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
Applicant’s election without traverse of Group 1 (claims 1-13), in the reply filed on February 17th, 2026 is acknowledged.
Applicant’s election of species without traverse of SEQ ID NO: 6 (P11-4) in the reply filed on February 17th, 2026 is also acknowledged.
Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process of use and process of making, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 17th 2026.
Claim Status
The claims listing filed on September 11th 2023 is pending. Claims 1-18 are pending. Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 1-14 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 10th, 2025 is in compliance with the provisions of 37 CFR 1.97.
The information disclosure statement filed July 22nd, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Payne et al (US20220062123A1: Published 2022) in view of Dawasaz et al (Dawasaz, A. A., Togoo, R. A., Mahmood, Z., Azlina, A., & Thirumulu Ponnuraj, K. (2022). Effectiveness of Self-Assembling Peptide (P11-4) in Dental Hard Tissue Conditions: A Comprehensive Review. Polymers (20734360), 14(4), 792)
.
Payne et al discloses unit-dose oral care compositions comprising a metal ion source [Abstract]. Payne et al. teaches that the unit-dose dentifrice comprises of a soluble fibrous composition from about 1-25% by weight of web forming material and a tin ion source of stannous fluoride [claims 1-2]. Payne defines a web as “a sheet of continuous filaments or fibers of any nature or origin that have been formed into a web by any means, and bonded together by any means” [0029]. Fluoride and calcium may comingle with the nonwoven web layer [0044]. The web forming material may comprise of a naturally source polymer, such as a protein-based polymer [0077-0078]. Payne et al does not teach that the protein-based polymer is a self-assembling peptide comprising of SEQ ID NO:6 and that self-assembling peptides are a sheet of continuous filaments or fibers.
Dawasaz et al. states that P11-4 “is a rationally designed synthetic peptide of 11 amino acids that undergoes hierarchical self-assembly into B-sheet tapes, ribbons, fibrils and fibres” [pg2 pgh 4]. Peptide fibers form from the β-sheet structure that self-assembles to generate nanotapes [Pg 8 pgh1]. The anionic groups in peptide P11-4 attract calcium ions and can precipitate hydroxyapatite crystals from scratch, mimicking the role of enamel matrix proteins [Pg 10 pgh 1 and Pg 7 pgh 2]. The P11-4 peptide works better combined with fluoride [pg 10 pgh 4]. Dawasaz et al. motivates an artisan of skill to use P11-4 because it reduces dentinal hypersensitivity [pg 11 pgh2] and treats early enamel caries by guided enamel remineralization [pg 12 pgh 2].
Thus, it would have been obvious to one of ordinary skill prior to the effective filing date to incorporate the P11-4 peptide taught by Dawasaz et al. in the composition disclosed by Payne et al because there is a reasonable expectation that P11-4 in combination with stannous fluoride would be successful at preventing demineralization and treating dentinal hypersensitivity.
Regarding claim 2, Payne et al teaches the range of the tin ion source, the narrowest range being 0.075%- 3% by weight [0136]. This encompasses the present range.
Regarding claims 3 and 4, the elected species, SEQ ID NO:6, is taught by Dawasaz et al. (please reference claim 1’s rejection).
Regarding claims 5 and 6, Payne’s unit dose dentifrice composition comprises of polyphosphate wherein the polyphosphate comprises of tripolyphosphates [claim 17 and 18]. The specification further details that sodium is a plausible cation for the tripolyphosphate [0163]. Thus, it would have been obvious prior to filing to create a dental care product with sodium tripolyphosphate.
Regarding claim 7, Payne et al states the polyphosphate source can be “from about 0.01% to about 1.5%, from about 0.1% to about 10%, from about 0.5% to about 5%, from about 1 to about 20%, or about 10% or less, by weight” [0164]. Thus, Payne’s range overlaps with the present range.
Regarding claim 8, the metal ion source of the oral care composition with a metal ion source can have sodium as the metal and gluconates as the salt [0134]. Therefore, it would have been obvious prior to the filing to add sodium gluconate to the composition taught by Payne et al and Dawasaz et al.
Regarding claim 9, the metal ion source, such as sodium gluconate, may comprise from 0.01-5% by weight of the invention [0135]. This encompasses the present range.
Regarding claim 10, Payne et al teaches that the uni-dose oral care composition can be in the form of “toothpaste, dentifrice, tooth gel, tooth powders, tablets, rinse, sub gingival gel, foam, mousse, chewing gum, lipstick, sponge, floss, prophy paste, petrolatum gel, denture product, nonwoven web, or foam” [0012].
Regarding claim 11, components a and b are referenced in claims 6-9’s rejections. Payne et al teaches that sugar alcohols sorbitol (c), xylitol (e), and erythritol (f) may be in the oral care composition [0184]. The web forming material of the unit dose dentifrice may comprise of carboxymethylcellulose, worded by applicant as cellulose gum (d) [claim 4]. The unit dose dentifrice also comprises of an abrasive [claim 1], which may be a silica abrasive [claims 10-14]. Payne further teaches the silica abrasive can comprise of hydrated silica [0121]. Water (j) can also be in the composition [0115].
Sodium hydroxide (i) is an optional component and therefore does not limit the claim’s scope. “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure” [see MPEP 2111.04]. Thus, sodium hydroxide is not considered a limiting factor for the obviousness rejections.
Payne et al does not teach the addition of phosphoric acid. Dawasaz teaches the use of phosphoric acid when applying the P11-4 peptide.
“It is pertinent to remove the superficial pellicle using 2% sodium hypochlorite followed by the application of 35% phosphoric acid for 20 s. After cleaning and drying the teeth, the surface must be assessed for the presence of open pores. This is intended for allowing the material to penetrate the lesion and initiate the process” [pg 7 pgh 4].
Thus, it would have been obvious to an artisan of ordinary skill prior to the effective filing date to add phosphoric acid to the dental care product taught by Payne et al to remove superficial pellicle and allow the material to penetrate enamel lesions.
Regarding claim 12, Dawasaz et al. teaches that P11-4 remains monomeric at higher pH values [pg 9 pgh 1]. The self-assembly occurs at a pH range of 6.8-7.2: “It changes to a nematic gel state during the self-assembly process, occurring at a pH range of 6.8–7.2.” Therefore, it would have been obvious prior to filing, to make a dental care product comprising of SEQ ID NO:6 with a pH encompassed by the range taught by Dawasaz so that the SEQ ID NO:6 self-assembles.
Regarding claim 13, claims 1-2, 7, 9, and 12’s rejections encompass the claim’s bounds.
Conclusion
The information disclosure statement (IDS) submitted on July 22nd, 2024 is objected to. Claims 1-14 are rejected under 35 U.S.C. 103.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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, 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.
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.
/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654