DETAILED ACTION
Examiner acknowledges receipt of the replies filed 3/06/2026 and 3/26/2026, in response to the restriction requirement mailed 2/05/2026.
Claims 1-3, 6-13, 17, and 20-27 are pending. Claims 4, 5, 18, and 19 are canceled. Claims 24-27 are newly added. Claims 3, 6-8, and 21-27 are withdrawn from further consideration for the reasons set forth below.
Claims 1, 2, 9-13, 17, and 20 are being examined on the merits in this office 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
The filing receipt dated 09/07/2023 provides the following information:
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Election/Restrictions
Applicant’s election of Group I (claims 1-13 and 17-21) without traverse in the reply filed on 3/26/2026 is acknowledged.
Claims 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/6/2026.
Applicant’s election applicants election of the following representative species is acknowledged:
Peptide- 100% SEQ ID NO:1
Claim 1, part b ii- calcium phosphate
Claims 1, 2, 9-13, 17, and 20 read on the elected species.
Claims 3, 6-8, 21, and 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/26/2026.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The invention relates,” “The disclosure defined by this invention,” “The disclosure describes,” “The invention provides”, “The inventors have discovered”, etc. “ In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Claim Objections
Claims 1, 11, and 12 are objected to because of the following informalities:
Claim 1 recites the acronym “ACP” which should be written out in full name in the first order of appearance in the claims.
Claims 11 and 12 should be amended to recite “selected from the group consisting of … a lozenge, and [[or]] a candy”.
Appropriate correction is required.
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.
Claims 1, 2, 9-13, 17, and 20 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 1 recites the limitation "the compositions" at line 5; and "the particles" at lines 7-8. There is insufficient antecedent basis for the limitations in the claim. To overcome this rejection, the claim should be amended to recite “the separate compositions” and “the calcium phosphate particles”.
Because claims 2, 9-13, 17, and 20 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, but not limited to, claims 11 and 12 recite the broad recitation a dry composition, and the claim also recites a lyophilized composition, as well as e.g., a chewing gum, toffee, a lozenge, which is the narrower statement of the range/limitation. It is further noted that a chewing gum and toffee can be construed as narrower limitations of the claim term “a candy”. Similarly, claims 11 and 12 recite the broad recitation of a water-based solution, and the claim also recites e.g., toothpaste, mouthwash, amount sprayed, etc. which are narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12 recites the limitation "the composition" at line 1. There is insufficient antecedent basis for the limitations in the claim. Specifically, claim 1 does not refer to a composition comprising the calcium phosphate particles [claim 1, part b)(ii)]. The compositions are limited to part b)(ii) referring back to calcium and phosphate ions in separate compositions, not calcium phosphate particles.
Claim 17 recites the limitation "the calcium phosphate precipitates". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claim should be amended to recite “the calcium phosphate particles
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.
Claims 1, 2, 9-13, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hug et al (U.S. 20190142724).
Hug et al teach dental care products (e.g., lozenge of Fig 1- construed as reading on a kit of the instant claims) comprising self-assembling peptides that are capable of undergoing self-assembly at a certain pH for use in dental care, e.g. preventing and/or treating a tooth lesion such as a caries lesion, remineralising a tooth surface or increasing smoothness or shine, or for increasing hardness of a tooth surface (abstract; paras. [0013], [0015]-[0018], [0033]; claims 1-3). The self-assembling peptides includes a peptide having 100% identity with instant SEQ ID NO:1 (SEQ ID NOs:1-2 of Hug et al). The dental care products further comprise calcium phosphate or dicalcium phosphate [construed as reading on calcium phosphate] (e.g., paras. [0059], [0085], [0097], [0109]-[0116]). Accordingly, the limitations of instant claim 1 are satisfied.
Regarding claim 2, Hug e teaches that the compositions can be used in remineralization of teeth (e.g., abstract, paras. [0013], [0015]-[0018], [0033]; claims 1-3). Regarding claim 9, the kit can comprise calcium phosphate particles (e.g., para [0007], [0085], Ex 6). Regarding claim 10, SEQ ID NO:1 and 2 of Hug et at comprises the amino acid sequence of instant SEQ ID NO:1 (e.g., paras. [0035]-[0039], [0049]-[0054], claim 9 and 21). Regarding claim 11, Hug et al teach that the self-assembling peptide can be in the form of a toothpaste, lozenge, tooth gel, mouthwash, chewing gum, candy, etc. (e.g., paras. [0088]-[0091], [0108]-[0113], Examples 1-7, claim 10).
Regarding claim 12, Hug et al teach that the dicalcium phosphate particles can be in the form of a toothpaste, lozenge, tooth gel, mouthwash, chewing gum, candy, etc. (e.g., paras. [0097], [0109]-[0116]). See also artificial saliva.
Regarding claim 13, Hug et al teach that the dental care product can be in the form of a solid or semisolid composition, e.g., lozenge of Fig 1, wherein the inner core may comprise the self-assembling peptide and the outer core can comprise an abrasive agent, e.g. dicalcium phosphate [reads on calcium phosphate] (e.g., paras. [0084]-[0087], [0109]-[0116]; Fig 1). Regarding claim 17, the calcium phosphate particles can be amorphous (e.g., para. [0002]).
Conclusion
No claims are allowed.
Claims 1-3, 6-13, 17, and 20-27 are pending. Claims 3, 6-8, and 21-27 are withdrawn.
Claims 1, 2, 9-13, 17, and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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