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 .
Application Status
Amended claims 8-13 are under examination.
Claim 1-7 and 14-19 are withdrawn from examination.
Claim 8-13 are rejected.
Withdrawn Rejection
The claim objection set forth in previous office action has been withdrawn in light of Applicant’s amendment.
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). With respect to new limitation of “non-uniform in size”, Copper’s formulation containing mixtures of different sizes of particles (‘626, col. 21, ln. 29-32; 49-60), hence the particles are considered non-uniform in size from each other.
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. With respect to new limitation of “…the particle size distribution includes a removed or partially removed portion within at least one particle size range, the particle size distribution includes at least one gap corresponding to the removed or partially removed portion…”, Copper discloses the least one nanoparticulate active agent (first particle type) (‘626, col. 22, claim 1, 2) of about less than about 900 nm; and a microparticulate active agent is greater than 1 micron and less than about 2 microns (‘626, col. 22, claim 3). In principle it is recognized that multi-modal particle size distribution with particles at varying size spectrum that has at least two pronounced particle sizes, a spaced apart from one another, results to the fact that gaps formed between the larger particles can be filled up by the smaller particles. Copper’s multiple populations of average particle size, having multi-modal particle size distribution is expected to have particle size distribution includes at least one gap corresponding to the removed or partially removed portion in different particle sizes.
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 (compacting) the mixture (second formula) in the dosage formulation into the tablet (pod) (‘626, col. 19, ln. 57-67). With respect to new limitation “…wherein the pod is configured to disintegrate upon exposure to liquid, and the non-uniform particles result in preferential paths for water penetration…” is considered a functional limitations of the claimed product when upon exposure to liquid; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
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).
Response to Arguments
Applicant asserts “…Cooper fails to disclose or suggest the claimed invention, specifically "particles that are non-uniform in size," "particle size distribution includes a removed or partially removed portion within at least one particle size range," and where "particle size distribution includes at least one gap corresponding to the removed or partially removed portion," which "result in preferential paths for water penetration..."
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive. 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). With respect to new limitation of “non-uniform in size”, Copper’s formulation containing mixtures of different sizes of particles (‘626, col. 21, ln. 29-32; 49-60), hence the particles are considered non-uniform in size from each other. With respect to new limitation of “…the particle size distribution includes a removed or partially removed portion within at least one particle size range, the particle size distribution includes at least one gap corresponding to the removed or partially removed portion…”, Copper discloses the least one nanoparticulate active agent (first particle type) (‘626, col. 22, claim 1, 2) of about less than about 900 nm; and a microparticulate active agent is greater than 1 micron and less than about 2 microns (‘626, col. 22, claim 3). In principle it is recognized that multi-modal particle size distribution with particles at varying size spectrum that has at least two pronounced particle sizes, a spaced apart from one another, results to the fact that gaps formed between the larger particles can be filled up by the smaller particles. Copper’s multiple populations of average particle size, having multi-modal particle size distribution is expected to have particle size distribution includes at least one gap corresponding to the removed or partially removed portion in different particle sizes.
With respect to new limitation “…wherein the pod is configured to disintegrate upon exposure to liquid, and the non-uniform particles result in preferential paths for water penetration…” is considered a functional limitations of the claimed product when upon exposure to liquid; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. CN-102781608 discloses a non-uniform multimodal distribution of particle sizes wherein space (gap) between particles [0068].
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 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
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