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 .
Summary
Receipt of Applicants Remarks and Restriction/Elections filed on 2/11/2026 is acknowledged. Claims 1-15 are pending.
Election/Restrictions
Applicant elects Group I without traverse, claims 1-8, drawn to a calcified tissue substitute. Group II, claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The election is made FINAL.
Claims 1-8 are pending and under examination in this application.
Priority
The current application filed on January 05, 2024 is a continuation-in-part of U.S. Application No. 18/454, 753, filed August 23, 2023, which is a continuation of U.S. Application No. 16/618,684, filed December 2, 2019, which is a U.S. National Stage under 35 U.S.C. § 371 of international Application No. PCT/AU2018/050541, filed June 01, 2018, which claims the priority benefit of Australian Application No. AU 2017902108, filed June 02, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/05/2024 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
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.
Claims 1 and 2 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 1 recites ground nacre “having a particle size of 50 mm or more” in step (i) and ground brushite “having a particle size of between 10 mm to 100 mm” in step (ii). Throughout the specification, the detailed description uses micrometers (µm) for particle sizes (¶ 0052 - ¶ 0057, ¶ 0104, ¶ 0107), not millimeters. The use of “mm” in the claims is therefore internally inconsistent with the specification and creates uncertainty as to the actual scope of the claims. A person of ordinary skill reading the claims alongside the specification cannot determine with reasonable certainty whether “mm” was intended as millimeters or micrometers, because both interpretations are facially plausible (though only micrometers are consistent with the operational chemistry disclosed). Moreover, specification (¶ 0139) expressly states “the particle size is critical for the setting time of calcified tissue substitutes”, therefore the unit of precise measurement suggests criticality. The inconsistency in the unit of measure renders claim 1 indefinite. It is suggested to amend the claim to replace “mm” with “µm” throughout the claims where particle size is recited. Appropriate correction is required.
Claim 2 recites the nacre:MCP ratio as “4 parts to 10 parts (4:10)” without specifying whether this is a weight ratio, mole ratio, or volume ratio. The specification at (¶ 0105) states “nacre particles were mixed with monocalcium phosphate in the ratio of 4:10 at room temperature” without explicit designation of the ratio type. While the working chemistry implies a weight or molar ratio, the claim is indefinite because a person of skill in the art (POSA) cannot determine with certainty from the claim language alone which type of ratio is intended, and the choice materially affects whether the claimed ratio falls within the scope of prior art combinations. It is suggested that Applicant should clarify. Appropriate correction is required.
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.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ni (Nacre surface transformation to hydroxyapatite in a phosphate buffer solution) in view of Simon (US 2006/0233849 A1) and further in view of Khairoun (US 2010/0068243 A1).
Ni discloses that nacre (mother-of-pearl), an organic/inorganic biocomposite of aragonite mineral comprising calcium carbonate (CaCO₃) and bioactive proteins, transforms to hydroxyapatite (HAP) when soaked in a phosphate buffer solution at room temperature. Ni characterizes the surface reaction as a dissolution-precipitation mechanism in which calcium ions released from the nacre aragonite surface react with phosphate ions in the buffered aqueous solution to precipitate HAP on the nacre particle surface. Ni characterizes the resulting HAP-coated nacre particles by SEM, XPS, SIMS, and FTIR, confirming conversion of the aragonite surface phase to calcium phosphate (abstract). Ni further discloses that nacre contains bioactive proteins that induce osteogenesis, that nacre exhibits excellent bone-binding affinity, and that nacre is a candidate material for dental implants and orthopedic bone repair applications (¶ Introduction). Ni establishes the foundational teaching that ground nacre particles react with aqueous phosphate sources via dissolution-precipitation chemistry to yield calcium orthophosphate-coated nacre particles (page 4325 – 4330). Therefore, the essential chemistry underlying claim 1 steps (i) and (iii) and the product of claim 6.
Simon discloses a composite bone graft material comprising a calcium matrix component and porogen particles (abstract). Simon explicitly teaches that demineralized mollusk nacre is a preferred osteoinductive demineralized bone matrix (DBM) substitute for use as the porogen particle component: “preferably demineralized mollusk nacre or brachiopod semi-nacre…preferably demineralized mollusk nacre.”
(¶ 0063). Moreover, Simon expressly claims a bone graft material wherein “said DBM substitute is osteoinductive-factor-supplemented demineralized mollusk nacre.” (claim 6) and discloses the demineralized bone matrix so prepared may be obtained directly from the demineralization process as an osteoinductive material, i.e. retaining its native bone growth-promoting factors. Osteoinductive factors native to such materials include, e.g.: bone morphogenetic proteins (BMPs). Such as osteocalcin, osteogenin, and osteonectin. Demineralized non-bony tissue matrix materials may also provide Some degree of osteoinductivity through the presence of other bioactive factors native thereto (¶ 0065). Additionally, Simon at (¶ 0023 – ¶ 0028) explicitly discloses that the calcium matrix component includes monocalcium phosphate monohydrate (MCPM, ¶ 0026), dicalcium phosphate dihydrate (DCPD/brushite, ¶ 0027), and tetracalcium phosphate (TTCP, ¶ 0028) as calcium phosphate compounds, and expressly claims a calcium matrix comprising dicalcium phosphate dihydrate (claim 2). Furthermore, Simon discloses that the composite provides an osteoinductive scaffold with differential resorption rates of component materials that enhance in vivo pore development and osteoblast colonization (¶ 0021), which correlates with the identical design rationale articulated in applicant’s specification at (¶ 0033 - ¶ 0039), and in (claim 16), Simon disclose bioactive agents and including bone morphogenetic proteins, antibiotics, anti-inflammatory agents, and growth factors incorporated into the composite (¶ 0043). Simon further discloses injectable and implantable forms (¶ 0022) and establishes that a POSA knew, as of 2006, that combining nacre with brushite/DCPD in a single bone substitute composition with differential resorption rates was a viable and desirable approach to bone repair and therefore directly identifying the target composition of instant claim 1.
Khairoun discloses a macroporous and highly resorbable apatitic calcium phosphate cement (CPC) comprising an inorganic component of one or more calcium phosphate compounds and an organic component of bioresorbable polymers, set with a liquid phase (abstract). Khairoun explicitly discloses dicalcium phosphate dihydrate (DCPD), naming it brushite: “dicalcium phosphate dihydrate (DCPD), CaHPO₄.2H₂O also called brushite” and also explicitly discloses monocalcium phosphate monohydrate (MCPH/MCPM), tetracalcium phosphate (TTCP), and α-TCP as CPC components (¶ 0049). Moreover, Khairoun states that an inorganic component comprising α-TCP, MCPH, and DCPD is “more preferred” (¶ 0052), and explicitly discloses: “a solution of 2 to 3% by weight of Na₂HPO₄ in distilled water” (¶ 0062) as the preferred liquid phase for the CPC. Khairoun discloses a working example using “an aqueous solution of Na₂HPO₄ (3%) as liquid phase” (¶ 0091), and further discloses working examples with “3% solution of Na₂HPO₄ in distilled water” as the liquid phase (¶ 0104). Khairoun also teaches that Na₂HPO₄ is a soluble phosphate salt accelerator for CPC setting, and that “typical concentrations in the mixing liquid phase are in the range of 0.05 to 1.00 M” (¶ 0067). Furthermore, Khairoun explicitly discloses that setting time “depends on…the particle sizes of the powder components” (¶ 0065), and in (¶ 0098) discloses that α-TCP is ground and sieved to a controlled particle size range of 0.1–80 µm to control reactivity and setting. Critically, Khairoun explicitly discloses calcium carbonate as a CPC component: “One particularly interesting compound is calcium carbonate,” (¶ 0068) and in FIG. 4 (¶ 0083]- ¶ 0084) disclose working CPCs containing CaCO₃ as a reactive powder component alongside CaHPO₄ and α-TCP, implanted in rabbit femur with confirmed bone formation. Khairoun explicitly disclose antibiotics, anti-inflammatory drugs, and growth factors incorporated in the CPC (¶ 0071 and claim 23), and discloses methods for treating bony defects and dental/bony implant preparation (claims 24, 26, and 27).
Regarding claim 1 step (i), the claim recites reacting ground nacre (≥50 mm) (Examiner believe “mm” is a typo error and interprets as ≥50 µm) with monocalcium phosphate and water to produce brushite:
Ni teaches that nacre (CaCO₃/aragonite) reacts with aqueous phosphate solutions at room temperature via a dissolution-precipitation mechanism. Specifically, Ni establishes that calcium ions released from nacre’s aragonite surface react with phosphate ions in solution, confirming that nacre is reactive in aqueous phosphate media(abstract and page 4324-4325). The underlying reaction of nacre as a CaCO₃ source with monocalcium phosphate monohydrate (MCPM, an acidic calcium phosphate) in water to produce brushite is the classical acid-base CPC reaction: CaCO₃ + Ca(H₂PO₄)₂·H₂O + 2H₂O → 2CaHPO₄·2H₂O + CO₂.
Simon discloses MCPM and DCPD/brushite as components of the calcium matrix (¶ 0026 - ¶ 0027).
Khairoun explicitly identifies MCPM (Ca(H₂PO₄)₂·H₂O) as a preferred CPC component (¶ 0049), and identifies MCPM/DCPD combinations as preferred (¶ 0052), and in (¶ 0068) explicitly discloses CaCO₃ as a reactive component in CPC chemistry, therefore directly suggests teaching a POSA that calcium carbonate sources participate in CPC setting reactions. Furthermore, Khairoun in Examples 10 and (¶ 0083 - ¶ 0084) disclose working CPCs comprising CaCO₃ alongside CaHPO₄ and α-TCP as reactive powder components with confirmed in vivo bone formation.
A POSA reading Ni (nacre is a CaCO₃-based material reactive with phosphate solutions), Simon (nacre combined with DCPD/brushite in a bone substitute), and Khairoun (CaCO₃ is a known reactive CPC component; MCPM + CaCO₃ → brushite is the known acid-base reaction) would have immediately recognized that reacting ground nacre as the CaCO₃ source with MCPM in water produces brushite via the well-established acid-base reaction. This is not a novel reaction; it is the application of a known reaction (CaCO₃ + MCPM + H₂O → brushite + CO₂) to a known CaCO₃-containing material (nacre), with a predictable and well-understood result. The product brushite is explicitly named and identified in both Simon and Khairoun as a desired CPC component.
Regarding claim 1 step (ii) - Grinding brushite to particle size of (10 mm – 100mm) (Examiner believe “mm” is a typo error and interprets as 10 µm - 100 µm):
Khairoun in (¶ 0065) explicitly discloses that setting time of the CPC “depends on…the particle sizes of the powder components,” and in (¶ 0098) discloses that α-TCP is ground and sieved to a controlled particle size range of 0.1–80 µm with average particle size of 15 µm. Khairoun establishes that grinding CPC powder components to controlled particle sizes by milling and sieving is a routine, standard practice in the CPC art. The 10 µm - 100 µm range recited in claim 1 falls squarely within the ranges disclosed and routinely practiced in Khairoun and the CPC field generally. Selecting a particle size within a known operative range to achieve a desired setting time is the optimization of a result-effective variable, which is prima facie obvious. See In re Applied Materials, 692 F.3d 1289, 1295 (Fed. Cir. 2012).
Regarding claim 1 step (iii) - Reacting second portion of nacre with ground brushite in disodium hydrogen phosphate solution:
As noted above, Ni teaches that nacre reacts with phosphate solutions in water to produce HAP-coated nacre particles. Simon teaches that nacre combined with DCPD/brushite in a single bone substitute produces an osteoinductive composite with differential resorption rates. Khairoun in (¶ 0062) explicitly teaches that a 2–3% Na₂HPO₄ aqueous solution is the preferred CPC setting liquid, and in (¶ 0091) and (¶ 0104) provide working examples using 3% Na₂HPO₄ as the liquid phase. Combining nacre and brushite as the powder phase with Na₂HPO₄ solution as the setting liquid is the direct application of: (a) Simon’s teaching that nacre + brushite is the target composite composition; (b) Ni’s teaching that nacre reacts with phosphate solutions to produce calcium orthophosphate-coated nacre particles; and (c) Khairoun’s teaching that Na₂HPO₄ solution is the standard CPC setting liquid for calcium phosphate systems including DCPD/brushite.
Accordingly, each step of claim 1’s three-step process is taught or rendered obvious by the combination of Ni, Simon, and Khairoun.
Regarding claim 6, the claim recites Particulate substitute with hydroxyapatite on particle surface:
As noted above, Ni explicitly and directly discloses this limitation. Ni’s central teaching is that nacre particles immersed in phosphate solution develop an HAP coating on their particle surface via dissolution-precipitation. The SEM, XPS, and FTIR data in Ni confirm HAP formation on the nacre surface. The product of claim 1’s three-step process, which involves reacting nacre particles in phosphate solution, directly and predictably produces HAP-coated nacre particles as taught by Ni. Claim 6 is therefore obvious over Ni alone, and additionally obvious in view of Khairoun confirming that the final setting product is calcium deficient apatite (¶ 0112).
Regarding claim 2, the claim recites that the nacre:MCP ratio in step (i) is 4 parts to 10 parts (4:10). The ratio of nacre (CaCO₃) to monocalcium phosphate in the brushite-forming reaction is governed by the reaction stoichiometry and by the desired conversion yield. Khairoun establishes that the proportions of CPC powder components, including CaCO₃ and calcium phosphate reactants, are result-effective variables that a POSA routinely adjusts through ordinary experimentation to achieve complete conversion and desired properties (¶ 0065). Simon in (¶ 0023 - ¶ 0028) discloses various ratios of matrix components as routine formulation choices. The 4:10 ratio falls within the range of ratios that a POSA would have systematically evaluated in optimizing the brushite-forming reaction, and its selection represents routine optimization of a result-effective variable. See In re Applied Materials, 692 F.3d 1289, 1295 (Fed. Cir. 2012); In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Regarding claim 3, the claim recites that the Na₂HPO₄ solution has a pH of 8.2-9.5 and is a 2.5-4% solution. Khairoun in (¶ 0062) explicitly discloses “a solution of 2 to 3% by weight of Na₂HPO₄ in distilled water” as the preferred liquid phase, which directly overlaps with the 2.5 - 4% range of claim 3. Khairoun in (¶ 0091) and (¶ 0104) provide working examples at 3% Na₂HPO₄. The 2-4% concentration range recited in claim 3 spans the 2-3% range explicitly taught by Khairoun and represents an obvious extension within the ranges routinely practiced in the CPC art. The pH of 8.2-9.5 is the characteristic physicochemical property of Na₂HPO₄ solutions in this concentration range - it is not a separately achieved result but rather a natural consequence of dissolving Na₂HPO₄ in water at these concentrations. Claim 3 is therefore obvious over Khairoun as the controlling reference, with Ni and Simon providing context.
Regarding claim 4, the claim recites that step (iii) further comprises tetracalcium phosphate (TTCP). Both Simon and Khairoun independently and explicitly disclose TTCP as a known CPC component. Simon in (¶ 0028) lists TTCP, Ca₄(PO₄)₂O, as a calcium matrix component. Khairoun in (¶ 0049) lists TTCP, Ca₄P₂O₉, as a calcium phosphate compound useful in the invention. The addition of TTCP to the nacre-brushite system of claim 1 is explicitly taught by both secondary references and was well-known in the CPC art. The motivation to add TTCP is explicit and documented: faster initial set, HAP formation, and differential resorption rates (i.e., Simon ¶ 0021) and (Khairoun ¶ 0049 explicitly disclose of TTCP as CPC component and ¶ 0068 disclose differential resorption context), all of which are specifically disclosed in Simon and Khairoun as desired properties of CPC bone substitutes. Claim 4 is therefore obvious as the express combination of known elements with known functions to yield predictable results.
Regarding claim 5, the claim recites that the substitute comprises an agent selected from antibiotics, antibodies, anti-inflammatory molecules, bone growth stimulants, OP-1, BMP-2, and EP1A. Simon (¶ 0043) and (¶ 0065) explicitly disclose bone morphogenetic proteins (including BMP-2), antibiotics, anti-inflammatory agents, and growth factors as bioactive agents incorporated into the composite. Khairoun (¶ 0071) and (claim 23) explicitly disclose antibiotics, anti-inflammatory drugs, anti-cancer drugs, drugs against osteoporosis, and growth factors incorporated in the CPC. The incorporation of bioactive and therapeutic agents into calcium phosphate bone substitutes was extensively documented in the art well before 2017 and represents routine practice within the knowledge of a POSA. Claim 5 is obvious over Simon and Khairoun independently, and over their combination with Ni.
Regarding claims 7-8, the claims are directed to the use of the calcified tissue substitute of claim 1 for repair of a calcified tissue, specifically tooth or bone. As noted above, Ni explicitly discloses nacre for dental and orthopedic bone repair. Simon in (claims 38 and 44) explicitly claim methods for repairing bone. Khairoun in (claims 24, 26, and 27) explicitly claim methods for treating bony defects and dental and bony implant preparation. The use of the claimed composition for the repair of bone and tooth, and the intended and stated purpose of the composition, follows necessarily from the nature of the composition and is directly and expressly taught by all three references. Claims 7 and 8 are obvious over the combination of Ni, Simon, and Khairoun.
It would have been prima facie obvious to a person having ordinary skill in the art (POSA) before the effective filing date of the claimed invention to combine the teachings of Ni, Simon, and Khairoun. A POSA would have had a reasonable expectation of success in producing the claimed calcified tissue substitute for the following reasons: The chemistry is predictable. The acid-base reaction CaCO₃ + Ca(H₂PO₄)₂·H₂O + 2H₂O → 2CaHPO₄·2H₂O + CO₂ is a well-understood, predictable chemical reaction with known stoichiometry. Ni confirms that nacre’s CaCO₃ reacts with phosphate solutions. Khairoun confirms that CaCO₃ is reactive in CPC systems. There is no unpredictability in applying this known chemistry to nacre as the CaCO₃ source. The setting system is established. Khairoun provides multiple working examples (¶ 0091), (¶ 0104), Examples 3, 6, 7, 8, 11) demonstrating that 3% Na₂HPO₄ solution successfully sets calcium phosphate cements comprising DCPD/brushite and MCPM to produce calcium-deficient apatite with measurable compressive strength and macroporosity. The Na₂HPO₄ setting system is not experimental or unpredictable, and it is an established, characterized, and documented CPC technology. Simon discloses nacre + DCPD/brushite in a bone substitute with demonstrated osteoinductive properties and bone repair applications. A POSA would have had high confidence that the same compositional combination, produced by the reactive manufacturing route of claim 1, would yield a material with the same beneficial properties, and because the composition, not the manufacturing route, determines the biological activity. Khairoun Examples 10 and 11 (¶ 0083 - ¶ 0139) disclose in vivo implantation in rabbit femur defects with confirmed new bone formation, good biocompatibility, and osteointegration for CPC systems comprising the same calcium phosphate components (CaHPO₄, CaCO₃, α-TCP, DCPD) as the combination suggested by the prior art. The POSA would have reasonably expected the nacre-brushite composite produced by claim 1’s process to exhibit at minimum comparable in vivo performance, and likely superior performance given nacre’s additional osteoinductive bioactive matrix. The prior art of record is well-established and highly predictable. Calcium phosphate cement technology is a mature field with extensive prior art literature. The components, reactions, and processing parameters involved in claim 1 are individually well-characterized. Combining them in the manner of claim 1 does not involve unpredictable results and it is the application of established chemistry to achieve a compositional target already identified in the prior art.
The motivation to combine Ni with Simon and to add Khairoun: Ni and Simon address the same technical problem, which is developing a superior bone substitute with improved osteoinductivity and controlled resorption and propose overlapping solutions. Specifically, both references identify nacre as an osteoinductive material with bioactive protein content that promotes bone formation. A POSA reading both references would immediately recognize that they converge on nacre as a critical osteoinductive component. Simon directly teaches that the limitation of nacre as a standalone bone substitute and its rapid resorption, and is addressed by combining nacre with calcium phosphate components of lower resorption rates, specifically brushite/DCPD, to produce a composite with differential resorption and in vivo pore formation (¶ 0021). This is precisely the design principle articulated by Ni (nacre converts to HAP via phosphate reaction, slowing its resorption) and by applicant’s specification in (¶0033 -¶ 0039). Ni provides the reactive chemistry (nacre + phosphate → HAP coating) while Simon provides the compositional target (nacre + brushite composite for bone repair). A POSA would have been directly motivated to use Ni’s phosphate-based chemistry to manufacture Simon’s disclosed nacre-brushite composite, because Ni tells the POSA how nacre interacts with phosphate and the precise chemistry needed to make Simon’s composition by the reactive route of claim 1.
The motivation to combine Ni and Simon is therefore explicit, direct, and grounded in the references themselves: Simon identifies the target composition and its bone-healing rationale; Ni provides the underlying reactive chemistry to make it.
Accordingly, a POSA would have had both clear motivation and reasonable expectation of success in combining the teachings of Ni, Simon, and Khairoun to arrive at the claimed invention.
Khairoun addresses the same problem as Ni and Simon by producing a resorbable, biocompatible bone substitute and provides the specific technical details needed to complete the manufacturing process of claim 1. Specifically: A POSA seeking to manufacture Simon’s disclosed nacre-brushite composite by the reactive route suggested by Ni would have immediately consulted the CPC literature to identify the appropriate setting liquid and processing conditions. Khairoun is precisely the type of reference a POSA would have encountered and relied upon, as it is a comprehensive disclosure of CPC manufacturing technology covering the exact components (DCPD/brushite, MCPM, TTCP) and the exact setting liquid (Na₂HPO₄ at 2–3%) needed to produce the claimed composition. Khairoun (¶ 0068) specifically teaches that CaCO₃ is a known reactive component in CPC systems, directly motivating the use of nacre (a CaCO₃-based material) as the calcium carbonate reactant in the brushite-forming step (i) of claim 1. A POSA who had read Khairoun’s explicit disclosure that CaCO₃ modifies CPC setting behavior, and who was also familiar with Ni’s teaching that nacre is a CaCO₃/aragonite material that reacts with phosphate solutions, would have had direct motivation to use nacre as the CaCO₃ source in Khairoun’s disclosed CPC chemistry.
Khairoun (¶ 0065] and (¶ 0098) teach that particle size control by grinding and sieving is a standard and routine step in CPC manufacturing, directly supporting step (ii) of claim 1. A POSA would have applied this routine processing step without inventive effort.
The motivation to add Khairoun to the combination of Ni and Simon is therefore: Khairoun provides the specific processing parameters (Na₂HPO₄ concentration, particle size control, setting conditions) that a POSA would have selected from the established CPC literature to manufacture the nacre-brushite composite identified by Simon using the reactive chemistry taught by Ni.
From the combined 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615