DETAILED ACTION
Formal Matters
Claims 19-23 are cancelled. Claims 1-18 are pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/US2022/045983 filed on 10/07/2022, which claims priority to 63/324,423 filed on 3/28/2022.
Information Disclosure Statements
The information disclosure statement (IDS) filed on 09/26/2024 has been considered by the examiner.
Claim Objections
Claim 9 is objected to for the typo in “dicalcium phosphate dihydrate (CaHPO4.2H2O)” as there is no subscripted 2 following the “Ca” that would denote it as being dicalcium. Appropriate correction is required.
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 1-18 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 is indefinite as item c) does not indicate whether items i)-iii) are all included with “and iii)”, optional with “or iii)” or optional with combinations “and/or iii)”. Thus, it is unclear whether all three are needed or if they are optional in some manner. For the purpose of compact prosecution, the examiner will consider these items of item c) as being optional of one another.
Claims 2-18 are rejected as being dependent on an indefinite claim.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The occurrence is in the phrase of “an amine fluoride such as Olafur”.
Claim 8 recites the limitation "said at least one anhydrous humectant component" in the claim without a prior recitation of this component in the claim or in claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 introduces “at least one humectant component” and does not provide antecedent basis for the anhydrous as part of it.
Regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may delete the recitation of ‘or abrasives such as”, which will allow the group of items to continue.
Claim 10 is rejected as being dependent on an indefinite claim.
Claim 16 is indefinite for having two occurrences of “and” in the group, which makes it indefinite where the options of the group end and if ending after “and buffering agents” would those other components not be part of the group of “a component”. If applicant intends all items to be part of the group, which examiner will read for compact prosecution, then applicant should remove the “and” between pH adjusting agents “and” buffering agents and insert a comma “,” instead.
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 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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).
Claims 1-6 and 8-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans US 20200197267 and Rege US 20180168956.
Evans teaches dentifrice compositions with high levels of sodium bicarbonate and a stannous ion source (abstract, also see table 1). The composition of table 1 has 0.25 wt% thickener, 67 wt% sodium bicarbonate, and 0.45 wt% stannous fluoride (paragraph 44). The composition of table 5 has 67 wt% of sodium bicarbonate, humectant and 0.5 wt% of thickener (paragraph 48, also see claims 1 and 2 of Evans with over 50% or 60 to 80 wt% of sodium bicarbonate). Evans teaches stannous fluoride (claim 5 of Evans) and the stannous ion source being 0.01 to 10 wt% of the composition (claim 3 of Evans and paragraph 22). Evans teaches humectants from 20% to 60% by weight of the composition or 30 to 50 wt% of the composition (paragraph 35). Options of humectant include glycerin, sorbitol and propylene glycol (paragraph 35). Evans teaches xanthan gum and polymers as other useful materials that are orally acceptable (paragraph 35). Evans teaches calcium phosphate and calcium carbonate as conventional abrasives or polishers as well as potassium metaphosphate, aluminum silicate and others (paragraph 21). Evans teaches fluoride ion sources including sodium fluoride, sodium monofluorophosphate, and others (paragraph 23). Evans teaches 3.5 wt% of amorphous silica in table 1. In table 4, Evans provides for 8 wt% of abrasive silica for a composition (paragraph 48). In table 6, Evans teaches abrasive silica at 20 wt% of the composition (paragraph 48). Table 4 teaches 8 wt% of thickening silica in a composition (paragraph 48, also see 1.5 wt% in table 6). Evans teaches use of polymers such as carboxymethylcellulose, polysaccharide gums, and carrageenan gum (paragraph 35). Evans teaches water from 1 to 20% of the composition (paragraph 40). Evans provides that water includes free water introduced as well as those introduced with other materials or components (paragraph 40). Evans teaches surfactants from 0.01 to 2% by weight while teachings surfactants like polyoxyethylene hydrogenated castor oil, sodium lauryl sulfate and ammonium cation surfactants (paragraph 32). Evans teaches adding surfactants and flavoring agents (paragraph 41). Evans teaches flavor, sweetener, and colors in table 5. Paragraph 12 provides for “one or more of buffering agents, humectants, surfactants, gum strips or fragments, breath fresheners, flavoring, fragrance, coloring, antibacterial agents, whitening agents, agents that interfere with or prevents bacterial attachment, calcium sources, and potassium salts”. Evans teaches toothpaste or gel (paragraphs 3 and 11).
As applicant does not define “anhydrous” to a particular amount of residual water and Evans recognizes that the compositions can contain down to 1 wt% of water (paragraph 40 of Evans) where the water might be introduced via addition of one of the components in Evans, Evans will provide for an anhydrous product. Additionally, applicant sees water from 0 to 50 or 1 to 45 wt% of the composition (paragraph 64 of applicant specification) in its formulations which applicant considers anhydrous (paragraph 1 of applicant). Therefore, teachings of Evans allow for anhydrous formulations in line with applicant’s specification.
Although Evans teaches polymers including xanthan gum, it does not connect it as thickener in order to connect with a concentration. Evans does not teach the other options of polyvinylpyrrolidone or carboxyvinyl polymer. Evans does not teach compounds of claims 6 and 7.
Rege teaches oral care compositions with a stannous source and fluoride source (abstract). Rege teaches carboxyvinyl polymers and xanthan (item 1.42 of contemplates which start in paragraph 6). Rege teaches thickeners including carboxyvinyl polymers, polyvinyl pyrrolidone and xanthan in amounts of 0.5 to 5% by weight (paragraph 16). Rege teaches humectants (paragraphs 121-122). Item 1.25 of Rege provides for sodium bicarbonate as an abrasive. Rege teaches tooth paste or gel (paragraphs 98-99). Rege teaches polyacrylate gels and other acrylic polymers (paragraphs 112-114). Renee teaches surfactants (paragraphs 101-105).
One of ordinary skill in the art before the time of filing would have included thickeners such as polyacrylates, polyvinylpyrrolidone and xanthan of Rege into compositions of Evans as Evans recognizes the use of thickeners in its sodium bicarbonate, stannous ion, and humectant formulations and Rege teaches these as acceptable thickeners for gel forms of an oral care formulation. In doing so, the compositions would be thickened as desired for products like tooth gels and tooth pastes. Therefore, there was a reasonable expectation of success in combining the teachings of Evans and Rege to provide thickened oral care/dentifrice formulations having ingredients such as sodium bicarbonate abrasives, stannous ions and fluoride ions. In regards to amounts of ingredients of the claims, the prior art provides for amounts within ranges and overlapping ranges for claimed ingredients (MPEP 2144.05 regarding obvious of ranges). One of ordinary skill in the art would have worked with such amounts and within such ranges to make acceptable oral care formulations with a reasonable expectation of success.
Claim 7 in addition to Claims 1-6 and 8-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans US 20200197267, Rege US 20180168956 and Gordon US 20070189983.
Evans and Rege teaches the claims as discussed above.
Evans and Rege do not teach the limitation of claim 7.
Gordon provides an anhydrous liquid tooth whitening composition (abstract). Gordon teaches bioadhesive carbomers including crosslinked copolymers of acrylic acid with alkylacrylate where the alkyl chain is C10-30 e.g. Pemulen TR1 and Pemulen TR2, available from Noveon Inc. as above (paragraphs 15-16). The bioadhesive is noted to enhance substantivity of the composition to the teeth (paragraph 15). Gordon teaches humectants (paragraph 13). It is notable that Gordon also teaches xanthan gum and PVP as other bioadhesive agents that are useful (paragraphs 18-20). In paragraph 20, Gordon provides xanthan gum, a carbomer and PVP and mixtures thereof. The bioadhesive agent is allowed in amounts from 0.5 to 30% w/w (paragraph 21). It is also notable that Gordon provides that anhydrous includes small amounts of water less than 5% to still be anhydrous (paragraph 7).
One of ordinary skill in the art before the time of filing would have included such carbomers (crosslinked acrylates) as well as xanthan gum and PVP as taught in Gordon into dentifrice compositions motivated by Evans and Rege as this is recognized to be a bioadhesive component to help the composition adhere to the teeth during use. Therefore, there is a reasonable expectation of success in including this agent of Gordon into a dentifrice composition to get better bioadhesiveness of the composition when using on teeth as in a toothpaste or gel.
Conclusion
No claims are 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 on M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/
Examiner, Art Unit 1613
