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, 2, 4-12, 14-18 and 2021 are presented for examination.
The amendments and remarks filed on 10/21/2025 have been received and entered.
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, 2, 4-18, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino et al. (US 20170095369) in view of Chang et al. (US 20160175408) and further in view of Dong et al. (Effects of anti-VEGF Drugs combined with photodynamic therapy in the treatment of age-related macular degeneration).
Andino teaches the embodiments described herein relate generally to the field of ophthalmic therapies
and more particularly to the use of a microneedle for delivery and/or removal of a substance, such as a
fluid therapeutic agent into and/or from ocular tissues for treatment of the eye. See Para [0002].
use of gold and stainless steel is taught in Para [0100]. Andino teaches a wide range of ocular diseases
and disorders may be treated by the methods and devices described herein. Non-limiting examples of
ocular diseases include uveitis, glaucoma, diabetic macular edema or retinopathy, macular
degeneration, retinoblastoma, and genetic diseases. The methods described herein are particularly
useful for the local delivery of drugs that need to be administered to the posterior region of the eye, for
example the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye. In one
embodiment, the delivery methods and devices described herein may be used in gene-based therapy
applications. For example, the methods may administer a fluid drug formulation into the suprachoroidal
space to deliver select DNA, RNA, or oligonucleotides to targeted ocular tissues. See Para [0103].
Andino teaches that The microneedles can be used to target delivery to specific tissues or regions within
the eye or in neighboring tissue. In various embodiments, the methods may be designed for drug
delivery specifically to the sclera, the choroid, the Bruch's membrane, the retinal pigment epithelium,
the subretinal space, the retina, the macula, the optic disk, the optic nerve, the ciliary body, the
trabecular meshwork, the aqueous humor, the vitreous humor, and other ocular tissue or neighboring
tissue in need of treatment. See para [0104]. Andino teaches representative examples of types of
drugs for delivery to ocular tissues include antibodies, anti-viral agents, chemotherapeutic agents (e.g.,
topoisomerase inhibitors), analgesics, anesthetics, aptamers, antihistamines, anti-inflammatory agents,
and anti-neoplastic agents. In one embodiment, the drug is triamcinolone or triamcinolone acetonide.
See para [0150]. The use of VEGF inhibitor is taught in Para [0052]. The use of chambers for containing
drugs is taught in Para [0045]. The use of a spring is taught in Para [0051] and [0067]. The use of a
plunger is taught in Para [0067] and [0069]. The use of grooves is taught in Para [0097]. The length and
diameter of the needle is taught in Para [0007] and [0009]. The needle being gold of stainless steel is
taught in Para [0100]. Andino teaches that the drug formulation can undergo a phase change upon
administration. For instance, a liquid drug formulation may be injected through hollow microneedles
into the suprachoroidal space, where it then gels and the drug diffuses out from the gel for controlled
release. See Para [0112]. Andino et al. teach that the drug is formulated for storage and delivery via the
microneedle device described herein. The "drug formulation" is a formulation of a drug, which typically
includes one or more pharmaceutically acceptable excipient materials known in the art. The term
"excipient" refers to any non-active ingredient of the formulation intended to facilitate handling,
stability, dispersibility, wettability, release kinetics, and/or injection of the drug. In one embodiment, the
excipient may include or consist of water or saline. See Para [0138]. Andino teaches that in some
embodiments, two drugs are delivered by the methods described herein. The compounds may be
administered in one formulation, or administered serially, in two separate formulations. See para
[0123].
Andino differs from the claimed invention in teaching one or more bioactive agents are in lyophilized or
powder form, the presence of a reservoir and the combination therapy of claims 16 and 17.
Chang et al. teach a microneedle delivery system comprises a plurality of microneedles with a channel
for liquid form to pass through. The microneedle delivery system can comprise a reservoir chamber
with a bioactive formulation. The microneedle delivery system can comprise a plunger that releases the
said compounds or formulations. The microneedle delivery system can comprise an optional security
material to anti-reverse lock the microneedles and the chamber. The microneedle delivery system can
comprise an optional adapter to fit any reservoir chamber. See Para [0114]. The use of a powder for
the preparation of sterile injectable is taught in Para [0214], [0247] and [0248]. Chang teaches A
microneedle array will consist of from about 1 to about 500 microneedles, which will be anywhere from
about 0.1 to about 2.5 mm in length and from 0.01 to about 0.5 mm in diameter, and be composed of
any metal, metal alloy, metalloid, polymer, or combination thereof, such as gold, steel, silicon, PVP
(polyvinylpyrrolidone), etc. The microneedles will each have one or more recesses running a certain
depth into the outer wall to allow for flow of the substance to be delivered down the microneedle and
into the dermis; these recesses can be in a plurality of shapes, including but not limited to: straight line,
cross shape (+), flat shape (-), or screw thread shape going clockwise or counterclockwise. The array will
be in any shape or combination of shapes, continuous, or discontinuous. The list of possible shapes
includes, but is not limited to, circles, triangles, rectangles, squares, rhomboids, trapezoids, and any
other regular or irregular polygons. The array will be attached to a reservoir to hold the substances to
be delivered, and the reservoir will be any volume (0.25 mL to 5 mL), shape, color, or material (glass,
metal, alloy, or polymer), as determined necessary. The reservoir will itself be attached to or contain a
means to encourage flow of the drug solutions contained in the reservoir into the skin. Two non-limiting
examples of such means are 1) a plate and spring that allows the contained solutions to flow only when
the device is tapped into the skin, and 2) a syringe that contains the drug solutions to be delivered and
includes a plunger that can be depressed to mechanically drive the solution into the skin. See Par
[0467]. Chang teaches he use of a reservoir for delivering a bioactive agents. Chang further teaches
that a microneedle direct applicator device will contain, in some instances, an array of from about 1 to
about 500 microneedles that are about from 0.1 to about 2.5 mm in length and about from 0.001 to
about 0.5 mm in diameter and be composed of materials that can be made as microneedles including
but not limited to, any metal, metal alloy, metalloid, ceramic, polymer, gold, steel, titanium, silicon, PVP
(polyvinylpyrrolidone), etc. or any combination thereof. See Para [0470]. Chang et al. teach that the
claimed microneedles for delivering a bioactive agent being in a powder form and using a reservoir as
old and well known. Dong teaches the use of anti-VEGF drugs by intraocular injection in combination
with photodynamic therapy for the treatment of macular degeneration. Dong makes clear that the
combination of injection and other types of treatment for ocular disorders as old and well known.
It would have been obvious to a person skilled in the art to use a reservoir in the microneedle delivery
device of Andino for the treatment of ophthalmic disorders, considering that Chang teaches the use of a
reservoir for delivering pharmaceutical formulations as old and well known. The use of the composition being in a powder form is also taught by Chang et al.. The use of array of microneedles in a circle shape is taught by Chang et al. The auto-reconstitution of bioactive agents does not create a patentably distinct method of treating an ocular disease with the bioactive agent. The combination therapy of ophthalmic disorders is taught by Dong et al.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks alleges criticality to the special features of the claimed invention in comparison with the relied upon references. Applicant argues that the claimed microneedles do not include a traditional lumen and are structurally defined by non-lumened microneedles or external grooves facilitating distributed flow. Instead, the invention enables fluid delivery along the entire length of microneedle, through specially designed opening or screw-like channel, facilitating targeted drug delivery to multiple tissue layers. It is the examiner’s position that the claims are not drawn to the special features that applicant alleges criticality to. Furthermore, claims 18, 20 and 21 are directed to a single or multi-chamber microneedles with no special feature as argued by the applicant.
THIS ACTION IS MADE FINAL. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617