #18, [0165]) such that:
wherein the analyzer is configured such that a transfer of the suction chamber unit into the maximum volume state causes the gas sample to be sucked out of the input unit through the input fluid connection into the measuring chamber (Mochizuki; [0113, 0165]).
Mochizuki does not teach a valve configured to be moved into a closing end position in which the valve interrupts the input fluid connection and to be moved into a releasing end position in which the valve releases the input fluid connection; and the drive unit configured to selectively move the valve into the closing end position or into the releasing end position and the drive unit being mechanically coupled to the valve, or a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state; or a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state.
However, Yosef teach the analogous art of an analyzer for analyzing a gas sample (Yosef; fig. 1, [0031]), the analyzer comprising an input unit (Yosef; figs. 1-2, #20, #22, #24, #36, [0031-0032]), a measuring chamber (Yosef; fig. 2, #42, [0033]), a drive unit (Yosef; figs. 2 & 4A-B, #34, [0037]), and a valve (Yosef; fig. 4A-B, #70, #138/#140, [0041, 0044-0045]) configured to be moved into a closing end position in which the valve interrupts the input fluid connection (Yosef; fig. 4B, [0058]) and to be moved into a releasing end position in which the valve releases the input fluid connection (Yosef; fig. 4A, [0055]); and the drive unit configured to selectively move the valve into the closing end position or into the releasing end position (Yosef; figs. 4A-B, [0055, 0058]) and the drive unit being mechanically coupled to the valve (Yosef; fig. 2, [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, because Yosef teaches the valve configured to be moved in the closing end position and the releasing position allows the patient sample supply to be governed in a controlled manner (Yosef; [0035, 0056]). Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Mochizuki and Yosef both teach analyzing a metered amount of substance in a metering chamber.
Regarding claim 2, modified Mochizuki teach the analyzer according to claim 1 above, wherein: the drive unit comprises: an actuator; and a mechanical valve connecting element; the valve comprises a closure part; and a closure part seat; and the valve connecting element mechanically connects the actuator to the closure part (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Yosef teach the drive unit 34 comprises an actuator 80; figs. 2 & 4, [0037]; and a mechanical valve connecting element; figs. 2 & 4, #164, [0049]; the valve comprises a closure part; figs 2 & 4, #138, [0044]; and a closure part seat; fig. 4, #120, [0041]; and the valve connecting element mechanically connects the actuator to the closure part; fig. 4, [0058]).
Regarding claim 3, modified Mochizuki teach the analyzer according to claim 1 above, wherein the measuring chamber is located between the input unit and the suction chamber unit (Mochizuki; fig. 6. Measuring chamber 16 is between input unit 30/21 and suction chamber unit 17).
Regarding claim 4, modified Mochizuki teach the analyzer according to claim 1 above, wherein: the drive unit comprises an actuator mechanically coupled to the valve and mechanically coupled to the suction chamber unit; and the suction chamber unit is located between the measuring chamber and the actuator (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Mochizuki and Yosef both teach the drive unit comprises an actuator (solenoid 18 in Mochizuki and solenoid 80 in Yosef). Yosef teach the solenoid 80 is mechanically coupled to the valve via shaft 164; fig. 4, [0058]. Mochizuki teach the drive unit mechanically coupled to the suction chamber unit; fig. 6, [0113, 0124] and the suction chamber unit 17 is located between the measuring chamber 15a and the actuator 18; fig. 6).
Regarding claim 5, modified Mochizuki teach the analyzer according to claim 1 above, wherein: the suction chamber unit comprises a suction chamber with variable volume and a chamber modifying element (Mochizuki teach suction chamber 17 is bellowed shape configured to expand and contract; fig. 6, [0165]); the drive unit comprises an actuator (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Mochizuki and Yosef both teach the drive unit comprises an actuator (solenoid 18 in Mochizuki and solenoid 80 in Yosef). and a mechanical suction chamber connecting element (Mochizuki teach solenoid 18 is connected to the suction chamber 17 such that when control unit 102 drives the solenoid, the suction chamber 17 compresses to push the sample in the suction chamber to the gas sensor 15a; fig. 6, [0125]. Accordingly, the drive 18 of Mochizuki comprises a mechanical suction chamber connecting element to perform the recited function. Furthermore, Yosef teach the solenoid 80 is mechanically coupled to the valve via shaft 164; fig. 4, [0058]); the suction fluid connection connects the suction chamber to the measuring chamber (Mochizuki; fig. 6, #23, [0113]); a movement of the chamber modifying element relative to the suction chamber causes the volume of the suction chamber to be changed; and the suction chamber connecting element mechanically connects the actuator to the chamber modifying element (The modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a).
Regarding claim 6, modified Mochizuki teach the analyzer according to claim 5 above, wherein the drive unit comprises: an actuator; and a mechanical valve connecting element; the valve comprises a closure part; and a closure part seat; and the valve connecting element mechanically connects the actuator to the closure part and comprises the suction chamber connecting element (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Yosef teach the drive unit 34 comprises an actuator 80; figs. 2 & 4, [0037]; and a mechanical valve connecting element; figs. 2 & 4, #164, [0049]; the valve comprises a closure part; figs 2 & 4, #138, [0044]; and a closure part seat; fig. 4, #120, [0041]; and the valve connecting element mechanically connects the actuator to the closure part; fig. 4, [0058] wherein the modification would result in the valve connecting element connecting the actuator to the closure part and comprising the suction chamber connecting element of Mochizuki).
Regarding claim 7, modified Mochizuki teach the analyzer according to claim 1 above, further comprising a volume flow sensor configured to measure an indicator of a volume flow of the gas sample through the input fluid connection into the measuring chamber, wherein the analyzer is configured to actuate the drive unit to move the valve into the closing end position, the actuation is performed depending on the measured volume flow (Mochizuki; fig. 17, S108-S111, [0205-0208]. The examiner notes pressure and volume and mathematically proportional and therefore either parameter could be used interchangeably to determine volume).
Regarding claim 8, modified Mochizuki teach the analyzer according to claim 1 above, further comprising a fluid guide unit, wherein: the valve comprises a closure part; the fluid guide unit surrounds the closure part; an intermediate space is present between the fluid guide unit and the closure part; and the input fluid connection passes through the fluid guide unit and includes the intermediate space (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Yosef teach fluid guide unit 120 and closure part 138, fig. 4, [0041, 0044]. The fluid guide unit surrounds the closure part; an intermediate space is present between the fluid guide unit and the closure part; and the input fluid connection passes through the fluid guide unit includes the intermediate space; Yosef; fig. 4A, [0055]).
Regarding claim 9, modified Mochizuki teach the analyzer according to claim 1 above, wherein the analyzer is configured such that the transfer of the suction chamber unit into the minimum volume state causes the gas sample to be conveyed through the input fluid connection out of the measuring chamber (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a).
Regarding claim 10, modified Mochizuki teach the analyzer according to claim 1, further comprising an input fluid guide unit, wherein: the input unit is configured to be connected to the input fluid guide unit; the input fluid connection passes through the input fluid guide unit; and the input fluid guide unit fully or at least partially surrounds the valve (The modification of the analyzer and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 1 above. Yosef teach an input fluid guide unit 120 configured to be connected to the input unit 24 which communicates with 36 and is connected to the input fluid guide unit 120 which at least partially surrounds the valve 138; figs. 2 & 4, [0032, 0054].
Regarding claim 11, Mochizuki teach a process for analyzing a gas sample delivered by a subject for a predetermined substance (Mochizuki; figs. 1, 6, 10, #1 [0106, 0136]), the process comprising the steps of:
providing an analyzer (Mochizuki; fig. 1, #1, [0106]), wherein the analyzer comprises an input unit (Mochizuki; fig. 1, #21, #30, [0106-0107]);
a measuring chamber (Mochizuki; fig. 6, #15a, [0113]);
a sensor (Mochizuki; fig. 6, #15, [0106, 0113]);
a suction chamber unit which can be selectively transferred into a minimum volume state or a maximum volume state (Mochizuki; fig. 6, #17, “air barrel 17 … can be expanded and contracted”; [0113]);
a drive unit (Mochizuki; fig. 6, #18, [0165]),
wherein the analyzer at least temporarily provides an input fluid connection between the input unit and the measuring chamber (Mochizuki; fig. 6, #21/22, [0113]) and at least temporarily provides a suction fluid connection between the suction chamber unit and the measuring chamber (Mochizuki; fig. 6, #23, [0113]);
inputting the gas sample into the input unit or receiving the gas sample by the input unit (Mochizuki; fig. 6, #30, #21, [0107]);
with the drive unit, transferring the suction chamber unit into the maximum volume state causing the gas sample to be sucked out of the input unit through the input fluid connection into the measuring chamber (Mochizuki; fig. 6, [0113]);
subsequent to the step of transferring the suction chamber unit into the maximum volume state, with the drive unit, transferring the suction chamber unit into the minimum volume state causing gas to be conveyed from the suction chamber unit through the suction fluid connection into the measuring chamber, and thereby the measuring chamber is purged from the gas sample(Mochizuki; fig. 6, [0113, 0165]); and
with the sensor, measuring at least one of an indicator of a concentration of the substance in the gas sample located in the measuring chamber and an indicator of an amount of the substance in the gas sample located in the measuring chamber (Mochizuki; fig. 6, [0114]).
Mochizuki does not teach a valve, the valve initially the valve being in a closing end position in which the valve interrupts the input fluid connection; with the drive unit, moving the valve into a releasing end position in which the valve releases the input fluid connection; wherein either: the step of moving the valve into the releasing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the maximum volume state are performed simultaneously, or the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously, and the step of moving the valve into the releasing end position and the step of transferring the suction chamber unit into the maximum volume state are performed simultaneously.
However, Yosef teach the analogous art of an analyzer for analyzing a gas sample (Yosef; fig. 1, [0031]), the analyzer comprising an input unit (Yosef; figs. 1-2, #20, #22, #24, #36, [0031-0032]), a measuring chamber (Yosef; fig. 2, #42, [0033]), a drive unit (Yosef; figs. 2 & 4A-B, #34, [0037]), and a valve (Yosef; fig. 4A-B, #70, #138/#140, [0041, 0044-0045]) initially being in a closing end position in which the valve interrupts the input fluid connection (Yosef; fig. 4B, [0058]), with the driving unit, moving the valve into a releasing end position in which the valve releases the input fluid connection (Yosef; fig. 4A, [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, because Yosef teaches the valve configured to be moved in the closing end position and the releasing position allows the patient sample supply to be governed in a controlled manner (Yosef; [0035, 0056]). Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving the valve to the releasing end position and the step of transferring the suction chamber unit into the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. Lastly, the modification would thus alternate between being in the closing end position and the releasing end position where gas is interrupted or permitted to flow. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Mochizuki and Yosef both teach analyzing a metered amount of substance in a metering chamber.
Regarding claim 12, modified Mochizuki teach the process according to claim 11 above, wherein: an event is detected that the flow of the gas sample into the input unit is started, wherein the step of moving the valve into the releasing end position is started if a predefined period of time has elapsed since the gas sample entered the input unit and/or if an opening event has occurred after the start of gas sample input, wherein the opening event depends on an indicator of the volume or amount of the gas sample previously input into the input unit (The modification of the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 11 above. Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving back the valve to the releasing end position and the step of transferring the suction chamber unit to the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. Mochizuki teach a predefined period of 5 seconds must elapse before activating the solenoid valve to transfer the sample to the sensor; fig. 17, S108-S111, [0205-0208]. Accordingly, the opening even depending on an indicator of the volume or amount of the gas sample previously input into the input unit).
Note: “if a predefined period of time has elapsed since the gas sample entered the input unit and / or if an opening event has occurred after the start of gas sample input, wherein the opening event depends on an indicator of the volume or amount of the gas sample previously input into the input unit” are contingent limitations and do not necessarily have to occur. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. (See MPEP 2111.04).
Regarding claim 13, modified Mochizuki teach the process according to claim 11 above, wherein at least once an indicator of the amount of gas that has so far flowed into the measuring chamber after the start of the step of moving the valve into the releasing end position is measured, and upon the measured amount having reached a predetermined quantity limit, the step of moving the valve back into the closing end position is triggered (The modification of the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 11 above. Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving back the valve to the releasing end position and the step of transferring the suction chamber unit to the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. Mochizuki teach a predefined period of 5 seconds must elapse before activating the solenoid valve to transfer the sample to the sensor; fig. 17, S108-S111, [0205-0208]).
Regarding claim 14, modified Mochizuki teach the process according to claim 11 above, wherein before carrying out the process, the suction chamber unit is in the maximum volume state, and the step of transferring the suction chamber unit to the minimum volume state is carried out before the step of transferring the suction chamber unit to the maximum volume state (The modification of the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 11 above, wherein the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving back the valve to the releasing end position and the step of transferring the suction chamber unit to the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. The examiner notes that the process may be sequentially repeated to define the starting and ending states).
Regarding claim 15, modified Mochizuki teach the process according to claim 11 above.
Modified Mochizuki does not explicitly teach wherein before carrying out the process, the suction chamber unit is in the minimum volume state, and the step of transferring the suction chamber unit into the maximum volume state is carried out before the step of transferring the suction chamber unit into the minimum volume state (The modification of the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 11 above, wherein the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving back the valve to the releasing end position and the step of transferring the suction chamber unit to the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. The examiner notes that the process may be sequentially repeated to define the starting and ending states).
Regarding claim 16, modified Mochizuki teach the process according to claim 11, wherein by means of a mechanical coupling of the drive unit with the valve and with the suction chamber unit, the drive unit moves the valve into one of the end positions and the drive unit transfers the suction chamber unit into the minimum or into the maximum volume state (The modification of the process, analyzer, and drive unit of Mochizuki to comprise a valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, has previously been discussed in claim 11 above. Mochizuki and Yosef both teach the drive unit (solenoid 18 in Mochizuki and solenoid 80 in Yosef). Yosef teach the solenoid 80 is mechanically coupled to the valve via shaft 164; fig. 4, [0058]. Mochizuki teach the drive unit mechanically coupled to the suction chamber unit; fig. 6, [0113, 0124]. Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that the step of moving back the valve to the releasing end position and the step of transferring the suction chamber unit to the maximum volume state are performed simultaneously since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and the step of moving the valve into the closing end position and the step of transferring the suction chamber unit into the minimum volume state are performed simultaneously since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/975,055 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 3-5 of copending Application No. 18/975,055 disclose:
an analyzer for analyzing a gas sample delivered by a subject for a predetermined substance (18/975,055 – Claim 1, “analyzer”), the analyzer comprises:
an input unit configured to input or receive the gas sample (18/975,055 – Claim 5, “input unit”);
a measuring chamber, the analyzer being configured to at least temporarily provide an input fluid connection between the input unit and the measuring chamber (18/975,055 – Claim 1, “measuring chamber”);
a sensor configured to measure at least one of an indicator of an amount of the substance in the gas sample located in the measuring chamber and an indicator of a concentration of the substance in the gas sample located in the measuring chamber (18/975,055 – Claim 1, “gas sensor”);
a suction chamber unit configured to be selectively transferred into a minimum volume state or a maximum volume state, the analyzer being configured to at least temporarily provide a suction fluid connection between the suction chamber unit and the measuring chamber (18/975,055 – Claim 4, “suction chamber unit”);
a valve configured to be moved into a closing end position in which the valve interrupts the input fluid connection and to be moved into a releasing end position in which the valve releases the input fluid connection (18/975,055 – Claim 1, “valve”); and
a drive unit configured to selectively move the valve into the closing end position or into the releasing end position and to selectively transfer the suction chamber unit into the minimum volume state or into the maximum volume state (18/975,055 – Claims 3 & 4, “fluid conveying unit” and “actuator”),
the drive unit being mechanically coupled to the valve and being mechanically coupled to the suction chamber unit such that (18/975,055 – Claims 1 and 3-4):
a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state; or a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state (18/975,055 – Claims 1 and 3-4),
wherein the analyzer is configured such that a transfer of the suction chamber unit into the maximum volume state causes the gas sample to be sucked out of the input unit through the input fluid connection into the measuring chamber (18/975,055 – Claims 1 and 3-5).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, filed 02/06/2026, have been fully considered.
Applicant argues, see pages 18-20 of their remarks, toward the 103 rejection over Mochizuki in view of Yosef, that the combination of references as a whole do not teach and do not suggest a valve for an input fluid connection and a synchronization between a movement of the valve and a transfer of a suction chamber unit as claimed. Specifically, applicant argues the valve assembly 34 of Yosef operates as a pneumatic switch and is not used for sucking in or otherwise conveying gas into the gas analysis chamber 42, and that a person of ordinary skill in the art would not consider using the solenoid valve assembly 34 of Yosef for sucking in a gas sample. Applicant further argues Yosef if void of a suction chamber unit and does not disclose that exhaled air is sucked in and therefore does not disclose a suction fluid connection.
The examiner respectfully disagrees and notes that applicant’s arguments are towards the references individually rather than the combination of references. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). That being said, the office action cites Mochizuki for disclosing the suction chamber unit configured to transfer into a minimum and maximum volume state using a drive unit, and relies Yosef for teaching a valve configured to move into a closing end position to interrupt the input fluid connection and a releasing end position to release the input fluid connection (i.e. a switch). The modification of the analyzer and drive unit of Mochizuki to further comprise the valve configured to be moved in a closing end position and a releasing position in which the valve interrupts the input fluid connection, as taught by Yosef, would therefore provide the additional benefit of allowing the patient sample supply to be governed in a controlled manner (Yosef; [0035, 0056]). Further, the modification of the drive 18 of Mochizuki to additionally comprise the valve 138/140 of Yosef would result in the valve operating to open and close the input unit 21 of Mochizuki and would thus be configured such that a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state since the valve would be transferred backwards to unblock input 21 as the bellow shape of the suction chamber 17 of Mochizuki expands when breath is blown into the suction chamber, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber unit into the minimum volume state since the valve would be transferred forward to block input 21 as the bellow shape of the suction chamber 17 of Mochizuki compresses to transfer the gas sample from the suction chamber 17 into the sensor chamber 15a. Accordingly, modified Mochizuki teach a valve for an input fluid connection and a synchronization between a movement of the valve and a transfer of a suction chamber unit as claimed.
Applicant argues on pages 20-21 that a person skilled in the art would be motivated to provide a separate drive for the valve of Yosef rather than modifying the drive unit disclosed in Mochizuki, and that it remains open how a person of ordinary skill in the art would amend the teaching of Mochizuki such that the air barrel 17 of Mochizuki is connected to a valve and can move a valve body. The examiner respectfully disagrees and notes that applicant’s assertion regarding the motivation of a person skill in the art to provide a separate drive is a matter of applicant’s opinion and would result in increased cost and design complexity. Second, Mochizuki and Yosef both teach a solenoid valve configured to translate linearly where Mochizuki teach the air barrel connected to the solenoid valve and Yosef teach the valve connected to the solenoid valve. Accordingly, the combination of references teach connections means for each device to a solenoid valve.
Applicant argues on page 21 of their remarks that Mochizuki and Yosef solve different problems using different systems and a person of ordinary skill in the art would not have reasonably looked to Yosef to modify the intake and sampling mechanism of Mochizuki. The examiner respectfully disagrees. In response to applicant's argument that Yosef is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Yosef and Mochizuki both teach an analyzer for analyzing a gas sample (Mochizuki; fig. 1, #1, [0106] and Yosef; fig. 1, [0031]), each analyzer comprising an input unit configured to receive a gas sample (Mochizuki; figs. 1-2, #21, #30 and Yosef; figs. 1-2, #20, #22, #24, #36, [0031-0032]), a measuring chamber (Mochizuki; fig. 6, #15a, [0113] and Yosef; fig. 2, #42, [0033]) and a drive unit (Mochizuki; fig. 6, #18, [0113] and Yosef; figs. 2 & 4A-B, #34, [0037]). Accordingly, Mochizuki and Yosef disclose inventions in the same field of endeavor and one of ordinary skill in the art would have been motived to modify the analyzer of Mochizuki to further comprise the valve, as taught by Yosef, because Yosef teaches the valve configured to be moved in the closing end position and the releasing position allows the patient sample supply to be governed in a controlled manner (Yosef; [0035, 0056]).
Applicant argues on pages 21-22 of their remarks that the modification of Mochizuki with Yosef amounts to hindsight reconstruction. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues on pages 22-23 of their remarks that application no 18/975,055 does not provide a drive unit that is mechanically coupled to a valve and a suction chamber such that: a movement of the valve into a releasing end position is synchronized with a transfer of the suction chamber unit into a minimum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber into the maximum volume state; or a movement of the valve into the releasing end position is synchronized with a transfer of the suction chamber unit into the maximum volume state, and a movement of the valve into the closing end position is synchronized with a transfer of the suction chamber into the minimum volume state. Applicant argues there is no recitation in claims 1 and 3-4 of copending application 18/975,055 as to a valve for an input fluid connection and a synchronization between a movement of the fluid and a transfer of a suction chamber unit as claimed. The examiner respectfully disagrees.
In response to applicant’s argument over the double patenting rejection, the drive unit that is mechanically coupled to a valve and a suction chamber is equivalent to the claimed fluid conveying unit configured to move the valve towards the released end position during suction and move the valve towards the closed end position during flushing, or the fluid conveying unit is configured to move the valve towards the closed end position during suction and towards the releasing end position during flushing (see claim 3). The examiner notes that claim 4 further defines the fluid conveying unit as comprising a suction chamber unit which is configured as a variable volume chamber, and an actuator. The examiner further notes that paragraph [0046-0047] of co-pending applications printed publication state “The fluid conveying unit comprises, for example, a piston-cylinder unit or a pump or a blow or a variable volume chamber, in particular a bellows, as well as an actuator or a motor or other drive … This actuator is mechanically connected to the fluid conveying unit and to a movable part of the valve”. Accordingly, although the claims at issue are not identical, they are not patentably distinct from each other.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571)272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798