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 and 5 are presented for examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2026 has been 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, 4 and 5 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) and further in view of Ludwig et al. (An International Guideline for the Preparation, Care and Use of Medicinal Products, Bouwman-Boer et al. (Eds.) (Springer 2009), Chapter 10 (Eye) by Ludwig et al., pp. 162-188 ("Ludwig").
Okigami teaches a pharmaceutical composition for treating eye diseases comprising of 3-[(3S,4R)-3- Methyl-6-(7H-pyrrolo[2,3-d]4-y)-1,6-diazaspiro[34]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) the presence of creatinine and boric acid.
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 0.03 to 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%, which encompasses the claimed concentration. See Para [0023]. Ludwig teaches boric acid is commonly used as an excipient in ophthalmic medicants to adjust pH. (Id., p.172, Table 10.5 and accompanying text).
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. Ludwig teaches the use of boric acid in ophthalmic formulations as old and well known. Applicant has selected a few concentrations within the scope of the relied upon reference and shows advantage in terms of stability of such concentrations. However, the selected concentrations are within the scope of the prior art concentrations and are not commensurate in scope with the claimed language, specifically as it relates to component B. Furthermore, there is no evidence of record that concentrations outside the claimed tested concentrations and within the scope of the prior art will not show the same advantage.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “Applicant submits that the cited references fail to suggest the claimed results of the invention. The cited references teach certain concentrations of delgocitinib but are silent regarding the concentrations recited in amended claim 1. While the skilled person in the field of the invention reading the cited references would reasonably expect that modifying these concentrations would yield different results, there is absolutely no suggestion, teaching or incentive in the cited references that would lead a skilled person in the field of the invention to expect the superior results achieved by the claimed invention.
In contrast to the predictable trends of the cited references, the claimed invention demonstrates completely unexpected properties. Specifically, as shown in In the Examples of the specification”. It is the examiner’s position that the examples in the specification teach the concentrations of 0.03 mass % and 0.3 mass% for delgocitinib, one concentration for creatinine and 3 concentrations for EDTA, within the scope of 0.0001 mass% to 0.1 mass% as claimed herein. The concentrations of component B are not commensurate in scope with the claimed language. There is also no evidence of record that if applicant selects another concentration within the scope of the prior art and outside the tested concentrations, such advantage will not be obtained.
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
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