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 June 18, 2026 were received and fully considered. Claim 1 was amended. Claims 14-16 are new. Claims 4-6 were cancelled. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 18, 2026 has been entered.
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:
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, 3, 7, 8, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Logan et al. (US PG Pub. No. 2012/0172679 A1) (hereinafter “Logan”) in view of Ransom (US PG Pub. No. 2008/0027502 A1).
Logan was applied in the previous office action.
With respect to claim 1, Logan teaches a flexible dental prosthesis comprising a wearable ventilatory monitoring system, said system comprising: an electronic circuit (processor 140 and PCB 144 equates to an electronic circuit; see Fig. 2); said electronic circuit comprises a pressure sensor (par.0066 “Dental appliance 110 may also include… air pressure sensors… that can then be transposed into a respiration rate for the user”) , wherein said electronic circuit is able to communicate with a computer or a mobile phone that acts as a central device of control receiving data measured by said pressure sensor (par.0034 “communicate with at least one (external) observer monitoring system… a smart phone 820”; see also Fig. 8); wherein the computer or the mobile phone calculates a respiratory rate of a patient by the data measured by said pressure sensor (abstract “the user monitoring system also measures… respiration rate”; par.0066 “Dental appliance 110 may also include… air pressure sensors… can then be transposed into a respiration rate for the user”).
However, Logan does not teach wherein the computer or the mobile phone calculates the respiratory rate of the patient by removing values, of the data measured by said pressure sensor, higher than a pre-determined threshold.
Ransom teaches removing values, of the data measured by said pressure sensor, higher than a pre-determined threshold (par.0015 “the signal from the pressure sensor can be filtered according to conventional methods to remove short duration artifacts characteristic of activity of the esophagus (e.g. swallowing)”; par.0021 “pressure sensor… measuring the frequency that a pressure measurement crosses (e.g., exceeds or drops below) a preset threshold… detect the event of interest”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Logan to remove values, of the data measured by said pressure sensor, higher than a pre-determined threshold in order to account for short duration artifacts characteristic of activity of the esophagus (e.g. swallowing), as evidence by Ransom (see par.0015, 21). Examiner also cites additional references that further demonstrate it is known in the art to remove/discard artifacts from pressure and/or breath related signals to account for various sources of noise, thereby providing additional motivation for PHOSITA to utilize a pre-determined threshold in the manner recited. See prior art cited, but not relied upon, at the end of the current office action for additional example teachings.
Although Logan’s Figs. 1-2 do not explicitly show a battery, further modification to incorporate a battery would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Logan expressly teaches electrical components (processor 140 and PCB 144 in Fig. 2), which impliedly would utilize a power source (e.g. battery). Moreover, other embodiments further disclose that dental appliance “can be recharged using an inductive energy (power) transfer” (see par.0045; Fig. 11), which expressly teachings the use of a power source. Therefore, PHOSITA would have had predictable success modifying Logan’s embodiment, as depicted in Figs. 1-2, to further incorporate a battery, a widely known power source, as doing so would allow for providing power to the electronic components of dental appliance 110.
With respect to claim 3, Logan teaches wherein said electronic circuit comprises a temperature sensor (par.0047).
With respect to claim 7, Logan teaches wherein said flexible dental prosthesis is made with a biocompatible plastic (par.0036).
With respect to claim 8, Logan teaches wherein said battery is rechargeable (par.0028).
With respect to claim 13, Logan teaches a method for measuring a respiratory rate of a patient by means of the wearable ventilatory monitoring system according to claim 1 (par.0028).
With respect to claim 14, Logan and Ransom do not explicitly teach wherein said pre-determined threshold is +/- 6 cmH2O. However, further modification to incorporate the use of the recited threshold would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Ransom expressly teaches utilizing predefined thresholds in order to remove sources of noise exhibited in a pressure signal (e.g. swallowing). See par.0015, 0021. Therefore, PHOSITA would have had predictable success utilizing pre-determined threshold is +/- 6 cmH2O in place of Ransom’s threshold as a simple substitution. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art (e.g. Ransom’s expressly discloses utilizing a threshold for removing unwanted artifacts in a pressure signal), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 15, Ransom teaches removing values higher than said pre-determined threshold accounts for a swallowing artefact and does not eliminate any useful respiratory information (par.0015, 0021). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Logan to remove values, of the data measured by said pressure sensor, higher than a pre-determined threshold in order to account for short duration artifacts characteristic of activity of the esophagus (e.g. swallowing), as evidence by Ransom (see par.0015, 21). Examiner also cites additional references that further demonstrate it is known in the art to remove/discard artifacts from pressure and/or breath related signals to account for various sources of noise, thereby providing additional motivation for PHOSITA to utilize a pre-determined threshold in the manner recited. See prior art cited, but not relied upon, at the end of the current office action for additional example teachings.
With respect to claim 16, Logan teaches the computer or the mobile phone displays the respiratory rate (appliance 820 in Fig. 8 has a liquid crystal display).
Claims 2, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Logan in view of Shanjani et al. (US PG Pub. No. 2020/0093571 A1) (hereinafter “Shanjani”).
Shanjani was applied in the previous office action.
With respect to claims 2, 9, 11, and 12, Logan teaches a wearable ventilatory monitoring system, as established above.
However, Logan does not teach the limitations further recited in claims 2, 9, 11, and 12.
Regarding claim 2, Shanjani teaches said pressure sensor is of the type piezo-resistive (par.0126, 0141).
With respect to claim 7, Shanjani teaches said flexible dental prosthesis is done with a biocompatible plastic (par.0015).
With respect to claim 9, Shanjani teaches said pressure sensor is protected by a gel and stainless antimagnetic steel cap (par.0129).
With respect to claim 11, Shanjani teaches said electronic circuit is embedded in a plastic sheet (par.0015, 0226-0227, 0229-0230, 0237).
With respect to claim 12, Shanjani teaches said electronic circuit is attached said flexible dental prosthesis using dental tape (par.0149).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Logan in the manner recited in claims 2, 7, 9, 11, and 12 in order to provide intraoral appliances comprising embedded intraoral sensors, allowing autonomous monitoring of physiological characteristics of patients, thereby providing data useful in the diagnosis of sleep disorders and other oral- and airway-related disorders, as evidence by Shanjani (par.0006).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PG Pub. No. 2006/0212273: par.54, 55, 69
US PG Pub. No. 2011/0144531: par.58
US PG Pub. No. 2015/0119743: par. 0177
US PG Pub. No. 2020/0254244: par.0045
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered, but are moot in view of the combination of references raised in the current office action. Please see prior art section above for more detail, updated citations (new secondary reference, Ransom), and updated obviousness rationale.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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