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
The office acknowledges Applicants filing of the claim amendments dated 9/29/2023. Claims 3-5, 9, 10, 12-15 have been amended. Claims 1-15 are pending and are being examined based on the merits herein.
Application Priority
This application filed on 09/29/2023 is a National Stage entry of PCT/EP2022/ 057790, International Filing Date: 03/24/2022, claims foreign priority to 21166452.9, filed 03/31/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 9/29/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Karavas et al. (WO 2017182138) and BASF (https://ptacts.uspto.gov/ptacts/public-informations/petitions/1462277/download-documents?artifactId=yE4QgP_v7mxGQsrdt OO4RQVYvw7IyOKfKX3j9XXuGYiBCPbamWU7uQk, 1997).
Karavas teachings are to preservative-free ophthalmic solution composition for the reduction of elevated intraocular pressure containing latanoprost (Abstract, p 3 lines 21-22, p 8, line 5). The reference teaches composition comprising latanoprost, solubilizing agent selected from polyoxyl 40 hydrogenated castor oil, polyoxyl 35 castor oil or a combination of polyoxyl 40 hydrogenated castor oil and poloxamer 407, buffering agents, tonicity agent and a chelating agent (claims 1-4), wherein the pH value is between 5.8 and 6.2 (claim 10).
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Karavas teach that tonicity plays an important role in successful administration of an aqueous solution and it refers to the osmotic pressure exerted by salts in the solution. Further taught is that propylene glycol as an alternative to the tonicity agent, sodium chloride (See p 6, lines 1-5).
BASF teach that the generic names of Cremaphor RH-40 are Polyoxyl 40 Hydrogenated Castor Oil (USP/NF), Macrogol-Glycerolhydroxystearat (DAB).
Polyoxyethylenglyceroltrihydroxystearat (DAC) (See p 2, lines 1-3).
From the teachings of Karavas a person skilled in the art would have found it obvious to arrive at the claimed aqueous composition comprising latanoprost (and in the amounts) because the reference teaches solutions comprising latanoprost (e.g. 0.005%), Cremophor RH-40 (e.g. 0.5%), tonicity agent, sodium chloride and water for injections. Karavas teach propylene glycol as an alternative tonicity agent in the compositions comprising ocular agents, e.g. latanoprost. A person skilled in the art would have found it obvious to add propylene glycol as a tonicity agent with a reasonable expectation of success and arrive at the claimed composition. Though the amount of propylene glycol is not taught as claimed, it is within the skill of an artisan to optimize the amount based on the tonicity agent properties and it is routine. It is noted that Cremophor RH-40 is macrogoglycerol hydroxystearate as evidenced by BASF. It is noted that the composition formulated from Karavas is free of preservatives and stabilizing agents. Thus claims 1, 3-4 are obvious over the prior art. From the reference it would have been obvious to add Macrogol-Glycerolhydroxy stearate as the only surfactant in the composition thus addressing claim 2. As to claims 5-8, Karavas teach another active ingredient timolol (0.5%) can be added in the latanoprost formulation.
As to claim 9, the reference teaches that sodium chloride can be added as a tonicity agent. A person skilled in the art would have found it obvious to add one or more tonicity agent in the solution of Karavas to adjust the osmotic pressure of the formulation and ensure it is isotonic. As to claims 10-11, Karavas teaches that ophthalmic solutions are ordinarily buffered at a pH that ensures maximum stability for the drugs they contain. The buffers are included to minimize any change in pH during storage which will affect the stability and solubility of the drug. pH in the range of 5.8 to 6.2 is considered optimum for ophthalmic solutions; suitable buffering agents include, but are not limited to, sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate (p 7, para 1). As to claim 12, Karavas teach compositions with a pH of 6.2 and do not teach pH as 6.4-7.0. However it is within the skill of an artisan to adjust the pH of the ophthalmic solution based on the active ingredients and other agents to 6.4 by adding the necessary buffering agents and arrive at the claimed pH.
As to claim 13, Karavas teach that the present invention also provides fixed-dose combinations (FDCs) that include Latanoprost and Timolol combined in a single dosage form (p 2, lines 30-33).
As to claims 14-15, for examination purposes, the claims are interpreted as a method of use of the composition. Karavas teach the aqueous composition comprising latanoprost can be used in treating reduction of elevated intraocular pressure and for the treatment of ocular hypertension (abstract, p 3, lines 12-15).
Claim(s) 1-4, 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yoda (US 9456980) in view of Wade (Handbook of Pharmaceutical Excipients, ed: Wade et al. 1994) and BASF (https://ptacts.uspto.gov/ptacts/public-informations /petitions/1462277/download- documents?artifactId=yE4QgP_v7mxGQ srdtOO4RQVYvw7IyOKfKX3j9XXuGYiBCPbamWU7uQk, 1997).
Yoda teach latanoprost-containing aqueous pharmaceutical composition comprising nonionic surfactant e.g. polyoxyethylene hydrogenated castor oil (e.g. polyoxyethylene hydrogenated castor oil 60) (abstract, col. 3, lines 30-31). It is taught that tonicity agents, e.g. sodium chloride is added to adjust the osmotic pressure of the pharmaceutical composition (col. 4, lines 4-8). The latanoprost amount ranges from 0.001 to 1 w/v %, and the concentration of the nonionic surfactant in the composition ranges from 0.001 to 5 w/v % and the composition do not contain preservatives (See claim 1). The composition can be eye drops (claim 2) and the composition has a pH of 5.0 to 8.0 adjusted by a pH adjustor selected from the group consisting of sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate (claims 3, 5, 6). The composition can further comprise a nonionic isotonic agent e.g. propylene glycol (claim 4, 7). In the formulation example, latanoprost is 0.005%, polyoxyethylene hydrogenated castor oil 60 is 0.5% and propylene glycol is 0.5%.
Yoda is not explicit in teaching the surfactant macroglycerol hydroxystearate 40 as in the instant claims.
Wade teach polyoxyethylene castor oil derivatives, polyoxyethylene castor oil 40 (Cremophor RH 40) and polyoxyethylene castor oil 40 (Cremophor RH 60) are non-ionic surfactants used in oral, topical and parenteral pharmaceutical formulations (See Table 1, p 371, col. 2, section 7, lines 1-3).
BASF teach that the generic names of Cremaphor RH-40 are Polyoxyl 40 Hydrogenated Castor Oil (USP/NF), Macrogol-Glycerolhydroxystearat (DAB).
Polyoxyethylenglyceroltrihydroxystearat (DAC) (See p 2, lines 1-3).
From the prior art teachings of Wade and BASF a person skilled in the art before the effective filing date of the invention would have found it obvious to add polyoxyethylene castor oil 40, aka Macrogol-Glycerolhydroxystearate for polyoxyethylene castor oil 60 in the formulation of Yoda because the art teach them as polyoxyethylene castor oil derivatives, function as non-ionic surfactants and is functionally equivalent. A person skilled in the art would have found it obvious to substitute polyoxyethylene castor oil 60 in the formulation of Yoda with polyoxyethylene castor oil 40 (Macrogol-Glycerolhydroxystearate) with a reasonable amount of success and use the formulation as eyedrops. The composition formulated from the combined teachings of the prior art can be free of preservatives and stabilizing agents. As to the amount, Yoda teach 0.001 to 1 w/v % of latanoprost and 0.001 to 5 w/v % of the nonionic surfactant and propylene glycol for example 0.5%. The amounts of the components in a composition can be routinely optimized and it is within the skill of an artisan. Claims 1-4, 9-12 are addressed by the combined teachings of the prior art.
Claims 5-8, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yoda (US 9456980) in view of Wade (Handbook of Pharmaceutical Excipients, ed: Wade et al. 1994) and BASF (https://ptacts.uspto.gov/ptacts/public-informations /petitions/1462277/download-documents?artifactId=yE4QgP_v7mxGQ srdtOO4RQVY vw7IyOKfKX3j9XXuGYiBCPbamWU7uQk, 1997) and further in view of Patel et al. (Drugs & Aging, 9, 5, 363-378, 1996).
Yoda, Wade and BASF as discussed above. The above rejection is incorporated herein.
The above prior art do not teach additional active ingredient in the composition comprising latanoprost.
Patel is explicit in teaching that latanoprost is an ester prodrug analogue of prostaglandin F2α effectively reduces intraocular pressure (lOP), once daily dose of 0.005% topical latanoprost is as effective as 0.5% timolol twice. A number of studies demonstrate that latanoprost enhances IOP-lowering effects when applied in combination with other antiglaucoma agents. Latanoprost can be used in the management of patients with primary open-angle glaucoma and ocular hypertension (Summary, p 364, para 1).
From the teachings of Patel a person skilled in the art before the effective filing date of the invention would have found it obvious to add timolol (0.5%), another active agent in the latanoprost composition with a reasonable expectation of success. A person skilled in the art would have been motivated to add timolol in combination with latanoprost to enhance the IOP-lowering effects. Thus claims 5-8 would have been obvious over the combined prior art teachings. As to claim 13, Patel teach single dose latanoprost being effective in treating intraocular pressure condition. As to claims 14-15, for examination purposes, the claims are interpreted as a method of use of the composition. From the prior art teachings a person skilled in the art would have found it obvious to use the aqueous latanoprost composition in treating ocular hypertension and/or open-angle glaucoma with a reasonable expectation of success.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-15 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claims 14-15 are directed to use claims without any steps.
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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 14-15 are to the use of the aqueous ophthalmic composition according to claim 1.
Since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Note: For examination purposes, the claim is interpreted as a method of treatment using the composition.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14.
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When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627
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