DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed June 04, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 amine group). In the response filed 04/03/2025 the applicant elected n-vinyl formamide 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 n-vinyl formamide is the elected repeat unit derived from monomers containing amines.
Claim Objections
Claims 25 and 28 are objected to because of the following informalities:
In claim 25 the % of the cationic copolymer should be defied (e.g., as a wt.%).
In claim 28 a comma should be written after “pH modifying agents”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph (New, Necessitated by Amendment)
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.
Claim 29 is 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 29 recites the limitation “the mouthwash composition" in line 2. There is insufficient antecedent basis for the limitation “the mouthwash” in the claim. To overcome this rejection, the limitation can be changed to “the composition”.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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.
Claims 21 and 23-30 are rejected under 35 U.S.C. 103 as being as being obvious over Musa et al. (US 2011/0293540 A1).
Examiner’s Note: As discussed above, an action on the merits has already been sent and n-vinyl formamide is fixed as the elected species of the repeat unit derived from monomers containing amines.
Regarding claim 21, Musa discloses the use of compositions with cationic copolymers that include N-vinyl pyrrolidone and N-vinyl formamide [0031] [0046]-[0047] [0159]-[0176], and repeating units thereof [0036], for oral care, such as to reduce and/or prevent the adherence of oral bacteria to the tooth enamel [0029] [0088]-[0089]. Musa discloses the compositions are contacted with a tooth surface [0041] [0138]-[0139]. The compositions also include an orally acceptable carrier [0103] [0107] and fluoride [0126] [0140]. Musa further discloses the composition includes mixtures of essential oils such as thymol and eucalyptol [0130].
Musa is not believed to be anticipatory because Musa 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 N-vinyl pyrrolidone and N-vinyl formamide [0031] [0046]-[0047] [0159]-[0176] and include a mixture of essential oils such as thymol and eucalyptol [0130].
Nevertheless, claim 21 is rendered prima facie obvious over the teachings of Musa, because 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 (e.g., N-vinyl pyrrolidone and N-vinyl formamide and a mixture of essential oils such as thymol and eucalyptol) were known in the prior art (e.g., Musa) 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 composition to be contacted with a tooth surface) to one of ordinary skill in the art. MPEP 2143.A.
Further regarding claim 21, while “inhibiting demineralization of a tooth” is not explicitly disclosed by Musa, Musa does disclose that the compositions are used to reduce and/or prevent the adherence of oral bacteria to the tooth enamel [0029] [0088]-[0089]. The compositions would therefore be expected to inhibit demineralization of a tooth because bacteria are known to cause tooth demineralization.
Furthermore, a chemical composition and its properties are inseparable. See MPEP 2112.01 II. Therefore, because the prior art discloses oral compositions with the same components (e.g., cationic N-vinyl pyrrolidone copolymers and fluoride; the latter of which is already known in the art to prevent demineralization – see the instant specification pg. 1, bottom paragraph), the properties the applicant discloses and/or claims would reasonably be expected to be necessarily present.
Claim 23 is rendered prima facie obvious because Musa discloses the composition includes fluoride [0126] [0140]. Fluoride is disclosed as a “metal precipitating chelating agent” which are incorporated in the oral care compositions in an amount within the range of 0.1% to about 8.0% by weight [0140]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 24 is rendered prima facie obvious because Musa discloses the composition is a mouthwash [0041] [0088].
Claim 25 is rendered prima facie obvious because Musa discloses the polymers are included in compositions in an amount up to 10 wt.%, such as 3 wt.% or 5 wt.% [0348]-[0350] [claim 18]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 26 is rendered prima facie obvious because Musa discloses the composition further includes a surfactant, such as sodium lauryl sulfate [0123]-[0124].
Claim 27 is rendered prima facie obvious because Musa discloses the compositions with the polymers have pH values such as 6.55, 6.74, and 6.82 [0369]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 28 is rendered prima facie obvious because Musa discloses the composition includes benzoic acid [0103].
Claim 29 is rendered prima facie obvious because Musa discloses the essential oils are flavors which are present in the composition in an amount of about 0.001% to about 5% by weight of the composition [0130]. While Musa discloses the w/w of flavors and the instant claim recites w/v, 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 condition of the amount of essential oils has been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of essential oils (in terms of w/v) via routine experimentation to achieve the desired flavor profile.
Claim 30 is rendered prima facie obvious because Musa discloses the composition further includes tripolyphosphate [0140]. While Musa discloses tripolyphosphate and the instant claim 30 recites “sodium tripolyphosphate”, there is an obviousness of species when the prior art teaches genus. See MPEP 2144.08.
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive.
Applicants argue that Musa does not teach or suggest the limitations as required by claim 21 as amended. In particular, the applicant argues that Musa is silent to repeat units derived from n-vinyl pyrroline and a claimed monomer containing amines and at least two essential oils selected from those claimed.
The Examiner disagrees. Musa discloses the use of compositions with cationic copolymers that include N-vinyl pyrrolidone and N-vinyl formamide (the elected monomer containing amines) [0031] [0046]-[0047] [0159]-[0176], and repeating units thereof [0036]. Musa further discloses the composition includes mixtures of essential oils such as thymol and eucalyptol [0130].
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 21 and 23-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent Application No. 18/114,937 in view of Musa et al. (US 2011/0293540 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 except for a cationic copolymer having repeat units derived from monomers containing amines, a surfactant such as sodium lauryl sulfate, a pH below 11, benzoic acid, and sodium tripolyphosphate.
Musa disclose the use of compositions with cationic copolymers that include N-vinyl formamide [0031] [0046]-[0047] [0159]-[0176] for oral care [0088]. Musa discloses the composition further includes a surfactant, such as sodium lauryl sulfate [0123]-[0124] and the compositions have pH values such as 6.55, 6.74, and 6.82 [0369]. The compositions further include benzoic acid [0103] and tripolyphosphate [0140].
It would have been prima facie obvious to one of ordinary skill in the art to include N-vinyl formamide, a surfactant such as sodium lauryl sulfate, a pH below 11, benzoic acid, and sodium tripolyphosphate within the copending claims. The ordinarily skilled artisan would have been motivated to formulate the composition, as taught by Musa [0031] [0046]-[0047] [0159]-[0176] [0123]-[0124] [0369] [0103] [0140].
The weight percentages of each component, 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 Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive.
Applicant argues that U.S. Patent Appl. No 18/114,937 has been abandoned and therefore the rejection should be rescinded.
The Examiner disagrees because U.S. Patent Appl. No 18/114,937 has not been abandoned.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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