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
To summarize the current election, the applicant elected group I, without traverse.
The restriction was deemed proper and therefore made FINAL.
Claims 14-17, 19-20, 22-23, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The applicant is reminded to update the claim status identifiers in accordance with those under examination, in light of the restriction and any amendments that have been made.
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.
Claims 12 and 13 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.
Claim 12 recites that the composition forms tri-calcium phosphate. This is a functional recitation whose corresponding scope is unclear. In one regard, it is unclear whether any of the compositions of claim 1 are unable to form tri-calcium phosphate, given the general discussion in the specification that the bioactive glasses of the invention maintain neutral pH which encourages the formation of tri-calcium phosphate (see paragraph 41). In addition, no explicit requirements for particular proportions of constituent materials are recited in the claim. Thus it is unclear which subset of compositions has the claimed functionality.
Claim 13 recites that the composition maintains a neutral pH as it degrades in contact with tissue. pH is a solution property; thus this limitation is not a feature of the claimed bioactive glass which is a solid. The claim does not recite the liquid environment in which the pH is to be assessed. In addition, no requirements for particular proportions of constituent material are recited in the claim. Thus it is unclear which subset of compositions has the claimed functionality such that the scope of the claim is narrower than that of the parent claim.
For the sake of application of prior art, the functional limitations of these claims will be deem as met when the recited structural limitations of the claims are met. Clarification is still required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7-8, 10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abokefa (“In vitro and in vivo response to a novel borophosphate bioactive glass” Spring - July 2021).
Abokefa discloses bioactive borophosphate glasses that are confirmed to be amorphous and composed of Na2O, CaO, B2O3, P2O5 and potentially also CuO and/or CoO (see page 8 last partial paragraph-page 9 first partial paragraph, and page 9 table 1). The glasses, made by calcining followed by melting at 1000-1150⁰C, had varied proportions of components, where the X40Co and X40Cu embodiments provide 13 wt% Na2O, 14 wt% CaO, 34 wt% B2O3, and 35 wt% P2O5 along with 4 wt% CoO or 4 wt% CuO, respectively (see page 38 table 1 – as calculated by the examiner for disclosed mole percentages based upon individual oxide molecular weights). According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the functionality of the composition as recited in instant claims 12-13 would follow from the composition disclosed by Abokefa with all the claimed components assembled in the same manner as instantly disclosed, absent evidence to the contrary. Therefore claims 1-4, 7-8, 10, and 12-13 are anticipated by Abokefa.
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.
Claim 1-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abokefa in view of Fechner et al. (previously cited).
Abokefa discloses bioactive borophosphate glasses that are confirmed to be amorphous and composed of Na2O, CaO, B2O3, P2O5 and potentially also CuO and/or CoO (see page 8 last partial paragraph-page 9 first partial paragraph and page 9 table 1). The glasses, made by calcining followed by melting at 1000-1150⁰C, had varied proportions of components, where the X40Co and X40Cu embodiments provide 13 wt% Na2O, 14 wt% CaO, 34 wt% B2O3, and 35 wt% P2O5 along with 4 wt% CoO or 4 wt% CuO, respectively (see page 38 table 1 – as calculated by the examiner for disclosed mole percentages based upon individual oxide molecular weights). The glasses are considered for their utility in tissue repair (see page 36). The presence of ZnO is not detailed.
Fechner et al. teach bioactive glass particles for wound healing applications that are similar to those of Abo-Naf et al. in view of Huang et al. and are envisioned to include B2O3, P2O5, CaO, and Na2O (see abstract and column 1 lines 49-58). They detail the presence of CuO or CoO at up to 4 wt% to provide color as desired as useful (see column 4 lines 9-12; instant claims 2-4). They additionally teach the inclusion of ZnO for anti-inflammatory and wound healing effects at a proportion of up to 8 wt% and preferable less than 2 wt% see column 3 lines 56-60; instant claims 5-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make an amorphous bioactive glass of Abokefa where ZnO for its healing benefits as taught by Fechner et al. This modifications would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The proportions of this addition as detailed by Fechner et al. overlaps that of the instantly claimed range and its presence produces ranges of the B2O3, P2O5, Na2O, and CaO that meet or overlap those instantly claimed, thereby rendering the instantly claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here the functionality of the composition as recited in instant claims 12-13 would follow from the composition disclosed by Abokefa with all the claimed components assembled in the same manner as instantly disclosed, absent evidence to the contrary. Therefore claims 1-8, 10, and 12-13 are obvious over Abokefa in view of Fechner et al.
Claims 1-4, 7-8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abokefa in view of Da Fonte Ferreira et al. (previously cited).
Abokefa discloses bioactive borophosphate glasses that are confirmed to be amorphous and composed of Na2O, CaO, B2O3, P2O5 and potentially also CuO and/or CoO (see page 8 last partial paragraph-page 9 first partial paragraph and page 9 table 1). The glasses, made by calcining followed by melting at 1000-1150⁰C, had varied proportions of components, where the X40Co and X40Cu embodiments provide 13 wt% Na2O, 14 wt% CaO, 34 wt% B2O3, and 35 wt% P2O5 along with 4 wt% CoO or 4 wt% CuO, respectively (see page 38 table 1 – as calculated by the examiner for disclosed mole percentages based upon individual oxide molecular weights). The glasses are considered for their utility in tissue repair (see page 36). The presence of phosphoric acid as a reactant is not detailed.
Da Fonte Ferreira et al. teach bioactive glass particles for wound healing applications that are similar to those of Abo-Naf et al. in view of Huang et al. and are envisioned to include B2O3, P2O5, CaO, and Na2O (see abstract, paragraphs 52-53 and example 4). They additionally teach of the inclusion of phosphoric acid as a phosphorus source envisioned as an option along with phosphorus pentoxide (P2O5) (see paragraph 48; instant claim 11). Further, Da Fonte Ferreira et al. teach a calcining-melt-quench process for preparing the amorphous glass similar to that of Abo-Naf et al. (see paragraph 145).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include phosphoric acid as an additional source of phosphorus in the reactant mixture of Abokefa in light of Da Fonte Ferreira et al. “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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the functionality of the composition as recited in instant claims 12-13 would follow from the composition disclosed by Abokefa with all the claimed components assembled in the same manner as instantly disclosed, absent evidence to the contrary. Therefore claims 1-4, 7-8, and 10-13 are obvious over Abokefa in view of Da Fonte Ferreira et al.
Claim 1, 7-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abo-Naf et al. (Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2015 144:88-98 – see IDS) in view Huang et al. (Journal of Materials Science: Materials in Medicine 2006 17:583-596).
Claims 1, 8, 10, and those that depend from them recite a product-by-process. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here a bioactive glass that occurs due to calcining and melting a mixture of oxides is recited but it is not apparent that this product is distinct from a bioactive glass with oxide proportions in this same range made by melting at a slightly different temperature and quenching (see instant claims 1 and 8).
Abo-Naf et al. teach melt-quench produced amorphous bioactive glass composed of Na2O, CaO, B2O3, and P2O5 (see abstract, page 59 second column second full paragraph, and page 90 second column second full paragraph). They vary the proportion of the B2O3 from 5 to 30 mol % and P2O5 from 40 to 65 mol%, while the molar proportion of Na2O and CaO, were held constant at 15 mol% each (see table 1). The 30 mol% B2O3 embodiment provides 22 wt% B2O3, 59 wt% P2O5, 9 wt% CaO, and 11 wt% Na2O (see B30 sample table 1 – as calculated by the examiner for disclosed mole percentages based upon individual oxide molecular weights). They also note that increasing the proportion of B2O3 yields greater bioactivity and hydroxyapatite formation when exposed to (simulated) bodily fluid (see page 97 second column). The instantly claimed proportions of Na2O, CaO, B2O3, and P2O5 are not explicitly detailed
Huang et al. teach borate glass and its rate of conversion into hydroxyapatite (see abstract). They note the full conversion of the glass to hydroxyapatite, a feature that is beneficial for bone bonding applications (see page 583 second column last partial paragraph and figure 14). The borate glass composition employed is melt quenched and has 48.6 wt% B2O3, 5.6 wt% P2O5, 22.9 wt% Na2O, and 22.9 wt% CaO (see table 1 sample 3B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make an amorphous bioactive glass of Abo-Naf et al. with proportions of Na2O, CaO, B2O3, and P2O5 as instantly claimed. As detailed in MPEP 2144.05, “a range can be disclosed in multiple prior art references instead of in a single prior art reference”. Here the combination of Abo-Naf et al. and Huang et al. yield a range of proportions of these components of 5 to 48.6 wt% B2O3, 5.6 to 65 wt% P2O5, 15 to 22.9 wt% Na2O, and 15 to 22.9 wt% CaO, where larger proportions of B2O3, are desirable due to the higher bioactivity of the resulting glass. The selection of a proportion of B2O3 toward the upper end of the range also is obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., increase bioactivity). The result is ranges of proportion of the recited oxides that overlap or embrace the instantly claimed ranges, thereby rendering the instantly claimed ranges obvious (see MPEP 2144.05; instant claims 1 and 7). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus instantly claimed functionalities would also follow, given that the composition rendered obvious by Abo-Naf et al. and Huang et al. has the instantly claimed components at the claimed proportions. Therefore claims 1, 7-8, 10, and 12-13 are obvious over Abo-Naf et al. and Huang et al.
Claims 1-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abo-Naf et al. in view of Huang et al. as applied to claims 1, 7-8, 10, and 12-13 above, and further in view of Fechner et al.
Abo-Naf et al. in view of Huang et al. render obvious the limitations of instant claims 1, 7-8, 10, and 12-13. The presence of ZnO, CuO, or CoO is not explicitly detailed.
Fechner et al. teach bioactive glass particles for wound healing applications that are similar to those of Abo-Naf et al. in view of Huang et al. and are envisioned to include B2O3, P2O5, CaO, and Na2O (see abstract and column 1 lines 49-58). They detail the presence of CuO or CoO at up to 4 wt% to provide color as desired as useful (see column 4 lines 9-12; instant claims 2-4). They additionally teach the inclusion of ZnO for anti-inflammatory and wound healing effects at a proportion of up to 8 wt% and preferable less than 2 wt% see column 3 lines 56-60; instant claims 5-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include CoO or CuO for color and ZnO for its healing benefits in the bioactive glass material Abo-Naf et al. in view of Huang et al. as taught by Fechner et al. These modifications would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The proportions of these additions as detailed by Fechner et al. overlap those of the instantly claimed range, thereby rendering the instantly claimed ranges obvious (see MPEP 2144.05). Therefore claims 1-8, 10, and 12-13 are obvious over Abo-Naf et al. in view of Huang et al. and Fechner et al.
Claims 1, 7-8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abo-Naf et al. in view of Huang et al. as applied to claims 1, 7-8, 10, and 12-13 above, and further in view of Da Fonte Ferreira et al.
Abo-Naf et al. in view of Huang et al. render obvious the limitations of instant claims 1, 7-8, 10, and 12-13 where a phosphorous source is included as a reactant (see paragraph 100). The presence of phosphoric acid as a reactant is not detailed.
Da Fonte Ferreira et al. teach bioactive glass particles for wound healing applications that are similar to those of Abo-Naf et al. in view of Huang et al. and are envisioned to include B2O3, P2O5, CaO, and Na2O (see abstract, paragraphs 52-53 and example 4). They additionally teach of the inclusion of phosphoric acid as a phosphorus source envisioned as an option along with phosphorus pentoxide (P2O5) (see paragraph 48; instant claim 11). Further, Da Fonte Ferreira et al. teach a calcining-melt-quench process for preparing the amorphous glass similar to that of Abo-Naf et al. (see paragraph 145).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include phosphoric acid as an additional source of phosphorus in the reactant mixture of Abo-Naf et al. and Huang et al. in light of Da Fonte Ferreira et al. “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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). Therefore claims 1, 7-8, and 10-13 are obvious over Abo-Naf et al. in view of Huang et al. and Da Fonte Ferreira et al.
Response to Arguments
Applicant's arguments filed July 21, 2026 have been fully considered. In light of the amendment to the claims the double patenting rejections, those under 35 USC 103, and those over claims 9 and 10 under 35 USC 112(b) are hereby withdrawn. New grounds of rejection are detailed to address the new claim limitations. The arguments directed toward the remaining rejections under 35 USC 112(b) are not persuasive.
The amendment to the claim reciting “tri-calcium phosphate” instead of “calcium phosphate” in claim 12 does not address the issue that was raised in regard to the scope of structures that corresponds to the bioactive glasses that form this compound. The claim should further limit the parent claim, yet it is unclear which, if any, of the bioactive glasses of the parent fail to be able to generate tri-calcium phosphate. Further, there are no conditions recited under which the formation is to occur. Thus the scope of glasses embraced by the claim remain vague such that the metes and bounds of the claim are not clear.
The amendment to claim 13 still does not recite which entity is to have the recited pH. The claims are drawn to a glass which has no pH, given that it is a solid. Thus the meaning of the criteria to be met remains unclear. Even if clarity is brought to the pH criteria, it still would leave the scope of qualifying glasses unclear, since there is no structural delineation amongst the disclosed glasses for those that have this pH maintenance function and those that do not.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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