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 . 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.
Response to Amendment
This Office Action is responsive to the amendment filed 01/15/2026 (“Amendment”). Claims 1, 3-18, 21-25, 27, and 28 are currently under consideration. The Office acknowledges the amendments to claims 1 and 11, as well as the cancellation of claim 2. Claims 19, 20, and 29-35 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Claim Objections
Claim 11 is objected to because of the following informalities: the recitation of “and” in line 5 should be deleted since this term is found in line 6. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 1, 3, 4, and 21-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Patent Application Publication 2013/0116512 (“Imran”).
Regarding claim 1, Imran discloses [a] device for measuring fatigue of a person, the device comprising: a frame configured to be worn within the mouth of the person (Fig. 3, mouthpiece 10, ¶ 0040); a microphone mounted within the frame and configured to measure sound data (Fig. 3, microphone 40); and a cavity located within the frame and adjacent to the microphone (Fig. 3, cavity 44), wherein: the cavity is provided such that substances from the environment surrounding the frame cannot enter the cavity (Fig. 5a, waterproof layer 46, ¶ 0053 – also note the small diameter of aperture 45); a first surface of the frame is configured to engage against the mouth or teeth when the frame is worn within the mouth of the person (¶¶s 0008, 0009, etc.); and the cavity is located between the microphone and a second surface of the frame that does not engage against the mouth or teeth when the frame is worn within the mouth of the person, the second surface opposing the first surface (Figs. 3 and 5a, e.g. a surface of the cavity opposite the aperture 45 does not engage both mouth and teeth – see below for exemplary surfaces, where either of the shorter lines can represent the second surface).
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Regarding claim 3, Imran discloses all the features with respect to claim 1, as outlined above. Imran further discloses wherein the microphone is substantially parallel to a surface of the frame at a point on the surface of the frame closest to the microphone (as shown in Fig. 5a).
Regarding claim 4, Imran discloses all the features with respect to claim 1, as outlined above. Imran further discloses wherein the microphone is mounted within a portion of the frame that is within the oral cavity of the person when the frame is worn within the mouth of the person (Fig. 3, ¶ 0046, etc.).
Regarding claims 21-23, Imran discloses all the features with respect to claim 1, as outlined above. Imran further discloses wherein at least a portion of the frame is configured to engage with the teeth of the person, wherein the frame is configured to surround one or more of the teeth of the person, wherein the frame is a mouthguard (Fig. 3, ¶¶s 0008, 0009, 0046, etc. Note that the bite structures 31 and 32 prevent teeth grinding, etc.).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2013/0116512 (“Imran”) in view of US Patent Application Publication 2009/0220921 (“Abolfathi”).
Regarding claim 5, Imran teaches all the features with respect to claim 4, as outlined above. Imran does not appear to explicitly teach wherein the microphone is positioned within a portion of the frame that engages with the roof of the mouth of the person when the frame is worn within the mouth of the person.
Abolfathi teaches arranging a microphone in a portion of a frame that engages with the roof the mouth (Fig. 28, microphone 294, ¶ 0109 – also see ¶ 0070, describing arch 19 as lying adjacent or along the palate).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an arch to locate the microphone of Imran as in Abolfathi, as the simple substitution of one sensor locating arrangement for another with predictable results (locating the microphone where it can collect breath sound data – also see e.g. Imran: ¶ 0058), and for the purpose of not requiring the user to bite during use (Imran: ¶ 0058).
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2013/0116512 (“Imran”).
Regarding claims 6-10, Imran teaches all the features with respect to claim 1, as outlined above. Imran does not appear to explicitly teach wherein the cavity has a minimum dimension of at least 0.05 mm, wherein the cavity has a maximum dimension of at most 5 mm, wherein a minimum distance between the microphone and an edge of the cavity is at most 0.1 mm, wherein the microphone is exposed to the cavity, wherein a minimum distance between the microphone and a surface of the frame is at most 10 mm. However, it does teach that the diameter of aperture 45 can be in the range of e.g. 0.001 to 0.00001 inches (¶ 0053), which is 0.0254 to 0.000254 mm, and based on the relative dimensions of e.g. Fig. 5a, these distances are achieved. Further, these dimensions are known results-effective variables because they can be changed as desired to control entry of fluids and to achieve desired levels of acoustic conduction (¶ 0053). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dimensions and spacings claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it would have been an obvious matter of design choice to use the dimensions and spacings claimed, since such a modification would have involved a mere change in the size/proportion of a component. A change in size or proportion is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Claims 11 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2013/0116512 (“Imran”) in view of US Patent Application Publication 2016/0367188 (“Malik”) and US Patent Application Publication 2019/0134396 (“Toth”).
Regarding claim 11, Imran teaches [a] device for measuring fatigue of a person, the device comprising: a frame configured to be worn within the mouth of the person (Fig. 3, mouthpiece 10, ¶ 0040); a microphone mounted within the frame and configured to measure sound data (Fig. 3, microphone 40); and a cavity located within the frame and adjacent to the microphone (Fig. 3, cavity 44); and a processor (¶ 0050, microphone 40 outputs a signal 42, which Fig. 5b shows as going to processor 170, which Fig. 8 shows as being remote from the mouthpiece, the communication happening via RF communication 97 (¶ 0045, using RF chips 95 and 96)), wherein: the cavity is provided such that substances from the environment surrounding the frame cannot enter the cavity (Fig. 5a, waterproof layer 46, ¶ 0053 – also note the small diameter of aperture 45); and the processor is configured to: receive sound data measured by the microphone (¶ 0050, microphone 40 outputs a signal 42, which Fig. 5b shows as going to processor 170); process the sound data to determine a breathing rate of the person and an amplitude of the sound data (¶ 0051, determining respiration rate based on repeating of breath sounds and determining depth or shallowness of respiration based on amplitude); … .
Imran does not appear to explicitly teach determining a fatigue metric representing a level of physical fatigue of the person using the breathing rate and the amplitude.
Malik teaches determining a fatigue metric representing a level of physical fatigue by using respiration rate data from an oral appliance (¶¶s 0104, 0179, etc., oximeter and respiration rates for fatigue).
Toth suggests that respiration depth is correlated with fatigue (¶ 0216).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a fatigue metric based on the microphone-based respiration rate and respiration depth data of Imran, as in Malik and Toth, for the purpose of monitoring health and being able to make decisions about the user’s ability to keep engaging in an activity (Malik: ¶¶s 0005, 0104, etc.; Toth: ¶¶s 0216).
Regarding claims 15-18, Imran-Malik-Toth teaches all the features with respect to claim 11, as outlined above. Imran-Malik-Toth further teaches wherein the device further comprises communication means mounted within the frame, wherein the communication means comprises a wireless communication means, wherein the wireless communication means communicates using at least one of Bluetooth®, Wi-Fi, or radio, wherein the processor is separate from the frame, and the communication means is configured to transmit the sound data to the processor (Imran: ¶ 0050, microphone 40 outputs a signal 42, which Fig. 5b shows as going to processor 170, which Fig. 8 shows as being remote from the mouthpiece, the communication happening via RF communication 97 (¶ 0045, using RF chips 95 and 96)).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Imran-Malik-Toth in view of US Patent Application Publication 2012/0172677 (“Logan”).
Regarding claim 12, Imran-Malik-Toth teaches all the features with respect to claim 11, as outlined above. Imran-Malik-Toth does not appear to explicitly teach a light emitter mounted within the frame and configured to emit light, wherein the processor is further configured to control emission of light by the light emitter based on the determined fatigue metric (although Imran does teach using a light emitter for determining oxygen saturation (Abstract)).
Logan teaches emitting light based on a user’s overall status using an emitter mounted with the frame of a dental appliance (¶ 0062).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to emit light based on fatigue status in the combination, as in Logan, for the purpose of indicating user parameters in a manner that makes them easily observable by others, to enable provision of medical attention as needed to increase safety (Logan: ¶¶s 0006, 0062, 0083, etc.; Malik: ¶¶s 0104, 0244, etc.).
Regarding claim 13, Imran-Malik-Toth-Logan teaches all the features with respect to claim 12, as outlined above. Imran-Malik-Toth-Logan further teaches wherein the processor is configured to control the light emitter to emit light when the fatigue metric is above a predetermined threshold (Logan: ¶ 0062, thresholds associated with ranges).
Regarding claim 14, Imran-Malik-Toth-Logan teaches all the features with respect to claim 12, as outlined above. Imran-Malik-Toth-Logan further teaches wherein the processor is configured to control the light emitter to emit light of a first colour when the fatigue metric is at or below a predetermined threshold, and to emit light of a second colour when the fatigue metric is above the predetermined threshold (Logan: ¶ 0062, different colors based on different thresholds).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of US Patent Application Publication 2014/0187875 (“Paris”).
Regarding claims 24 and 25, Imran teaches all the features with respect to claim 1, as outlined above. Imran does not appear to explicitly teach wherein the frame is formed from an energy absorbing material, ethylene-vinyl acetate, or EVA, wherein components of the device mounted within the frame are embedded within the energy absorbing material.
Paris teaches forming a mouth guard from EVA, and embedding components therein (¶¶s 0097, 0098).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the frame of Imran from EVA, embedding components therein, as in Paris, since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of US Patent Application Publication 2020/0054278 (“Joseph”).
Regarding claim 27, Imran teaches all the features with respect to claim 1, as outlined above. Imran does not appear to explicitly teach wherein the microphone is a microelectromechanical system, MEMS, microphone.
Joseph teaches that a miniature electronic microphone can be made using MEMS technology (¶ 0113).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a MEMS microphone in Imran as in Joseph, as the simple substitution of one type of microphone for another with predictable results (Joseph: ¶ 0113, transducing airflow during breathing to measure respiratory rate).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2013/0116512 (“Imran”) in view of US Patent Application Publication 2016/0367188 (“Malik”)
Regarding claim 28, Imran teaches all the features with respect to claim 1, as outlined above. Imran does not appear to explicitly teach a memory module configured to store the measured sound data, and/or store information calculated using the measured sound data (although it does teach use of a memory chip 75: Fig. 4, ¶ 0045).
Malik teaches storing sensor data in wireless storage or in a digital storage device (¶¶s 0014, 0016, 0061, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to store the microphone data of Imran in a memory such as its memory chip 75, as in Malik, for the purpose of being able to retrieve and analyze the data (Malik: ¶¶s 0016, 0061, etc.).
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, 3-18, 21-25, 27, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 15 of copending Application No. 16/632,968 (“the reference application”) in view of Imran, Abolfathi, Malik, Toth, Logan, Paris, and/or Joseph. Claims 1, 12, and 15 of the reference application teach all features of the present claims 1-18, 21-25, 27, and 28 except for those made up by Imran, Abolfathi, Malik, Toth, Logan, Paris, and/or Joseph as outlined above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed 01/15/2026 have been fully considered.
Regarding claim interpretation, the section above states – “[c]laim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.” As is evident, this applies at least to the use of “communication means” in claims 15, 16, and 18.
The Office disagrees that the second surface, opposite the first surface, is not disclosed in Imran. Refer to the figure above.
Regarding claim 11, it should first be noted that Imran teaches obtaining both respiration rate and amplitude. Then, Malik and Toth teach the relevance of these metrics to fatigue.
Thus, all claims remain rejected in light of the prior art. Double patenting rejections are maintained for similar reasons.
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 ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791