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 .
Response to Election/Restrictions
Applicant’s election without traverse of Group I and two separate gums in the reply filed on October 23, 2025 is acknowledged.
Claims 6-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 23, 2025.
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.
Claims 4-5 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 4 recites the limitation "the tablet excipient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Further, the claim recites such that sodium bicarbonate is present at three times or more compared to the amount of the table excipient. It is not clear as to which tablet excipient the claim is referring to, such as one specific excipient or all the excipients. Therefore the claims are 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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnold (WO 2021107946).
Arnold discloses a chewable composition for teeth-whitening comprising a first region and a second region separated by a barrier layer; the first region comprising carbamide peroxide having a water content of about 2% or less, a wetting agent (e.g., glycerin), an anhydrous chewing gum base having a water content of about 1% or less, an anhydrous fruit acid, and one or more gum additives; and the second region comprising a chewable composition comprising a gum base, a source of bicarbonate ion, and one or more gum additives. A kit comprising separate chewable compositions corresponding to the first and second regions, and methods for whitening teeth using the chewable composition are also provided (Abstract). The ratio of the abrasive gum base:peroxide:fruit acid, in percent weight relative to the composition, is about 10-50:1-20:0.5-8 (meeting the ratio of component A) (paragraph 0047). The fruit acid meets a gum additive. The ratio of bicarbonate activator:gum base, in percent weight relative to the second composition is about 5-30:15-50 (meeting the ratio of component B) (paragraph 0073). The bicarbonate component comprises 0.001-1% by weight of a metal carbonate (paragraph 0064). Ingredients used in component B include sodium carbonate (instant claim 3), magnesium stearate and microcrystalline cellulose. A two gum composition comprises 200 mg carbamide peroxide, 660 mg of gum base, 900 mg of xylitol, 100 mg of spearmint oil, 40 mg of glycerin, 50 mg citric acid, 15 mg sucralose and 50 mg amorphous silica in the peroxide component and 300 mg of sodium bicarbonate, 30 mg of amorphous silica, 650 mg of a gum base, 100 mg peppermint oil, 60mg glycerin, 890 mg xylitol, 5 mg surfactant, 5 mg calcium carbonate, 5 mg sodium carbonate (instant claim 3), 60 mg sucralose, 5 mg titanium dioxide and 3 mg lecithin in the sodium bicarbonate component (Example 5).
In regards to the 3 times or more of bicarbonate compared to the amount of tablet excipient of instant claim 4, a tablet excipient is recited for component A. Silica is used in an amount of 50 mg of a chewing gum composition in the peroxide containing component A. The amount of sodium bicarbonate is 300 mg in component B. Therefore sodium bicarbonate is used in more than 3 times the amount of silica.
Arnold anticipates the instant claims.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,110,045. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims are two distinct chewing gum compositions comprising carbamide peroxide in one component and sodium bicarbonate in a separate component. The instant claims differ from the patented claims insofar as they do not recite a specific excipient. However, it would have been obvious to have used an acid as an additive in the composition of the instant claims because it is additive used in chewing gums and the instant claims do not exclude additives such as acids.
2) Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,648,192. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims are two distinct chewing gum compositions comprising carbamide peroxide in one component and sodium bicarbonate in a separate component. The instant claims differ from the patented claims insofar as they do not recite a specific excipient. However, it would have been obvious to have used an acid as an additive in the composition of the instant claims because it is additive used in chewing gums and the instant claims do not exclude additives such as acids.
3) Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,707,424. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims are two distinct chewing gum compositions comprising carbamide peroxide in one component and sodium bicarbonate in a separate component. The instant claims differ from the patented claims insofar as they do not recite a method. However, it would have been obvious to have used the composition of the instant claims in the method of the patented claims because the patented claims use a two component chewing having substantially the same ingredients.
4) Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,707,423. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims are two distinct chewing gum compositions comprising carbamide peroxide in one component and sodium bicarbonate in a separate component. The instant claims differ from the patented claims insofar as they do not recite a method. However, it would have been obvious to have used the composition of the instant claims in the method of the patented claims because the patented claims use a two component chewing having substantially the same ingredients.
5) Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,239,725. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims are two distinct chewing gum compositions comprising carbamide peroxide in one component and sodium bicarbonate in a separate component. The instant claims differ from the patented claims insofar as they do not recite a specific excipient or recite a method. However, it would have been obvious to have used an acid as an additive in the composition of the instant claims because it is additive used in chewing gums and the instant claims do not exclude additives such as acids. It would also have been obvious to have used the composition of the instant claims in the method of the patented claims because the patented claims use a two component chewing having substantially the same ingredients.
Claims 1-5 are rejected.
Claims 6-21 are withdrawn.
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