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 Status
Claims 1-11, 13, 16, 18-19, and 23-24 are pending.
Claims 1-11, 13, 16, 18-19, and 23-24 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
Claims 3, 10, 13, 18, 19, 23, and 24 will not be accorded the benefit of the filing date of 15-Apr-2022 because the provisional application does not provide written description for the limitations according to 112(a).
Claim 3 recites a sodium fluoride solution concentration between 0.8 M and 0.95 M NaF. The provisional application concentration is between 0.8 M and 0.9 M NaF.
Claim 10 recites mixing for a predetermined time between 1 and 24 hours, the provisional application discloses mixing for a predetermined time.
Claim 13, 18, and 23 recites sodium fluoride hopper crystals having a Hall density of 0.68 ±0.04 g/cm3 and a surface area to mass ratio of 0.22 ±0.04 m2/g. The provisional application does not disclose either Hall density or the surface area to mass ration.
Claim 19 recites that the sodium fluoride hopper crystals are present in an oral care product at 2.5 wt%. The provisional application does not disclose the claimed concentration of 2.5 wt%.
Claim 24 recites the release profile of at least 50 ppm/g formulation within 50 minutes. The provisional application does not disclose a release profile.
Accordingly, foregoing claims is instead accorded the effective filing date of the PCT application PCT/US2023/018410 of 13-Apr-2023. Therefore, the effective filing date for Claims 3, 10, 13, 18, 19, 23, and 24 is 13-Apr-2023, and for Claims 1-2, 4-9, 11, and 16 is 15-Apr-2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 02-Oct-2024 and 17-Dec-2025 has been considered by the examiner.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figure 5 includes lines drawn with a thick market, resulting in jagged and uneven edges for the conductivity versus time of sodium fluoride solutions, which lacks the clarity for patent drawings. The lines are not of uniform thickness, overlap at the 9000 second mark, making interpretation questionable. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 22, “at at least 5:1” has repeated word.
Paragraph 93, “radio of Antisolvent” should be ratio.
Appropriate correction is required.
The use of the term “Parafilm”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: The embodiments of Paragraph 27 are substantially duplicated of Paragraph 8.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
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, 6, 10-11, 13, 16, 18-19, and 23-24 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.
The term “high surface area” in claim 1 is a relative term which renders the claim indefinite. The term “high surface area” 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. No clear structure or methodology was defined in the specifications for the relative term “high”.
The term “80% and 95%” in claim 6 and 23 is a relative term which renders the claim indefinite. The term “80% and 95%” 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. 80% and 95% ethanol is unclear as to the percentage refers to volume % or weight % since both formats have been previously recited in the specifications.
The term “portion” in claim 16 is a relative term which renders the claim indefinite. The term “portion” 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. A “portion” is unclear as to the amount of sodium fluoride required in the oral care product composition.
Regarding claim 24, the phrase "present in a sufficient quantity and structure to provide a release profile" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "present in a sufficient quantity and structure to provide"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 10 recites the limitation "HSA crystal formation". There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "HSA crystals” in section d and e. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "formed crystals” in section f. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "solution" in section d of claim 11. Only NaF solution is mentioned prior. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toure et al. (2012, Processes for working-up an aqueous fluosilicic acid solution).
In regards to Claim 1, Toure teaches that sodium fluoride is insoluble in alcohols. Toure further teaches the addition of an antisolvent comprising of ethanol into a solution of sodium fluoride. The sodium fluoride is then precipitated and filtered out (Page 1 and Page 2, Figure 3).
In regards to Claim 2, Toure teaches that the aqueous sodium fluoride is mixed with the antisolvent ethanol in reactor 1 (Page 2, Figure 3).
In regards to Claim 4-5, Toure teaches that sodium fluoride is precipitated using a volume of ethanol, and water is present in the system (Page 2, Figure 3):
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In regards to Claim 9, Toure teaches that the NaF is filtrated using a diaphragm pump, thus removing the antisolvent (Page 2).
In regards to Claim 10, Toure teaches that the NaF is reacted at 80°C for 2 hours (Page 4), resultant products are diaphragm filtered to remove the antisolvent (Page 2).
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 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 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 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).
Claim(s) 1-11, 13, 16, 18-19, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toure et al, and further in view of Fevzioglu et al. (US010881123B2, Published: 05-Jan-2021) and Elevate Oral Care (Wayback Machine: 28-Nov-2021).
Toure teaches the sodium fluoride method of making comprising dissolving NaF in water, addition of an antisolvent, and precipitating the resultant crystals as discussed above.
For Claim 3, Toure teaches the final NaF was obtained through reacting 21 grams of sodium fluosilicate (90% purity) and 17 grams of calcium hydroxide (96% purity) in 200 mL of water (Page 2).
Mass of Na2SiF6: 21 grams*90% = 18.90 g; Molar Mass = 18.90 g / 188.06g/mol = 0.1005 moles
Mass of Ca(OH)2: 17 gram*96% = 16.32 g; Molar Mass = 16.32 g / 74.09g/mol = 0.2203 moles
Na2SiF6 + 2Ca(OH)2 → 2NaF + 2CaF2 + SiO2 + 2H2O
The balanced equation requires a 2:1 ratio of Ca(OH)2 versus Na2SiF6, and since the calcium hydroxide is in excess, the sodium fluosilicate is the limiting reactant.
Moles of sodium fluoride = 0.1005 moles Na2SiF6 * 2 = 0.2010 moles NaF
M = 0.2010 moles NaF/0.200 L = 1.005 M NaF.
For Claims 4-8, Toure teaches an antisolvent ethanol solution to precipitate NaF.
For Claim 11, Toure teaches diaphragm filtration (Page 2).
For Claim 13, 18, and 23, Toure teaches NaF solution concentration, antisolvent solution, precipitation, and filtrate (Page 2, Figure 3).
For Claim 16, 19, and 24, Toure teaches NaF precipitate and filtrate.
Toure does not teach a NaF solution between 0.8 M and 0.95 M NaF of claim 3. Toure does not teach an antisolvent solution comprising ethanol and an impurity of water with a ratio of ethanol to water of between 80 to 95% ethanol to water, an antisolvent to NaF ratio from 5:1 to 15:1, and an antisolvent to NaF ratio from 10:1 to 15:1 of claims 4-8. Toure does not teach the Hall density or surface area of the NaF crystals of claim 13, 18, and 23. Toure does not teach an oral care product with 2.5 wt% sodium fluoride hopper crystals or a release profile of at least 50 ppm/g within 50 minutes of claim 24. For this reason, Fevzioglu and Elevate Oral Care is added.
Fevzioglu teaches an antisolvent solution comprising 95 vol% ethanol, and the resultant salt crystals were hopper cubes crystals ranging in size from 30-150 µm along with some solid cubes of about 20 µm (Col. 5, line 36-40). Fevzioglu teaches that the antisolvent solution has ethanol in the range greater than 80 vol% but less than 100 vol% ethanol in water (Col 5, line 55-57). Fevzioglu teaches salt crystals with hopper cube morphology was obtained by mixing the salt solution with the antisolvent as described above at mass ratio of salt solution to anti solvent in the range of 1:20 to 1:1.25 or 1:10 to 3:5 (Col 5, line 59-63). Fevzioglu teaches hopper cubes having a surface area of 0.21 m2/g and a hall density of 0.74 g/cm3.
Elevate Oral Care teaches a 2.5 wt% oral care composition comprising of sodium fluoride, shellac, propylene glycol, ethyl alcohol, flavorings, sweeteners, and hydroxyapatite (Page 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sodium fluoride precipitation process of Toure using the ethanol and water antisolvent concentrations, antisolvent to salt solution ratios, and hopper crystal forming conditions taught by Fevzioglu. Both references are directed to antisolvent crystallization of inorganic salts and Fevzioglu recognizes that solvent composition, salt concentration, and mixing conditions affect the resultant crystal morphology. A person having ordinary skill in the art would have recognized that these parameters are result-effective variables and would have been motivated to optimized them through routine experimentation to optimize them to obtain the desired crystal morphology and dissolution characteristics.
Further, the modification would have been no more than the predictable use of prior art elements according to their established functions. Fevzioglu teaches that the claimed ethanol and water concentrations and solution ratios promote hopper crystal formation. Applying those same crystallization parameters to the sodium fluoride process of Toure would have yielded predictable results with reasonable expectation of success of obtaining sodium fluoride crystals having the same hopper morphology and overlapping physical characteristics such as Hall density and surface area.
Furthermore, it would have been obvious to incorporate the resulting sodium fluoride crystals into the oral care compositions of Elevate Oral Care, including compositions comprising 2.5 wt% sodium fluoride, because sodium fluoride is a known fluoride source in oral care products. The resulting dissolution and release characteristics would have been a predictable result of using a high surface area crystal morphology in a known sodium fluoride oral care composition. For the foregoing reasons, Claims 3-8, 11, 13, 16, 18-19, and 23-24 are rendered obvious by the teachings of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L./Examiner, Art Unit 1614
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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