DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/03/2025, with respect to claim objections have been fully considered and are persuasive. The objection of claim 5, 9, 14, 17, 19 has been withdrawn.
Claim 24 has been cancelled. All previous rejection and objections of claim 24 are now moot and withdrawn.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/03/2025, with respect to claim rejection under 35 USC 112 have been fully considered and are persuasive. The 112 rejection of claim 13-14 has been withdrawn.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 11/03/2025, with respect to the rejection(s) of claim(s) 1-2, 4-6, 9, 11, 13-14, 17, 19, 22-23 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following:
Claim(s) 1-2, 4, 9, 11, 13-14, 17, 19, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub 20180310881 to Yoon et al. (previously presented) in view of US Pat Pub 20120172677 to Logan et al. (previously presented) in further view of US Pat Pub 20220117777 to Lasry et al.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon as modified by Logan and Lasry as applied to claims above, and further in view of EP3598934A1 to Yoshida et al. (previously presented).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon as modified by Logan and Lasry as applied to claims above, and further in view of WO2018044959A1 to Amish et al. (previously presented).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-2, 4, 9, 11, 13-14, 17, 19, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub 20180310881 to Yoon et al. (hereinafter “Yoon” - IDS) in view of US Pat Pub 20120172677 to Logan et al. (hereinafter “Logan” – IDS) in further view of US Pat Pub 20220117777 to Lasry et al. (hereinafter “Lasry”).
Regarding claim 1. (Original) Yoon discloses a mouthpiece for a fitness tracking and/or monitoring system (para 0003, 0016, 0023, etc.), the mouthpiece shaped and configured to be worn, in use, within a user's mouth (see figs AS, 1D, 2C), the retainer member being formed of at least two layers of elastomeric material (para 0013 “2D and 2E are images of the carbon nanofiber embedded in the PDMS”) having a physiological sensor therebetween (para 0032).
Yoon fails to explicitly disclose the mouthpiece to comprise a retainer member.
Logan, from a similar field of endeavor teaches that it is known for the mouthpiece to be an orthodontic retainer (para 0034, 0036). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yoon with the teachings of Logan to provide the predictable result of providing orthodontic treatments while monitoring the teeth.
Yoon as modified by Logan renders the limitations above obvious, Yoon discloses having a having photoplethysmography (PPG), an optical technique that detects blood volume changes in microvascular tissues (para 0019, 0026, 0040) but fails to disclose wherein said first physiological sensor is located within said retainer member such that, in use, it is located adjacent the user's palate, and wherein said first physiological sensor comprises a photoplethysmography sensor comprising a light source for, in use, shining a light on a region of the inside of a user's mouth and a sensor for receiving light reflected from said region of the inside of the user's mouth and generating electrical signals representative thereof.
Lasry, from a similar field of endeavor teaches a similar measurement device having a palatal base having a photoplethysmogram (PPG) sensor mounted on the sleep monitoring device 1100 facing the palate of the wearer, such that the PPG sensor is in contact or close proximity with one or more blood vessels of the wearer. The PPG sensor can be used to measure blood O2 levels, heart rate and may further provide basic data to extract respiratory rate and blood pressure. The data produced by a plurality of photoplethysmogram (PPG) sensors and a Pulse Transit Time (PTT) may be combined to compute the blood pressure in real time (para 0059, 0108, 0117, etc.). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yoon as modified by Logan with the teachings of Lasry to provide the predictable result of determining various measurements in real time.
Regarding claim 2. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein said first physiological sensor is configured to generate signals representative of a cardiorespiratory signal of a user (Yoon para 0023, 0026 “heart rate”).
Regarding claim 4. (Currently Amended) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein at least one of the two layers of elastomeric material nearest the inner surface of the user's mouth is substantially
Regarding claim 9. (Currently Amended) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein said physiological sensor is incorporated on a substrate, said substrate further incorporating a control module, a power supply unit and a memory module, and wherein said substrate further incorporates a wireless communication module and antenna configured to wirelessly transmit data representative of signals generated by said sensor to a remote receiver (para 0022, 0034, 0037, fig. 1A-1B, 3A-3B).
Regarding claim 11. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein said first physiological sensor is incorporated at one end of a first elongate flexible connector, and wherein a second elongate flexible connector is provided or integrally formed at the other end of the first elongate flexible connector, said second elongate flexible connector having incorporated at one end thereof at least one or more of a control module, a power supply unit, a memory module, a wireless communication module and a wireless communication antenna (Logan, para 0035, 0044, 0046, fig. 2).
Regarding claim 13. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 11, wherein said first and second elongate flexible connectors, together, form a T-shaped connector (Yoon, para 0034; Logan, para 0035, 0044, 0046, fig. 2).
Regarding claim 14. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein said first physiological sensor and a second physiological sensor are provided on a flexible connector between said first and second layers of elastomeric material, wherein said second physiological sensor compromise an accelerometer (Yoon, para 0023-0024; Logan, para 0010, Lasry, para 0063 accelerometer and/or gyroscope sensor).
Regarding claim 17. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein the retainer member is formed of at least two layers of elastomeric material, with said first physiological sensor being located between said at least two layers, and wherein the mouthpiece further comprises a removable mouthguard or gumshield device configured to fit over the retainer member and a user's teeth and gum, in use (Yoon, figs 1A, 1D).
Regarding claim 19. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein the retainer member is formed of at least three layers of elastomeric material, with said first physiological sensor being located between first and second layers, nearest the inner surface of the user's mouth when in use, and a third layer formed over said second layer, wherein said first and third layers are substantially transparent and said second layer is substantially opaque, and wherein said first physiological sensor is provided on a flexible connector (see rejection of claim 1; MPEP 2143, 2144 duplication of parts or adding an additional layer is not inventive; see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)).
Regarding claim 22. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious a mouthpiece assembly comprising the mouthpiece according to claim 1, a storage case for receiving said mouthpiece, when not in use, the mouthpiece comprising a receiving element of a wireless charging system and said storage case comprising a transmitting element of a wireless charging system and, wherein said transmitting element is positioned adjacent said receiving element when the mouthpiece is located within the storage case (Logan, fig. 11, para 0045).
Regarding claim 23. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece assembly according to claim 22, wherein said receiving element comprises a conductive coil printed or otherwise provided on a flexible printed circuit board located between said at least two layers of elastomeric material, and said transmitting element comprises a plurality of overlapping conductive coils (Logan, fig. 11, para 0045).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon as modified by Logan and Lasry as applied to claims above, and further in view of EP3598934A1 to Yoshida et al. (hereinafter “Yoshida” - IDS).
Regarding claim 5. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, but fails to disclose wherein at least one of the two layers of elastomeric material furthest from the inner surface of the user's mouth is substantially opaque.
Yoshida, from a similar field of endeavor teaches that it is known to provide light shielding properties in areas other than the light transmitting parts (para 0017) to provide the predictable result of applying light only to the intended area. It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yoon as modified by Logan and Lasry with the teachings of Yoshida to provide the predictable result of applying light only to the intended area.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon as modified by Logan and Lasry as applied to claims above, and further in view of WO2018044959A1 to Amish et al. (hereinafter “Amish” - IDS).
Regarding claim 6. (Previously Presented) Yoon as modified by Logan and Lasry renders obvious the mouthpiece according to claim 1, wherein the elastomeric material is an elastomeric polymer (para 0013 “2D and 2E are images of the carbon nanofiber embedded in the PDMS” – MPEP 2143 states that it a simple substitution of one known element for another to obtain predictable result is obvious […]). But fails to disclose the material being Ethylene-Vinyl Acetate.
Amish, from a similar field of endeavor, teaches that it is known to include poly (vinyl acetate-ethylene) copolymer clear thermoplastic (para 0123). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yoon as modified by Logan and Lasry with the known teachings of Amish to provide the predictable result of forming the mouthpiece.
Conclusion
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 SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796