DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to Applicant’s amendment filed 12/23/25.
Response to Arguments
Applicant's arguments filed 12/23/25 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: The claims should read “dimensional proportions of the first tooth are maintained”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-4, 7-14, and 16-20 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Bardach et al (US 2003/0205234 A1).
Regarding claims 1 and 11, Bardach et al discloses a method of treatment of a dentition (see abstract, claims 43-46), the method comprising: placing a dental appliance (10) on the dentition (e.g. in embodiment where some blanks 18 remain left in appliance at certain sites [0059]), the dental appliance made of a polymer (EVA see [0051]-[0052] and including a plurality of cavities that fit on a corresponding plurality of teeth of the dentition (e.g. cavities corresponding to teeth I, P, M in Fig. 2, after customization; [0055]), wherein the plurality of cavities include: a scaled-up cavity having a shape in accordance with a first tooth of the plurality of teeth (e.g. a cavity which has spaces to accommodate blanks and/or inserts on the buccal and lingual sides, encompassed by Bardach, [0050], [0057]-[0059]), the scaled-up cavity having a size that is larger than the first tooth such that dimensional proportions of the first tooth are maintained in the scaled-up cavity to establish a substantially uniform space between an inner surface of the scaled-up cavity and the first tooth (see Fig. 2 and 7; substantially uniform space formed by areas accommodating blanks and inserts, with the blanks and inserts removed; insets 15; Figs. showing the dimensional proportions being maintained at least to some degree), the space (as explained above) adapted to accept a chemical to chemically treat the first tooth (e.g. agent contained in hydrogel of spacer 14, when inserted therein and blank not present; [0060]), the inner surface having a/plurality of spacer(s) (blanks 18) made of the polymer material (EVA [0055]) configured to maintain the space between the inner surface of the scaled-up cavity and the first tooth (blanks maintain space of cavity when inserted; prevent collapse thereof); and a fitted cavity having a shape and size in accordance with a second tooth of the plurality of teeth, the fitted cavity configured to snuggly fit on the second tooth to create a fixed orientation of the dental appliance with respect to the plurality of teeth to ensure the chemical within the space is in contact with the first tooth (e.g. another of tooth receiving cavities that is customized to tooth and does not have an inset and is therefore not scaled up; encompassed by Bardach [0050]).
Bardach further discloses wherein the method further comprising delivering the chemical within the scaled-up cavity of the dental appliance (e.g. inserting the insert with agent, see abstract and citations above; per claims 2 and 13); wherein the space is adapted to accept a particular chemical having a particular characteristic, wherein the particular characteristic includes one or both of a viscosity and a type of chemical (e.g. a particular chemical used with the hydrogel inserts; see [0073]-[0090]; per claim 3); wherein the chemical is in the form of a liquid, a gel, a powder or a foam (e.g. liquid combined with hydrogel [0017]; per claims 4 and 14); wherein the chemical includes one or more of a whitening agent, an antibacterial agent, an antifungal agent, a mouth freshening agent and a plaque removal agent (see [0073]-[0090]; per claim 7); wherein the spacer (blanks 18) protrudes toward the first tooth by a distance substantially equal to an offset (space corresponding to blank/insert; inset 15) between the inner surface of the scaled-up cavity and the first tooth (see Figs. 3-5 and 7; per claims 8 and 17); wherein the scaled-up cavity includes at least two spacers configured to maintain the space between the inner surface of the scaled-up cavity and the first tooth (e.g. in cavity with buccal and lingual blanks, encompassed by Bardach, see citations above; per claims 9, 10, 12, 18); further comprising removing the dental appliance from the patient’s dentition (e.g. to remove blanks and place inserts; see [0071] or at the end of use; per claim 16); wherein the dental appliance includes more than one scaled-up cavity (see Fig. 2) to maintain corresponding spaces between inner surfaces of the more than one scaled-up cavity and corresponding first teeth (see [0050]-[0051]; per claim 19); and wherein the dental appliance includes more than one fitted cavity configured to snuggly fit on corresponding second teeth (any number of cavities can be configured to be scaled up (have insets) or not scaled up (no insets); see [0050]-[0051]; per claim 20).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5-6 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bardach et al in view of Kuo et al (US 6607382 B1).
Regarding claims 5-6 and 15, Bardach et al does not teach wherein when the dental appliance is on the dentition, the dental appliance applies controlled forces on one or more teeth of the dentition to gradually move the one or more teeth toward a new configuration according to an orthodontic treatment plan or wherein, when the dental appliance is on the dentition, the spacer applies a controlled force on the first tooth according to an orthodontic treatment plan as required.
Kuo et al, however, teaches a medicament dispensing oral device (see Figs. 2, 6, 7-8) having a spacer (15/60/62) which also applies forces to the teeth to move the teeth according to an orthodontic treatment plan (see col 10 lines 13-49 and col 12, line 51 through col 13, line 2). The Examiner further notes that in cavities with the spacer, at least some of the force applied would be applied at or through the spacer structure by virtue of its contact with the teeth. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of Bardach to include Kuo’s teaching of providing a medicament dispensing oral device with spacers that also allows for the application of orthodontic forces to the teeth, as such modification would allow for concurrent treatment of two oral conditions, allowing improved treatment efficiency. The Examiner notes that should the device of Bardach be modified for the application of orthodontic forces thereby as taught by Kuo, the appliance, via contact with the teeth with the blanks (spacers) and/or inserts would apply the controlled orthodontic forces to the teeth according to the treatment plan, at least to some degree.
Conclusion
THIS ACTION IS MADE FINAL. 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 EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772