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 § 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.
Claims 1, 4, 7, 10, 68, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over DeSimone et al. (US 7,641,828 B2) as evidenced by Dumé (NPL cited and mailed 10/02/2023) and further in view of Burrell et al. (US 5,681,575).
Claim 1, DeSimone discloses a dental appliance (Fig. 1) comprising:
a polymeric shell (10)[col. 4 lines 18-19] with a first major surface (the surface on the inside of the device adjacent to the teeth and the outside of the device away from the teeth have a surface) comprising a plurality of cavities for receiving one or more teeth (Fig. 1)[col. 4 lines 18-20]; and
a second transparent barrier layer on the first major surface (Fig. 4, 310)[col. 10 lines 25-27].
DeSimone is silent regarding the second transparent barrier layer is a substantially continuous layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof, wherein the layer is substantially free of discrete nanoparticulate islands and the substantially continuous layer penetrates below the first major surface.
However, Burrell discloses anti-microbial coatings for medical devices [abstract] such as dental devices [col. 7 line 36]. Burrell further teaches that it is known to the those of ordinary skill in the art that it would be obvious to modify a medical device in need of a protective coating by applying a metal oxide layer directly onto the substrate (Col. 4, lines 1-4 sets forth “metal” may mean metal-oxide; Col. 6, lines 10-15: “directly deposited”).
Burrell discloses the layer is a substantially continuous layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof (Col. 4, lines 1-4 sets forth “metal” may mean metal-oxide; Col. 5, lines 40-46 sets forth silver and other metals; taken together silver-oxide is disclosed), wherein the layer is substantially free of discrete nanoparticulate islands and the substantially continuous layer penetrates below the first major surface (Col. 4, lines 41-65; paragraph 0031 of applicant’s specification cites to Burrell as a suitable physical vapor deposition technique that would result in the claimed structure; also see Col. 6, lines 17-24 which discloses “etching the substrate or forming a mixed interface between the substrate and the coating” which would result in the claimed layer penetrating below the first major surface).
It would therefore be obvious to one of ordinary skill in the art, at the time of filing to cause the second layer of DeSimone to be a metal oxide layer as claimed as taught by Burrell as doing so would improve the device of DeSimone according to known methods.
Claim 68, DeSimone as modified discloses a method of orthodontic treatment, comprising: positioning a dental appliance of claim 1 (see claim 1 rejection above) around one or more teeth (DeSimone Fig. 1)[DeSimone col. 4 lines 19-21].
Claim 73, DeSimone as modified discloses wherein the polymeric shell (DeSimone 10) comprises polyethylene terephthalate [DeSimone col. 6 line 9].
Claims 4, 7 and 10, Burrell et al. discloses anti-microbial coatings for medical devices [abstract] such as dental devices [col. 7 line 36] wherein the thickness of the metal oxide (including zinc oxide) is about 1nm to 200 nm [col. 15 lines 24-29](100 Angstroms to 3300 Angstroms is equivalent to 10nm to 330 nm).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify DeSimone by having the layer thickness of the metal oxide to be between 1nm to 200nm as Burrell teaches a similar device which effectively contains the thickness as claimed. Further it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. MPEP 2144.05 (I).
Claim 4, DeSimone as modified as set forth above, disclose the device as claimed, wherein the dental appliance transmits at least 60% of incident light with a wavelength of about 400-750 nm (Transparency is an inherent property of metal oxides, as referenced by NPL document, Dumé. Further, DeSimone discloses a transparent device [DeSimone abstract]). A metal oxide as made obvious, as set forth above, having the claimed thickness would necessarily have the claimed transparency.
Claim 10, DeSimone as modified discloses the device as claimed, wherein the layer of metal oxide is substantially transparent to visible light with a wavelength of 400-750 nm (Transparency is an inherent property of metal oxides, as referenced by NPL document, Dumé. Further, DeSimone discloses a transparent device [DeSimone abstract]).
A metal oxide as made obvious, as set forth above, having the claimed thickness would necessarily have the claimed transparency.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone et al. (US 7,641,828 B2) and evidenced by Dumé, further in view of Burrell et al. (US 5,681,575) and further in view of Reynaud et al. (US 2007/0208102 A1).
Claim 14, DeSimone as modified above disclose the device as claimed. DeSimone as modified above does not explicitly disclose wherein the layer of metal oxide exhibits at least a 1-log microbial reduction against S. aureus and S. mutans following 24 hour contact (however it is noted that the anti-microbial effects of the metal oxide are inherent properties of the material).
Further, Reynaud discloses an anti-microbial dental device [abstract] wherein the device has a layer of metal oxide [0032] which exhibits at least a 1-log microbial reduction against S. aureus [0066] and S. mutans [0067, table above 0072] following 24 hour contact.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the device of DeSimone as modified exhibits at least a 1-lof microbial reduction as doing so is necessary to the anti-bacterial properties of the coating.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive.
Applicant argues that Burrell does not disclose a standalone layer of silver oxide applied directly onto a substrate and that none of the references set forth a substantially continuous layer that is substantially free of nonparticulate islands and that penetrates below the first major surface. However, the Examiner respectfully disagrees.
Burrell discloses the layer is a substantially continuous layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof (Col. 4, lines 1-4 sets forth “metal” may mean metal-oxide; Col. 5, lines 40-46 sets forth silver and other metals; taken together silver-oxide is disclosed), wherein the layer is substantially free of discrete nanoparticulate islands and the substantially continuous layer penetrates below the first major surface (Col. 4, lines 41-65; paragraph 0031 of applicant’s specification cites to Burrell as a suitable physical vapor deposition technique that would result in the claimed structure; also see Col. 6, lines 17-24 which discloses “etching the substrate or forming a mixed interface between the substrate and the coating” which would result in the claimed layer penetrating below the first major surface).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ERIC J ROSEN whose telephone number is (571)270-7855. The examiner can normally be reached Monday-Friday 930am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marivelisse Santiago-Cordero can be reached at (571) 272-7839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
