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, 3-18, 21 and 22.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/05/2026 has been entered.
Applicants' arguments, filed 06/05/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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(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, 3-18, 21 and 22 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.
Claim 1 recites the limitation "according to the Chemistry-Only Pellicle Cleaning method" in the penultimate line. There is insufficient antecedent basis for this limitation in the claim. It is not clear what the Chemistry-Only Pellicle Cleaning method is since the claim does not describe it and it does not appear to be a known method in the art. Although the specification discloses on page 35 wherein ChemPC is calculated by comparing the before and after images of a treated stained-bovine chip and determining the change in the *L value in the CIELAB color space, it is unclear whether the Chemistry-Only Pellicle Cleaning method recited is in reference to or is limited to this method or to another method. As such, the scope of the Chemistry-Only Pellicle Cleaning method is unclear.
Claim 3 recites wherein the composition further comprises malonic acid. The claim is indefinite since malonic acid is a dicarboxylic acid and claim 1 limits the dicarboxylic acid to only succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, and tartronic acid. Thus, the scope of what dicarboxylic acids may be incorporated into the composition is unclear.
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, 3-8, 11-18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2002/0061282, May 23, 2002) in view of JP 2004510801 A (Apr. 8, 2004).
Georgiades discloses a tooth-whitening composition including at least one dicarboxylic acid, such as malonic acid, as a whitening agent (abstract). 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]). The pH of the composition is preferably buffered. Suitable buffers include citric acid-sodium citrate in an amount up to about 1% (¶ [0041]).
Georgiades differ from the instant claim insofar as not disclosing wherein the composition comprises succinic acid.
However, JP 2004510801 A discloses a teeth whitening composition containing at least one dicarboxylic acid such as succinic acid and malonic acid as whitening agents (abstract).
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 at least one dicarboxylic acid. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated succinic acid into the composition of Georgiades since it is a known and effective dicarboxylic acid compatible with malonic acid for oral compositions as taught by JP 2004510801 A.
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 claim 1 reciting wherein the composition has a ChemPC ΔL of at least about 16, the composition of the prior art comprises substantially the same dicarboxylic acid and amount thereof as claimed; therefore, the composition of the prior art would necessarily have substantially the same ChemPC ΔL value as the claimed composition.
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 JP 2004510801 A (Apr. 8, 2004), and further in view of Kawanobe et al. (WO 2019/017332 A1, Jun. 6, 2019) (hereinafter Kawanobe).
The teachings of Georgiades and JP 2004510801 A are discussed above. Georgiades and JP 2004510801 A 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 in the Declaration, Mr. Groth indicates that he recreated the toothpaste formulation in Table 1 of Georgiades and tested it according to the ChemPC method. The result was an average ΔL of 12.3. Thus, Georgiades does not teach or suggest a toothpaste with a ΔL value of at least 16.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided the Declaration. Therefore, the Examiner cannot evaluate the Declaration to determine whether Applicant’s argument is persuasive. Also, a prior art reference is evaluated for all that it suggests and is not limited to working examples. Table 1 of Georgiades uses oxalic acid as the dicarboxlic acid. Even if oxalic acid does not produce a composition with a ΔL of least 16 that does not mean the other embodiments of Georgiades won’t. 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, 3-18, 21 and 22 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 16, 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, 3-18, 21 and 22 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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