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 and 3 are presented for examination.
The amendments and remarks filed on 10/31/2025 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 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okigami et al. (US
20160367556) in view of Takada et al. (US 20080269353).
Okigami teaches a pharmaceutical composition for treating eye diseases comprising of 3-[(3S,4R)-3-
Methyl-6-(7H-pyrrolo[2,3-d] 4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile
(delgocitinib), which it can be used as an active ingredient of a therapeutic or preventive agent for
various eye diseases involving VEGF, such as age-related macular degeneration, diabetic retinopathy,
macular edema, neovascular maculopathy, retinal vein occlusion and neovascular glaucoma. See the abstract and Para [0001]. Okigami teaches the use of the eye drop comprises disodium edetate as a
stabilizer. See bara[0063]. Okigami teaches that an eye drop or an insert that, for example, comprises
the active ingredient Compound A at a concentration of approximately 0.0001% to 0.1% (w/v) can be
administered to an adult patient (body weight: about 60 kg) per day at a time or in several divided
doses. See Para [0066].
Okigami does not teach the concentration of delgocitinib, edetic acid (EDTA) and the presence of creatinine.
The determination of optimum proportions or amounts of delgocitinib is considered to be within the skill of the art in the absence of evidence to the contrary. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising 0.3% w/w delgocitinib
through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the composition disclosed by Okigami in order to effect the dosage of the active ingredient, delgocitinib.
Takada teaches liquid preparation for ophthalmic use containing a preservative composition for
ophthalmic use comprising a chlorite and at least one stabilizer selected from the following 1) to 7): 1)
creatinine; 2) geraniol; 3) glucose; 4) tocopherol acetate; 5) oxyquinoline sulfate; 6) a sugar alcohol; and
7) a polyoxyethylene sorbitan fatty acid ester can prevent the generation of chlorine dioxide, and is
therefore excellent in safety and exhibits a sustained preservative effect for a prolonged period of time.
See The abstract, Para [0008] and Para [0010]. The concentration of creatinine is taught to be 0.00001
to 5%. See Para [0023].
It would have been obvious to a person skilled in the art to add creatinine to the composition of
Okigami, motivated by the teachings of Takada, which teaches the use of creatinine encompassing the
claimed concentration in an ophthalmic formulation as a stabilizer as old and well known. The
determination of optimum proportions or amounts are considered to be within the skill of artisan in the
absence of evidence to the contrary. Applicant's attention is drawn to in re Aller, 220 F.2d 454, 456, 105
USPQ 233, 235 (CCPA 1955), where the court stated that Generally, 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." It would have been obvious to add creatinine to delgocitinib motivated by the teachings of Takada, which teaches the use of creatinine as a stabilizer to
ophthalmic formulations as old and well known.
Applicant has presented no evidence to the unexpected or unobvious nature of the claimed invention,
and as such, claims 1 and 3 are properly rejected under 35 U.S.C. 103 (a).
Response to arguments
Applicant’s arguments regarding obviousness have been noted. Applicant in his remarks argues that “ Okigami teaches that the concentration of delgocitinib in ophthalmic solutions is typically
0.0001% to 0.1% (w/v). Therefore, a skilled person in the field of the invention when viewing
Okigami would not be motivated to increase the upper limit to 0.3 mass%. The high limitation of the range in Okigami (0.1 mass%).
This argument is not persuasive. The prior art discloses the concentration of
delgocitinib is a result effective variable insofar as disclosing delgocitinib as the active
agent. One of ordinary skill in the art would have appreciated that varying the
concentration of the active (i.e., delgocitinib) would have affected the dosage of the
composition. Therefore, the instantly claimed amount of delgocitinib would have been
obvious because 1) "where 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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105
USPQ 233)), and 2) the prior art identifies the concertation of delgocitinib as a result
effective variable. Applicant in his remarks further argues that “As further evidence of this premise, in the Examples, it has been demonstrated that, in an aqueous composition containing 0.3 mass% of delgocitinib, the addition of edetic acid significantly suppresses discoloration and improves stability even in the presence of trace amounts of copper”. It is the examiner’s position that Okigami teaches the use of delgocitinib in combination with EDTA. Therefore, the advantages claimed by the applicant are the inherent property of Okigami, in the absence of evidence to the contrary. Takada was relied upon to show the use of creatine as a stabilizing agent in ophthalmic formulations as old and well known.
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