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 April 27, 2026 were received and fully considered. Claims 1, 6-8, and 10 were amended. Claims 2-5 were cancelled. Claims 14-21 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 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wilke (US PG Pub. No. 2017/0014048 A1) in view of Borody (US PG Pub. No. 2012/0330111 A1).
Wilke was applied in the previous office action.
With respect to claim 14, Wilke teaches a wearable breath analysis device (Title “Respiratory sampling with support structure”), comprising: a housing that 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 (Figs. 3A-6 shows housing comprising a wearable support structure, flexible tubes, etc. that conform to the patient’s head/neck area), wherein the housing is configured to be worn around a neck of the user (par.0108 “configured to be wearable by a subject, for example, on a subject’s… neck… and provides a connector, which is part of a breath sampling apparatus”); a breath sample collection device coupled to the housing, wherein the breath sample collection device comprises a flexible tube that extends from the housing, the flexible tube configured such that the user can exhale into the flexible tube while the housing is worn around the neck (Figs. 3A-6 shows a breath sampling device with wearable support structure, flexible tubes, etc. that conform to the patient’s head/neck area and allow for the user to breathe/exhale into); a mouthpiece comprising a housing with a proximal end and a distal end (par.0093 “sample breath collector 610 designed to collect breath samples from a mouth of a subject 630”), the housing comprising a connector positioned at the proximal end and configured to be connected to the flexible tube and an opening positioned at the distal end and configured to be positioned in a mouth of the user (Figs. 3A-6 shows housing comprising a wearable support structure, connector, flexible tubes, etc. positioned in a mouth of the user); an analyte sensor configured to analyze the breath sample obtained with the breath sample collection device (par.0002 “detector for detecting changes in concentrations of molecules of interest within the respiratory gases”; par.0049 “tubing system for delivering the collected samples to a detector and/or analyzing unit”); a notification device operatively configured to provide at least one of a haptic and auditory notifications to the user (par.0023 “indication mechanism configured to provide indication… to a breath analyzer”; see also par.0074+); and
However, Wilke does not teach the housing further comprising a one-way valve to allow a breath sample to pass the housing through from the distal end toward the proximal end; and a processor that is configured to control the notification device.
Borody teaches the housing further comprising a one-way valve to allow a breath sample to pass the housing through from the distal end toward the proximal end (par.0039 “bite block 18 includes a one-way valve 22 across the opening 20 having an open position and a closed position”; par.0043 “oxygen supplied… can not escape”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Wilke to incorporate a one-way valve in order to allow passage of an endoscopic device into and through the opening while ensuring oxygen supplied can not escape during endoscopic procedure, as evidence by Borody (par.0039, 0043). Although Wilke does not explicitly teach a processor, further modification to incorporate a processor in the manner recited would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
With respect to claim 15, Borody teaches wherein the housing of the mouthpiece further comprises a collar and a valve positioned proximal to the opening, the valve configured to transition from a closed position to an open position in which the breath sample is allowed to pass though the housing responsive to the user biting the collar (par.0039, 0043). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wilke to incorporate a collar and a valve in the manner recited in order to allow passage of an endoscopic device into and through the opening while ensuring oxygen supplied can not escape during endoscopic procedure, as evidence by Borody (par.0039, 0043).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Borody, as applied to claim 14 above, in further view of Birch (US PG Pub. No. 2012/0285468 A1).
With respect to claim 16, Wilke and Borody teach wearable breath analysis device, as established above.
However, Wilke and Borody do not teach the limitations further recited in claim 16.
Birch teaches wherein the housing of the mouthpiece further comprises a desiccant filter positioned proximal to the connector and configured to remove moisture from the breath sample (par.0198 “filter media 123A, may be imbued with a desiccant (e.g., silica, activated charcoal, or the like) in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wilke and Borody to incorporate a desiccant filter in the manner recited in order to assist in controlling moisture level on the interior of patient interface 110 to reduce fogging and/or to improve patient comfort, and in order to maintain filter media 123A in a dry state which is can kill viruses and is non-conducive to formation of funguses, as evidence by Birch (par.0198).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Borody, 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, Wilke and Borody teach a wearable breath analysis device, as established above.
However, Wilke and Borody do not teach the limitations further recited in claim 17.
Francis teaches the processor is configured to use the notification device to provide measurement reminders to the user according to a schedule (par.0077).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wilke and Borody 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).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Borody, as applied to claim 14 above, in further view of Satterfield et al. (US PG Pub. No. 2014/0276100 A1) (hereinafter “Satterfield”).
Satterfield was applied in the previous office action.
With respect to claims 18 and 19, Wilke and Borody teach a wearable breath analysis device, as established above.
However, Wilke and Borody do not teach the limitations further recited in claims 18 and 19.
Regarding claim 18, Satterfield teaches wherein the analyte sensor comprises a single-use cartridge containing an interactant material that interacts with an analyte in the breath sample (abstract).
Regarding claim 19, Satterfield teaches wherein the analyte sensor is a solid state sensor (par.0209).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wilke and Borody to utilize a single-use cartridge containing interactant material and a solid state sensor as the analysis unit as this is an alternative analyte sensing device that would provide indication to the user with respect to breath analyte levels in the collected breath sample, as evidence by Satterfield.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Borody, as applied to claim 14 above, in further view of Baxi et al. (US PG Pub. No. 2016/0157779 A1) (hereinafter “Baxi”).
Baxi was applied in the previous office action.
With respect to claims 20 and 21, Wilke and Borody teach a wearable breath analysis device, as established above.
However, Wilke and Borody do not teach the limitations further recited in claims 20 and 21.
Regarding claim 20, Baxi teaches a wireless transceiver, wherein the processor is programmed to communicate via the wireless transceiver with a command device (Fig. 5 shows two-way communication from wearable sensors and mobile device 520). Therefore, one of ordinary skill in the art when the invention was filed would have had predictable success modifying Wilke and Borody to utilize wireless communication, in the manner recited, to allow for two-way communication between wearable apparatus and a user’s mobile device, as evidence by Braxi.
Regarding claim 21, Baxi teaches wherein the processor is configured to report breath analysis measurements to the command device (mobile device 520 receives breath parameter measurements; see Fig. 5). Therefore, one of ordinary skill in the art when the invention was filed would have had predictable success modifying Wilke and Borody to utilize wireless communication, in the manner recited, to allow for two-way communication (including providing measurement reports) between wearable apparatus and a user’s mobile device, as evidence by Braxi.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claim 1 was amended to incorporate allowable subject matter, as indicated in the previous office action. Therefore, claims 1, and all dependent claims thereof (claims 6-13) are allowable over the prior art.
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.”
Response to Arguments
Applicant’s arguments filed with respect to the claim objections raised in the previous office action were persuasive in view of amendment. Therefore, these objections are withdrawn.
Applicant’s arguments filed with respect to the double patenting rejections raised in the previous office action were persuasive in view of the approved terminal disclaimer on April 27, 2026. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the prior art rejections previously applied to claims 1 and 6-13 were persuasive in view of amendment. Therefore, these rejections are withdrawn. However, new claims 14-21 are rejected via new prior art references. Please see prior art section above for more detail, updated citations, and updated obviousness rationale.
Conclusion
No claim is allowed.
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 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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