DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/28/2026, 06/10/20265, and 12/29/2023 have been considered by the examiner.
Status of the Claims
The response and amendment filed 01/28/2026 is acknowledged.
Claims 1-3, 6-9, 12-13, 15, 18-19, 24, 30, 39-42 and 44-45 are pending.
Applicant’s election without traverse of Group I, claims 1-3, 6-9, 12, 13, 15, 18, 19, 24, 30, and 39-42 in the reply filed on 01/28/2026 is acknowledged.
Applicant’s election without traverse of carrageenan as film forming polymer in the reply filed on 01/28/2026 is acknowledged.
It is confirmed “metal” was a clerical error.
Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2026.
Claims 1-36, 9, 12, 13, 15, 18, 19, 24, 30, and 39-42 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 9, 12, 15, 19, 24, 30, and 39-42 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tanner, US 20060099246 A1.
Tanner teaches soft capsule (softgel) dosage forms (Tanner, e.g., Abstract, 0002) comprising a shell having a film forming polymer, e.g., carrageenan, and a plasticizer (Tanner, entire document, e.g., 0029 and Table III and claim 4 and claim 26), which shell encapsulates a fill material comprising an alcohol, e.g., polyethylene glycol in an amount of 32.76% (Tanner, entire document, e.g., Example 3, table XVI) or 68% (Tanner, entire document, e.g., example 2, Table XIV). The claimed ‘alcohol’ reads on polyethylene glycol. The prior art capsules have the recited properties absent evidence to the contrary. These meet the structural limitations of claims 1-2.
Applicable to the properties recited in claims 1, 3, 30, 39, and 40-42: these claims recite capsule weight loss properties. The weight loss change properties are characteristic to the capsule shell and fill composition. As such the weight loss change properties are presumed to inhere to the structure recited in the claim absent evidence to the contrary. As the prior art softgel capsule has: a) the recited film forming polymer and plasticizer, and b) fill composition comprising at least about 20wt% alcohol, the “weight loss change” limitations are consequently presumed to be inherent absent evidence to the contrary. See MPEP 2112.01.
Applicable to claim 12: Tanner teaches carrageenan present in the shell formulation in an amount ranging from 6-8 wt% which is entirely within the claimed range.
Applicable to claims 15 and 24, the shell further comprises a buffer, water, and starch, i.e., a thickening agent (Tanner, e.g., Table III, 0050).
Applicable to claim 19: the plasticizer comprises sorbitol and sorbitan (Tanner, e.g., 0050). See POLYSORB throughout examples.
Tanner anticipates the subject matter of instant claims 1-3, 6, 9, 12, 15, 19, 24, 30, and 39-42.
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 of this title, 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.
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 1-3, 6, 9, 12, 13, 15, 19, 24, 30, and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Tanner, US 20060099246 A1 in view of Brox, US 4888239.
The teachings of Tanner enumerated above apply here. Given the express teachings of Tanner, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to arrive at a softgel capsule comprising a shell comprising carrageenan and a plasticizer such as a sorbitol/sorbitan mixture, which shell encapsulates a fill material comprising an alcohol in an amount within the claimed range as set forth in Tanner with a reasonable expectation of success. Claims which are anticipated would also be considered obvious to the skilled artisan given that anticipation is the epitome of obviousness.
Applicable to claim 13: Tanner teaches the fill material comprising an alcohol, e.g., polyethylene glycol, but does not the teach the fill material comprising ethanol, isopropanol or a combination thereof.
Brox teaches similar soft capsules containing a fill material comprising an alcohol, e.g., ethanol, in an amount of at least 5% by weight ethanol (Brox, entire document, e.g., Abstract and claims). Brox teaches ethanol may be used in the fill material in addition to polyethylene glycol (Brox, e.g., claim 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine the teachings of Tanner and Brox to arrive at the presently claimed subject matter with a reasonable expectation of success. Since Brox teaches ethanol as a solvent for fill materials in softgel capsules, the skilled artisan would have found it obvious to include ethanol in Tanner’s carrageenan shell softgels as a solvent to produce predictable results. The skilled artisan may have seen this modification as a substitution of one known solvent for another where each were known and used as a solvent in softgel capsules. Alternatively, the skilled artisan may have considered this modification since Brox expressly teaches ethanol may be used as a solvent in softgel capsules in combination with polyethylene glycol. In this case Brox provides an express suggestion to make this modification. The skilled artisan would have had a reasonable expectation of success since Tanner’s carrageenan capsules already contain solvents, and since Brox teaches ethanol and PEG were alternative solvents useful together in softgel fill compositions.
Accordingly, the subject matter of claims 1-3, 6, 9, 12, 13, 15, 19, 24, 30, and 39-42 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-3, 6, 9, 12, 15, 18, 19, 24, 30, and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Tanner, US 20060099246 A1 in view of Tanner, US 6582727 (Tanner, 727).
The teachings of Tanner enumerated above apply here. Given the express teachings of Tanner, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to arrive at a softgel capsule comprising a shell comprising carrageenan and a plasticizer such as a sorbitol/sorbitan mixture, which shell encapsulates a fill material comprising an alcohol in an amount within the claimed range as set forth in Tanner with a reasonable expectation of success. Claims which are anticipated would also be considered obvious to the skilled artisan given that anticipation is the epitome of obviousness.
Tanner teaches the shell comprising water, as enumerated above, but does not expressly teach water preset in the shell in an amount ranging from about 8wt% to about 25 wt%.
Tanner, 727 teaches similar softgel capsules, wherein the shell material comprises, inter alia, carrageenan, a plasticizer, and water (Tanner, 727, e.g., c5: table 1), and wherein the shell comprises an amount of bound water ranging from 6-12 wt% (Tanner, 727, e.g., c5:34-50). Drying and setting are terms for forming the shell from the film forming composition (Tanner, 727, e.g., c18, example 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to optimize the amount of water in Tanner’s plasticized carrageenan shells within the range suggested by Tanner, 727 with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification since Tanner, 727 teaches water in the range of about 6 to 12 wt% is considered dry, i.e., set, and thus found it obvious to optimize the amount of water in Tanner’s shells within this range to produce a shell material with effective barrier properties. The skilled artisan would have had a reasonable expectation of success since Tanner, 727 teaches the dry film shells will typically contain about 6 to 12 weight% of water which is not easily removable.
Accordingly, the subject matter of claims 1-3, 6, 9, 12, 15, 18, 19, 24, 30, and 39-42 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. West, US 20030124225 A1 teaches capsules containing ethanol as a fill composition, wherein the fill composition is about 5 to about 95% ethanol (West, e.g., claims).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
Prosecution Insights