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 .
Status of Claims
Claims 1-15 are pending and under examination.
Priority
This application is a national stage entry of PCT/EP2024/085611 filed on 12/11/2024, which claims priority to EP23216082.0 filed on 12/12/2023.
Information Disclosure Statement
The information disclosure statements filed on 1/24/2025 and 3/26/2025 have been considered by the examiner.
Claim Objection
Claims 1, 9 and 11 are objected to for using a period “.” after “a”, “b”, “c”, etc in the claim where one period is allowed unless necessary for an abbreviation. Application may consider using a), b), c) or another such option.
Claims 9 and 11 are objected to because they also use a, b, c, d and claim 1 uses a, b, c, d. In claims 9 and 11, applicant may consider a different system for the items such as i), ii), iii), iv).
Claims 9 and 11 are objected to for using capital letters to begin each item when the only capital letter necessary is for “The” at the beginning of the claim.
Claim 12 is objected to for the unnecessary comma between “one or more of” and “sorbitol”. Applicant may delete this extra comma.
Claim 13 is objected to for using “and” for this group of options introduced by “one or more of…”. The claim should end with “or mixtures thereof.”
Appropriate corrections are required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15 is rejected under 35 U.S.C. 101 because the claim is a “Use” claim. As the claim could be construed as product with intended use, kit or method of using, the claim may be construed to be multiple categories of invention rather than to just one “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof”. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112 - Indefiniteness
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 10, 14 and 15 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 10 recites the limitation "the gelling polymer" but the recitation from claim 9 is “at least one gelling polymer”. Thus, it is unclear which “the gelling polymer” is being referred to. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the recitation to “the at least one gelling polymer…”
Claim 14 recites the limitation "the minor ingredients" but the recitation from earlier in the claim is “one or more minor ingredients”. Thus, it is unclear which “the minor ingredients” is being referred to. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the recitation to “the one or more minor ingredients…”
Claim 15 is indefinite for being a “Use” claim. It is unclear if this is meant to be a method claim or a product claim with an intended use. If meaning to be a method of using, it does not set forth any steps. Applicant might consider amending the claim to “A product comprising a dentifrice composition according to claim 1 and a brush….” as one possible option. See MPEP 2173.05(q).
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.
Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas US 11246809 and Wang US 20120308626A1.
Lucas teaches dentifrice compositions comprising spherical, anhydrous, amorphous, silica gel particles having a pore volume of less than 0.1 ml/g and an orally acceptable carrier (abstract). Lucas teaches the particles having a. a pore volume from 0.03 ml/g to less than 0.1 ml/g; b. a mean particle size from 1μ to 10μ; c. a BET surface area of 50 m2/g or less; d. an oil absorption capacity of 20 to 50 ml/100 g; and e. a water content of less than 0.2 wt. %. (claim 1 of Lucas). Lucas teaches supplementary abrasive, desensitizing agent and fluoride ion source (claims 4, 7 and 8 of Lucas). Lucas teaches potassium nitrate (column 9, lines 7-10). Lucas teaches “sodium fluoride , an alkali metal monofluorophosphate such a sodium monofluorophosphate , stannous fluoride , or an amine fluoride (column 9, lines 46-55). Lucas teaches bioglass (column 9, lines 21-40). Lucas teaches surfactants and humectants (column 9, lines 64-67). Lucas teaches humectants like glycerin, sorbitol, polyethylene glycol and others (column 10, lines 31-36). Lucas teaches surfactants including sodium lauryl sulfate and cocamidopropylbetaine (column 10, lines 3-22). Humectants are taught as 10 to 80% or 20 to 70% by weight of the composition (column 10, lines 35-39). Surfactants are taught to be 0.1 to 15% by weight of the composition (column 10, lines 26-30). Lucas teaches water from 5 to 70% by weight and 10 to 50% by weight (column 8, lines 18-25). Lucas teaches a formulation of example 1 with opacifier (titanium dioxide) at 0.1%, flavor oil at 1.2%, sweetener at 0.35% and pH adjuster at 0.01%, which adds up to 1.66 wt%. Example 1 also includes xanthan gum thickener which would be a polymeric gelling agent and it is at 0.8% by weight. Example 1 teaches sodium fluoride and potassium nitrate. Humectants (glycerin, polyethylene glycol and sorbitol) in example 1 add up to 41% and surfactants add up to 1.2%. The Sunsphere NP-30 particles are 0.5% by weight in example 1. Thus, such spherical silica particles in example 1 fit into the ranges of applicant’s claims. It is noted that Lucas provides for perlite as an option of supplementary abrasive agent along with others (column 6, lines 40-45). Lucas teaches silica gel particles in an amount up to 1% as well as from 0.3 to 8% by weight (column 6, lines 18-32). Examples 2 and 3 provide for brushing with toothbrushes with the composition.
Lucas does not motivate perlite particularly or provide a range for this component.
Wang teaches “A composition for cleaning teeth may include natural glass, wherein the natural glass has a top particle size (d90) less than 50 μm and a median particle size (d50) less than 30 μm, and wherein the natural glass ranges from 0.1 percent to 20 percent by weight of the composition.” (abstract and claim 1 of Wang). It is noted that Wang provides 2% perlite in paragraph 63). Wang teaches perlite as the natural glass (claims 2-5 of Wang). Wang teaches using the composition in a toothpaste base (abstract). Wang teaches thickening agents or gelling agents of various types (paragraph 34). Wang teaches surfactants and humectants (paragraphs 35-36). Wang teaches the small perlite particles are known to provide effective teeth cleaning and tooth polishing (paragraph 70). Table 2 provides for d50 of particles of 18.21 and 20.47 microns (paragraph 48, also see paragraphs 44-45).
One of ordinary skill in the art before the time of filing would have included perlite with d50 particle size of less than 50 microns since this was seen as advantageous for teeth cleaning and polishing in Wang into the dentifrice formulations of Lucas that have spherical silica particles and other ingredients. There would be a reasonable expectation of success in providing a toothpaste/tooth cleaning formulation that has better ability to clean and polish teeth by the combined teachings of the references.
Claim 10 in addition to Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas US 11246809; Wang US 20120308626A1 and Utima US 20210275413.
Lucas and Wang teach the claims as discussed above.
Lucas and Wang do not provide for carbomer gelling agent.
Utima teaches calcium carbonate oral care compositions with thickening systems having synthetic polyacrylic acid polymer (carbomer) (abstract). Utima teaches carbomer/Carbopol (paragraph 6). Utima teaches that desired rheological properties can be achieved by formulation the composition with Carbopol and xanthan gum (paragraph 11). An example toothpaste formulation is provided in table 3.
One of ordinary skill in the art before the time of filing would have utilized carbomers as in Utima in an oral care formulation as they are seen as aiding to provide desirable rheological properties for an oral care composition. Therefore, there would be a reasonable expectation of success of incorporating carbomer taught in Utima into formulations motivated by Lucas and Wang and achieving desired rheological properties for the oral care formulation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-10 of U.S. Patent No. US 11246809 in view of Lucas US 11246809 and Wang US 20120308626A1.
‘809 claims provide for the dentifrice composition with spherical silica particles and the addition of other ingredients including additional abrasives.
‘809 claims do not motivate perlite particularly or provide a range for this component.
Lucas teaches dentifrice compositions comprising spherical, anhydrous, amorphous, silica gel particles having a pore volume of less than 0.1 ml/g and an orally acceptable carrier (abstract). Lucas teaches the particles having a. a pore volume from 0.03 ml/g to less than 0.1 ml/g; b. a mean particle size from 1μ to 10μ; c. a BET surface area of 50 m2/g or less; d. an oil absorption capacity of 20 to 50 ml/100 g; and e. a water content of less than 0.2 wt. %. (claim 1 of Lucas). Lucas teaches supplementary abrasive, desensitizing agent and fluoride ion source (claims 4, 7 and 8 of Lucas). Lucas teaches potassium nitrate (column 9, lines 7-10). Lucas teaches “sodium fluoride , an alkali metal monofluorophosphate such a sodium monofluorophosphate , stannous fluoride , or an amine fluoride (column 9, lines 46-55). Lucas teaches bioglass (column 9, lines 21-40). Lucas teaches surfactants and humectants (column 9, lines 64-67). Lucas teaches humectants like glycerin, sorbitol, polyethylene glycol and others (column 10, lines 31-36). Lucas teaches surfactants including sodium lauryl sulfate and cocamidopropylbetaine (column 10, lines 3-22). Humectants are taught as 10 to 80% or 20 to 70% by weight of the composition (column 10, lines 35-39). Surfactants are taught to be 0.1 to 15% by weight of the composition (column 10, lines 26-30). Lucas teaches water from 5 to 70% by weight and 10 to 50% by weight (column 8, lines 18-25). Lucas teaches a formulation of example 1 with opacifier (titanium dioxide) at 0.1%, flavor oil at 1.2%, sweetener at 0.35% and pH adjuster at 0.01%, which adds up to 1.66 wt%. Example 1 also includes xanthan gum thickener which would be a polymeric gelling agent and it is at 0.8% by weight. Example 1 teaches sodium fluoride and potassium nitrate. Humectants (glycerin, polyethylene glycol and sorbitol) in example 1 add up to 41% and surfactants add up to 1.2%. The Sunsphere NP-30 particles are 0.5% by weight in example 1. Thus, such spherical silica particles in example 1 fit into the ranges of applicant’s claims. It is noted that Lucas provides for perlite as an option of supplementary abrasive agent along with others (column 6, lines 40-45). Lucas teaches silica gel particles in an amount up to 1% as well as from 0.3 to 8% by weight (column 6, lines 18-32). Examples 2 and 3 provide for brushing with toothbrushes with the composition.
Wang teaches “A composition for cleaning teeth may include natural glass, wherein the natural glass has a top particle size (d90) less than 50 μm and a median particle size (d50) less than 30 μm, and wherein the natural glass ranges from 0.1 percent to 20 percent by weight of the composition.” (abstract and claim 1 of Wang). It is noted that Wang provides 2% perlite in paragraph 63). Wang teaches perlite as the natural glass (claims 2-5 of Wang). Wang teaches using the composition in a toothpaste base (abstract). Wang teaches thickening agents or gelling agents of various types (paragraph 34). Wang teaches surfactants and humectants (paragraphs 35-36). Wang teaches the small perlite particles are known to provide effective teeth cleaning and tooth polishing (paragraph 70). Table 2 provides for d50 of particles of 18.21 and 20.47 microns (paragraph 48, also see paragraphs 44-45).
One of ordinary skill in the art before the time of filing would have included perlite with d50 particle size of less than 50 microns since this was seen as advantageous for teeth cleaning and polishing in Wang into the dentifrice formulations of ‘809 in view of Lucas ‘809 that have spherical silica particles and other ingredients. There would be a reasonable expectation of success in providing a toothpaste/tooth cleaning formulation that has better ability to clean and polish teeth by the combined teachings of the references.
Conclusion
No claims allowed.
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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