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 .
Claims 1-4 are pending in the instant application. Claims 1-4 are rejected.
Information Disclosure Statements
The information disclosure statements filed on November 16, 2023 and November 20, 2024 have been considered and signed copies of form 1449 are enclosed herewith.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 5,290,774.
U.S. Patent No. 5,290,774 discloses an ophthalmic solution comprising bunazosin hydrochloride which is prepared by dissolving bunazosin hydrochloride, conc. glycerol and benzalkonium chloride in sterile purified water (see column 3). Therefore, an ophthalmic preparation for myopia suppression comprising bunazosin and an ophthalmic preparation for myopia suppression comprising a composition containing bunazosin are anticipated by the reference. The reference also discloses an improved ophthalmic solution comprising an ophthalmic solution containing bunazosin hydrochloride which is unstable against light, the improvement comprising said ophthalmic solution further containing a photostabilizing effective amount of glyercol and boric acid, to form a photostable ophthalmic solution (see claim 18). Therefore, a method of manufacturing an ophthalmic preparation for myopia suppression comprising using a composition containing bunazosin is also anticipated by the reference.
With respect to the art rejection above, it is noted that the reference does not teach that the compositions can be used in the manner instantly claimed (i.e., for myopia suppression). However, the intended use of the claimed ophthalmic preparations does not patentably distinguish the preparations, per se, since such disclosed use is inherent in the reference compositions. In order to be limiting, the intended use must create a structural difference between the claimed preparations and the prior art compositions. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
According to the MPEP 2111.02 (II), if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).”
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.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0277521 A1 in view of WO 2006/137368 A1.
US 2023/0277521 A1 discloses sterile pharmaceutical compositions comprising a pharmaceutical agent for the treatment of ophthalmic diseases and conditions including but not limited to presbyopia, myopia, droopy or red eyes (see [0005]) wherein the pharmaceutical agent in the sterile pharmaceutical compositions comprises an alpha-adrenergic agent, such as bunazosin (see [0021]). It is also disclosed that, in some aspects, the methods described in the reference can be useful for treatment of myopia (see [0133]).
US 2023/0277521 A1 does not disclose the use of bunazosin specifically, however.
WO 2006/137368 A1 discloses a preventative or a remedy for glaucoma which comprises a combination of a Rho kinases inhibitor with a α1 blocker (see abstract). It is also disclosed in the reference that bunazosin is a preferred blocker (see 0023]).
WO 2006/137368 A1 does not disclose using bunazosin for the suppression of myopia, however.
Since both references disclose using bunazosin in ophthalmic compositions for the treatment of ophthalmic diseases or conditions, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to carry out a method of treating specifically myopia as disclosed in US 2023/0277521 A1 but using a composition containing specifically bunazosin as disclosed in WO 2006/137368 A1 and to arrive at a method of the instant claim with a reasonable expectation of success. The motivation would have been to find an optimal ophthalmic preparation for the treatment of myopia or for myopia suppression. Thus, a prima facie case of obviousness has been established.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622