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 1-7 and 10-22.
Applicants' arguments, filed 12/16/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 1-7 and 10-22 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2019/0343737, Nov. 14, 2019) (hereinafter Baig).
Baig discloses a unit-dose oral care composition with a fluoride ion source (abstract). Suitable fluoride ion sources include sodium fluoride (¶ [0133]). The oral care composition can comprise from about 0.0025% to about 20% of the fluoride ion source (¶ [0131]). The fluoride ion source can be at an amount suitable to obtain a theoretical fluoride concentration of from about 200 ppm to about 10000 ppm (¶ [0132]). The oral care composition has at least about a 1500 ppm fluoride uptake (claim 8). The oral care composition can comprise a metal ion source. Suitable metal ion sources include stannous ion sources, zinc ion sources, and combinations thereof (¶ [0136]). Suitable tin ion sources include stannous chloride (¶ [0141]). Suitable zinc ion sources include zinc citrate (¶ [0143]). The oral care composition can comprise a calcium ion source. The calcium ion source can comprise a calcium salt (¶ [0147]). The oral care composition can comprise from about 0.01% to about 10% of a calcium ion source (¶ [0149]). The unit-dose oral care composition can be in the form of a tablet composition or an assembly of one or more forms (¶ [0041]). The oral care composition can be a fibrous oral care composition and a nonfibrous composition. The fibrous composition can comprise at least one web (¶ [0052]). The web forming material can comprise a polymer (¶ [0082]). Suitable polymers include polyvinyl alcohol (¶ [0096]). The fibrous composition can comprise from about 0.1% to about 50% polymer (¶ [0102]). The fluoride ion source can be formed within the fibrous composition, added to the surface of the fibrous composition, or included in the nonfibrous composition (¶ [0135]). The oral care composition can comprise a nonfibrous composition which may not be greater in weight percentage than the fibrous composition (¶ [0058]). The fibrous composition may comprise water, SLS, cocamidopropyl betaine, polyvinyl alcohol, sodium saccharin, xylitol and sucrose. The nonfibrous composition may comprise flavor, sodium hexametaphosphate, and sodium fluoride (Ex. 3 and 4 in Table 1). The oral care composition may comprise polyethylene glycol (PEG) (¶ [0164]). The PEG can be included in the nonfibrous composition (¶ [0165]). The composition may comprise one or more surfactants (¶ [0150]). Suitable surfactants include poloxamers (¶ [0158]). The surfactant can be formed within the fibrous composition and included in the nonfibrous composition (¶ [0160]). The oral care composition can comprise a silica abrasive (¶ [0121]). The abrasive can be included in the nonfibrous composition (¶ [0129]).
Baig differs from the instant claims insofar as not disclosing wherein the composition has a salivary fluoride pk AUC that is at least 60% or at least 80% of a reference salivary fluoride pK AUC of a reference standard toothpaste having a reference treatment mass in a range of about 1 g to about 1.25 g when the unit-dose oral care composition is dosed according to manufacturer’s instructions.
However, Baig discloses a unit-dose oral care composition comprising a fibrous composition and a nonfibrous composition. The fibrous composition comprises water, sodium lauryl sulfate, cocamidopropyl betaine, polyvinyl alcohol, sodium saccharin, xylitol and sucralose. The nonfibrous composition comprises flavor, sodium hexametaphosphate, sodium fluoride, PEG and poloxamer. The amount of sodium fluoride may be about 0.0025% to about 20%.
The instant specification states on page 3, lines 2-6 wherein fluoride release and dispersal from an oral care composition can be significantly altered due to (i) presence of excipients, (ii) dose form, (iii) concentration of fluoride, (iv) dose of fluoride, (v) distribution of fluoride within a heterogeneous composition, and (vi) manufacturer’s usage instructions. Tables 1 and 4 of the instant specification states wherein Ex. 1 comprising a fibrous composition comprising water, sodium lauryl sulfate, cocamidopropyl betaine, polyvinyl alcohol, sodium saccharin, xylitol, and sucrose; and a nonfibrous composition comprising flavor, sodium hexametaphosphate, PEG 12, Poloxamer 407, silica, and 0.84% sodium fluoride has a salivary fluoride pK AUC that is 94% of a reference salivary fluoride pK AUC.
Accordingly, since the composition of Baig is a unit-dose composition comprising a fibrous composition and a nonfibrous composition, wherein each of the fibrous and nonfibrous composition comprises substantially the same excipients and amount of sodium fluoride as Ex. 1 of the instant specification, the composition of Baig necessarily has a salivary fluoride pK AUC that is 94% of a reference salivary fluoride pK AUC like Ex. 1. Baig 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 claim 19 reciting wherein the fibrous composition extends beyond a perimeter of the non-fibrous composition, Baig discloses wherein the nonfibrous composition may not be greater than the fibrous composition. Therefore, it would have been obvious to one of ordinary skill in the art that the nonfibrous composition may be included in low amount such that the fibrous composition extends beyond a perimeter of the non-fibrous composition.
Response to Arguments
Applicant argues that it cannot be said that the unit-dose oral care compositions of Baig necessarily exhibit a salivary fluoride pK AUC that is at least 60% of a reference salivary fluoride pK AUC merely because they include fluoride and are compositionally similar to Example 1 of the present application.
The Examiner does not find Applicant’s argument to be persuasive. Examples 1 and 4 having a higher fluoride pK AUC % of reference standard does not appear to be unexpected. Examples 1 and 4 have a higher amount of fluoride compared to examples 2 and 3. Therefore, it would have been expected for examples 1 and 4 to have a higher fluoride pK AUC % of a reference standard than examples 2 and 3. With regards to example 5, example 5 differs from examples 1 and 4 by having fluoride present in the fibrous composition instead of the nonfibrous composition. Therefore, if having fluoride present in the nonfibrous composition contributes to the higher fluoride pK AUC % of reference standard, this is unpersuasive since Baig teaches in Examples 3 and 4 fluoride present in the nonfibrous composition. As such, since Applicant has not shown Examples 1 and 4 to be unexpected, Applicant has not shown wherein the unit-dose oral care compositions of Baig won’t necessarily exhibit a salivary fluoride pK AUC that is at least 60% of a reference salivary fluoride pK AUC. Therefore, Applicant’s argument is unpersuasive.
Moreover, Applicant’s argument is further unpersuasive since the claims do not recite what the reference standard toothpaste comprises. Therefore, essentially any fluoride toothpaste may be used as a reference standard toothpaste. Thus, it would have been obvious to one of ordinary skill in the art that the composition of Baig would have a fluoride pK AUC that is at least 60% of a reference fluoride pK AUC of a reference standard toothpaste depending on whichever fluoride toothpaste one chooses as a reference toothpaste.
Applicant argues that regarding example 5, it was expected that including fluoride in the fibrous composition would deliver fluoride to the mouth more completely and more rapidly. However, this was not the case.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not explained why that would be the case. Also, as discussed above, fluoride in the nonfibrous composition is not unexpected since Baig discloses examples with fluoride in the nonfibrous composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding examples 3 and 4, it was unexpected that the fluoride dose was not linearly proportional to the AUC, as demonstrated by having higher concentrations of fluoride than the USP NaF reference, but a lower fluoride dose than the reference.
The Examiner does not find Applicant’s argument to be persuasive. Examples 3 and 4 show wherein having a higher amount of fluoride leads to a higher fluoride AUC, which is expected. It is not clear how the relationship not being linear is of practical significance. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b)(I). As such, Applicant’s argument is unpersuasive.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,932,996. Although the claims at issue are not identical, they are not patentably distinct from each other. The conflicting claims differ from the pending claims insofar as not reciting a salivary fluoride pK AUC. However, the instant specification states on page 3, lines 2-6 wherein fluoride release and dispersal from an oral care composition can be significantly altered due to (i) presence of excipients, (ii) dose form, (iii) concentration of fluoride, (iv) dose of fluoride, (v) distribution of fluoride within a heterogeneous composition, and (vi) manufacturer’s usage instructions. Therefore, because the conflicting claims recite substantially the same amount of fluoride and dose form as claimed, the conflicting claim composition necessarily has the same salivary fluoride pK AUC claimed.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/130,092 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims limits the composition to a specific form) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that it cannot be said that the claimed property is inherent in a unit-dose oral care composition that includes fluoride.
The Examiner does not find Applicant’s argument to be persuasive and submits that this argument has been addressed above.
Conclusion
Claims 1-7 and 10-22 are rejected.
No claims are allowed.
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.
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/TRACY LIU/Primary Examiner, Art Unit 1614