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 . Claims included in the prosecution are claims 1 and 6-21.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Applicants' arguments, filed 05/12/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
1. Claims 1, 6-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Arora et al. (WO 2021/071867 A1, Apr. 15, 2021) (hereinafter Arora).
Arora discloses an oral care composition comprising a cannabinoid source, a thickening system, wherein the thickening system comprises xanthan gum and carrageenan, and an orally acceptable carrier (abstract). The thickener system is present in an amount of 0.05 to 5% (page 5, 1.15). The composition further comprises an abrasive (page 5, 1.21). The abrasive may be silica (page 5, 1.22). The silica may be present from 1% - 25% (page 5, 1.24). The composition may also comprise silica as a thickening agent (page 6, 1.29). The composition further comprises a zinc ion source (page 6, 1.30). The zinc ion source comprises a zinc salt, such as zinc phosphate (page 6, 1.31). The composition may comprise a stannous ion source (page 6, 1.32). Suitable stannous ion sources include stannous fluoride (page 6, 1.33). The composition may further comprise a fluoride ion source (page 7, 1.42). The fluoride ion source may be stannous fluoride or sodium fluoride (page 7, 1.43). The composition may comprise a surfactant system comprising an acyl glutamate. The acyl glutamate may be present in an amount of from 0.1% - 5%. Suitable acyl glutamates include sodium cocoyl glutamate (¶ [0038]). The composition may comprise amphoteric surfactants, such as cocamidopropylbetaine (¶ [0037]). The surfactant system may comprise an alkyl glucoside (¶ [0038]). Mixtures of compatible surfactants can be present in the composition in 0.1% to 5% (¶ [0040]). The composition may comprise a humectant (page 8, 1.51). Suitable humectants include polyols (page 8, 1.52). The humectant includes 15% to 70% by weight of the composition (¶ [0057]).
The prior art discloses an oral care composition (abstract) comprising a surfactant system comprising sodium cocoyl glutamate (i.e., amino acid derived surfactant) (¶ [0038]), cocamidopropylbetaine (i.e., amphoteric surfactant) (¶ [0037]), alkyl glucoside (¶ [0038]), a zinc salt (page 6, 1.31), and a stannous ion source (page 6, 1.33). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art 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 yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claims 1 and 21 reciting wherein the composition is free of sodium lauryl sulfate, Arora discloses Formulations B, C and D wherein sodium lauryl sulfate is not present. Therefore, it would have been obvious to one of ordinary skill in the art that the composition of Arora may be free of sodium lauryl sulfate.
In regards to the amount of amphoteric surfactant recited in instant claim 8, Arora discloses that mixtures of compatible surfactants can be present in the composition in 0.1% to 5%. Accordingly, one of ordinary skill in the art would have arrived at the claimed range from this range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claim 9, after obtaining an amount of cocamidopropylbetaine and knowing that acyl glutamate may be present in an amount of from 0.1% - 5%, one of ordinary skill in the art would have arrived at a ratio between the two components that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
2. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arora et al. (WO 2021/071867 A1, Apr. 15, 2021) (hereinafter Arora) in view of Bhadra et al. (US 2019/0183748, Jun. 20, 2019) (hereinafter Bhadra).
The teachings of Arora are discussed above. Arora does not teach wherein the silica abrasive has a N2 BET surface area of less than 50 m2/g, an Einlehner hardness of from 4 to 11, and an oil absorption of from 80 cc/100 g to 100 cc/100 g.
However, Bhadra discloses a dentifrice composition comprising stannous fluoride and a silica abrasive having a N2 BET surface area of less than 50 m2/g and an Einlehner hardness of from 4 to 11 (abstract). The silica abrasive has an oil absorption of from 60 cc/100 g to 120 cc/100 g (¶ [0013]). It has been found that silica abrasives having a N2 BET surface area of less than 50 m² / g exhibit high stannous and fluoride ions compatibility (¶ [0005]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the silica abrasive of Bhadra into the composition of Arora since the composition of Arora comprises silica abrasives, a stannous ion source, and a fluoride ion source and the silica abrasive of Bhadra is a known and effective silica abrasive for oral compositions that is highly compatible with stannous and fluoride ions as taught by Bhadra.
Response to Arguments
Applicant argues that Arora does not teach or suggest the presently claimed three-surfactant system.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Arora teaches wherein the composition comprises a surfactant system and wherein sodium cocoyl glutamate, cocamidopropylbetaine (i.e., amphoteric surfactant), and alkyl glucoside (i.e., nonionic surfactant) are suitable surfactants. Since Arora discloses the use of various surfactants individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by Arora to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. As such, Applicant’s argument is unpersuasive.
Applicant argues that the presently claims surfactant architecture provides unexpectedly beneficial performance.
The Examiner does not find Applicant’s argument to be persuasive.
With regards to tin uptake, Table 4 of the specification shows Compositions B and C having an uptake on hard tissue of 1.48 ± 0.07 and 1.62 ± 0.05, respectively, while Comparative Composition 1 has an uptake on hard tissue of 1.20 ± 0.10. Table 5 of the specification discloses Compositions B and C having an uptake on soft tissue of 2.44 ± 0.10 and 2.39 ± 0.14, respectively, while Comparative Composition 1 has an uptake on soft tissue of 2.10 ± 0.12. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See MPEP 716.02. Applicant has not shown wherein the difference in tin uptake on hard and soft tissue between Compositions B and C and Comparative Composition 1 is of statistical and practical significance to make a composition containing sodium cocoyl glutamate, an amphoteric surfactant, and alkyl glucoside, that is free of sodium lauryl sulfate, unexpected. For example, it is unclear whether such difference in tin uptake would result in a noticeable visual change to the teeth of a subject or whether such difference would result in a noticeable therapeutic change to a subject. As such, Applicant’s argument is unpersuasive.
With regards to Composition B exhibiting improved antibacterial performance relative to Comparative Composition 1, the showing in Example 5 does not appear to be unexpected. Composition B and Comparative Composition 1 differ in that Composition B additionally comprises sodium cocoyl glutamate and alkyl polyglucoside. As evidenced by Ataman Chemicals, alkyl polyglucoside has widespread antibacterial activity. As evidenced by Maha, sodium cocoyl glutamate is anti-microbial. As such, since Composition B comprises more antibacterial agents compared to Comparative Composition 1, one of ordinary skill in the art would reasonably expect Composition B to have improved antibacterial performance relative to Comparative Composition 1. As such, Applicant’s argument is unpersuasive.
Applicant argues that Bhadra does not cure the deficiencies of Arora.
The Examiner submits that arguments regarding Arora have been addressed above and are unpersuasive. Therefore, the rejection with Bhadra is maintained.
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 and 6-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40-60 of copending Application No. 18/516,422, claims 1-3, 5-7, 9-15, 18-24 of copending Application No. 18/513,925, and claims 37-56 of copending Application No. 18/436,344 in view of Arora et al. (WO 2021/071867 A1, Apr. 15, 2021) (hereinafter Arora).
The pending claims differ from the copending claims insofar as further comprising a zinc salt. However, Arora discloses wherein zinc salts as antibacterial agents (page 9, 1.60). Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated zinc salts into the pending claims to formulate a composition with antibacterial properties as taught by Arora.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1 and 6-21 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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