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 Status
Applicants’ amendments and arguments filed 12/26/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1, 2, 4, 6, 8, 10, 19, and 38 are amended.
Claims 3, 5, 7, 9, 11-12, 16, 20-24, 27, 29-30, 35-37, and 39-105 remain canceled.
Claims 1-2, 4, 6, 8, 10, 13-15, 17-19, 25-26, 28, 31-34 and 38 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/28/2025 is being considered by the examiner. The non-patent literature (NPL) document, “ANONYMOUS, “Polymer, “February 2025, 15 Pages. Retrieved From Online URL:[https://goo.su/Hj0iz]” does not correspond to any uploaded NPL document within the application folder, therefore this document is not being considered. Further, a copy of the foreign patent CO42246 is not found within the application folder, therefore, the patent is not being considered.
Claim Interpretation
Regarding the limitation of claim 1, that requires a softshell composition “a soft shell composition derived from:” has been interpreted to require that the following ingredients are included in the shell of the capsule.
Regarding the limitation of claim 1 that requires “povidone”. Povidone is believed to be an abbreviated form of polyvinylpyrrolidone in view of instant application’s specification [0027] and this does not need to be recognized at the time the relevant time, See MPEP 2112(II). As such a prior art reference teaching povidone or polyvinylpyrrolidone is believed to teach on the required Povidone.
Regarding the limitation of claim 28 that requires “a shelf life”, Applicant is reminded this is a composition/product claim and the prior art teaches the composition of the independent claim 1, thereby since a product is not separable from its physical properties then it necessarily teaches the composition having a gel mass shelf life of up to about 60 days or a shelf life of about 60 days. Applicants observation that it also has ‘a shelf life of 60 days’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
Regarding the limitation of claims 31-32 which requires “rapeseed oil”, rapeseed oil is believed to be the same compound as canola oil in view of GoodRx (“Is Rapeseed Oil Healthy? The Benefits of Canola Oil.” GoodRx, GoodRx, www.goodrx.com/well-being/diet-nutrition/is-rapeseed-oil-healthy. Accessed 23 Oct. 2024) and this does not need to be recognized at the time the relevant time, See MPEP 2112(II). As such a prior art reference teaching canola oil or rapeseed is believed to teach on the required rapeseed oil.
Regarding the limitations burst strength of claim 32-34, it does not appear as though the applicant has disclosed how the tests regarding burst strength are carrier out. As such, prior art which achieves the recited burst strength under any method of testing is understood to meet the burst strength requirements of claims 32-34.
Regarding the limitation of claim 38 that requires “a water activity of about 0.150 Aw about 0.500 Aw”, Applicant is reminded this is a composition/product claim and the prior art teaches the composition of the independent claim 1, thereby since a product is not separable from its physical properties then it necessarily teaches the composition having a water activity of about 0.150 Aw about 0.500 Aw. Applicants observation that it also has ‘a water activity of 0.150 Aw about 0.500 Aw’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
New Rejections Necessitated by Amendments
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.
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.
Claim(s) 1-2, 4, 6, 8, 10, 13-15, 17-19, 25-26, 28, 31-34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (WO2014152098A1, published 09/25/2014, hereafter Fang) in view of Hauss (Hauss, D.J. (Ed.). (2007). Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs (1st ed.). CRC Press. https://doi.org/10.3109/9781420017267, hereafter Hauss) in view of BMJ (BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3468 (Published 21 August 2017)Cite this as: BMJ 2017;358:j3468, hereafter BMJ).
Fang claims an oral enteric soft capsule shell formed from a gel mass composition comprising a carrageenan composition, a filler, a methacrylic acid copolymer, one or more plasticizers, an alkaline aqueous solvent/ alkali neutralizing agent, and water (claim 1 and page 4, lines 10-15; according to the claim limitations of the instant claims 1-2, and 4). Fang teaches the carrageenan is iota carrageenan and kappa carrageenan (claim 4; according to the claim limitations of the instant claims 1, 4, and 6). Fang teaches the one or plasticizers comprises sorbitol, non-crystallizing sorbitol, sorbitol special, corn syrup, maltitol, glycerol, polyethylene glycol, citric acid, citric acid esters, triethyl citrate, or combinations thereof (claims 19-20; according to the claim limitations of the instant claims 1-2, 4, 10, and 18). Fang claims the composition further comprises a sealant, an opacifier, a preservative, a coloring, a flavoring, or a pharmaceutically acceptable excipient (claim 24 and page 15, lines 6-8; according to the claim limitations of the instant claims 13, 15, and 17). Furthermore, Fang teaches the optional opacifier to be titanium dioxide (table 1, page 8, lines 10-12; according to the claim limitations of the instant claim 14). Fang teaches the filler comprises a modified starch, specifically hydroxypropyl starch phosphate (claims 16-17; according to the claim limitations of the instant claim 1). Fang provides a sample composition which comprise iota carrageenan, kappa carrageenan, methacrylic acid copolymer, glycerol, sorbitol, ammonia, triethyl citrate, titanium dioxide, coloring, and water (page 8, table 1, lines 10-12; according to the claim limitations of the instant claims 1-2, 4, 6, 10, 13-15, and 18). The same table of Fang teaches the concentration of the polymer to be from 8-20% and the concentration of water to be from 50-70% (page 8, table 1, lines 10-12; according to the claim limitations of the instant claim 25). Fang provides a list of additional pharmaceutical excipients to include buffering/alkalizing agents, disintergrants, colorants, flavorants, and preservatives that may be used in any of the oral dosage forms as described herein (page 22-24, lines 15-30 of page 22 to lines 1-9 of page 24; according to the claim limitations of the instant claims 8, 13-15 and 17). Fang teaches the alkalizing agents to be ammonia solution, ammonium carbonate, diethanolamine, diisopropanolamine, potassium hydroxide, sodium bicarbonate, sodium borate, sodium carbonate, sodium hydroxide, and trolamine (page 21, lines 18-20; according to the claim limitations of the instant claim 8). Furthermore, Fang teaches the addition of buffers (page 20, lines 1-2), specifically buffering agents to include acetic acid, ammonium carbonate, ammonium phosphate, boric acid, citric acid, lactic acid, phosphoric acid, potassium citrate, potassium metaphosphate, potassium phosphate monobasic, sodium acetate, sodium citrate, sodium lactate solution, dibasic sodium phosphate, and monobasic sodium phosphate (pages 21-22, lines 30-31 and 1-2 respectively; according to the claim limitations of the instant claims 1 and 8). Fang teaches the colorant to be caramel, red, yellow, black or blends, ferric oxide (page 22, line 8; according to the claim limitation of the instant claim 13). Fang lists possible flavors to include: anethole, benzaldehyde, ethyl vanillin, menthol, methyl salicylate, monosodium glutamate, orange flower oil, peppermint, peppermint oil, peppermint spirit, rose oil, stronger rose water, thymol, tolu balsam tincture, vanilla, vanilla tincture, and vanillin (page 22, lines 19-22; according to the claim limitations of the instant claim 15). Fang teaches a list of preservatives to include: benzalkonium chloride, benzalkonium chloride solution, benzethonium chloride, benzoic acid, benzyl alcohol, butylparaben, cetylpyridinium chloride, chlorobutanol, chlorocresol, cresol, dehydroacetic acid, ethylparaben, methylparaben, methylparaben sodium, phenol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric 25 nitrate, potassium benzoate, potassium sorbate, propylparaben, propylparaben sodium, sodium benzoate, sodium dehydroacetate, sodium propionate, sorbic acid, thimerosal, and thymol (page 21, lines 21-26; according to the claim limitations of the instant claim 17). Fang teaches the addition of disintegrants such as alginic acid, microcrystalline cellulose, croscarmellose sodium, crospovidone, polacrilin potassium, and sodium starch glycolate (page 23, lines 20-21; according to the claim limitations of the instant claims 2 and 19). Fangs teaches that their compositions and methods are for enteric soft capsules that do not contain gelatin as a film forming polymer (title and page 1, lines 6-10; according to the claim limitations of the instant claim 26). Fang provides a list of exemplary lipids for the fill to include canola oil, medium chain monoglycerides, and polyethylene glycol (page 20, lines 16-30; according to the claim limitations of the instant claims 31-34). Furthermore, Fang teaches the fill composition to comprise polyethylene glycol as a emulsifier and a solvent/solubility enhancing agent (page 20, lines 11-12 and page 21, lines 1-8). Fang teaches the thickness of the capsule shell is from about 0.010 inches to about 0.050 inches (page 4, lines 7-9 and page 16, lines 1-9; according to the claim limitations of the instant claims 32-33). Lastly, Fang teaches a list of solvents/solubility enhancing agents useful in the matrix fill to include crospovidone, povidone K17, and povidone K30 (page 21, lines 1-7; according to the claim limitations of the instant claims 1-2).
Fang fails to teach explicitly teach povidone aka polyvinylpyrrolidone (PVP) in the shell capsule as in instant claim 1.
Hauss teaches an oral suspension solution, referencing the commercially available Cipro Oral Suspension which contains ciprofloxacin that is encapsulated into solid microcapsules containing povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and polysorbate 20 (page 30, oral suspensions).
Although Fang provides alternative options to starch, it fails to explicitly teach the composition is starch-free as in instant claim 1.
BMJ teaches medicines, excipients, and dietary intolerances (title). Further, BMJ teaches pharmaceutical starch is used in oral dose formulations and could be problematic for people with celiac disease (page 2, paragraph 2).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would claim an oral enteric soft capsule composition comprising a filler, carrageenan, a methacrylic acid copolymer, one or more plasticizers, an alkaline aqueous solvent/alkali neutralizing agent, and water as outlined by Fang a modify it with the known capsule product of a povidone, methacrylic acid copolymer, and gelling agent (magnesium stearate) as outlined by Hauss. Adding povidone to the softshell capsule composition as claimed by instant claim 1 would be obvious to combine a known method of encapsulating with a known product of modified capsules and would be a predictable solution with a reasonable expectation of success. Further, it would be obvious to one skilled in the art before the effective filing date of the claimed invention to modify an oral enteric soft capsule composition comprising a filler, carrageenan, a methacrylic acid copolymer, one or more plasticizers, an alkaline aqueous solvent/alkali neutralizing agent, and water as outlined by Fang by the selection of a starch-free as outlined by BMJ under TSM, see MPEP 2143(G). As outlined by BMJ, pharmaceutical starch can be problematic for people with coeliac disease which would motivate someone skilled in the art to advantageously select a starch-free filler for the composition of Fang as it would have a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 6, 8, 10, 13-15, 17-19, 25-26, 28, 31-34 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,090,232 in view of Fang et al. (WO2014152098A1, published 09/25/2014, hereafter Fang) in view of Hauss (Hauss, D.J. (Ed.). (2007). Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs (1st ed.). CRC Press. https://doi.org/10.3109/9781420017267, hereafter Hauss). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The instant applications is drawn to a soft gel capsule comprising a synthetic polymer, a natural gelling agent, a buffering agent, a plasticizer, water, and a fill composition.
The conflicting claims are drawn to a soft gel composition comprising a filler material and a shell with a gelling agent (iota carrageenan), plasticizer, and water.
The conflicting claims fails to teach the use of povidone.
As outlined above, Fang in view of Hauss teaches a enteric soft capsule comprising a synthetic polymer, a gelling agent (iota carrageenan), a plasticizer, and water with motivational addition of PVP also known as povidone. Furthermore, Fang teaches that in recent years a need for gelatin alternatives for soft capsule has arisen due to consumer restrictions such as vegetarians and religious restrictions (page 1, lines 22-24).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify the softgel composition comprising filler material and a shell with a gelling agent, plasticized, and water outlined by US12090232B2 by the obvious to replace the of gelatin for other known encapsulation polymers such as PVP and/or methacrylic polymers as outlined by Fang in view of Hauss. Adding povidone to the soft gel capsule composition of US12090232B2 as claimed by instant claim 1 would be obvious as combination of a known product and known method of encapsulation would yield a predictable solution with a reasonable expectation of success.
Response to Applicant’s Arguments
Applicant’s arguments filed on 12/26/2025 have been considered by the examiner.
In regards to the Claim Interpretations against claims 28 and 38, Applicant argues that the prior art does not teach the composition of record that “these properties should be given patentable weight”.
In response to Applicant’s arguments against the claim interpretation, Applicant provides no reasoning as to why the prior arts composition would vastly differ from the instantly claimed composition, therefore, as stated above since a product is not separable from its physical properties then it necessarily teaches the composition having a water activity of about 0.150 Aw about 0.500 Aw. Furthermore, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed composition.
In regards to the 35 USC § 103 rejection, Applicant’s amendments have necessitated new grounds of rejection.
In regards to the Double Patenting rejections, Applicant argues the claimed invention is patentable over Fang in view of Hauss, therefore, the two cannot cure the deficiencies of the copending applications.
It is first noted that in regards to the double patenting rejections, both Fang and Hauss are secondary and tertiary references. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, Applicant has failed to provide any reasoning as to why the double patenting rejections should be withdrawn in regards to the copending applications themselves.
In summary, the Examiner is not persuaded by Applicant’s arguments. The double patenting rejection over US12,090,232 is maintained and updated for amendments.
Conclusion
No claims allowed.
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 ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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