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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/15/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group I, Species A1B2, drawn to claims 117-135, in the reply filed on 5/11/2026 is acknowledged.
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.
Currently, there are no limitations in the instant claims are being interpreted as invoking a 35 USC 112(f) interpretation.
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 117-123, 125, 127 and 128 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida et al (US 2021/0282651 A1).
Regarding claims 117-123, 125 and 128; Yoshida discloses a system for intraoral sensing (figures 1-17), the system comprising:
a sensor unit (elements 2) comprising a housing (elements 3 and 4) having a flange (element 4h) extending at least partially around a base of the housing (figure 9, 10 and 13), wherein the housing (elements 3 and 4) at least partially encloses a sensor (element 22) (paragraphs [0049]-[0060]; figures 1-4, 9, 10, 13 and 16);
a processor (element 24) that is configured to receive physiological readings from the sensor (element 22) (paragraph [0049]-[0060]; figure 16); and
an intraoral device (element 1) comprising a body forming a tooth-receiving cavity that is configured to fit over a subject's teeth (see at least figure 1-3), and an opening (opening in the inner wall to which the sensor unit element 2 is inserted; see figure 10 and 13) through a wall (inner surface of the intraoral device element 1, wherein the examiner notes that the recess extends through the thickness of the inner wall) of the tooth receiving cavity (see figure 1-3, 10 and 13), wherein the opening is configured to receive the housing of the sensor unit (figures 1-3, 10 and 13), so that the flange (element 4h) engages with an inner surface (element 1d) of the tooth-receiving cavity (defined by the inner surface of the intraoral device) to secure the sensor unit (element 2) in position when the intraoral device is worn on the teeth (figure 1-3, 10 and 13).
Further regarding claim 118; Yoshida discloses the opening is configured to hold the base of the housing flush with the inner surface of the intraoral device (paragraph [0070]; figures 10 and 14).
Further regarding claim 119; Yoshida discloses the opening is configured to hold the base of the housing in parallel with the inner surface of the intraoral device when the intraoral device is worn (paragraph [0070]; figures 10 and 14).
Further regarding claim 120; Yoshida discloses the opening extends through a buccal side of the intraoral device (paragraph [0039]; figure 3).
Further regarding claim 121; Yoshida discloses the opening extends through a lingual side of the intraoral device (paragraph [0039]; figure 2).
Further regarding claim 122; Yoshida discloses the opening further comprises a recessed region (element 1d) that is recessed into the inner surface of the tooth-receiving cavity and configured to receive the flange of the intraoral device (paragraph [0045]-[0047]; figure 10)
Further regarding claim 123; Yoshida discloses the opening is configured to seal to the housing of the sensor unit (wherein the examiner notes that absent any specific definition of seal, the protrusion element 4h holding the sensor unit within the recess meets the BRI of seal to the housing of the sensor unit; figures 1-3, 10 and 13)
Further regarding claim 125; Yoshida discloses the sensor unit (element 2) further comprises one or more accelerometers configured to detect movement data and to store, transmit or store and transmit the movement data (paragraph [0053], [0059] and [0099]).
Further regarding claim 127; Yoshida discloses the intraoral device comprises one or more of: an aligner, a retainer, and/or a palatal expander (wherein Yoshida discloses the intraoral device is an orthodontic instrument and figures 2 and 3 depict either a aligner or retainer; paragraph [0050], [0061]-[0062]; figures 2 and 3).
Further regarding claim 128; Yoshida discloses the processor (element 24) is configured to store, transmit or store and transmit thermal data (paragraphs [0049]-[0060]; figure 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.
Claim 124 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida as applied to claim 117 above, and further in view of Badarinath (examiner provided non-patent literature “Different Range of Temperature Sensors in Accuracy and Responsiveness”).
Regarding claim 124; Yoshida is described in the rejection of claim 117 above; however Yoshida does not explicitly disclose that the sensor unit is configured to measure a temperature having a sensitivity of 0.1 degree Celsius or greater.
Badarinath teaches the different uses of temperature sensors and their accuracy and responsiveness wherein temperature sensors are used in medical settings and that modern thermistors and RTDs typically have an accuracy of 0.1 degree Celsius.
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to use a temperature sensor in Yoshida that has at least a sensitivity of modern temperature sensors of 0.1 degree Celsius as taught by Badarinath as use of a known technique (temperature sensors having sensitivity of 0.1 degree Celsius) to a known device (Yoshida’s device) to yield predictable results (Yoshida’s device have an accurate temperature sensor with a sensitivity of 0.1 degree Celsius or greater).
Claim 126, 129 and 135 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida as applied to claim 117 and 128 above, and further in view of Singh et al (US 2021/0345884).
Regarding claim 126; Yoshida is described in the rejection of claim 117 above; furthermore, Yoshida discloses measuring and monitoring temperature throughout the day (paragraphs [0058] and [0098]).
However, Yoshida does not explicitly disclose that the sensor unit is configured to continuously record temperature readings.
Singh teaches using wearables which include temperature sensors to continuously monitor a patient’s temperature so that they can utilize the temperature profile to assess a user’s health (paragraph [0023]).
To summarize, Yoshida teaches an apparatus which is worn by the user that includes a temperature sensor and monitors daily changes in temperature and can record and/or transmit the temperature profile. Singh teaches using wearable devices with temperature sensors to continuously measure temperature over time in order to create diurnal curves in order to assess user health. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Yoshida such that the temperature sensor continuously records temperature readings as taught by Singh in order to monitor daily changes in temperature (as suggested by Yoshida) and to create diurnal curves for assessing user health as taught by Singh.
Regarding claims 128, 129 and 135; Yoshida is described in the rejection of claim 128 above; however, Yoshida does not explicitly disclose that the processor is configured to determine an illness condition or an infection condition based on the thermal data.
Singh teaches using the diurnal curves comprising thermal data created by monitoring temperature over a period of time using a wearable wherein the diurnal curves are fed to a processor to determine an illness condition or an infection condition based on the thermal data (paragraphs [0032], [0052]-[0055], [0062]-[0068]; figures 12-14).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Yoshida’s device processor to utilize the stored and/or transmitted data to determine an illness condition or an infection condition based on the thermal data of the biurnal curve as taught by Singh in order to assess the patient’s health and identify issue.
Claims 130, 131 and 134 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida in view of Singh as applied to claims 129 and 135 above, and further in view of Kent et al (US 2023/0084205 A1).
Regarding claims 130, 131, and 134; the Yoshida/Singh combination is described in the rejection of claim 128 above, wherein Singh teaches using the measured temperature during a period of time for comparison and analysis to identify conditions based on the measured thermal data.
However, the Yoshida/Singh combination does not explicitly disclose using the thermal data from the monitored temperature changes over a time period to determine a fitness metric, an ovulation or pregnancy condition, or one or more sleep/wake cycles and to determine a sleep abnormality condition based on the identified sleep/wake cycles.
Kent teaches using biometric data from a user over a time period from a wearable device (element 104) including thermal data from a temperature sensor on the wearable (paragraphs [0053]-[0055]) to analyze behavior and physiological characteristics (paragraph [0018]) in order to determine and provide insight to the user’s health including for fitness (paragraphs [0148]-[0151]), ovulation/pregnancy condition (paragraph [0018]), and sleep/wake cycles and sleep conditions based on the sleep/wake cycle (paragraph [0018], [0027], [0095]-[0098]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the processor of the Yoshida/Kent combination’s wearable apparatus which include a plurality of different physiological sensors (as described by Yoshida) to further monitor and analyze the thermal data along with other physiological signals to determine additional conditions including fitness, ovulation/pregnancy and sleep/wake cycles and sleep conditions based on sleep/wake cycles as taught by Kent as use of a known techniques (utilizing biometric data to identify physiological conditions) with a known device (Yoshida/Singh combination wearable physiological monitoring device) ready for improvement to yield a predictable result (Yoshida/Singh combination apparatus further analyzing the monitored biometric data to detect/identify additional physiological conditions).
Claim 132 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida as applied to claims 117 and 128 above, and further in view of Meisal (US 2022/0000375 A1).
Regarding claim 132; Yoshida is described in the rejections of claims 117 and 128 above; however, Yoshida does not explicitly disclose that the processor is configured to determine compliance with a dietary plan and/or fitness plan based on thermal data.
Meisal teaches a physiological sensor which measures a plurality of physiological signals including temperature and uses the monitored physiological signals including thermal data to monitor diet intake including compliance with a dietary plan (paragraph [0118], [0124], and [0169]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Yoshida’s processor and apparatus to determine compliance with a dietary plan based on physiological signals including thermal data as taught by Meisal in order to ensure a patient is receiving sufficient dietary intake.
Claim 133 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida as applied to claims 117 and 128 above, and further in view of Shinjani et al (US 2018/0000563 A1).
Regarding claim 133; Yoshida is described in the rejections of claims 117 and 128 above; however, Yoshida does not explicitly disclose that the processor is configured to determine compliance based on thermal data.
Shinjani teaches an oral applicant having at least one sensor including a temperature sensor (paragraph [0138]; figure 3a) which uses the temperature/thermal data to determine compliance with wearing the device (abstract; figure 19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Yoshida apparatus and processor to determine compliance with the wearing of an orthodontic appliance as taught by Shinjani in order to ensure a user is wearing their orthodontic appliance as suggested by a professional.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2015/0170504 A1 to Jooste; discloses the use of a wearable device with sensors for monitoring a user to determine conditions of the user (see at least figures 8a-8b).
US 2020/0060553 A1 to Tsuchimoto; discloses a body temperature monitoring device which continuously monitors a user’s temperature such as an oral temperature to identify and diagnose conditions of the patient.
US 2017/0252140 A1 to Murphy et al; discloses a dental appliance having sensing capabilities.
US 2025/0222646 A1 to Weinstein et al; discloses an intraoral monitor and method of manufacture.
US 2023/0030704 A1 to Weinstein et al; discloses systems for measuring patient physiologic parameters including temperature using an intraoral appliance.
US 2010/0152599 A1 to DuHamel et al; discloses a oral appliance compliance monitoring system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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