DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 10/22/2024, are acknowledged.
Claims 1-3, 5-19, 22-23 are pending in this action. Claims 4, 20, 21, 24-44 have been cancelled. Claims 1, 3, 5-7, 9-12, 14-18, 22-23 have been amended. Claims 1-3, 5-19, 22-23 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/US2022/076965, filed September 23, 2022, which claims benefit of provisional U.S. Application No. 63/247,560, filed September 23, 2021.
Inventorship
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.
Specification
The lengthy specification (44 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises references on foreign application and/or publications (e.g., Para. 0006, 0107, 0108, 0155). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises multiple acronyms without proper definition, e.g., “LMW”, “HMW” (Para. 0039); “SEM” (Para. 0085, 0090), “EDX” (Para. 0089), etc. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The specification comprises typographic errors. e.g., “Crospovidone, Chlorpheniramine Maleate, Ibuprofen, and Dexamethasone” (Para. 0041, 0136, 0137, 0149), Poloxamer (Para. 0111, 0112) that need to be corrected as crospovidone, chlorpheniramine maleate, ibuprofen, dexamethasone, poloxamer, respectively. Appropriate correction is required.
The data recited in Para. 0051 (i.e., “molecular weight”) are unclear, because the data are shown without units of measurements, e.g., Da, kDa. Clarification is required.
The use of the trademarks/trade names/product names has been noted in this application, e.g., “HPMC-K15M Premium CR” (Para. 0120), “Ceolus” (Para. 0133, 0135), “Tween 20” (Para. 0143, 0151, 0152). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names/product names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement, filed 03/21/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Objections
Claims 1-2, 5-6, 8, 10-11, 13-15, 19, 23 are objected to because of the following informalities:
Claim 1 comprises the typographic error “3 C” that need to be corrected to “3 oC” for clarity. Similar is applied to claim 2.
It is suggested that in claim 6 the limitation “is selected from favipiravir, …” should be corrected to “is selected from the group consisting of favipiravir, …” for clarity. Similar is applied to claims 5, 8, 10-11, 13-15, 19.
Claim 23 comprises the typographic errors “comprises about 200 mg to 800 mg total API” that need to be corrected to “comprises from about 200 mg to 800 mg of total API”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3, 5-19, 22-23 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “mixing a poorly soluble active pharmaceutical ingredient (API) and a surfactant” that is not reasonably clear, because the constituents to be mixed are not clearly delineated. First, it is unclear under what conditions said API should be poorly soluble. Second, it is unclear what compounds should be used as surfactants. To this it is noted that “surfactant” is a chemical compound that decreases the surface tension or interfacial tension between two liquids, a liquid and a gas, or a liquid and a solid (see Wikipedia), i.e., between different phases. Therefore, it is unclear what is understood as a surfactant in the claimed method. Third, it is noted that claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. In the present case, the claim language does not set forth well-defined boundaries of the invention, but only states a problem to be solved and/or a result to be obtained. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Similar is applied to claim 19. Clarification is required.
Claim 1 recites the limitation “temperature within a range of approximately the melting point of the surfactant” that is unclear. The term “approximately” is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claim 3, as well as to claim 23 regarding the term “about”. Clarification is required.
Claim 1 is unclear and indefinite, because said claim recites a broad range/limitation (API content is at least 60%) together with a narrow range/limitation (i.e., at least 70%, at least 80%, at least 90%) that falls within the broad range/limitation in the same claim. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claims 15, 19. Clarification is required.
Claim 9 recites the limitation “surfactant comprises one or more of” that is not reasonably clear. Does this limitation defines a surfactant as a mixture that may include other compounds even in a large amounts (i.e., comprising)? Similar is applied to claims 12, 13 regarding the limitation “excipients comprise”, Clarification is required.
Claim 19 discloses a dosage form comprising granulates of a poorly soluble API and a surfactant, wherein “the API granulates are capable of being compressed into tablets at a compaction pressure of more than 300 psi” that is not reasonably clear. To this point, it is noted that said claim attempts to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. To this point, it is noted that it is well known in the field that properties of multicomponent systems (e.g., compositions/granulates) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/product. Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Clarification is required.
Claim 23 recites the limitation “dosage form comprising pure API granulates” that is not reasonably clear. In the present case, it is unclear what the term “pure API granulates” does imply – without surfactant and prepared by a different method, or a certain level of purity of API in use. Clarification is required.
Claims 2, 5-8, 10-11, 14, 16-18, 22 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-3, 5-19, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Vasanthavada et al., US 2010/0152299A1 (hereinafter referred to as Vasanthavada’299), in view of Vasanthavada et al., US 2008/0226731A1 (hereinafter referred to as Vasanthavada’731), and Gail et al., US 20170281615 A1 (hereinafter referred to as Gail).
Vasanthavada’299 teaches a process for preparing solid dosage forms that contain , wherein the preparation of said dosage forms includes such steps as: (i) combining a therapeutic compound with at least one granulation excipient to form a mixture; (ii) blending or kneading the mixture in a twin-screw extruder, while heating the mixture to a temperature less than the melting point or melting range of the therapeutic compound; and extruding the mixture through an optional die to form an extrudate; and (iii) milling the extrudate into granules and subsequently compressing using conventional means into a solid oral dosage form (Abstract; Para. 0001, 0006, 0007, 0020 as applied to claims 1, 10). Vasanthavada’299 teaches that one can use such granulation excipient as glyceryl monostearate (Para. 0036 as applied to claims 1, 9-10) identified in the instant invention as a surfactant (see instant specification, Para. 0014, 0021).
Vasanthavada’299 teaches the use of such therapeutic compounds as anti-inflammatory drugs/agents, e.g., indomethacin, ibuprofen, and/or such anti-septic agent as cetylpyridinium chloride (Para. 0016 as applied to claims 1, 5-9) identified in the instant invention as a surfactant (see instant specification, Para.0014, 0021).
Vasanthavada’299 teaches that once the granules are obtained, the granules may be formulated into solid oral dosage forms, e.g., tablets, capsules (Para. 0043 as applied to claims 14, 18) by adding additional conventional excipients such as crospovidone, hydroxypropyl methylcellulose (Para. 0045, 0046as applied to claims 11-13).
Vasanthavada’299 teaches that said therapeutic compounds can be present in the pharmaceutical compositions in an amount of 0.05-99 wt% (Para. 0017 as applied to claims 1, 19, 23).
Vasanthavada’731 teaches a process for preparing solid dosage forms providing sustained release of imatinib, wherein said compositions/dosage forms comprise at least 50 wt% of imatinib, and are milled or granulated and compressed into monolithic tablets or encapsulated into capsules (Para. 0006, 0007, 0011, 0021). Vasanthavada’731 teaches the use of glyceryl monostearate as a non-polymeric release retardant agent (Para. 0036, 0037), and also teaches the use of hydroxypropyl methylcellulose, methylcellulose as polymeric release retardant agents (Para. 0022-00026). Vasanthavada’731 teaches that preparation of said dosage forms includes: (i) granulating imatinib with a release retardant and optionally a release modifier in a twin-screw extruder while heating to a temperature below the melting temperature of imatinib or its salt, to form melt granules; and (ii) compressing the melt granules into a tablet (Para. 0074-0079).
Gail teaches extended-release dosage forms (e.g., tablets or capsules) that comprise: (i) particles comprising plastic/elastic polymers and at least one active pharmaceutical ingredient (API) and prepared by a hot melt extrusion process using twin-screw-extruder (Abstract; Para. 0044-0045, 0094-0098); and (ii) a binder, e.g., methylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose (Para. 0056). Gail teaches that said particles may include: (iii) such active agent as ibuprofen, indomethacin, estradiol, fenofibrate, carbamazepine, etc. (Para. 0033); and (iv) poloxamers, polysorbates as wetting agents (Para. 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare particles/granulates comprising an active agent in combination with other constituents as instantly claimed by twin-screw process with controllable temperature. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used for providing dosage forms with controllable distribution of the active agents and desired/controllable drug release rate. Claims 2-3, 15-17, 22 are rejected as being dependent upon a rejected base claim. Applicant is advised to clarify the claim language/scope, the constituents/compounds to be used in the claimed method and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the applicant in condition for allowance.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5-19, 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims MMMM of copending Application No. 17/906,514.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application, since the referenced copending application and the instant application are claiming common subject matter, as follows: A process for manufacturing an oral dosage form by mixing/introducing an API (e.g., ibuprofen, carbamazepine, fenofibrate, indomethacin, imatinib, flufenamic acid, erlotinib hydrochloride, vitamin D, estradiol or a combination thereof) and a surfactant (e.g., comprising poloxamer, polyoxyethylene stearate, cetylpyridinium chloride, polysorbate, and glyceryl monostearate) into a twin-screw processor and continuously heating and shearing the API and surfactant in the twin-screw processor at a processing temperature that is below the melting point of the surfactant to form melt-coated API particles. In the present case, the conflicting claims are not patentably distinct from each other, because copending application claims are merely broader than instant claims that include additional limitation (i.e., melt coated and melt-granulated API granulates) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615