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 .
Election/Restrictions
Applicant’s election of Group II, claim 8-13 in the reply filed on 11/24/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 1-7 and 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Application Status
Claim 8-13 are under examination.
Claim 1-7 and 14-19 are withdrawn from examination.
Claim 8-13 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/29/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: claim 8, line 7 recites “a pod” and should be “the pod” since antecedent basis have been established in line 1. Appropriate correction is required.
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) 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (US 6,908,626 B2).
Regarding claim 8, Cooper et al. (Cooper) discloses a method of preparing a formulation (‘626, col. 7, ln. 33-45, col 16, ln. 40-51) in dosage form, wherein the dosage form includes capsule and tablet (pod) (‘626, col. 9, ln. 30-51). Copper discloses the formulation comprising forming at least one nanoparticulate active agent (first particle type) and least one surface stabilizer (second particle type) (‘626, col. 7, ln. 33-45; col. 16, ln. 43-47).
Copper discloses the nanoparticulate active agent comprise multiple populations of average particle size, having multi-modal particle size distribution (‘626, col. 14, ln. 40-50; ln. 62-66). Copper discloses the formulation of the at least one nanoparticulate active agent (first particle type) and the at least one surface stabilizer (second particle type) (‘626, col. 7, ln. 33-45) which is considered as first formula. Copper discloses the formulation (first formula) comprising the at least one nanoparticulate active agent (first particle type) in an amount of 0.5% to about 90% by weight (‘626, col. 16, ln. 25-26) and the at least one surface stabilizer in an amount of about 0.5% to about 99.99% (‘626, col. 16, ln. 29-30), wherein a combined range overlaps the cited range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Cooper discloses adding at least one microparticulate active agent (third particle type) (‘626, col. 7, ln. 39-45) to the least one nanoparticulate active agent (first particle type) and the at least one surface stabilizer (second particle type) (‘626, col. 7, ln. 33-45) to form a mixture (second formula). Cooper teaches compressing the mixture (second formula) in the dosage formulation into the tablet (pod) (‘626, col. 19, ln. 57-67).
Regarding claim 9, Copper discloses the method comprising coating the tablet (pod) (626, col. 20, ln. 8-11).
Regarding claim 10 and 11, Copper discloses the least one nanoparticulate active agent (first particle type) and the at least one surface stabilizer (second particle type) are supplements (‘626, col. 10, ln. 22-67, col. 11, ln. 21-26) including protein (‘626, col. 10, ln. 24).
Regarding claim 12 and 13, Copper discloses at least one microparticulate active agent (third particle type) includes pharmaceutical excipients (additives) including effervescent agents (‘626, col. 15, ln. 29-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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/HONG T YOO/Primary Examiner, Art Unit 1792