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
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2025.
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(s) 1, 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US20140161742A1), hereinafter ‘Hong’, in view of Xin et al. (CN101734639A), hereinafter ‘Xin’, and Zhou et al. (Comparative study of porous hydroxyapatite/chitosan and whitlockite/chitosan scaffolds for bone regeneration in calvarial defects, International Journal of Nanomedicine, 2017), hereinafter ‘Zhou’.
Regarding Claim 1, Hong discloses a method for producing whitlockite (2.1. Preparation of MWH microspheres), comprising:
a step of preparing a precursor solution by mixing a first solution containing a calcium (Ca) ion source material, a second solution containing a magnesium (Mg) ion source material, and a third solution containing a phosphate (PO4) source material ([0077]-[0078]: 0.385 mol of calcium nitrate and 0.115 mol magnesium nitrate, considered calcium and magnesium (Mg) ion source materials, are added to distilled water to form a solution – this results in the formation of a first solution containing a calcium (Ca) ion source material, and a second solution containing a magnesium (Mg) ion source material – further, 0.475 mol of phosphoric acid, considered a third solution containing a phosphate (PO4) source material is added to the Ca-Mg solution under stirring – this results in the mixture of the first, second, and third solutions, resulting in the preparation of a precursor solution);
a heat-treatment step of heat-treating the precursor solution ([0078]: after the addition of the phosphoric acid, the solution was stirred for 6 hours at 80 °C – this step is considered a heat-treatment step of heat-treating the precursor solution); and
a step of separating and purifying a precipitate formed in the solution, after the heat-treatment step ([0079]: after heat treatment, the solution was filter pressed and lyophilized to produce whitlockite powder – this is considered a step of separating and purifying a precipitate formed in the solution after heat treatment).
Further regarding Claim 1, it is noted that Hong discloses a method of manufacturing whitlockite comprising reacting calcium nitrate, magnesium nitrate, and a phosphate source in water at 80 °C ([0078]), which is considered a hydrothermal reaction per the addition of heat to drive the reaction in the presence of water, as discussed above.
However, Hong does not disclose that phosphate source material comprises sodium hydrogen phosphate.
Xin discloses a method for the hydrothermal synthesis of whitlockite ([0002]-[0003]), comprising mixing calcium nitrate, magnesium nitrate, and a phosphate source, and performing a hydrothermal reaction to produce said whitlockite ([0007]; it is noted that whitlockite in Xin is referred to as “nano magnesium white phosphate calcium ore powder”). A person of ordinary skill in the art would have recognized Xin as analogous to Hong, as both references are drawn to the same field of endeavor as the claimed invention, the hydrothermal synthesis of whitlockite - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. Further, Xin discloses the use of Na2HPO4, or sodium hydrogen phosphate, as a phosphate ion source material in said synthesis, and the use of such a phosphate ion source material is disclosed as resulting in the formation of whitlockite ([0007], step 3).
Given that both phosphoric acid and sodium hydrogen phosphate are recognized by the prior art as materials that may be used as a phosphate ion source for the hydrothermal reaction of calcium nitrate, magnesium nitrate, and said phosphate source to result in the synthesis of whitlockite, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the phosphoric acid as disclosed by Hong with sodium hydrogen phosphate as disclosed by Xin, as both compounds are known in the art for use as a phosphate ion source in the synthesis of whitlockite, and the substation thereof would act predictably in the method of Hong in providing a phosphate source required for the synthesis of whitlockite. As held by the court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), the simple substitution of one known element for another to obtain predictable results is prima facie obvious in the absence of unexpected results – see MPEP 2143(I)(B).
Further regarding Claim 1, it is noted that Hong discloses a method of manufacturing whitlockite comprising reacting calcium, magnesium, and a phosphate source in water at 80 °C ([0078]), which is considered a hydrothermal reaction per the addition of heat to drive the reaction in the presence of water, as discussed above.
However, Hong does not disclose that the calcium ion source material is calcium chloride, or that the magnesium ion source material is magnesium chloride.
Zhou discloses a method for the synthesis of porous hydroxyapatite/chitosan and whitlockite/chitosan scaffolds for bone regeneration in calvarial defects (Title). A person of ordinary skill in the art would have recognized Zhou as analogous to Hong as modified above, as both references are drawn to the same field of endeavor as the claimed invention, the synthesis of whitlockite - a reference is analogous art to the claimed invention if the reference is from the same field of endeavor as the claimed invention, In re Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.
Further, Zhou discloses the use of CaCl2, or calcium chloride, and MgCl2, or magnesium chloride, as magnesium and calcium ion source material in said synthesis, and the use of such calcium and magnesium ion source material is disclosed as resulting in the formation of whitlockite (Materials).
Further, it is noted that both calcium and magnesium nitrate as disclosed by Hong and calcium and magnesium chloride as disclosed by Zhou are substantially similar in structure, and only differ in their respective cations – these cations do not actively participate in the reaction to produce whitlockite, as whitlockite does not comprise sodium or acidic groups, and it is only the magnesium and calcium cations in these compounds that actually reacts with phosphate to form whitlockite ([0025] of Xin show the hydrothermal reaction – only magnesium, calcium, and phosphate are present in the resulting whitlockite, and the rest of the produced components are salts that form via the ion exchange of the reaction). Therefore, when considering precursor materials that may provide phosphate ions for the production of whitlockite, there is no real material difference between phosphoric acid and sodium phosphate other than what ancillary salts are formed as byproducts in the reaction.
Given that both nitrates and chlorides of magnesium/calcium are recognized by the prior art as materials that may be used as a magnesium/calcium ion source for the hydrothermal reaction of calcium, magnesium, and phosphate to result in the synthesis of whitlockite, and given the substantial chemical similarity between the two compounds, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the calcium and magnesium nitrates as disclosed by Hong with calcium and magnesium chloride as disclosed by Xin, as both compounds are known in the art for use as a magnesium and calcium ion source in the synthesis of whitlockite, and the substation thereof would act predictably in the method of Hong in providing a phosphate source required for the synthesis of whitlockite. As held by the court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), the simple substitution of one known element for another to obtain predictable results is prima facie obvious in the absence of unexpected results – see MPEP 2143(I)(B).
Regarding Claim 5, Hong discloses the step of preparing the precursor solution comprises preparing a mixed solution by mixing the first solution with the second solution, and then mixing the third solution with the mixed solution ([0077]-[0078]: 0.25 mol of calcium nitrate and 0.25 mol magnesium nitrate, considered calcium and magnesium (Mg) ion source materials, are added to distilled water to form a solution – this results in the formation of a first solution containing a calcium (Ca) ion source material, and a second solution containing a magnesium (Mg) ion source material – further, 0.335 mol of phosphoric acid, considered a third solution containing a phosphate (PO4) source material, is added to the Ca-Mg solution under stirring – this described order of adding ingredients corresponds to that claimed).
Regarding Claim 6, Hong does not disclose the step of preparing the precursor solution comprises mixing the first solution, the second solution and the third solution together simultaneously.
However, these claims are drawn to limitations pertaining to the sequence of adding ingredients – as held by the court in In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), the selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results associated with the claimed order of adding said ingredients. In the instant case, considering the instant specification at [0056], it is disclosed that “[w]hen the solutions are mixed together simultaneously as described above, there is an advantage in that the process efficiency is increased due to simplification of the process” – while this presents simultaneous mixing as having an advantage in simplification of the process, this is not considered to rise to the level of unexpected results, as a reduction in mixing steps would clearly result in a process having less steps, thereby reducing process complexity, and therefore such an advantage is not considered unexpected. As such, absent other evidence of such new or unexpected results associated with the sequence of adding ingredients, the claimed sequence of ingredients is considered prima facie obvious over the disclosure of Hong, which discloses the sequence of adding ingredients disclosed in Claim 5.
Regarding Claim 7, Hong discloses the calcium ion source material and the magnesium ion source material are mixed together such that a molar ratio between Ca2+ and Mg2+ is 10: 1 to 1: 4 ([0077]: 0.25 moles of calcium nitrate, corresponding to 0.25 moles of Ca2+, and 0.25 moles of magnesium nitrate, corresponding to 0.25 moles of Mg2+, are mixed – this corresponds to a ratio between Ca2+ and Mg2+ of 1:1, meeting the instant claim).
Response to Arguments
Applicant’s arguments, filed 10/08/2025, are acknowledged.
With respect to arguments in regard to prior art rejections under section 102, Applicant’s arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under section 103 in view of Zhou.
Further, the arguments of Applicant, as they may apply to the grounds of rejection above, are not considered persuasive. Namely, while applicant argues that the use of chlorides are the only feasible means for performing a scaled-up synthesis of whitlockite, Zhou has shown the use of such chlorides as routine in making whitlockite, such that it would be obvious to choose chlorides in the process of Hong as modified above. Further, all arguments regarding “industrial scale continuous mixing” is unpersuasive, as such a feature is currently unclaimed.
Conclusion
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.
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LOGAN LACLAIR
Examiner
Art Unit 1738
/L.E.L./ Examiner, Art Unit 1738
/ANTHONY J ZIMMER/ Supervisory Patent Examiner, Art Unit 1736