DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 08/12/2026 are acknowledged.
Claims 1-5, 7-8, 10-20 and 25-26 are pending.
3. Claims 1-5, 7-8 and 10-19 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 20 and 25-26, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, Applicant is advised that if claims directed to any of the rejoined inventions are presented in a continuation or divisional application, such claims may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
4. The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
5. Claims 25-26 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method for treating age-related macular degeneration (AMD), geographic atrophy (GA), choroidal neovascularization (CNV), central retinal vein occlusion (CRVO), corneal angiogenesis, and retinal angiogenesis,
does not reasonably provide enablement for a method for preventing these diseases, of for a method for treating a generically recited “eye disease,” including uveitis, diabetic and other ischemia-related retinopathy, diabetic macular edema, pathological myopia, a von Hippel-Lindau disease, and ocular histoplasmosis.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
The claims encompass in their breadth treatment of any and all eye diseases irrespective of pathological mechanisms.
The specification discloses evaluation of the claimed fusion protein in animal models of macular degeneration (Examples 10-13). The present invention is based on inhibition of vascularization and complement activation, and therefore a person of ordinary skill in the art would reasonably conclude that experimentation aimed at treating diseases other than those mediated by vascularization and/or complement would most likely be unsuccessful, and as such unnecessarily, and improperly, extensive and undue.
The burden of enabling a method of preventing a disease is much greater than that of enabling a method of treating a disease, due to the inherent difficulty of identifying healthy human subjects susceptible the disease, and especially the hurdle of proving that the administered treatment was the factor that resulted in prevention of the disease. The specification provides no working examples, guidance or direction as to how one skilled in the art would screen the population to select the subjects in need of prevention of any of the diseases within the scope of the claims, nor is guidance or direction provided as to the protocol to be utilized in order to establish the efficacy of the claimed treatment in preventing these conditions. Accordingly, the entire scope of experimentation required to develop methods of preventing eye diseases by the claimed method is left to those skilled in the art, the present claims and disclosure amounting to nothing more than an invitation to the skilled artisan to invent such methods.
6. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
