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 .
Priority
Acknowledgement is made of the Applicant’s claim of foreign priority to application EP23202902.5 filed 11 October 2023.
Status of the Claims
Claims 1-19 are pending.
Claims 1-19 are rejected.
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 12 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 12 recites the limitation "the anionic surfactant." There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 4-12, 14, and 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Joziak et al. (US 8,802,060).
Joziak teaches a composition comprising malic acid (3.00%), cocoamidopropyl betaine (1%; surfactant), and water (90.92%) in Example 1 (col 8, lns 30-40). Joziak further teaches that the pH of all of their examples is about 3 to about 5 (col 2, lns 12-14). The composition of Joziak does not comprise any abrasives but does contain sodium saccharin, a sweetening agent (col 8, lns 30-40). As such, the composition of Example 1 anticipates instant claims 1, 4-12, 14, and 16.
Claims 1, 4-12, and 14-17 are rejected under 35 U.S.C. 102a1 as being anticipated by Atsushi et al. (US 2003/0124068).
Atsushi teaches an example dental composition comprising malic acid (10%), sorbitol (35%; humectant), propylene glycol (5%; humectant), polyoxyethylene hydrogenated castor oil (1%; nonionic surfactant), hydroxyethyl cellulose (0.5%; thickening agent), and water (qs) wherein the pH is 4 (Table 3, example 3-3). In a different example, the oral composition comprises malic acid (5%, which anticipates “about” 4.0%), sodium lauryl sulfate (1%; anionic surfactant), and water (q.s) wherein the pH is 4.5 (Table 2, example 2-3). In Example 2-3, the balance of water equals about 95% (id). None of the examples include an abrasive agent. It is noted that the total amount of humectant (sorbitol plus propylene glycol) is 40% in example 3-3. As such, the compositions of Atsushi anticipate instant claims 1, 4-12, and 14-17.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Atsushi et al. (US 2003/0124068) in view of Nowak et al. (US 2012/0100193) in view of Witt et al. (US 6,077,502).
Atsushi teaches an example dental composition comprising malic acid (10%), sorbitol (35%; humectant), propylene glycol (5%; humectant), polyoxyethylene hydrogenated castor oil (1%; nonionic surfactant), hydroxyethyl cellulose (0.5%; thickening agent), and water (qs) wherein the pH is 4 (Table 3, example 3-3). In a different example, the oral composition comprises malic acid (5%, which anticipates “about” 4.0%), sodium lauryl sulfate (1%; anionic surfactant), and water (q.s) wherein the pH is 4.5 (Table 2, example 2-3). In Example 2-3, the balance of water equals about 95% (id). None of the examples include an abrasive agent. It is noted that the total amount of humectant (sorbitol plus propylene glycol) is 40% in example 3-3. As alternative acids to malic acid, Atsushi teaches oxalic acid [0016]. Regarding the surfactant, the total amount thereof can range from 0.1-5% [0022]. The purpose of the composition of Atsushi is as a whitening composition when applied to the surface of the teeth [0001] which can be done by way of a toothpaste [0034]. It is well known that toothpaste compositions are applied to a toothbrush and then applied to the teeth by brushing, followed by expectoration or rinsing.
Atsushi does not teach the Pellicle Cleaning Ratio of the composition nor does it teach a method of applying it to the teeth.
Nowak teaches the PCR is a known method to measure the efficacy of removing tooth stains relative to a standard [0088]. A desired PCR level to remove stain from a tooth is from 80-105 [0088].
Witt teaches that in a method for whitening teeth, the whitening composition (in the case of Witt, a chlorite ion) is applied to the toothbrush and then to the surface of the teeth wherein it is preferably left for 20 second to about 10 minutes before expectoration and rinsing (col 17, lns 29-42).
It would have been prima facie obvious to prepare the composition of Atsushi and modify it to comprise oxalic acid instead of malic acid. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). Moreover, it would have been obvious to use amounts of surfactant up to and including 5%.
Regarding the PCR value of the composition, Atsushi is silent to the value. Thus it would have been obvious to look to Nowak which teaches that for whitening of teeth, a PCR value of 80-105 is desired.
It would have been obvious to take the resulting oral composition and apply it to a toothbrush and then brush it onto the teeth followed by leaving it in place for up to 10 minutes before expectorating and rinsing.
Claims 1-19 are accordingly obvious in view of the prior art.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, 14-21, and 26-28 of copending Application No. 17/580,685 in view of Atsushi et al. (US 2003/0124068).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘685 claims recite an oral composition comprising oxalic acid and thickening agents at a pH of from 4-6 but do not require a surfactant. Atsushi teaches that inclusion of a surfactant in an oral care composition heightens the whitening effect of teeth [0022]. Atsushi also provides examples wherein the acid is used in amounts ranging from 5-10% (Table 2-3). It would have been obvious to include a surfactant in the composition of ‘685 and to use oxalic acid in 5-10%, thus rendering obvious instant claims 1-15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7-19, 23-25, and 27 of copending Application No. 17/971,728 in view of Atsushi et al. (US 2003/0124068).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘728 claims recite an oral composition comprising methylmalonic acid and thickening agents at a pH of from 4.5-5 but do not require a surfactant. Atsushi teaches that inclusion of a surfactant in an oral care composition heightens the whitening effect of teeth [0022]. Atsushi also provides examples wherein the acid is used in amounts ranging from 5-10% (Table 2-3). It would have been obvious to include a surfactant in the composition of ‘728 and to use the acid in 5-10%, thus rendering obvious instant claims 1-2 and 4-15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16-18, and 21 of copending Application No. 18/484,713 in view of Atsushi et al. (US 2003/0124068).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘713 claims recite an oral composition comprising malonic acid (2-10%) and thickening agents at a pH of from 4-5 but do not require a surfactant. Atsushi teaches that inclusion of a surfactant in an oral care composition heightens the whitening effect of teeth [0022]. Atsushi also provides examples wherein the acid is used in amounts ranging from 5-10% (Table 2-3). It would have been obvious to include a surfactant in the composition of ‘713 and to use malonic acid in 5-10%, thus rendering obvious instant claims 1-15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/911,395 in view of Atsushi et al. (US 2003/0124068).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘395 claims recite an oral composition comprising malonic and/or oxalic acid and thickening agents at a pH of from 4-6 and a PCR of at least 115 but do not require a surfactant. Atsushi teaches that inclusion of a surfactant in an oral care composition heightens the whitening effect of teeth [0022]. Atsushi also provides examples wherein the acid is used in amounts ranging from 5-10% (Table 2-3). It would have been obvious to include a surfactant in the composition of ‘395 and to use oxalic acid in 5-10%, thus rendering obvious instant claims 1-15 and 18.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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