DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 March 2026 has been entered.
Status of Claims
Claim(s) 1-2, 6-8 and 11 is/are currently amended. New claim(s) 21 has/have been added. Claim(s) 1-21 is/are pending.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 11 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11 and claims dependent thereon, Applicant discloses, "In decision block 68 [of Figure 2], which may be performed either during or after the task of generating the ketone measurement, the process determines whether the exhalation characteristics during the regulated flow phase satisfy the criteria for generating a valid ketone measurement. Preferably, this involves determining whether the pressure downstream from the valve 36 remains (or remained) within a target range for a selected time interval, such as 3 seconds, 4 seconds, or some other duration. For example, the process may generate the ketone measurement 7 seconds after exhalation begins, and may treat this measurement as invalid if the downstream pressure did not remain in the target range for the 3-second time period starting at 4 seconds from initiation of exhalation. In embodiments in which the device 28 includes a downstream pressure sensor 44, this task 68 is preferably performed based partly or wholly on the pressure monitored by that sensor 44. If no downstream pressure sensor 44 is provided, the pressure monitored by the upstream pressure sensor 34 may be used. A ketone measurement may be treated as invalid in block 68 if, for example, the user did not blow hard enough, did not blow long enough, or did not blow with a sufficiently constant force" (¶ [0019]). Decision 68 is shown/described as having a binary Y/N outcome, with no indication that any single method includes both outcomes, i.e., there is no disclosed method that comprises both, at a first time, measuring and providing a concentration of an analyte in the breath sample responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, and a different, second time, providing an error responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, particularly with the same breath sample, as required/encompassed by claim 11. Accordingly, the limitation(s) "at a first time: responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, measuring a concentration of an analyte in the breath sample with the analyte sensor and providing the concentration of the analyte in the breath sample measured with the analyte sensor; and at a second time: responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, providing an error" lack sufficient support in the application as filed, and therefore are directed to and/or encompass new matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-7, 9-12, 14, 16-17 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0224251 A1 (previously cited, Ahmad) in view of US 2017/0059245 A1 (previously cited, Konishi), US 2011/0066060 A1 (von Bahr) and US 2018/0120293 A1 (Neumann).
Regarding claims 1, 6 and 21, Ahmad discloses/suggests a portable breath analysis device (e.g., Figs. 1-2), the device comprising:
a breath input port fluidly coupled to a flow path (¶ [0209] breath input port fluidly coupled to a flow path);
an analyte sensor positioned along the flow path (¶¶ [0212]-[0218] analyzing/analysis portion fluidically coupled to and in fluid communication with a first conduit) the analyte sensor capable of measuring a level of an analyte in a breath sample that passes along the flow path under an exhalation force created by a user (¶¶ [0212]-[0218] analysis portion comprises a sensor disposed at/within a reaction vessel so that fluid entering the analysis portion contacts and interacts with a reactive component(s) of said sensor to sense an analyte);
a valve positioned along the flow path (¶ [0214] valving device disposed in the flow path of the conduit); and
a processor (¶ [0220] processor disposed within the housing) configured to regulate a rate of flow of the breath sample past the analyte sensor by adjusting a position of the valve during exhalation of the breath sample by the user (¶ [0221] processor is operatively coupled to the valving device (i.e., segmentation means), so that the processor can both control the position or state of the device and monitor its position), such that the processor is thereby configured to compensate for variations in an exhalation force created by the user (Abstract, control flow of a breath sample into an analysis chamber as the user exhales into a port; ¶ [0262] isolating the sample provided to the sensor to a breath profile segment(s) having desired pressure or flow characteristics by excluding initial and terminal breath profile segments where fluid flow rate is changing (i.e., controlling the valving device to be in a second open position, as described in ¶ [0214], during said breath segment(s)) and focusing on breath segment(s) having essentially steady or linear flow rates (i.e., controlling valving device to be in a first open position (e.g., ¶ [0214]) during said breath segment(s); etc.).
Ahmad does not expressly disclose the processor is configured to dynamically adjust the position of the valve to maintain the rate of flow of the breath sample past the analyte sensor in a threshold flow rate range during exhalation of the breath sample by the user, thereby compensating (or further compensating) for variations in exhalation force created by the user. However, Ahmad further discloses flow rate or pressure of breath as it is collected from a user can vary quite considerably, and flow rate variations are known to impact, often significantly, the response of chemical sensors (¶ [0022]), thereby suggesting a steady flow rate past such an analyte sensor is preferred. Indeed, Ahmad expressly discloses and/or suggests breath profiles that are essentially steady may be provided to such sensors (e.g., ¶ [0261]). Ahmad further discloses the device may include means for controlling certain flow characteristics, such as flow rate. Specifically, Ahmad discloses the apparatus may include at least one fluid conditioner for appropriately conditioning the breath sample as it enters the breath input and is directed to the analyzing portion, including, e.g., controlling a flow rate (e.g., ¶ [0212]). Accordingly, Ahmad discloses/suggests the rate of flow of the breath sample past the analyte sensor should be maintained at a steady rate, such as one of the exemplary disclosed flow rates (e.g., ¶ [0108]), and further discloses/suggests the device may include means for controlling the flow rate of said breath sample past the analyte sensor.
Konishi teaches/suggests a device comprising a valve (Fig. 4, drive valve 25), and a flow rate sensor positioned downstream from the valve (Fig. 4, flow sensor 27), wherein a processor is configured to dynamically adjust a position of a valve based at least partly on the on the output of the downstream (i.e., flow) sensor to maintain the rate of flow of the breath sample at a desired rate (¶ [0055] flow adjuster 22 reduces the aperture of the valve hole 24 with the drive valve 25 if the flow of exhalation sensed by the flow sensor 27 is large, and increases the aperture of the valve hole 24 with the drive valve 25 if the flow of exhalation sensed by the flow sensor 27 is small to stabilize the flow of exhalation to the chamber 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ahmad with a flow rate sensor positioned along the flow path (e.g., downstream of the valve) and with the processor being configured to dynamically adjust a position of the valve to maintain the rate of flow of the breath sample past the analyte sensor in a threshold flow rate range during exhalation of the breath sample as taught and/or suggested by Konishi in order to further/better stabilize/regulate breath flow directed to the sensor (Konish, ¶ [0055]; Ahmad, ¶ [0212]; etc.) in a threshold/desired flow rate range (Ahmad, ¶ 0108]), thereby reducing flow perturbations provided to the sensor and increasing accuracy and/or reliability of the analyte measurement(s) (Ahmad, ¶ [0022]; ¶ [0262]; etc.).
Ahmad further discloses the processor may be configured to: responsive to determining the breath sample does not satisfy threshold exhalation requirements, provide an error (e.g., ¶ [0121] analyzing flow exhalation properties of a breath sample to determine the validity of a value indicative of the concentration of the analyte in said breath sample; ¶ [0331] if exhalation property variables are within an acceptable range, the device accepts the test as valid, etc.; ¶ [0496] a controller may determine whether the user's exhalation satisfies one or more requirements, and may notify the user when it does not (e.g., display an error message); etc.). However, Ahmad does not expressly disclose the processor is configured to, responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, provide the level of the analyte in the breath sample measured by the analyte sensor; and responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, provide an error.
von Bahr discloses/suggests, in order to acquire repeatable, reliable and/or accurate analyte measurements, exhaled breath, or a portion thereof, should be delivered at a flow and during a duration of time adapted to the response time of the analyte sensor (e.g., ¶ [0043]; ¶ [0061]; etc.).
Neumann, similarly, discloses a system for measuring an analyte (e.g., alcohol) in an exhaled breath sample, disclosing users should exhaled within a threshold range of flow rates and for a minimum duration of time (e.g., ¶ [0004]; ¶ [0039]), wherein the system comprises a processor configured to responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, provide the level of the analyte in the breath sample measured by the analyte sensor; and responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, provide an error (e.g., Abstract, ¶ [0049], etc. processing device 160 determines if each measured attribute of airflow is within a threshold range; when conditions are met, then breath analysis processing begins and testing results are subsequently obtained, and, when conditions are not met, a read error may be conveyed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ahmad with the processor being configured to provide the level of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time; and provide an error responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time as taught/suggested by Neumann in order to ensure the breath sample directed past the analyte sensor meets the requirements for obtaining valid (accurate, reliable, repeatable, etc.) analyte measurements (Ahmad, ¶ [0331]; von Bahr, ¶ [0061]; Neumann, ¶ [0004], ¶ [0039], etc.), and notify the user when the breath sample is inadequate to measure the analyte (Neumann, ¶ [0039]).
Regarding claims 11 and 14, Ahmad discloses/suggests a process performed by a breath analysis device, the breath analysis device comprising a breath input port fluidly coupled to a flow path and comprising an analyte sensor positioned along the flow path (e.g., Figs. 1-2; see discussion of claim 1 above), the process comprising, under control of a processor of the breath analysis device (e.g., Figs. 1-2; see discussion of claim 1 above):
as a user exhales a breath sample into the breath input port, regulating a rate of flow of the breath sample along the flow path and past the analyte sensor by adjusting a position of a valve (Abstract, control flow of a breath sample into an analysis chamber as the user exhales into a port; ¶ [0262] isolating the sample provided to the sensor to breath segments having desired pressure or flow characteristics by excluding initial and terminal breath profile segments where fluid flow rate is changing (i.e., controlling the valving device to be in a second open position, as described in ¶ [0214] during said breath segment(s)) and focusing on breath segment(s) having essentially steady or linear flow rates (i.e., controlling the valving device to be in a first open position (¶ [0214]) during said breath segment(s); etc.); and
measuring a concentration of an analyte in the breath sample with the analyte sensor (e.g., ¶ [0218] sensing analyte; Fig. 1, acetone concentration; etc.).
Ahmad does not expressly disclose dynamically adjusting the position of the valve to maintain the rate of flow of the breath sample past the analyte sensor in a threshold flow rate range during exhalation of the breath sample by the user. However, Ahmad discloses the flow rate or pressure of breath as it is collected from a user can vary quite considerably, and flow rate variations are known to impact, often significantly, the response of chemical sensors (e.g., ¶ [0022]). Ahmad further discloses the device may include means for controlling certain flow characteristics, such as flow rate (e.g., ¶ [0212]), and discloses a desired flow rate range during the measurement cycle (e.g., ¶ [0108]).
Konishi teaches/suggests a device comprising a valve (Fig. 4, drive valve 25), and a flow rate sensor positioned downstream from the valve (Fig. 4, flow sensor 27), wherein a processor is configured to dynamically adjust a position of a valve based at least partly on the on the output of the downstream (i.e., flow) sensor to maintain the rate of flow of the breath sample at a desired rate (¶ [0055] flow adjuster 22 reduces the aperture of the valve hole 24 with the drive valve 25 if the flow of exhalation sensed by the flow sensor 27 is large, and increases the aperture of the valve hole 24 with the drive valve 25 if the flow of exhalation sensed by the flow sensor 27 is small to stabilize the flow of exhalation to the chamber 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Ahmad with measuring a flow rate along the flow path (e.g., downstream of the valve) and dynamically adjusting a position of the valve to maintain the rate of flow of the breath sample past the analyte sensor in a threshold flow rate range during exhalation of the breath sample as disclosed/suggested by Konishi in order to further/better stabilize/regulate breath flow directed to the sensor (Konish, ¶ [0055]; Ahmad, ¶ [0212]; etc.) in a threshold/desired flow rate range (Ahmad, ¶ 0108]), thereby further reducing flow perturbations provided to the sensor and increasing accuracy/reliability of the analyte measurement(s) (Ahmad, ¶ [0022]; ¶ [0262]; etc.).
Ahmad further discloses the method may comprise, responsive to determining the breath sample does not satisfy threshold exhalation requirements, providing an error (e.g., ¶ [0121] analyzing flow exhalation properties of a breath sample to determine the validity of a value indicative of the concentration of the analyte in said breath sample; ¶ [0331] if exhalation property variables are within an acceptable range, the device accepts the test as valid, etc.; ¶ [0496] a controller may determine whether the user's exhalation satisfies one or more requirements, and may notify the user when it does not (e.g., display an error message); etc.). However, Ahmad does not expressly disclose the method comprises at a first time, responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, measuring a concentration of an analyte in the breath sample with the analyte sensor and providing the concentration of the analyte in the breath sample measured with the analyte sensor; and at a second time: responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, providing an error.
von Bahr discloses/suggests, in order to acquire repeatable, reliable and/or accurate analyte measurements, exhaled breath (or a portion thereof) should be delivered at a particular flow for a duration of time adapted to the response time of the analyte sensor (e.g., ¶ [0043]; ¶ [0061]; etc.).
Neumann, similarly, discloses a method for measuring an analyte (e.g., alcohol) in an exhaled breath sample, disclosing users should exhaled within a threshold range of flow rates and for a minimum duration of time (e.g., ¶ [0004]; ¶ [0039]), wherein the method comprises, at a first time: responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, measuring a concentration of an analyte in an exhaled breath sample with an analyte sensor and providing the concentration of the analyte in the breath sample measured with the analyte sensor; and, at a second time: responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time, providing an error (e.g., Abstract, ¶ [0049], etc. processing device 160 determines if each measured attribute of airflow is within a threshold range; when conditions are met, then breath analysis processing begins and testing results are subsequently obtained, and, when conditions are not met, a read error may be conveyed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ahmad with measuring the concentration of the analyte in the breath sample with the analyte sensor and providing the level of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time; and/or providing an error responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time as taught/suggested by Neumann in order to ensure the breath sample directed past the analyte sensor meets the requirements for obtaining valid (accurate, reliable, repeatable, etc.) analyte measurements (Ahmad, ¶ [0331]; von Bahr, ¶ [0061]; Neumann, ¶ [0004], ¶ [0039], etc.), and notify the user when a given breath sample is inadequate to measure the analyte (Neumann, ¶ [0039]).
Regarding claims 2 and 12, Ahmad as modified discloses/suggests the device further comprises a first pressure sensor positioned along the flow path (¶ [0212] means (e.g., Fig. 2, reference number 22, since reference number 24 is presumably the fluid conditioner, based on, e.g., ¶ [0215]) are included for measuring or controlling certain gas properties or conditions and flow characteristics as breath is inputted into and passes through the apparatus, where gas properties include pressure), wherein the processor is configured to control the position of the valve based at least partly on pressure measurements generated by the first pressure sensor (¶ [0262] sample is isolated to segments having desired pressure; ¶ [0264] sensor-based fractionation or segmentation of a breath relies on using a sensor to detect one or more characteristic of the breath (e.g., pressure) and actively causing a response by the fractionator (such as movement of a valve or solenoid)).
Regarding claim 3, Ahmad as modified discloses/suggests the valve is positioned upstream from the analyte sensor, and the pressure sensor is positioned upstream from the valve (Fig. 2, reference number 22 is upstream of valving device, i.e., reference number 26).
Regarding claim 7, Ahmad as modified discloses/suggests the valve is coupled to another flow path through which a portion of the breath sample is vented from the portable breath analysis device without passing by the analyte sensor (¶ [0214] when in the second open position, valving device directs flow to the second conduit but prevents flow to the first conduit; ¶ [0129]; etc.).
Regarding claims 9 and 16, Ahmad as modified discloses/suggests the analyte sensor is a ketone sensor (Abstract, Fig. 1, etc., where concentration of acetone is determined).
Regarding claims 10 and 17, Ahmad as modified discloses/suggests the analyte sensor is a semiconductor sensor (e.g., ¶ [0217]).
Regarding claim 20, Ahmad as modified discloses/suggests the processor is further configured to adjust the level of the analyte measured by the analyte sensor based on the rate of flow of the breath sample (¶ [0306] the device senses a real time exhalation characteristic, such as flow rate, logs this information and uses the logged information to adjust associated acetone measurements to compensate for deviations in how the user exhaled).
Claim(s) 4-5, 8, 13, 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad in view of Konishi, von Bahr and Neumann as applied to claim(s) 3 and 11 above, and further in view of US 6,152,135 A (previously cited, DeVries).
Regarding claims 4-5 and 13, Ahmad as modified discloses/suggests the limitations of claims 1 and 11, and discloses/suggests the device comprises a first pressure sensor positioned along the flow path upstream from the valve, wherein the processor is configured to control the position of the valve based at least partly on pressure measurements generated by the first pressure sensor (see discussion of claims 2-3 above, wherein at least determining when to position the valve such that flow is directed to the conduit/flow path having sensor analyzing or analysis portion, may be based on the output of a sensor detecting a characteristic of the breath, such as pressure, and actively causing a response by the fractionator (such as movement of a valve or solenoid)). Ahmad does not disclose the device comprises a second pressure sensor positioned downstream from the valve, wherein the processor is configured to adjust the position of the valve based at least partly on a differential pressure between the first pressure sensor and the second pressure sensor.
DeVries discloses/suggests a device comprising a valve positioned along a flow path (flow valve 12) a first pressure sensor positioned upstream from the valve and a second pressure sensor positioned downstream from the valve (col. 4, lines 1-5, means for measuring differential pressure across the flow valve); and a processor (microprocessor 82) configured to adjust the position of the valve based at least partly on a differential pressure between the first and second pressure sensors (col. 3, lines 51-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and process of Ahmad to comprise a first pressure sensor positioned upstream of the valve, a second pressure sensor positioned downstream from the valve, wherein the processor is configured to adjust the position of the valve based at least partly on a differential pressure between the first pressure sensor and the second pressure sensor, as taught/suggested by DeVries as a simple substitution of one suitable means for measuring flow rate downstream of the valve in order to control/regulate flow therethrough for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 8 and 15, Ahmad as modified discloses/suggests the limitations of claims 1 and 11, as discussed above, and discloses/suggests the device further comprises means mechanically coupled to the valve, wherein the processor adjusts the position of the valve by controlling said means (e.g., ¶ [0120] a valve may be mechanically driven), but does not expressly disclose said means comprises a stepper motor.
DeVries discloses/suggests a comparable processor-controlled valve, as discussed above, comprising a stepper motor mechanically coupled to a valve (flow valve 12 is digitally operated by a step motor 80), wherein a processor (microprocessor 82) adjusts the position of the valve by controlling the stepper motor (e.g., col. 3, lines 51-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ahmad with a stepper motor mechanically coupled to the valve, wherein the processor is configured for adjusting the position of the valve by controlling the stepper motor as disclosed/suggested by DeVries as a simple substitution of one suitable means/method for controlling the position of the valve as desired, and therefore flow there-through, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 19, Ahmad as modified discloses/suggests the limitations of claim 1, but does not expressly disclose the processor is configured to dynamically adjust the position of the valve based on a look-up table that maps differential pressure measured between a first location upstream from the valve and a second location downstream from the valve to the position of the valve.
DeVries discloses/suggests a comparable processor-controlled valve, as discussed above, wherein the processor is configured to dynamically adjust the position of the valve based on a look-up table that maps differential pressure measured between a first location upstream from the valve and a second location downstream from the valve to the position of the valve (col. 3, line 65 - col. 4, line 37, controller 82 operates the valve positioning motor 80 in accordance with a pair of look-up tables which are empirically generated, wherein the position calculation from the lookup table is continuously updated by the controller in order to deliver the desired flow; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ahmad with the processor being configured to dynamically adjust the position of the valve based on a look-up table that maps differential pressure measured between a first location upstream from the valve and a second location downstream from the valve to the position of the valve as taught/suggested by DeVries in order to deliver the desired flow through the valve (DeVries, col. 3, line 65 - col. 4, line 37).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad in view of Konishi, von Bahr and Neumann as applied to claim(s) 1 above; or alternatively, over Ahmad in view of Konishi, von Bahr and Neumann as applied to claim(s) 1 above, and further in view of US 20150059859 A1 (previously cited, Takahashi).
Regarding claim 18, Ahmad as modified discloses/suggests the limitations of claim 1, and further discloses/suggests the valve remains in a partially opened position during exhalation of the breath sample by the user (e.g., at least during segment(s) of the breath profile having essentially steady or linear flow rates, as described in ¶ [0262]), and the processor is configured to dynamically adjust the position of the valve during said exhalation in order to further/better stabilize/regulate breath flow directed to the sensor, thereby further reducing flow perturbations provided to the sensor and increasing accuracy/reliability of the analyte measurement(s) (see discussion of claim 1 above). Ahmad does not expressly disclose the processor is configured to dynamically adjust the position of the valve relative to a position in which the valve is 50% open.
However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Ahmad with the processor is configured to dynamically adjust the position of the valve relative to a position in which the valve is 50% open because Applicant has not disclosed that adjusting the position of the valve relative to the disclosed position provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the adjustment taught/suggested by Konichi (e.g., ¶ [0055]) because either arrangement permits stabilizing and/or regulating breath flow directed to the sensor for increased analyte measurement accuracy.
Alternatively/Additionally, Takahashi discloses device comprising a processor-controlled valve, wherein the valve is initially opened to a pre-set valve opening degree, such as a 50% opening degree (e.g., ¶ [0057]), and the processor is configured to dynamically adjust the position of the valve relative to a position in which the valve is 50% open so that the valve remains in a partially opened position (e.g., ¶ [0023]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ahmad with the processor being configured to dynamically adjust the position of the valve relative to a position in which the valve is 50% open, as taught/suggested by Takahashi, so that the valve remains in a partially opened position during exhalation of the breath sample by the user, in order to provide an initial valve opening degree at which the valve opens when a desired segment of the breath profile is being exhaled (Ahmad, ¶ [0262]), and from which valve adjustments may be made in order to control flow through the valve at a desired rate, or range of rates (Takahashi, ¶ [0023]).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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.
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Claim(s) 1-21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-15 of USPN 11,497,414 and Ahmad in view of Konishi, von Bahr and Neumann; Ahman in view of Konishi, von Bahr, Neumann and DeVries; and/or Ahmad in view of Konishi, von Bahr, Neumann and Takahashi.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of USPN 11,497,414 anticipate each limitation of claims 1-17 and 21 of the present application, with the exception of expressly reciting the position (or state) of the valve is dynamically adjusted to maintaining the rate of flow of the breath sample past the analyte sensor in a threshold flow rate range during exhalation of the breath sample by the user; and providing the level of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample has remained in the threshold flow rate range for a threshold period of time, and providing an error responsive to determining that the rate of flow of the breath sample has not remained in the threshold flow rate range for the threshold period of time. However, as noted in the rejection(s) of record above, Ahmad at least suggests the rate of flow of the breath sample past the analyte sensor should be maintained in a threshold flow rate, and Konishi discloses a sensor/valve arrangement for achieving this regulated/stable flow. Further, von Bahr and Neumann disclose/suggest providing the level of the analyte in the breath sample measured by the analyte sensor responsive to determining that a breath sample satisfies pre-set exhalation requirements, such as the rate of flow of the breath sample remaining in the threshold flow rate range for a threshold period of time, and providing an error when a breath sample does not satisfy said requirements. Accordingly, it would have been obvious to modify claims 1-15 of USPN 11,497,414 with the above-noted feature(s) for at least the reasons discussed above with respect to the prior art rejections. Claims 1-15 USPN 11,497,414 does not recite the limitations of claims 18-20. However, the combination(s) of references noted above discloses these features, and would have been an obvious modification to the claims 1-15 USPN 11,497,414 for substantially the same reasons as discussed in the above prior art rejections above.
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground(s) of rejection does/do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2014/0371619 A1 discloses an acetone sensing device that senses the flow rate of breath through the device and requires that the user maintain a minimum breath flow rate for a threshold amount of time before beginning acetone detection (¶ [0033]).
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/Meredith Weare/Primary Examiner, Art Unit 3791