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 .
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) 1,4,6-10,21,22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannetel (US2009/0208568) in view of Zhang(English translation WO 2009021377A1)
Regarding claim 1, Hannetel teaches a seamless capsule comprising:
a capsule content(abstract, para 2); and
a shell layer that coats the capsule content(para 2),
wherein
the shell layer comprises at least deacylated gellan gum and modified starch(para 19), and the capsule content comprises an oily component(para 56).
Hannetel teaches that the shell layer comprises the deacylated gellan gum and another component such as modified starch in a ratio of 80/20, i.e. 80% gellan gum an 20% modified starch(para 21).
Hannetel teaches the use of modified starch but does not specifically teach the use of oxidized starch. However, teaches a shell composition for a capsule where in the hard shell comprises a gelling agent, binder and water(p.2). The gelling agent can comprise gellan gum and the binder can comprise oxidized starch(p.4). Zhang teaches that the composition has good mouthfeel. It would have been obvious to use oxidized starch as the modified starch in Hannetel because Zhang teaches that gellan gum and oxidized starch shell components provide a good mouthfeel for capsule compositions.
Regarding claim 4, Hannetel teaches that the seamless capsule has a particle size of 0.5 to 8.0mm(para 5) and a shell ratio of 8 to 50%.
Regarding claims 6 and 7, Hannetel teaches that the oil component in the capsule can contain a flavor such as orange(example 3).
Regarding claim 8, Hannetel teaches a two layer structure including the capsule content and the shell layer(para 2).
Regarding claims 9 and 10, Hannetel in view of Zhang does not specifically teach that the capsule has a value of XY/xy is within a range of 0.76 or more and 1.15 or less, where X (N) is a load required to break the seamless capsule by pressing in a minimum particle size direction after the seamless capsule is stored for 60 minutes under a condition of a relative humidity of 90% RH at 60°C, and Y (mm) is a displacement at break, and similarly, x (N) is a load required to break the seamless capsule by pressing in a minimum particle size direction after the seamless capsule is stored for 120 minutes under a condition of a relative humidity of 60% RH at 25°C, and y (mm) is a displacement at break.
However, Hannetel and Zhang teach the composition of claim 1 including the use of deacylated gellan gum and oxidized for the shell layer as claimed. Therefore, one of ordinary skill in the art would expect the composition of Hannetel to have the claimed properties.
Regarding claims 21 and 22, Hannetel and Zhang are silent on the claimed properties. However, Hannetel and Zhang teach the composition of claim 1 including the use of deacylated gellan gum and oxidized for the shell layer as claimed. Therefore, one of ordinary skill in the art would expect the composition of Hannetel to have the claimed properties.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannetel (US2009/0208568) in view of Borregaard(Comparison of Microfibrillated Cellulose and Microcrystalline Cellulose).
Regarding claim 3, Hannetel teaches that the shell can comprise cellulose but does not specifically teach that the cellulose is crystalline cellulose. However, Borregaard.com teaches that microcrystalline cellulose is commonly used as tableting aid in pharmaceutical applications(p.2). It would have been obvious to use microcrystalline cellulose as the cellulose in the shell of Hannetel because Borregaard.com teaches that microcrystalline cellulose is commonly used as tableting aid in pharmaceutical applications.
Response to Arguments
Applicant's arguments filed 5/21/2026 have been fully considered but they are not persuasive.
The applicant argues that the examples in the instant spec demonstrate unexpected results when using oxidized starch as the modified starch. However, the examples in the spec are not commensurate in scope with the claimed invention. Specifically, the examples in the spec use an intermediate layer that is not recited in claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D LEBLANC whose telephone number is (571)270-1136. The examiner can normally be reached 8AM-4PM EST M-F.
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
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