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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 36-43, drawn to a stannous-associated phosphopeptide (PP) stabilized ACP or ACFP complex.
Group II, claim(s) 44-50, drawn to a method for treating or preventing dentinal sensitivity in an individual in need thereof having exposed dentine by administering to the individual the stannous-associated PP stabilized ACP or ACFP complex of claim 36.
Group III, claim(s) 51-55, drawn to a method for forming the stannous-associated PP stabilized ACP or ACFP complex of claim 36.
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a stannous-associated phosphopeptide (PP) stabilized ACP or ACFP complex, which has a stannous ion content of 1.2-2.2 moles of stannous per mole of PP, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Reynolds (WO 2015/095932A1) as explained in detail in Paragraph 8 below.
During a telephone conversation with Ms. Courtenay C. Brinckerhoff (attorney for applicant) on August 24, 2026, a provisional election was made with traverse to prosecute the invention of Group I, claims 36-43. Affirmation of this election must be made by applicant in replying to this Office action. Claims 44-55 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 § 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.
Claim(s) 36-43 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (WO 2015/095932 A1, which is equivalent to US 2016/0317404 A1).
In claims 1 and 2, Reynolds teaches a stannous-associated amorphous calcium phosphate (ACP) and/or amorphous calcium fluoride phosphate (ACFP) complex, wherein the ACP and/or ACFP is phosphopeptide (PP) stabilized. Reynolds further teaches (see the last paragraph on pg.5) that preferably the phosphopeptide is a casein phosphopeptide (as claimed in instant claim 41). In claim 3, Reynolds furthermore teaches that the complex has a stannous ion content of at least 1 mole of stannous per mole of PP. Reynolds’s range at least 1 mole overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Reynolds’s range at least 1 mole of stannous per mole of PP also overlaps with instant range about 1.6 moles (of claim 40) thus rendering instant range of claim 40 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given by Reynolds (i.e., the stannous ion content for the complex being at least 1 mole of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Thus, Reynolds renders obvious instant claims 36-41.
With respect to instant claim 42, Reynolds teaches (pg.10, lines 22-24) a composition containing its stannous-associated stabilized ACP or ACFP complex, and such composition preferably further includes a pharmaceutically acceptable carrier, diluent or excipient. Thus, Reynolds renders obvious instant claim 42.
With respect to instant claim 43, Reynolds teaches that the composition containing its stannous-associated stabilized ACP or ACFP complex is in the form of dentifrice including toothpaste, tooth powder and liquid dentifrice (see claims 12 and 18). Thus, Reynolds renders obvious instant claim 43.
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 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10 and 19 of U.S. Patent No. 10,912,722 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of Pat.’722 teaches the following:
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The range at least 1 mole for the stannous ion content per mole of phosphopeptide overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In re Wertheim, supra. The range at least 1 mole of stannous per mole of PP also overlaps with instant range about 1.6 moles (of claim 40) thus rendering instant range of claim 40 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given in claim 1 of Pat.’722 (i.e., the stannous ion content for the complex being at least 1 mole of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Claim 19 of Pat.’722 teaches that the phosphopeptide of claim 1 is casein phosphopeptide. Thus, claims 1 and 19 of Pat.’722 render obvious instant claims 36-41.
With respect to instant claims 42 and 43, claim 7 of Pat.’722 teaches an oral care formulation comprising the stannous-associated phosphopeptide-stabilized amorphous calcium phosphate and/or amorphous calcium fluoride phosphate complex of claim 1, and claims 8-10 of Pat.’722 teach that such oral care formulation is in the form of dentifrice such as a toothpaste. Furthermore, when the oral care formulation is in the form of a toothpaste, it would be naturally obvious to one skilled in the art to include excipients or carriers that are necessary in forming a toothpaste in a toothpaste formulation. Thus, claims 1 and 7-10 of Pat.’722 render obvious instant claims 42 and 43.
Claims 36-40, 42 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11,564,873 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of Pat.’873 teaches a stannous-associated phosphopeptide-stabilized amorphous calcium phosphate complex and/or a stannous-associated phosphopeptide-stabilized amorphous calcium fluoride phosphate complex, wherein the complex has a stannous ion content of at least 1 mole of stannous per mole of phosphopeptide. The range at least 1 mole for the stannous ion content per mole of phosphopeptide overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In re Wertheim, supra. The range at least 1 mole of stannous per mole of PP also overlaps with instant range about 1.6 moles (of claim 40) thus rendering instant range of claim 40 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given in claim 1 of Pat.’873 (i.e., the stannous ion content for the complex being at least 1 mole of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Thus, claim 1 of Pat.’873 renders obvious instant claims 36-40.
With respect to instant claims 42-43, claim 9 of Pat.’873 teaches that the complex of claim 1 can be in a form of a toothpaste (instant dentifrice of claim 43), and it would be naturally obvious to one skilled in the art to use excipients or carriers, which are necessary in forming a toothpaste, together with the complex of claim 1 with a reasonable expectation of forming a toothpaste. Thus, claims 1 and 9 of Pat.’873 renders obvious instant claims 42-43.
Claims 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4 and 9-12 of U.S. Patent No. 12,239,723 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claims 1 and 3 of Pat.’723 teaches a stannous-associated phosphopeptide-stabilized ACP and/or ACFP complex, wherein the complex has a stannous ion content of 1-10 moles of stannous per mole of phosphopeptide. The range 1-10 moles for the stannous ion content per mole of phosphopeptide overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In re Wertheim, supra. The range 1-10 moles for the stannous per mole of PP also overlaps with instant range about 1.6 moles (of claim 40) thus rendering instant range of claim 40 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given in claims 1 and 3 of Pat.’723 (i.e., the stannous ion content for the complex being 1-10 moles of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Claim 4 of Pat.723 teaches that the phosphopeptide of claim 1 is casein phosphopeptide. Claim 9 of Pat.’723 teaches an oral care formulation comprising the stannous-associated phosphopeptide-stabilized amorphous calcium phosphate and/or amorphous calcium fluoride phosphate complex of claim 1, and claims 10-12 of Pat.’723 teach that the oral care formulation of claim 9 can be in the form of a dentifrice such as a toothpaste. Furthermore, when the oral care formulation is in the form of a toothpaste, it would be naturally obvious to one skilled in the art to include excipients or carriers that are necessary in forming a toothpaste in the toothpaste formulation with a reasonable expectation of success. Thus, claims 30, 32, 33 and 38-41 of App.’989 renders obvious instant claims 36-40, 56, 59 and 60.
Claims 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,303,548 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of Pat.’548 teaches a stannous-associated phosphopeptide-stabilized ACP and/or ACFP complex, wherein the complex has a stannous ion content of 1.4-2.0 moles of stannous per mole of phosphopeptide, wherein the phosphopeptide is a casein phosphopeptide. The range 1.4-2.0 moles for the stannous ion content per mole of phosphopeptide overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given in claim 1 of Pat.’548 (i.e., the stannous ion content for the complex being 1.4-2.0 moles of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Claim 2 of Pat.’548 teaches that the complex of claim 1 has a stannous ion content of about 1.6 moles of stannous per mole of PP. Claim 3 of Pat.’548 teaches a composition comprising the complex of claim 1 and a pharmaceutically acceptable carrier, diluent or excipient, and claim 4 of Pat.’548 teaches that such composition of claim 3 can be in the form of dentifrices, mouthwashes, mouth rinses, mouth spray, varnishes, dental cements, troches, chewing gums, dental pastes, gingival massage creams, gargle tablets and dairy products. Thus, claims 1-4 of Pat.’548 renders obvious instant claims 36-43.
Claims 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 14 and 15 of U.S. Patent No. 12,551,417 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claims 1, 4 and 9 of Pat.’417 teach a stannous-associated phosphopeptide-stabilized ACP and/or ACFP complex, wherein the complex has a stannous ion content of 1-10 moles of stannous per mole of phosphopeptide, wherein the phosphopeptide is a casein phosphopeptide. The range 1-10 moles for the stannous ion content per mole of phosphopeptide overlaps with instant range 1.2-2.2 moles of stannous per mole of PP thus rendering instant range of claim 36 prima facie obvious. In re Wertheim, supra. The range 1-10 moles for the stannous ion content per mole of PP also overlaps with instant range about 1.6 moles (of claim 40) thus rendering instant range of claim 40 prima facie obvious. In re Wertheim, supra. Furthermore, under the guideline given in claims 1 and 4 of Pat.’417 (i.e., the stannous ion content for the complex being 1-10 moles of stannous per mole of PP), instant stannous ion contents (1.4 mole, 1.8 mole and 2.0 mole) of claims 37-39 would also have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. Claims 14-15 of Pat.’417 teaches an oral care composition comprising the complex of claim 1, which can be in the form of dentifrice, such as toothpaste. Furthermore, when the oral care formulation is in the form of a toothpaste, it would be naturally obvious to one skilled in the art to include excipients or carriers that are necessary in forming a toothpaste with a reasonable expectation of success. Thus, claims 1, 4, 9, 14 and 15 of Pat.’417 renders obvious instant claims 36-43.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 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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/SIN J LEE/
Primary Examiner, Art Unit 1613
September 19, 2026
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