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 40-44, 46-53, 55-58, 61 and 62.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/12/2026 has been entered.
Applicants' arguments, filed 06/12/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112
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 46 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 46 fails to further limit claim 40 since the recitation of wherein the oral care composition is free of sodium lauryl sulfate and sodium lauryl ether sulfate is already recited in claim 40.
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.
Claims 40-44, 46-53, 55-58, 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2021/0093551, Apr. 1, 2021) (hereinafter Baig) in view of Hayes et al. (US 4,456,585, Jun. 26, 1984) (hereinafter Hayes), as evidenced by Canham et al. (US 2011/0236493, Sep. 29, 2011) (hereinafter Canham).
Baig discloses an oral care composition comprising hops (abstract). The oral care composition can comprise one or more surfactants (i.e., a surfactant system). Suitable surfactants are safe and effective amounts of anionic, cationic, nonionic, zwitterionic, amphoteric, and betaine surfactants (¶ [0092]). Suitable anionic surfactants include sodium methyl acyl taurate (i.e., a non-sulfate based anionic surfactant) (i.e., an acyl taurate) (¶ [0096]). Suitable betaine surfactants include cocamidopropyl betaine (i.e., an amphoteric surfactant) (¶ [0097]). The one or more surfactants can also include sodium cocoyl glutamate (i.e., an amino acid surfactant) (i.e., glutamate surfactant) and lauryl glucoside (i.e., nonionic surfactant) (i.e., glucoside surfactant) (¶ [0100]). The oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15% (¶ [0102]). The oral care composition can comprise tin, such as from a tin ion source. Suitable tin ion sources include stannous fluoride (¶ [0054]). The oral care composition can comprise from about 0.0025% to about 5% of a tin ion source (¶ [0055]). The oral care composition can comprise calcium, such as from a calcium ion source (¶ [0056]). The calcium ion source can comprise a calcium salt, such as calcium nitrate (i.e., a nitrate ion source) (¶ [0058]). The oral care composition can comprise from about 1% to about 50% of a calcium ion source (¶ [0059]). The oral care composition can comprise a calcium abrasive and/or a non-calcium abrasive, such as insoluble sodium metaphosphate (i.e., a phosphate source) (¶ [0076]). The oral care composition can comprise one or more thickening agents (¶ [0103]). The oral care composition can comprise one or more biofilm modifiers. A biofilm modifier can comprise a polyol (¶ [0063]).
Baig differs from the instant claims insofar as not disclosing wherein the oral care composition is transparent or translucent.
However, Hayes discloses a visually clear pigmented dentifrice (abstract). Visually clear dentifrices have been marketed in recent years in view of their desirable aesthetic aspect combined with their ability to provide desired hygienic and prophylactic effects to teeth and the oral cavity. In visually clear dentifrices, it is necessary to select insoluble solid components with care since a close match between the refractive index of a solid component and the refractive index of the liquid vehicle is needed in order to provide clarity (col. 1, lines 7-15). The dentifrice is visually clear in appearance to the extent of being transparent or translucent (claim 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the oral care composition of Baig to be transparent or translucent since visually clear dentifrices are desirable in the art as taught by Hayes. One of ordinary skill in the art would have had a reasonable expectation of success since Hayes discloses wherein matching the refractive index of a solid component to the refractive index of a liquid vehicle provides clarity.
In regards to instant claims 40, 57, 61 and 62 reciting a weight ratio of the total amount of the taurate surfactant to the total amount of the betaine surfactant is from about 1:5 to about 5:1 or about 1:1 to about 5:1, Baig discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, the claimed weight ratio would have been obvious when one selects an amount of anionic surfactant and an amount of amphoteric surfactant within this range and obtaining a weight ratio 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 claims 40, 59, 61 and 62 reciting a weight ratio of the total amount of the glutamate surfactant to the total amount of the glucoside surfactant is from about 1:5 to about 5:1 or about 1:4 to about 4:1, Baig discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, the claimed weight ratio would have been obvious when one selects an amount of amino acid surfactant and an amount of nonionic surfactant within this range and obtaining a weight ratio 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 claims 40, 46 and 62 reciting wherein the oral care composition is free of sodium lauryl sulfate and sodium lauryl ether sulfate, this limitation would have been obvious since Baig does not require either of these compounds as surfactants and discloses wherein the anionic surfactant may be sodium methyl acyl taurate.
In regards to instant claims 47 and 55, since the oral care composition comprises one or more surfactants and suitable surfactants include sodium methyl acyl taurate (i.e., a non-sulfate based anionic surfactant), cocamidopropyl betaine (i.e., an amphoteric surfactant), lauryl glucoside (i.e., a nonionic surfactamnt), and sodium cocoyl glutamate (i.e., an amino acid surfactant), it would have been obvious to one of ordinary skill in the art to have the composition comprise only these four surfactants.
In regards to instant claim 50, Baig discloses about 0.0025% to about 5% of a tin ion source, such as stannous fluoride, and about 1% to about 50% of a calcium ion source, such as calcium nitrate. Accordingly, the claimed molar ratio would have been obvious when one derives an amount of stannous ions and nitrate ions from these ranges of stannous fluoride and calcium nitrate, converts the amounts to molar amounts, and arrive at a molar ratio 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 61 reciting the transitional phrase “consisting of,” the composition of Baig only requires hops (see abstract, ¶ [0001], and examples). As evidenced by Canham in paragraph [0076], hops is a flavoring agent. Instant claim 61 recites wherein the composition optionally consists of flavoring agents. As such, the hops of Baig does not teach away from instant claim 61.
Response to Arguments
Applicant argues that the applied art simply does not render it obvious to exclude sodium lauryl sulfate and sodium lauryl ether sulfate, and prepare and oral care composition having a surfactant system comprising four or more surfactants including at least one taurate surfactant, at least one betaine surfactant, at least one glucoside surfactant, and at least one glutamate surfactant – much less in the specifically claimed weight ratio of the total amount of the taurate surfactant to the total amount of the betaine surfactant of from about 1:5 to about 5:1 and the claimed weight ratio of the total amount of the glutamate surfactant to the total amount of the glucoside surfactant of from about 1:5 to about 5:1.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Baig discloses an oral care composition comprising one or more surfactants. Thus, an oral care composition with four or more surfactants would have been obvious to one of ordinary skill in the art. Baig also discloses wherein suitable surfactants include sodium methyl acryl taurate, cocamidopropyl betaine, sodium cocoyl glutamatem and lauryl glucoside. Thus, an oral care composition comprising least one taurate surfactant, at least one betaine surfactant, at least one glucoside surfactant, and at least one glutamate surfactant would have been obvious to one of ordinary skill in the art. Baig further discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, the claimed weight ratios would have been obvious when one selects an amount of each surfactant within this range and obtains a weight ratio that overlaps with the claimed range. Baig does not disclose wherein the anionic surfactant is required to be sodium lauryl sulfate or sodium lauryl ether sulfate. Thus, a composition free of sodium lauryl sulfate or sodium lauryl ether sulfate would have been obvious. Applicant has not shown wherein the claimed combination of surfactants or the claimed weight ratios or the exclusion of sodium lauryl sulfate or sodium lauryl ether sulfate are critical or unexpected. As such, Applicant’s argument is unpersuasive and the rejection is maintained.
Applicant argues that the instantly claimed oral care composition is not obvious to try and the rejection improperly applies excerpts from Merck & Co., Inc. b Biocraft Labs.
The Examiner does not find Applicant’s argument to be persuasive. In the Merck & Co., Inc. b Biocraft Labs decision, it was stated that “the '813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art. See In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985) (obviousness rejection of claims affirmed in light of prior art teaching that "hydrated zeolites will work" in detergent formulations, even though "the inventors selected the zeolites of the claims from among 'thousands' of compounds"); In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425, 58 CCPA 1074 (1971) (obviousness rejection affirmed where the disclosure of the prior art was "huge, but it undeniably include [d] at least some of the compounds recited in appellant's generic claims and it is of a class of chemicals to be used for the same purpose as appellant's additives").” Thus, the court has found in numerous cases that a multitude of effective combinations does not render any particular formulation less obvious. Thus, selecting from the various surfactants disclosed by Baig would have been obvious.
Additionally, the court decision does not state wherein obvious to try was not applicable because the prior art provided express teaching that instructed the skilled artisan to select from specific diuretic agents. In the court decision, Merck imputes undue significance to the district court's finding that neither amiloride nor hydrochlorothiazide are highlighted in the '813 patent. However, the court stated that “in a section 103 inquiry, "the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered." In re Lamberti, 545 F.2d 747, 750, 192 USPQ 278, 280 (CCPA 1976).” As such, obvious to try is still applicable when the prior art instructs the skilled artisan to select from specific diuretic agents. Additionally, Applicant has not shown where in Baig does Baig instruct the skilled artisan to select from specific surfactants. Although the claims recite specific surfactants. One of ordinary skill in the art is not selecting from the claimed surfactants, since the claims are not prior art. 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 40-44, 46-53, 55-58, 61 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-21 of copending Application No. 18/515,651 in view of Baig et al. (US 2021/0093551, Apr. 1, 2021) (hereinafter Baig).
The pendings claims differ from the copending claims insofar as reciting a non-sulfate based anionic surfactant, a nitrate ion source, and a phosphate source. However, Baig discloses an oral care composition (abstract) comprising one or more surfactants such as anionic, cationic, nonionic, zwitterionic, amphoteric, and betaine surfactants (¶ [0092]). Suitable anionic surfactants include sodium methyl acryl taurate (¶ [0096]). The composition can comprise calcium nitrate to deliver calcium ions to the oral cavity (¶ [0058]). The composition can comprise insoluble sodium metaphosphate as an abrasive (¶ [0076]). Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated a non-sulfate based anionic surfactant since oral care composition may comprise more than one surfactant and this is a known surfactant as taught by Baig. It would have been obvious to one of ordinary skill in the art to have incorporated calcium nitrate motivated by the desire to provide calcium ions into the oral cavity and it would have been obvious to one of ordinary skill in the art to have incorporated insoluble sodium metaphosphate motivated by the desired to provide an abrasive to the composition.
This is a provisional nonstatutory double patenting rejection.
Claims 40-44, 46-53, 55-58, 61 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-15 and 18-24 of copending Application No. 18/513,925 (reference application) and claims 37-56 of copending Application No. 18/436,344 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because although the copending claims do not recite the exact combination of a non-sulfate based anionic surfactant, an amphoteric surfactant, a nonionic surfactant, and an amino acid surfactant, the copening claims recite wherein the composition comprises one or more surfactants and these surfactants would have been obvious from the copending dependent claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The rejections are maintained since Applicant has not addressed them.
Conclusion
Claims 40-44, 46-53, 55-58, 61 and 62 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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