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.
Status of the Claims
The response and amendment filed 09/04/2026 is acknowledged.
Claims 1-3, 6-9, 12, 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.
Claims 44-45 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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Claims 7-8 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-3, 6, 9, 12, 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 Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 1-3, 6, 9, 12, 15, 19, 24, 30, and 39-42 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tanner, US 20060099246 A1 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-3, 6, 9, 12, 15, 18, 19, 24, 30, and 39-42 under 35 U.S.C. 103 as being unpatentable over Tanner, US 20060099246 A1 in view of Tanner, US 6582727 (Tanner, 727).
Tanner does not expressly teach the fill material comprising ethanol, isopropanol or a combination thereof as required by amended claim 1.
Response to Arguments
Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive.
Applicant submits that the combination of Tanner in view of Brox fails to teach or suggest "a fill composition comprising at least about 20 wt. % alcohol, wherein the alcohol comprises ethanol, isopropanol, or a combination thereof." Applicant argues Tanner and Brox are directed to capsules having different capsule shell materials. Applicant argues there is no motivation to modify the non-gelatin based softgel capsules of Tanner with a fill used in a gelatin based softgel capsule of Brox. Applicant acknowledges that Tanner teaches the non-gelatin shell material to encapsulate fills "that, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules." [0026] of Tanner. Applicant argues Brox teaches concentrated ethanol is difficult to encapsulate in a gelatin shell because ethanol in excess of 10% may deteriorate the gelatin shell material. Applicant acknowledges this is a “gelatin specific teaching,” such that one of skill in the art would understand that Brox teaches how to prevent ethanol from softening gelatin. Applicant argues Brox says nothing whatsoever about the behavior of ethanol in a starch and/or carrageenan shell of the type taught in Tanner. Applicant has argued the Action has not identified any reason why one of skill in the art would look to a gelatin- specific ethanol stabilization strategy in order to modify Tanner's non-gelatin system.
This argument is not persuasive.
The rejection does not rely on motivation to look to Brox for a gelatin specific ethanol stabilization strategy as argued at least because Tanner does not use a gelatin shell material. Rather, Brox shows that the skilled artisan familiar with Tanner understood ethanol was known and used as being a good solvent for many pharmaceutically active agents (Brox, e.g., c1:59-67 and claims). The skilled artisan also understood that polyethylene glycol as found in Tanner was a solvent for active agents in fill compositions but is not a good solvent for all active agents (Brox, e.g., c1:34-c2:26 and claims). The skilled understood that polyethylene glycol may be used in combination with ethanol as a fill material solvent system (Brox, e.g., claims, e.g., claims 18 and 20) and that ethanol may be used as a fill material in an amount within the claimed range, e.g., about 5-50% by weight in the capsule fill composition (Brox, e.g., claim 5) even when the fill material is encapsulated in a shell material which is not stable to ethanol. Ethanol and polyethylene glycol were art recognized solvents for pharmaceutical agents as a fill material in softgel capsules. See MPEP 2144.06 art recognized equivalence for the same purpose.
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.
Applicant argues that beyond being directed to a different shell material, Tanner teaches away from gelatin capsules, and one of skill in the art starting with Tanner would have been discouraged from looking to a gelatin capsule formulation art such as Brox. Applicant argues one of skill in the art looking at Tanner would been led away from a gelatin-based shell of Brox.
This argument is unpersuasive.
The rejection does not rely on substituting gelatin for Tanner’s shell material. Tanner teaches the shell material of the elected species because 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). Tanner teaches a shell material (carrageenan) which the skilled artisan would expected to solve known problems of encapsulating pharmaceutical agents and carriers that have proved difficult in gelatin shell materials. Ethanol was a known carrier which was known to be a problem to encapsulate in gelatin as evident from Brox.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s argument that Action's rationale rests on selecting the ethanol disclosure of Brox in isolation while disregarding both the gelatin-specific premise that gives that disclosure its meaning and Tanner's discouragement of gelatin-based shell is unpersuasive. Applicant is conflating a teaching regarding gelatin with ethanol. Neither reference teaches away from ethanol. There is no hindsight required for the skilled artisan to recognize Brox’s teaching that ethanol and polyethylene glycol were both known and used as solvents for pharmaceutically active ingredients prior to the filing date of the presently claimed invention.
Applicant has argued that even if one of skill in the art were to combine Tanner and Brox, there would be no reasonable expectation of success in such combination. Applicant argues that because Brox's data are directed to ethanol partitioning into and deformation of a gelatin envelope, they furnish no predictive basis for how a fill comprising at least about 20 wt. % ethanol or isopropanol would behave in Tanner's starch/carrageenan shell.
This is unpersuasive at least because Tanner’s fill materials comprise solvents without stabilization problems and, as pointed out by Applicant, Tanner teaches carrageenan-based shells are better for encapsulating those pharmaceutical agents and carriers that have heretofore proved refractory to encapsulation in gelatin capsules, due either to the effect of the concentration of the agent or carrier, or the basic nature of the fill." [0024] of Tanner. Tanner set an expectation that using the known carrier/solvent ethanol in a carrageenan shell would have been met success.
Applicant argues Tanner teaches away from the proposed use of low molecular weight alcohols in the fill. Applicant argues Tanner describes that "water, propylene glycol, glycerin and low molecular alcohols, ketones, acids, amines and esters cannot be filled in softgels by themselves, or may only be present in small amounts." [0015] of Tanner. Applicant argues ethanol and isopropanol are precisely such low molecular weight alcohols. Applicant argues the primary reference discourages the very modification the Action proposes, namely, the incorporation of at least about 20 wt. % ethanol or isopropanol into Tanner's fill.
These arguments are unpersuasive.
When read in context, Tanner, 0015, refers to the known problems of gelatin softgels like those discussed in Brox. Tanner ¶s 0012-0016 are each directed to gelatin capsules. Tanner names gelatin in 0015 and does not extend this teaching to any other shell material. Tanner, 0015, does not teach away from water, propylene glycol, glycerin and low molecular weight alcohols, ketones, acids, amines and esters generally or specifically in a carrageenan softgel shell material. For example, Tanner exemplifies fill materials comprising water (Tanner, e.g., 0068 and Table XIV and 0071, Table XVI).
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.
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).
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.
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 according to the elected spesice 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. The prior art capsules have the recited properties absent evidence to the contrary. These meet the structural limitations of claims 1-2.
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.
Accordingly, the subject matter of claims 1-3, 6, 9, 12, 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, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tanner, US 20060099246 A1 in view of Brox, US 4888239 as applied to claims 1-3, 6, 9, 12, 15, 19, 24, 30, and 39-42 above and further 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).
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.
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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