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 1-18 and 21.
Applicants' arguments, filed 02/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 3 and 6 are 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 3 recites wherein the dicarboxylic acid comprises malonic acid or a salt thereof. Claim 3 fails to further limit the subject matter of claim 1 since claim 1 limits the dicarboxylic acid to methylmalonic acid, dimethylmalonic acid, and dihydroxymalonic acid, which is narrower in scope.
Claim 6 recites wherein the whitening dentifrice comprises greater than 2% to about 10% dicarboxylic acid. Claim 6 fails to further limit the subject matter of claim 1 since claim 1 limits the amount of dicarboxylic acid to about 0.7% to about 5%, which is narrower in scope.
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 1-8, 11-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2002/0061282, May 23, 2002) in view of Putt et al. (US 5,028,412, Jul. 2, 1991) (hereinafter Putt).
Georgiades discloses a composition for oral administration, said composition comprising a whitening agent selected from the group consisting of dicarboxylic acids and salts of dicarboxylic acids (claim 1). Said whitening agent is a member selected from the group consisting of oxalic acid, malonic acid, tartaric acid and salts thereof (claim 2). The composition has a pH of about 4.2 (claim 8). The whitening agent is present in a concentration of less than about 10% (claim 5). Fluoride-releasing compounds are preferably used in the composition. Typical fluoride-releasing compounds include stannous fluoride (¶ [0058]). The composition may comprise 36.1413% water, xanthan gum (i.e., polysaccharide thickener), and silica amorphous, synthetic (Sylodent 750) (i.e., silica abrasive) (Table 1). Polishing materials are generally present in an amount from about 1% to about 99% and include silica (¶ [0037]). The composition may be in the form of a toothpaste (i.e., dentifrice) (¶ [0017]). The composition may comprise zinc salts as anticalculus agents (¶ [0060]).
Georgiades differ from the instant claim insofar as not disclosing wherein the composition comprises methylmalonic acid and/or dimethylmalonic acid.
However, Putt discloses an anti-calculus oral composition (abstract). The composition may comprise stable, complexing carboxylic acids such as dicarboxylic acids (e.g., malonic, methylmalonic, dimethylmalonic, and oxalic) (col. 4, lines 27-30).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Georgiades discloses wherein the composition comprises dicarboxylic acids and salts of dicarboxylic acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated methylmalonic acid and/or dimethylmalonic acid into the composition of Georgiades since these are known and effective dicarboxylic acids for oral compositions as taught by Putt.
In regards to instant claims 1, 4, 11 and 18 reciting wherein the composition is free of polyphosphate, peroxide, chlorohexidine, bicarbonate, potassium, and/or abrasive, claim 1 of Georgiades does not recite wherein the composition comprises these components. Thus, a composition free of these ingredients would have been obvious.
In regards to instant claims 1 and 2 reciting wherein the composition has a ChemPC ΔL of at least about 7 or 10, respectively, as noted on page 35, lines 7-9 of the instant specification, Ex. 1-7 had ChemPC ΔL values of about 7 and higher. The specification discloses that the results indicate a significant stain removal potential directly attributed to the dicarboxylate anion. Accordingly, since a ChemPC ΔL value of about 7 and higher is attributed to a dicarboxylate anion and the composition of Georgiades comprises a dicarboxylate anion by comprising at least one dicarboxylic acid, the composition of Georgiades necessarily has a ChemPC ΔL value of about 7 and higher. Also, Ex. 1 of Table 2 of the instant specification discloses wherein methylmalonate has a ΔL value of 11.18 and the composition of the prior art comprises methylmalonic acid. Thus, one of ordinary skill in the art would reasonably expect the composition of the prior art to have a ChemPC ΔL value of about 7 and higher.
In regards to instant claim 21 reciting wherein the dicarboxylic acid is present in an amount effective to inhibit a bacterial virulence factor, since Georgiades discloses an amount of dicarboxylic acid that overlaps with the entire claimed ranged, the dicarboxylic acid of the prior art is necessarily present in an amount effective to inhibit a bacterial virulence factor.
2. Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2002/0061282, May 23, 2002) in view of Putt et al. (US 5,028,412, Jul. 2, 1991) (hereinafter Putt), and further in view of Kawanobe et al. (WO 2019/017332 A1, Jun. 6, 2019) (hereinafter Kawanobe).
The teachings of Georgiades and Putt are discussed above. Georgiades and Putt do not teach wherein the composition comprises zinc citrate or potassium nitrate.
However, Kawanobe discloses an oral composition comprising an oral stain removing agent (abstract). Optional active ingredients for the composition include hypersensitivity improving agents such as potassium nitrate and zinc compounds such as zinc citrate (page 9 of translation, third paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Georgiades discloses wherein the composition comprises zinc salts. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated zinc citrate into the composition of Georgiades since it is a known and effective zinc salt for oral care compositions as taught by Kawanobe.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated potassium nitrate into the composition of Georgiades motivated by the desire to have the composition improve hypersensitivity as taught by Kawanobe.
Response to Arguments
Applicant argues that the present application discloses that certain dicarboxylic acid compounds are particularly suitable as these compounds have been shown to have an unexpectedly high whitening benefit and substantially more than the conventional whitening agent pyrophosphate. Unexpectedly, the inventive composition has significantly fewer instances of adverse events compared to conventional whitening toothpastes.
The Examiner does not find Applicant’s argument to be persuasive. The claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). In the instant case, the closest prior art is not pyrophosphate since it is not a dicarboxylic acid. Table 2 of the instant specification compares the claimed dicarboxylic acid with other known dicarboxylic acid. Table 2 shows wherein methylmalonate has a ΔL of 11.18, dimethylmalonate has a ΔL of 6.92, and malonate has a ΔL of 23.97. Thus, since malonate has a higher ΔL than methylmalonate and dimethylmalonate, which indicates more whitening, Applicant has not shown wherein methylmalonate and dimethylmalonate are unexpected. It should also be noted that Georgiades teaches malonic acid. Furthermore, Applicant has only shown wherein Ex. 14 comprising malonic acid has fewer instances of adverse events. Applicant has not shown wherein the claimed dicarboxylic acids have fewer instances of adverse events. As such, Applicant has not shown wherein the claimed invention is unexpected; therefore, 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 1-18 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 17/971,728, 18/317,971, 17/308,080, 17/308,083, 17/308,085, and 17/308,078 (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 recite additional required ingredients) and thus read on the instant claims. In regards to the instant claims reciting a ChemPC ΔL of at least about 7, the instant specification discloses on page 5, lines 3-7 wherein a composition comprising a dicarboxylic acid and free of polyphosphate has a ChemPC ΔL of at least about 7. Therefore, since the copending claimed compositions comprises dicarboxylic acid and is free of polyphosphate, one of ordinary skill in the art would reasonably expect the copending claimed composition to have a ChemPC ΔL value substantially the same as the pending claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-18 and 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