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
Applicant’s election without traverse of Group 1 (claims 1-13), in the reply filed on February 17th, 2026 was acknowledged.
Applicant’s election of species without traverse of SEQ ID NO: 6 (P11-4) in the reply filed on February 17th, 2026 was also acknowledged.
Claims 14-18 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected process of use and process of making, there being no allowable generic or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 May 20th, 2026 is pending. Claims 1-18 are pending. Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 1-13 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 1st, 2026, January 10th, 2025, and July 22nd, 2024 are in compliance with the provisions of 37 CFR 1.97.
The information disclosure statement (IDS) submitted on June 23rd, 2026 was filed after the mailing date of the applicants’ arguments on May 20th, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
Response to Arguments
Applicant's arguments filed May 20th, 2026 have been fully considered but they are not persuasive.
Applicant argues that a “skilled person would have understood that a beta-sheet is NOT a web in the sense required by Payne. Otherwise, Payne would have been understood to teach that any peptide which comprises a beta-sheet would be suitable for stabilizing the metal ions.” However, this is a misanalysis of Payne and Dawasz’s teachings as Payne does not teach away from using a SAP as a web-forming material.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp. [MPEP 2141.02 (I)].
The broadest reasonable interpretation of web-forming material, in light of Payne’s specifications, is “a sheet of continuums filaments or fibers of any nature or origin that have been formed into a web” [0029]. This includes protein-based polymers [0078]. Payne does not scope the interpretation of “web” to macroscopic fibrous sheet materials. Rather, the EDANA interpretation that applicant argues is Payne’s definition is:
“nonwoven web” means 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, with the exception of weaving or knitting.” [0030]
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
While Dawasz does teach that the SAP forms beta-sheet tapes, Dawasz also states that the SAP forms fibrils and fibres [pg 2 pgh 4], falling under the Payne’s broadest reasonable definition of a web.
Furthermore, Kind et al. teaches that P11-4 peptides, taught by Dawasaz, are rationally designed small peptides that self-assemble into a 3-dimensional scaffold with surface characteristics mimicking the enamel matrix [pg 2 pgh 2 line 16] (Kind, L., Stevanovic, S., Wuttig, S., Wimberger, S., Hofer, J., Müller, B., & Pieles, U. (2017). Biomimetic Remineralization of Carious Lesions by Self-Assembling Peptide. Journal of dental research, 96(7), 790–797.). Kind et al. shows that the self-assembly of P11-4 results in a network of fibers, shown with transmission
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electron microscopy (TEM) [pg 3 Fig 1]. One of ordinary skill in the art would know that the figure illustrates a web.
Therefore, the applicant’s argument that Payne’s web-forming material does not read on the molecular scale SAPs is not found persuasive because Payne does not scope the web-forming material to not include molecular scale SAPs and the combined teachings of Payne and Dawasaz would have suggested to one of ordinary skill in the art use the P11-4 peptide as the web forming material.
Applicant also argues that “Payne's webs are intentionally manufactured, mechanically formed, macroscopic structures. In contrast, P11-4 assemblies are spontaneous, supramolecular, nanoscale structures driven by environmental triggers such as pH and ionic strength. Macroscale non-woven webs are required by Payne to achieve a specific functionality.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The use of Payne as a reference is not to show that Dawasaz’s peptide can perform the same functionalities, but that it would have obvious to try and incorporate the SAP into Payne’s composition for a reasonable expectation of forming a successful dental care product.
Applicant also argues that “Dawasaz provides no reasonable expectation that assembled P11-4 could remain assembled and functional in a SnF2-containing oral care formulation. P11-4 assembly is highly sensitive to pH, ionic strength, and ionic composition, while Sn2+ ions are reactive and would be expected to affect the peptide. Neither Payne nor Dawasaz, nor the combination thereof teaches or suggests a stable SnF2 formulation containing assembled P11-4.”
Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.") [MPEP 2145].
The applicant does not provide evidence that P11-4 is incompatible with Payne’s composition. Furthermore, Dawasaz mentions that “another study reported that P11-4 peptide worked better when it was combined with either fluoride or CCP-ACPF than when used alone” [pg 10 section 7.1 pg 3 line 10]. Dawasaz teaches that the P11-4 peptide is not only compatible, but synergistic with fluoride, and therefore one of ordinary skill in the art would have found it obvious to try and combine it with stannous fluoride as per Payne’s teachings.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e a stable SnF2 formulation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the rejections of claims 1-13 are maintained as applicant’s arguments are unpersuasive.
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 1-13 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 claims 2 and 13, 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 claims 7 and 13, 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 claims 9 and 13, 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 claims 12 and 13, 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.
Conclusion
Claims 1-13 are rejected under 35 U.S.C. 103. No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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