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 .
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.
Previously presented rejection of claim 1 rejected under 35 U.S.C. 103 as being unpatentable over Gudas, Biochim Biophys Acta. 2012 January ; 1821(1): 213–221, Campochiaro US 6075032 and US 6852311 and US 5433944 is maintained for reasons of record.
Applicants arguments are not persuasive.
According to Applicant,
Gudas teaches R667 as a RAR agonist, Gudas does not teach the use of palovarotene (R667) for ophthalmic purposes, nor the instant amount of R667;
Campochiaro’s R does not teach the RAR agonist R667 nor the instant amount of R667, rather a structurally different RAR agonist which is administered into the vitreous cavity, by intravitreal injection.
6852311 teaches ophthalmic ointment for treating infective eye diseases containing 0.01 to 5.0% of vancomycin hydrochloride and not R667 to treat ocular infections. Further 6852311 teaches not 10% (w/w) liquid paraffin rather 15-20% (w/w).
5433944 discloses ophthalmic ointments large molecule interleukin-6 not R667, containing paraffin and white petrolatum, Nishida does not teach an ophthalmic ointment containing a therapeutically effective amount of the small molecule R667.
Therefore
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that is 0.3% (w/w), R667 and 10% (w/w),
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Applicants arguments will not be persuasive.
The rejection is not under 35 USC § 102.
The active ingredient R667 is known in the cited prior art Gudas. The intended use for ophthalmic ointment predicated on the inherent property of R667 as per Campochiaro: as pointed out in the previous action page 3
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The use of liquid paraffin and white petrolatum are also known in the cited prior art in compositions for ophthalmic treatment 6852311 and 5433944. The term ophthalmic at once suggests intravitreal injection to deliver medicine directly into the eye's vitreous gel.
The w/w numbers relate to optimal workable range and concentrations of the active and inactive excipients.
It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The following is summary of explicit Examination guidelines to the situation at hand:
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients active and inactive ingredients for their known benefit since each is well known in the art for their beneficial properties. Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Note: As indicated at page 4 of previous action method claims of
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are drawn to the instant product claim.
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024].
From office action 08/27/2025:
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gudas, Biochim Biophys Acta. 2012 January ; 1821(1): 213–221, Campochiaro US 6075032 and US 6852311 and US 5433944
Gudas teach the instantly recited compound R667 also known as palovarotene (CAS REG No. 410528-02-8) is a retinoic acid receptor gamma agonist (RARγ agonist), at page 8 4th full paragraph.
Campochiarois invoked with regards to the preamble relating to
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Campochiarois teaches that ocular diseases are inexorably linked to RAR agonist activity, at Abstract”
Proliferation of retinal pigment epithelium following surgery or
trauma or resulting in ocular diseases associated with choroidal
neovascularization, e.g. age-related macular degeneration and
histoplasmosis syndrome, is prevented by contacting retinal pigment
epithelium cells with a therapeutic amt. of a retinoic acid receptor
(RAR) agonist, preferably one with specific activity for retinoic acid
receptors. Preferably the RAR agonist is also a potent antagonist of
AP1-dependent gene expression. Alternatively, the proliferation of
retinal pigment epithelium is ameliorated with a therapeutic amt. of
an AP-1 antagonist, alone or in combination with an RAR agonist. The
drug can be administered by bolus injection into the vitreous cavity
using a dosage from about 50 to 150 μg. or by slow release from
liposomes or an oil tamponade injected into the vitreous cavity.
Formulations for preventing proliferation of retinal pigment.
Taken together there is suggestion to the instant use of R667 in pharmaceutical formulations for the use of eye diseases. Combining active ingredients with optimized amounts of previously known ingredients (here liquid paraffin and white petrolatum) does not make the composition any more novel. US patent data base is replete with use of paraffin and petrolatum in ophthalmic ointments. See claims of US 6852311 and US 5433944.
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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625