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 the Preliminary Amendments dated November 22, 2023 and November 29, 2023 is acknowledged.
Claims 1-16 are pending in this application.
Claims 1-15 have been amended.
Claim 16 is new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on November 22, 2023; December 5, 2023; and June 13, 2024 is acknowledged. A signed copy is attached to this office action.
Claim Rejections - 35 USC § 112
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 1-16 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 1-16 recite “a coating solution, suspension, or dispersion comprising or consisting of..” in lines 7-8. Applicant has not particularly pointed out what the coating layers are limited to. It is unclear what is excluded/included in the claim based on the comprising/consisting of language. For purposes of prosecution in application of prior art, the claims are being examined utilizing “comprising”. The claims must be limited to one transition phrase.
Regarding claim 10, the claim recites “the process according to claim 1, wherein up to 400 % by weight, based on the total weight of the at least one polymer a) comprises the at least one additive.” It is unclear how the polymer and additive component can be 400% of the polymer. Clarification is requested.
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 1-16 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 Azarbayjani et al. (Impact of Surface Tension in Pharmaceutical Sciences, J Pharm Pharmaceut Sci 12(2) 218-228 (2009)).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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).
Examples 2-4 comprise glyceryl monostearate, which is a known emulsifier and glidant; polysorbate 80 which is a known emulsifier; and triethyl citrate which is a known plasticizer.
The coating amount can be from about 1 to about 8 mg/cm2 (page 17, lines 21-22).
Regarding claim 2, the material of the body and cap may be selected from the HPMC, starch, gelatin, pullulan and a copolymer of C1- to C4-alkylester of (meth)acrylic acid and (meth)acrylic acid (page 9, lines 25-28).
Regarding claim 3, the polymer or polymer matrix can comprise anionic (meth) acrylate copolymers (page 10, lines 10-12).
Regarding claims 4 and 6, 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 5, Example 2 discloses the use of Eudragit FS30D and Eudragit L30D-55 which meets the limitation of ii.
Regarding claim 7-8, as noted above, glidants and emulsifiers include glycerol monostearate, which possess duel functionality. Examples discloses it being used in amounts of 7.5-8.5%.
Regarding claim 9, as noted above, examples disclose the use of triethyl citrate. It is present in the amount of 8.23-14.07%.
Regarding claim 10, 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.
Regarding claim 11, it is disclosed the body and the cap are comprising encircling notches or dimples in the area where the cap overlaps the body, that allow the capsule to be closed by a snap-into-place mechanism either in the pre-locked state or in the final-locked state (claim 11).
Regarding claim 12, the body of the capsule comprises a tapered rim (claim 12).
Regarding claim 13, the coating layer is from about 1 to about 8 mg/cm2 (page 17, lines 14-22).
Regarding claim 14, following the method of instant claim 1 results in a polymer coated hard shell capsule.
Regarding claim 15, the capsule can be used to administer an active pharmaceutical agent within the capsule. The recitation of immediate, delayed, or sustained would encompass all release profiles of capsules.
Regarding claim 16, there is no disclosure of the coating being applied anywhere but the outer surface of the capsule.
While Guha discloses a coated hard capsule meeting the structural elements of the instant claims, he does not disclose the surface tension of said coating.
Azarbayjani discloses the chemical activity, adsorption, dissolution, and bioavailability of a drug may depend on the surface of a molecule, therefore, surface properties and their manipulation in a certain application are play important roles (Introduction).
Coating can improve product appearance, mask taste and odor or control that rate of drug release. If the surface tension is too high, the wetting process will be hindered. If the surface area is too low the leveling process will be influenced leading to an orange peel surface. Therefore, it is important to control the surface tension of the coating solution for a presentable product. Film coating is defined as the adhesion and spreading of polymers over the tablet surface, therefore the surface tension of the polymer solution will have a major influence on interfacial events.
The rate and extent of drug absorption in the gastrointestinal (GI) tract are determined by factors such as dissolution, disintegration and the aqueous solubility of the drug. These factors should be considered because they have a significant impact on properties of drugs, such as uptake, distribution, transport, and eventually bioavailability. By applying special surface treatments such as contact angle and surface tension measurements to pharmaceutical compounds, drug distribution, dissolution behavior and release pattern in various body fluids can be improved. The surface tension of human gastric juice is in the range of 35-45 mNm. In vitro conditions can be mimicked by the addition of pepsin and/or surfactants to the HCl solution. Lack of surface tension lowering agent in the dissolution media would give results that are not representative of in vivo rates (Section 2.1.1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention that adjusted and optimized the surface tension of the polymeric coating on the capsules in order to take advantage of new and better performing products since it is disclosed surface tension can influence the development, production and performance of pharmaceutical, food, biomaterial and other products since considerations of parameters such as contact angle and surface tension of surfaces may provide the critical component to solve industrial problems and improve product quality.
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 1-16 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. 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.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/563,327. 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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