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 .
Information Disclosure
Examiner again notes that an IDS was not filed in this application. Applicant is reminded of the duty of disclosure as per 37 CFR 1.56 and detailed in MPEP § 2000.
Status
Applicant amended the claims such that claims 1-7, 9-20, 22-25 are pending.
Rejections not reiterated in this action are withdrawn.
Priority
This application is a 371 of PCT/US2021/050723 (09/16/2021),
PCT/US2021/050723 has PRO 63/079,376 (09/16/2020).
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/079,376, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Applicant amended the scope of the independent claims to Formula (I) which does not have sufficient written description support in the ‘376 application. Accordingly, claims 1-7, 9-20, 22-25 are not entitled to the benefit of the prior application.
New Claim Rejections - 35 USC § 102
Claims 1-7, 9-11, 15-20, 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shemano (US3947593).
Shemano teaches “A method of treating conditions of delayed hypersensitivity which comprises administering to a patient” compounds including tilorone (claims 1 and 11: “ 2,7-bis(2-diethylaminoacetyl)fluorene”) topically where hypersensitivity includes contact hypersensitivity in the skin (col 4, lines 30, 57).
Regarding the claim limitations reciting IC50 values and “pi-pi interactions”, these values/elements are inherent properties of the compounds and would be present in the prior art. MPEP 2112.01:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Thus, the claims are anticipated.
New Claim Rejections - 35 USC § 103
Claims 1-7, 9-14, 16-20, 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over by Vignaux et al. (Chem.Res.Toxicol. 2021,34, p. 1296−1307, published 2021-01-05) in view of Albuquerque et al. (Proc Natl Acad Sci, 2006 Aug 29;103(35):13220-5).
Vignaux teaches tilorone is a potent and selective Acetylcholinesterase (AChE) inhibitor for treating disease (title, abstract) which anticipates and also renders claims 1-7, 9, 24 obvous. Regarding claim 10, Vignaux does not teach the disease is organophosphorous poisoning (OP).
Albuquerque teaches that AChE inhibitors are effective in preventing OP from nerve agents and insecticides (Title, Abstract). The prior art are both in the same field of endeavor of therapeutic use of AChE inhibitors and given the same mechanism of action, one of ordinary skill in the art would have had a reasonable expectation of success in utilizing the compounds of Vignaux for the same purpose taught by Albuquerque and arrive at the claimed invention.
Regarding claims 11-13, one of ordinary skill in the art would have considered administering the inhibitor appropriately to provide maximal efficacy include to those “at risk” or “prior a potential exposure” and arrive at the claimed invention.
Regarding claim 14 and 23, Albuquerque teaches the use of atropine and the combination of two agents for the same purpose (inhibiting AChE for therapeutic use) is prima facie obvious. MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claim 16-18 limitations reciting IC50 values, these values/elements are inherent properties of the compounds and would be present in the prior art. MPEP 2112.01:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Thus, these claims are also rendered obvious.
Regarding claims 19-20, the prior art teaches administration to human patients including routes that would be considered routine in the art including oral, intravenous, and subcutaneous.
Regarding claims 22-25 Vignaux specifically teaches tilorone.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Conclusion
No claims allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626