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 .
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.
Claim 14 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 14 recites the limitation "the plurality of polyols" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, such recitation is interpreted herein as referring to “the polyol” in claim 13.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-14 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drucker (U.S. Patent No. 4,895,721; issued 23 January 1990).
Drucker discloses a dentifrice gel (i.e., an oral care composition) comprising 1.5 wt% CARBOPOL 940 (i.e., carbomer, cross-linked branched polyacrylic acid), 30 wt% polyethylene glycol 400 (i.e., polyol), 25 wt% glycerine (i.e., glycerin, polyol), 10 wt% hydrogen peroxide (35% sol.) (i.e., 3.5 wt% hydrogen peroxide whitening agent and 6.5 wt% water), 29 wt% calcium pyrophosphate (i.e., a calcium-based abrasive, an insoluble phosphate salt), and 1 wt% tetrasodium pyrophosphate (i.e., an anti-calculus agent) (Example II column 4 lines 47-65). Drucker discloses no peroxidase or complexed peroxides in Example II.
Regarding claim 20, such recited abrasivity property is presumed inherent in the dentifrice gel of Example II of Drucker as discussed above per MPEP 2112(V) and 2112.01(I) given that such dentifrice gel and the composition of claim 20 are at least substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Claim(s) 1-3, 6-15, 17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al. (CN 116270266 A; published 23 June 2023; of record; citations herein to English machine translated dated 18 February 2025 filed by applicant; of record).
Fan et al. discloses an anhydrous toothpaste (i.e., an oral care composition) comprising 10 wt% PVP-hydrogen peroxide (i.e., a whitening agent, a peroxide), 0.85 wt% carbomer (i.e., a cross-linked branched polyacrylic acid), 17.5 wt% PEG-8 (i.e., polyethylene glycol, a polyol), 20 wt% glycerin (i.e., a polyol), 35 wt% calcium pyrophosphate (i.e., a calcium-based abrasive, an insoluble phosphate salt), 0.76 wt% sodium monofluorophosphate (i.e., a fluoride source) (Example 2 pages 9-10). Fan et al. discloses no peroxidase in Example 2.
Regarding the claimed recitation of water in an amount up to 10 wt%, such recitation includes 0 wt% water (i.e., anhydrous) as in Example 2 of Fan et al., per MPEP 2173.05(c)(II)(“the term ‘up to’ includes zero as a lower limit”).
Regarding claim 20, such recited abrasivity property is presumed inherent in the dentifrice gel of Example 2 of Fan et al. as discussed above per MPEP 2112(V) and 2112.01(I) given that such dentifrice gel and the composition of claim 20 are at least substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
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, 6-10, 12-14, 17, and 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10,363,210.
Although the claims at issue are not identical, they are not patentably distinct from each other because the concentration ranges overlap, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
The recited abrasivity property is presumed inherent in the oral care composition of the ‘210 claim per MPEP 2112(V) and 2112.01(I) given that they are at least substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Claims 1-3, 6-10, 12-14, 17, and 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,540,996.
Although the claims at issue are not identical, they are not patentably distinct from each other because the concentration ranges overlap, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
The recited abrasivity property is presumed inherent in the oral care composition of the ‘996 claim per MPEP 2112(V) and 2112.01(I) given that they are at least substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Claims 1-3, 6-10, 12-14, 17, and 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,048,854.
Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been prima facie obvious to optimize whitening effect, abrasive effect, and humectant/moisturizing effect, of the oral care composition of the ‘854 claim by varying the concentration therein of hydrogen peroxide whitener, calcium abrasive, and humectant polyols PEG and/or glycerin, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. Moreover, the concentration ranges of carbomer in the instant claims and the ‘854 claim overlap, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Substantially anhydrous is defined as less than 2% water (column 3 section 1.6 of ‘854), which overlaps the instantly claimed range.
The recited abrasivity property is presumed inherent in the oral care composition of the ‘854 claim per MPEP 2112(V) and 2112.01(I) given that they are at least substantially identical, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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