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 .
DETAILED ACTION
Response to Amendments
The claims submitted 05/07/2026 appear to be exact copies of the claims submitted 09/26/2025 save that claims 12-15 no longer have the status signifier “withdrawn”. However, the claims submitted 04/15/2026 introduce the limitation “one or more surfactants from a group comprising sodium taurocholate, lecithin, glyceryl mono-oleate, and sodium oleate;” which is not present in the claims of 05/07/2026.
The claims submitted 04/15/2026 were not entered for improper status signifiers. As the claims submitted 04/15/2026 appear to be a bona fide attempt to amend the claims for continue examination, this action will be based on the amendments and remarks submitted 04/15/2026 but is in response to the reply submitted 05/07/2026.
Status of Claims
Claims currently pending are claims 1, 8, 11, and 16-20.
Claims currently withdrawn are claims 11 and 16-20.
Claims under examination are claims 1 and 8.
Withdrawn Rejection
The NSDP rejection over U.S. Patent No. 11,730,733 has been withdrawn in view of the terminal disclaimer filed 04/15/2026.
Modified 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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin II (CA3068254A1, published 12/27/2018) in view of Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
In regards to claim 1, Levin II is broadly to compounds derived from trimetazidine (structure shown below).
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Levin II on p. 6 and p. 23 teaches the compound CV8972 shown below:
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Levin II on p. 81 denotes the hydrochloric acid salt of the compound above as CV8972.
Levin II on p. 28 further contemplates embodiments of its invention, which include the CV8972 molecule above, as pharmaceutical compositions.
Levin II on p. 28, l. 2-3 contemplates oral administration.
Levin II on p. 93, table 66 teaches dose amounts of the CV8972 compound ranging from 142.08 mg to 779.06 mg.
Levin II teaches compositions comprising compound (X) above do not explicitly have the erodible polymer composed of two polymeric forms with specific properties or extended-release formulations. This is bridged by the combination of Aswathy, which teaches biphasic polymers of HPMC, and Maggi, which teaches extended-release tablets.
In regards to claims 1 and 8, Aswathy at p. 47, table 1 teaches biphasic HPMC layers (F7-F11). The same table also teaches mixtures wherein trimetazidine hydrochloride constitutes 10% by weight of a 200 mg mixture (F1-F11). Aswathy explicitly teaches trimetazidine but does not teach compound (X) of claim 1 or explicitly state CV8972. However, applicant in the specifications, p. 1, l. 25 states CV-8972 is a modified form of trimetazidine. Therefore, one of ordinary skill in the art would recognize that CV8972 and the compound of formula (X) are alternatively useable or equivalent.
Further, Aswathy teaches controlled-released administration as discussed on p. 44, sec. Introduction and on p. 68-69, Sec. Conclusion.
In regards to claim 1, Abrahamsson et al (herein after Abrahamsson) at p. 70, sec. 2.1 teaches hydrophilic gel matrix tablets comprised of approximately 50% HPMC.
Abrahamsson does not explicitly teach viscosity grade, cP, or methoxyl substitution.
In regards to claim 1, Maškova et al (herein after Maškova) on p. 697, Table 1 teaches “Commercial products of HPMC, viscosity grade and typical viscosity values for 2% (w/v) aqueous solution (measured at 20oC)” shown below:
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The table gives the inherent properties of HPMC forms including viscosity measurements, methoxyl substitution percentage, and hydroxypropoxyl substitution.
In regards to claim 1, which states “wherein the pharmaceutical composition is formulated as a 200 mg 8-hour modified release oral tablet,” Maggi in its abstract teaches double-layer tablets comprising HPMC which can slow drug delivery rate to a range of “a few hours up to 24h.”
Levin II teaches the compound (X) shown above as a pharmaceutical compound. Aswathy teaches HPMC and biphasic HPMC combinations as drug delivery compounds. Abrahamsson and Maškova teach the specific characteristics of the HPMC polymers, showing that the claimed characteristics are properties that can be selected via the various HPMC polymers. Maggi teaches the extended-release properties of the tablets. Drummond teaches about glyceryl mono-oleate.
The only element not explicitly taught by that art is the limitation “such that the geometric mean t1/2 of trimetazidine in a subject following administration of the pharmaceutical composition is between 6.5 hours and 9.5 hours.” Regarding this limitation, the instant specification states that the compound CV8972 above is “subsequently converted in the body to trimetazidine.” Therefore, trimetazidine is a metabolite of the CV8972 and the concentration present within the body would be caused by administering a certain dose of the CV8972. This limitation would be obvious because it is within the skillset of one of ordinary skill to formulate a composition from a known compound with known polymers to achieve a specific concentration by varying the concentrations of each component of the sustained-release agent, evidence to the contrary.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Additionally, Prabhakar discuss tablets formulated for sustained release and provide motivation to one of ordinary skill in the art. Prabhakar in col. 1, l. 10-28 discusses the advantages of sustained release of a single dose of a pharmaceutical compound. Prabhakar states “The convenience of administering a single dose of medication which release active ingredient over an extended period of time as opposed to the administration of a number of single doses at regular intervals has long been recognized in the pharmaceutical art. The advantage to the patient and clinician in having consistent and uniform blood levels of medication over an extended period of time are likewise recognized.”
Regarding the new limitation “one or more surfactants selected from a group comprising sodium taurocholate, lecithin, glyceryl mono-oleate, and sodium oleate,” Drummond teaches that “glyceryl mono-oleate” (GMO) is a well-known and commonly used excipient. Specifically, Drummond in sec. 3 Cubic phase states “To date GMO has been the surfactant of choice (either the sole or principal surfactant used) in formulating cubic phases for drug delivery. The reasons for this choice are worth document, as it provides guidelines for selecting alternative surfactants to GMO in future cubic phase formulations. GMO is non-toxic, biocompatible and biodegradable. GMO has low solubility in water…but can swell in water. The GMO-water phase diagram has been well characterized. Most importantly for the purpose of drug delivery, GMO forms a reversed biocontinuous cubic phase that is thermodynamically stable in excess water. The cubic phase has three-dimensional period of conduit structure of surfactant bilayers. And water channels…with a high specific surfactant/water interfacial area.”
Drummond continues “A wide variety of drugs with different physicochemical properties have been incorporated in GMO-based cubic phases. As well as those where sustained release has been experimentally measured, the drugs include… (See below for full listing)”. Therefore, not only is glyceryl mono-oleate a well-known surfactant with well-known properties, it is known within the art that including the glyceryl mono-oleate into drug formulations adds the benefit of delayed release. Therefore, one of ordinary skill in the art would find it obvious to add the glyceryl mono-oleate surfactant to a formulation in order to formulate the compound and/or composition into a delayed-release formulation.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have combined the teachings of Levin II, Aswathy, Maškova, Abrahamsson, Maggi, Prabhakar, and Drummond.
One of ordinary skill in the art would have been motivated to combine the teachings in efforts to create controlled-release composition.
Listing of drugs incorporated into drug formulations using GMO
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Maintained Double Patenting Rejections
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.
Patented Cases
Claim 1 and 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 of U.S. Patent No. 10,556,013 (previously co-pending application No. 16/011,196) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The claims in the ‘013 patent are drawn to the compound of formula (X) and e.g. oral, compositions thereof. As discussed in the 103 rejections above, one of ordinary skill in the art could formulate a composition comprising what is claimed in the instant claims via the teachings of the references above.
Claims 1 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,793,807 (previously application 17/540,653) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
Claims 1 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,969,422 (formerly application 17/540,638) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-10 of U.S. Patent No. 11,844,840 (formerly application 17/828,640) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
Claims 1 and 8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-32 of U.S. Patent No. 10,953,102 (formerly application 16/722,691) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
Claims 1 and 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 22-25 of US Patent 12,569,480 (formerly application 17/614,815) in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
Co-pending Applications
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-9, and 14-17 of copending Application No. 17/439,763 in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 39 of copending Application No. 17/282,584 in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17/614,826 in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/922,890 in view of Levin II (CA3068254A1, published 12/27/2018), Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75) and Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Response to arguments
Applicant’s remarks submitted 05/07/2026 are drawn to the status signifier of claims 12-15. Remarks in reply to the office action of 10/20/2025 are dated 04/15/2026.
Applicant’s remarks submitted 04/15/2026 have been considered but are not persuasive. Applicant argues that “None of Levin II, Aswathy, Abrahamsson, Maskova, and Prabhaker alone or in any proposed combinations, teach the claimed formulation which includes a compound of Formula X, one or more surfactants…and hydroxypropyl methylcellulose (HPMC) comprising a first polymeric form and a second polymeric form. The surfactants such as bile acids, lecithins, or glyceryl mono-oleate provide the unexpected benefit of ‘protecting’ the compound and slow down its hydrolysis rate, extending the T1/2 of the formulation”.
This is not persuasive for the reasons discussed in the 103 rejection above. Drummond teaches to the common use of glyceryl mono-oleate and it’s predictable effect. See KSR rationales B and C. The unexpected benefit is actually well known within the art. The “protecting” effect can be attributed to the use of glyceryl mono-oleate as taught by Drummond. Applicant has not indicated how the specific combination of surfactant and HPMC polymers leads to an unexpected effect that the art does not teach.
Regarding the double patenting rejections, applicant simply states that “the remaining double patenting rejections are deficient for the same reasons as those rejections under § 103.” No terminal disclaimer has been filed for the remaining double patenting rejections.
New Double Patenting Rejections
Application 18/269,820
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-21, and 31-40 of copending Application No. 18/269,820 in view of Levin II (CA3068254A1, published 12/27/2018) in view of Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to combination therapy comprising administering the compound CV8972 and a formulation comprising compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Application 17/735,594
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/735,594 in view of Levin II (CA3068254A1, published 12/27/2018) in view of Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Application 18/703,512
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 22, 32, 42, and 54 of copending Application No. 18/703,512 in view of Levin II (CA3068254A1, published 12/27/2018) in view of Aswathy et al (IJPPR Human, 2018; Vol. 13 (1):43-71), Abrahamsson et al (European Journal of Pharmaceuticals and Biopharmaceutics, 46, 1998, 69-75), Maškova et al (Journal of Controlled Release, 324, 2020, 695-727), Maggi (European Journal of Pharmaceutics and Biopharmaceutics, 1999, 48, 37-42), Prabhakar (US4140755, published 1979) and Drummond (Current Opinion in Colloid & Interface Science 4, 2000, 449-456).
The reference claims are drawn to methods comprising administering the compound CV8972. One of ordinary skill would find it obvious to formulate the compound via the references above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
Pertinent Art not Cited
Sodium taurocholate, lecithin, and sodium oleate are also well known within the art as surfactants and/or pharmaceutical excipients. For brevity, only Drummond was applied in the 103 rejection above. However, any of Park (Biotechnology and Bioprocess Engineering 2010, 15:66-75), Fricker (Pharm Res 2010, 27:1469-1486), and/or Morigaki (Current Opinion in colloid & Interface Science, vol. 12, Iss 2, 2007) can be applied.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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