DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/12/2026 has been entered.
Claims 55-80, 84-86 are pending.
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.
Claim(s) 55-80, 84-86 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2015/195842 (Brooks et al.), reference of record from the parent application, in view of US 9,636,332 (‘332), Rodrigues et al., Journal of Ocular Pharmacology and Therapeutics, Volume 27, Number 2, 2011, 197-203, Gallemore et al., https://www.aao.org/eyenet/article/intravitreal-kenalog-injections#:~:text=The, Oct 2004, retrieved 2/12/2025, and CA 3 010 862 (‘862).
Brooks discloses a method of treating macular edema associated with uveitis in a human subject in need thereof, the method comprising non-surgically administering an effective amount of a drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment. The particularly preferred and exemplified drug is triamcinolone, in particular, 4 mg of triamcinolone acetonide. See the Abstract; paragraphs [1009], [1010], [1223], [1225], [1129], and [1241]; and claims 1, 17 and 18. At least one dose is administered and additional doses of the formulation may be administered every 2 weeks, 1 month, 2 months, 3 months, or about 6 months (reading on instant claims 3 and 34). See paragraph [1009], for example. As recited by instant claim 6, the treatment of non-infectious is disclosed by Brooks. See, for example, paragraph [1010] and Example 2. An embodiment of the method of treating macular edema associated with uveitis teaches an improvement in retinal edema, as measured by a decrease in retinal thickness from baseline prior to treatment, “of at least about 20 μm, or at least about 40 μm, or at least about 50 μm, or at least about 100 μm, or at least about 150 μm or at least about 200 μm, or from about 50-100 μm, and all values in between. In another embodiment, the patient experiences a ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20%, ≥ 25% decrease in retinal thickness”, reading on instant claims 10 and 28. See paragraphs [1144] and [1237]. Brooks et al. teaches the particle size D50 is 1um or less. See paragraph [1161]. Brooks et al. teaches the TA composition comprising 0.5% (w/v) carboxymethylcellulose sodium and 0.015% polysorbate 80. See paragraph [1224].
Example 2 (paragraphs [1223] to [1240] of Brooks discloses a human study of 4 mg triamcinolone acetonide administered (by microinjection) to the SCS in patients with non-infectious uveitis (intermediate, posterior or pan-uveitis) with macular edema. Patients were reevaluated the day after the injection and at weeks 1, 2, 4, 8, 12, 16, 20 and 26. The mean reduction in macular edema at 26 weeks post-injection was over 100 μm (reading the limitation of instant claim 16). An improvement in BCVA, based on the ETDRS visual acuity charts, as demonstrated by a gain of about 3 lines (i.e., 15 letters) was measured at 26 weeks post-injection (para. [1150] and [1236].
Example 3 of Brooks (pages 97-108) discloses a randomized, masked, multicenter study to assess the safety and efficacy of triamcinolone acetonide injectable suspension in the treatment of human subjects having macular edema following non-infectious uveitis. Administration into the SCS as a single injection of either 4 mg or 0.8 mg of the triamcinolone suspension, using a microinjector is used. The protocol for the assessments of efficacy in the subjects is disclosed at paragraphs [1261] to [1271]. BCVA is assessed using the ETDRS protocol. BCVA is assessed for the treated eye and untreated eye. Vitreous haze is measured using the vitreous haze scale presented in Table 4 ([1271]).
Treating macular edema associated with uveitis in a human subject by non-surgically administering 4 mg of a triamcinolone formulation to the SCS of the eye of the subject, as taught by Brooks, would result in the same therapeutic benefits as instantly claimed because administration of the same drug, at the same dose, to the same site (the SCS of the eye), to the same patient population, would result in the same therapeutic effects. This is further evidenced by the disclosure by Brooks at, e.g., Example 2, supra.
However, Brooks et al. does not expressly teach the length and the gauge of the microneedle. Brooks et al. does not expressly teach the technique of the administration recited in the claims.
‘332 teaches the injection being perpendicular and the microneedle length as 600micron to 1000micron (see col. 3, lines 55-57; col. 15, lines 11-20).
Rodrigues et al. teaches 29- or 30-gauge needle has less reflux and less pain for patients (See page 201, col. 1, last paragraph, and page 202, col. 1, second paragraph).
Gallemore et al. teaches an injection technique for administering Triamcinolone composition including “The tip of the TB syringe (without needle) also can be used to measure: Compression perpendicular to the sclera with the tip of the TB syringe tangential to the limbus will leave a circular mark, the back edge of which is 3.5 to 4 mm posterior to the limbus. The Kenalog is then injected through the pars plana with the needle directed toward the optic nerve.” (see injection Technique, point 7). The examiner notes that the injection is making a depression or dimple – “circular mark” and then inject the composition into the target area.
‘862 teaches a device to deliver drug into the suprachoroidal space for treating macular edema associated with uveitis (see [1007]). Such device has the needle part that about 28-gauge or less such as 30 gauge. The length of the needle is 900 µm (see [1128], [1132]; part 166 in Fig. 12, 17 for example).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed injection technique and the herein claimed microneedle in the method of treating macular edema associated with uveitis.
One of ordinary skill in the art would have been motivated to employ the herein claimed injection technique and the herein claimed microneedle in the method of treating macular edema associated with uveitis. Employing known method of injection with well-known microneedle with effective parameters (i.e., gauge and length) to deliver the same triamcinolone compounds to treat macular edema would be prima facie obvious. In addition, the resulting therapeutic effects by the injection of the triamcinolone acetonide would be reasonably expected to be affected as the triamcinolone compound is administered in the similar manner as the cited prior art did to the same patient population that suffered from macular edema associated with uveitis.
The length (900 µm) and gauge (30 gauge) of microneedle are well-known in the art being suitable for suprachoroidal space administration. Accordingly, it would have been obvious to one of ordinary skill in the art would using microneedle with those parameter to deliver triamcinolone in a method to treat macular edema associated with uveitis.
Response to Arguments
Applicant’s arguments with respect to claim(s) 55-80, 84-86 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that the gauge and length of the microneedle employed in the instant method as unique. However, it is well-known in the art that 30 gauge and 900 µm be suitable for suprachoroidal space administration. Employing such microneedle would be reasonably expected to be effective in delivering the active to treat macular edema associated with uveitis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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