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 .
Response to Amendment
The amendment filed on 12/17/2025 has been entered. Claims 1-2, and 4-12 are pending in the application. Claims 6-12 are withdrawn. Applicant’s amendments to the claims have introduced new matter. Applicant points to Pg. 8, lines 8-14 and Pg. 16, Example 1 of the instant specification as providing support for the limitation “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5,” introduced in the amendment filed 12/17/2025. This limitation is not considered supported by the disclosure, as explained in detail in the 112(a) section below.
Applicant’s amendment has overcome the Claim Objections and 112(b) presented in the action dated 10/17/2025 and those Objections and Rejections are withdrawn.
Response to Arguments
Applicant’s arguments, see Pg. 5-7 filed 12/17/2025 with respect to claim 1, have been fully considered however are solely directed to the claim limitation “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5” introduced in the amendment filed 12/17/2025, which postdates the non-final rejection mailed 10/17/2025.
Upon further search and consideration and as necessitated by the amendment, the 35 U.S.C. 102(a)(1) rejection of 10/17/2025 is withdrawn and a new grounds of rejection is made under 35 U.S.C. 103 as being unpatentable over Chen et. al (CN106187746; WIPO Machine Translation Attached) in view of Nicholls (US2396115).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement of new matter. The claim contains new subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites the limitation “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5”. Applicant introduced this amendment in response to a 112(b) rejection in the action dated 10/17/2025 regarding the limitation “the shell powder and citric acid are mixed in a molar ratio of 1:0.8 to 1:5.” In the remarks, Pg. 4-5 filed 12/17/2025, Applicant points to Pg. 8, lines 8-14 and Example 1 on Pg. 16 of the instant specification for providing support, stating that the specification describes “that the shell powder is composed of substantially calcium carbonate (CaCO3) (see Pg. 8, lines. 8-14)” and thereby example 1, which provides 1,000 g of pulverized shell powder relative to 3,843 g of citric acid to provide a molar ratio of shells to citric acid of 1:2 “unequivocally demonstrates that the molar ratio in the examples is determined based on the CaCO3 content in the shell powder”. This argument is not convincing.
Examiner notes Pg. 8, lines. 8-14 of the instant specification explicitly states “at this time, shell powder may be prepared by crushing oyster shells, wherein oyster shells may not be subjected to heat treatment, and may comprise calcium carbonate (CaCO3) as a main component”. The instant specification does not provide further details, with all instances of “calcium carbonate” appearing on Pg. 8, 11, and 21 and the term “substantially” not being found in the application. The terms “main component” and “composed of substantially calcium carbonate” are not equivalent terms, nor would a skilled artisan assume that the term “shell powder” is equivalent to the term “substantially calcium carbonate”. Shell powders are known by skilled artisans to have variable amounts of calcium content, as evidenced by Abinaya et al. (Int. J. Inn. Res. Sci. Eng. Tech. 2016, 5, 6, 11785-11789) teaching river oyster and sea oyster shells containing 95.9 and 89.6% CaCO3, with the remaining contents including a variety of chemical species, including SiO2, MgO, Al2O3, SrO, P2O5, Na2O and SO3 (Pg. 11786, Table 1). Applicant further does not provide an explicit alternative definition of shell powder to be equivalent to calcium carbonate.
Therefore, the limitation “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5” is considered to be new matter that is not supported by the instant application.
In the interest of compact prosecution, the term “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5” was addressed with prior art as outlined in the 35 USC 103 rejection below.
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 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 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et. al (CN106187746; WIPO Machine Translation Attached) in view of Nicholls (US2396115).
Regarding claim 1, Chen teaches a method for preparing calcium citrate from fish scales (Title). In the interest of the clarity of the record, fish scales meet the broadest reasonable interpretation of the claimed ‘shell’.
Specifically, Chen teaches (see top of Page 2 of the attached machine translation):
1) washing the fish scales and weighing the fish scales;
2) adding an aqueous citric acid solution to the fish scale in step 1, and stirring to obtain a calcium citrate suspension and a decalcification fish scale;
3) filtering the calcium citrate suspension obtained in step 2 and the decalcification fish scale through a screen to obtain a calcium citrate suspension;
4) the calcium citrate suspension obtained in step 3 was subjected to solid-liquid separation, and the precipitate was collected and dried to obtain calcium citrate.
The addition of an aqueous citric acid solution would necessarily require the aqueous citric acid solution to have been prepared. Thus, Chen implicitly teaches the claimed step 1 of “preparing a citric acid aqueous solution by dissolving citric acid in water”.
Additionally, Chen’s disclosed drying of the collected calcium citrate would meet the claimed ‘heat drying’.
Lastly, Chen does not expressly state that the obtained calcium citrate is mono calcium citrate (C12-H14CaO14) powder as claimed, however, it has been held that ‘[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In the instant case, there is a strong presumption that the calcium citrate of Chen includes mono calcium citrate because Chen uses a shell material, i.e. fish scales, that is combined with an aqueous citric acid solution, filtered, dried, and obtains calcium citrate which is identical to the method claimed by Applicant.
Moreover, the USPTO does not possess the capabilities to manufacture, test, and make comparisons of the prior art products In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
The claim further requires “the shell powder and citric acid are mixed such that a molar ratio of calcium carbonate (CaCO3) contained in the shell powder to citric acid is 1:0.8 to 1:5,” to which Chen does not explicitly provide a ratio of calcium carbonate to citric acid.
Nicholls teaches a method of producing mono-calcium citrate by reacting calcium carbonate with citric acid in aqueous solution where the molar ratio of calcium carbonate to citric acid ranges from 1:2 to 1:3.1 (Title; Pg. 2, right col., lines 1-70; Pg. 3, right col., lines 27-38). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 (I). In the instant case, the range taught by Nicholls (1:2 to 1:3.1 calcium carbonate to citric acid) overlaps with the claimed range (1:0.8 to 1:5 calcium carbonate to citric acid). Therefore, the range in Nicholls renders obvious the claimed range.
Advantageously, providing a ratio of calcium carbonate to citric acid taught by Nicholls provides pure mono-calcium citrate that can be readily removed from by-products (Pg. 2, right col., lines 60-70).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to mix the calcium carbonate and citric acid in a molar ratio of 1:2 to 1:3.1 in the method of Chen in order to provide pure mono-calcium citrate that can be readily removed from byproducts as taught by Nicholls.
Regarding claim 2, Chen and Nicholls teach the method of claim 1 and the claim further requires “wherein the heat drying is performed in an oven at 50 °C to 80 °C, or wherein the rapid drying is performed by either lyophilization or spray drying,” to which Chen teaches drying is performed (Claim 4) but Chen does not specify the temperature.
Nicholls teaches mono-calcium citrate is preferably dried at heat up to 140 °F (i.e. 60 °C, with temperatures of 120 to 125 °F being preferably (i.e. 48.9 to 51.7 °C) (Pg. 3, left col., lines 36-41). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 (I). In the instant case, the range taught by Nicholls (48.9 to 60 °C) overlaps with the claimed range (heat drying at 50 to 80 °C). Therefore, the range in Nicholls renders obvious the claimed range.
Advantageously, drying at the temperatures taught by Nicholls provides calcium citrate material that retains its properties and remains stable over an extended period of time (Pg. 4, right col., lines 16-20).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to dry the material at a temperature from 48.9 to 60 °C in the method of Chen in order to provide a stable product that retains its properties over an extended time, as taught by Nicholls.
Regarding claim 5, Chen and Nicholls teach the method of claim 1.
Chen further teaches after mixing the citric acid solution with the fish scale, the calcium citrate suspension is passed through a screen filtration aperture (Claim 4; Pg. 2, Contents of Invention). A skilled artisan would recognize filtration is a technique for removing particulate impurities and the limitation “to remove impurities” is considered met by Chen teaching filtration of a suspension obtained after mixing a citric acid solution with fish scales, which is equivalent to “after step 2)” required by the claim.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et. al (CN106187746) in view of Nicholls (US2396115) and further in view of Ding et al. (CN110256231A English)
Regarding claim 4, Chen and Nicholls teach the method of claim 1 and the claim further requires “stirring is performed for 1 minute to 300 minutes” to which Chen and Nicholls do not explicitly state the stirring duration.
Ding teaches a process of producing calcium citrate by using waste shell material and citric acid (Abstract). Ding teaches the reaction mixture comprising shell material, citric acid, and water is reacted for 3 hours (i.e. 180 minutes) with stirring (Pg. 2, Summary of Invention, Preparation of Calcium Citrate; Pg. 3, Example 1, Step 2). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 (I). In the instant case, the value taught by Ding ( 3 h; 180 minutes) overlaps with the claimed range (1 minutes to 300 minutes). Therefore, the value in Ding renders obvious the claimed range.
Advantageously, the reaction stirring time of 180 minutes allows all the calcium in the shell to be fully dissolved and converted to calcium citrate (Pg. 2, Summary of Invention, (2) Preparation of calcium citrate).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to stir the shell and citric acid solution for 180 minutes in the method of Chen in order to fully dissolve all the calcium in the shells as taught by Ding.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jordan Wayne Taylor whose telephone number is (571)272-9895. The examiner can normally be reached Monday - Friday, 7:30 AM - 5 PM EST; Second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sally A. Merkling can be reached on (571)272-6297. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.W.T./Examiner, Art Unit 1738
/SALLY A MERKLING/SPE, Art Unit 1738