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 August 13, 2026 were received and fully considered. Claims 1, 9, 14, and 17 were amended. Claims 22 and 23 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 13, 2026 has been entered.
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 14 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rigas (US PG Pub. No. 2017/0105656 A1).
With respect to claim 14, Rigas teaches a wearable breath analysis device (par.0072 “portable, hand-held breath analyzer”), comprising: a flow path (user exhales via mouthpiece 12 and breath flows into housing 100; see Fig. 16); a mouthpiece comprising a housing with a proximal end and a distal end (mouthpiece 12 includes a first portion 16 with proximal/distal ends; see Fig. 16), the housing comprising a connector positioned at the proximal end and configured to be connected to the flow path and an opening positioned at the distal end and configured to be positioned in a mouth of a user (Fig. 16 shows various intermediary components 16, 18, 20, 100, etc. that are all fluidly connected such that the most distal end of mouthpiece 12 is positioned in/on a mouth of a user for exhaling into the breath analyzer 10), a one-way valve supported by the housing and configured to allow a breath sample to pass through the housing from the distal end toward the proximal end and block flow in a reverse direction (par.0050 “one-way valve 20… exhaled breath moves forward pass the one-way valve 20 and becomes trapped. In other words, the exhaled breath cannot move backward past the one-way valve 20 and toward the first portion 16”; see Fig. 16); a desiccant filter supported by the housing and positioned downstream of the one-way valve, the desiccant filter configured to remove moisture from the breath sample (par.0061 “breath analyzer 10 can include an optional desiccant assembly 60… helps remove excess moisture from the exhaled breath”; par.0066 “The breath sample moves pass the one way valve 20 and through the optional desiccant/gas filter 60”); an analyte sensor positioned in the flow path and configured to analyze the breath sample (sensor 50 in Fig. 16; par.0046 “sensor 50 detects breath ammonia”), wherein the desiccant filter is configured to remove moisture from the breath sample before the breath sample moves through the flow path and contacts the analyte sensor (par.0061 “Exhaled breath first moves through the desiccant assembly 60 before coming into contact with the sensor 50”); and a processor configured to provide
Although Rigas does not expressly each providing at least one type of notification to the user, further modification to incorporate this feature would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Rigas expressly discloses utilizing a display 30 operably connected to a processor 22 to provide indication of ammonia concentration in breath sample (par.0058). As such, Rigas expressly teaches providing display/notification to the user based on sensed ammonia levels in exhaled breadth. Therefore, PHOSITA would have had predictable success modifying Rigas such that at least one type of notification is presented to the user to show results of a comparison between a concentration of ammonia between two different breath samples, as suggested by Rigas (par.0058).
With respect to claim 18, Rigas teaches wherein the analyte sensor comprises a single-use cartridge containing an interactant material that interacts with an analyte in the breath sample (par.0040 “ammonia selective material 56 includes doped polyaniline”; par.0055 “user can also replace an old sensor 50 with a new sensor”).
With respect to claim 19, Rigas teaches wherein the analyte sensor is a solid state sensor (par.0038).
With respect to claim 20, Rigas teaches further comprising a wireless transceiver, wherein the processor is programmed to communicate via the wireless transceiver with a command device (par.0058 “optional wireless connector… that transmits data calculated by the processor 22 to an external computer”).
With respect to claim 21, Rigas teaches wherein the processor is configured to report breath analysis measurements to the command device (par.0058).
With respect to claim 22, Rigas does not explicitly teach wherein the housing comprises a flexible member that is configured to bend to enable the housing to be adjusted to conform to a part of a body on which the device is worn by a user. However, further modification to incorporate a flexible member, in the manner recited, would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Rigas expressly discloses the portable/handheld nature of the device (par.0032). Moreover, and absent added structural specificity with regards to the arrangement of the flexible member, it would have been obvious to PHOSITA when the invention was filed to utilize a flexible member (string, rope, band, etc.) as alternate means to transport Rigas’ portable/handheld device.
With respect to claim 23, Rigas does not explicitly teach wherein the housing is configured to be worn around a neck of the user. However, further modification such that the housing is worn around a neck of the user would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Rigas expressly discloses the portable/handheld nature of the device (par.0032). Moreover, it would have been obvious to PHOSITA when the invention was filed to utilize a string, rope, band, etc. as alternate means to transport Rigas’ portable/handheld device around a user’s neck.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rigas, as applied to claim 14 above, in further view of Glaser (US Patent No. 5081871).
With respect to claim 15, Rigas teaches a wearable breath analysis device, as established above.
However, Rigas does not teach the limitations further recited in claim 15.
Glaser teaches wherein the housing of the mouthpiece further supports a collar and a valve positioned proximal to the opening and upstream of the one-way valve, the valve configured to transition from a closed position to an open position in which the breath sample is allowed to pass through the housing responsive to the user biting the collar (col. 11, lines 1-17).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to further incorporate a collar and a valve, in the manner recited, in order to allow the patient to breath by mouth only during sampling of volumetric quantities of human exhaled breath, as evidence by Glaser.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rigas, as applied to claim 14 above, in further view of Francis (US PG Pub. No. 2015/0186092 A1).
Francis was applied in the previous office action.
With respect to claim 17, Rigas teaches a wearable breath analysis device, as established above.
However, Rigas does not teach the limitations further recited in claim 17.
Francis teaches wherein the at least one type of notification comprises measurement reminders according to a schedule. (par.0077).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Rigas to incorporate various communication details (e.g. event/schedule alert) in order to provide various communication alerts to the user, as evidence by Francis (par.0077).
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claims 1 and 6-13 are allowable over the prior art for the reasons set forth in the previous office action.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
No claim is allowed.
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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