DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the reply filed 3/17/2026.
Election/Restrictions
Claims 12-14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/9/2024.
Response to Arguments
The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The arguments in the response filed 3/17/2026 will be addressed below to the extent they apply to the current rejections.
112(b) Rejection
In view of the amendments and arguments presented 3/17/2026 the 112(b) rejection over claims 6, 10-11 and 15 are withdrawn.
103 Rejections
Applicant argues there is no motivation to arrive at the claimed preformed solid dosage form being a tablet or a caplet. Neither the microcapsules of Carminati nor the minicapsules Moodley would be understood to correspond to the claimed tablet or caplet by one of skill in the art.
Applicant are directed to the new and/or modified rejection below wherein this limitations as newly amended is addressed.
Applicant argues that incorporating a dosage form such as tablets within soft gelatin dosage forms "retains the established pharmaceutical characteristics of the preformed solid dosage form in combination with a liquid phase, such as physical and chemical stability, active ingredient release profile of the solid dosage form, bioavailability and clinical performance." This is not taught or suggested in either Carminati or Moodley.
This is not persuasive, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that there would be no motivation to modify the microcapsules to be a tablet or caplet because Carminati and Moodley both are directed to formulations including microcapsules, which would render them inoperable for its intended purpose.
This is not persuasive. While Carminati teaches microcapsules the intended purpose of Carminati appears to be formulating a pharmaceutical composition comprising stabilized statin and teaches this stabilization to be achieved via use of a coating, not the microcapsules themselves, thus the use of coated tablets instead of microcapsules would be expected to result in a composition having stabilized statin.
Regarding Moodley, while Moodley teaches formulations comprising minicapsules or minispheres the intended purpose appears to be formulations which enhance the bioavailability of pharmaceutical and nutritional active [0001], and teaches this can be achieved by formulating a minicapsule to comprise an active entity in a solid form and an encapsulating medium (Moodley – claim 138). It is well known in the art that tablets are capable of having solid cores with active ingredients and can comprise outer coatings (i.e. an encapsulating medium) and as both minitablets and minicapsules comprising ibuprofen are known in the art to be used to fill gelatin capsules, so there is a reasonable expectation of success in using minitablets as the preformed dosage form in the composition of Moodley.
Double Patenting Rejections
Applicant argues that the claims as amended are patentably distinct from the cited patents because the amendments are not explicitly recited in the claims.
This is not persuasive as all copending applications and patents listed above teach preformed dosage forms as tablets and liquid phases comprising active ingredients which reads on the claimed 1st and 2nd active.
New Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 3-4, 6-9, 11, 17-19, 21 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carminati (EP1803440), Tanner (US 2002/0081331) and Knapp (US 2005/0053651).
Carminati discloses a pharmaceutical formulation comprising a suspension comprising an oil having more than 60% alkyl esters of polyunsaturated fatty acid (PUFA) and microcapsules comprising at least one polymer and a statin. The PUFA is selected from EPA and/or DHA (Carminati – claim 1). The microcapsule suspensions are taught to be encapsulated by soft gelatin capsules for oral administration (Carminati – claim 1, 3 and 17).
Regarding claim 3: The microcapsules comprising statin reads on the preformed solid dosage form having an active ingredient and the oil reads on liquid fill phase. Carminati teaches the soft gelatin capsule comprising the encapsulated microcapsules to have an enteric coating (Carminati – claim 18), reading on a barrier coating.
Regarding the 1st active: The microcapsules are taught to comprise statin.
Regarding the 2nd active: The oil comprises DHA, a functional excipient which reads on an active.
Claim 3 recites “wherein the … are independently introduced in the soft capsule,” this is a product-by-process step and the patentability of the claim rests on the structure implied by the recited method step, not the performance of the step itself. Carminati makes obvious a capsule having a preformed solid dosage form and a liquid fill phase, as such the limitations of the claim have been met.
Regarding claim 4: Carminate teaches a pharmaceutical dosage form suitable for administration comprising microcapsule suitable for administration, this reads on finished dosage form. (Title).
Regarding claim 6: Carminati teaches the microcapsules to comprise statin, which reads on active pharmaceutical agent.
Regarding claims 7-9: Carminati teaches the oil to comprise at least 60% EPA and/or DHA, which reads on lipophilic diluent oils which are pharmaceutically acceptable.
Regarding claim 11: Carminati teaches the oil to comprise at least 60% EPA and/or DHA, thus the use of both EPA and DHA is obvious, which reads on at least a functional excipient and active ingredient.
Regarding claims 17 and 19: Carminati teaches the microcapsules to have a polymer coating comprising gelatin (Carminati – claim 7).
Regarding claim 18: Carminati teaches the microcapsules to have a polymer coating wherein the coating provides stabilization of the statin [0007] which reads on protective coating.
Regarding claim 21: Carminati teaches the microcapsules to have a polymer coating wherein the coating provides stabilization of the statin [0007] which reads on coating having a functional excipient.
Regarding claim 26: Carminati teaches an oil and microcapsule which reads on the 1st active and 2nd active being present in different phases and further teaches the statin to be isolated from the EPA and/or DHA, as such interaction between the oil and statin is prevented.
However, Carminati fails to teach the outer capsule (i.e. reading on shell) to be one not having gelatin.
Tanner discusses the manufacturing of soft capsules (Abs). Tanner teaches that using gelatin has its disadvantages such as cost and continuity of supply, along with a variety of other drawbacks. For example, bovine sources are somewhat unattractive to individuals that prefer vegetarian food sources. Also, gelatin is prone to cross-linking, either caused by aging or due to reaction with compounds such as aldehydes. Cross-linking reduces the gelatin insoluble in gastric fluids, a generally undesirable quality for soft capsules. Thus, there is a need in the soft capsule industry for a replacement for the gelatin based compositions [0012]. Tanner teaches forming the soft capsule dry shell using a combination of iota-carrageenan (reading on functional polymeric material), modified starch, plasticizer and a buffer system (Tanner – claim 27). Tanner teaches the soft capsule to be a replacement for gelatin capsules which many of the desirable important characteristics of gelatin. The inventive compositions form films that are mechanically strong and exhibit elasticity sufficient to allow the film to stretch during filling (blow-molding). Thus, the invention films have dimensional stability, elasticity and strength adequate for use in a continuous process which requires their removal from a casting drum and subsequent transport to rotary dies. Unexpectedly, the fusion or sealing temperature is substantially less than the melting point of the inventive film. Thus, films formed from the compositions of the invention simultaneously fuse together during the filling and cutting portion of the rotary die process when subjected to sufficient pressure and elevated temperature [0039].
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to modify the teachings of Carminati with those of Tanner. A skilled artisan would have been motivated to substitute the gelatin soft capsule of Carminati with the soft capsule of Tanner as Tanner teaches its soft capsule to be an alternative that avoids the disadvantages of using gelatin, such as being suitable for vegetarians, while at the same time imparting many of the desirable important characteristics of gelatin as discussed above. One of skill in the art would have a reasonable expectation of success as Tanner teaches their soft capsule composition to be a suitable replacement for gelatin soft gel capsules.
However, Carminati teaches the performed solid dosage form to be microcapsules and not a tablet or caplet as claimed.
Knapp teaches pharmaceutical compositions in gelatine capsule form (Abs). Knapp teaches that active core composition comprising the active ingredient can be in the form of microcapsules, minicapsules or minitablets [0055]
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to modify the teachings of the above references with those of Shah. A skilled artisan would have recognized that the microcapsules of Carminati could be effectively formulated as minitablets with a reasonable expectation of success as both microcapsules and minitablets are acceptable forms for incorporation into capsules and its prima facie obvious for a skilled artisan to pursue the known options within his or her own technical grasp to achieve the predictable results of formulating capsules filled active agents in the form of tablets.
Maintained/Modified Claim Rejections - 35 USC § 103
Claims 3-4, 6, 11, 15, 17-19, 21 and 25-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moodley (US 2008/0113031), Carminati (EP1803440), Tanner (US 2002/0081331) and IE 912885.
Moodley discloses a formulation comprising a plurality of seamless minicapsules, the minicapsules have a core containing an active entity and an encapsulating body, this reads on preformed solid dosage form comprising at least one active agent (Abs).
Moodley teaches a formulation where a plurality of the microcapsules are inside a capsule, wherein the capsule contains another entity in a liquid form which further comprises an active entity (Moodley – claim 131-134), this entity reads on liquid fill phase as recited by instant claims 3 and 10. Moodley teaches this liquid to fill the empty space between the microcapsules when inside a larger hard gelatin capsule [0403].
Regarding the 1st and 2nd active: Moodley teaches that the in the microcapsule technology the active entities dispersed in the encapsulating medium, in the coating, or present in a layer or coating maybe the same of different active entities [0406-0407], which suggests that the active entity in the liquid form maybe the same or different as the active entity in the microcapsules and the choice of active agent is simply a matter of design choice. Moodley also teaches that various combinations of active agents are suitable for use [0536], thus the use of a single active ingredient or multiple active ingredients in the microcapsules or liquid phase is prima facie obvious.
Claim 3 recites “wherein the … are independently introduced in the soft capsule,” this is a product-by-process step and the patentability of the claim rests on the structure implied by the recited method step, not the performance of the step itself. Moodley teaches capsule having a liquid fill space and minicapsules dispersed throughout the liquid fill space, thus the limitations of the claimed have been met.
Regarding claim 4: Moodley teaches the formulation to be used for oral administration of pharmaceutical active entities [0065].
Regarding claim 6: Moodley teaches that a suitable active ingredient for the minicapsules includes ibuprofen [0511].
Regarding claim 11: Moodley teaches that a suitable active ingredient for use includes ibuprofen, therefore, it would have been prima facie obvious to use ibuprofen in the liquid phase as its prima facie obvious to select a known material for its recognized suitability.
Regarding claim 17-18: Moodley teaches that the minicapsules (i.e. the preformed solid dosage form) can have at least one coating to control the time and/or location of release, the coating can be for immediate release and/or sustained release, be an enteric coating etc. [0041-0042].
Regarding claim 19: Moodley teaches a sustained release coating and teaches the use of Eudragit RS and Eudragit RL polymers which are swellable film formers, which reads on a film coating [0222].
Regarding claim 21: Moodley teaches that the shell of the minicapsules is further coated with a bioadhesive material, an enteric material, as well as other functional entities [0178] or combinations, which are made up of ethylcellulose, PVP, lecithin, chitosan, etc., this reads on functional excipients [0117-0119].
Regarding claim 26: Moodley teaches the inclusion of active ingredients in both the microcapsules and the liquid phase, thus teaching these active to be present in different phases as such they are isolated from each other as required by the instant claim and interaction between them is expected to be prevented. Furthermore, Moodley teaches the shell of the microcapsules to have a coating, which is taught by the originally filed specification to help prevent interaction (pg. 13).
Moodley teaches an outer hard gelatin capsule, but does not teach a soft gelatin capsule.
Carminati discloses a pharmaceutical formulation comprising a suspension comprising an oil having more than 60% alkyl esters of polyunsaturated fatty acid (PUFA) and microcapsules comprising at least one polymer and a statin. The PUFA is selected from EPA and/or DHA (Carminati – claim 1). (Carminati – claim 1, 3 and 17).
Carminati teaches that the final product can be soft gelatin capsules, hard gelatin capsules, tablets, granules, etc. [0007], but soft gelatin capsules are preferred. These soft gelatin capsules preferably have an enteric coating [0018].
In view of the teaching of Carminati, a skilled artisan would recognize that both hard capsules and soft capsules are suitable for oral administration and equivalent for use, therefore, the decision to use either is simply a matter of design choice and it would have been prima facie obvious to formulate Moodley to use soft capsules with a reasonable expectation of success.
Regarding claims 3 and 25: Moodley teaches that apart from insertion into hard gelatin capsules the minicapsules can be blended with various excipients and pressed into a tablet, pellet or pill formats that maybe further coated with various controlled release polymers. These forms maybe gastro retentive and swell in the stomach, preventing passage into the small intestines [0403-0404]. Carminati teaches that soft gelatin capsules preferably have an enteric coating [0018]. It would have been prima facie obvious to fill the minicapsules into a soft gelatin capsule and coat this capsule with controlled release polymers, such as enteric, as suggested by Moodley and Carminati with a reasonable expectation of success as Carminati taches that its known in the art to coat soft gelatin capsules with enteric coating, which reads on an enteric coating having a functional excipient as claimed.
However, the above references fails to teach the outer capsule (i.e. reading on shell) to be one not having gelatin.
Tanner discusses the manufacturing of soft capsules (Abs). Tanner teaches that using gelatin has its disadvantages such as cost and continuity of supply, along with a variety of other drawbacks. For example, bovine sources are somewhat unattractive to individuals that prefer vegetarian food sources. Also, gelatin is prone to cross-linking, either caused by aging or due to reaction with compounds such as aldehydes. Cross-linking reduces the gelatin insoluble in gastric fluids, a generally undesirable quality for soft capsules. Thus, there is a need in the soft capsule industry for a replacement for the gelatin based compositions [0012]. Tanner teaches forming the soft capsule dry shell using a combination of iota-carrageenan (reading on functional polymeric material), modified starch, plasticizer and a buffer system (Tanner – claim 27). Tanner teaches the soft capsule to be a replacement for gelatin capsules which many of the desirable important characteristics of gelatin. The inventive compositions form films that are mechanically strong and exhibit elasticity sufficient to allow the film to stretch during filling (blow-molding). Thus, the invention films have dimensional stability, elasticity and strength adequate for use in a continuous process which requires their removal from a casting drum and subsequent transport to rotary dies. Unexpectedly, the fusion or sealing temperature is substantially less than the melting point of the inventive film. Thus, films formed from the compositions of the invention simultaneously fuse together during the filling and cutting portion of the rotary die process when subjected to sufficient pressure and elevated temperature [0039].
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to modify the teachings of the above references with those of Tanner. A skilled artisan would have been motivated to substitute the gelatin soft capsule of the above references with the soft capsule of Tanner as Tanner teaches its soft capsule to be an alternative that avoids the disadvantages of using gelatin, such as being suitable for vegetarians, while at the same time imparting many of the desirable important characteristics of gelatin as discussed above. One of skill in the art would have a reasonable expectation of success as Tanner teaches their soft capsule composition to be a suitable replacement for gelatin soft gel capsules.
However, the above references do not teach the active ingredient of the preformed solid dosage form to be an ibuprofen tablet and the active of the liquid fill phase to be ibuprofen as recited by instant claim 15.
Moodley teaches that a suitable active ingredient for use includes ibuprofen and teaches that the active ingredients present in the different active entities can be the same or they can be different [0023], thus it would have been prima facie obvious to use ibuprofen in both the minicapsules and the liquid fill phase with a reasonable expectation of success.
IE’885 teaches an oral dosage dorm comprising different small tablets, each having prolonged or controlled release, filled into hard gelatin capsules (Abs). IE’885 discloses making minitablets of ibuprofen (working examples).
It would have been prima facie obvious at the time the invention was made to formulate the minicapsules of Moodley to be minitablets, as both minitablets and minicapsules comprising ibuprofen are known in the art to be used to fill gelatin capsules, so there is a reasonable expectation of success in using minitablets in the composition of Moodley. As the minitablets comprise ibuprofen, this reads on the active pharmaceutical ingredient being an ibuprofen tablet.
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 3-4, 6-9, 11, 15, 17-19, 21 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,173,125 and Tanner (US 2002/0081331). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose multi-phase soft capsule for oral administration, the soft capsule comprising: at least one preformed solid dosage form comprising at least one active ingredient, wherein the at least one preformed solid dosage form is a tablet, a caplet or a slug of solid material (instant claim 4); at least one liquid fill phase; and wherein the at least one solid dosage form and the at least one liquid fill phase are independently introduced in the multi-phase soft capsule (reading on instant claims 3 and 5). Both teach the at least one preformed solid dosage form is a pharmaceutical grade finished dosage form (instant claim 4), wherein the at least one active ingredient in the at least one preformed solid dosage form is selected from the group consisting of: an active pharmaceutical ingredient, nutraceutical, nutritional supplement, therapeutic substance, functional excipients and combinations thereof (instant claim 6), wherein the at least one liquid fill phase is lipophilic or hydrophilic; comprises diluent oils and comprises vegetable oils, mineral oils, food grade oils, pharmaceutically acceptable oils or mixtures thereof (instant claims 7-10), wherein the liquid fill phase further comprises at least one active ingredient such as ibuprofen and the preformed solid dosage form is an ibuprofen tablet (instant claims 10-11 and 15), wherein the preformed solid dosage form and the soft gelatin capsules have the same types of coatings (instant claims 17-19, 21, 23 and 25). US’125 teaches that the active ingredient in the liquid phase and the preformed solid for can be the same or different. Regarding claim 26: US’125 teaches the inclusion of active ingredients in both the microcapsules and the liquid phase, thus teaching these active to be present in different phases as such they are isolated from each other as required by the instant claim and interaction between them is expected to be prevented.
However, US’125 teaches a gelatin soft capsule, while the instant claim require a capsule shell not containing gelatin.
The teachings of Tanner are discussed above and are incorporated into this rejection and the instant claims are obvious for the same reasons.
Claims 3-4, 6-9, 11, 17-19, 21 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,975,108 and Tanner (US 2002/0081331). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose multi-phase soft oral capsule dosage form comprising single preformed tablet comprising an active ingredient and a liquid fill phase comprising omega-3 fatty acids consisting of an ethyl ester of eicosapentaenoic acid (EPA) (instant claims 3 and 6-7); wherein liquid fill phase further comprises an active pharmaceutical ingredient, diluent oils such as vegetable oils, mineral oils, food grade oils, pharmaceutically acceptable oils or mixtures thereof (instant claims 8-11); the preformed solid dosage form has at least one coating selected from the group consisting of: film coating, gelatin coating, and combinations thereof and wherein the preformed tablet comprises a moisture shield coating (instant claim 17-19 and 21); and wherein the preformed tablet is a pharmaceutically finished tablet (instant claim 4). Claim 3 recites “wherein the … are independently introduced in the soft capsule,” this is a product-by-process step and the patentability of the claim rests on the structure implied by the recited method step, not the performance of the step itself. US’108 teaches capsule having a liquid fill space and a tablet as claimed, thus the limitations of the claimed have been met. US’125 teaches that the active ingredient in the liquid phase (i.e. EPA) and the preformed solid (i.e. statin) are different. Regarding claim 26: US’108 teaches the inclusion of active ingredients in both the microcapsules and the liquid phase, thus teaching these active to be present in different phases as such they are isolated from each other as required by the instant claim and interaction between them is expected to be prevented.
However, US’108 teaches a gelatin soft capsule, while the instant claim require a capsule shell not containing gelatin.
The teachings of Tanner are discussed above and are incorporated into this rejection and the instant claims are obvious for the same reasons.
Claims 3-4, 6-9, 11, 17-19, 21, 23 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,544,341 (copending Application No. 18/130142) and Tanner (US 2002/0081331). Although the claims at issue are not identical, they are not patentably distinct from each other because both teach multi-phase soft oral capsule dosage form comprising single preformed dosage form comprising an active ingredient and a liquid fill phase comprising omega-3 fatty acids (DHA and/or EPA) which are independently introduced (instant claims 3 and 6): wherein the preformed dosage form is a pharmaceutically finished dosage form in the form of a table or capsule (instant claims 4-5); wherein the liquid fill phase comprises an active in gradient such as an active pharmaceutical ingredient and comprises diluent oils (vegetable, mineral, etc.) (instant claims 7-11); the preformed solid dosage form has at least one coating selected from the group consisting of: film coating, gelatin coating, and combinations thereof and wherein the preformed tablet comprises a moisture shield coating (instant claim 17-19 and 21) and the coating also comprises an active ingredient (instant claim 21); and wherein the soft gelatin capsule also has a coating such as an enteric coating further comprising an active ingredient (instant claims 23 and 25). US’125 teaches that the active ingredient in the liquid phase (i.e. omega-3 fatty acids) and the preformed solid (i.e. statin) are different Regarding claim 26: US’142 teaches the inclusion of active ingredients in both the microcapsules and the liquid phase, thus teaching these active to be present in different phases as such they are isolated from each other as required by the instant claim and interaction between them is expected to be prevented.
However, US’142 teaches a gelatin soft capsule, while the instant claim require a capsule shell not containing gelatin.
The teachings of Tanner are discussed above and are incorporated into this rejection and the instant claims are obvious for the same reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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