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
Claim Status
Claims 1-20 are pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 21 Dec 2023 and 03 Jul 2024 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term Gelucire, Tween, Labrasol, Brij, and Pluronics (e.g. pages 2, 4, 14 and 15) which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: The third and thirteenth lines in claim 1 recite “the implantable device.” The claim would have improved consistency by noting the “administered” device. For example, “the implantable or administered device.”
Appropriate correction is required.
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 1-20 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.
Claim 1 is indefinite for the recitation in line nine of the claim of “the pharmaceutically active agent.” This lacks proper antecedent basis back to the “at least one pharmaceutically active agent” and it is unclear if the “the pharmaceutically active agent” is intended to include one agent or more than one agent. Amending the claim to recite “the at least one pharmaceutically active agent” would overcome this rejection. Claims 2-20 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
Claim 4 contains the trademark/trade names labrasol, gelucire, pluronics and tween. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a biocompatible organic solvent and, accordingly, the identification/description is indefinite.
Claim 7 is indefinite for the limitation that “multiple pharmaceutical agents are combined in a single tablet or in sandwiched tablets.” Tablets are not mentioned in claim 1 and it is unclear at what point the agents are meant to be combined into tablets. For example, it is not clear if the tablets are intended to represent implantable device or if this is an alternative structure to the implantable device that the agents are part of.
Claims 12 and 13 lacks proper antecedent basis for “the tablet” as there is no tablet in claim 1.
Claim 13 is indefinite in the recitation of an “undefined shape.” It is not clear what limitation is intended to be imposed on the tablet by defining it as an undefined shape. For example, it is not clear if this is intended to require that tablet has a non-polygonal shape or if there is some other structure intended which is understood as undefined.
Claim 14 recites the limitation "the pharmacologically active agent". There is insufficient antecedent basis for this limitation in the claim. Base claim 1 recites “at least one pharmaceutically active agent”, which encompasses multiple pharmaceutical agents, and it is unclear whether “the pharmacologically active agent” includes refers to just one or more than one pharmaceutically active agents. Amending claim 14 to recite “the at least one pharmaceutically active agent” would overcome this rejection.
Claims 19 and 20 are indefinite for depending from claims 16 and 17 respectively and referring to the method of those claims. Claims 16 and 17 are product claims and it is not clear what method claims 19 and 20 are referring to.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 5,702,716, published 30 Dec 1997, listed on IDS filed 12/21/2023) in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development).
Dunn teaches a system for controlled release of biologically active materials and a liquid composition for its formation (abstract). Dunn teaches that the composition is capable of forming a biodegradable and/or bioerodible microporous, solid polymer matrix that is useful as an implant in patients for delivery of biologically active substances to tissues or organs (abstract), rendering obvious a controlled release drug delivery system comprising an implantable device as recited. Regarding the phase inversion technique of claim 1, Dunn teaches that the liquid composition is composed of a biocompatible, biodegradable thermoplastic polymer (component (a) of instant claim 1), an organic solvent (component (b) of instant claim 1), bioactive material (component (c) of instant claim 1) and a rate modifying agent (component (d) of instant claim 1) (see col 2 lines 18-30). Dunn teaches that the interaction of the liquid composition with an aqueous medium either in situ in the body or external to the body to coagulate the composition in to the polymer system at least in part causes the desired controlled release profile (col 2 lines 42-48). Dunn teaches that when the liquid composition is added to the aqueous medium, the organic solvent diffuses into the surrounding medium (body fluids or an external water medium) and the polymer coagulates to form the solid matrix (polymer system) (col 2 lines 52-56). Dunn teaches that the polymer system is substantially insoluble in aqueous media (col 2 lines 37-41). Thus, the phase inversion technique of claim 1 which recites introducing a solution comprising (a), (b), (c) and (d) to an aqueous medium wherein the solvent diffuses into the aqueous medium to provide an insoluble solid composition is made obvious by the method of forming an implant as taught by Dunn. Regarding the species of biodegradable polymer, Dunn teaches that suitable thermoelastic polymers for incorporation as the solid matrix of the controlled release polymer system are solids, pharmaceutically compatible and biodegradable by cellular action and/or by the action of body fluids (col 4 lines 18-22) and that preferred materials include polylactides, polyglycolides, polycaprolactones, and copolymers thereof (col 4 lines 34-34), rendering obvious claim 4. Regarding claim 6 and the specific biocompatible organic solvent (component (b) of instant claim 1), Dunn teaches the use of solvents such as N-methyl-2-pyrrolidone (NMP), dimethyl sulfoxide, and acetone (col 5 lines 30-44).
Regarding the ratio of polymer to solvent as recited in instant claim 2, Dunn teaches that the concentration of the polymer in the system can be varied to adjust the release rate of the incorporated bioactive material and that the more dilute the polymer concentration, the more readily the bioactive material will be released (col 8 lines 54-60). Dunn also teaches that the amount of organic solvent can affect the porosity of the polymer system (col 9 lines 24-28). Thus, in view of the teachings of Dunn that the polymer concentration can be varied to adjust the release rate of bioactive material and that the amount of organic solvent can affect the porosity of the polymer system, the amounts of polymer and organic solvent in the composition is an art-recognized result effective variable such that determining that the ratio should be 1:2-1:10 as in instant claim 2 would be a matter of optimization through routine experimentation. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, it would be obvious to one of ordinary skill to vary the polymer and organic concentrations to achieve desirable release characteristics and porosity structure for the intended use. Regarding component (c), the pharmaceutically active agent of instant claims 1 and 8-11, Dunn teaches that generally any drugs or bioactive materials that can be dissolved or dispersed in an aqueous environment can be utilized in the liquid composition and polymer system of the present invention (col 10 lines 17-20) and teaches a variety of suitable drugs such as for the treatment of viral diseases (col 10 line 25) and for male and female birth control agents (col 10 lines 30-47).
Dunn also teaches that when the polymer system is formed outside the body it can be molded or adapted into substantially the appropriate shape of the cavity or other space of the body into which it is being fitted (col 3 lines 1-4). Dunn teaches that the implantation of the polymer system made from the method as described above can occur anywhere within the body of a patient in need of therapeutic treatment, such as muscle, oral, or the cul-de-sac of the eye and that the polymer system can be inserted by known surgical techniques (col 3 lines 33-46). Dunn does not teach the serum level as in claim 1, however, achieving a therapeutic treatment requires that the serum level is at a sufficient level for to achieve efficacy.
Dunn does not specifically teach the polymer PLGA (claim 5) and does not teach that the insoluble polymer system is micronized and compressed to form the implantable device or the formation of tablets (claims 12 and 13) with the release parameters of claims 14 and 15 and does not teach an antiretroviral (claims 9 and 10). These deficiencies are made up for in the teachings of Whitcup.
Whitcup teaches methods and implants which can provide an extended treatment of an ocular condition after release of a therapeutic amount of a drug from an implant (([0006], [0039]). Whitcup teaches that the implants can include an active agent mixed with or dispersed within a biodegradable polymer ([0081]) and teaches that the implant compositions can vary according to the preferred drug release profile, the particular active agent used, the ocular condition being treated, and the medical history of the patient ([0081]). Whitcup teaches that it is desirable to have extended release durations of 6, 8, 12 months or more ([0038]). Whitcup teaches that active agents include anti-viral drugs such as azidothymidine ([0081]). As evidenced by NIH, azidothymidine is known for treating HIV infection and suppressing HIV replication (page 1 AZT: the first drug to treat HIV infection). Whitcup teaches that the active agent may be homogenously dispersed in the biodegradable polymer of the implant ([0086]). Whitcup teaches that the biodegradable polymer may be copolymers of glycolic and lactic acid, where the biodegradation is controlled by the ratio of glycolic to lactic acid and teaches that poly(lactic-co-glycolic) acid (PLGA) copolymer is suitable for the invention and that the percent of each monomer in the PLGA may vary ([0089]). Whitcup teaches that various techniques may be employed to make implants within the scope of the invention, including compression methods ([0101]) and Whitcup teaches an example of forming a compressed tablet where micronized dexamethasone and micronized 50/50 PLGA were formed using a tablet press ([0119]). Whitcupp teaches that the size and shape of the implant may be used to control the rate of release, period of treatment and active agent concentration at the site of implantation ([0095]) and teaches implants as discs and rods ([0096]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a controlled drug delivery system as an implant by introducing a liquid composition composed of a biocompatible, biodegradable thermoplastic polymer such as PLGA (component (a) of instant claim 1), an organic solvent (component (b) of instant claim 1), bioactive material such as an anti-infective agent (component (c) of instant claim 1) and a rate modifying agent (component (d) of instant claim 1) into an aqueous medium to form the matrix and to have micronized the solid matrix and compressed the micronized matrix into a tablet to form the implant. The biodegradable polymer for the solid matrix may include copolymers of polylactides and polyglycolides as taught by Dunn and PLGA is a copolymer suitable for implants that can affect the biodegradation rate by the ratio of glycolic to lactic acid, as taught by Whitcup, thus providing one of ordinary skill a reasonable expectation of controlling the biodegradation rate of the implant through use a PLGA polymer. Administering the implant in muscle, orally, or in the eye is known from Dunn, rendering obvious the method of administering in claim 18. Additionally, compression methods, such as forming compressed tablets by using a micronized active agent and micronized PLGA, are known for forming implants for ocular conditions and that have extended release patterns, as taught by Whitcup. Thus, it would have been obvious to one of ordinary skill in the art to modify the method of forming a polymeric implant of Dunn, which as taught by Dunn may be used in the eye and may be molded or adapted to fit the body cavity into which they are being fitted, by additionally micronizing the solid drug-polymer and compressing to form a tablet for ocular implant, as this compressed tablet formation method is suitable for forming ocular implants with extended release patterns and one of ordinary skill in the art would have a reasonable expectation of success as it has been previously demonstrated with PLGA polymers by Whitcup. Regarding claim 14, the constant release would be an result of the product formed by the method and the components used. As the art teaches the same product as the instant claims, the constant release would necessarily be a result of forming the product. Regarding claim 15, it is desirable to form implants with extended release patterns of 6-12 months or more, as taught by Whitcupp. Regarding claims 16 and 17, administering the device to a subject afflicted with a communicable disease such as HIV is an intended use of the product and does not distinguish the product from the prior art as the intended use of a product claim carries no patentable weight. See MPEP 2111.02.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 5,702,716, published 30 Dec 1997, listed on IDS filed 10/21/2022) in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development) as applied to claims 1-18 above and further in view of Felstead et al. (WO 2008/099278, published 21 Aug 2008).
The teachings of Dunn and Whitcup are described supra.
Dunn and Whitcup do not teach administering to a subject afflicted with, susceptible to or considered high risk for a communicable disease such as HIV. This deficiency is made up for in the teachings of Felstead.
Felstead teaches the use of a CCR5 antagonist to elevate lipid levels in patients in need thereof such as HIV infected patients (page 1 lines 4-6) and that the CCR5 antagonists may be administered directly to the eye as an implant (page 46 lines 13-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the controlled drug delivery implant obvious over the teachings of Dunn and Whitcup with a CCR5 antagonist to a patient infected with HIV. The implants are suitable for a variety of active compounds such as those for treating viral diseases and may be administered in locations such as the eye, as known from Dunn and Whitcup, and CCR5 antagonists which treat HIV infected patients are suitable for administration with an implant to the eye of a patient, as known from Felstead. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have administered a CCR5 antagonist in the implant material to treat an HIV patient as the implants are known for use with a variety of actives such as for treating viral diseases and the addition of the CCR5 antagonist thus merely represents and obvious use of a known prior art element with the known method of treatment with an extended delivery implant system. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-8 and 14-18 were rejected above and are alternatively rejected below using the teachings of Cleland, Parent and Shangraw.
Claims 1-8, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cleland et al. (US 2017/0080092, published 23 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression).
Cleland teaches controlled delivery formulations for treatment of ocular disorders (abstract). Cleland teaches administration of active compounds over a period of at least two, three, four, five or six months or more in a controlled release that is linear and that is at or above a therapeutically effective dose ([0023]). Cleland does not teach the serum level as in claim 1, however, achieving a therapeutically effective dose requires that the serum level is at a sufficient level for to achieve efficacy. A linear release renders obvious a constant release as in claim 14. Cleland teaches that the active agent may include Sunitinib ([0022]) which is a cancer drug ([0155]). Cleland teaches an implant as a suitable dosage form ([0322]). Cleland teaches the drug delivery system comprises particles including biocompatible polymers such as poly(lactic-co-glycolic acid) ([0362]-[0363]). Cleland teaches that particles of the invention can be formed from drugs using a phase inversion method where the polymer matrix and one or more drugs is dissolved in a “good” solvent and the solution is poured into a strong non solvent for the drug to spontaneously produce microparticles or nanoparticles ([0394]). Cleland teaches that the particles formed by phase inversion can be formulated into a tablet ([0395]).
Cleland does not teach micronizing or direct compression, the ratio of polymer to solvent (claim 2), in situ formation (claim 3) or the solvent NMP (claim 6). These deficiencies are made up for in the teachings of Parent and Shangraw.
Parent teaches PLGA in situ implants formed by phase inversion (title). Parent teaches that NMP as a solvent and PLGA as a biodegradable polymer is used in commercialized products (page 293 bottom left column). Parent teaches water as a non-solvent for phase inversion (page 293 right bottom paragraph). Parent teaches a ternary phase diagram for the polymer, solvent, and non-solvent where it is shown that the ratio of each component determines whether the composition is stable or unstable (Figure 1). Parent teaches that injection of the polymeric solution into water leads to a fast diffusion of the solvent towards the aqueous medium (page 294 right column).
Shangraw teaches compressed tablets by direct compression (title), which is the process by which tablets are compressed directly from powder blends of the active ingredient and suitable excipients (page 196 lines 7-9). Shangraw teaches blending and compression as a common process for direct compression and that prior micronization may be necessary (page 198 second paragraph). Shangraw teaches that direct compression of tablets is economical and allows for processing without the need for moisture and heat (page 198 paragraphs 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a controlled delivery device by a phase inversion process utilizing PLGA as the polymer and NMP as the solvent and to micronize and use direct compression to form a tablet implant. Forming particles from phase inversion and turning the particles into a tablet is known form Cleland. The solvent NMP is known for use in phase inversion and it has been combined with PLGA, as taught by Parent, rendering it obvious to use NMP as the solvent as it is known for use in such a phase inversion process. Further, the process of phase inversion is done in situ, as known from Parent, rendering obvious claim 3. The formation of a tablet is known from Cleland and micronization and direct compression steps are known procedures for forming tablets, as taught by Shangraw. One of ordinary skill would thus have a reasonable expectation of success in forming a tablet from direct compression as Cleland teaches tablets and micronizing and direct compression are known processes for forming tablets, providing one of ordinary skill a reasonable expectation of success in using these techniques in forming the tablets. Regarding claims 16 and 17, administering the device to a subject afflicted with a communicable disease such as HIV is an intended use of the product and does not distinguish the product from the prior art as the intended use of a product claim carries no patentable weight. See MPEP 2111.02. Regarding the ratio of polymer to solvent as recited in instant claim 2, Parent indicates that the relative amounts of polymer, solvent and non-solvent impact the phase inversion process leading to stable or unstable compositions. Thus, in view of the teachings of Parent, the amounts of polymer and organic solvent in the composition is an art-recognized result effective variable such that determining that the ratio should be 1:2-1:10 as in instant claim 2 would be a matter of optimization through routine experimentation. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, it would be obvious to one of ordinary skill to vary the polymer and organic concentrations to achieve stable compositions for use. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 10, 13, 15-17, 21, 23, 24, 26, 29, 30, and 39 of copending Application No. 17/427,190 in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development. The ‘190 application has been allowed and claims referenced below refer to the claims as presented in the examiner’s amendment of the notice of allowance.
Claim 15 of the ‘190 application is presented below.
A controlled release drug delivery system comprising an implantable or administered device that provides controlled release of at least one pharmaceutically active agent throughout an extended drug delivery time period, the implantable device comprising a drug-loaded polymer formed by a process comprising:
utilizing a phase inversion technique to produce an insoluble solid composition, the phase inversion technique comprising introducing a solution to an aqueous medium, the solution comprising (a) a biodegradable polymer, wherein the biodegradable polymer is poly(lactic-co-glycolic acid (PLGA), (b) a water miscible biocompatible organic solvent, wherein the water miscible biocompatible organic solvent comprises N-methyl-2-pyrrolidone (NMP), (c) at least one pharmaceutically active agent, and optionally (d) a release rate-limiting agent, wherein the ratio of biodegradable polymer to water miscible biocompatible organic solvent in the solution is from 1:2 to 1:6, to cause the polymer and active agent to precipitate to provide [[an]] the insoluble solid composition comprising the pharmaceutically active agent and the polymer;
completely removing residual water miscible biocompatible organic solvent from the insoluble solid composition, thereby providing a dry insoluble composition;
micronizing the dry insoluble solid composition; and
utilizing direct compression of the micronized dry insoluble solid composition to form a solid tablet forming the implantable or administered device,
wherein following implantation or administration of the device into a subject, the device results in a serum level of the pharmaceutically active agent sufficient to achieve therapeutic efficacy during the extended drug delivery time period.
Claim 29 of the ‘190 application recites
The drug delivery system of claim 15, wherein the at least one pharmaceutically
Claim 30 recites a delivery time form six months to about 1 year.
Claims 8, 10, 24 and 26 recite an antiretroviral agent and a contraceptive agent. Inclusion of an antiretroviral agent renders obvious administering to a subject with a communicable disease such as HIV. Claim 17 recites in situ formation. Claim 21 recites multiple pharmaceutical agents combined in a single tablet or sandwiched tablet.
These claims render obvious instant claims 1-11 and 14-20.
The claims of the ‘190 application do not recite forming the tablet into shapes and sizes such as those of instant claims 12 and 13. This deficiency is made up for in the teachings of Whitcupp.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the tablet implant of the ‘190 application in various shapes such as discs and rods. The formation of tablets for implantation, where the tablets have various shapes such as discs and rods is known from the teachings of Whitcupp. Thus, it would have been obvious to one of ordinary skill to form the tablets of the ‘190 application with shapes such as discs and rods as these are suitable shapes for implants.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14-21 and 23-26 of copending Application No. 18/836,156 in view of Dunn et al. (US 5,702,716, published 30 Dec 1997, listed on IDS filed 10/21/2022), Whitcup et al. (US 2014/0328835, published 16 Nov 2016) and Felstead et al. (WO 2008/099278, published 21 Aug 2008).
.
Claim 1 of the ‘156 application recites an extended releases composition comprising a drug or active agent, a biocompatible solvent, a biodegradable polymer and an amphiphilic or hydrophobic additive. Claim 2 recites an in-situ forming implant, claim 14 recites that the solvent is NMP and claim 18 recites that the polymer is PLGA.
The ‘156 application does not teach the phase inversion method, micronization and compression, formation of a tablet, the active agents of the instant claims or administering to a subject with a communicable disease such as HIV. These deficiencies are made up for in the teachings of Dunn, Whitcupp and Felstead.
The teachings of Dunn, Whitcupp and Felstead are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the extended release composition as a tablet by introducing the PLGA and NMP with active agent into an aqueous medium and to micronize and compress the resulting solid. Formation of implantable components with PLGA and NMP by injection into an aqueous medium is known from Dunn and micronization and compression are standard methods for forming implantable tablets, as taught by Whitcupp. Both Dunn and Whitcupp teach implants formed for the eye and these steps would have obvious means to combine to one of ordinary skill for forming the extended release composition. The inclusion of birth control agents into the implants is known from Dunn and the formation of the tablets with various shapes such as rods and discs is known from Whitcupp, rendering these features as obvious. It is further known that CCR5 antagonists, which treat pateients with HIV, may be incorporated into eye implants, as taught by Felstead, and thus it would be obvious to include a CCR5 antagonist as it is known for use in implants in similar areas as taught by Dunn and Whitcupp.
This is a provisional nonstatutory double patenting rejection
Claims 1-20 directed to an invention not patentably distinct from claims 1-3, 5, 7-10, 14-21 and 23-26 of commonly assigned application 18/836,156. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned application 18/836,156, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600