DETAILED ACTION
The claims 1-17 are pending and presented for the examination.
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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/26/2023, 10/11/2023, 04/02/2024, 04/24/2024, 06/10/2024, 10/08/2024, 03/04/2025, and 09/16/2025 are being considered by the examiner.
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 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 contains limitations to ranges for four components with a lower bound of 0 wt% for each. This indicates that the limitation is met if the amounts of each of said four components is not greater than the maximum amount of the corresponding range, and the limitation would be met if the amount of each component was 0 wt%. Because the other dependent claims in the application that contain limitations to ranges of additional components each have >0 wt% (greater than zero) as their lower bound, it is unclear if this is also the intended limitation for the ranges of claim 5. The lack of clarity in this regard renders the scope of what is intended to be covered by the claim unclear under USC 112.
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, 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.
Claims 1, 3-7, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Moimas et al (US 8093166 B2) in view of Danielson et al (US 2017/0174555 A1).
Regarding claim 1, Moimas et al teaches a bioactive glass composition comprising SiO2, MgO, P2O5, and CaO in amounts that each fall within the corresponding ranges of the instant claim. See i.e. Table 1, glass A and glass D). Moimas et al teach that the inventive glass, as a bioactive material, induces the formation of a surface layer of hydroxycarbonate apatite onto the glass in the presence of an environment of simulated body fluid (see column 1, lines 20-30). Thus, the glass forms a bioactive (apatite) crystalline phase in a simulated body fluid.
Moimas et al does not teach that the inventive glass has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719. However, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to modify Moimas et al in view of Danielson et al in order to produce a glass with this hydrolytic resistance property. Danielson et al teaches a glass composition that has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719 (see paragraph 0066). One of ordinary skill in the art would have had motivation to modify Moimas et al in view of Danielson et al in order to achieve this hydrolytic resistance property because doing so would enhance the chemical durability of the glass compositions, thereby improving their stability (see Danielson paragraph 0038). One of ordinary skill would have had a reasonable expectation of success in the modification because Moimas and Danielson are each drawn to similarly composed glasses used in the same medical applications. As such, each limitation of instant claim 1 is met by the teachings of the prior art of record, and the claim is obvious and not patentably distinct.
Regarding claim 3, Moimas et al teaches glasses comprising Na2O in an amount of less than 10 wt% (see Table 1, glass A and glass D).
Regarding claim 4, the claim differs from Moimas et al because Moimas et al does not teach that the glasses contain ZrO2. However, as discussed above, it would have been obvious to a skilled artisan to modify Moimas et al in view of Danielson et al. Danielson et al teaches that the inventive glasses contain ZrO2 in minor amounts added as fining agents and/or to further enhance the chemical durability of the glass composition (see paragraph 0038). Each of these would provide motivation to include greater than 0 wt% ZrO2 in the Moimas et al glass, and as such the further limitations of claim 4 are met by the teachings of the prior art of record.
Regarding claim 5, Moimas et al teaches glasses comprising between 0 and 5 wt% B-2O3 (see Table 1).
Regarding claim 6, Moimas et al teaches a glass comprising 25 wt% MO and 18 wt% R2O (see Table 1, glass A).
Regarding claim 7, Moimas et al teaches that the surface layer crystalline phase formed is hydroxycarbonate apatite (see column 1, lines 20-30).
Regarding claim 15, Moimas et al teaches that the inventive glass is used in the form of fibers in combination with a biocompatible polymeric film (see column 8, lines 37-42).
Regarding claim 16, Moimas et al teaches that the glass is attached to the polymer film.
Regarding claim 17, as discussed above, Moimas et al teaches that the glass forms apatite crystalline phase in a simulated body fluid environment. As this is an aqueous medium, Moimas et al thus teaches an aqueous environment comprising the inventive glass composition.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Moimas et al (US 8093166 B2) in view of Danielson et al (US 2017/0174555 A1) and in further view of Da Fonte Ferreira et al (US 9238044 B2).
Regarding claim 2, the claim differs from Moimas et al as applied above because Moimas et al does not teach that the inventive glass comprises greater than 0 wt% to 5 wt% F-. However, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to modify Moimas et al in further view of Da Fonte Ferreira et al in order to include a fluoride component in the inventive glass. Da Fonte Ferreira et al teaches a bioactive glass that is compositionally similar to that taught by Moimas and used in the same applications, and teaches that the inventive glass comprises >0-5 wt.% F- (see paragraph 0034, calcium fluoride in the form of CaF2, between 0-5%; paragraph 0035, in mol% corresponding to 0-3.90 wt.% CaF2 or 0-1.90 wt.% F-). One of ordinary skill would have had motivation to include the F- component from Da Fonte Ferreira et al in the Moimas et al glass in order to realize the advantageous result of promoting the formation of a thermodynamically stable mixed apatite, thereby preventing dissolution of the glass composition (see paragraph 0117). One would have had a reasonable expectation of success in the motivation because Moimas et al and Da Fonte Ferreira et al are drawn to similarly composed glass compositions used for bioactive applications. Each limitation of instant claim 4 is therefore met by the teachings of the prior art of record, and the claim is obvious and not patentably distinct
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Da Fonte Ferreira et al (US 9238044 B2) in view of Danielson et al (US 2017/0174555 A1).
Regarding claim 1, Da Fonte Ferreira et al teaches a bioactive glass composition that promote a layer of carbonated hydroxyapatite upon immersion in simulated body fluid (see Abstract). Da Fonte Ferreira et al teaches a glass composition that meets each compositional limitation of instant claim 1 (see Table 1, example FA-30; converted from mol% to wt% this glass comprises 39.10 wt% SiO2, 12.74 wt% P2O5, 13.12 wt% MgO, 35.04 wt% CaO). The Da Fonte Ferreira et al glass forms a bioactive (apatite) crystalline phase in a simulated body fluid.
Da Fonte Ferreira et al does not teach that the inventive glass has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719. However, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to modify Da Fonte Ferreira et al in view of Danielson et al in order to produce a glass with this hydrolytic resistance property. Danielson et al teaches a glass composition that has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719 (see paragraph 0066). One of ordinary skill in the art would have had motivation to modify Da Fonte Ferreira et al in view of Danielson et al in order to achieve this hydrolytic resistance property because doing so would enhance the chemical durability of the glass compositions, thereby improving their stability (see Danielson paragraph 0038). One of ordinary skill would have had a reasonable expectation of success in the modification because Da Fonte Ferreira and Danielson are each drawn to similarly composed glasses used in the same medical applications. As such, each limitation of instant claim 1 is met by the teachings of the prior art of record, and the claim is obvious and not patentably distinct.
Regarding claim 2, Da Fonte Ferreira et al teaches that the inventive glass comprises >0-5 wt.% F- (see paragraph 0034, calcium fluoride in the form of CaF2, between 0-5%; paragraph 0035, in mol% corresponding to 0-3.90 wt.% CaF2 or 0-1.90 wt.% F-).
Regarding claim 3, Da Fonte Ferreira et al teaches that the inventive glass contains oxides such as Na2O in amounts less than 10 wt% (see column 7, lines 1-8 and Table 3).
Regarding claim 4, the claim differs from Da Fonte Ferreira et al because Da Fonte Ferreira et al does not teach that the glasses contain ZrO2. However, as discussed above, it would have been obvious to a skilled artisan to modify Da Fonte Ferreira et al in view of Danielson et al. Danielson et al teaches that the inventive glasses contain ZrO2 in minor amounts added as fining agents and/or to further enhance the chemical durability of the glass composition (see paragraph 0038). Each of these would provide motivation to include greater than 0 wt% ZrO2 in the Da Fonte Ferreira et al glass, and as such the further limitations of claim 4 are met by the teachings of the prior art of record.
Regarding claim 5, Da Fonte Ferreira et al teaches glass comprising SrO in amounts of less than 10 wt% (see Table 7 and claim 10).
Regarding claim 6, the aforementioned Da Fonte Ferreira et al FA-30 glass comprises 48.16 wt% MO and 0 wt% R2O.
Regarding claim 7, Da Fonte Ferreira et al teaches the formation of carbonated hydroxyapatite.
Regarding claim 8, the aforementioned Da Fonte Ferreira et al FA-30 glass comprises 47.78 wt% P2O5+CaO.
Regarding claim 9, Da Fonte Ferreira et al teaches a bioactive glass composition that promote a layer of carbonated hydroxyapatite upon immersion in simulated body fluid (see Abstract). Da Fonte Ferreira et al teaches a glass composition that meets each compositional limitation of instant claim 9 (see Table 1, example FA-30; converted from mol% to wt% this glass comprises 39.10 wt% SiO2, 12.74 wt% P2O5, 13.12 wt% MgO, 35.04 wt% CaO). The Da Fonte Ferreira et al glass forms a bioactive (apatite) crystalline phase in a simulated body fluid.
Da Fonte Ferreira et al does not teach that the inventive glass has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719. However, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to modify Da Fonte Ferreira et al in view of Danielson et al in order to produce a glass with this hydrolytic resistance property. Danielson et al teaches a glass composition that has a hydrolytic resistance of glass grains (HGB) of at most 3 as measured by International Organization for Standardization section 719 (see paragraph 0066). One of ordinary skill in the art would have had motivation to modify Da Fonte Ferreira et al in view of Danielson et al in order to achieve this hydrolytic resistance property because doing so would enhance the chemical durability of the glass compositions, thereby improving their stability (see Danielson paragraph 0038). One of ordinary skill would have had a reasonable expectation of success in the modification because Da Fonte Ferreira and Danielson are each drawn to similarly composed glasses used in the same medical applications. As such, each limitation of instant claim 9 is met by the teachings of the prior art of record, and the claim is obvious and not patentably distinct.
Regarding claim 10, Da Fonte Ferreira et al teaches that the inventive glass comprises >0-3 wt.% F- (see paragraph 0034, calcium fluoride in the form of CaF2, between 0-5%; paragraph 0035, in mol% corresponding to 0-3.90 wt.% CaF2 or 0-1.90 wt.% F-).
Regarding claim 11, Da Fonte Ferreira et al teaches that the inventive glass contains oxides such as Na2O in amounts less than 10 wt% (see column 7, lines 1-8 and Table 3).
Regarding claim 12, the claim differs from Da Fonte Ferreira et al because Da Fonte Ferreira et al does not teach that the glasses contain ZrO2. However, as discussed above, it would have been obvious to a skilled artisan to modify Da Fonte Ferreira et al in view of Danielson et al. Danielson et al teaches that the inventive glasses contain ZrO2 in minor amounts added as fining agents and/or to further enhance the chemical durability of the glass composition (see paragraph 0038). Each of these would provide motivation to include greater than 0 wt% ZrO2 in the Da Fonte Ferreira et al glass, and as such the further limitations of claim 12 are met by the teachings of the prior art of record.
Regarding claim 13, Da Fonte Ferreira et al teaches the formation of carbonated hydroxyapatite.
Regarding claim 14, the aforementioned Da Fonte Ferreira et al FA-30 glass comprises 47.78 wt% P2O5+CaO.
Regarding claim 15, Da Fonte Ferreira et al teaches that the inventive glass is used as incorporated into a matrix that is a toothpaste (see column 15, lines 55-60).
Regarding claim 16, the Da Fonte Ferreira et al glass is mixed into the toothpaste.
Regarding claim 17, Da Fonte Ferreira et al teaches that the inventive glass can be present in aqueous environments (see column 5, lines 17-20).
Conclusion
15. No claim is allowed.
16. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH S WIESE whose telephone number is (571)270-3596. The examiner can normally be reached on Monday-Friday, 7:30am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amber Orlando can be reached on 571-270-3149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH S WIESE/Primary Examiner, Art Unit 1731
NSW28 January 2026