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
Applicants’ response, dated 06/22/2026, is acknowledged. Claims 6, 8, 13-16, 19, 31-33, 38-39, 44, 54-55, 65-66 were amended and claims 68-94 were added, no new matter was added. Claims 1-2, 6-23, 31-34, 37-46, 54-55 and 58-94 are now evaluated on its merits.
Priority
This application claims domestic benefit to U.S. provisional application 62/900,379, dated 09/13/2019.
Response to Arguments
Applicants’ arguments filed 06/22/2026 have been fully considered but they are not persuasive. Applicant argues (Page 5) the prior art of Green et al. (US Patent No. 20160177298) “broadly discloses connexin hemichannel modulators, including tonabersat, and generally discusses ocular disorders. It does not teach or suggest the use of connexin hemichannel modulators, including tonabersat, in methods to return the retina to pre-disease states, including, for example, in diabetic retinopathy. Most importantly, Green et al. does not disclose the experimental findings that form the basis of the present claims.”
It is noted the prior art teaching of Green is of the same compound administered to the same patient population of diabetic retinopathy within the same claimed dosage range as of claimed invention. Thus, the property of rescuing or restoring retinal function is an inherent feature taught by the prior art of Green as per MPEP 2112 (I): [T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The rejection of claims 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-67 is maintained.
Applicants have overcome the 112b rejection of claims 31 and 44 by the amendment to the claims to delete the trademark name Xiflam and overcome the claim objections of claims 60-61 and 65-66 with a period at the end of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-94 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (US Patent No. 20160177298) in view of Nor et al. Sustained Connexin43 Mimetic Peptide Release From Loaded Nanoparticles Reduces Retinal and Choroidal Photodamage, Vision Science, May 2018, Pages 3682-3693.
Regarding claims 1-2, 6-19, 20-23, 31-34, 37-46, 54-55 and 58-94, Green teaches methods for treating ocular and other disorders, including age related macular degeneration (AMD), retinal ischemic diseases or ocular ischemic diseases, diabetic macular edema caused by microaneurysms (relevant to claim 83) and diabetic retinopathy (DR) (relevant to claims 37-38, 78, 90) comprising administration of a therapeutically effective amount of compounds of formula I
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, in particular tonabersat (relevant to claims 1-2, 6-8, 20, 31, 34, 54, 69, 80) (para. 0010, 0035-0036, 0050, 0302). Of the tonabersat Green teaches the compound administered to a human by rote of injection or orally once a day or once a week at a dose of approximately 2 mg to approximately 40 mg, a dose range of approximately 0.1 to approximately 6 mg/kg/day and circulating concentration in the ranges of approximately 0.001 micromolar to approximately 200 micromolar (relevant to claims 9-17, 32-33, 44, 55, 72-74, 79, 84-86, 91-94) (para. 0015, 0245, 0511-0513 and 0523).
Green additionally teaches the compound may or may not be formulated into a microparticle (relevant to claim 18) (para. 0373) and administration of the above compound results in preventing retinal pigment epithelium degeneration associated with conditions of dry or wet AMD (relevant to claims (45, 58-62, 75-77, 82, 87-89) (para. 0052) and reduce inflammation in the inner retina (relevant to claims 42, 63-67) (para. 0050).
Green fails to teach the compounds to treat ocular disorders wherein retinal vascular endothelium and normal retinal layer structure is recovered as well as restoring retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function.
Nor teaches in AMD, local inflammation is associated with an immune cell–mediated process that leads to a chronic inflammatory environment. According to recent reports, the inflammatory reaction is associated with an increase in connexin43 (Cx43) expression and Cx43 also forms hemichannels in the plasma membrane. Thus, administration of Cx43MP and Cx43MP-NP improved a-wave and b-wave function of the ERG, prevented photoreceptor, restoring PII and PIII rod and cone function (abstract, Pg. 3682, 3685).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the compound tonabersat to treat ocular disorders, wherein retinal vascular endothelium and normal retinal layer structure is recovered as well as restoring retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function. One would have been motivated to do so from the teachings of Green of the ocular disorders lead to vascular endothelial growth and the teachings of Nor on treatment of AMD leads to improvement of b-wave function of the ERG and restoring PII and PIII rod and cone function. It is also noted from applicant the retinal function and structure are directly related, thus improvement in one directly improves the other. There is a reasonable expectation of restoring retinal vascular endothelium, normal retinal layer structure, retinal functions of mixed a-wave function, mixed b-wave function and/or PII and PIII rod and cone function by the administration of tonabersat taught by Green.
Additionally, the administration of the compounds taught by Green in the desired claimed dosage ranges would inherently restore retinal function and structure as per MPEP 2112 (I): [T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977), and MPEP 2112.01 (II): Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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