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
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claim 2 is 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 2 recites that the composition is substantially free of water. However, it does not appear that “substantially” is defined by the instant specification. The instant specification states “Additionally or alternatively, the oral care compositions typically have less than about 5 wt.% of water. In some embodiments, the amount of water present in the oral care composition is less than about 4 wt.%, less than about 3 wt.%, less than about 2 wt.%, less than about 1 wt.%, less than about 0.5 wt.%, less than about 0.1 wt.%, based on the total weight of the oral care composition. In some instances, the oral care composition is substantially free of or free of added water. In further instances, the oral care composition is substantially free of or free of water.” However, it is not clear if the lower amounts are the parameters for or the scope of “substantially” free of water or if “substantially” free includes slightly higher amounts. Therefore the claim is indefinite.
Claim Rejections - 35 USC § 102 - Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10, 12, 15-16, 19-23 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fei et al. (US 2019/0175466).
Fei et al. disclose an oral care composition with increased stability. The oral care composition may include an orally acceptable vehicle, a thickening system, and a whitening agent. The orally acceptable vehicle may include propylene glycol, and the thickening system may include a polymeric thickener (Abstract). The polymeric thickener may be or include ammonium acryloyldimethyltaurate/VP copolymer (paragraph 0033). The whitening agent includes hydrogen peroxide and/or hydrogen peroxide releasing substances. This indicates that the whitening agents may be used in combinations. The amount of hydrogen peroxide source may be from about 1% or range from 1% to 30% (paragraph 0032). Fluoride sources include sodium fluoride and stannous fluoride (paragraph 0048, instant claims 19-20) A composition comprises 52.96% propylene glycol (a polyol meeting instant claims 1, 5-7 and 27), 15% sodium metaphosphate (an insoluble phosphate salt meeting instant claims 1 and 27), 0.55% of a copolymer of ammonium salt of 2-acrylamidomethylprophanesulfonic acid and N-vinylpyrrolidone (a thickening agent of instant claim 1 and 3-4), 7.5% polyethylene glycol/polypropylene glycol copolymer (nonionic surfactant), 16.5% PVP complexed with hydrogen peroxide (a hydrogen peroxide whitening agent of instant claim 1 and 10), flavor, color, 2% sodium lauryl sulfate (an anionic surfactant of instant claims 21-22), 0.76% of a fluoride source (instant claim 19) and pyrophosphates (such as tetrasodium pyrophosphate, instant claims 15-16) (TABLE 1, Ex. (2)). The composition does not comprise water meeting substantially free of or free water (instant claim 2).
In regards to ammonium acryloyldimethyltaurate/VP copolymer, one would only need to substitute a copolymer of ammonium salt of 2-acrylamidomethylprophanesulfonic acid and N-vinylpyrrolidone with ammonium acryloyldimethyltaurate/VP copolymer to arrive at the composition of claims 12 and 27.
Fei et al. anticipate the instant claims.
Claim Rejections - 35 USC § 103 - Obviousness
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Fei et al. (US 2019/0175466) in view of Midha et al. (US 2017/0281486).
Fei et al. are discussed above and differ from the instant claims insofar as they do not disclose potassium nitrate.
Midha et al. disclose oral care composition comprising potassium nitrate and peroxide. Potassium nitrate is used in oral care compositions to help reduce pain from sensitive teeth (dentinal hypersensitivity).
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. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added potassium nitrate to the composition of Fei et al. motivated by the desire to treat dentinal hypersensitivity.
Obvious Type 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.
1) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,324,677. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim an anhydrous composition, hydrogen peroxide, thickener, and less than 30% water.
2) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-50, 52-55, 57 and 60-62 of copending Application No. 18/212478 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an anhydrous solvent system, e.g. 10-90% of a polyol, a peroxide (e.g. hydrogen peroxide), a thickening system, and the composition is free of water or substantially free of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-18 and 21-23 of copending Application No. 18/109,223 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an anhydrous composition comprising a polyol, hydrogen peroxide, a thickening system (e.g. polyvinylpyrrolidone), a insoluble phosphate abrasive (calcium pyrophosphate) and the composition is free of water or substantially free of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 13-14, 16-18, 23-24, 28, 32, 34 and 39 of copending Application No. 18/043,703 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an anhydrous composition comprising a polyol (copending claim 17), hydrogen peroxide, a thickening system and the composition is free of water or substantially free of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 10-11, 14, 16, 18, 21, 25, 27, 35 and 38-39 of copending Application No. 18/043,695 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a composition comprising a polyol, hydrogen peroxide, a thickening agent, and the composition is free of water or substantially free of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6) Claims 1-8, 10, 12, 15-16, 19-24 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, 15, 17, 19, 24, 30, 35 and 37-38 of copending Application No. 18/043,679 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a composition comprising about 5 to about 80% of a polyol, hydrogen peroxide, a thickening system, and is free or substantially free of water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims are 1-8, 10, 12, 15-16, 19-24 and 26-27 are rejected.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612