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
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 27, 2026. Claims 1-15 and 17-21 remain pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 18, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on September 13, 2024 are accepted.
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 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.
Claims 1-2, 4-6, 15, 17 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinstein et al. (US 2023/0030704 A1) (“Weinstein”).
Regarding claim 1, Weinstein discloses A dental appliance comprising (Abstract and entire document):
a polymeric shell comprising a plurality of cavities configured to receive a subject's teeth (FIG. 31-34 and associated paragraphs, retainer, see also at least [0121], [0329] – [0331]); and
an intraoral sensor coupled to the polymeric shell, wherein the intraoral sensor comprises a pH-sensitive molecule that is configured to change in color based on a pH of the subject's intraoral cavity, and wherein the pH-sensitive molecule is immobilized in the intraoral sensor (FIG. 31-34 and associated paragraphs, retainer, see also at least [0341 – 0345] discussing attaching sensor to polymeric shell; see also [0197] and [0118 – 0119], and [0134 – 0137]).
Regarding claim 2, Weinstein discloses The dental appliance of claim 1, wherein the intraoral sensor is a film comprising the pH-sensitive molecule and a biocompatible polymer ([0156], [0296]).
Regarding claim 4, Weinstein discloses The dental appliance of claim 2, wherein the film comprises: a first surface configured to be coupled to a buccal surface of the dental appliance, and a second surface configured to be directly exposed to the subject's intraoral cavity ([0224 – 0229] and FIG. 31-35 and [0324]).
Regarding claim 5, Weinstein discloses The dental appliance of claim 1, further comprising a color reference marker coupled to the polymeric shell ([0197] color calibration guide, color strip).
Regarding claim 6, Weinstein discloses The dental appliance of claim 5, wherein the color reference marker is part of the intraoral sensor ([0197] color calibration guide, color strip).
Regarding claim 15, Weinstein discloses The dental appliance of claim 2, wherein the intraoral sensor further comprises: an adhesive configured to couple the film to a surface of the dental appliance ([0204], [0307], [0331]).
Regarding claim 17, Weinstein discloses The dental appliance of claim 1, wherein the pH-sensitive molecule is configured to change in color when the pH of the subject's intraoral cavity is within a range from 5 to 7 ([0163]).
Regarding claim 20, Weinstein discloses The dental appliance of claim 5, wherein the color reference marker has a fixed color ([0197] color calibration guide, color strip).
Regarding claim 21, Weinstein discloses The dental appliance of claim 1, wherein the dental appliance comprises an aligner, a palatal expander, a mouth guard, a night guard, or a retainer (FIG. 31-34 and associated paragraphs, retainer, see also at least [0121], [0329] – [0331]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstein in view of Wang et al. (US 2016/0338626 A1) (“Wang”).
Regarding claim 3, Weinstein discloses The dental appliance of claim 2, Weinstein fails to disclose wherein the pH-sensitive molecule is covalently conjugated to the biocompatible polymer.
However, in the same field of endeavor, Wang teaches wherein the pH-sensitive molecule is covalently conjugated to the biocompatible polymer ([0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the dental appliance as taught by Weinstein to include wherein the pH-sensitive molecule is covalently conjugated to the biocompatible polymer as taught by Wang to have an integrated platform for real time monitoring ([0074 – 0075]).
Claims 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein in view of Leviton (US 2023/0320817 A1) (“Leviton”).
Regarding claim 8, Weinstein discloses A system comprising: the dental appliance of claim 1; and Weinstein fails to disclose an optical sensing device configured to generate data indicative of the color of the pH- sensitive molecule.
However, in the same field of endeavor, Wang teaches an optical sensing device configured to generate data indicative of the color of the pH- sensitive molecule ([0069], [00764] and [0076], smartphone based optical sensing device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Weinstein to include an optical sensing device configured to generate data indicative of the color of the pH- sensitive molecule as taught by Leviton to utilize components of smartphone and reduce cost ([0049], [0057]).
Regarding claim 9, Weinstein as modified discloses The system of claim 8, Weinstein as modified further discloses wherein the optical sensing device comprises an imaging device or a spectrophotometer (Leviton [0069], [00764] and [0076], smartphone based optical sensing device see also [0049]).
Regarding claim 10, Weinstein as modified discloses The system of claim 8, Weinstein as modified further discloses wherein the optical sensing device is a part of a mobile device (Leviton [0069], [00764] and [0076], smartphone based optical sensing device see also [0049]).
Regarding claim 11, Weinstein as modified discloses The system of claim 8, Weinstein as modified further discloses further comprising a receptacle configured to receive a portion of the dental appliance including the intraoral sensor, wherein the optical sensing device is part of the receptacle (Weinstein FIG. 17A-17G and associated paragraphs and see also Leviton, attachment receptacle 30).
Regarding claim 12, Weinstein as modified discloses The system of claim 8, Weinstein as modified further discloses further comprising one or more processors configured to: access the data generated by the optical sensing device, determine a pH associated with the intraoral cavity based on the data, and send instructions to an output device to display an output indicative of the determined pH of the intraoral cavity (Weinstein [0090], [0170], [0173], FIG. 1K, 1L, 1M).
Regarding claim 13, Weinstein as modified discloses The system of claim 12, Weinstein as modified further discloses further comprising a color reference marker, wherein the data generated by the optical sensing device is indicative of a color of the color reference marker, and wherein the one or more processors are configured to determine the pH associated with the intraoral cavity based on the color of the color reference marker (Weinstein [0197] color calibration guide, color strip).
Regarding claim 14, Weinstein as modified discloses The system of claim 12, Weinstein as modified further discloses further comprising one or more processors configured to: determine whether the determined pH falls within a pH range associated with an oral disease or condition, determine one or more recommendations for remedying the oral disease or condition, and send instructions to an output device to display the one or more recommendations (Weinstein [0163], [0173]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstein in view of Rubin (US 6,482,009 B1) (“Rubin”).
Regarding claim 18, Weinstein discloses The dental appliance of claim 1, Weinstein fails to disclose wherein the pH-sensitive molecule comprises one or more of chlorophenol red, methyl red, or bromocresol purple.
However, in the same field of endeavor, Rubin teaches wherein the pH-sensitive molecule comprises one or more of chlorophenol red, methyl red, or bromocresol purple (Col. 4 methyl red, known pH testing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the dental appliance as taught by Weinstein to include wherein the pH-sensitive molecule comprises one or more of chlorophenol red, methyl red, or bromocresol purple as taught by Rubin to provide a clear color change (Col. 4).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstein in view of Li et al. (US 2020/0214598 A1) (“Li”).
Regarding claim 19, Weinstein discloses The dental appliance of claim 1, Weinstein fails to disclose wherein the biocompatible polymer comprises one or more of agarose, cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, chitosan, gelatin, pectin, poly(2-hydroxyethyl methacrylate) (pHEMA), polyacrylamide, polyurethane, poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), polystyrene, polyvinylpyrrolidone (PVP), poly(lactic-co-glycolic acid) (PLGA), or starch.
However, in the same field of endeavor, Li teaches wherein the biocompatible polymer comprises one or more of agarose, cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, chitosan, gelatin, pectin, poly(2-hydroxyethyl methacrylate) (pHEMA), polyacrylamide, polyurethane, poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), polystyrene, polyvinylpyrrolidone (PVP), poly(lactic-co-glycolic acid) (PLGA), or starch ([0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the dental appliance as taught by Weinstein to include wherein the biocompatible polymer comprises one or more of agarose, cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, chitosan, gelatin, pectin, poly(2-hydroxyethyl methacrylate) (pHEMA), polyacrylamide, polyurethane, poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), polystyrene, polyvinylpyrrolidone (PVP), poly(lactic-co-glycolic acid) (PLGA), or starch as taught by Li to exhibit strength, stiffness, biocompatibility, etc. ([0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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