DETAILED ACTION
Status of Application
Receipt of the response to the restriction/election requirement and applicant arguments/remarks, filed 12/03/2025, is acknowledged.
Applicant has elected the invention of Group I, claims 1-16, drawn to sustained release osmotic-controlled pharmaceutical compositions comprising: a core comprising an active ingredient comprising lurasidone or salt thereof, a polymer and an osmogene; and a semi-permeable membrane coated on the core and comprising a membrane body and at least one pore distributed in the membrane body. Because the applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. MPEP § 818.01(a).
Claims 1-20 are pending in this action. Claims 17-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-16 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, filed October 16, 2023, claims benefit of provisional U.S. Application No. 63/418,029, filed October 20, 2022.
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 (33 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 typographic errors, e.g., “lager fluctuation” (Para. 0002) that need to be corrected. Appropriate correction and/or clarification is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Para. 0023, 0076, 0082, 0111, 0114, 0117-0118, 0126-0128, 0131-0132, 0135-0136, 0139-0140, 0156-0157, 0160-0162, 0165-0166). Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0003, 0030, 0031, 0111-0113, 0117, 0126, 0128, 0131, 0135, 0139, 0156, 0160, 0165, 0167, 0170-0171, 0179). 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 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 statements, filed 10/16/2023 and 02/06/2024, are acknowledged and have 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 4, 13 are objected to because of the following informalities:
Claim 4 the typographic error “the carboxymethyl cellulose” that needs to be corrected to “carboxymethyl cellulose”.
Claim 13 recites the term “semi- permeable” that should be corrected to “semi-permeable”.
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 1-16 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses “a sustained release osmotic-controlled composition comprising (i) a core comprising a 1st polymer, a 1st osmogene, and a 1st active ingredient comprising lurasidone; and (ii) a semi-permeable membrane coated on the core and comprising a membrane body and at least one pore” that is not reasonably clear. In the present case, it is noted that claiming a result (i.e., a sustained release osmotic-controlled composition) 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. Clarification is required.
Claim 1 recites the limitation “1st active ingredient comprising lurasidone” that is not reasonably clear. Does this limitation imply the use of a mixture of compounds (i.e., comprising), or lurasidone as the active ingredient? Similar is applied to claim 4 regarding the limitation “the 1st polymer comprising”, to claims 5 and/or 6 regarding the limitation “the 1st osmogen comprises”, to claim 9 regarding the limitation “membrane body comprises”, to claim 15 regarding the limitation “the 2nd active ingredient comprises”. Applicant is advised to use the proper Markush group language, i.e., “selected from the group consisting of A, B, … and mixtures thereof” for clarity (MPEP §803.02) to clearly define the scope of the claims. Clarification is required.
Claim 1 recites the limitations “a 1st polymer and a 1st osmogene” that is unclear. In the present case, it is noted that the instant specification (Para. 0011, 0013) as well as the instant claims disclose the use of “sodium carboxymethyl cellulose” as the 1st polymer (see “sodium salt of carboxymethyl cellulose” in claim 4) and as the 1st osmogene (see “sodium carboxymethyl cellulose” in claim 6). Clarification of constituents to be used in the claimed composition is required.
Claim 1 recites the limitation “one pore distributed in the membrane body” that is unclear. Clarification is required.
Claim 8 recites the limitation “a weight percentage of the semi-permeable membrane is from 1% to 45% based on 100% by weight of the core” that is not clear. Does this limitation disclose a weight ratio of the semi-permeable membrane to the core? Similar is applied to claim 14 regarding the limitation “weight percentage of the film”, and to claim 15 regarding the limitation “a weight percentage of the 2nd active ingredient”. Clarification is required.
The ranges recited in claim 12 are unclear and indefinite, given that the ranges are shown without units of measurements (e.g., mol%, wt%, etc.). Therefore, the metes and bounds of the claim are not clear. Similar is applied to claim 16. Clarification is required.
Claims 2, 3, 7, 10, 11 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gan et al., US 2008/0089937A1 (cited in IDS; hereinafter referred to as Gan), in view of Khera et al., US 2014/0348909 A1 (hereinafter referred to as Khera).
Gan teaches controlled release drug compositions for enhancing controlled delivery of pharmaceutical active agents with low solubility in water (i.e., less than 10 mg/ml; Title; Abstract; Para. 0002, 0011, 0044), wherein said compositions comprise: (i) a drug core comprising the drug and hydroxypropyl cellulose, polyvinylpyrrolidone, crosslinked carboxylmethyl cellulose sodium (i.e., 1st polymer; Para. 0013, 0014, 0026 as applied to claims 1, 4); (ii) such osmogenes as sodium chloride, potassium chloride, magnesium chloride, sodium sulphate, magnesium sulphate, and/or such carbohydrates as mannitol, sorbitol, glucose, sucrose (i.e., 1st osmogene; Para. 0015, 0028 as applied to claims 1, 5-6); and (iii) a wall surrounding the core and comprising a semi-permeable material permeable to the passage of an exterior fluid and substantially impermeable to the passing of the biologically active substance, e.g., such wall material as cellulose acetate, ethyl cellulose (Para. 0017, 0018, 0030, 0054 as applied to claims 1, 9). Gan also teaches that said compositions may also include (iv) organic acids, e.g., ascorbic acid, tartaric acid (i.e., acidifiers; Para. 0013 as applied to claim 7); (v) other ingredients and/or push layer comprising such sustained-release materials as carbomers, hydroxypropyl methylcellulose/hypromellose, lactose, fructose (Para. 0034, 0035 as applied to claim 10). Gan further teaches that said systems/compositions can be further coated with a film coat over said semi-permeable membrane (Para. 0055 as applied to claim 13).
Though Gan teaches that a large variety of drugs with slight solubility in water (Para. 0045-0047) can be used/included in said compositions, Gan does not specifically teach the use of lurasidone or a pharmaceutically salt thereof (claim 1).
Khera teaches pharmaceutical compositions of lurasidone or salts thereof (i.e., a drug(s) having a solubility in water of 0.224 mg/ml; see Wikipedia) in a form of tablets (e.g., coated and/or multi-layer tablets) providing a modified release (Para. 0034-0038), wherein said compositions/tablets may include crosslinked sodium carboxymethylcellulose/sodium croscarmellose, ethyl cellulose (Para. 0033), hypromellose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, cellulose acetate, citric acid/acidifier (Para. 0054, 0059, 0063, 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try/include lurasidone or salts thereof (i.e., a pharmaceutical active agents with low solubility in water) as taught by Khera into the pharmaceutical compositions providing enhanced controlled delivery of pharmaceutical active agents with low solubility in water as taught by Gan, because it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. (MPEP 2144.06). In the present case, the cited prior art teaches pharmaceutical compositions providing desirable/controllable delivery of poorly water-soluble active agents/drugs.
With regard to the relative concentrations as instantly claimed (claims 2-3, 8, 11, 14-15), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding the properties of the disclosed formulations (claims 12, 16) it is noted that the cited prior art teaches formulations that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Applicant is advised to clarify the claimed language, the structure of the claimed formulations 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 application in condition for allowance.
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.
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, 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.
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.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615