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 .
Claims 1-17 are pending in the instant application.
Claims 1-12 are presented for examination.
The amendments and remarks filed on January 14, 2026 have been received and entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) s 1, 2, 4, 5 and 8-11 is/are rejected under 35 U.S.C. 102(a)(2) as being (anticipated by Fu et al. (Wo 2016100392 submitted by the applicant).
Fu et al. teach object of the invention to provide formulations of sunitinib or its analog or pharmaceutically acceptable salt with improved duration, stability, safety, and efficacy.
It is a further object of the invention to provide methods for encapsulation or incorporation into polymeric matrices, including nano- and micro-particles, with increased loading. See page 2, line 8-13. Methods for increasing the encapsulation or incorporation of sunitinib or its analog or pharmaceutically acceptable salt into polymeric matrices have been developed. The resulting formulations provide for more sustained controlled release of sunitinib or its analog or salt for treatment of cancer, inhibition of angiogenesis, ocular diseases, and other applications. See page 2, lines 16-21. Fu teaches that nanoparticles, microparticles, or combinations thereof for the controlled release of the sunitinib or its analog or pharmaceutically acceptable salt thereof can be prepared by combining the drug in the matrix with one or more pharmaceutically acceptable excipients. The nanoparticles, microparticles, or combination thereof can be formed from one or more drugs, or blends of drugs with one or more polymers. See 3, lines 24-29. The suprachoroidal injection is taught in Figures 5A and 5B. Fu teaches Controlled release dosage formulations for the delivery of one or more drugs in a polymeric vehicle are described herein. The polymeric matrix can be formed from non-biodegradable or biodegradable polymers; however, the polymer matrix is preferably biodegradable. The polymeric matrix can be formed into implants (e.g., rods, disks, wafers, etc.), microparticles, nanoparticles, or combinations thereof for delivery. Upon administration, the sunitinib or its analog or pharmaceutically acceptable salt is released over an extended period of time, either upon degradation of the polymer matrix, diffusion of the one or more inhibitors out of the polymer matrix, or a combination thereof. The drug can be dispersed or encapsulated into the polymer or covalently bound to the polymer used to form the matrix. The degradation profile of the one or more polymers may be selected to influence the release rate of the active agent in vivo.
The polymers may be hydrophobic, hydrophilic, conjugates of hydrophilic and hydrophobic polymers (i.e., amphiphilic polymers), block co-polymers, and blends thereof. See page 21, lines 20-28 and page 22, lines 1-7. Fu teaches Examples of suitable hydrophobic polymers include, but are not limited to, polyhydroxyesters such as polylactic acid, polyglycolic acid, or copolymers thereof, polycaprolactone, polyanhydrides such as polysebacic anhydride, polydioxidone, blends and copolymers of any of the above. In one embodiment, a blend of PLGA and polylactic acid ( PLA) is used. See page 22, lines 8-12. The representatives of synthetic polymers is taught in page 23, lines 1-25. The use of coating is taught on page 32, lines 25-27 and page 33, lines 1-2. The representative of therapeutic agents is taught on pages 26-28. The injection into the suprachoroidal space is taught in method of administration. Fu teaches a method of increasing encapsulation efficiency of a compound of the. following formula or salts thereof into polymeric matrices using an emulsion of an organic solvent and an aqueous solvent. The treatment of choroidal neovascularization is taught in claim 16. Fu teaches a significant reduction CNV was observed in all animals and the protective effect was sustained for at least 9 weeks after injection of microparticles. See page 84, lines 15-17. Biocompatible and biodegradable PLGA microspheres allowed a sustained release of sunb-malate and a prolonged retention of drug on ocular surface. The safe dose of Sunb-malate MS was determined by concentration-gradient analysis in the animal models. SC injection of Sunb-malate MS significantly inhibited the corneal NV in the suture-induced model. Together, the sustained release of sunb-malate by SC injection of Sunb-malate MS could improve the efficacy, reduces the toxicity and overcomes the non-compliance of patients. The study provides a therapeutic strategy targeting against corneal NV. See page 80, lines 5-12.
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.
Claim(s) 1-12 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (WO 2016100392) in view of Haffner et al. (20120078362).
Fu et al. teach object of the invention to provide formulations of sunitinib or its analog or pharmaceutically acceptable salt with improved duration, stability, safety, and efficacy.
It is a further object of the invention to provide methods for encapsulation or incorporation into polymeric matrices, including nano- and micro-particles, with increased loading. See page 2, line 8-13. Methods for increasing the encapsulation or incorporation of sunitinib or its analog or pharmaceutically acceptable salt into polymeric matrices have been developed. The resulting formulations provide for more sustained controlled release of sunitinib or its analog or salt for treatment of cancer, inhibition of angiogenesis, ocular diseases, and other applications. See page 2, lines 16-21. Fu teaches that nanoparticles, microparticles, or combinations thereof for the controlled release of the sunitinib or its analog or pharmaceutically acceptable salt thereof can be prepared by combining the drug in the matrix with one or more pharmaceutically acceptable excipients. The nanoparticles, microparticles, or combination thereof can be formed from one or more drugs, or blends of drugs with one or more polymers. See 3, lines 24-29. The suprachoroidal injection is taught in Figures 5A and 5B. Fu teaches Controlled release dosage formulations for the delivery of one or more drugs in a polymeric vehicle are described herein. The polymeric matrix can be formed from non-biodegradable or biodegradable polymers; however, the polymer matrix is preferably biodegradable. The polymeric matrix can be formed into implants (e.g., rods, disks, wafers, etc.), microparticles, nanoparticles, or combinations thereof for delivery. Upon administration, the sunitinib or its analog or pharmaceutically acceptable salt is released over an extended period of time, either upon degradation of the polymer matrix, diffusion of the one or more inhibitors out of the polymer matrix, or a combination thereof. The drug can be dispersed or encapsulated into the polymer or covalently bound to the polymer used to form the matrix. The degradation profile of the one or more polymers may be selected to influence the release rate of the active agent in vivo.
The polymers may be hydrophobic, hydrophilic, conjugates of hydrophilic and hydrophobic polymers (i.e., amphiphilic polymers), block co-polymers, and blends thereof. See page 21, lines 20-28 and page 22, lines 1-7. Fu teaches Examples of suitable hydrophobic polymers include, but are not limited to, polyhydroxyesters such as polylactic acid, polyglycolic acid, or copolymers thereof, polycaprolactone, polyanhydrides such as polysebacic anhydride, polydioxidone, blends and copolymers of any of the above. In one embodiment, a blend of PLGA and polylactic acid ( PLA) is used. See page 22, lines 8-12. The representatives of synthetic polymers is taught on page 23, lines 1-25. The use of coating is taught on page 32, lines 25-27 and page 33, lines 1-2. The representative of therapeutic agents is taught on pages 26-28. The injection into the suprachoroidal space is taught in method of administration. Fu teaches a method of increasing encapsulation efficiency of a compound of the following formula or salts thereof into polymeric matrices using an emulsion of an organic solvent and an aqueous solvent. The treatment of choroidal neovascularization is taught in claim 16. Fu teaches a significant reduction CNV was observed in all animals and the protective effect was sustained for at least 9 weeks after injection of microparticles. See page 84, lines 15-17. Biocompatible and biodegradable PLGA microspheres allowed a sustained release of sunb-malate and a prolonged retention of drug on ocular surface. The safe dose of Sunb-malate MS was determined by concentration-gradient analysis in the animal models. SC injection of Sunb-malate MS significantly inhibited the corneal NV in the suture-induced model. Together, the sustained release of sunb-malate by SC injection of Sunb-malate MS could improve the efficacy, reduces the toxicity and overcomes the non-compliance of patients. The study provides a therapeutic strategy targeting against corneal NV. See page 80, lines 5-12.
Fu differs from the claimed invention in teaching the size of the particles, particles contain the agent in the loading between about 0.1% and 20% and the use of the small molecules of claim 12.
The determination of optimum proportions, amounts and particle size is considered to be within the skill of artisan in the absence of evidence to the contrary. Haffner teaches the use of an implant in a suprachoroidal space for treating ophthalmic disorders. See Para [0024] and claim 16. The use of doxorubicin as claimed in claim 12 is taught in Para [0316}.
It would have been obvious to a person skilled in the art to substitute the small molecule taught by Haffner for Fu’s small molecules and deliver it to suprachoroidal space motivated by the teachings of Haffner, which teaches the use of an implant for delivering of doxorubicin to suprachoroidal section of the eye.
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.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617