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
Status of Claims
Note: The amendment of July 9th 2026 has been considered.
Claim 1 has been amended.
Claims 2-3, 5, 10-16 and 23-24 are cancelled.
Claims 1, 4, 6-9, 17-22 and 25 are pending in the current application.
Claims 6-9, 17-22 and 25 are withdrawn from consideration.
Claims 1 and 4 are examined in the current application.
Any rejections not recited below have been withdrawn.
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 4 are rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Regarding claim 1: The phrase “from 1 to 2%” in line 18 of claim 1 renders the claim indefinite, because it is unclear what is the relative content of the silicon dioxide in the powder, as the claimed percentage fail to include whether they depict mass fractions, volume fractions, molar ratios, or any other unit. Accordingly, a skilled artisan would read the phrase with more than one reasonable interpretation, and thus such skilled artisan would not be reasonably apprised of its meaning. Applicant is urged to correct and/or clarify the metes and bounds of the phrase and the claim as recited without introducing new matter.
Regarding claim 4: In view of the fact that dependent claim 4 depends on independent claim 1, and since independent claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite, claim 4 is rejected as being indefinite for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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.
Note: In the previous Office Action dated May 5th 2026, the examiner noted the limitation of freeze drying the active compounds with silicone dioxide renders the invention patentable over the prior art; However, upon further consideration, a new ground of rejection is made under 35 USC §103 over in view of NPL Silva et al., in view of Funemi et al., NPL Siew, NPL Schaffazick et al. and 21 CFR §172.480, as the use of silicone in freeze drying is well known and conventional (see discussion, below).
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Silva et al., “Ultrasound-assisted encapsulation of annatto seed oil: Retention and release of a bioactive compound with functional activities” (from Food Research International 78(2015) 159-168) in view of Funemi et al. (JP 2006109786 A), NPL Siew, “Freeze-Drying Process Optimization” (from Pharmaceutical Technology, Vol. 42, No. 5, pp 18-23, May 2018), NPL Schaffazick et al., “Freeze-drying polymeric colloidal suspensions: nanocapsules, nanospheres and nanodispersion. A comparative study (from European Journal of Pharmaceutics and Biopharmaceutics 56 (2003) 501-505) and 21 CFR §172.480.
Regarding claims 1 and 4: Silva discloses a lyophilized freeze-dried powder of Annatto Bixa Orellana L. (see Silva abstract; sections 2.3 and 2.5.1), but fails to disclose freeze-drying with dextrin; However, Funemi discloses freeze drying foods and active ingredients (e.g., powdered active ingredients) with dextrin in order to preserve the active ingredient/food (e.g., powder), while enhancing its stability and availability (i.e., bioavailability) (see Funemi abstract; pages 2-3). Therefore, it would have been obvious to a skilled artisan at the time the application was filed to have modified Silva and to have added dextrin to the annatto powder before freeze drying in order to preserve the active ingredient/food (e.g., powder), while enhancing its stability and availability (i.e., bioavailability), and thus arrive at the claimed limitations.
As to the annatto powder comprising from 1% to 2% silicon dioxide, as recited in claim 1: While Silva fails to disclose freeze drying with silicon dioxide, Schaffazick discloses in the abstract and Introduction, that freeze-drying active ingredients with silicon dioxide is used across the pharmaceutical, nutraceutical, and biotechnology industries. As silicon dioxide serves important roles when integrated into the freeze-drying processes of active pharmaceutical ingredients (APIs) and bioactive compounds, such as drying excipient, providing a nanocoating matrix, moisture scavenging, cake stabilizing and preventing particle aggregation. Moreover, given the fact the FDA limits amorphous silicon dioxide to a maximum of 2% by weigh in finished food, supplement, and pharmaceutical applications to ensure safe consumption (see 21 CFR §172.480), it would have been obvious to a skilled artisan at the time the application was filed to have modified the Silva and to have used silicon dioxide in the freeze drying process to attain its processing and product benefits, and thus arrive at the claimed limitations.
As to the two steps freeze drying method recited in the claims: Silva and Funemi disclose freeze drying, but fail to disclose the claimed two steps freeze drying method; However, Siew discloses a two-stage freeze-drying process is known, as the temperature (i.e., -40°C to -60°C), pressure and duration of the first stage, where most of the moisture is removed, are optimized in order to allow the ice to sublime and maintain product quality (i.e., prevent product collapse) (see Siew bottom of page 1 to top of page 5). Siew further disclose the second stage, where the remaining water is removed, the temperature is increase to about room temperature, and the pressure and duration are adjusted to allow the water to sublime, while preventing product collapse (see Siew bottom half of page 5 to bottom of page 6). Therefore it would have been obvious to a skilled artisan at the time the application was filed to have further modified Silva and to have freeze dried the lyophilized Anneto powder through two stages and adjust the temperatures, durations and pressures of the stages in order to attain desired product while preventing product collapse, and thus arrive at the claimed limitations. As set forth in MPEP §2144.05 discovering an optimum value of a result effective variable, involves only routine skill in the art.
As to the bulk density recited in the claims: While modified Silva fails to disclose the bulk densities following the freeze drying steps, given the fact the freeze-drying process in modified Silva is similar to the freeze drying process recited in the claims, it is examiner’s position the bulk densities following the freeze-drying steps recited in claim 1, is inherently present in modified Silva. As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
Response to Arguments
Note: In the previous Office Action dated May 5th 2026, the examiner noted the limitation of freeze drying the active compounds with silicone dioxide renders the invention patentable over the prior art; However, upon further consideration, a new ground of rejection is made under 35 USC §103 over in view of NPL Silva et al., in view of Funemi et al., NPL Siew, NPL Schaffazick et al. and 21 CFR §172.480, as the use of silicone in freeze drying is well known and conventional (see discussion, above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached on M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
