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 .
Priority
This application is a 371 of PCT/US2021/027453 (04/15/2021) which has PRO 63/011,231 (04/16/2020).
Status
Claims 1-24, 27 are pending.
Rejections not reiterated in this action are withdrawn.
New Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gil et al. (WO2018215795).
Regarding claims 1-6, Gil teaches administration of a therapeutically effective amount of eltrombopag to treat Alzheimer’s disease, inflammatory bowel disease, and glaucoma (claim 23-28). Regarding claims 7-8, 10, Gil further teaches combinations with anti-cancer agents (p. 35, 53). Regarding claims 11-14, Gil further teaches administration following anti-cancer therapy (p. 35: “after the other treatment the agent can eliminate cancer cells that have been pushed to senescence”; p. 9, Fig 13). Regarding claims 15-16, Gil further teaches the subject is a human (p. 31). Regarding claim 17-18, Gil further teaches therapeutic administration orally (p. 50-52).
New 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.
Claims 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gil et al. (WO2018215795).
Gil anticipates claims 1-8 and 10-18 as above, incorporated herein, and also renders these claims obvious as one of ordinary skill in the art would have readily considered utilizing the same therapeutics to arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 9, 19-23, although Gil teaches combination with the anti-cancer therapeutics, Gil does not specifically recite a single embodiment of eltrombopag with navitoclax. However, Gil does teach navitoclax (also known as ABT-263 – see page 8 of instant Specification)(Gil p. 3, 9-10) for the same purpose. “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); See MPEP 2144.06.
Regarding claims 24, 27, Gil further teaches treatment following doxorubicin induced cardiotoxicity (p. 25-26, 35-36, 56-57).
With each of the above claims rejected under 35 USC 103, 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 teachings of the primary reference in with the secondary reference all of which are in the same field of endeavor. Through the combined teachings, 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, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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