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
Previous Rejections
Applicants' arguments, filed 09/08/25 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-3, 6, 8-9, 12, 16, 20, 22, 26-29, 35 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Lvov et al. (US PG Pub. 2011/0038939 A1) in view of Kaplan et al. (US PG Pub. 2015/0045764A1) and further in view of Kaplan et al. (WO 2013/126799 of record).
Lvov discloses methods of using layer by layer technology to make very thin and stable polymeric layers to surround the drug or compound in a capsule with a luminal compartment. Bilayers (two polymeric layers) are formed with opposing (and varying charges as applicable). Multiple bilayers can be formed and the bilayer can be formed with a first and second (different) polymer [see para's [0005-0011], [0024], [0077], [0078], para [0154 (rod shaped), FIG 1A].
Lvov teaches a drug delivery composition by disclosing a stable colloid nanoparticles comprising poorly soluble drugs, see abstract. Lvov teaches A stable nanoparticle comprising: (a) a compound; (b) a first defined solid polymeric layer comprising a first polymer, the first layer surrounding the compound; and (c) a second defined solid polymeric layer comprising a second polymer, the second layer surrounding the first layer, the first polymer and the second polymer having opposite charges, and the nanoparticle having a diameter of about 100 nm to about 500 nm, wherein the compound is present at about 5% by weight to about 95% by weight, wherein the first polymeric layer and the second polymeric layer have a combined thickness of about 5 nm to about 30nm, wherein the first polymer is positively charged and the second polymer is negatively charged, wherein the first polymer is negatively charged and the second polymer is positively charged, wherein the nanoparticle comprises more than two defined, solid, polymeric layers, see claims 1-6. The reference teaches paclitaxel comprising nanoparticles which are rod-like shaped, see [0154]. The polymer layer can be chitosan or biodegradable polycaprolactone, see [0083]-[0084]. The layers can be 3 layers, see [0082]. Formulation can be in capsule form, see [0122]. By varying the charge density on each polymer, or the number of coating cycles, drug particles can be prepared with a different surface charge and different thickness of the polymeric coat. This, in turn, provides a way to control drug release from such particles, see [0077]. The reference does not teach that at least one luminal compartment, wherein the one or more therapeutic agents are present. However, it would have been obvious to one of ordinary skill in the art to form or observe a spaced out bi-layer wall around the therapeutic agent to produce a luminal compartment by routine experimentation to optimize loading and encapsulating the therapeutic agent (para [0077], "... forms a firm electrostatic complex with the first layer (i.e., a "bilayer"). This results in the appearance of a very thin, but stable, polymeric layer or shell around each nanoparticle of a compound. This shell can prevent particle agglomeration, and can be easily and reproducibly formed on the surface of any compound particle"; para [0083], “The nanoparticles described herein can be produced by encapsulating a compound described herein within one or more layers of polymers, creating a defined polymeric layer"). Lvov teaches the drug delivery composition of claim 1, wherein the composition is intended for injection into the eye of a subject (para [0079], "A nanoparticle as described herein can contain many types of compounds, such as therapeutic drugs or agents. Such therapeutic agents can be, but are not limited to... ocular drugs"; para [0110], "In some instances, a nanoparticle described herein is administered locally. This is achieved, for example... by injection"). Therefore, the claimed drug delivery composition would have been prima facie obvious under the rationale of combining prior art elements according to known methods to yield predictable results. Thus, the art teaches use of drug delivery composition to the eye comprising capsules with bilayered walls. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results a drug delivery system, see MPEP 2143 part (I)(A).
Lvov does not teach the claimed length of the capsules, the diameter of the capsules or the wall thickness.
Kaplan et al. discloses a silk-based drug delivery compositions for controlled, sustained delivery of therapeutics agents, see abstract. The drug delivery composition is in the form of a capsule-like composition, tube with both the ends closed. Therapeutic agent is inside the tube in the lumen of the tube. The cross-section of the tube is injectable and can be in the form of oval, elliptical, square or triangular, see [0025] and [0029]. Kaplan teaches that generally, the silk reservoir implant or silk injectable reservoir can have any length desired. For example, length of the silk reservoir implant or silk injectable reservoir can be from about 1 mm to about 10 cm. In some embodiments, length of the silk reservoir implant or silk injectable reservoir can be from about 1 mm to about 5 cm, see [0027]. The wall thickness of the silk reservoir implant or silk injectable reservoir can affect the release rate of the therapeutic agent encapsulated in the silk reservoir implant or silk injectable reservoir. Accordingly, the silk reservoir implant or silk injectable reservoir can be selected to have a wall thickness that provides a desired rate of release. For example, wall thickness can range from about 50 µm to about 5 mm, see [0028]. Both the dimensions overlap with the claimed amount and thus create a case of obviousness or provide guidance to one of ordinary skill to manipulate the size of the thickness of the wall/bilayer of the Lvov et al. to manipulate the release profile. The diameter of the lumen can vary ranging from about 100nm to about 10mm, see [0030]. Any amount of therapeutic agent can be loaded ranging from about 0.1mg to about 1000mg, see [0031].
Kaplan et al. teaches that the term "sustained delivery" is refers to continual delivery of a therapeutic agent in vivo or in vitro over a period of time following administration. For example, sustained release can occur over a period of at least several days, a week or several weeks. Sustained delivery of the agent in vivo can be demonstrated by, for example, the continued therapeutic effect of the agent over time. Alternatively, sustained delivery of the agent may be demonstrated by detecting the presence of the agent in vivo over time. In some embodiments, the sustain release is over a period of one week, two weeks, three weeks, four weeks, one month, two months, three months, four months, five months, six months or longer. As described above, wall thickness can affect the release rate of the therapeutic agent encapsulated in the silk reservoir implant or silk injectable reservoir, see [0035]. Additives can be added, see [0074]. The additive can be a biocompatible polymer such as collagen, chitosan, polycaprolactone etc., see [0075].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the lumen in the capsule as taught by Kaplan et al. for enclosing a therapeutic agent and further would have made a drug delivery capsule for injectable purposes with a dimension of length ranging from about 0.1cm to about 5cm, inner diameter from about 100 microns to about 2000 microns and wall thickness of about 25 microns to about 150microns based on the guidance provided by Kaplan et al. One of ordinary skill would have been motivated to do so because Kaplan teaches an injectable drug delivery composition wherein the drug is encapsulated within a layered wall in the lumen wherein the thickness of the wall of the capsule can be manipulated to tailor the sustained release profile of the drug. Kaplan as discussed above teaches that the silk reservoir implant or silk injectable reservoir can be selected to have a wall thickness that provides a desired rate of release. For example, wall thickness can range from about 50 µm to about 5 mm, see [0028]. Both the dimensions overlap with the claimed amount and thus create a case of obviousness or provide guidance to one of ordinary skill to manipulate the size of the thickness of the wall/bilayer of the Lvov et al. to manipulate the release profile. The diameter of the lumen can vary ranging from about 100nm to about 10mm, see [0030]. Any amount of therapeutic agent can be loaded ranging from about 0.1mg to about 1000mg, see [0031]. Therefore, one of ordinary skill would have had a reasonable expectation of success in obtaining a capsular drug delivery come to the claimed dimensions. Since the art teaches that manipulations of the wall- thickness can be performed in order to manipulate the drug release profile as discussed above, one of ordinary skill would have manipulated the thickness of the wall to tailor the release profile for optimum therapeutic effect.
While the refences suggest adding various therapeutic drugs, the references do not teach use of bevacizumab.
Kaplan et al.’799 teaches compositions and methods for ocular delivery of a therapeutic agent. See Title. In particular Kaplan et al. compositions for sustained release of an anti-vascular endothelial growth factor therapeutic agent. See para. [0006]. Kaplan et al. teaches treating AMD. Kaplan et al. teaches bevacizumab. See para. [0012].
It would have been obvious to one of ordinary skill before he effective filing date of he claimed invention to have utilized the known drug, bevacizumab into the capsular drug delivery composition of Lvov et al. as modified by Kaplan et al. One of ordinary skill would have been motivated to do so because Lvov and Kaplan suggest adding various therapeutic agent for ocular delivery and Kaplan ‘799 teaches a specific drug, bevacizumab for AMD treatment. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Applicants arguments are moot in view of new rejections made above necessitated by claim amendments wherein Kaplan teaches various capsule dimensions for ophthalmic delivery of drugs and provides guidance with respect to their drug delivery and release pattern by varying the capsular wall size or thickness as discussed above.
Action is Final
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
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612