DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on July 2, 2026 were received and fully considered. Claims 1, 4-6, 8, and 15-19 were amended. Claims 20-23 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
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.
Claims 1-4, 6-8, 12, 15, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier et al. (US PG Pub. No. 2015/0335267 A1) (hereinafter “Cormier”) in view of Giron et al. (US PG Pub. No. 2005/0177056 A1) (hereinafter “Giron”).
Cormier and Giron were applied in the previous office action.
With respect to claims 1 and 16, Cormier teaches a handheld breath analysis device and method, comprising: a breath input port comprising a mouthpiece that enables a user to exhale a breath sample (user exhaled breath via mouthpiece 102, see Fig. 1); a valve fluidly coupled to the breath input port (4-way valve 105 coupled downstream of mouthpiece 102, see Fig. 1), the valve switchable between a first position in which the breath sample exhaled into the breath input port is vented from the handheld breath analysis device without passing through a cartridge (par.0035 “During the first part of the exhalation, which typically will comprise non-alveolar breath, the breath is conveyed through a 4-way valve and vented out of the instrument via the exhaust 106”), and a second position in which the breath sample exhaled into the breath input port is routed into the cartridge (par.0035 “breath passing through as reached the appropriate threshold level indicating alveolar breath, the Microprocessor 203 responds by signaling the relay array to in turn adjust the positioning of the 4-way valve 205 thereby to convey the remainder of the incoming breath exhalation into the collection chamber 107”); and a controller configured to control the valve during exhalation to cause a first portion of the breath sample to be vented from the handheld breath analysis device and to cause a second portion of the breath sample to be routed into the cartridge (microprocessor 203 controls the valve to vent out initial non-alveolar breath via exhaust 106, and collect subsequent alveolar breath for analysis, see par.0035+).
However, Cormier does not teach a pressure sensor configured to detect an initiation of exhalation into the breath input port; and the controller further configured to control a timing with which the valve is switched from the first position to the second position based at least partly on a measurement of an amount of time that has transpired since initiation of exhalation has been detected using the pressure sensor and data regarding at least one characteristic of the user.
Giron teaches a pressure sensor configured to detect an initiation of exhalation into the breath input port (par.0079 “the breath from the input tube is passed into a pressure sensor 34, whose output signal is processed by the controller 14, and which is operable to switch the solenoid valve 18 to collect or discard part of the breath sample”; Note: Giron’s pressure sensor senses positive pressure at the system input, which includes when the user initially exhales into the breath tube); and the controller further configured to control a timing with which the valve is switched from the first position to the second position based at least partly on
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Cormier to incorporate a pressure sensor (in place of Cormier’s flow meter 103) and further taking into consideration a physiological characteristic of the user in order to control a timing of Cormier’s valve 105, thereby isolating exhaled alveolar breath samples in an alternative manner, as evidence by Giron (par.0022). Although Giron does not expressly teach control a timing with which the valve is switched based at least partly on a measurement of an amount of time that has transpired since initiation of exhalation, further modification to incorporate this feature would have been obvious to PHOSITA when the invention was filed for the following reasons. First, Giron expressly teaches operating a valve for the purpose of collected portions of exhaled breath that also takes into consideration predetermined time intervals (par. 37-41). As such, Giron’s valve is operated such that a temporal component is at least suggested. Giron also expressly teaches that these predetermined time intervals may be fixed or may be determined by a physiological characteristic of the subject (par.0041), thereby suggesting that time intervals can be utilized based on a measurement. As such, controlling a timing of the valve based on a measurement of an amount of time, in the manner recited, would only involve routine skill in the art. Lastly, PHOSITA would have had added motivation to combine Cormier and Giron since both teachings relate to the same narrow field of endeavor, i.e. utilizing valves to collect particular portions of exhaled breath (e.g. alveolar breath) for subsequent analyte analysis.
With respect to claim 2, Giron teaches further comprising a temperature sensor positioned along an influent flow path between the breath input port and the valve, the temperature sensor connected to the controller (par.0034-35 “Alternatively and preferably, the predetermined times may be determined by at least… temperature”). Therefore, PHOSITA would have had predictable success modifying Cormier to incorporate a temperature sensor as a means for directing samples of breath for collection prior to analysis, as evidence by Giron (par.0034-35).
With respect to claim 3, Cormier teaches further comprising a gas sensor positioned along an influent flow path between the breath input port and the valve, the gas sensor connected to the controller and configured to measure a particular type of gas in exhaled breath samples (par.0035 “capnometer 104 detects… CO2”).
With respect to claims 6 and 18, Cormier teaches further comprising a status indicator that notifies a user that initiation of exhalation has been detected (par.0030 “user interface display 207 for displaying Apparatus status information”). Although Cormier does not explicitly teach that the user is notified as to initiation of exhalation is detected, this would be obvious to PHOSITA when the invention was filed as it is widely known in capnograph devices to provide indication (e.g., via LED) to the user of initiation of collection breadth.
With respect to claim 8, Cormier teaches wherein the cartridge comprises a multi-chamber cartridge that is slidable between multiple positions, each position placing a respective chamber of the multi-chamber cartridge in fluid communication with the breath input port (4-way valve 105, see Fig. 1).
With respect to claim 12, Giron teaches the pressure sensor is positioned along a flow path between the breath input port and the valve (pressure sensor 34 is positioned along a flow path between the breath input port and valve 18, see Fig. 2A). Therefore, PHOSITA would have had predictable success modifying Cormier to incorporate a pressure sensor (in place of Cormier’s flow meter 103) for controlling a timing of Cormier’s valve 105 in an alternative manner that would allow for collecting a part of the breath sample which arises from a pulmonary output pressure above a predetermined value, as evidence by Giron (par.0079).
With respect to claims 15 and 19, Cormier teaches wherein the controller is further configured to determine a volume of breath exhaled by the user based at least in part on the measurement of the amount of time that has transpired since initiation of exhalation (par.0021, 23, 36).
Claims 4, 7, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier and Giron, as applied to claims 1 and 16 above, in further view of Martino et al. (US PG Pub. No. 2013/0303929 A1) (hereinafter “Martino”).
Martino was applied in the previous office action.
With respect to claims 4, 7, 21, and 23, Cormier and Giron teach a handheld breath analysis device and method, as established above.
However, Cormier and Giron do not teach the limitations further recited in claims 4, 7, 21, and 23.
Regarding claim 4, Martino teaches further comprising: a light emitting diode positioned to illuminate a reaction chamber of the cartridge through a transparent window of the cartridge; and a photodiode positioned to measure light from the light emitting diode that is reflected from the reaction chamber (par.0019, 29). Therefore, PHOSITA would have had predictable success modifying Cormier to incorporate a light emitting diode, photodiode, etc. in the manner recited in order to measure bacteria-produced analytes in exhaled mammalian breath, as evidence by Martino.
Regarding claim 7, Martino teaches the handheld breath analysis device of claim 1, in combination with the cartridge (abstract; par.0016, 19, 28). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Cormier to incorporate a cartridge comprising for the purpose of increasing reactivity of bacteria-produced analytes in collected exhaled breath, as evidence by Martino (abstract; par.0016, 19, 28)
Regarding claims 21 and 23, Martino teaches the handheld breath analysis device further comprises a cartridge insertion port configured to receive the cartridge comprising a reaction chamber containing an interactant (abstract “Reactivity of the analytes with the array is increased by advance oxidizing and/or heating the analytes”; par.0016 “chemoresponsive colorants”; par.0019 “colorimetric sensor array cartridge 20… spectral response characteristic changed when exposed to bacteria-produced analytes in the exhaled mammalian breath”; par.0022 “oxidizer 31 and/or 34”; par.0028 “heaters 66… for heating the bacteria-produced analytes… thereby increasing the reactivity”). Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Cormier to incorporate a cartridge comprising a reaction chamber containing an interactant for the purpose of increasing reactivity of bacteria-produced analytes in collected exhaled breath, as evidence by Martino (abstract; par.0016, 19, 28).
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier and Giron, as applied to claims 1 and 16 above, in further view of Rigas (US PG Pub. No. 2015/0250407 A1) (hereinafter “Rigas”).
Rigas was applied in the previous office action.
With respect to claims 5 and 17, Cormier and Giron teach a handheld breath analysis device and method, as established above.
However, Cormier and Giron do not teach the limitations further recited in claims 5 and 17.
Rigas teaches further comprising a wireless transceiver, wherein the handheld breath analysis device is configured to communicate with a smartphone using the wireless transceiver (par.0055).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Cormier and Giron to incorporate a wireless transceiver in order to transmit data to an external computer (or smartphone), as evidence by Rigas (par.0055). Examiner also takes official notice that wirelessly transmitting physiological information (from a medical device, wearable monitor, etc.) to a user’s smartphone is widely known.
Claims 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier and Giron, as applied to claims 1 and 16 above, in further view of Allardyce et al. (WO 2008/060165 A1) (hereinafter “Allardyce”).
With respect to claims 20 and 22, Cormier and Giron teach a handheld breath analysis device and method, as established above.
However, Cormier and Giron do not teach the limitations further recited in claims 20 and 22.
Regarding claims 20 and 22, Allardyce teaches the at least one characteristic of the user comprises dead space volume for the user (pg. 12, lines 15-29 “the breath collection device is automated using program controlled solenoid valves that are opened to collect the appropriate (typically alveolar) breath sample… check that all subsequent breaths fall within an acceptable standard. This is effected by separating the breath sample into 'dead space' and 'alveolar' fraction… The separation is generally arranged by the device assigning the first part of the tidal volume as the 'dead space' fraction. The breath samples that come within the desired profile can then be stored and/or analysed”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Cormier and Giron such that the at least one characteristic of the user comprises dead space volume for the user for the purpose of collect the appropriate (typically alveolar) breath sample and separating from dead space volume based on the exhaled profile of the breath, as evidence by Allardyce (pg. 12, lines 15-29).
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.
Claims 1-8, 12, and 15-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,806,128. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but they are moot in view of the updated combination of references applied in the current office action. Please see prior art rejection section above for more detail, updated citations (new embodiments cited from maintained Giron reference), and updated obviousness rationale.
Applicant's arguments filed with respect to the double patenting rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains that the claimed invention, as set forth in the current amendment, raises double patenting issues. Please see corresponding rejection heading above for more detail.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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