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 amendments filed 3/30/2026 appear to overcome the previous objections to the claims.
Applicant's amendments and arguments filed 3/30/2026 have been considered but they are not fully persuasive. On pp. 5-6 of the Remarks filed 3/30/2026, Applicant alleges that Shanjani does not teach “the optical sensor configured to monitor muscle activity of the masseter muscle and capable of emitting light and receiving the light as reflected off of the masseter muscle, and wherein the monitoring information collected is indicative of activity of the masseter muscle.”
By contrast, the examiner considers this amendment to be directed to an intended use of the claimed device. Applicant has only required that the optical sensor of Shanjani is capable of the claimed function and therefore, the Examiner considers Shanjani to teach this limitation. However, in the interest of compact prosecution, attention is further brought to Nduka (U.S. Patent Application Publication No. 2019/0380644).
Nduka teaches using an optical sensor (¶[0099], ¶[0106]) to monitor masseter muscle activity (Table 1) based on detected changes in skin contour (¶[0106]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the optical sensors of Shanjani to specifically monitor masseter muscle activity, as taught by Nduka because biofeedback is an effective treatment for inhibiting overuse of facial muscles (Nduka ¶[0007], ¶[0011]) including jaw clenching (Table 1, ¶[0126]).
As this grounds for rejection is brought in response to the amendment, this is considered new grounds for rejection necessitated by the amendment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 41, 43-48, and 50-59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanjani et al. (U.S. Patent Application Publication No. 2020/0093571) hereinafter referred to as Shanjani; in view of Nduka (U.S. Patent Application Publication No. 2019/0380644) hereinafter referred to Nduka.
Regarding claim 1, Shanjani teaches an apparatus (¶[0115] removable intraoral appliance) for mounting within a buccal cavity (¶[0137] within an intraoral cavity, ¶[0138] buccal region) to monitor masseter muscle activity (¶[0184] monitor mastication movement), the apparatus comprising
an optical sensor (Fig. 10A, element 1002 emitter, element 1004 detector) and a transmitter (¶[0144]) that is operable to transmit monitoring information collected by the optical sensor wirelessly to a remote receiver unit (¶[0144] wireless communication methods, ¶[0307] transmit the data to a remote receiver),
the optical sensor (Fig. 10A, element 1002 emitter, element 1004 detector) and the transmitter (Fig. 3A, sensors and electronics including communication unit) being positioned on a support (¶[0138] monitoring device is mounted on the intraoral appliance) that is configured to be fixed relative to at least one tooth adjacent to the masseter muscle (¶[0138] fixed with respect to the location of any tooth), with the optical sensor facing the masseter muscle (¶[0181] facing buccal surface, therefore adjacent a masseter muscle); and
the optical sensor (Fig. 10A-B, ¶¶[0178-0179]) configured to monitor muscle activity of the masseter muscle and capable of emitting light and receiving the light as reflected off of the masseter muscle (¶[0178] buccal surface, where the masseter muscle is located and further this limitation is considered an intended use and given limited patentable weight as the device of Shanjani is capable of this use), and wherein the monitoring information collected is indicative of activity of the masseter muscle (¶[0184]).
Although Shanjani broadly teaches the optical sensor responsive to variations in reflected optical signal caused by mastication, an activity “indicative” of activity of masseter muscle, the examiner does not consider Shanjani to explicitly teach using an optical sensor to monitor masseter muscle activity. Therefore in case Applicant disagrees with the examiner’s BRI of the claims as directed to an intended use of the device, attention is further drawn to the Nduka reference, which teaches using an optical sensor (¶[0099], ¶[0106]) to monitor masseter muscle activity (Table 1) based on detected changes in skin contour (¶[0106]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the optical sensors of Shanjani to specifically monitor masseter muscle activity, as taught by Nduka because biofeedback is an effective treatment for inhibiting overuse of facial muscles (Nduka ¶[0007], ¶[0011]) including jaw clenching (Table 1, ¶[0126]).
Regarding claim 41, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the optical sensor is a photoplethysmogram (PPG) sensor (¶[0220], Fig. 10A, element 1002 emitter).
Regarding claim 43, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the optical sensor is configured to monitor muscle activity by emitting and receiving infrared (IR) light only (¶[0181], ¶[0184]).
Regarding claim 44, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the support is configured for mounting on molars in the buccal cavity (¶[0153], Fig. 4A-B, ¶[0329] features of multiple embodiments are disclosed as combinable).
Regarding claim 45, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the support comprises a dental retainer, nightguard or orthodontic fixture (¶[0007], ¶[0127], ¶[0287]).
Regarding claim 46, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the support is demountably engageable with teeth within the buccal cavity of a wearer (¶[0135] removable when the appliance is removed).
Regarding claim 47, Shanjani teaches the apparatus of Claim 1.
Shanjani teaches further including at least one sensor additional to the optical sensor being an accelerometer (¶[0141]), a gyroscope (¶[0141]), a temperature sensor (¶[0141]), a pressure sensor (¶[0141]), a humidity sensor (¶[0141]) and/or a pH sensor ¶[0141]).
Regarding claim 48, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches comprising at least two optical sensors (¶[0141] redundant sensors of the same type, including light sensors and PPG sensors).
Regarding claim 50, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the support is configured to complement a specific wearer's teeth (¶[0324]).
Regarding claim 51, Shanjani teaches the apparatus of Claim 1.
Shanjani further teaches wherein the optical sensor and the transmitter are contained or encapsulated in a sealed sensor module (¶¶[0229-0230]).
Regarding claim 52, Shanjani teaches the apparatus of Claim 51.
Shanjani further teaches wherein the apparatus further includes at least one sensor additional to the optical sensor being an being an accelerometer (¶[0141]), a gyroscope (¶[0141]), a temperature sensor (¶[0141]), a pressure sensor (¶[0141]), a humidity sensor (¶[0141]) and/or a pH sensor ¶[0141]) and the at least one additional sensor is also contained or encapsulated in the sensor module (Fig. 3A, sensors and electronics including communication unit).
Regarding claim 53, Shanjani teaches the apparatus of Claim 51.
Shanjani further teaches wherein the sensor module is enclosed within a housing appended to the support (¶[0226] inserted into a receptacle and sealed).
Regarding claim 54, Shanjani teaches the apparatus of Claim 53.
Shanjani further teaches configured such that, when the apparatus is fixed relative to a tooth opposed to the masseter muscle, the housing lies beside that tooth in an oral vestibule of the buccal cavity (¶[0153], Fig. 4A-B, ¶[0329] features of multiple embodiments are disclosed as combinable).
Regarding claim 55, Shanjani teaches the apparatus of Claim 53.
Shanjani further teaches wherein the housing embeds or surrounds the sensor module seamlessly (¶[0151] physically integrated with the shell).
Regarding claim 56, Shanjani teaches the apparatus of Claim 53.
Shanjani further teaches wherein the housing is a pocket having an aperture through which the sensor module is insertable into the housing, the aperture being closed by a cap (¶[0226] inserted into a receptacle and sealed).
Regarding claim 57, Shanjani teaches the apparatus of Claim 53.
Shanjani further teaches wherein the housing is formed integrally with the support (¶[0151]).
Regarding claim 58, Shanjani teaches the apparatus of Claim 57.
Shanjani further teaches wherein the housing and the support are formed together by an additive manufacturing process (¶[0129], ¶[0151]).
Regarding claim 59, Shanjani teaches the apparatus of Claim 53.
Shanjani further teaches, wherein the housing is an overmolding on the support (¶[0230], ¶[0246]).
Regarding claim 60, Shanjani as modified teaches the apparatus of claim 1.
Shanjani further teaches wherein the monitoring information collected comprises information related to the time of such activity of the masseter muscle (¶[0184]), adequate to plot the activity over a period of time (this is considered an intended use and the device of Shanjani is capable of this use).
Although Shanjani broadly teaches the optical sensor responsive to variations in reflected optical signal caused by mastication, an activity “indicative” of activity of masseter muscle, the examiner does not consider Shanjani to explicitly teach using an optical sensor to monitor masseter muscle activity. Therefore in case Applicant disagrees with the examiner’s BRI of the claims as directed to an intended use of the device, attention is further drawn to the Nduka reference, which teaches monitoring information collected comprising information related to the time of such activity of the masseter muscle (Table 1, ¶[0116]), adequate to plot the activity over a period of time (¶[0116]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the optical sensors of Shanjani to specifically monitor masseter muscle activity, as taught by Nduka because biofeedback is an effective treatment for inhibiting overuse of facial muscles (Nduka ¶[0007], ¶[0011]) including jaw clenching (Table 1, ¶[0126]).
Regarding claim 61, Shanjani as modified teaches the apparatus of claim 1.
Shanjani further teaches wherein the optical sensor is also configured to emit light capable of penetrating into the interior of the masseter muscle (¶[0184] transmissive optical signal, this is considered an intended use and the device of Shanjani is capable of this use).
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.
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) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani and Nduka as applied to claim 1 above, and further in view of Logan et al. (U.S. Patent Application Publication No. 2015/0306486) hereinafter referred to as Logan.
Regarding claim 42, Shanjani teaches the apparatus of Claim 41.
Shanjani further teaches auxiliary LEDs of the PPG sensors (¶[0179], ¶[184]).
Shanjani does not teach being configured to indicate its status by illuminating at least one auxiliary LED of the PPG sensor.
Attention is brought to the Logan reference, which teaches an oral device configured to indicate its status by illuminating at least one auxiliary LED (¶[0061]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the apparatus of Shanjani to include a status LED, as taught by Dillon, because status indicators encourage attention at the required urgency (Dillon ¶[0061]).
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani and Nduka as applied to claim 1 above, and further in view of Kuhar (U.S. Patent Application Publication No. 2018/0220956) hereinafter referred to as Kuhar.
Regarding claim 49, Shanjani teaches the apparatus of Claim 48.
Shanjani does not teach at least one optical sensor arranged to be placed elsewhere on the wearer's body, outside the buccal cavity.
Attention is drawn to the Kuhar reference, which teaches at least one optical sensor (¶[0060]) arranged to be placed elsewhere on the wearer's body, outside the buccal cavity (Fig. 1, element 100, outside the buccal cavity).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the apparatus of Shanjani to further include an extra-oral optical sensor, as taught by Kuhar, because the sensor of Kuhar measures a plurality of biological signals and reduces bruxism (Singer ¶[0059]).
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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