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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/12/2026 has been entered.
Response to Arguments
Applicant's amendments and arguments filed 6/12/2026 have been considered but they are not fully persuasive. On pp. 6-7 of the Remarks filed 6/12/2026, Applicant alleges that Shanjani does not teach “the optical sensor configured to monitor muscle activity of the masseter muscle and emit light capable of penetrating into the interior of the masseter muscle and receive 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 emit light that is capable of the claimed function and therefore, the Examiner considers Shanjani to teach this limitation. Further noted, the claims are directed to an apparatus and therefore, the function performed by the apparatus are intended use. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant’s structure requires the emission of light that is capable of penetrating tissue, and the examiner’s position is that infrared (IR) light as taught by Shanjani, is capable of penetrating tissue. Evidence for this property of IR light can be found in Yoon et al. (U.S. Patent Application Publication No. 2018/0310881) in ¶[0026].
On p. 6, Applicant emphasizes that Shanjani teaches reflective optical sensing, rather than any penetrative light. However, Shanjani also teaches transmissive optical sensing in ¶[0184]. According to Applicant’s disclosure, the penetrative nature of the claimed light is obtained by virtue of using infrared light. Therefore, in combination with disclosure found in Yoon, the examiner considers that light capable of penetrating to the masseter muscle is an intrinsic property of infrared light.
On p. 7, Applicant argues that the teachings of Nduka of detecting the changing topology of muscles by virtue of skin topology is not capable of detecting muscle activity at the masseter muscle. However, Applicant is detecting masseter muscle activity by detecting a change in “girth” of the muscle, therefore detecting a change in topology. Therefore, the examiner considers that the teachings of Nduka, combined with the infrared optical sensor of Shanjani, teach the claimed invention. Further, PHOSITA would obtain a benefit to modifying Shanjani with Nduka: 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]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Optical Myography to measure hemodynamic occlusion and Infrared Direct Current baseline shifts to measure internal blood volume displacement, and providing a proxy for muscle force) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claim 1 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18/177,391 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims fully encompass every feature of the instant claims, thereby anticipating the instant claims.
Claim 1 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/069,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims fully encompass every feature of the instant claims, thereby anticipating the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1, 41, 43-48, and 50-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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 emit light capable of penetrating into the interior of the masseter muscle (¶[0184] optical sensor using infrared light, ¶[0187] transmissive in addition to reflective) and receive 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], ¶[0187]).
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(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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2018/0310881 to Yoon et al. teaches the penetrative properties of infrared light in ¶[0026].
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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