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 .
DETAILED ACTION
The Amendments filed on 6/9/2026 has been received and entered.
Claims 1-3 and 5-10 are pending. Claims 1-3 and 5-6 are examined on the merits. Claims 7-10 are withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-6) in the reply filed on 1/28/2026 is acknowledged.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/28/2026.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 2/12/2026 and 8/30/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 112
Claims 1-3 and 5-6 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.
In Claim 1, line 7; Claim 2, line 2; Claim 3, lines 1-2, the term “early-harvested” is indefinite because it is unclear when is the time considered “early” for harvesting the fruit. Please define or describe.
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.
Claim(s) 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Doan et al. (2020, Evidence Based Complementary and Alternative Medicine, vol. 2020, pages 1-9) in view of Chen (CN 106261323 A, translation provided). This is a new rejection.
Doan et al. teaches Chrysophyllum cainito fruit shows anticancer activity against osteosarcoma (Abstract). The fruit colors are red-purple, dark-purple or pale-green (page 2, left column, paragraph 2). The treatment against osteosarcoma would inherently result in improving bone quality of Claims 4-6 because the same ingredients used in the same method would result in the same mechanisms.
However, Doan et al. does not teach adding 0.1% cellulase complex in water, ratio of Claim 2.
Chen teaches a nutritional solution of Chrysophyllum cainito extract obtained by enzymolysis in 0.05-0.07% pectinase at temperature of 45-55 degree C, pH 5.5, 30-50 min (Claim 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use enzymatic process to extract C. cainito because Chen teaches a nutritional solution of Chrysophyllum cainito extract obtained by enzymolysis in 0.05-0.07% pectinase at temperature of 45-55 degree C, pH 5.5, 30-50 min (Claim 2). One would have been motivated to make a medicament for the expected benefit of treating osteoporosis with C. caimito extract as taught by Doan et al. (Abstract). Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising adding 0.1% cellulase complex in water, ratio of Claim 2 of the active agent combination for the following reasons. The reference does teach the composition for treating C. cainito. Chen teaches a nutritional solution of Chrysophyllum cainito extract obtained by enzymolysis in 0.05-0.07% pectinase at temperature of 45-55 degree C, pH 5.5, 30-50 min (Claim 2). Thus, it would have been obvious to make a concentrated cellulase for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claim(s) 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Doan et al. (2020, Evidence Based Complementary and Alternative Medicine, vol. 2020, pages 1-9) in view of Chen (CN 106261323 A, translation provided) as applied to claims 1-2 and 4-6 above, and further in view of Luo et al. (2002, J. Agric. Food Chem., Vol. 50, No. 6, pages1379-1382). This is a new rejection.
The teachings of Doan et al. and Chen are set forth above and applied as before.
The combination of Doan et al. and Chen do not specifically teach the ice crystal wall breaking, -10 degree C to 0 degree C for 7 days, extract at 45-60 degree C for 50-70 min and 85 for 50-70 min.
Luo et al. teaches extraction of C. caimito fruit by using fresh frozen fruit. Frozen fruits were shipped and stored at -20 °C until extracted (Plant Material).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use frozen fruit and enzymatic process to extract C. cainito because Chen teaches a nutritional solution of Chrysophyllum cainito extract obtained by enzymolysis in 0.05-0.07% pectinase at temperature of 45-55 degree C, pH 5.5, 30-50 min (Claim 2). Luo et al. teaches extraction of C. caimito fruit by using fresh frozen fruit. Frozen fruits were shipped and stored at -20 °C until extracted (Plant Material). One would have been motivated to make a medicament for the expected benefit of treating osteoporosis with C. caimito extract as taught by Doan et al. (Abstract). Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The references also do not specifically teach performing the process in the time span and temperature range claimed by applicant. Chen teaches a nutritional solution of Chrysophyllum cainito extract obtained by enzymolysis in 0.05-0.07% pectinase at temperature of 45-55 degree C, pH 5.5, 30-50 min (Claim 2). The high temperature is to inactivate the enzyme pectinase. The process in the time span and temperature range is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal process in the time span and temperature range to use in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Response to Arguments
Applicant argues that “early-harvest” fruits are not taught.
In response to Applicant’s argument, this term is not defined. Here, harvested fruit would meet the limitation of “early-harvested”.
Applicant argues that the “promoting production of osteocalcin in osteoblasts” is not taught.
In response to Applicant’s argument, Doan et al. teaches Chrysophyllum cainito fruit shows anticancer activity against osteosarcoma (Abstract). The fruit colors are red-purple, dark-purple or pale-green (page 2, left column, paragraph 2). The treatment against osteosarcoma would inherently result in improving bone quality of Claims 4-6 because the same ingredients used in the same method would result in the same mechanisms.
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.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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