DETAILED ACTION
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 .
According to paper filed on May 26, 2026, the applicant’s have elected preparation of Vamorolone as specific species for further prosecution.
Claims 1-20 are pending in the application. Claims 14 and 19 are withdrawn from further consideration as being directed to non-elected subject matter.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no written description for preparing every known 9,11 steroid from 9,11 epoxy steroid in the art. The only written description is for preparing 9,11 steroids of formula I as mentioned on page 3 of the specification.
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.
Claims 15-18 and 20 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Fu (EP 0969012 A2, cited on applicant’s form 1449).
Fu discloses a process for preparing delta 9,11 and 21-chloro corticosteroids having therapeutic utility. The compounds of formula I (see page 2) anticipate the instant claims when the dashed bond is a double bond and variable R1 represents OH in the instant compounds of claims 2 and 5. It is of note that claims 15-18 and 20 are directed to products by process claims and therefore, the process is irrelevant.
Allowable Subject Matter
Claims 2-4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 5-13 are allowed since the instant method of preparing compounds of formula I from compounds of formula II using hydroiodic acid, is neither disclosed nor obvious over the prior art. In the prior art, Zeng (CN 108191938 A, cited on applicant’s form 1449) discloses a process for preparing compounds of formula II from compounds of formula I which is related to the instant method. However, the process of Zeng differs from the instant method of using trimethylchlorosilane and sodium iodide instead of hydroiodic acid (see claims and examples 1-3 of English translation of CN 108191938 A). Furthermore, there is no teaching, suggestion or motivation in the prior art to modify the process of Zeng to arrive at the instant method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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