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 .
Response to Amendment
The amendment to the claims filed 07 August 2026 has been entered. Claim(s) 1, 11 and 21 is/are currently amended. Claim(s) 20 has/have been canceled. New claim(s) 22-23 has/have been added. Claim(s) 1-20 and 22-23 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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, determining an adjusted concentration of an analyte in breath sample by adjusting concentration of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and providing the adjusted concentration of the analyte in the breath sample; 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, particularly with the same breath sample, as required and/or encompassed by claim 11. Accordingly, the limitations of claim 11 (and claims dependent thereon) lack sufficient support in the application as filed, and therefore are directed to and/or encompass new matter.
Applicant contends, "The Office Action interprets claim 11 as requiring a single method that performs both branches for the same breath sample. Applicant respectfully submits that this is not the broadest reasonable interpretation of claim 11 in view of the claim language and the specification. Amended claim 11 recites two conditional operations: 1) determining and providing the adjusted analyte concentration "responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time" and 2) providing an error "responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time." These "responsive to" clauses define alternative actions triggered by alternative determinations. They do not require that both mutually exclusive determinations be true for the same breath sample" (Remarks, pg. 8).
While the examiner does not dispute that the specification provides adequate support for a method in which either of the "responsive to…" limitations are performed (Fig. 2, steps 68, 70, 72, for example), such a method is not recited in claim 11. Claim 11 recites, in part (emphasis added):
[…] the process comprising, under control of a processor of the breath analysis device:
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 dynamically adjusting a position of a valve to maintain the rate of flow past the analyte sensor in a first threshold flow rate range during exhalation of the breath sample by the user;
at a first time:
responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time, determining an adjusted concentration of an analyte in the breath sample by adjusting concentration of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and providing the adjusted concentration of the analyte in the breath sample; and
at a second time:
responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time, providing an error.
As highlighted above, claim 11 does not require performing one of the "responsive to…" limitations or the other. The claim requires "at a first time: responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time, determining an adjusted concentration of an analyte in the breath sample […]; and at a second time: responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time, providing an error. Each "responsive to…" limitation refers to the same previously-recited "breath sample," and the language of the claim (i.e., the use of the conjunction "and") indicates both limitations are required or performed.
To the best of the examiner's understanding in view of Applicant's remarks, it is at least Applicant's intention that claim 11 is directed to a method in which either one of the "responsive to…" limitations is performed for a given breath sample, e.g., within the scope of:
[…] the process comprising, under control of a processor of the breath analysis device:
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 dynamically adjusting a position of a valve to maintain the rate of flow past the analyte sensor in a first threshold flow rate range during exhalation of the breath sample by the user; and
at a first time:
responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time, determining an adjusted concentration of an analyte in the breath sample by adjusting concentration of the analyte in the breath sample measured by the analyte sensor responsive to determining that the rate of flow of the breath sample does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and providing the adjusted concentration of the analyte in the breath sample; or
at a second time:
responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time, providing an error.
However, if the above is consistent with Applicant's intention of claim scope, it is unclear under this interpretation as to what the "first time" and "second time" refer, i.e., how is a first or second time factored into performing either of the two alternative outcomes? For the purpose of this Office action, particularly in view of Applicant's submitted remarks, claim 11 will be discussed with the understanding that a method comprising either of the "responsive to…" limitations, in combination with the remaining recited required steps, meets the limitations of claim 11.
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) 11-12, 14 and 16-17 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 (previously cited, von Bahr) and US 2018/0120293 A1 (previously cited, Neumann).
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 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 providing an error responsive to determining that the rate of flow of the breath sample has not remained in a first 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 claim 12, Ahmad as modified discloses/suggests the device performing the process 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 of the device is configured for adjusting 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 16, Ahmad as modified discloses/suggests the analyte sensor is a ketone sensor (Abstract, Fig. 1, etc., where concentration of acetone is determined).
Regarding claim 17, Ahmad as modified discloses/suggests the analyte sensor is a semiconductor sensor (e.g., ¶ [0217]).
Claim(s) 13 and 15 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) 11 above, and further in view of US 6,152,135 A (previously cited, DeVries).
Regarding claim 13, Ahmad as modified discloses/suggests the limitations of claim 11, and discloses/suggests the device performing the method comprises a first pressure sensor positioned along the flow path upstream from the valve, wherein the processor is configured to adjust the position of the valve based at least partly on pressure measurements generated by the first pressure sensor (see discussion of claim 12 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 performing the method 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 process of Ahmad with the device comprising a first pressure sensor positioned upstream of the valve, a second pressure sensor positioned downstream from the valve, wherein the processor is configured for adjusting the position of the valve based at least partly on a differential pressure between the first pressure sensor and the second pressure sensor, as disclosed and/or 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 15, Ahmad as modified discloses/suggests the limitations of claim 11, as discussed above, and discloses/suggests the device performing the method further comprises means mechanically coupled to the valve, wherein the processor is configured for adjusting 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 process of Ahmad with device comprising 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 and/or 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).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0137480 A1 (Arregui San Martin) in view of Neumann and US 2008/0041172 A1 (Jaffe).
Regarding claim 21, Arregui San Martin discloses/suggests a portable breath analysis device, comprising:
a breath input port (¶¶ [0015]-[0023] air inlet through which a patient exhales air into the device; Fig. 1, air inlet 1; etc.) fluidly coupled to a flow path (¶¶ [0015]-[0023] fluid line(s) through which air exhaled by the patient moves through the device; Fig. 1, fluid path from air inlet 1 to air outlet 12; ¶ [0055]; etc.);
an analyte sensor positioned along the flow path (¶¶ [0015]-[0023] nitric oxide sensor; nitric oxide sensor 6), 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 (e.g., ¶ [0050]); and
a processor configured to provide a level of analyte the breath sample (control unit 7 and/or means for calculating concentration of NO in the air exhaled by the patient, as described in, e.g., ¶¶ [0058]-[0059]; etc.).
Arregui San Martin does not expressly disclose the processor is configured to provide an error in response to determining that the rate of flow of the breath sample has not remained in a first threshold flow rate range for the threshold period of time. However, Arregui San Martin does disclose and/or suggest a rate of flow of the breath sample should remain in a first threshold flow rate range for a threshold period of time in to measure the analyte level (e.g., ¶ [0026] maintaining exhalation flow rate within the ATS and/or ERS range(s); ¶ [0056] patient exhales for about 10 seconds; etc.).
Neumann, similarly, discloses/suggests 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 device of Arregui San Martin with the processor being configured for providing an error responsive to determining that the rate of flow of the breath sample has not remained in a first 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 acceptable industry guidelines (Arregui San Martin, ¶ [0026]; Neumann, ¶ [0004]; etc.) and/or notify the user when a provided breath sample is inadequate to measure the analyte (Neumann, ¶ [0039]).
Arregui San Martin discloses/suggests the user is guided to exhale at a constant flow rate within the first threshold flow rate range for the threshold period of time in order to reliably provide/measure the level of analyte in the breath sample (e.g., ¶ [0056]). Accordingly, Arregui San Martin as modified does not disclose, responsive to determining that a rate of flow of the breath sample has remained in a first threshold flow rate range for a threshold period of time, determine an adjusted level of the analyte in the breath sample by adjusting 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 does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and provide the adjusted level of the analyte in the breath sample.
Jaffe similarly discloses/suggests providing a constant flow rate to an analyte sensor positioned along a flow path in order to reliably provide/measure the level of analyte in the breath sample. However, Jaffe further discloses, in response to measuring a flow rate that is not sufficiently constant, adjusting the level of the analyte in the breath sample measured by the analyte sensor and providing the adjusted level of the analyte in the breath sample (e.g., ¶ [0013] less constant flow within a sampling apparatus may also be used, but requires additional compensation calculations; ¶ [0050] correcting for errors caused by an inconsistent flow rate; 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 Arregui San Martin with the processor being configured for, responsive to determining that a rate of flow of the breath sample has remained in a first threshold flow rate range for a threshold period of time, determining an adjusted level of the analyte in the breath sample by adjusting 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 does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range (e.g., a sufficiently constant flow rate within the first threshold flow rate range) and providing the adjusted level of the analyte in the breath sample as disclosed/suggested by Jaffe in order to enable correcting/compensating for inconsistent and/or less constant flow within the first threshold flow rate range (Jaffe, ¶ [0013], ¶ [0050], etc.), thereby providing a more accurate and/or reliable level of analyte for users who are not as adept at maintaining a precisely constant flow rate.
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.
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 (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(s) 11-17 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10-15 of USPN 11,497,414 in view of Ahmad, Konishi, von Bahr and Neumann.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 10-15 of USPN 11,497,414 anticipate each limitation of claims 11-17 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 at least one of the "responsive to" limitations, e.g., responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time, providing an error. 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 10-15 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.
Response to Arguments
Applicant's arguments with respect to claim 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant's remarks with respect to rejections under 35 U.S.C. 112(a) have been addressed in the rejection(s) above.
With respect to the prior art rejection of claim 11, Applicant submits the cited prior art does not disclose or suggest the amended limitation "responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time, determine an adjusted level of the analyte in the breath sample by adjusting 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 does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and provide the adjusted level of the analyte in the breath sample." As indicated by Applicant's own interpretation of the scope of claim 11 (Remarks, pgs. 8-9), claim 11 encompasses two alternate outcomes. The prior art of record discloses and/or suggests at least one of those outcomes and therefore meets the requirements of claim 11.
Allowable Subject Matter
Claim(s) 1-10, 18-19 and 22-23 is/are allowed.
The prior art of record fails to disclose/suggest a portable breath analysis device including, in combination with the remaining recited elements, a processor configured to: regulate a rate of flow of the breath sample past the analyte sensor by dynamically adjusting a position of the valve during exhalation of the breath sample by the user to maintain the rate of flow of the breath sample past the analyte sensor in a first threshold flow rate range during exhalation of the breath sample by the user, thereby compensating for variations in an exhalation force created by the user; responsive to determining that the rate of flow of the breath sample has remained in the first threshold flow rate range for a threshold period of time, determine an adjusted level of the analyte in the breath sample by adjusting 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 does not satisfy a second threshold flow rate that corresponds to a target flow rate within the first threshold flow rate range and provide the adjusted level of the analyte in the breath sample; and responsive to determining that the rate of flow of the breath sample has not remained in the first threshold flow rate range for the threshold period of time, provide an error.
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.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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