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 .
Election/Restrictions
Applicant’s election of Invention I, claim 1-9 in the reply filed on November 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 1 is objected to because of the following informalities:
“processing … and transferring” in the third-to-last line should be amended to “process … and transfer” for grammatical correctness (so the limitation should state “a device module configured to: … process … and transfer …” instead of “a device module configured to: … processing … and transferring …”). Note how the two steps recited immediately prior are “collect” and “store” rather than “collecting” and “storing.”
“store and transfer sensor data” should be corrected to “store and transfer the sensor data” to have proper antecedent form.
Similarly, in the next line, “processing sensor data” should be corrected to “processthe sensor data.”
Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “an oral cavity” should be corrected to “the oral cavity” since claim 5 depends from claim 4 which already recites “an oral cavity.” Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “sensor data” should be amended to “the sensor data” to have proper antecedent form. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, “a flexible substrate” is recited in line 2, and then again in line 3. The second recitation fails to refer back to the first recitation using “the” or “said,” and thus it is unclear whether another flexible substrate is being recited in line 3, or if it is merely improper antecedent form.
In claim 6, the claim recites “wherein PPG signals … are resistant to moisture.” It is unclear how “signals” can be resistant to moisture. This renders the scope of the claim unclear. The Examiner suggests amending the claim to specify that the PPG sensors are resistant to moisture, rather than the signals.
Regarding claims 2, 4, 7, and 9, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Similarly also regarding claim 4 again, the phrase “e.g.” (as in “(e.g., relative acidity or alkalinity)”) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Similarly regarding claim 8, the phrase “like …” (as in “like sleep stage monitoring …”; in this case, being used synonymously with “such as”) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claims are rejected by virtue of depending from rejected claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claims 5-7 each begin with “The plurality of sensors as claimed in claim 4 …” instead of specifying that they include the entirety of the device of claim 4 (which includes the device of claim 1, from which claim 4 depends). As such, as currently written, claims 5-7 appear to be an attempt to only claim some of the limitations found in claim 4, rather than including all limitations of claim 4 (i.e. including all of the limitations of claim 1). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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 and 8-9 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being clearly anticipated by US 2022/0117777 A1 to Lasry et al. (hereinafter “Lasry”).
Regarding Claim 1, Lasry teaches an intraoral monitoring device comprising:
a flexible substrate (see e.g. Para. 9: “at least one intraoral flexible substrate of the electronics-compatible substrates” and Para. 55: “the single-arch sleep monitoring device of the sleep monitoring device 1100 may be produced on a flexible substrate”);
a plurality of sensors embedded in a flexible substrate (see e.g. Paras. 59-66 discussing various sensors that can be included, e.g. PPG, pressure, temperature, etc.; also see e.g. Para. 108);
a rechargeable battery (see e.g. Para. 57: “The power source may be mounted or integrated within sleep monitoring device 1100 or directly within the electronics module 1110. In some embodiments, the power source is rechargeable (wirelessly rechargeable batteries; gyroscope-based rechargeable batteries; solar-power rechargeable batteries)”; also see e.g. Para. 116);
a device module (e.g. 1110 and/or 2110) configured to: collect sensor data from the sensors; store and transfer sensor data to other entities; processing sensor data and transferring data to the intraoral device (see e.g. Paras. 57, 103, 106, 136-137); and
a communication module for enabling data communication from and to the intraoral device (see e.g. Paras. 115 and 136).
Regarding Claim 2, see e.g. Para. 9: “at least one intraoral flexible substrate of the electronics-compatible substrates” and Para. 55: “the single-arch sleep monitoring device of the sleep monitoring device 1100 may be produced on a flexible substrate.”
Regarding Claim 3, see e.g. Para. 57: “The power source may be mounted or integrated within sleep monitoring device 1100 or directly within the electronics module 1110. In some embodiments, the power source is rechargeable (wirelessly rechargeable batteries; gyroscope-based rechargeable batteries; solar-power rechargeable batteries)”; also see e.g. Para. 116.
Regarding Claims 8-9, see e.g. Paras. 115 and 136 and 2170-2178 in FIG. 16.
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 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 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of US 2019/0223751 A1 to Weinstein et al. (hereinafter “Weinstein”).
Regarding Claim 4, Lasry teaches a variety of sensors including multiple PPG, motion, intraoral pressure, temperature, and acoustic (see e.g. Paras. 59-66). Lasry fails to explicitly teach a pH sensor. However, it was well known to incorporate a pH sensor in similar intraoral monitoring devices. As one example, Weinstein teaches an analogous intraoral monitoring device which includes pH sensing (see e.g. the abstract and Para. 7). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Lasry to further include a pH sensor, as seen in Weinstein, because it would predictably and advantageously increase the total amount of useful diagnostic data gathered.
Regarding Claim 6, Lasry’s PPG sensor is resistant to moisture as evidenced by its inclusion in the intraoral device, i.e. it is specifically configured for an extremely moist environment.
Regarding Claim 7, see e.g. Paras. 47, 52, and 123 of Lasry (in addition to other disclosures of a “sound sensor” such as in Para. 65).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Weinstein as applied to claim 4 above, and further in view of WO 2018/172409 A1 to Dillon et al. (hereinafter “Dillon) and WO 2022/234145 A1 to Cogan et al. (hereinafter “Cogan”).
Regarding Claim 5, Lasry as modified teaches claim 4 as discussed above, but fails to specifically teach that the PPG sensors are positioned to measure muscle activity of a lateral pterygoid, buccinator and masseter muscles from inside the oral cavity. Another reference, Cogan, teaches that PPG can be used in an intraoral device to measure muscle activity, including the masseter muscle (see e.g. “Currently preferred embodiments of the invention propose the use of a PPG sensor, as an example of an optical sensor, to measure masseter muscle activity. The sensor faces the masseter muscle, positioned on a retainer on the upper jaw or on the lower jaw in the buccal cavity” on Page 7 lines 17-22). Furthermore, Dillon teaches an intraoral appliance including sensors positioned to measure the pterygoid, buccinator and masseter muscles (see e.g. Col. 2 lines 27-31). In view of these teachings together, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Lasry to position the PPG sensors to measure muscle activity of the pterygoid, buccinator and masseter muscles because this would predictably and advantageously increase the amount of useful diagnostic information obtained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792