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 .
Applicant argues that the prior art formulation is not “eye-drops” however Nakamura indicates that the formulation can be applied directly to the eye with a syringe making the formulation functionally “eye drop” absent any added structural limitation to the composition.
Applicant's arguments filed 3/6/26 have been fully considered but they are not persuasive. The claims remain rejected for the reasons of record. Applicant again argues that the composition of Nakamura should not be considered “eye drops” but as previously argued, there is o clear structural requirement that would preclude the Nakamura composition from being considered “drops.”
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 1-8 are rejected under 35 U.S.C. 102(a)(1)(2)as being anticipated by NAKAMURA et al (2010/0087486).
Nakamura et al is drawn to medicant compositions in liquid form to be applied directly to the eye (eye drops) with the TGF-Beta inhibitor 4-[4-(1,3-benzodioxole-5-yl)-5- pyridinyl)-1 H-imidazole-2-yl]benzamide (also known was SB-431542 – applicant’s exemplified as in claim 5) [006][0019] and combined with other active ingredients, excipients etc.
The reference anticipates the claim subject matter as the intended use “medicant for…” does not impart a structural difference from the compound disclosed in the prior art (or the myriad of other known TGF-Beta signal inhibiting agents).
Nakamura indicates that the formulation can be applied directly to the eye with a syringe making the formulation functionally “eye drop” absent any added structural limitation to the composition.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
THIS ACTION IS MADE FINAL. 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/ Primary Examiner, Art Unit 1657
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