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 I (claims 1-12) in the reply filed on 01/12/26 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-12 are included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 04/24/24; 06/10/24; 10/08/24; and 03/04/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copy of PTO-1449.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, penultimate line, the article “an” should be added before the term “artificial.” 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.
Claim(s) 1-12 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.
Claims 1 and 2 recite “Table 1A or 1B”. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claims 3-12 are included for not correcting the defects of the claims from which they depend.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Materials Today Communications 28 (2021): 102515, pp. 1-9 – “Wang”) in view of Gibson et al. (US 2011/0244430 A1 – “Gibson”).
Instant claim 1 is drawn to a composition, comprising:
an amino acid; and
a bioactive glass, comprising:
15-55 wt.% SiO2;
0.1-15 wt.% ZrO2;
20-60 wt.% CaO; and
5-30 wt.% P2O5;
wherein, when the composition is subjected to artificial saliva of Table 1A or 1B at 37°C, a bioactive crystalline phase is formed within 7 days.
Wang teaches that a combination of an amino acid containing peptide (an arginine-glycine-aspartate-serin (RGDS) peptide) and bioactive glass induces dentin remineralization (Title and Abstract). The RGDS peptide could bind to dentin, promote the attachment of nanobioactive glass (nBG), and lead to remineralization of dentin (Abstract, sections 2.1, 2.2, 3.1-3.4, Figs. 1-5). The nBG has molar compositions of 58% SiO2; 33% CaO; and 9% P2O5 (section 2.2). The film composition comprises bioactive glass in an amount of about 1-60% by weight of the film (claims 1 and 9).
Wang does not expressly teach a composition 0.1-15 wt.% ZrO2.
Gibson teaches a film composition for tooth remineralization, wherein the film comprises a bioactive glass (Abstract). The bioactive glass includes less than about 15%, and sometimes less than about 10%, 5%, or even about 2% by weight of ZrO2 ([0052]). Gibson teaches that saliva dissolves the film and releases calcium and phosphorous ions to help form hydroxy carbonate apatite on the tooth ([0030]). The film comprises 40-80% by weight of SiO2 (claims 1 and 10), less than about 15%, and sometimes less than about 10%, 5%, or even about 2% by weight of ZrO2 ([0052]), about 4-46% by weight of CaO (claims 1 and 10), and 1-15% by weight of P2O5 (claims 1 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition containing a combination of amino acids and nanobioactive glass (nBG) that leads to remineralization of dentin, wherein the nBG has molar compositions of 58% SiO2; 33% CaO; and 9% P2O5, as taught by Wang, in view of the film composition for tooth remineralization, wherein the composition comprises a bioactive glass which includes less than about 15% of ZrO2, and wherein saliva dissolves the film and releases calcium and phosphorous ions to help form hydroxy carbonate apatite on the tooth, as taught by Gibson, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references teach compositions containing the same components, i.e., bioactive glass, for the same purpose, i.e., remineralization of teeth. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
One of ordinary skill in the art would have found it obvious to use the bioactive glass containing less than about 15% by weight of ZrO2, as taught by Gibson in the combination taught by Wang based on MPEP 2144.06(I) which states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said bioactive glass constituents with a reasonable expectation of success because the constituents of the bioactive glass are taught to be useful for the same purpose and it is prima facie obvious to combine said constituents to form a third composition to be used for the very same purpose.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a composition comprising an amino acid and a bioactive glass would have been obvious over the combination of an amino acid containing peptide (an arginine-glycine-aspartate-serin (RGDS) peptide) and bioactive glass induces dentin remineralization (Title and Abstract), as taught by Wang.
Regarding instant claim 1, the limitation of a bioactive glass comprising 15-55 wt.% SiO2 would have been obvious over the film comprising an overlapping amount of 40-80% by weight of SiO2 (claims 1 and 10), as taught by Gibson. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 1, the limitation of a bioactive glass comprising 0.1-15 wt.% ZrO2 would have been obvious over the bioactive glass which includes an overlapping amount of less than about 15%, and sometimes less than about 10%, 5%, or even about 2% by weight of ZrO2 ([0052]), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 1, the limitation of 20-60 wt.% CaO would have been obvious over the film comprising an overlapping amount of about 4-46% by weight of CaO (claims 1 and 10), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 1, the limitation of 5-30 wt.% P2O5 would have been obvious over the film comprising an overlapping amount of 1-15% by weight of P2O5 (claims 1 and 10), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 1, the limitation of “wherein, when the composition is subjected to artificial saliva of Table 1A or 1B at 37°C, a bioactive crystalline phase is formed within 7 days” would have been obvious over the saliva dissolving the film and releasing the calcium and phosphorous ions to help form hydroxy carbonate apatite on the tooth ([0030]), as taught by Gibson. The limitation of the specific artificial saliva recited in Tables 1A or 1B would have been an obvious experimental variant over the saliva taught by Gibson and the composition would be expected to form the bioactive crystalline phase since hydroxy carbonate apatite is formed on the tooth. The time period of 7 days would have been expected variant based on the desired level of tooth mineralization and the patient’s level of tooth decay in need of mineralization.
Regarding instant claim 2, the limitation of “wherein, when the composition is subjected to artificial saliva of Table 1A or 1B at 37°C, a bioactive crystalline phase is formed within 1 day” would have been obvious over the saliva dissolving the film and releasing the calcium and phosphorous ions to help form hydroxy carbonate apatite on the tooth ([0030]), as taught by Gibson. The time period of 7 days would have been expected variant based on the desired level of tooth mineralization and the patient’s level of tooth decay in need of mineralization.
Regarding instant claim 3, the limitation of the bioactive crystalline phase comprising apatite would have been obvious over the formation of hydroxy carbonate apatite on the tooth ([0030]), as taught by Gibson.
Regarding instant claim 4, the limitation of the bioactive glass present in an amount of >0-20 wt.%, based on the total weight of the composition would have been obvious over the film composition that comprises bioactive glass in an overlapping amount of about 1-60% by weight of the film (claims 1 and 9), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 5, the limitation of the bioactive glass comprising 25-35 wt.% SiO2 would have been obvious over the film comprising 40-80% by weight of SiO2 (claims 1 and 10), as taught by Gibson. The upper limit of the claimed range, i.e., 35 wt.%, is closed to the lower limit of the claim disclosed by Gibson. MPEP 2144.05(I) states: “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
Regarding instant claim 5, the limitation of 35-50 wt.% CaO would have been obvious over the film comprising an overlapping amount of about 4-46% by weight of CaO (claims 1 and 10), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 5, the limitation of 15-25 wt.% P2O5 would have been obvious over the film comprising 1-15% by weight of P2O5 (claims 1 and 10), as taught by Gibson. The lower limit of the claimed range, i.e., 15% is the same as the upper limit of the range disclosed by Gibson. Please see MPEP 2144.05.
Regarding instant claim 5, the limitation of 3-12 wt.% ZrO2 would have been obvious over the bioactive glass which includes an overlapping amount of less than about 15% ZrO2 ([0052]), as taught by Gibson. Please see MPEP 2144.05.
Regarding instant claim 6, the limitation of CaO + P2O5 in an amount of 40-70 wt.% based on the total weight of the bioactive glass would have been obvious over the film comprising about 4-46% by weight of CaO and 1-15% by weight of P2O5 (claims 1 and 10), as taught by Gibson. Based on the disclosure by Gibson the calculated weight percentage range of CaO + P2O5 is 5-61%, which overlaps and renders obvious the claimed range of 40-70 wt.%. Please see MPEP 2144.05.
Regarding instant claim 8, the limitation of glycine would have been obvious over the RGDS peptide which contains glycine (Abstract), as taught by Wang.
Regarding instant claim 9, the limitation of arginine would have been obvious over the RGDS peptide which contains arginine (Abstract), as taught by Wang.
Regarding instant claim 10, the limitation of a polymer film would have been obvious over the film composition (Abstract) which contains a water soluble polymeric film former (claim 1), as taught by Gibson.
Regarding instant claim 11, the limitation of a dentifrice would have been obvious over the dentifrices ([0066] and [0101]), as taught by Gibson.
Regarding instant claim 12, the limitations of glycerin, a humectant, a fluoride ion source, a flavoring, a surfactant, a sweetener, a thickening agent, and a preservative would have been obvious over the glycerol ([0086]), humectants ([0061] and [0118]), fluorides and fluoride ion sources ([0041], [0049], [0058], [0061], [0074], [0095]), the flavor oils and additional flavorings ([0077]-[0079]), surfactants ([0061]), sweetening agents ([0080]-[0085]), thickening agents ([0061]), and preservatives ([0061]), as taught by Gibson.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Materials Today Communications 28 (2021): 102515, pp. 1-9 – “Wang”) in view of Gibson et al. (US 2011/0244430 A1 – “Gibson”), as applied to claims 1-6 and 8-12 above, in view of Zaidel et al. (US 2012/0020899 A1 – “Zaidel”).
Instant claim 7 is drawn to the composition of claim 1, wherein the amino acid is present in an amount of >0-25 wt.%, based on the total weight of the composition.
The teachings of Wang and Gibson are discussed above.
Wang and Gibson do not expressly teach that the amino acid is present in an amount of >0-25 wt.%, based on the total weight of the composition.
Zaidel teaches an oral care composition comprising bioactive glass and one or more bioadhesive agents (Abstract, claim 1). The bioadhesive agent comprises amino acids including arginine (claims 2 and 5). The bioadhesive agent comprises from 0.1 wt.% to 70 wt.% by weight of the composition ([0031] and claim 4). The composition additionally comprises one or more occlusion agents (claim 3), which include arginine/calcium carbonate, arginine bicarbonate/calcium carbonate (claim 4). Suitable bioacceptable and bioactive glasses may have compositions including: from 40 wt. % to 86 wt. % of silicon dioxide (SiO2); from 4 wt. % to 46 wt. % of calcium oxide (CaO); and from 1 wt. % to 15 wt. % of phosphorus oxide (P2O5) ([0077]). Zaidel teaches remineralizaing enamel in a subject in need thereof comprising contacting a tooth structure with an effective amount of one or more occlusion agents and one or more bioadhesive polymers ([0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition containing a combination of amino acids and nanobioactive glass (nBG) that leads to remineralization of dentin, wherein the nBG has molar compositions of 58% SiO2; 33% CaO; and 9% P2O5, as taught by Wang, in view of the film composition for tooth remineralization, wherein the composition comprises a bioactive glass which includes less than about 15% of ZrO2, and wherein saliva dissolves the film and releases calcium and phosphorous ions to help form hydroxy carbonate apatite on the tooth, as taught by Gibson, further in view of the oral care composition comprising bioactive glass and one or more bioadhesive agents, wherein the bioadhesive agent comprises amino acids including arginine and the bioadhesive agent comprises from 0.1 wt.% to 70 wt.% by weight of the composition, as taught by Zaidel, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references teach compositions containing the same components, i.e., bioactive glass, for the same purpose, i.e., remineralization of teeth. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
One of ordinary skill in the art would have found it obvious to use the amino acid in an amount of 0.1 wt.% to 70 wt.% by weight of the composition ([0031] and claim 4), as taught by Zaidel in the combination taught by Wang based on MPEP 2144.06(I).
Regarding instant claim 7, the limitation of the amino acid present in an amount of >0-25 wt.%, based on the total weight of the composition would have been obvious over the oral care composition comprising bioactive glass and one or more bioadhesive agents (Abstract, claim 1), wherein the bioadhesive agent comprises amino acids including arginine (claims 2 and 5), and wherein the bioadhesive agent comprises from 0.1 wt.% to 70 wt.% by weight of the composition ([0031] and claim 4), as taught by Zaidel. Please see MPEP 2144.05.
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 1-12 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9, 11-12, and 14 of copending Application No. 18/642,098 (the ‘098 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a composition, comprising: an amino acid; and a bioactive glass, comprising: 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P2O5; wherein, when the composition is subjected to artificial saliva of Table 1A or 1B at 37°C, a bioactive crystalline phase is formed within 7 days, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘098 Application recites an aqueous dentifrice formulation whereas instant claim 1 recites a broader composition. However, the aqueous dentifrice formulation of the ‘098 Application anticipates and renders the obvious the generic composition recited in instant claim 1. Furthermore, instant claim 2 recites that the composition comprises water, thereby obviating the aqueous limitation. Also, instant claim 11 recites a dentifrice composition, thereby obviating the dentifrice limitation.
Another difference is that claim 1 of the ‘098 Application recites a carrier whereas instant claims are silent with respect to a carrier. However, instant claims recite the transitional phrase “comprising,” which is considered open language and allows the inclusion of additional components. Moreover, since instant claim 11 recites a dentifrice one of ordinary skill in the art would have found it obvious to include a suitable carrier for the dentifrice.
Yet another difference is that claim 1 of the ‘098 Application recites several properties of the bioactive glass which are not recited in the instant claims. However, the same bioactive glass having the same constituents with overlapping concentrations are recited in both sets of claims. For example, instant claim 1 recites the bioactive glass comprises 15-55 wt.% SiO2; 0.1-15 wt.% ZrO2; 20-60 wt.% CaO; and 5-30 wt.% P2O5; and claim 6 of the ‘098 Application recites 15-65 wt.% SiO2; 150-60 wt.% CaO; and 1-30 wt.% P2O5; and claim 7 of the ‘098 Application recites >0-20 wt.% ZrO2. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” Since the same compositions are recited in both claim sets the same properties would have been expected.
Therefore, instant claims are obvious over claims of the ‘098 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615