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 .
Status of Claims
Claims 1-13 are pending and currently under consideration for patentability under 37 CFR 1.104
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications are 62/290689 filed on Feb. 3, 2016; 15/423382 filed on Feb. 2, 2017; and 16/375033 filed on Apr. 4, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 26, 2023 has been considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: “a user” should be changed to --the user--. Appropriate correction is required.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke (U.S. PG Pub. No. 2017/0014048 A1) in view of Lindner et al. (U.S. PG Pub. No. 2010/0121210 A1) (hereinafter "Lindner").
Wilke and Linder were cited in applicant’s IDS filed on 10/26/2023.
With respect to claim 1, Wilke teaches a wearable breath analysis device (abstract), comprising: a housing (connector 450 in Figs. 4A,4B; par.0079+) that comprises a flexible member that is configured to bend to enable the housing to be adjusted to conform to a part of the body on which the device is worn by a user (positioning element 409 reads on flexible member as it is manipulated in manner that allows for adjustment in various positions per the user's comfort; see Figs.4A,4B; par.0079+); a breath sample collection device coupled to the housing (sample collector 410 in Figs.4A,4B); an analyte sensor configured to analyze a breath sample obtained with the breath sample collection device (par.0014 “a breath analyzer”; par.0049 “delivering the collected sample to a detector and/or analysis unit”).
However, Wilke does not teach a notification device operatively configured to provides at least one of a haptic and auditory notifications to the user; and a processor that is configured to control the notification device to provide at least one type of notification to the user.
Lindner teaches a notification device operatively configured to provides at least one of a haptic and auditory notifications to the user; and a processor that is configured to control the notification device to provide at least one type of notification to the user (par.0030 “audio device.. controlled by CPU/processor 112 to indicate various conditions resulting from patient P exhaling into inlet 104").
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Wilke to utilize an audio device in order to indicate various conditions resulting from patient exhaling into inlet, as evidence by Lindner.
Claims 2, 3, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Lindner, and in further view of Baxi et al. (U.S. PG Pub. No. 2016/0157779 A1) (hereinafter “Baxi”).
Baxi was cited in applicant’s IDS filed on 10/26/2023.
With respect to claims 2, 12, and 13, Wilke and Lindner teach a wearable breath analysis device, as established above.
However, Wilke and Lindner do not teach the limitations recited in claims 2, 12, and 13.
Regarding claim 2, Baxi teaches the housing is configured to be worn around the neck of the user (sensor 504 may be attached to a user’s neck; see Fig.5, par.0051). One of ordinary skill in the art when the invention was filed would have had predictable success modifying Wilke and Lindner such that the wearable apparatus is positioned around the user's neck in order to sense and measure a range of neck movement, breath parameters, or posture, as evidence by Baxi (see par.0051).
With respect to claim 3, Wilke teaches a flexible tube that extends from the housing, the tube configured such that the user can exhale into the tube while the housing is worn around the neck (Figs. 4A,4B).
Regarding claim 12, 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). One of ordinary skill in the art when the invention was filed would have had predictable success modifying Wilke and Lindner to utilize wireless communication in order to allow for two-way communication between wearable apparatus and a user's mobile device, as evidence by Baxi.
Regarding claim 13, Baxi teaches the processor is configured to report breath analysis measurements to the command device (mobile device 520 receives breath parameter measurements; see Fig.5). One of ordinary skill in the art when the invention was filed would have had predictable success modifying Wilke and Lindner to utilize wireless communication in order to allow for two-way communication between wearable apparatus and a user's mobile device, as evidence by Baxi.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Lindner, and in further view of Ramsay et al. (U.S. PG Pub. No. 2010/0152545 A1) (hereinafter “Ramsay”).
Ramsay was cited in applicant’s IDS filed on 10/26/2023.
With respect to claim 4, Wilke and Lindner teach a wearable breath analysis device, as established above.
However, Wilke and Lindner do not teach a watch band configured to conform to a wrist of the user.
Ramsay teaches a watch band configured to conform to a wrist of the user (par.0037).
Therefore, it would have been prima facie obvious to one of ordinary skill when the invention was filed to modify Wilke and Lindner to utilize a wristwatch device that works in concert with the other wearable devices in order to provide haptic feedback to the user, as evidence by Ramsay (par.0037).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke, Lindner, and Ramsay, as applied in claim 4 above, in further view of Fein et al. (U.S. PG Pub. No. 2017/0020443 A1) (hereinafter “Fein”).
Fein was cited in applicant’s IDS filed on 10/26/2023.
With respect to claim 8, Wilke, Lindner, and Ramsay teach a wearable breath analysis device, as established above.
However, Wilke, Lindner, and Ramsay do not teach the limitations recited in claim 8.
Fein teaches the processor executes an application that provides interactive functionality for a user, via a watch display, to at least view, track, and tag ketone measurements (par.0017 "smart watch"; par.0029 "body feature is selected from... glucose/ketone levels").
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Wilke, Lindner, and Ramsay to allow for the user to utilize an ancillary device (e.g. smart watch) in order to view, track, and tag ketone measurements, as evidence by Fein.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Lindner, as applied in claim 1 above, in further view of Francis et al. (U.S. PG Pub. No. 2015/0186092 A1) (hereinafter “Francis”).
Francis was cited in applicant’s IDS filed on 10/26/2023.
With respect to claim 9, Wilke and Lindner teach a wearable breath analysis device, as established above.
However, Wilke and Lindner do not teach the processor is configured to use the notification device to provide measurement reminders to the user according to a schedule.
Francis teaches a wearable electronic device that provides schedule alerts to the user (par.0077).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Wilke and Lindner to utilize a watch that provides schedule alerts to the user, as evidence by Francis.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wilke and Lindner, as applied in claim 1 above, in further view of Satterfield et al. (U.S. PG Pub. No. 2014/0276100 A1) (hereinafter “Satterfield”).
With respect to claims 10 and 11, Wilke and Lindner teach a wearable breath analysis device, as established above.
However, Wilke and Lindner do not teach the limitations recited in claims 10 and 11.
Regarding claim 10, Satterfield teaches a single-use cartridge containing an interactant material that interacts with an analyte in the breath sample (abstract).
Regarding claim 11, Satterfield teaches a solid state sensor (par.0209).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Wilke and Lindner 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.
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 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,285,642. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claim 5, and all dependent claims thereof, recites "the watch band comprises a plurality of receptacles configured to a hold a plurality of breath analysis cartridges", which in combination with claims 1 and 4 are believed to be allowable over the prior art. The closest teaching(s) to the indicated allowable subject matter are the references cited in the current office action in addition to newly cited Shaw reference (2007/0093725 A1). While Shaw generally discloses integrating breathalyzer into a watch (par.0050), the prior art of record does not teach and/or suggest the watch band comprises a plurality of receptacles configured to a hold a plurality of breath analysis cartridges.
Claims 5-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.”
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shaw (US PG Pub. No. 2007/0093725 A1), see par.0050 “breathalyzer 500 integrated into handheld devices, such as… watches”
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791