DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after June 2, 2026, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 06/02/2026 in the matter of Application N° 18/157,134. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-27 represent all claims currently under consideration.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US5443505A) in view of Schneider et al. (US2019/0358166A1).
Regarding claim 1, Wong et al. teach a method for treating an ocular condition by introducing an implantable drug-delivery device into an eye. Wong et al. specifically teach placement of an implant within the suprachoroidal space and explain that an implant positioned within the suprachoroidal space may be used to deliver a therapeutic agent to ocular tissues, including the choroid and anatomically apposed retina (See column 2, summary of the invention, lines 15-28). Wong et al. further teach that the implant comprises a polymeric material containing a therapeutic agent, wherein the therapeutic agent may be encapsulated, dissolved, or dispersed within the polymeric material (See column 3, lines 35-40). Wong et al. disclosed non-biodegradable polymers suitable for forming the implant, including ethylene-vinyl ester copolymers, having an ester content of 4-80% such as ethylene-vinyl acetate copolymer, as suitable implant materials. Wong et al. further disclose therapeutic-agent concentrations that overlap the presently claimed range of about 20 wt.% to about 70 wt%. and polymer concentrations that overlap the presently claimed range of about 30 wt.% to about 80 wt.% (See column 3, lines 35-40, lines 40-45, lines 47-57, and column 4, lines 1-3).
Wong et al., however, do not expressly disclose that the implant comprises a core defining an outer peripheral surface, wherein the core comprises a core polymer matrix containing an EVA copolymer having the specifically recited melt flow index and thermal characteristics, or that one or mor radiocontrast agents are incorporated into the core.
Schneider et al. teach an implantable drug delivery device comprising a core defining an outer surface and having a core polymer matrix containing a therapeutic agent dispersed therein (See paragraph 0003, Abstract and claim 1). Schneider et al. expressly teach that the core polymer matrix may comprise an ethylene-vinyl acetate copolymer (See paragraph 0035).
Schneider et al. further teach that the polymer may have a melt flow index of about 0.2 to about 100 g/10 minutes, as determined according to ASTM D1238-13 at a temperature of 190°C and a load of 2.16 kilograms (See paragraph 0033). Thus, Schneider et al. expressly disclose the presently claimed melt flow index range and the same temperature and load conditions recited in claim 1. Although Schneider et al. identify the ASTM D1238-13 version rather than ASTM D1238-20 recited in the present claim, Schneider et al. nevertheless teach measurement of the same polymer property under the same specified temperature and load conditions.
Schneider et al. additionally teach copolymers containing a polar monomer in an amount of 10 wt.% to about 60 wt.%., expressly identify vinyl acetate as a suitable polar monomer, and expressly identify ethylene-vinyl acetate copolymers as suitable polymers for the core polymer matrix (See paragraph 0034). Schneider et al. further teach EVA polymers having melting temperatures of about 40°C to about 60°C as determined according to ASTM D3418-15 (See paragraph 0034). which falls entirely within the presently claimed range of about 20°C to about 70°C.
Schneider et al. also disclose amounts of therapeutic agent and core polymer matrix that overlap the presently claimed ranges. in particular, Schneider et al. teach therapeutic agent concentrations of about 5 wt.% to about 60 wt.% (See paragraph 0029), including narrower ranges falling within or overlapping the presently claimed range of about 20 wt.% to about 70 wt.% (See paragraph 0030). Schneider et al. further teach a core polymer matrix concentration of about 40 wt.% to about 95 wt.% (See paragraph 0029), which overlaps the presently claimed range of about 30 wt.% to about 80 wt.%.
Furthermore, Schneider et al. teach that the core may contain one or more additional excipients, including one or more radio contrast agents. Schneider et al. explain that incorporation of a radiocontrast agent permits the implantable device to be detected using X-ray-based imaging and identify suitable radiocontrast materials, including barium -iodine-, and zirconium-based compounds (See paragraph 0038). Thus, Schneider et al. teach incorporating a radiocontrast agent into the core of an implantable drug-delivery device.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date of the claimed invention to modify the suprachoroidal ocular drug-delivery implant taught by Wong et al. by employing the EVA containing core polymer matrix and associated polymer characteristics taught by Schneider et al, Wong et al., already teach the use of EVA as a suitable polymer for an ocular drug-delivery implant, while Schneider et al. teach that EVA polymers having the recited melt flow, vinyl acetate content, and thermal characteristics are suitable for forming the core polymer matrix of an implantable controlled drug-delivery device. Accordingly, one of ordinary skill in the art would have had reason to employ the EVA materials taught by Schneider et al. in the EVA containing ocular implant of Wong et al. to provide a polymer matrix suitable for incorporating and controlling the release of a therapeutic agent from the implanted device, with a reasonable expectation of success.
It would further have been obvious to incorporate the radiocontrast agent taught by Schneider et al. into the core of the modified ocular implant of Wong et al. because Schneider et al. expressly teach that such an agent permits an implanted device to be detected using X-ray based imaging. One of ordinary skill in the art would therefore have had reason to include a radiocontrast agent in the core of the suprachoroidal implant to facilitate visualization and localization of the implanted device following placement in the patient’s eye.
Claims 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zarnitsyn et al. (US9636332) in view of Tu et al. (US9066782), and Troncoso (Use of Tantalum Implants for Inducing a Permanent Hypotony in Rabbits Eyes, 1949).
Zarnitsyn et al. teach a radiocontrast agent, and a core polymer matrix comprising an ethylene-vinyl acetate (EVA) copolymer. Zarnitsyn et al. explicitly teach microneedles formed of polymeric structural materials. Representative non-biodegradable polymers include polymers of ethylene-vinyl acetate and copolymers thereof. This reasonably teaches a core polymer matrix comprising EVA, even if “core” is not explicitly labeled. Structural polymers forming the microneedle inherently form the body/core. Zarnitsyn et al. teach image-guided feedback methods, including: X-ray, optical coherence tomography, use of materials detectable under imaging, metallic materials including: Gold, Tantalum, Stainless steel, and other metals and alloys. Radiocontrast agents are materials visible under radiographic imaging, and metal-based agents (e.g. gold, tantalum) are well-recognized radiocontrast materials. Therefore, Zarnitsyn et al. reasonably teach incorporation or radiopaque materials in the microneedle body/core to enable imaging and placement verification. Troncoso teaches the use of tantalum in ophthalmic implants. Tantalum is radiopaque, biocompatible, used for implant localization and monitoring. Placement in anterior chamber and perichoroidal/suprachoroidal regions. This directly supports the radiocontrast agent limitation, especially in an ocular implant context.
Zarnitsyn et al. teaches EVA copolymers. Zarnitsyn et al. does not explicitly recite melt flow index (MFI) values. Melt flow index is an inherent material property, and a result-effective variable, and a matter of routine optimization. Although Zarnitsyn et al. do not explicitly disclose that the ethylene-vinyl acetate copolymer has a melt flow index of from about 0.2 to about 100g/10min as measured under ASTM D1238-20 conditions, selection of an EVA copolymer having a particular melt flow index represents a routine optimization of a known polymer property to achieve desired processing or mechanical characteristics. It is well within the level of ordinary skill in the art to select an EVA copolymer having an appropriate melt flow index for fabrication of medical device structures such as microneedles. In re Aller, In re Peterson, or MPEP 2144.
It would have been obvious to one of ordinary skill in the art to include a known radiocontrast agent such as tantalum, as taught by Troncoso, in the polymeric microneedle core of Zarnitsyn et al. in order to allow visualization and confirmation of placement of the implant within ocular tissues using imaging techniques, as expressly contemplated by Zarnitsyn et al.
Tu et al. teach treatments for eye conditions and implants are offered. One technique is inserting an implant into the eye’s anterior chamber. In order for the proximal end of the implant to remain in the anterior chamber after implantation, it is placed into the eye tissue next to the anterior chamber. The implant elutes a medical substance into the eye. The therapeutic agent’s release from the implant should ideally be regulated. The therapeutic drug may be released under control at a specific rate and/or for a specified amount of time, which may be periodic or episodic. The therapeutic agent may be an anti-inflammatory medication, an antiproliferative agent, or a substance used to treat ocular hypertension or glaucoma (See abstract, and claim 1).
Regarding claims 1 and 3, In addition, Zarnitsyn et al. also teach the same subject matter of treatments for eye conditions. Zarnitsyn et al. teach in order to treat a posterior ocular illness or choroidal malady, procedures and instruments are presented for the targeted non-surgical administration of a medication formulation to the suprachoroidal space of a human subject’s eye. One version of the technique involves putting a hollow microneedle into the eye at an insertion site and then injecting a drug formulation into the eye’s suprachoroidal space through the microneedle. During the infusion, the infused drug formulation moves away from the insertion site and into the suprachoroidal space. The fluid drug formulation comprises drug nanoparticles or microparticles (See abstract and Description paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to include the teachings of Zarnitsyn et al. into the teachings of Tu et al. in which a hollow microneedle is inserted into the eye at an insertion site, and the drug formulation is then injected through the microneedle into the suprachoroidal space of the eye, and Tu et al. in which an implant is placed into the anterior chamber of the eye is one method. The implant is inserted into the eye tissue adjacent to the anterior chamber so that the proximal end will stay there after implantation.
Regarding claim 2, Zarnitsyn et al. teach (Review core of pg. 76, column 64, lines 24-30) the art of encapsulating nanoparticles or microparticles is well established. The drug formulation in one embodiment consists of drug particles suspended in a solution with a D99 of 10 µm or less. The drug formulation in one embodiment consists of drug particles suspended in a solution with a D99 of 7 µm or less. Drug particles suspended in a solution with a D99 of 3 µm or less make up the drug formulation in a different embodiment.
Regarding claims 4, 5, and 10, Zarnitsyn et al. teach a hollow microneedle is inserted into the eye at an insertion site in one embodiment of the technique. A drug formulation is then infused through the microneedle and into the eye’s suprachoroidal space, where it flows along the suprachoroidal space and away from the insertion site (See abstract).
Regarding claims 6, and 7, 8, 9, Zarnitsyn et al. teach after the non-surgical drug administration is finished, the drug may be released into the ocular tissues from the infused volume (or, for example, from microparticles or nanoparticles in the drug formulation) for a long time, such as several hours, days, weeks, or months. This can be advantageous since it can boost the medication’s bioavailability in comparison to other methods, such as topical application of the drug formulation to the surfaces of ocular tissue or intravitreal injection of the same dosage of the drug (pg. 49, lines 48-60).
Regarding claim 11, Zarnitsyn et al. teach in a further embodiment, the additional ocular disease is drusen, sickle cell retinopathy, central serous chorioretinopathy, typical neovascular (type 1 or 2) age related macular degeneration,
melanocytoma of the optic nerve (See pg. 60, lines 6-10).
Regarding claim 12, Zarnitsyn et al. teach it is possible for microparticles and nanoparticles to have a spherical shape. Microparticles and nanoparticles with an exterior shell enclosing a core of another material are known as microcapsules and nanocapsules. A liquid, gel, solid, gas, or a combination of these can be the core. The medicine is placed on the surface of the outer shell, in the outer shell itself, or in the core of the microcapsule or nanocapsule, which can also be a microbubble or nanobubble with an outer shell encircling a gas core (See pg. 76, lines 24-32). A matrix material may also be included in the microparticles or nanoparticles. A polymer, amino acid, saccharide, or another substance recognized in the field of microencapsulation could serve as the shell or matrix material (See pg. 76. Lines 40-43).
Zarnitsyn et al. make no mention of the 20 wt% to about 70 wt%, and from about 30 wt% to about 80 wt % of the core.
Regarding claims 13, 14, 16, and 23, Zarnitsyn et al teach the microneedle can be formed/constructed of different biocompatible materials, including metals, glasses, semi-conductor materials, ceramics, or polymers. Examples include nylons, polyesters, polymers of ethylene-vinyl acetates and other acyl substituted cellulose acetates (See pg. 51, column 13, lines 19-20).
Zarnitsyn et al. make no mention of the vinyl acetate monomer 10 wt% to about 60 wt % and a melt flow index from 0.2 to about 100 grams, and a molecular weight of 1kDa.
Regarding claim 15, Zarnitsyn et al. teach wherein the therapeutic agent consists of a protein (pg. 62), peptide and enzyme (pg. 51, lines 50-55), antibody (pg. 62, lines 3-10), nucleotide (pg. 62, col 36, line 11), lipid (pg. 60, line 51), interleukin (pg. 46, line 65), interferon (pg. 63, lines 33-35), vaccination (pg. 62, col 36, line 14), or a derivative (pg. 66, line 57), or analogue (pg. 65, line 14 and line 18).
Regarding claim 17, Zarnitsyn et al. teach tyrosine kinase or tyrosine kinase receptor antagonists are one kind of the VEGF modulator (See pg. 64, lines 27-30).
Regarding claim 18, Zarnitsyn et al. teach wherein the tyrosine kinase inhibitor includes (axitinib pg. 56, line 54), bosutinib, cabozantinib, crizotinib, dasatinib, erlotinib, gefitinib, (imatinib pg. 64, line 52), lapatinib, nilotinib, (pazopanib pg. 64, line 53), (ponatinib, pg. 64, line 53), (ruxolitinib, pg. 72, line 48), (sorafenib, pg. 56, line 53), sunitinib (pg. 64, line 52), (vatalanib pg. 65, line 18), vemurafenib, or a combination thereof.
Zarnitsyn et al. make no mention of bosutinib, cabozantinib, crizotinib, dasatinib, erlotinib, gefitinib, and lapatinib, nilotinib.
Regarding claim 19, Zarnitsyn et al. teach the drug formulation delivered by the methods described herein, in one embodiment, comprises an effective amount
of a steroid or a non-steroidal anti-inflammatory drug (NSAID) (See pg. 46, lines 58-61).
Regarding claim 20, Zarnitsyn et al. teach wherein the steroidal agent comprises (hydrocortisone, pg. 62, line 41), (cortisone acetate, pg. 69, lines 21-22), cortisone/cortisol (pg. 68, line30), fluorocortolone, (fluocinolone, pg. 65, line 8), (fluorometholone, pg. 62, line 41), (prednisone, pg. 66, line 46), (prednisolone, pg. 62, line 41), methylprednisolone, (triamcinolone, pg. 66, line 47), (dexamethasone, pg. 62, line 40), (betamethasone, pg. 62, line 40), paramethasone, derivatives thereof, or a combination of any of the foregoing.
Regarding claim 21, Zarnitsyn et al. teach wherein the core can be
liquid, gel, Solid, gas, or a combination thereof (pg. 76, 27-28).
Regarding claim 22, Zarnitsyn et al. teach retinopathy, retinopathy of prematurity, epiretinal membrane, peripheral retinal degeneration (pg. 73, 39-41).
Regarding claim 24, Zarnitsyn et al. teach microneedles can be formed with shafts that have a circular cross-section in the perpendicular, or the cross-section can be non-circular (See pg. 52, lines 49-51)
Regarding claim 25, Zarnitsyn et al. teach that the device was attached to a micropipette holder with tubing that was connected to a carbon dioxide gas cylinder for application of infusion pressure (See pg. 77, lines 30-34).
Regarding claim 26, Zarnitsyn et al. teach a volume of 15 µL was injected and, in this particular cross-section taken in the plane of the insertion site, the injection had spread approximately 20 mm, which corresponds to about 36% of the total circumference of the eye (See pg. 78, lines 21-25).
Instead of Zarnitsyn et al. mentioning 5 mm, Zarnitsyn mentions 20mm.
Regarding claim 27, Zarnitsyn et al. teach in other particular embodiments, the microneedle may be designed such that the tip portion is only a portion of the microneedle that is inserted into the ocular tissue and generally has a length that is less than about 75% of the total length of the microneedle, less than about 50% of the total length of the microneedle, or less than about 25% of the total length of the microneedle (See pg. 52, lines 67-72).
Instead of Zarnitsyn et al. mentioning 25 millimeters, Zarnitsyn mentions 25%.
Response to Arguments
Applicant's arguments filed June 2, 2026, have been fully considered but they are not persuasive.
The Office acknowledges Applicant’s arguments regarding the specific teachings of Zarnitsyn et al. However, the rejection has been supplemented by the teachings of Wong et al. and Schneider et al., which provide additional evidence regarding the disputed claim limitations.
In particular, Wong et al. teach methods for treating ocular conditions by introducing an implantable drug-delivery device into the eye and expressly disclose placement of such an implant within the suprachoroidal space. Wong et al. further teach polymeric implants containing therapeutic agents and identify ethylene-vinyl acetate (EVA) copolymers as suitable polymeric materials for ocular drug delivery implants. Wong et al. additionally disclose amounts of therapeutic agent and polymer that overlap the ranges presently claimed.
Schneider et al. further teach an implantable drug-delivery device comprising a core having a core polymer matrix containing a therapeutic agent dispersed therein, wherein the polymer matrix may comprise an EVA copolymer. Schneider et al. expressly teach a melt flow index of about 0.2 to about 100 g/10 minutes, measured according to ASTM D1238-13 at 190°C under a load of 2.16 kg. Accordingly, the presently relied-upon art provides an express teaching of the claimed melt flow index range under the same specified temperature and load conditions, rather than requiring the claimed melt flow characteristics to be derived solely through routine optimization.
Schneider et al. additionally teach copolymers having a polar monomer content of about 10 wt.% to about 60 wt%, identify vinyl acetate as a suitable polar monomer, and identify ethylene vinyl acetate copolymers as suitable materials for the core polymer matrix. Schneider et al. further disclose EVA polymers having melting temperatures falling within the presently claimed range. Schneider et al. also teach therapeutic-agent and core-polymer-matrix concentrations that overlap the presently claimed ranges.
Furthermore, Schneider et al. teach that the core of the implantable drug-delivery device may contain one or more radiocontrast agents to permit visualization or detection of the implanted device using X-ray based imaging.
Therefore, Applicant’s argument that the claimed polymer characteristics could only be obtained through hindsight-based routine optimization of the hollow infusion needle of Zarnitsyn et al. is not persuasive with respect to the rejection presently maintained. The rejection does not depend solely upon modifying or optimizing the hollow infusion needle of Zarnitsyn et al. to obtain the presently claimed solid implant. Rather, Wong et al. expressly establish that EVA-containing drug-delivery implants were known for treatment of ocular conditions, including placement within the suprachoroidal space, while Schneider et al. expressly teach implantable drug-delivery cores comprising EVA polymer matrices having the presently claimed or overlapping polymer properties, compositional ranges, and radiocontrast-agent characteristics.
One of ordinary skill in the art, prior to the instant effective filing date would have had reason to apply the EVA core-polymer teachings of Schneider et al. to the ocular drug-delivery implant taught by Wong et al., because both references concern implantable polymeric devices configured for controlled administration of therapeutic agents, and Wong et al. already identify EVA as a suitable material for an ocular implant. The modification would have amounted to employing a known EVA drug-delivery core having known material characteristics for its recognized function of incorporating and controlling the release of a therapeutic agent. Further, Schneider et al. provide a reason for incorporating a radiocontrast agent into the core, namely, to facilitate detection and localization of the implanted device by imaging.
Accordingly, Applicant’s distinction between the hollow infusion needle of Zarnitsyn et al. and the presently claimed solid implant does not overcome the rejection because the rejection, as presently formulated, is supported by the additional teachings of Wong et al. and Schneider et al. The combined prior art provides teachings or suggestions of the disputed structural, compositional, and polymer-property limitations and provides sufficient reason for one of ordinary skill in the art to make the proposed combination with a reasonable expectation of success.
Therefore, Applicant’s arguments do not overcome the rejection, and the rejection is maintained and made FINAL.
Conclusion
No claim is allowed.
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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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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