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 .
Status of the Claims
Claims 1-20 are pending and under examination.
Priority
This application claims priority from US provisional application 63/531,963 filed on 8/10/2023.
Information Disclosure Statement
The information disclosure statement filed on 10/14/2025 has been considered by the examiner.
Claim Objections
Claims 3 and 18 are objected to for being dependent on claims that are rejected. Applicant may import the limitations of these claims carrying in the limitations required by the dependency into the independent claims, which they depend on, to produce allowable claims.
Specification Objection
The specification is objected to for use of “AA2P” as the claims and specification appear to use it for both L-ascorbic acid-2-phospate and L-ascorbic acid-3-phosphate, which makes it confusing if the form AA2P is used to allow for either one or both of the options.
Claim Rejections - 35 USC § 112 (b)
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 5-7, 9, 13-17 and 19-20 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.
Claims 5-7, and 15-16 are indefinite for use of “AA2P” as the claims and specification appear to use it for both L-ascorbic acid-2-phospate and L-ascorbic acid-3-phosphate, which makes it confusing if the form AA2P is used to allow for either one or both of the options. It is suggested that applicant, delete the recitations of AA2P and use the full chemical name. For the purpose of compact prosecution if the prior art teaches either or both of L-ascorbic acid-2-phospate and L-ascorbic acid-3-phosphate, it will read on the AA2P limitation.
Claim 9 is rejected for being dependent on an indefinite claim.
Claim 9 recites the limitation "the MPTS" in dependence to claim 7, which does not introduced MPTS (3-methacryloxypropyltrimethoxysilane). There is insufficient antecedent basis for this limitation in the claim. It appears this claim should probably be dependent on claim 8.
The term “predetermined duration” in claim 13 is a relative term which renders the claim indefinite. The term “predetermined duration” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Predetermined duration” does not provide a particular time frame for the duration, and thus, it does not make it clear what the duration would be. For the purpose of compact prosecution, if the prior art allows for any time/duration for the contact, it will read on the limitation.
Claims 14-17 and 19-20 are rejected for being dependent on an indefinite claim.
Claim 19 recites the limitation "the divalent" in dependence to claim 13, which introduces “a divalent metal cation”. As “divalent” on its own could refer to various other divalent materials such as divalent organic cations, this does not particularly point back to “a divalent metal cation”. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 is rejected as being dependent on an indefinite claim.
Claim 19 is indefinite for having “remineralization” and “increased ad diametral tensile strength” as these appear to be results of the treatment rather than further defining the treating to a particular item a subject might need. Applicant may consider using “remineralizing” and “increasing” as active words and further provide that the contacting is to dentin in need thereof. This would provide the dentin being treated is dentin needing to be improved/treated. For the purpose of compact prosecution, the examiner will consider each of these as being items needing treating in dentin being contacted.
Claim 20 is rejected as being dependent on an indefinite claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-2, 4-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wada US6534044.
“Oral” in the preamble of claim 1 is toward the intended use of the composition (see MPEP 2111.02). If the prior art teaches a composition with the claimed components, it will meet the limitations. “Orally acceptable” is used to describe the salt and salt components. If the prior art teaches such a salt of the claims, it is deemed to be orally acceptable.
Wada teaches (1) a cosmetic material comprising silica-coated metal oxide particles further surface-treated with a hydrophobicizing agent, and (2) metal oxide particles having a specified infrared absorption spectrum intensity ratio and refractive index which are further treated with a hydrophobicizing agent, and to a process for their production. Wada teaches “First, according to one aspect of the invention, the cosmetic material comprises surface-hydrophobicized coated metal oxide particles that have been surface treated with a hydrophobicizing agent. The surface-hydrophobicized coated metal oxide particles are sufficiently effective so long as the surfaces are hydrophobicized. The present inventors found that a cosmetic material with the desired properties can be obtained by adding surface-hydrophobicized silica-coated metal oxide particles prepared by coating metal oxide particles with a silica film and further hydrophobicizing their surfaces” (column 9). The invention further relates to a silica-coated metal oxide sol which gives such particles (abstract). Wada teaches a combination of antioxidants including magnesium L-ascorbate-2-phosphate that is then combined with silica coated titania particles (columns 29 and 30 and column 22). Wada teaches using coupling agents that are under hydrophobizing agents, which include silane coupling agents including gamma-(methacryloyloxypropyl)trimethoxysilane (also known as 3-methacryloxypropyltrimethoxysilane), alkylalkoxysilanes and others (columns 17 and 18). The hydrophobizing agent is used to directly hydrophobize the silica-coated metal oxide particles (paragraph 17, lines 39-40) while the antioxidant is combined to minimize photocatalytic activity in the materials (column 22, lines 36-39). Wada teaches the form of a cream, form dispersed in solvent, solution, among other forms (column 21). Wada teaches a cream formulation as cosmetic example 12 having antioxidant formulation (columns 36 and 37) and as cosmetic examples 13 and 14. Production examples 1a, 1b, 2a and 2b provide for use of silanes to produce silane coated particles (columns 24 and 25). It should be also noted that cosmetic formulations are not limited to particular uses in the teachings of Wada. In regards to amounts of divalent metal cation and ascorbic acid phosphate counterion, this will be dependent on the antioxidant need (amount for minimizing photocatalytic activity) of the formulation as Wada provides for magnesium ascorbate-2-phosphate as an acceptable antioxidant. Wada teaches an antioxidant mixture with 20% of the magnesium ascorbate-2-phosphate (the salt that includes the combined parts). In regards to amounts of the silane coupling agent, this will be dependent on the degree of hydrophobization desired for the particles when making Wada’s formulations.
One of ordinary skill in the art before the time of filing would have combined the components including magnesium ascorbate phosphate and silane coupling agent of Wada into a formulation and adjusted amounts of the ingredients based on the antioxidant function and particle hydrophobizing function desired for the formulation. Wada further allows for various cosmetic forms including creams and solutions. Therefore, there was a reasonable expectation of success in using the teachings of Wada with routine optimizations to achieve recognized results/functions of the prior art, and in doing so, reasonably provide formulations as in applicant’s claims.
Claims 10 and 11 in addition to Claims 1-2, 4-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wada US6534044 and Derakhshankhah et al (Int J Nanomedicine, Jan 2020, volume 15, pages 363-386).
Wada teaches the claims as discussed above. Wada allows for other components including antimicrobial and antiseptic agents in its disclosure (column 22 of Wada).
Wada does not teach nano-zeolite or concentrations thereof.
Derakhshankhah teaches zeolitic nanoparticles for biomedical applications (abstract). Derakhshankhah teaches zeolite and excipient functionality. Derakhshankhah teaches “Significant prominence of nanozeolites as compared to another nanostructured porous materials are their low cytotoxicity, high payload capacity, and efficient delivery” (Highlights). Derakhshankhah teaches “Zeolites nanoparticles as promising antidiarrheal agents, antitumor adjuvants, antibacterial agents, drug carriers, and MRI contrast agents due to their favorable cytotoxicity, excipient functionality, protein corona composition, and biological interactions” (Highlights). Figure 3 teaches testing of diverse amounts of nano zeolites where cell viability was maintained.
One of ordinary skill in the art before the time of filing would have included nano-sized zeolites in formulations of the prior art as it has benefits for such formulations including antibacterial activities and usefulness as an excipient in teachings of Derakhshankhah. Therefore, there was a reasonable expectation of success in adding nano zeolite into formulations of Wada to obtain the benefits that it offers such as for antibacterial/antimicrobial function. One of ordinary skill in the art would optimize the zeolite to obtain antibacterial or excipient benefit while recognizing that it can be used in a number of concentrations due to its low toxicity while also being motivated to adjust amounts based on the needed effect of the user.
Claims with Allowable Subject Matter
The combination of divalent metal cations with concentrations as laid out in claim 3 when read in light of the limitations of independent claim 1 (on which it has indirect dependency) were not found to be taught or motivated in the prior art. If applicant imported the limitation of claim 3 into claim 1 to define the divalent metal cation, this would produce an allowable claim barring any issues added during applicant’s amendment.
In regards to independent claim 13, it is currently rejected under USC 112(b) as provided above (it is notable that claim 18 would repair the 112(b) deficiency). However, the prior art did not teach or motivate a method of using the composition in such a way to treat dentin by contacting to the dentin with the composition, then rinsing the dentin in the claimed manner. The closest prior art utilities relating to methods of use were indicated for other topical/cosmetic uses such as skin or hair. When considering the two composition items (orally acceptable salt as claimed with divalent metal cation and ascorbic acid phosphate counterion; and silane coupling agent) separately for dental uses, they had distinct purposes and were not taught to have a motivation to combine together. If applicant repairs the issue set out in the rejection under USC 112(b), claim 13 could become allowable.
Conclusions
No claim is allowed. Claims 1-2. 4-17, 19 and 20 are rejected. Claims 3 and 18 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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