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 .
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, 112, 159 and 210-226 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jarrett et al. (US 20160331738) in view of Hussain et al. (Stargardt macular dystrophy and evolving
therapies ).
The claims are drawn to a sustained release biodegradable ocular implant comprising a
hydrogel and an active agent comprising a complement protein C5 agent, wherein active agent
particles are dispersed within the hydrogel, and wherein the implant in its dry state has a length
of less than about 17 mm, wherein the active agent is not a tyrosine kinase inhibitor.
Jarett et al. teach a method of agent delivery to a tissue comprising forming a hydrogel implant in situ with a therapeutic agent in the hydrogel (e.g., dissolved, suspended, dispersed throughout), the agent having a low solubility or a very low solubility in water (paragraph 0328). The method is for treatment of a back of the eye disease (paragraph 0341). The back of the eye disease is age-related macular degeneration (AMD) cystoid macular edema (CME), diabetic macular edema (DME), posterior uveitis, diabetic retinopathy, retinal vein occlusion, or glaucoma (paragraph 0342). The therapeutic agent may comprise a macromolecule, for example an antibody or antibody fragment; the therapeutic macromolecule may comprise a VEGF inhibitor, for example ranibizumab (paragraph 0115). Jarrett teaches that hydrogels made with a polyethylene glycol (PEG) matrix at a solids concentration of a 5% or 10% w/w PEG, see Table 3. The hydrogels were made from a first PEG precursor having an electrophilic end group (succinimidyl azelate, SAZ) and a second PEG precursor having nucleophilic end group (amine). The PEGs had 4 or 8 arms and a nominal molecular weight of 20 k each (paragraph 0031). Jarrett teaches that various agents were suspended in hydrophilic hydrogel precursor solutions crosslinked and formed as cylindrical depots. The agent-suspended gels were removed from the tubing and ex vivo release was initiated in dissolution media (Paragraph 0039). Jarrett teaches that Hydrogels may be formed from natural, synthetic, or biosynthetic polymers. Natural polymers may include glycosminoglycans, polysaccharides, and proteins (paragraph 0066). Jarrett teaches that a hydrophilic portion may be, for instance, a polyether, for example, polyalkylene oxides such as polyethylene glycol (PEG), polyethylene oxide (PEO), polyethylene oxide-co-polypropylene oxide (PPO), co-polyethylene oxide block or random copolymers, and polyvinyl alcohol (PVA), poly (vinyl pyrrolidinone) (PVP), poly (amino acids, dextran, or a protein (Paragraph 0074). Jarrett teaches that hydrogels can be made, e.g., from a multi-armed precursor with a first set of functional groups and a low molecular-weight precursor having a second set of functional groups. For example, a six-armed or eight-armed precursor may have hydrophilic arms, e.g., polyethylene glycol, terminated with primary amines, with the molecular weight of the arms being about 1,000 to about 40,000. See Para [0082]. The use of hydroxysuccinimidyl is taught in Para [0098]. The phosphate buffer at the pH of 5-7.5 is taught in Para [0098]. Jarrett teaches that electrophilic groups such as SG (N-hydroxysuccinimidyl glutarate), SS (N-hydroxysuccinimidyl succinate), SC (N-hydroxysuccinimidyl carbonate), SAP (N-hydroxysuccinimidyl adipate) or SAZ (N-hydroxysuccinimidyl azelate) may be used and have esteric linkages that are hydrolytically labile. See Para [0110]. The release rate of 2-36 months is taught in claim 20. Jarrett teaches that the particles may be separated into collections with a desired size range and distribution of sizes by a variety of methods. Very fine control of sizing is available, with sizes ranging from 1 micron to several mm. See Para [0136].
Jarrett differs from the claimed invention in specifically teaching a complement C5 agent, such as avacincaptad being delivered by the claimed hydrogel. Hussain et al. teach Avacincaptad pegol (Zimura®, Ophthotech Corporation) is a C5 complement inhibitor which may prevent formation of the MAC, and consequently reduce cell death caused by destruction of the cell membrane. It is delivered by intravitreal injection and is being explored as a potential treatment option for a number of eye diseases including STGD1, dry AMD (GA), wet AMD, idiopathic polypoidal choroidal vasculopathy, and posterior uveitis. See page 1055.
It would have been obvious to a person skilled in the art to use the hydrogel of Jarrett et al. for delivery of a C5 protein inhibitor, such as, avacincaptad, considering that such compound has been used for the treatment of conditions of posterior section of the eye. Furthermore, Jarrett clearly teaches that large molecules can be delivered into the eye by its hydrogel implant.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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