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 . Claims included in the prosecution are claims 8-27.
Election/Restrictions
Applicant's election with traverse of Group II, claims 8-27 in the reply filed on 09/24/2025 is acknowledged. The traversal is on the ground(s) that Gibson does not disclose a process that would result in the claimed composition and the examples do not teach the claimed Ca/(P+Si) and Ca/P. This is not found persuasive because the claimed process is not a shared technical feature amongst the groups and a prior art is evaluated for all that it reasonably suggests and is not limited to working examples.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-7, 30, 31, 33 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim 27 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi et al. (Preparation of a Silicate Substituted Calcium Deficient Hydroxyapatite by Coprecipitation, Feb. 15, 2007) (hereinafter Shi).
Shi anticipates the instant claim insofar as disclosing a silicate-substituted calcium deficient hydroxyapatite (SiCDHA) (abstract).
Regarding claim 27 reciting “obtainable by a method according to claim 8,” the term “obtainable” is merely a functional recitation requiring the ability to fulfill that function; the claim does not require, however, for obtaining to actually occur. Since Shi discloses a silicate-substituted calcium deficient hydroxyapatite and claim 8 is a method of producing a calcium-deficient silicate-substituted calcium phosphate apatite composition, the silicate-substituted calcium deficient hydroxyapatite of Shi is obtainable by the method of claim 8.
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.
1. Claims 8-15 and 18-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (Preparation of a Silicate Substituted Calcium Deficient Hydroxyapatite by Coprecipitation, Feb. 15, 2007) (hereinafter Shi) in view of Gibson et al. (WO 2010/079316, Jul. 15, 2010) (IDS reference) (hereinafter Gibson) and Obadia et al. (Calcium-Deficient Apatite Synthesized by Ammonia Hydrolysis of Dicalcium Phosphate Dihydrate: Influence of Temperature, Time, and Pressure (May 5, 2006) (hereinafter Obadia), as evidenced by Utah Tech (pKa Chart, 2025) and TutorOceanCorp (Frequently Asked Questions about Ammonia (NH3)), 2025).
Shi discloses a coprecipitation method to synthesize silicate-substituted calcium deficient hydroxyapatite (SiCDHA). The starting materials were calcium nitrate tetrahydrate, phosphoric acid, tetraethylorthosilicate, and ammonia water aqueous solution. Calcium nitrate tetrahydrate, phosphoric acid and tetraethylorthosilicate were mixed and stirred for 35 minutes as precursor solution. Ammonia water (i.e., claimed acidic solution) as a precipitator was added to the precursor solution to pH 10. The slurry was aged for 24 hours at 60°C. The precipitate was separated by filtration, washed repeatedly with distilled water, and dried for 24 hours at 105°C. A fraction of dried samples was calcined for 2h at 700°C or 900°C to control their crystallization (page 83, Materials and Methods). The synthesized silicate-substituted calcium deficient hydroxyapatite (SiCDHA) may have a Ca/P molar ratio of 1.66 and a Ca/(P+Si) molar ratio of 1.52 (Table 1). Bioactivity of hydroxyapatite is significantly enhanced by incorporation of silicon in its structure (page 83, Introduction).
Shi differs from the instant claims insofar as not disclosing wherein the precursor is a powder having an apatite phase, a Ca/P molar ratio of from 2.3 to 2.6, a Ca/(P+Si) molar ratio of from 1.56 to 1.66, a silicon atom content from 4 to 6 wt. %, a specific surface area of from 10 to 90 m2/g, a formula according to formula (I) of instant claim 11, and a Dv50 less than 100 µm.
However, Gibson discloses an inorganic silicate-substituted calcium phosphate hydroxyapatite having a Ca/P molar ratio in the range of 2.05 to 2.55 and a Ca/(P+Si) molar ratio less than 1.66. The silicon atom content is in the range of 2.9 to 6 wt. %. The hydroxyapatite may be represented by formula (I): Ca10-Ᵹ(PO4)6-x(SiO4)x(OH)2-x wherein 1.1 ≤ x ≤ 2.0 and Ᵹ represents a Ca deficiency (page 4, lines 25-34). The silicate-substituted hydroxyapatite is used as a powder (page 5, lines 17-19). The specific surface area of the powder is in the range 10 to 90 m2/g (page 7, lines 27-28). The powder has an average particle size in the range 0.05 to 100 µm (page 10, lines 13-14). The silicate-substituted hydroxyapatite particle is substantially phase pure with a single silicate-substituted hydroxyapatite phase (page 8, lines 4-11).
Obadia discloses synthesizing calcium-deficient apatites (CDA) with controlled Ca/P ratios via hydrolysis of dicalcium phosphate dihydrate (DCPD; CaHPO4·2H2O) in aqueous ammonia solution. The use of ammonia allows to obtain CDA free of cationic substitution (page 32, right column, first paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Shi discloses a coprecipitation method to synthesize silicate-substituted calcium deficient hydroxyapatite (SiCDHA) by combining a precursor with an ammonia aqueous solution. Accordingly, it would have been obvious to one of ordinary skill in the art to have used the inorganic silicate-substituted calcium phosphate hydroxyapatite of Gibson as the precursor in Shi’s method since is a known and effective precursor as it is a silicate-substituted hydroxyapatite that is not calcium deficient as taught by Gibson. One of ordinary skill in the art would have had a reasonable expectation of success since Obadia discloses wherein apatite compounds can become calcium deficient when combined with an aqueous ammonia solution.
In regards to instant claim 8 reciting an acidic solution, Shi discloses an ammonia aqueous solution. As evidenced by TutorOceanCorp, ammonia is a weak acid.
In regards to instant claim 15 reciting wherein the acid component is an acid having a pKa of greater than -1.73, as evidenced by Utah Tech, ammonia has a pKa of 36.
In regards to instant claims 24 and 25 reciting wherein the Ca/P molar ratio is greater than 2.25 to 2.35 or 2.15 to 2.30, Table 1 of Shi discloses wherein the Ca/P molar ratio depends on the amount of Si substitution and Shi discloses in the introduction wherein silicon enhances bioactivity. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed Ca/P molar ratio through routine experimentation based on the amount of Si substitution desired for bioactivity enhancement.
In regards to instant claim 18 reciting mixing the acidic solution and the starting material in a weight ratio of at least 5:1, since use of ammonia allows to obtain calcium deficient apatites free of cationic substitution, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed mixing ratio through routine experimentation based on the amount of calcium deficiency desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
2. Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (Preparation of a Silicate Substituted Calcium Deficient Hydroxyapatite by Coprecipitation, Feb. 15, 2007) (hereinafter Shi) in view of Gibson et al. (WO 2010/079316, Jul. 15, 2010) (IDS reference) (hereinafter Gibson), Obadia et al. (Calcium-Deficient Apatite Synthesized by Ammonia Hydrolysis of Dicalcium Phosphate Dihydrate: Influence of Temperature, Time, and Pressure (May 5, 2006) (hereinafter Obadia), and further in view of Koroleva et al. (Biomaterial Based on Doped Calcium Carbonate-Phosphate for Active Osteogenesis, Apr. 2012) (hereinafter Koroleva).
The teachings of Shi, Gibson, and Obadia are discussed above. Shi, Gibson, and Obadia do not teach wherein the ammonia aqueous solution is an aqueous ammonia chloride solution.
However, Koroleva discloses wherein sedimentation of calcium carbonate-phosphate can be carried out in an ammonium chloride environment (page 233, left column, second paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Shi discloses ammonia water as a precipitator. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated ammonium chloride as the ammonia source since it is a known and effective precipitator of calcium phosphate compounds as taught by Koroleva.
In regards to instant claim 17 reciting an ammonium chloride concentration of from 0.01% w/v to 15% w/v, since ammonium chloride is used as a precipitator, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the amount of precipitates desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Conclusion
Claims 8-27 are rejected.
Claims 1-7, 30, 31, 33 and 34 have been withdrawn.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614