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 December 29th 2025 has been considered.
Claim 1 has been amended.
Claims 2, 3, 5, 10-16 and 24 are cancelled.
Claims 1, 4, 6-9, 17-23 and 25 are pending in the current application.
Claims 6-9, 17-22 and 25 are withdrawn from consideration.
Claims 1, 4 and 23 are examined in the current application.
Any rejections not recited below have been withdrawn.
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.
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) and NPL Siew, “Freeze-Drying Process Optimization” (from Pharmaceutical Technology, Vol. 42, No. 5, pp 18-23, May 2018).
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 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.
Allowable Subject Matter
Claim 23 recite allowable subject matter: While silicone dioxide (i.e., silica) is a known excipient in the pharmaceutical art, neither Silva, nor any other prior art reference disclose freeze drying a pharmaceutical with silicone dioxide.
Response to Arguments
Applicant's arguments filed on December 29th 2025 have been fully considered but they are not persuasive.
Applicant argues in the “Remarks” that the prior art references fail to render the claimed invention obvious, because Silva discloses a starting material that comprises annatto and other constituents. The examiner respectfully disagrees.
Given the fact the claims are not limited to only annatto powder, as the transitional phrase “comprising” is used, the Annatto emulsion in Silva meets the claimed limitations.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
NPL Vanbillemont et al., “Model-Based Optimisation and Contorl Strategy for the Primary Drying Phase of a Lyophilisation Process” (from Pharmaceutics 2020, 12, 181), discloses factors such as, temperature, pressure and length of time of freeze-drying primary phase (i.e., first step) and their optimization to attain desired freeze-dried product.
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.
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Prosecution Insights