DETAILED ACTION
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 .
Status of Application
Receipt of Applicants’ remarks and amended claims filed on July 31, 2026 is acknowledged.
Claims 1-15 are pending in this application.
Claim 1 has been amended. No claims have been cancelled.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on July 31, 2026 is acknowledged. A signed copy is attached to this office action.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1-15 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 because claim 1 recite “a first (second) coating solution, suspension, or dispersion comprising or consisting of..” in lines 9-10 and 17-18 and it is unclear what is excluded/included in the claim based on the comprising/consisting of language has been withdrawn in view of the cancellation of the “consisting of” language from the claim.
Claim Rejections - 35 USC § 103
The rejection of claims 1-15 under 35 U.S.C. 103 as being unpatentable over Haksar et al. (WO 2021/115649) in view of Jain et al. (EP 3986969) has been withdrawn in view of the prior art and the instant application having common ownership and receipt of the certified English translation of the Indian Priority Document.
Newly Applied Rejections
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, 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being obvious over Guha et al. (WO 2019/096833, cited on IDS dated 11-21-2023) in view of Lovgren et al. (CA 1,292,693).
Guha discloses a process for preparing a polymer-coated hard shell capsule, suitable as container for pharmaceutical or nutraceutical biologically active ingredients, wherein the hard shell capsule is comprising a body and a cap, wherein in the closed state the cap overlaps the body either in a pre-locked state or in a final-locked state, wherein the hard shell capsule is provided in the pre-locked state and spray-coated with a coating solution, suspension or dispersion comprising a polymer or a mixture of polymers to create a coating layer which covers the outer surface of the hard shell capsule in the pre-locked state (abstract).
The polymer or polymer mixture comprised in the coating layer are preferably film-forming polymers and may be selected from the groups of anionic polymers, cationic polymers and neutral polymers or any mixtures thereof (page 10, lines 33-35).
The coating layer can optionally comprise excipient (page 18, lines 28-30). Suitable excipients include plasticizers, fillers, glidants, and pigments (page 23-25).
The coating layer is from about 1 to about 8 mg/cm2 (page 17, lines 14-22).
A sub coat may be located between capsule and the coating layer, comprising the polymer or polymer mixture as disclosed. A sub coat has essentially no influence on the active ingredient release characteristics but may for instance improve the adhesion of the polymer coating layer. A sub coat is preferably essentially water-soluble, for instance it may consist of substances like HPMC as a film former. The average thickness of a sub-coat layer is usually very thin, for example not more than 15 μm (page 25, lines 10-19).
There is no disclosure of the coating being applied anywhere but the outer surface of the capsule.
Regarding claim 2, the material of the body and cap is selected from hydroxypropyl methyl cellulose, starch, gelatin, pullulan and a copolymer of C1- to C4- alkylester of (meth)acrylic acid and (meth)acrylic acid.
Regarding claim 3, as noted above, the sub coat (a1) can be HPMC.
Regarding claims 4-6, the polymer or polymer matrix (a2) can comprise anionic (meth) acrylate copolymers (page 10, lines 10-12). Suitable anionic (meth)acrylate copolymers are those polymerized from of 40 to 60% by weight methacrylic acid and 60 to 40% by weight methyl methacrylate or 60 to 40% by weight ethyl acrylate (page 11, lines 18-20), for example.
Regarding claim 7, as noted above, the at least one polymer a1) can be HPMC.
Regarding claims 10-13, , the coating layer excipients can include glidants, emulsifiers, plasticizers, and flow agents, fragrances, pigments, flavoring agents, flow aids, or stabilizers (page 23, line 7-12), which would be addition additives. Examples recite the polymer is present in the amount of about 77-84% , which reads on the up to 400% recited in the claim.
Guha does not disclose the sub coating comprises an alkaline component.
Lovgren discloses a sub coating applied to capsule formulations. The sub coating comprises inert reacting compounds which are soluble or rapidly disintegrating in water, or polymeric, water soluble film forming compounds, optionally containing pH-buffering alkaline compound (abstract).
Regarding claim 8, examples of the alkaline compound include magnesium oxide (page 6, lines 1-36).
Regarding claim 9, Table 2 discloses a separating layer comprising a polymer and the alkaline agent in a 2.0:0.3 ratio.
Regarding claim 14, following the method of instant claim 1 results in a polymer coated hard shell capsule.
Regarding claim 15, the claim recites a functional property of the instant capsule. Since the capsule has been rendered obvious by the prior art, it would necessarily have the same functional properties, or in the alternative, it would have been obvious to one of ordinary skill in the art to adjust and optimize the components of the coating in order to obtain a coated capsule with the desired dissolution rates through routine experimentation.
It would have been obvious to one of ordinary still in the art prior to the effective filing date of the invention to have included an alkaline compound into the sub coating of Guha, as suggested by Lovgren since it is disclosed as providing a stabilizing effect.
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 terminal 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,980,692; claims 1-14 of U.S. Patent 11,523,992, and claims 1-20 of U.S. Patent No. 12,192,993 in view of Lovgren et al. (CA 1,292,693).
The patents disclose a capsule coating comprising the same components as those recited in the instant claims. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patented claims are drawn to processes of preparing a polymer coated hard capsule shell utilizing the same polymeric coating.
The cited patented cases do not recite a sub coating.
Lovgren discloses a sub coating applied to capsule formulations. The sub coating comprises inert reacting compounds which are soluble or rapidly disintegrating in water, or polymeric, water-soluble film-forming compounds, optionally containing pH-buffering alkaline compound (abstract).
It would have been obvious to one of ordinary still in the art prior to the effective filing date of the invention to have included sub coating comprising a polymer and alkaline compound, as suggested by Lovgren, since it is disclosed as providing a stabilizing effect.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/563,327 in view of Lovgren et al. (CA 1,292,693).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the copending claims are drawn to processes of preparing a polymer coated hard capsule shell utilizing the same polymeric coating.
The copending claims do not recite a sub coating.
Lovgren discloses a sub coating applied to capsule formulations. The sub coating comprises inert reacting compounds which are soluble or rapidly disintegrating in water, or polymeric, water-soluble film-forming compounds, optionally containing pH-buffering alkaline compound (abstract).
It would have been obvious to one of ordinary still in the art prior to the effective filing date of the invention to have included sub coating comprising a polymer and alkaline compound, as suggested by Lovgren, since it is disclosed as providing a stabilizing effect.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Due to the new grounds of rejection presented in this office action, this action is made Non-Final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 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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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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