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 without traverse of Group II (claims 6-7, 10-11, and 13) in the reply filed on 02 February 2026 is acknowledged.
Claims 1-5 and 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02 February 2026.
Newly submitted claim 12 is directed to an invention that is independent or distinct from the inventions originally claimed (see restriction requirement dated 03 December 2025) for the following reasons:
III. Claim 12, drawn to a method for banding an enteric hard capsule, comprising: coupling a capsule upper portion and a capsule lower portion to form a coupling portion; and applying the enteric capsule banding solution of claim 6 to a region comprising a boundary of the coupling portion, classified in CPC A61K 9/4833.
The inventions are independent or distinct, each from the other because:
Inventions I and III are directed to an unrelated product and process. Product and process inventions are unrelated if it can be shown that the product cannot be used in, or made by, the process. See MPEP § 802.01 and § 806.06. In the instant case, the product cannot be used in the process because the process of Invention III specifies use of a product different from the product of Invention I.
Inventions II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product such as banding a non-enteric capsule.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classification; and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02 February 2026.
Claims 6-7, 10-11, and 13 are under current consideration.
Claim Warning
Applicant is advised that should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (JP 2019-6726 A; published 17 January 2019; of record; citations herein to English machine translation provided by applicant on 17 January 2024 and dated 11.10.2023; of record) in view of Kim (KR 101219541 B1; published 09 January 2013; citations herein to English machine translation made 06 March 2026).
Regarding the claim 6 recitation of an enteric capsule banding solution comprising 75-85 parts by weight of distilled water, 2.5-6 parts by weight of pectin, 0.05-2 parts by weight of a plasticizer, and 10-20 parts by weight of an alcohol, wherein the solution is configured to hermetically seal a boundary of an enteric capsule coupling portion; Tanaka discloses a band seal solution comprising a first thickening agent such as pectin and a mixed solvent of water and alcohol (paragraph [0014]) wherein a preferred metal crosslinking thickener is pectin (paragraph [0020]) wherein the content of metal crosslinking thickener in the band seal is preferably 5-90% by weight (paragraph [0024]) wherein plasticizer adjusts the viscosity of a band seal liquid and prevents cracking on the surface of the band seal and makes it smooth and adhesion to the capsule surface is improved (paragraph [0045]) wherein the band seal may contain glycerin as plasticizer (paragraph [0046]) wherein the total content of plasticizer in the band seal is preferably 0-30% by mass (paragraph [0047]) wherein the capsule to be used is not particularly limited and is preferably a hard capsule and may comprise gelatin (paragraph [0055]) wherein the band seal prevents leakage of contents by sealing the body portion and the cap portion of the capsule to prevent the content unstable to oxygen from deteriorating (paragraph [0058]) wherein the total content of thickener is preferably 30-90 mass % (paragraph [0081]) wherein the band seal liquid is a solution (paragraph [0085]) wherein the solvent used for the band sealing liquid is a mixed solvent of water and alcohol wherein the alcohol is preferably ethanol (paragraph [0093]) wherein the amount of water in the solvent is adjusted in order to adjust the viscosity of the band seal liquid to be able to be applied to the capsule (paragraph [0095]) wherein the solvent dissolves the thickener (paragraph [0108]) wherein the seal seals the fitting portion between the body portion and the cap portion of the hard capsule (paragraph [0017]).
Further regarding claim 6, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Tanaka as discussed above and to make the capsule band seal solution thereof comprising 5-90 wt% pectin thickener, 0-30 wt% glycerin plasticizer, and water and ethanol mixed solvent, with a reasonable expectation of success. Such concentration ranges of 5-90 wt% pectin and 0-30 wt% glycerin plasticizer overlap the claimed ranges of 2.5-6 parts by weight pectin and 0.05-2 parts by weight plasticizer, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Further regarding claim 6, although Tanaka does not explicitly disclose that the capsule is enteric as recited, such is an intended use recitation that requires no structure/ingredients/limitations upon the claimed solution additional to that already recited and discussed herein. Moreover, Tanaka discloses that the capsule to be used is not particularly limited (paragraph [0055]).
Further regarding claim 6, with respect to the recitation that the solution is configured to hermetically seal a boundary of a capsule coupling portion, such is an intended use recitation that requires no structure/ingredients/limitations upon the claimed solution additional to that already recited and discussed herein. Nevertheless, Tanaka discloses that the band seal prevents leakage of contents by sealing the body portion and the cap portion of the capsule to prevent the content unstable to oxygen from deteriorating (paragraph [0058]), which reads on such recitation.
Further regarding claim 6, although Tanaka does not specifically disclose the claimed concentration ranges of water of 75-85 parts by weight and alcohol of 10-20 parts by weight, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize dissolution of thickener in the capsule band seal solution of Tanaka as discussed above by varying the concentration of solvent (i.e., water and ethanol mixture) therein, and to optimize viscosity and capsule application of the capsule band seal solution of Tanaka as discussed above by varying the concentration of water in the solvent thereof, which necessarily varies the concentration of ethanol in the solvent thereof, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Tanaka explicitly discloses that the solvent dissolves the thickener (paragraph [0108]) and that the amount of water in the solvent is adjusted in order to adjust the viscosity of the band seal liquid to be able to be applied to the capsule (paragraph [0095]).
Further regarding claim 6, Tanaka does not disclose the water as distilled water as claimed.
Further regarding claim 6, Kim discloses capsules (title) of gelatin (abstract) wherein water therein is purified to distilled water (page 5 paragraph 10).
Further regarding claim 6, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tanaka and Kim by using the distilled water of Kim as the water in the capsule band seal solution of Tanaka as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to exclude impurities from the solution and keep the water and thus the solution pure as suggested by Kim.
Regarding claim 7, Tanaka discloses that the band seal may contain glycerin as plasticizer (paragraph [0046]) and that the alcohol is preferably ethanol (paragraph [0093]), which reads on the claimed plasticizer being glycerin and the alcohol being ethanol.
Claim(s) 6-7, 10-11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Kim as applied to claims 6-7 above, and further in view of Scott et al. (US 2003/0175335 A1; published 18 September 2003).
Tanaka and Kim are relied upon as discussed above.
Tanaka and Kim do not disclose an enteric capsule as in claim 10.
Regarding claim 10, Scott et al. discloses pectin film compositions (title) wherein an aqueous solution thereof is used for the banding process of enteric capsules (claim 16).
Further regarding claim 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tanaka, Kim, and Scott et al. by using enteric capsules as in Scott et al. as the hard capsules that are banded using the capsule band seal solution of Tanaka in view of Kim as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a type of capsule known to be suitable to be banded by aqueous pectin compositions as suggested by Scott et al. given that Tanaka suggests using any type of capsule including hard capsules.
Further regarding claim 10, the claimed recitation of a capsule upper portion and a capsule lower portion coupled at a coupling portion, and a band formed from the capsule banding solution disposed on a region comprising a boundary of the coupling portion, is encompassed by the disclosure of Tanaka that the band seal seals the body portion and the cap portion of the capsule (paragraph [0058]) wherein the seal seals the fitting portion between the body portion and the cap portion of the hard capsule (paragraph [0017]).
Regarding claim 11, Tanaka discloses that the band seal may contain glycerin as plasticizer (paragraph [0046]) and that the alcohol is preferably ethanol (paragraph [0093]), which reads on the claimed plasticizer being glycerin and the alcohol being ethanol.
Regarding claim 13, Tanaka discloses that the band seal may contain glycerin as plasticizer (paragraph [0046]) and that the alcohol is preferably ethanol (paragraph [0093]), which reads on the claimed plasticizer being glycerin and the alcohol being ethanol.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617