The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-24, are pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 10-16, 18-19, 24, are 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.
Claims 10-16, are drawn to crystals. The structure of a crystal is determined by the process of making it. The specification fails to disclose how the crystals are made. There is no incorporation by reference of publications where the procedures could be found. There is no evidence in the specification that established correlation between the specification disclosure and crystals. See Ex parte Mass, 9 USPQ2d 1746, (1987). Deleting the claims will overcome the rejection.
Claims 18-19, are drawn to treating cancer. However, there is no evidence in the specification that the instant compounds would treat all the five categories of cancer: carcinoma, sarcoma myeloma, leukemia, lymphoma and mixed types, or the individudal cancer cited in claim 19. There are no assays with cell line from each category of cancer. Even though “the state of cancer treatment has advanced remarkably, decisional law would seem to indicate that the utility is sufficiently unusual to justify an examiner’s requiring substantial evidence, which may be in the form of animal tests.” Ex parte Krepelka, et al., 231 USPQ 746 (BdPatApp&Int, 1986).
There is no support in the specification that all known therapeutic agents are applicable in the invention. Therefore, claim 24 lacks adequate support in the specification.
“Failure of patent applicants to provide basis for believing speculative statements placed in the specification as positive assertion is true, and failing such, ignorance of PTO in not being able to provide scientific reason why assertion is not sound is not justification for permitting assertion to be made, where those of ordinary skill in the art would not accept assertion as believable without some data or other evidence to support it.” In re Hozumi, 226 USPQ 353, (ComrPats, 1985). “Proof of utility is sufficient if it is convincing to one [of] ordinary skill in the art, amount of evidence required depends on facts of each individual case, character and amount of evidence needed may vary, depending on whether alleged utility appears to accord with or to contravene scientific principles and beliefs.” In re Jolles, 206 USPQ 885 (CCPA, 1980). By deleting claims 18-19, the rejection will be overcome.
Multiple Dependent
Claim 17 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from a multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim is not been further treated on the merits.
Allowability
Claims 1-9, 20-23, are allowable over prior arts of record.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625
December 29, 2025