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 .
Status of Claims
Amendment filed on 01/07/2026 is acknowledged.
Claims 1 and 6 are amended. Claims 3-4 and 8 are cancelled.
Claims 1-2 and 5-7 are pending and being examined on merits herein.
Priority
This instant application 18402309, filed on 01/02/2024, claims foreign priority of Taiwan 112146525, filed on 11/30/2023, no English copy of priority document is in record.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 10/16/2025) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 01/07/2026.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “wherein an amount of the Mg…, and an amount of the Sr …”. The article “an” should be revised to “the” because each element can only have one unique amount as “the amount”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Melek et al. (WO2014021797, publication date 02/06/2014, filing date 07/24/2013 or earlier, PTO-892).
Melek throughout the reference teaches using biocompatible regenerating cement materials that trigger desirable tissue regeneration and prevent invasion of microorganisms (e.g., Claim 1; Pg. 1, Lines 23-27).
Melek teaches that eggshell powder can be a new cement material (Pg. 2, Line 15). The eggshell contains 0.8% magnesium carbonate and 0.8% tricalcium phosphate (Pg. 2, Lines 24-25), and calcified eggshell is a mineral matrix (Pg. 2, line 30) containing 3% Mg (Pg. 3, Line 14), Na, K, Zn, Mn, Fe, Cu, and relatively high amounts of Sr (30,000 ppm feed level corresponds to 11.0% eggshell strontium) (Pg. 3, Lines 21-22), which does not require incorporation of artificial element ions. Melek teaches using ostrich eggshell powder 150g with 10g CMC, 10g sodium trimetaphosphate in 100 ml 0.1 M phosphate buffer to make the ceramic material (Pg. 13, 6. Gel preparation), corresponding to eggshell content at about 55.6% in the composition containing Mg (0.8% or 3%)*55.6% = 0.4% or 1.7% (corresponding to 4000 ppm or 17000 ppm) (4000 ppm falling within Mg amount range in instant claim 1). MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Melek does not directly teach Sr level in the eggshell, but indicating it is dependent upon the feed Sr level, such as 11% *55.6%=6.1% (61000 ppm at 30,000 ppm feed level), suggesting that Sr level, e.g., 100-1000 ppm, is achievable when feed level is lower. MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
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.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cazalbou (US20170165398, 06/15/2017) and Melek et al. (WO2014021797, publication date 02/06/2014, filing date 07/24/2013 or earlier, PTO-892) and Mora et al. (The condor 109:199-205, 2007, PTO-892).
Cazalbou throughout the reference teaches modified calcium phosphate ceramics for orthopedics, dentistry or reconstructive surgery, in particular use for bone repair including bone filling or bone substitute (e.g., Abstract; [0024]) (corresponding to instant claim 7).
Cazalbou indicates that the calcium phosphate in the calcium phosphate ceramic can be in anyone of the forms: α-tricalcium phosphate ( α-TCP), β-tricalcium phosphate (β-TCP), hydroxyapatite (HA), tetracalcium phosphate (TTCP), monocalcium phosphate monohydrate, monocalcium phosphate anhydrous, dicalcium phosphate anhydrous, dicalcium phosphate dihydrate, octa calcium phosphate, amorphous calcium phosphate, as well as the deficient or ion-substituted calcium orthophosphates (e.g., [0028]) (corresponding to main component species in instant claim 1). Cazalbou points out modifying the surface of calcium phosphate ceramic comprising the main components, HA, TCP, or BCP, reacting to supercritical CO2 in the presence of an aqueous solution, comprising bioactive components such as drugs, ionic species as Mg, Ag, Sr, Zn, Cu, etc., or calcium or phosphate species, to allow the surface of the ceramics to obtain the same composition as that of bone mineral, or can be simulated body fluid with an ion concentration close to that of human blood plasma (e.g., [0066-0072]). Cazalbou exemplifies that the main component of the calcium phosphate ceramic (dimension 3 mm * 3 mm * 3 mm, 0.82 g, [0134]) is the mixture of biphasic calcium phosphate BCP containing 65% hydroxyapatite and 35% tricalcium phosphate (corresponding to instant claim 2), and 2 mM (equals to 2 ppm) Mg and Sr.
Cazalbou teaches the total porosity between 60 and 85% (overlapping with the range of 50% to 90% in instant claim 5), and the pore size is between 150 and 400 um (falling within the pore size ranging from 0 to 1000 um, and matching at least 70% pores having pore size greater than 100 um as instant claim 6) (e.g., Example 10, [0134-0136]).
Cazalbou does not teach Mg is 1000 – 10000 ppm, Sr is 100-1000 ppm, and that the calcium phosphate ceramic does not require incorporation of artificial element ions as recited in instant claim 1.
Melek throughout the reference teaches using biocompatible regenerating cement materials that trigger desirable tissue regeneration and prevent invasion of microorganisms (e.g., Claim 1; Pg. 1, Lines 23-27).
Melek teaches that eggshell powder can be a new cement material (Pg. 2, Line 15). The eggshell contains 0.8% magnesium carbonate and 0.8% tricalcium phosphate (Pg. 2, Lines 24-25), and calcified eggshell is a mineral matrix (Pg. 2, line 30) containing 3% Mg (Pg. 3, Line 14), Na, K, Zn, Mn, Fe, Cu, and relatively high amounts of Sr (30,000 ppm feed level corresponds to 11.0% eggshell strontium) (Pg. 3, Lines 21-22). Melek teaches using ostrich eggshell powder 150g with 10g CMC, 10g sodium trimetaphosphate in 100 ml 0.1 M phosphate buffer to make the ceramic material (Pg. 13, 6. Gel preparation), corresponding to eggshell content at about 55.6% in the composition containing Mg (0.8% or 3%)*55.6% = 0.4% or 1.7% (corresponding to 4000 ppm or 17000 ppm) (overlapping with Mg amount in instant claim 1). Melek does not directly teach Sr level in the eggshell, but indicating it is dependent upon the feed Sr level, such as 11% *55.6%=6.1% (61000 ppm at 30,000 ppm feed level).
Mora throughout the reference teaches the Sr concentrations in passerine birds from four regions in Arizona, and indicates that Sr levels range from 70 to 1360 ug g-1 dry weight (equal to 70-1360 ppm, overlapping with Sr in instant claim 1) and these are among the highest levels of Sr that have been reported in bird eggshells in North America (e.g., Abstract).
It would have been prima facie obvious for a person with ordinary skills in the art to incorporation the teaching of Melek and Mora into Cazalbou’s calcium phosphate ceramic to arrive at current invention. Because Cazalbou teaches that Mg and Sr ions are known for their ability to stimulate osteoblast activity (e.g., [0136]) , while Melek teaches that the eggshell can be new ceramic material and it contains the substances controlling the shape and growth of calcium crystals (CaCO3), the substances preventing the bacterial growth, and also high amounts of Sr and Mg with low level of toxic heavy metal, and the calcified eggshell powder also makes it a more advantageous source than other calcium and strontium sources (Pg. 8 bottom-Pg. 9 top), moreover, the shell matrix protein osteopontin plays significant roles in bone modeling and remodeling, via increasing adhesion of osteoblasts to organic matrix and binds to hydroxyapatite (e.g., Pg. 4, Lines 7-10), the advantageous of eggshell powder would have motivated artisans in the field to substitute the artificial element ions, e.g., Mg and Sr, with the biological eggshell powder which is rich in natural trace elements including Mg and Sr, and this modification would have provided reasonable expectation of success of the bone repair material of calcium phosphate ceramic. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the porosity, pore size, Mg and Sr amounts overlap with prior art. Although Cazalbou exemplifies Mg and Sr amounts at much lower concentrations as instantly claimed ranges, both Melek and Mora teaches that eggshell can contain higher levels of Mg and Sr, which overlap with instantly claimed ranges, and Melek shows that higher level of Mg and Sr in the eggshell are suitable for the ceramic composition. Artisans in the field would have chosen higher levels of Mg and Sr based upon the availability of these trace elements in the natural eggshells. Especially, Cazalbou and Melek both teaches Mg and Sr are beneficial for osteoblasts, while natural sources of these trace elements at higher levels would be advantageous for artisans to implement into the composition for convenience and benefits taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant’s remarks/arguments filed on 01/07/2026 have been fully considered. Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SUE X. LIU can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights