The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-25, 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 1-25, 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.
Structures of the co-formers are not disclosed in claims 1-2, 4-5, 8-25. The claims invite a POSA to identify applicable co-formers and make them using any means/procedure known to the artisan. There is no incorporation by reference of US documents where the co-formers and their enablements can be found. This is also true for claim 3, wherein R1-R5 are selected from CO2H, NH2 or SH; the ratios in claims 4-5; non-limiting ratios in claims 1-3, 6-8. The co-former must be limited to the embodiments, which have support in the specification including enablements.
Claim 25, lacks adequate support in the specification. There are no assays in the specification establishing nexus between each disorder and the cocrystals. The disorders are deemed speculations. For example, Diabetes I, aka insulin resistance, is a genetic disorder but, there is no evidence the drug can correct inherited abnormal gene.
Claim 25, is drawn to treating cancer. However, there is no evidence in the specification that the instant compounds will treat all the five categories of cancer: carcinoma, sarcoma myeloma, leukemia, lymphoma and mixed types. 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).
“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 the claim the rejection will be overcome.
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.
Claim(s) 9-19, are rejected under 35 U.S.C. 103 as being unpatentable over Friscic et al., RSC Drug Discovery Series (2012),16:154-87, in view of Hasa et al., Adv Drug Deliv Rev (2017), 117:147-61; Wong et al., Pharmaceutics (2020), 12,1209, 1-20 pages; Alhalaweh et al., Mol Pharmaceutics (2014), 11:3123-32.
Friscic et al., teaches application of mechanochemistry in the synthesis and discovery of co-crystals. The grinding method has outstanding efficiency for making single and co-crystals, see introduction. The co-crystals can be in stoichiometric ratios, e.g., 1:1 or 2:1, pp. 164. The prior art teaches guidelines for selecting co-formers, pp. 168; screening for applicable solvents, and the amounts, pp. 157. It teaches how to select of solvents for API and co-formers, and for determining their melting points; the effect of vapor phase, pp. 168 (humidity: measure of water in the air); the effect of grinding and microscopic size, and the effect of temperature, pp. 172-173. The prior art exemplified resorcinol and orcinol, pp. 167, which are known equivalents, and claimed in the instant.
Hasa et al., teaches a practical guideline for screening new solid forms (crystals, co-crystals) using mechanochemistry. The prior art teaches it provides reduced effort, time, and potential reduced amount of material. See the abstract. The prior art teaches preferred screening experiments; effect of grinding, temperature, volume and microscopic size, pp. 148-52
Wong et al., teaches the effect of co-former’s glass-forming ability (GFA) and annealing conditions on co-crystallization. The study provides a simple guideline for efficient screening of co-crystal based on annealing temperature (Tg) and time of structurally similar co-formers. The prior art provides understanding of the transition of supercooled amorphous to co-crystal; the effect of co-formers on GFA; the effect of annealing temperature and annealing time on crystallization efficiency, the cocrystal and it’s purity.
Alhalaweh et al., teaches computational predictions of GFA and the tendency toward crystallization. See the entire document, particularly, the title, figure 1 and table 1.
Having known the procedures set forth above and the advantages thereof, a POSA would have known how to make the instant co-crystals and be motivated do so at the tome the invention was made with reasonable expectation of success. Claim 19, is drawn to common technique well-known in the art.
The claims are not allowable over the combination of the prior arts and knowledge well-known in the art.
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
September 9, 2025