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 prosecution are claims 1-8.
Election/Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-20, drawn to oral care compositions, classified in A61Q 11/00.
II. Claim 21, drawn to a method for treating/preventing erosion and/or caries, classified in A61P 1/02.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product such as in a method of stain removal.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification.
The inventions have acquired a separate status in the art due to their recognized divergent subject matter.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species:
If Group I is elected, please elect a composition from each of the following.
The oral care composition recited in claims 1-8;
The oral care composition recited in claims 9-15; OR
The oral care composition recited in claims 16-20;
The species are independent or distinct because they have materially different components, features, properties, applications, and/or reactivities. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claim 1 is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification.
The species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized subject matter.
The species or grouping of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with John Powell on 6/9/26 a provisional election was made without traverse to prosecute the invention of Group, claims 1-20. Furthermore, the composition of claims 1-8 were elected in response to the Election requirement. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
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.
1. Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groth et al. (US 2021/0353516, Nov. 18, 2021) (hereinafter Groth).
Groth discloses oral care compositions including dicarboxylic acid and tin (Abstract). The oral care composition can comprise fluoride, which can be provided by a fluoride ion source. The fluoride ion source can comprise one or more fluoride containing compounds, such as stannous fluoride, sodium fluoride, amine fluoride, sodium monofluorophosphate, and/or mixtures thereof (satisfies fluoride ion and claim 5) (¶ [0039]). The oral care composition can comprise a fluoride ion source capable of providing from about 50 ppm to about 5000 ppm of free fluoride ions (satisfies claim 6) (¶ [0043]). The composition can comprise tin, which can be provided by a tin ion source. The tin ion source can comprise stannous fluoride, stannous chloride, and/or mixture thereof (satisfies stannous ion and claim 7) (¶ [0047]). The pH of the oral care compositions can be from about 4 to about 6 (satisfies claim 8) (¶ [0051]). In Ex. 1, the composition contained 0.454% stannous fluoride, 0.5619% stannous chloride, 1.3% sodium gluconate, 1.205% sodium citrate, as well as 3.14% potassium oxalate (Table 1). In Ex. 2, the composition contained 0.243% sodium fluoride, 0.275% citric acid, as well as 3.14% potassium oxalate (Table 1).
In regards to the ratio, the ratio of stannous ion to the mixture of dentate ligands in Ex. 1 is 1:2.81.
The prior art anticipates the indicated claims because it discloses oral care compositions comprising a combination of stannous ion sources and fluoride ion sources, a first polydentate ion along with either a monodentate ion or a second polydentate ion as instantly claimed in amounts encompassed by those instantly claimed
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.
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.
1. Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groth et al. (US 2021/0353516, Nov. 18, 2021) (hereinafter Groth).
Groth discloses oral care compositions including dicarboxylic acid and tin (Abstract). The unique properties of small molecule mono-, di-, tri-, and tetra-carboxylic acids, like gluconic acid, oxalic acid, and citric acid, allow them to be highly effective stabilizing ligands in a particular pH range (¶ [0012]). Suitable dicarboxylic acids include oxalic acid (satisfies first polydentate ligand) (¶ [0037]). The oral care composition can comprise from about 1 % to about 5% of dicarboxylic acid (satisfies claim 4) (¶ [0038]). The oral care composition can comprise fluoride, which can be provided by a fluoride ion source. The fluoride ion source can comprise one or more fluoride containing compounds, such as stannous fluoride, sodium fluoride, amine fluoride, sodium monofluorophosphate, and/or mixtures thereof (satisfies fluoride ion and claim 5) (¶ [0039]). The oral care composition can comprise a fluoride ion source capable of providing from about 50 ppm to about 5000 ppm of free fluoride ions (satisfies claim 6) (¶ [0043]). The composition can comprise tin, which can be provided by a tin ion source. The tin ion source can comprise stannous fluoride, stannous chloride, and/or mixture thereof (satisfies stannous ion and claim 7) (¶ [0047]). The oral care composition can comprise from about 0.2% to about 1%, by weight of the oral care composition, of tin and/or a tin ion source (satisfies claim 7) (¶ [0048]). The pH of the oral care compositions can be from about 4 to about 6 (satisfies claim 8) (¶ [0051]). The oral care composition can comprise a monodentate ligand (¶ [0060]). Suitable monodentate ligands include gluconate (satisfies monodentate ligand) (¶ [0065]). The oral care composition can include from about 1 % to about 5% of the monodentate ligand (satisfies claim 4) (¶ [0066]). The oral care composition can comprise a polydentate ligand (¶ [0067]). Suitable polydentate ligands include oxalic acid, citric acid, and/or combinations thereof (satisfies second polydentate ligand and claim 3) (¶ [0071]). The oral care composition can include from about 1 % to about 5% of the polydentate ligand (satisfies claim 4) (¶ [0071]).
It is believed that Groth anticipates that instantly recited claims, however, purely arguendo and for the purposes of this rejection, Groth does not exemplify the molar ratio of stannous ions to the mixture of dentate ligands.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Groth discloses wherein suitable monodentate ligands include gluconic acid and wherein suitable polydentate ligands include oxalic acid. Groth further discloses that suitable ratios of tin to the monodentate ligand to polydentate ligand can be from about 1:0.5:0.5 to about 1:5:5 (¶ [0072]). Accordingly, because the ratios recited in the instant claims overlap with and/or lie inside the range disclosed by Groth, the range disclosed by Groth meets the instantly recited limitations.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/911,389 in view of Groth et al. (US 2021/0353516, Nov. 18, 2021) (hereinafter Groth).
The copending claims differ from the pending claims insofar as reciting lactic acid instead of gluconate.
However, Groth discloses oral care compositions (Abstract). Suitable monodentate ligands include lactic acid and gluconate (¶ [0063 & 0065]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the copending claims to comprise lactic acid since it is a known monodentate ligand along with gluconate for use in oral care compositions as taught by Groth.
This is a provisional nonstatutory double patenting rejection.
2. Claims 1-8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/911,383 in view of Groth et al. (US 2021/0353516, Nov. 18, 2021) (hereinafter Groth).
The copending claims differ from the pending claims insofar as reciting lactic acid instead of gluconate.
However, Groth discloses oral care compositions (Abstract). Suitable monodentate ligands include lactic acid and gluconate (¶ [0063 & 0065]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the copending claims to comprise lactic acid since it is a known monodentate ligand along with gluconate for use in oral care compositions as taught by Groth.
This is a provisional nonstatutory double patenting rejection.
3. Claims 1-8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/911,374 in view of Groth et al. (US 2021/0353516, Nov. 18, 2021) (hereinafter Groth).
The copending claims differ from the pending claims insofar as reciting malic acid instead of oxalic acid.
However, Groth discloses oral care compositions (Abstract). Suitable polydentate ligands include oxalic acid and malic acid (¶ [0071]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the copending claims to comprise malic acid since it is a known polydentate ligand along with oxalic acid for use in oral care compositions as taught by Groth.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-8 are rejected.
Claims 9-21 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
Prosecution Insights