DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 04/06/2026, is acknowledged. Amendments to the specification have been entered. Affidavit Declaration under 37 CFR 1.132, filed 04/06/2026, regarding the use of trademark(s) and the meaning of “dissolution percentage” is acknowledged.
Applicant has previously 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.
Claims 1-3, 5-20 are pending in this action. Claim 4 has been cancelled. Claims 1-3, 5-17, 20 have been amended. Claims 17-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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 1-3, 5-16 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 comprises the typographic error “weight percentage of the 1st active ingredient is from 2%-30%” that needs to be corrected to “weight percentage of the 1st active ingredient is from 2% to 30%” or clarified. 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, 5-16 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 pharmaceutical composition comprising (i) a core comprising a 1st polymer, a 1st osmogene, and a 1st active ingredient; and (ii) a semi-permeable membrane coated on the core and comprising a membrane body and at least one pore”, wherein said composition provides a specific dissolution of the 1st active ingredient. First, it is noted that the instant claim does not provide a clear definition for the semi-permeable membrane, i.e., what compounds should be used for allowing a liquid to flow into the said composition and provide/control the release of the claimed active ingredient. As stated previously, “Claiming a result (i.e., a specific as claimed dissolution percentage of the 1st active ingredient) 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. Second, the instant claim discloses the presence of “a 1st active ingredient”. Does this limitation imply the presence of other active ingredients, e.g., 2nd, 3rd, etc.? To this point, 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 the limitations “a 1st polymer”, “a 1st osmogene”, as well as to claims 10 and 11 regarding the limitations “a 2nd polymer”, “a 2nd osmogene”. Clarification is required.
As stated previously, claim 1 recites the limitation “one pore distributed in the membrane body” that is unclear. In the present case, it is unclear how one pore can be distributed. Clarification is required.
Claim 1 recites the limitation “a first dissolution percentage of the first active ingredient is from 0% to 30% within 2 hrs” that is unclear. In the present case, it is unclear what is disclosed as “1st dissolution percentage”. This limitation was interpreted as best understood as “a dissolution percentage of the first active ingredient within 2 hrs is from 0% to 30%”. Similar is applied to claim 12 regarding the limitation “a second dissolution percentage of the first active ingredient is from 30% to 100% within 10 hrs” Clarification is required.
Claim 5 recites the limitation “selected from the group consisting of a water-soluble salt, a carbohydrate, a water-soluble amino acid and mixtures thereof" that is not reasonably clear. In the present case, it is noted that the members of the Markush group must belong to a recognized physical or chemical class or to an art-recognized class. MPEP §803.02. In the present case, some members of said group are defined by their properties (e.g., water-soluble), whereas other members are defined by their chemical properties (e.g., carbohydrates). Clarification is required.
Claim 9 recites the limitation “the membrane body is selected from the group consisting of cellulose acetate, ethyl cellulose and mixtures thereof“ that is not reasonably clear, because the structural element (i.e., membrane body) is defined as a compound. Does this limitation imply/disclose the membrane body consisting of claimed compounds? Clarification is required.
Claims 2-3, 6-8, 13-16 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 35 USC § 103 - MAINTAINED
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, 5-16 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 polyvinylpyrrolidone, crosslinked carboxylmethyl cellulose sodium (i.e., 1st polymer; Para. 0013, 0014, 0026 as applied to claim 1); (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, xanthan gum, ethyl cellulose, hypromellose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, cellulose acetate, citric acid/acidifier (Para. 0033, 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 1, 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.
Response to Arguments
Applicant's arguments, filed 04/06/2026, have been fully considered. Any rejection or objection not reiterated in this action is withdrawn. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In the present case,
All cited references are reasonably drawn to the same field of endeavor that is controlled release drug compositions for enhancing controlled delivery of pharmaceutical active agents with low solubility in water.
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), wherein said composition may include structural elements/constituents and compounds as instantly claimed.
Khera teaches pharmaceutical compositions of lurasidone or salts thereof (i.e., a drug(s) having a solubility in water of 0.224 mg/ml) in a form of coated and/or multi-layer tablets providing a modified release.
Therefore, the examiner maintains the position that 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 agent 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. One would do so with expectation of beneficial results, because Gan teaches compositions and constituents providing desirable/controllable delivery of poorly water-soluble active agents/drugs. To this point, it should be noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
In response to applicant’s argument that the cited prior art does not teach dissolution profile in Mcilvaine buffer as instantly claimed, it is noted that given that said characteristic of the claimed product, i.e., “a reference dissolution profiles’’ depends on user’s choice (i.e., a specific buffer, pH, temperature, concentrations, etc.) said limitation is not sufficiently definite, because it refers to a variable. MPEP 2173.05(b)(ll). The cited prior art teaches compositions 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 properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claimed language, the structure of the claimed compositions 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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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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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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