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 .
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 1-11 and 26-27 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.
Claims 1 and 26 recite the following in the preamble: “An apparatus comprising a dental appliance, the apparatus comprising: a dental appliance body . . . ” which is a confusing preamble leaving what is actually claimed indefinite. The apparatus is claiming to comprise a “dental appliance” but then does not actually claim the dental appliance, but rather a “dental appliance body.” Additionally the preamble states that the apparatus comprises differing limitations. The examiner believes that the intent of this preamble was “An apparatus comprising a dental appliance, the appliance comprising” a dental appliance body . . .” and for the purpose of examination will interpret the claim as such. If this is indeed the intent of the applicant, the examiner suggests amending the claim with the above suggested wording.
Regarding Claim 5, the capacitance measurement recites the limitation "the capacitance measurement" or the “capacitance event threshold amount” in lines 15 and 16. There is insufficient antecedent basis for these limitations in the claim.
All claims not specifically addressed above are rejected based on their dependency on Claims 1 and 26.
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 1-5, 8-11, 18, and 20-21, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kreifeldt et al. (US 2022/0039920 A1, hereinafter “Kreifeldt”) in view of Bedford et al. (US 2024/0206813 A1, hereinafter “Bedford”).
Regarding Claims 1-3, 5, 18, 20, 25, and 26, Kreifeldt discloses an apparatus comprising a dental appliance body (the abstract discloses that the device may be an orthodontic retainer, Figure 1A, 105), the apparatus comprising a sensing module (Figures 1B, 130) coupled to the dental appliance body, the sensing module comprising a temperature sensor (135), a corroborating sensor (strain gauge 145), one or more processors (microcontroller 110 includes a processor as disclosed in [0023]), and a memory coupled to the one or more processors (described in [0023]). Kreifeldt is capable of storing instructions, that, when executed by the one or more processors (as described in [0023]), perform a method comprising setting, during a device initialization stage, a wear-status state for the dental appliance, wherein the wear-status state is either 'worn' or 'not worn', switching the wear-status state when either or both of a change in a temperature reading from the temperature sensor exceed a temperature event threshold amount and/or a change in a corroboration sensor reading exceeds a corroboration event threshold amount, and outputting the wear-status (as described in [0006] and the abstract, the objective of Kreifeldt is to provide a device to detect when a device is being worn – [0045] discloses that the device can be programmed to communicate with a personal electronic device that received information generated by the wear sensor 130 indicating if the device is installed or not installed within the wearer’s mouth, i.e. in a “worn” or “not worn” state, and that the temperature exceeds a certain threshold). Kreifeldt further discloses that the device is capable of being set, during the device initialization stage, with an ambient temperature value and updating the ambient temperature value when the wear-status state switched from worn to not worn (as described in [0028] ambient temperatures are measured and therefore would be input as settings for the device to determine wear status as described in [0045]). Additionally, Kreifeldt discloses that additional temperature reading can be taken, including those of body temperature range ([0023]), and therefore Kreifeldt would be programmed to update the ambient temperature value by recording a new temperature reading from the temperature sensor and setting the ambient temperature value to the new temperature reading if both the ambient temperature value and the new temperature reading are outside of a body temperature range and setting the status state to 'not worn', or setting the ambient temperature value to the new temperature reading and switching the state of the status state if the ambient temperature value is within the body temperature range and the new temperature reading changes more than a temperature event threshold amount from one or more immediately prior temperature readings or if the new temperature reading does not change more than the temperature event threshold amount but a change in a corroborating sensor measurement from the corroborating sensor exceeds a threshold amount, otherwise leaving the ambient temperature value and the state of the status state the same if the ambient temperature value is within the body temperature range, the new temperature does not change more than the temperature event threshold amount, and the change in the capacitance measurement does not exceed the capacitance event threshold amount (as described in [0047], programming for the functionalities as claimed can be performed on a server computer and executed via the microprocessor) .
Kreifeldt discloses the invention substantially as claimed and discloses that the appliance can be an orthodontic retainer, but does not specifically disclose that the appliance has a dental appliance body forming one or more tooth-receiving cavities configured to be worn on a subject's teeth. In the art of intra-oral devices, Bedford discloses a dental appliance body forming one or more tooth-receiving cavities configured to be worn on a subject's teeth (Figure 1, 100). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the dental appliance of Bedford as the orthopedic retainer of Kopelman in order to provide a secure fitting device upon which to attach the sensor of Kreifeldt.
Regarding Claims 4, 21, and 27, Kreifeldt in view of Bedford discloses the apparatus of claim 1, and Kreifeldt further discloses that the corroborating sensor comprises one or more a pressure sensor (strain gauge 145 would also measure pressure changes that result in deformation/movement of material thus measuring pressure changes).
Regarding Claims 8 and 24, Kreifeldt in view of Bedford discloses the apparatus of claim 1, and Bedford further discloses a sensing module (Figure 1, 140) is capable of being removably coupled to the dental appliance body (as seen in Figure 1, assembly 140 is a separate element and therefore can be removed). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize the removable sensing module of Bedford as the sensing module of Kreifeldt in order to provide an avenue for replacement for a defective or failed sensor element of the dental appliance without requiring a new appliance to be manufactured.
Regarding Claim 9, Kreifeldt in view of Bedford discloses the apparatus of claim 1, and Bedford further discloses that the sensing module comprises a base (see Figure 1, where base is broader portion of sensing module) having a flange (square portion of 140 is considered the flange) that is configured to engage with an opening through the dental appliance body (as seen in Figure 1, module 140 is seen on the inner surface of 110 and therefore would extend through an opening in the dental appliance body). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize the sensing module with a base and a flange that extends through an opening of Bedford as the sensing module of Kreifeldt in order to provide a secure connection for the sensing module to the dental appliance.
Regarding Claim 10, Kreifeldt in view of Bedford discloses the apparatus of claim 1, and Kreifeldt further discloses that the sensing module further comprises a force sensor configured to measure an amount of force exerted on a region of the dental appliance (strain gauge 145 would also be a force sensor).
Regarding Claim 11, Kreifeldt in view of Bedford discloses the apparatus of claim 1, and Kreifeldt further discloses that the sensing module further comprises a force sensor configured to measure pressure changes within the intraoral cavity (strain gauge 145 would also measure pressure changes that result in deformation/movement of material thus measuring pressure changes).
Claims 6 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kreifeldt in view of Bedford as applied to claims 1 and 18 above, and further in view of Brawn et al. (US 2023/0210453 A1, hereinafter “Brawn”).
Regarding Claim 6 and 22, Kreifeldt in view of Bedford discloses the apparatus of claims 1 and 18, but does not specifically discloses that the corroborating sensor comprises a capacitance sensor. In the same art of orthodontic appliance devices, Brawn teaches a device with signals to detect capacitance change ([0171] and sensors 2549 in Figure 95). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sensors of Kreifeldt in view of Bedford with a capacitance sensor as taught by Brawn in order to detect change in capacitance and therefore monitor the electronic components of the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kreifeldt in view of Bedford in view of Brawn, in further view of Gassman et al. (US 2022/0338802 A1, hereinafter “Gassman”).
Regarding Claim 7, Kreifeldt in view of Bedford in view of Brawn discloses the apparatus of claim 5, but does not disclose that the memory is further configured to determine compliance with a treatment plan on a continuous or semi-continuous manner, wherein the treatment plan specifies an amount of time that the dental appliance is required to be worn during a day, and the memory is configured to determine compliance with the treatment plan based a determination as to whether the dental appliance is being worn for specified amount of time. In the same art of orthodontics, Gassman teaches an orthopedic retainer with a sensor and a system for creating a treatment plan (treatment protocol as described in [0035]) and determining compliance (see Figure 11 and [0041]). It would have been obvious to modify the device of Kreifeldt in view of Bedford in view of Brawn with the treatment protocols and compliance tracking as taught by Grossman, as treatment plans and tracking are necessary for evaluation of the effectiveness of a device and to achieve desired results.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kreifeldt in view of Bedford, in further view of Gassman et al. (US 2022/0338802 A1, hereinafter “Gassman”).
Regarding Claim 23, Kreifeldt in view of Bedford discloses the apparatus of claim 18, but does not disclose that the memory is further configured to determine compliance with a treatment plan on a continuous or semi-continuous manner, wherein the treatment plan specifies an amount of time that the dental appliance is required to be worn during a day, and the memory is configured to determine compliance with the treatment plan based a determination as to whether the dental appliance is being worn for specified amount of time. In the same art of orthodontics, Gassman teaches an orthopedic retainer with a sensor and a system for creating a treatment plan (treatment protocol as described in [0035]) and determining compliance (see Figure 11 and [0041]). It would have been obvious to modify the device of Kreifeldt in view of Bedford with the treatment protocols and compliance tracking as taught by Grossman, as treatment plans and tracking are necessary for evaluation of the effectiveness of a device and to achieve desired results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 9-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE L NELSON/Examiner, Art Unit 3772
/EDWARD MORAN/Primary Examiner, Art Unit 3772
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