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, 4 and 6-21.
Applicants' arguments, filed 02/23/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112(b)
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, 4 and 6-21 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.
The term “substantially free” in claims 1 and 21 is a relative term which renders the claim indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification discloses in paragraph [0045] wherein the composition may have sulfate based anionic surfactants in an amount of about 5 wt. % or less, this is not a definition for “substantially free” and it is unclear if a substantially free amount is within this range, smaller than this range, or greater than this range.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites wherein the acyl glutamic acid derived surfactant has an aliphatic carbon chain of 4 to 19 carbons. Claim 4 fails to further limit the subject matter of claim 1 since claim 1 limits the acyl glutamic acid derived surfactant to sodium cocoyl glutamate which has a set number of carbons in its aliphatic carbon chain. Claim 4 does not specify wherein the acyl glutamic acid derived surfactant is different from sodium cocoyl glutamate.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 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]). 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]), 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 substantially 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% and acyl glutamate may be present in an amount of from 0.1% - 5%. Accordingly, if the composition were to comprise acyl glutamate and cocamidopropylbetaine (i.e., amphoteric surfactant) as the only surfactants, one of ordinary skill in the art would have obtained an amount of cocamidopropylbetaine from these ranges that overlaps with the claimed 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 consistently teaches sodium lauryl sulfate as a preferred anionic surfactant.
The Examiner does not find Applicant’s argument to be persuasive. Arora discloses in Formulations, B, C and D wherein sodium lauryl sulfate is not present. As such, the composition of Arora may be free of sodium lauryl sulfate and Applicant’s argument is unpersuasive.
Applicant argues that the specification demonstrates unexpected results for compositions containing sodium cocoyl glutamate that are free of sodium lauryl sulfate.
The Examiner does not find Applicant’s argument to be persuasive. Compositions containing sodium cocoyl glutamate that are free of sodium lauryl sulfate are known. Arora discloses in Formulations B, C, and D compositions containing sodium cocoyl glutamate that are free of sodium lauryl sulfate. Thus, compositions containing sodium cocoyl glutamate that are free of sodium lauryl sulfate is not unexpected.
With regards to a higher soluble tin of Compositions A-C over Comparative Composition 1, Table 2 of the specification discloses Compositions A-C having a soluble tin % of 0.24 or 0.23 at 13 weeks, while Comparative Composition 1 has a soluble tin % of 0.21 at 13 weeks. 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 a difference of 0.02 or 0.03 is of statistical and practical significance to make a composition containing sodium cocoyl glutamate that is free of sodium lauryl sulfate unexpected.
With regards to foam volume, Table 3 of the specification discloses Compositions A-C having a foam height at 120 sec of 347 ml, 355 ml, and 368 ml, respectively, while Comparative Example 1 has a foam height at 120 sec of 342 ml. Applicant has not shown wherein 347 ml, 355 ml, and 368 ml compared to 342 ml is of statistical and practical significance to make a composition containing sodium cocoyl glutamate that is free of sodium lauryl sulfate unexpected.
With regards to tin uptake, Table 4 of the specification discloses Compositions A-C having an uptake on hard tissue of 1.33 ± 0.12, 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 A-C having an uptake on soft tissue of 2.36 ± 0.10, 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. Applicant has not shown wherein the difference in tin uptake on hard and soft tissue between Compositions A-C and Comparative Composition 1 is of statistical and practical significance to make a composition containing sodium cocoyl glutamate that is free of sodium lauryl sulfate unexpected. It should also be noted that when accounting for standard deviation, the tin uptake of Comparative Composition 1 and Composition A overlap. Thus, showing wherein it does not appear that the claimed composition is unexpected.
Applicant argues that Bhadra does not cure he 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, 4 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, 4 and 6-21 are rejected.
No claims are allowed.
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.
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/TRACY LIU/ Primary Examiner, Art Unit 1614