DETAILED ACTION
Applicants' arguments, filed 07/01/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 instant application claims domestic priority to PRO 63/027,679 filed 05/20/2020 and is a 371 of PCT/US2021/033370 filed 05/20/2021.
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.
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.
A) Claims 1, 6-7, 12, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Moshaverinia et al. (US Patent Application Publication 20190274932A1, provided in the IDS filed 01/26/2023).
Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1) as per instant claim 12. Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2) as per instant claims 6 and 17. Moshaverinia recites a method of using a composition to generate a layer of hydroxyapatite at the surface of a tooth, said method comprising: disposing the polydopamine-coated fluoroaluminosilicate glass particles in a resin to form a resin/particle composition; applying the resin/particle composition to white spots on said surface of said tooth (Moshaverinia at claim 19) as per instant claim 1. Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]) as per instant claims 1 and 12. Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]) as per instant claims 7 and 18.
Moshaverinia differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Moshaverinia teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Moshaverinia to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
B) Claims 1, 3-4,6-7,10-12, 17-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Moshaverinia et al. (US Patent Application Publication 20190274932A1, provided in the IDS filed 01/26/2023) in view of Fowler (US Patent Application Publication 20100291163A1, provided in the IDS filed 01/26/2023).
Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2). Moshaverinia recites a method of using a composition to generate a layer of hydroxyapatite at the surface of a tooth, said method comprising: disposing the polydopamine-coated fluoroaluminosilicate glass particles in a resin to form a resin/particle composition; applying the resin/particle composition to white spots on said surface of said tooth (Moshaverinia at claim 19). Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]). Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]). Moshaverinia teaches that the composition may be a gel that can be used as over-the-counter product against enamel white spots (pre-carious lesions) and dentin sensitivity (Moshaverinia at [0023]).
The teachings of Moshaverinia differs from the instant claims insofar as they do not specifically teach that the nanoparticle coated is titanium dioxide. The teachings of Fowler cure this deficit.
Fowler recites an oral care composition comprising nanoparticulate titanium dioxide surface-coated (Fowler at claim 1). Fowler further teaches that nanoparticulate titanium dioxide strengthens and hardens dental enamel thereby providing protection against dental erosion and/or tooth wear (Fowler at [0013]). Fowler teaches an oral care composition comprising nanoparticulate titanium dioxide surface-coated with a polyol or polyvinylpyrrolidone (PVP) or a derivative thereof and an orally acceptable carrier or excipient (Fowler at [0018]). Fowler further teaches that the composition may be used for whitening teeth (Fowler at [0019]). Fowler further teaches that the composition with the coated nanoparticles may be a toothpaste (Fowler at [0034]). Fowler teaches that the toothpaste comprises between 0.25 and 20 % w/w of nanoparticulate titanium dioxide, for example between 0.5 and 10% w/w (Fowler at [0027]).
The teachings of Fowler differ from the instant claim insofar as they do not specifically disclose the use of polydopamine. The teachings of Moshaverinia cure this deficit.
One would have been motivated to have included titanium dioxide nanoparticles as the coated nanoparticles for their benefit to tooth strength, hardness and whitening as taught by Fowler. See MPEP 2144(II).
Regarding instant claim 1, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]). Moshaverinia recites a method of using a composition to generate a layer of hydroxyapatite at the surface of a tooth, said method comprising: disposing the polydopamine-coated fluoroaluminosilicate glass particles in a resin to form a resin/particle composition; applying the resin/particle composition to white spots on said surface of said tooth (Moshaverinia at claim 19).
Regarding instant claim 3, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Fowler teaches an oral care composition comprising nanoparticulate titanium dioxide surface-coated with a polyol or polyvinylpyrrolidone (PVP) or a derivative thereof and an orally acceptable carrier or excipient (Fowler at [0018]).
Regarding instant claim 4, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Fowler teaches an oral care composition comprising nanoparticulate titanium dioxide surface-coated with a polyol or polyvinylpyrrolidone (PVP) or a derivative thereof and an orally acceptable carrier or excipient (Fowler at [0018]).
Regarding instant claim 6, Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2).
Regarding instant claim 7, Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]).
Regarding instant claim 10, Moshaverinia teaches that the composition may be a gel that can be used as over-the-counter product against enamel white spots (pre-carious lesions) and dentin sensitivity (Moshaverinia at [0023]). Fowler further teaches that the composition with the coated nanoparticles may be a toothpaste (Fowler at [0034]).
Regarding instant claim 11, Fowler teaches that the toothpaste comprises between 0.25 and 20 % w/w of nanoparticulate titanium dioxide, for example between 0.5 and 10% w/w (Fowler at [0027]), which overlaps the instantly claimed range of about 1 to about 100mg/ml.
Regarding instant claim 12, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]).
Regarding instant claim 17, Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2).
Regarding instant claim 18, Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]).
Regarding instant claim 21, Moshaverinia teaches that the composition may be a gel that can be used as over-the-counter product against enamel white spots (pre-carious lesions) and dentin sensitivity (Moshaverinia at [0023]). Fowler further teaches that the composition with the coated nanoparticles may be a toothpaste (Fowler at [0034]).
Regarding instant claim 22, Fowler teaches that the toothpaste comprises between 0.25 and 20 % w/w of nanoparticulate titanium dioxide, for example between 0.5 and 10% w/w (Fowler at [0027]), which overlaps the instantly claimed range of about 1 to about 100mg/ml.
C) Claims 1, 3, 6-9, 12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moshaverinia et al. (US Patent Application Publication 20190274932A1, provided in the IDS filed 01/26/2023) in view of Weiss et al. (WO2019173834A1, as provide in the IDS filed 01/26/2023).
The teachings of Moshaverinia are discussed above.
The teachings of Moshaverinia differ from the instant claim insofar as they do not specifically teach alginate. The teachings of Weiss cure this deficit.
Weiss recites a dental hydrogel composition comprising: (a) polysaccharide; (b) polydopamine conjugated to the polysaccharide, wherein between 5 and 35% of polysaccharide sugar moieties are conjugated to polydopamine; (c) RGD peptide coupled to the polysaccharide-polydopamine conjugate; and (d) moieties that are crosslinkable upon exposure to light coupled to the polysaccharide; wherein components (a)-(d) are disposed in the composition such that the hydrogel composition: exhibits an adhesive strength of at least 10 kPa upon cross linking of crosslinkable moieties; and exhibits an elasticity between 5 kPa and 100 kPa upon cross linking of crosslinkable moieties (Weiss at claim 1).Weiss recites wherein the polysaccharide is selected from the group consisting of alginate, hyaluronic acid, heparin, chitosan, chondroitin sulfate, and carrageenan (Weiss at claim 10). Weiss further teaches an embodiment in Table 1 reproduced below;
PNG
media_image1.png
482
701
media_image1.png
Greyscale
.
The teachings of Weiss differ from the instant claims insofar are they do not specifically teach polydopamine HCl. The teachings of Moshaverinia cure this deficit.
Generally, it is prima facie obvious to select a known material (e.g. the alginate of Weiss) for incorporation into a composition (that of Moshaverinia), based on its recognized suitability for its intended use (a dental hydrogel comprising polydopamine). See MPEP 2144.07.
Regarding instant claim 1, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]). Moshaverinia recites a method of using a composition to generate a layer of hydroxyapatite at the surface of a tooth, said method comprising: disposing the polydopamine-coated fluoroaluminosilicate glass particles in a resin to form a resin/particle composition; applying the resin/particle composition to white spots on said surface of said tooth (Moshaverinia at claim 19).
Regarding instant claim 3, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Fowler teaches an oral care composition comprising nanoparticulate titanium dioxide surface-coated with a polyol or polyvinylpyrrolidone (PVP) or a derivative thereof and an orally acceptable carrier or excipient (Fowler at [0018]).
Regarding instant claim 6, Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2).
Regarding instant claim 7, Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]).
Regarding instant claim 8, Weiss recites wherein the polysaccharide for the dental hydrogel is selected from the group consisting of alginate, hyaluronic acid, heparin, chitosan, chondroitin sulfate, and carrageenan (Weiss at claim 10).
Regarding instant claim 9, Weiss recites a dental hydrogel composition comprising: (a) polysaccharide; (b) polydopamine conjugated to the polysaccharide, wherein between 5 and 35% of polysaccharide sugar moieties are conjugated to polydopamine (Weiss at claim 1). Weiss further shows polydopamine in a gel in an amount of 0.5% to 5% which overlaps the instantly claimed range of about 1% to about 5%. 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).
Regarding instant claim 12, Moshaverinia recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Moshaverinia at claim 1). Moshaverinia teaches that the particles coated in the polydopamine may be nanoparticles (Moshaverinia at [0085]).
Regarding instant claim 17, Moshaverinia recites wherein the thickness of the polydopamine or polydopamine HCl coating layer ranges between 5 and 100 nanometers in thickness (Moshaverinia at claim 2).
Regarding instant claim 18, Moshaverinia teaches that the particles coated in the polydopamine may be a hydrogel (Moshaverinia at [0071]).
Regarding instant claim 19, Weiss recites wherein the polysaccharide for the dental hydrogel is selected from the group consisting of alginate, hyaluronic acid, heparin, chitosan, chondroitin sulfate, and carrageenan (Weiss at claim 10).
Regarding instant claim 20, Weiss recites a dental hydrogel composition comprising: (a) polysaccharide; (b) polydopamine conjugated to the polysaccharide, wherein between 5 and 35% of polysaccharide sugar moieties are conjugated to polydopamine (Weiss at claim 1). Weiss further shows polydopamine in a gel in an amount of 0.5% to 5% which overlaps the instantly claimed range of about 1% to about 5%. 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).
D) Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Moshaverinia et al. (US Patent Application Publication 20190274932A1, provided in the IDS filed 01/26/2023) in view of Zhou (Polydopamine-induced Tooth Remineralization,2012, as provided in the IDS filed 01/26/2023).
The teachings of Moshaverinia are discussed above.
The teachings of Moshaverinia differ from the instant claim insofar as they do not specifically teach just polydopamine as the particle. The teachings of Zhou cure this deficit.
Zhou teaches that polydopamine on dental tissue induces enamel and dentin remineralization. Polydopamine promoted demineralized dentin remineralization and dentin tubules were occluded by densely packed hydroxyapatite (Zhou at abstract). Zhou further teaches that dopamine spontaneously forms polydopamine in aqueous solutions due to oxidative polymerization.
One would have been motivated to have simplified the methodology of creating polydopamine nanoparticles by producing the polydopamine in the manner taught by Zhou for a less expensive production method. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. See MPEP2144 (II). It would have been obvious to one of ordinary skill in the art to simplify the preparation of the polydopamine nanoparticles by using the methodology of Zhou to create a nanoparticle substantially made of polydopamine. See MPEP 2143(I)(F).
E) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Moshaverinia et al. (US Patent Application Publication 20190274932A1, provided in the IDS filed 01/26/2023) in view of Wang (US Patent Application Publication 20110171144A1, provide by the IDS filed 01/26/2023).
The teachings of Moshaverinia are discussed above.
The teachings of Moshaverinia differ from the instant claim insofar as they do not specifically teach the use of polyethylene glycol.
The teachings of Wang cure this deficit.
Wang recites a method for treating or inhibiting an oral disease or disorder in a subject, said method comprising administering to said subject a composition comprising:
a) micelles comprising i) at least one amphiphilic block copolymer linked to at least one tooth targeting moiety and ii) at least one encapsulated compound; and
b) at least one pharmaceutically acceptable carrier (Wang at claim 1). Wang recites wherein said oral disease or disorder is dental caries (Wang at claim 2). Wang recites the use of polyethylene glycol or PEG as a base for the micelles (Wang at claims 25-27). Wang teaches that the polyethylene glycol containing compositions are well-characterized and impart to the drug increased solubility, increased metabolic stability, and increased circulation time (Wang at [0028-0034]).
Wang does not specifically teach the use of polydopamine coating. The teachings of Moshaverinia cure this deficit.
One would have been motivated to have included PEG nanoparticles as the coated nanoparticles for their benefit to increased solubility, stability, and circulation as taught by Wang. See MPEP 2144(II).
Response to Arguments
Applicant's arguments filed 07/01/2025 have been fully considered but they are not persuasive.
Applicant argues that Moshaverinia is not prior art because of a 102(a)(2) and 102(a)(1) exception.
The Examiner does not agree. See MPEP 2153.01(a). If, however, the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies.
In this case, the publication (which is the Moshaverinia ‘932 prior art reference) names Tara C. Aghaloo; however, this individual is not named as an inventor of the instant application. As such, in view of the above-indicated text from the MPEP, it is not readily apparent that the instant application is an inventor originated disclosure. As such, Moshaverinia ‘932 remains prior art under AIA 35 U.S.C. 102(a)(1). Applicant’s arguments are insufficient to show that Moshaverinia ‘932 is not prior art.
The attorney argument has overcover the 102(a)(2) rejection in view of 35 U.S.C. 102(b)(2)(C). However, this does not overcome the 102(a)(1) rejection. AIA 35 U.S.C. 102(b)(1)(A) provides that a grace period disclosure shall not be prior art to a claimed invention under AIA 35 U.S.C. 102(a)(1) if the disclosure was made by the inventor or a joint inventor. An applicant may show that a disclosure was made by the inventor or a joint inventor by way of an affidavit or declaration under 37 CFR 1.130(a) (an affidavit or declaration of attribution). See In re Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA 1982) and MPEP § 717.01(a)(1). See MPEP2155.01. As such, the Applicant’s argument is not persuasive and the obviousness rejection stands.
New Rejections -Second Action Non-final
F) Claims 1-2, 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (Polydopamine-induced Tooth Remineralization,2012, as provided in the IDS filed 01/26/2023) in view of Bao et al. (“Polydopamine Nanoparticles as Efficient Scavengers for Reactive Oxygen Species in Periodontal Disease.” ACS Nano 2018, 12, 8882−8892).
Zhou teaches that polydopamine on dental tissue induces enamel and dentin remineralization. Polydopamine promoted demineralized dentin remineralization and dentin tubules were occluded by densely packed hydroxyapatite (Zhou at abstract). Zhou further teaches that dopamine spontaneously forms polydopamine in aqueous solutions due to oxidative polymerization. Zhou teaches polydopamine induced tooth remineralization.
Zhou differs from the claimed invention because in Zhou, the polydopamine is formed in situ from dopamine and is not presented in a nanoparticle form.
Bao is drawn to polydopamine nanoparticles for treatment of periodontal disease.
Bao differs from the claimed invention because Bao does not teach that polydopamine inherently results in tooth remineralization and does not suggest a hypocalcified tooth structure.
It would have been prima facie obvious for one of ordinary skill in the art to have administered the polydopamine nanoparticles of Bao to have achieved tooth remineralization, as desired by Zhou. Zhou teaches that polydopamine nanoparticles cause tooth remineralization. Bao teaches a method of introducing polydopamine nanoparticles to teeth. As such, the skilled artisan would have been motivated to have used the nanoparticles of Bao to have predictably remineralized teeth, as desired by Zhou, with a reasonable expectation of success, because Zhou teaches that polydopamine remineralizes teeth and Bao is drawn to polydopamine intended to be applied to teeth.
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.
A) Claims 1, 6-7, 12, 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US 10667994 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a fluoroaluminosilicate glass which is not required by the instant invention.
The instant application recites a method for remineralizing a hypocalcified tooth structure, said method comprises contacting said tooth structure with a composition comprising polydopamine nanoparticles. The instant application further recites a composition for remineralizing a hypocalcified tooth structure, said composition comprising polydopamine nanoparticles.
The reference patent recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Patent ‘994 at claim 1). The reference patent recites wherein the thickness of the polydopamine coating layer ranges between 5 and 100 nanometers in thickness (Patent ‘994 at claim 2). The reference patent recites wherein said polydopamine comprises polydopamine HCl (Patent ‘994 at claim 13). The reference patent recites a method of using the cement composition of claim 3 in dentistry, the method comprising: a) mixing said fluoroaluminosilicate glass particles coated by polydopamine (PDA) with said fluoroaluminosilicate glass particles not coated by polydopamine (PDA) to form a powder mixture; b) disposing the formed mixture at an in vivo site (Patent ‘994 at claim 14).The reference patent recites wherein the method further comprising applying said cement to a tooth such that said cement composition acts as a material to bond to carious lesions, a material to reduce teeth sensitivity, as a material to promote mineralization of teeth white spots or to any combination thereof (Patent ‘994 at claim 18).
B) Claims 1, 3-4,6-7,10-12, 17-18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US 10667994 B2 in view of Fowler (US Patent Application Publication 20100291163A1, provided in the IDS filed 01/26/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a fluoroaluminosilicate glass which is not required by the instant invention.
The instant application recites a method for remineralizing a hypocalcified tooth structure, said method comprises contacting said tooth structure with a composition comprising polydopamine nanoparticles. The instant application further recites a composition for remineralizing a hypocalcified tooth structure, said composition comprising polydopamine nanoparticles.
The reference patent recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Patent ‘994 at claim 1). The reference patent recites wherein the thickness of the polydopamine coating layer ranges between 5 and 100 nanometers in thickness (Patent ‘994 at claim 2). The reference patent recites wherein said polydopamine comprises polydopamine HCl (Patent ‘994 at claim 13). The reference patent recites a method of using the cement composition of claim 3 in dentistry, the method comprising: a) mixing said fluoroaluminosilicate glass particles coated by polydopamine (PDA) with said fluoroaluminosilicate glass particles not coated by polydopamine (PDA) to form a powder mixture; b) disposing the formed mixture at an in vivo site (Patent ‘994 at claim 14).The reference patent recites wherein the method further comprising applying said cement to a tooth such that said cement composition acts as a material to bond to carious lesions, a material to reduce teeth sensitivity, as a material to promote mineralization of teeth white spots or to any combination thereof (Patent ‘994 at claim 18).
The teachings of the reference patent differs from the instant claims insofar as they do not specifically teach that the nanoparticle coated is titanium dioxide. The teachings of Fowler. Cure this deficit.
Fowler recites an oral care composition comprising nanoparticulate titanium dioxide surface-coated (Fowler at claim 1). Fowler further teaches that nanoparticulate titanium dioxide strengthens and hardens dental enamel thereby providing protection against dental erosion and/or tooth wear (Fowler at [0013]). Fowler teaches an oral care composition comprising nanoparticulate titanium dioxide surface-coated with a polyol or polyvinylpyrrolidone (PVP) or a derivative thereof and an orally acceptable carrier or excipient (Fowler at [0018]). Fowler further teaches that the composition may be used for whitening teeth (Fowler at [0019]). Fowler further teaches that the composition with the coated nanoparticles may be a toothpaste (Fowler at [0034]). Fowler teaches that the toothpaste comprises between 0.25 and 20 % w/w of nanoparticulate titanium dioxide, for example between 0.5 and 10% w/w (Fowler at [0027]).
The teachings of Fowler differ from the instant claim insofar as they do not specifically disclose the use of polydopamine. The teachings of the reference patent cure this deficit.
One would have been motivated to have included titanium dioxide nanoparticles as the coated nanoparticles for their benefit to tooth strength, hardness and whitening as taught by Fowler. See MPEP 2144(II).
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
C) Claims 1, 3, 6-9, 12, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US 10667994 B2 in view of Weiss et al. (WO2019173834A1, as provide in the IDS filed 01/26/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a fluoroaluminosilicate glass which is not required by the instant invention.
The instant application recites a method for remineralizing a hypocalcified tooth structure, said method comprises contacting said tooth structure with a composition comprising polydopamine nanoparticles. The instant application further recites a composition for remineralizing a hypocalcified tooth structure, said composition comprising polydopamine nanoparticles.
The reference patent recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Patent ‘994 at claim 1). The reference patent recites wherein the thickness of the polydopamine coating layer ranges between 5 and 100 nanometers in thickness (Patent ‘994 at claim 2). The reference patent recites wherein said polydopamine comprises polydopamine HCl (Patent ‘994 at claim 13). The reference patent recites a method of using the cement composition of claim 3 in dentistry, the method comprising: a) mixing said fluoroaluminosilicate glass particles coated by polydopamine (PDA) with said fluoroaluminosilicate glass particles not coated by polydopamine (PDA) to form a powder mixture; b) disposing the formed mixture at an in vivo site (Patent ‘994 at claim 14).The reference patent recites wherein the method further comprising applying said cement to a tooth such that said cement composition acts as a material to bond to carious lesions, a material to reduce teeth sensitivity, as a material to promote mineralization of teeth white spots or to any combination thereof (Patent ‘994 at claim 18).
Weiss recites a dental hydrogel composition comprising: (a) polysaccharide; (b) polydopamine conjugated to the polysaccharide, wherein between 5 and 35% of polysaccharide sugar moieties are conjugated to polydopamine; (c) RGD peptide coupled to the polysaccharide-polydopamine conjugate; and (d) moieties that are crosslinkable upon exposure to light coupled to the polysaccharide; wherein components (a)-(d) are disposed in the composition such that the hydrogel composition: exhibits an adhesive strength of at least 10 kPa upon cross linking of crosslinkable moieties; and exhibits an elasticity between 5 kPa and 100 kPa upon cross linking of crosslinkable moieties (Weiss at claim 1).Weiss recites wherein the polysaccharide is selected from the group consisting of alginate, hyaluronic acid, heparin, chitosan, chondroitin sulfate, and carrageenan (Weiss at claim 10). Weiss further teaches an embodiment in Table 1 reproduced below;
PNG
media_image1.png
482
701
media_image1.png
Greyscale
.
The teachings of Weiss differ from the instant claims insofar are they do not specifically teach polydopamine HCl. The teachings of the reference patent cure this deficit.
Generally, it is prima facie obvious to select a known material (e.g. the alginate of Weiss) for incorporation into a composition (that of the reference patent), based on its recognized suitability for its intended use (a dental hydrogel comprising polydopamine). See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
D) Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US 10667994 B2 in view of Zhou (Polydopamine-induced Tooth Remineralization,2012, as provided in the IDS filed 01/26/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a fluoroaluminosilicate glass which is not required by the instant invention.
The instant application recites a method for remineralizing a hypocalcified tooth structure, said method comprises contacting said tooth structure with a composition comprising polydopamine nanoparticles. The instant application further recites a composition for remineralizing a hypocalcified tooth structure, said composition comprising polydopamine nanoparticles.
The reference patent recites a glass ionomer cement composition comprising fluoroaluminosilicate glass particles coated by polydopamine (PDA) (Patent ‘994 at claim 1). The reference patent recites wherein the thickness of the polydopamine coating layer ranges between 5 and 100 nanometers in thickness (Patent ‘994 at claim 2). The reference patent recites wherein said polydopamine comprises polydopamine HCl (Patent ‘994 at claim 13). The reference patent recites a method of using the cement composition of claim 3 in dentistry, the method comprising: a) mixing said fluoroaluminosilicate glass particles coated by polydopamine (PDA) with said fluoroaluminosilicate glass particles not coated by polydopamine (PDA) to form a powder mixture; b) disposing the formed mixture at an in vivo site (Patent ‘994 at claim 14).The reference patent recites wherein the method further comprising applying said cement to a tooth such that said cement composition acts as a material to bond to carious lesions, a material to reduce teeth sensitivity, as a material to promote mineralization of teeth white spots or to any combination thereof (Patent ‘994 at claim 18).
The teachings of the reference patent differ from the instant claim insofar as they do not specifically teach just polydopamine as the particle. The teachings of Zhou cure this deficit.
Zhou teaches that polydopamine on dental tissue induces enamel and dentin remineralization. Polydopamine promoted demineralized dentin remineralization and dentin tubules were occluded by densely packed hydroxyapatite (Zhou at abstract). Zhou further teaches that dopamine spontaneously forms polydopamine in aqueous solutions due to oxidative polymerization.
One would have been motivated to have simplified the methodology of creating polydopamine nanoparticles by producing the polydopamine in the manner taught by Zhou for a less expensive production method. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. See MPEP2144 (II). It would have been obvious to one of ordinary skill in the art to simplify the preparation of the polydopamine nanoparticles by using the methodology of Zhou to create a nanoparticle substantially made of polydopamine. See MPEP 2143(I)(F).
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
Response to Arguments
Applicant's arguments filed 07/01/2025 have been fully considered but they are not persuasive.
Applicant states that should the double-patenting rejection remain after allowable subject matter is found, Applicant will address it at that time.
Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejections are maintained.
Conclusion
No claims are presently allowable. This is a non-final rejection due to the new rejection not required by amendment.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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, Frederick Krass can be reached on (571) 272-0580. 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.
/AMANDA MICHELLE PETRITSCH/ Examiner, Art Unit 1612
/ISAAC SHOMER/Primary Examiner, Art Unit 1612