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 I carrageenan a.i and gelatin b.ii in the reply filed on 7/28/2026 is acknowledged.
Claims 25, 27 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 7/28/2026.
Claims 21-24, 26 and 29-40 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/28/2024, 8/4/2025, 11/18/2025 and 7/28/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 21-24, 26 and 29-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 6-11 of U.S. Patent No. 12,090,232. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a softgel capsule comprising a fill material and an enteric shell composition comprising 2.75-10%w/w iota carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers. The present claims are drawn to a method of treating disease by administering a subject a softgel capsule comprising a fill material and an enteric shell composition comprising 2-10% w/w carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers.
It is proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. 12,090,232 teaches treating and preventing conditions by administering an effective amount of active ingredients in the claimed softgels (column 2, lines 25-35). Therefore claims 21-24, 26 and 29-33 are also obvious in view of the teachings in the patented claims. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
Claims 34-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 6-11 of U.S. Patent No. 12,090,232 in view of Popp (US2005/0158377; published July, 21, 2005) . Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a softgel capsule comprising a fill material and an enteric shell composition comprising 2.75-10%w/w iota carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers. The present claims are drawn to a method of treating disease by administering a subject a softgel capsule comprising a fill material and an enteric shell composition comprising 2-10% w/w carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers.
Claims 34 and 35 requires an active selected from corticosteroids, preferably beclomethasone. Claim 36 requires the fill material or enteric shell comprises and excipient selected from peanut oil, castor oil, monoglycerides. Claims 37-40 further add excipients selected from dyes, flavoring agents and sweeteners such as sorbitol. It is for this reason that Popp is joined.
Popp teach methods of treating dermatological disorders by orally administering softgel capsules comprising gelatin, plasticizers, water, colorants and flavorants, wherein the active ingredient is selected from anti-infective and steroids (claim 1). The active is selected from immunomodulators, antiviral agents, hormones, peptides, analgesics or a corticosteroids, preferably beclomethasone [0102; 120]. The external gelatin layer can include flavorants, plasticizers, water, antioxidants or colorants selected from dyes or pigments [0048,0083]. The liquid phase includes oils selected from peanut oil, castor oil and mono-,di- or tri-glycerides [0094]. The soft gel includes carrageenan to provide controlled release [0124]. Capsules may comprise the sweetener sorbitol [0153].
Since both 12,090,232 and Popp are drawn to methods of treating conditions with soft gel capsules it would have been prima facie obvious to combine the teachings to include active ingredients selected from beclomethasone because Popp teach it is a known steroid used to treat dermatological disorders. It would have been prima facie obvious to combine the teachings to include dyes, oils selected from peanut oil and castor oil, flavoring agents and sweetening agents because Popp teach softgel capsules are known to further include colorants selected from dyes, oils selected from peanut oil and castor oil, flavoring agents and sweetening agents selected from sorbitol.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-24, 26 and 29-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites a method of treating disease or condition by administering an enteric softgel capsule comprising a fill material and an enteric shell composition comprising 2-10% w/w carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers. However, the specification fails to show possession of the method of treating a disease or condition with the softgel capsule. The specification fails to show possession of a method of treating any disease or condition nor provide effective amounts of pharmaceutically active ingredients needed to provide desired effects.
Claims 21-24, 26 and 29-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification fails to enable one of ordinary skill to administer the softgel capsule comprising a fill material and an enteric shell composition comprising 2-10% w/w carrageenan, 10-30% w/w gelatin, 10-35% w/w plasticizer and 20-50% w/w solvent which is free of conventional enteric polymers to treat any disease or condition.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the nature of the invention
2) the state of the prior art
3) the relative skill of those in the art
4) the predictability of the art
5) the breadth of the claims
6) the amount of direction or guidance provided
7) the presence or absence of working examples
8) the quantity of experimentation necessary
The instant specification fails to provide guidance that would allow one skilled in the art to treat a disease or condition with the softgel capsule of the instant invention without resorting to undue experimentation.
The nature of the invention.
The claimed invention relates to a method of treating any disease or condition with a softgel capsule which is extremely broad.
The state of the prior art & predictability of the art
It is generally accepted that treating a disease or condition requires extensive research including in vitro or in vivo testing based on the specific active ingredient within the softgel capsule. For Example, Popp et al. (2005/0158377) teach methods of treating dermatological disorders by orally administering softgel capsules comprising gelatin, plasticizers, water, colorants and flavorants, wherein the active ingredient is selected from anti-infective and steroids (claim 1). Additional data related to the disease or condition is needed such as the patient’s age [0128], health factors [0129-134 and timing of therapy [0135-137]. Furthermore, which disease and conditions treated requires knowledge of the active ingredient, effective amounts, route of administration and dosage to avoid overdose [145-150].
The breadth of the claims
The recitation of a method of treating a disease or condition is extremely broad and includes a wide range of symptoms and disorders. The active ingredients encompass a variety of pharmaceutically active compounds, oral vaccines, proteins, peptides, hormones and even contraceptives and spermicides which are known to have different properties. The bioavailability and efficacy of all active ingredients within soft gel capsules is not known.
The presence or absence of working examples
The specification fails to provide any working examples that show any effective treatment with the softgel capsule.
The quantity of experimentation necessary & relative skill in the art
To determine how to treat all diseases and conditions with the softgel capsule comprising various ingredients would require undue experimentation for one skilled in the art.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 37 recites the limitation "the at least one pharmaceutically acceptable excipient" in reference to the method of claim 21. Claims 38 recites the limitation "the additive" in reference to the method of claim 37. There is insufficient antecedent basis for these limitations in the claim. Claims 36-40 are rejected for depending on claim 37.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fukasawa et al. (2018/0221288).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/KYLE A PURDY/Primary Examiner, Art Unit 1611
Prosecution Insights