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 Sep. 1, 2026, the applicants have elected compound 12 as specific species for further prosecution. The applicants have also amended claims 1, 13, 18 and 19.
Claims 1-3, 5-6, 9-10 and 12-24 are pending in the application.
The elected species is allowable over the prior art. Therefore, Search has now been extended to additional species.
Claim Rejections - 35 USC § 112
5. 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.
Claims 21 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating metastatic breast cancer, does not reasonably provide enablement for treating any other cancer including glioblastoma, ovarian cancer, lung cancer etc. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
The specification teaches inhibitory effect of instant compounds on eIFe3. Based on these teachings, the instant compounds will have therapeutic utility for treating specific diseases where inhibitors of eIFe3 are well known in the art to have therapeutic utility such as metastatic breast cancer. However, there is no teaching either in the specification or prior art references provided showing well established utility of eIFe3 inhibitors for treating every known cancer including glioblastoma, ovarian cancer, lung cancer etc. There are no working examples present showing efficacy of instant compounds in vitro cell lines of every known cancer including glioblastoma, ovarian cancer, lung cancer etc. In absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant compounds in vitro cell lines of every known cancer including glioblastoma, ovarian cancer, lung cancer etc. and hence their utility for treating every known cancer including glioblastoma, ovarian cancer, lung cancer etc.
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 1-3, 6, 9-10, 14, 17-20 and 24 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Goodman (Bioorganic & Med. Chem. Letters).
Goodman discloses CB2 selective compounds for treating pain. The compounds 44 and 46 (see table 3 on page 312) disclosed by Goodman anticipate the instant claims when variable R3 represents CH3 group, variables R1 and R2 together form morpholine ring and one of variables R8 and R9 represents halogen in the instant compounds of claim 1. It is of note that eIFe3, SIXiILYA2 interaction and translation will be inherently inhibited following administration of compounds 44 and 46 for treating pain.
Claims 1-3, 5-6, 9 and 13-15 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by compound with RN 956785-61-8, entered STN on Dec. 5, 2007. This compound anticipates the instant claims when instant variable R3 represents alkoxy group, variables R1 and R2 together form piperidine ring and variable R9 represents substituted 5-membered heteroaryl group in the instant compounds of claim 1.
IMPROPER MARKUSH GROUP
Claims 1-3, 5-6, 9-10 and 12-24 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1-3, 5-6, 9-10 and 12-24 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity for the following reasons: In the instant compounds of claim 1, specific values of variables R1, R2, R3 and Z are critical for the common core of instant compounds.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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