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 .
Status of Application
Receipt of Applicant’s remarks, amended specification, and amended claims filed on February 12, 2026 is acknowledged.
Claims 1, 6-10, and 16-18 are pending in this application.
Claims 2-5 and 11-15 have been cancelled.
Claims 1 and 7 have been amended.
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
All pending claims are under examination in this application.
Withdrawn Objections/Rejections
Claim Rejections - 35 USC § 103
The rejection of claims 1, 6-10 and 15-18 under 35 U.S.C. 103 as being unpatentable over He et al. (Drying Behavior and Kinetics of Drying Process of Plant-based Enteric Hard Capsules, Pharmaceutics 2021, 13(3), 335) in view of Shi et al. (CN 101167705) and further in view of Son et al. (US 10,793,687) has been withdrawn in view of the clarification that the carrageenan as the gel forming agent is I (iota). The prior art cited does not disclose i-carrageenan.
Newly Applied Rejections
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites “the plant-based hard capsule is disintegrated in a pH 1.2 hydrochloric acid solution, a pH 4.5 phosphate buffer solution, deionized water, or a pH 6.8 phosphate buffer solution for less than 15 minutes.” This does not read well. It is suggested the claim be amended to recite “in” in place of “for” .
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.
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, 7-10, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (EP 0 714 656 A1).
Yamamoto discloses a capsule shell prepared from a composition comprising:
parts by weight hydroxypropyl methylcellulose (HPMC);
parts by weight of carrageenan as a gelling agent; and
0.05-0.6 parts by weight of a potassium and/or calcium ion as a co-gelling agent (abstract).
Carrageenan is blended as a gelling agent. Iota and Kappa carrageenan have gelling ability and are suitable for use (page 3, lines 53-55).
The composition forms a capsule shell of 0.1 mm thickness with an opening time within 4 minutes when immersed in an aqueous solution of 0.1 M potassium chloride (page 4, lines 31-33). It is the position of the Examiner that since the prior art teaches the same composition, it would necessarily have the same properties, including disintegration times.
According to Example 1, potassium chloride (coagulant aid) was dissolved in pure water at about 75 ˚C. k-carrageenan was added to the solution and dissolved therein. With stirring HPMC was added to the solution and dispersed therein. The solution was cooled to a temperature of 50 ˚C and further agitated for dissolving the HPMC. The solution was allowed to stand for deaeration.
It is noted that a plasticizer is not a required component of the capsule composition since it is present in the range of 0-3% in the claims.
A conventional capsule shell forming apparatus was changed with the immersion solution which was maintained at 52 ˚C. The apparatus was operated with a conventional dipping technique to prepare the capsule shells.
Regarding claim 7, as noted above, potassium chloride is disclosed in example 1. Calcium chloride can also be blended into the composition (page 4, line 6-7).
Regarding claim 8, as noted above, HPMC is disclosed .
Regarding claim 9, the instant claim differ from the references only in the specific ratios of the selected components for the compositions. However, It would have been deemed prima Facie obvious to one having ordinary skill in the art at the time of the invention to optimize the film forming and gelling agents, to prepare a composition used to prepare hard capsule shells. Therefore, the invention as Whole has been prima face obvious to one of ordinary skill in the art at the time the invention was made.
Regarding claims 10, 16-18, the claims are interpreted as product by process claims. Applicant is directed to MPEP 2113 which discloses "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Yamamoto does not exemplify the use of iota-carrageenan, he does disclose it to be a suitable alternative to the exemplified kappa carrageenan. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have substituted the k-carrageenan in the examples for i-carrageenan with the expectation of forming a suitable capsule shell.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gilinski (WO2006/020134) discloses hard capsules having acid-resistance properties and composed of a main cellulose, dispersants and plasticizers, and of a minimum proportion of a mixture of gelling agents. The main polymer is selected from the group of celluloses, preferably hypromellose (HPMC) and carboxymethyl cellulose, while the mixture of gelling agents is preferably a combination of gellant gum and kappa carrageenan. The capsule can additionally contain coloring agents, sweeteners and flavoring agents (abstract).
The capsule is based on a polymer or mixture of cellulose polymers of preferably in ranges between 80% and 95%, which contains percentages of Hydroxypropyl between 4.5 and 12%, a plasticizing agent at a maximum 5%, of the group of glycols such as sorbitol, glycerin, ethylene glycol and polyethylene glycol; and a mixture of gelling agents up to 3.5%, which may be carrageenan. Carrageenan type Kappa carrageenan which have the property of dissolving in cold water.
Iota-carrageenan was not disclosed. Nor is there motivation to replace the kappa-carrageenan. Additionally, the capsules have a gastro resistance greater than 20 minutes and can be modified until obtaining 2 hours of gastroresistance by varying the percentages in the mixtures of the gelling agents.
There is no motivation to reduce the amount of the polymer blend to the instantly claimed 5-25% instead of the 80-95% recited in Gilinski.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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