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 1-11 are presented for examination.
Claims 12-19 are withdrawn from examination.
The amendments and remarks filed on 12/30/2025 have been received and entered.
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.
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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ni (US
20170172915) in view of Witt et al. (US 20220143137).
Ni teaches a method for treating primary and recurrent pterygium by administering (1) a
multikinase inhibitor, (2) an antimetabolite or (3) a combination of a multikinase inhibitor and an
antimetabolite to the eye of a subject in need of such treatment. See Para [0004]. Ni teaches that
multikinase inhibitor targets kinase receptors of VEGFR (1, 2, 3) and PDGFR (a, ß). In certain aspect, the
multikinase inhibitor is in a topical ocular formulation administered topically to the affected eye. In
certain aspect, the topical ocular formulation is a solution, a suspension or an emulsion. See Para
[0004]. Ni teaches that the concentration of nintedanib in the formulation is from 0.001% to 10%. See
para [0004]. Ni teaches that the multikinase inhibitor is selected from the group consisting of Afatinib,
Amuvatinib, Axitinib, Cabozantinib, Canertinib, Cediranib, Ceritinib, Crenolanib, Crizotinib, Dabrafenib,
Dacomitinib, Dasatinib, Erlotinib, Foretinib, Gefitinib, Golvatinib, Ibrutinib, Icotinib, Idelalisib, Imatinib,
Lapatinib, Lenvatinib, Neratinib, Nilotinib, Nintedanib, Palbociclib, Pazopanib, Ponatinib, Quizartinib,
Regorafenib, Ruxolitinib, Sorafenib, Sunitinib, Tandutinib, Tivantinib, Tivozanib, Trametinib, Vandetanib,
Vatalanib, and Vemurafenib. See Para [0008] and [0041]. Ni teaches that solutions, suspensions or
emulsions used for ophthalmic application can include the following components: a sterile diluent such
as water for injection, saline solution, fixed oils, polyethylene glycols, glycerin, propylene glycol and
ethanol. See Para [0057] and [0058]. Ni teaches that Compositions for use in the present methods may
include a multikinase inhibitor at a concentration of 0.001% to 10% by weight or by volume the total amount of composition. For example, an aqueous composition comprises 0.001%, 0.01%, 0.1%, 0.5%,
1.0%, 1.5%, 2.0%, 5.0% or up to 10% nintedanib. See Para [0068].
Ni does not specifically teach the use perfluorohexyloctane (F6H8) as a liquid vehicle.
Witt et al. teach an ophthalmic compositions comprising particles of a powder preparation suspended in
a liquid vehicle comprising a semifluorinated alkane, wherein the particles comprise an anti-VEGF-
protein, are suitable for the treatment of ocular neovascularization. See Para [0016]. Witt teaches that
Preferably, the anti-VEGF protein of the present invention is selected from bevacizumab (Avastin),
aflibercept (VEGF Trap-Eye; EYLEA) and ziv-aflibercept (VEGF Trap; ZALTRAP). See Para [0027]. Witt
teaches that a composition comprising an anti-VEGF protein and a liquid vehicle comprising a
semifluorinated alkane shows anti-neovascularization activity when topically applied to the surface of
the eye. See Para [0045]. Witt teaches The term liquid vehicle comprising a semifluorinated alkane
refers to a liquid composition comprising at least one semifluorinated alkane. The liquid vehicle may
comprise further compounds. Preferably, the liquid vehicle comprises one or more semifluorinated
alkanes. More preferably, the liquid vehicle consists of at least one semifluorinated alkane or a mixture
of semifluorinated alkanes. See Para [0050]. Witt teaches the ophthalmic composition comprises anti-
VEGF containing particles of a protein powder preparation suspended in a vehicle comprising F6H8, a
protein stabilizing agent and a buffering agent. See Para [0070] and claim 7. The treatment of ocular
neovascularization is taught in Para [0075]-[0084] and claim 12.
It would have been obvious to a person skilled in the art to use F6H8 as a liquid vehicle in the
composition of Ni, motivated by the teachings of Witt, which teaches the use of F6H8 in an ophthalmic
formulation for the treatment of ocular neovascularization in combination with a VGEF inhibitor as old
and well known. The substitution of the VEGFRs of claim 3 for VEGF receptor inhibitor of Witt would
have been obvious to a person skilled in the art in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “Office Action at page 3. The Office at 4 relies on Witt as allegedly disclosing
ophthalmic compositions containing F6H8. However, as recognized at page 4 of the Office
Action, Witt's compositions comprise an anti-VEGF protein, preferably an antibody (e.g.,
bevacizumab) or a fusion protein (e.g., aflibercept and ziv-aflibercept) (see Witt at, e.g.,
paragraphs [0016], [0027] and Office Action at 4). Nevertheless, the Office combines the
references to conclude that "[i]t would have been obvious to a person skilled in the art to use
F6H8 as a liquid vehicle in the composition of Ni, motivated by the teachings of Witt, which
teaches the use of F6H8 in an ophthalmic formulation for the treatment of ocular
neovascularization in combination with a VEGF inhibitor as old and well known." Office Action
at page 4. Not only is this a conclusory statement with insufficient rationale, but the Office also
fails to provide any indication of reasonable expectation of success in using F6H8 as a liquid
vehicle in a topical ophthalmological composition comprising a multikinase inhibitor that
inhibits VEGFRs”. It is the examiner’s position that claim 1 is directed to multikinase inhibitor that inhibits VEGFRs. Therefore, the combination of perfluorohexyloctane with any VEGFRs inhibitor, such as anti-VEGF protein reads on claim 1. Furthermore, the substitution of one VEGRRs inhibitor for another and use it with F6H8 would have been obvious to a person skilled in the art in the absence of evidence to the contrary . Additionally, Witt teaches the use of F6H8 in as a vehicle in ophthalmic formulations. Therefore, it would have been obvious to a person skilled in the art to use a well known ophthalmic vehicle with any ophthalmic active ingredient in the absence of evidence to the contrary.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617