DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 06/18/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restriction
In the requirement for restriction/election dated 02/03/2025 the Office required election of a single species of R1 (the repeating unit containing an anionic phosphate or phosphate group). In the response filed 04/03/2025 the applicant elected vinyl phosphonic acid as R1 without traverse. Election becomes fixed when the claims in an application have received an action on their merits by the Office. See MPEP 818. As an action on the merits has already been sent, the election is fixed and vinyl phosphonic acid is the elected anionic monomer compound containing phosphorous or phosphate functional groups.
Claim Objections
Claim 22 is objected to because of the following informality:
Claim 22 recites the monomer “MOEP” twice, once as methacryloxyethyl phosphate and once as methacryloxyethyl phosphate acid. It is the examiner’s understanding that these are chemically equivalent compounds, and the duplicate recitation should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 103 (Maintained)
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 22 is rejected under 35 U.S.C. 103 as being as being obvious over Charmot et al. (WO 2005/027862 A1).
Examiner’s Note: As discussed above, an action on the merits has already been sent and vinyl phosphonic acid is fixed as the elected species of the anionic monomer compound containing phosphorous or phosphate functional groups.
Regarding claim 22, Charmot discloses an oral composition comprising a polymer which is delivered to oral surfaces during toothbrushing for the treatment or prevention of oral care related conditions such as caries or tartar [pg. 1, lines 3-12]. The polymer is obtainable by copolymerizing a mixture of comonomers including anionic monomers, where the monomers are selected from N-vinylpyrrolidone, vinyl phosphonic acid, and mixtures thereof [Abstract]. Charmot teaches vinyl phosphonic acid is present in an amount from 40-90 mol% and the remainder is monomers such as N-vinyl pyrrolidone [pg. 6, lines 8-16]. The composition also includes a carrier [pg. 12, line 21]. The composition further comprises fluoride [pg. 11, line 15].
Charmot is not believed to be anticipatory because Charmot could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose vinyl phosphonic acid and N-vinylpyrrolidone [abstract] [pg. 6, lines 8-16], a carrier [pg. 12, line 21], and fluoride [pg. 11, line 15] to formulate the composition.
Nevertheless, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (i.e., N-vinylpyrrolidone, vinyl phosphonic acid, a carrier, fluoride) were known in the prior art (i.e., Charmot) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a method of inhibiting demineralization of a tooth) to one of ordinary skill in the art. MPEP 2143.A.
In regards to the ratio of n-vinyl pyrrolidone to vinyl phosphonic acid, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of the amount of n-vinyl pyrrolidone and vinyl phosphonic acid have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum ratio via routine experimentation.
Further regarding claim 22, while “inhibiting demineralization of a tooth” is not explicitly disclosed by Charmot, Charmot does teach that the composition is delivered to oral surfaces during toothbrushing for the treatment or prevention of oral care related conditions such as caries or tartar [pg. 1, lines 3-12] and would be reasonably be expected to inhibit demineralization of a tooth (a cause of caries). Furthermore, a chemical composition and its properties are inseparable. See MPEP 2112.01 II. Therefore, because the prior art teaches an oral composition with the same components (e.g., N-vinylpyrrolidone, vinyl phosphonic acid, and fluoride – the last species already being known known in the art to prevent demineralization; see instant specification pg. 1, bottom paragraph), the properties the applicant discloses and/or claims would reasonably be expected to be necessarily present.
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant argues that Charmot does not teach or suggest a copolymer derived from polymerization of the anionic monomers recited in the present claims.
The Examiner disagrees. Vinyl phosphonic acid is fixed as the elected species of the anionic monomer compound containing phosphorous or phosphate functional groups and Charmot discloses that the polymer is obtainable by copolymerizing a mixture of comonomers including anionic monomers, where the monomers are selected from N-vinylpyrrolidone, vinyl phosphonic acid, and mixtures thereof [Abstract].
Claims 23-24 are rejected under 35 U.S.C. 103 as being as being obvious over Charmot et al. (WO 2005/027862 A1) and further in view of Deckner et al. (US 8,221,723 B2).
The 35 U.S.C. 103 rejection over Charmot was previously discussed.
Regarding claim 23, Charmot does not disclose the composition includes at least one essential oil, such as menthol.
Deckner discloses an oral care composition [Abstract] with the essential oil, menthol. Deckner teaches that essential oils provide antiseptic activity and act as flavoring agents [Col 22, lines 7-15].
Since Charmot generally teaches an oral care composition, it would have been prima facie obvious to one of ordinary skill in the art to include an essential oil, such as menthol, within the teachings of Charmot, because Deckner teaches essential oils such as menthol in an oral care composition. An ordinarily skilled artisan would be motivated to use an essential oil, such as menthol, because Deckner teaches that essential oils provide antiseptic activity and act as flavoring agents [Col 22, lines 7-15].
Claim 24 is rendered prima facie obvious because Charmot discloses the composition includes fluoride [pg. 11, line 15].
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant argues that Deckner does not cure the deficiencies of Charmot.
The Examiner disagrees because Charmot is not deficient expect where Deckner teaches menthol.
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 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 and 23-30 of U.S. Patent No. 18/114,950 in view of Charmot et al. (WO 2005/027862 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for an anionic monomer compound containing phosphorous or phosphonate functional groups.
Charmot discloses an oral composition comprising a polymer where the polymer is obtainable by copolymerizing a mixture of comonomers including anionic monomers, where the monomers are selected from N-vinylpyrrolidone, vinyl phosphonic acid, and mixtures thereof [Abstract]. Charmot teaches vinyl phosphonic acid is present in an amount from 40-90 mol% and the remainder is monomers such as N-vinyl pyrrolidone [pg. 6, lines 8-16].
It would have been prima facie obvious to one of ordinary skill in the art to include an anionic monomer compound containing phosphorous or phosphonate functional groups, within the copending claims. The ordinarily skilled artisan would have been motivated to formulate the composition, as taught by Charmot [Abstract] [pg. 6, lines 8-16].
The ratio of the monomers, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection.
Response to Double Patenting Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Applicant argues that Charmot does not teach or suggest a copolymer derived from n-vinyl pyrrolidone and an anionic monomer recited in the present claims, therefore, the present claims are not prima facie obvious in view of Charmot.
The Examiner disagrees. Vinyl phosphonic acid is fixed as the elected species of the anionic monomer compound containing phosphorous or phosphate functional groups and Charmot discloses that the polymer is obtainable by copolymerizing a mixture of comonomers including anionic monomers, where the monomers are selected from N-vinylpyrrolidone, vinyl phosphonic acid, and mixtures thereof [Abstract], therefore, the claims remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 18/114,950 in view of Charmot.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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