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, 4-8 and 10-37 are presented for examination.
The amendments and remarks filed on 02/27/2026 have been received and entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 6, 14 and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is indefinite as to the phrase “a reduced IOP peak at 0.6%, wherein 1.5% is more effective. The phrase fails to set forth how the IOP peak at 0.6% is less effective that 1.5%, when the bell shape graph shows more efficacy for 0.6%.
Claim 6 is indefinite as to the phrases “POAG/OH” . the phrase fails to set for the intended meaning.
Claim 14 recites the limitation "wherein implantable device" in claim 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 is indefinite as to the phrase “RocK”. The phrase fails to set forth the intended meaning.
Claims dependent on the rejected claims are also rejected as they have all the limitations of the rejected claims.
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.
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(s) 1, 2, 4-8, 10-19, 21-26 and 28-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al. (Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 and 4 Weeks of Twice-Daily Ocular Trabodenoson in Adults with Ocular Hypertension or Primary Open-Angle Glaucoma) and further in view of Parikh et al. (US 20190046696) (submitted by the applicant).
Myers teaches the use of trabodenoson or the treatment of patients primary open angle glaucoma. Myers teaches trabodenoson, a highly selective adenosine mimetic targeting the adenosine A1 receptor, is safe and well tolerated and produces clinically and statistically significant IOP reductions in eyes with ocular hypertension or POAG. See page 50, column 2, Discussion. Myers teaches IOP reductions in the 500 mcg group were significantly greater than placebo at all time points at Day 28. Mean IOP reductions from diurnal base- line ranged from -3.5 to -5.0 mmHg with a mean change of -4.1 mmHg in the 500 mcg group compared -1.0 to -2.5 mmHg with a mean change of -1.6 mmHg for the placebo group, and the Day 28 drop was significantly greater than at Day 14 (P=0.0163) indicating improvement in IOP lowering with longer treatment time. IOP remained significantly reduced 24h after the final 500 mcg dose (P=0.048).. See the abstract. Myers does not teach the use of an implantable device made of PLGA or PEG biodegradable or non-biodegradable for delivery of trabodenoson to the eye. However, Parikh teaches that the present invention relates to the field of biodegradable stents, and more particularly, to tube- shunt implants. See Para [0003]. Parikh teaches the device is used for reducing the intraocular pressure (IOP) in a patient by facilitating drainage of aqueous humor, without the use of surgical "fixers" such as sutures. See Para [0016]. Parikh teaches that the stents contain one or more biodegradable, biocompatible fibers made of suitable polymers. The one or more biodegradable, biocompatible polymers can be homopolymers or copolymers. See Para [0087]. The use of PLGA is taught in Para [0089] and [0091]. Parikh teaches The stents also contain one or more generally non-biodegradable fibers made of suitable polymers. See Para [0039]. It would have been obvious the composition of Li in an implant delivery device, such as a stent, motivated by the teachings of Parikh, which teaches the use of an implant, such as a stent having PLGA polymer for delivering of compounds being used for treating intraocular pressure or glaucoma as old and well known. Parikh teaches the device used for reducing intraocular pressure, can be implanted to connect the anterior chamber to the subconjunctival space or to the suprachoroidal space of an eye to permit outflow or venting of aqueous humor. See para [0016]. The use of rod is taught in Para [0052]. Parikh teaches the implant is at least partially coated with at least one polymer film that contains therapeutic, prophylactic or diagnostic agent, the polymer film permitting a delivery of a quantity of the agent to ocular tissues over time. See Para [0104]. Parikh teaches that the stents may include one or more therapeutic, prophylactic, and/or diagnostic agents that are encapsulated, blended or conjugated to the polymer of the stents, or encapsulated in, blended/conjugated to sustained release nanoparticle/microparticle formulations that are entrapped in between or conjugated with the fibers of the stents. Agents may be encapsulated in the biodegradable inner core, the exterior coating of the stents, or in the outer slower degrading or non-degrading layer of the tubular device. See Para [0107]. It would have been obvious to a person skilled in the art to use the device of claims 14 and 15 and the polymers of claim 37, motivated by the teachings of Parikh, which teaches the use of the claimed device and polymers for delivering ophthalmic formulations as old and well known. Parikh also teaches the use of implant for the delivering the antiglaucoma agents, such as prostaglandin analogs such as travoprost and latanoprost, prostamides such as bimatoprost; beta- adrenergic receptor antagonists such as timolol, betaxolol, levobetaxolol, and carteolol, alpha-2 adrenergic receptor agonists such as brimonidine and apraclonidine, carbonic anhydrase inhibitors such as brinzolamide, acetazolamine, and dorzolamide. To combine trabodenoson with the antiglaucoma compounds claimed in claim 17, would have been obvious to a person skilled in the art. Their combination flows logically from their individual use for the same purpose. Applicant's attention is drawn to In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), where the court stated, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose... [T]he idea of combining them flows logically from their having been individually taught in the prior art". The mechanism by with the glaucoma has been treated does not create a patentably distinct method of use, as long as the same compound has been used for the treatment of the same disorder. Inducing the MMP-mediated trabecular meshwork tissues of the eye, basement membrane change, repairing and rejuvenating pressure sensors is the inherent property of using trabodenoson for the treatment of glaucoma.
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(s) 20 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (Topical Trabodenoson Is Neuroprotective in a Rodent Model of Anterior Ischemic Optic Neuropathy (rNAION) in view of Polska et al. (Effects of Adenosine on Intraocular Pressure, Optic Nerve Head Blood Flow).
Regarding claim 20 and 27, Guo teaches the use of trabodenoson in treating nonarteritic anterior ischemic optic neuropathy (NAION). Guo teaches that While previous clinical trials focused on trabodenoson ocular antihypertensive effect, our data suggest trabodenoson's primary target may be both the retina and optic nerve head (ONH). Selective adenosine A1 agonists may prove an appropriate neuroprotective adjunctive for ischemia-related ON diseases such as NAION and glaucoma. See the abstract. Guo teaches that trabodenoson is a highly selective adenosine receptor mimetic initially developed clinically for primary open-angle glaucoma (OAG) because it was previously shown to lower intraocular pressure (IOP) by increasing conventional outflow facility. See page 2, column 1. The topical use as an eye drop is taught in column 1, page 2. Guo makes clear that trabodenoson is an adenosine receptor agonist being used for the treatment of anterior ischemia.
Guo does not teach the treatment of choroidal ischemia. However, Polska teaches the use of adenosine in increasing choroidal blood flow. Polska teaches that adenosine induced a significant increase in choroidal blood flow. See the abstract
It would have been obvious to a person skilled in the art to use trabodenoson, which is an adenosine A1 agonist being used for treating anterior ischemia and use it for the treatment of choroidal ischemia, motivated by the teachings of Polska, which teaches the use of adenosine in increasing blood flow to choroid region of the eye. The mechanism by which the choroidal ischemia is treated does not create a patentably distinct method of use.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “As set forth in the Specification as originally filed, "Phase 3 clinical trials [performed at 3-6% doses] failed to meet the IOP endpoint at 3 months [...]" Specification at I [0016). Thus, the 3- 6% dose range disclosed in Li was clinically ineffective for achieving intraocular pressure (IOP) reduction, with only 3-4 mmHg reduction seen at week 12 by 3-6% eye drops, similar to saline effect (Phase 3 pivotal trial is shown in FIG. 5A). In contrast, the presently claimed about 1.0% to about 2.0% range represents a distinct dosing window that is effective for achieving the claimed therapeutic outcome (IOP normalization, with 6-7 mmHg reduction achieved by the 1.5% dose, as shown in FIG. 5B)” It is the examiner’s position that it appears that applicant’s arguments and data are based on phase 2 and 3 of clinical trials. The examiner is not clear if such clinical trials were done by the applicant, FDA or some other entity. The clarification is requested, considering that applicant is selecting the effective concentrations from the results presented by the clinical trials. Additionally, since Myers teaches the use of trabodenoson at the concentrations of up to 0.5% for lowering IOP, there has to be a side by side comparison between the claimed concentrations and Myers concentrations in terms of lowering IOP and treating glaucoma. Furthermore, there is no evidence of record to superior activity of the claimed concentrations in treating Choroidal ischemia.
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.
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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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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