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 .
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, 4, 7, 10, 14, 50, 68 and 73 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.
Claim 1 recites “a layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, and a combination thereof” (emphasis added) and then later recites “the layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof” (emphasis added). It is unclear if the claim requires all of the listed oxides and the alloys thereof to be part of the layer or if the claim scope includes a layer with only one of the listed oxides. For the purpose of examination, the claim is interpreted to read “a layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof”.
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, 50, 68, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over DeSimone et al. (US 7,641,828 B2) in view of Payton (US 20180168164 A1) 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 layer of silver oxide, copper oxide, gold oxide, zinc oxide, magnesium oxide, titanium oxide, chromium oxide, an alloy thereof, or a combination thereof.
Payton discloses antimicrobial coatings for dental applications [paragraph 0177] including wherein a layer of metal oxide can be applied on a surface of a dental article [abstract, paragraphs 284-286], wherein the layer of metal oxide comprises AgOx (paragraph 0096). It is noted that a coating layer comprising AgOx is interpreted as being a “layer of metal oxide” as claimed since the claim does not limit the layer of metal oxide to consist solely of the metal oxide.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the second layer of DeSimone to be a metal oxide as taught by Payton as doing so would improve the device of DeSimone according to known methods. DeSimone discloses utilizing an outer layer to protect from harmful substances [DeSimone col. 10 lines 25-27]. Payton further teaches a coating which protects from harmful microbes including a metal oxide. Therefore, one of ordinary artisan would be motivated to modify the device of DeSimone with the material of Payton for the purpose of protecting a user from harmful microbes and bacteria.
Furthermore, Burrell et al. 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 (claim 10; abstract). 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 taught by Payton and Burrell as doing so would improve the device of DeSimone according to known methods.
Claim 50, DeSimone as modified disclose the device as claimed, Payton further discloses wherein the layer of metal oxide penetrates below the first major surface [paragraph 0103] (the composition of the metal oxide can be in the surface and coat the surface of the polymeric shell 10 of DeSimone).
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 thickness of the metal oxide of DeSimone/Payton 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 by Payton and Burrell, 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 Payton as applied to claim 1 above 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 12/17/2025 have been fully considered but they are not persuasive.
Applicant argues that Payton teaches a metal oxide within an inorganic particulate mineral. The Examiner respectfully disagrees. While this is one embodiment taught by Payton, the reference also sets forth (emphasis added):
[0099] The antimicrobial metal may, for example, not be embedded within the structure of the inorganic particulate mineral particles.
[0102] In certain embodiments, the antimicrobial metal may be present on the surface of the inorganic particulate mineral.
[0104] The antimicrobial metal may be chemically bonded to the inorganic particulate mineral.
Furthermore, Burrell et al. 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 (claim 10; abstract).
Furthermore, the claim does not require the metal oxide layer to consist solely of the metal oxide. Applicant’s own specification recites that the metal oxide layer may include dyes or pigments [0026], additional metal compounds [0034] and additional additives [0035], wherein the amount of metal oxide in the metal oxide layer may be only 50 wt % metal oxide layer [0037]. Thus, the claim does not require the metal oxide itself to be in contact with the first major surface of the polymeric shell. The claim only requires a “metal oxide layer” which includes a metal oxide to be in contact with first major surface of the polymeric shell. Furthermore, the first major surface of the polymeric shell is not required by the claim to consist of polymeric material. Applicant argues that the layer taught by Payton would not have a thickness of 1 nm-200nm. This is not required by claim 1 but is only set forth in claim 7, wherein this limitation is taught by Burrell.
Conclusion
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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/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772