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 .
Claims Status
Applicant’s election without traverse of Group I (claims 1-5) and the species of iron oxide Fe3O4, chlorhexidine antibiotic, and quaternary ammonium silane antibacterial shell in the reply filed on 07/03/2026 is acknowledged.
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/03/2026.
Claims 1-5 are under current examination as directed to the elected species of Fe3O4, chlorhexidine and quaternary ammonium silane shell.
Information Disclosure Statements
No Information Disclosure Statements have been filed.
Claim Rejections - 35 USC § 112-indefinite
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.]
Claim 5 is 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 5 recites the dental adhesive of claim 1 wherein the biomedical composition has a formula of CHX@SiQuac@Fe3O4@m-SiO2. Since the silica is listed last it would appear that the outer shell in the formula is the silica coating. However, claim 1 recites an antibacterial outer shell. Therefore, the structure of the core shell particle of the formula in claim 5 is not clear. Claim 1 requires an antibiotic and an antibacterial outer shell. However, chlorhexidine is a compound that can comprise an antibacterial shell or antibiotic. Therefore, it is unclear how the chlorhexidine, SiQuac, Fe3O4and m-SiO2 meet within the structural limitations of claim 1 since silica appears to be the outer shell in this formula but is not an antibacterial compound. For the purpose of examination, the outer shell will be interpreted as the SiQuac and not the mesoporous silica.
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 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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (WO2009064964) in view of Yan et al. (Chlorhexidine-encapsulated mesoporous silica-modified dentin adhesive) and Bai et al. (Bimodal antibacterial system based on quaternary ammonium silane-coupled core-shell hollow mesoporous silica)
Jin et al. teach drug delivery vehicles comprising a core of magnetic particles and drug surrounded by a silica shell, see Figures 4-6 and 13. Examples of drug include antibiotics, see page 6 at line 26. The magnetic nanoparticles include Fe3O4 coated with silica shells, see page 8, line7-15, column 17, lines 8-17 and entire document. These drug delivery vehicles can be used in dentistry such as dental repair, see page 4, lines 1-2.
Jin does not teach that the antibiotic is chlorhexidine surrounded by a mesoporous silica or that the silica has an antibacterial shell of quaternary ammonium silane. These deficiencies are cured by the teachings of Yan and Bai.
Yan et al. teach chlorhexidine within mesoporous silica enables the continuous release of chlorhexidine which inhibits the growth of S. mutans biofilm providing desirable dental bonding and caries prevention, see abstract, introduction and conclusion sections.
Bai et al. teach quaternary ammonium silane QHMS shell grafted to mesoporous silica for delivery of drug in the core, see abstract, sections 2.2 and 3.1. The drug carrier enables sustained bimodal antibacterial function with excellent biocompatibility, see abstract and introduction and discussion. The drug carrier system serves as a model for loading of antibiotic-resistant drugs and can have dental application, see discussion and conclusion.
It would have been prima facie obvious to provide the antibiotic of Jin as a chlorhexidine surrounded by mesoporous silica.
One of ordinary skill would have been motivated to provide chlorhexidine surrounded by mesoporous silica because Yan teaches that such shells enable the continuous release of chlorhexidine antibiotic against biofilms which are desirable for dental adhesive bonding applications. There would have been a reasonable expectation of success because Jin teaches particles with silica surrounding a core which can comprise antibiotics and Fe3O4.
It would have additionally been prima facie obvious to provide a quaternary ammonium silane over the mesoporous silica because Bai teaches that such drug delivery enables for the sustained bimodal antibacterial function with excellent biocompatibility. There would have been a reasonable expectation of success given Bai suggested that such compositions can be useful for dental application.
Regarding claim 1 which recites “for use as a dental restoration” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the prior art is capable of performing the intended use given Jin teaches dental restoration applications. Furthermore, Yan teaches that chlorhexidine antibiotic encapsulated with mesoporous silica provides usefulness as a dental adhesive and prevents biofilm adhesion, and Bai teaches that quaternary ammonium silane shell grafted to mesoporous silica for delivery of drugs in the core is useful in dental application for providing sustained bimodal antibacterial function.
Conclusion
Currently, no claims are allowed and claims 1-5 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619