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 .
Claim Status
Claims 1 and 15-31 are pending. Claims 1, 25-27 and 31 are rejected. Claims 15-24 and 28-30 are objected to.
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) 1, 26-27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020239107A1 by Li et al. (cited in the IDS filed 05/22/2023).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “tetracyclic compounds as cdc7 inhibitors” and discloses the following CDC7 inhibitor on page 17 (original document):
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The prior art teaches pharmaceutically acceptable salts of the compound above including acid addition salts formed with maleic acid (page 37 of translation).
Regarding instant claims 26-27 and 31, Li et al. teach
a pharmaceutical composition comprising pharmaceutically acceptable salts of the CDC7 inhibitor and uses of the composition as medicine to treat tumors of colorectal or pancreatic cancers (page 35 of translation).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses the free compound of formula (II), hydrochloride salts thereof and suggests pharmaceutically acceptable salts formed using maleic acid but does not explicitly recite maleate salts of the CDC7 inhibitor.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person of ordinary skill seeking to prepare pharmaceutical compositions comprising the CDC7 inhibitor would have been motivated to test additional pharmaceutically acceptable salts of the prior art compound such as the maleate salt in order to improve therapeutic outcome when administering the composition.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over WO2020239107A1 by Li et al. as applied to claims 1, 26-27 and 31 above, and further in view of Gupta et al. (2018). Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations. Molecules (Basel, Switzerland), 23(7), 1719.
Li et al. teach the maleate salt represented by instant formula (II) and pharmaceutical compositions comprising the compound but do not teach crystalline compositions comprising the compound.
Gupta et al. discuss (title) “Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations”. Regarding polymorphism Gupta et al. teach (page 4, section 2.6. Polymorphism):
Polymorphism is the ability of a solid compound to exist in more than one crystalline form. Most drugs exhibit structural polymorphism or multiple crystalline forms. In order for a molecule to develop into a potential drug, the existence of a stable polymorph or a suitable pseudopolymorph needs to be established. The polymorphs (or pseudopolymorphs) of drugs show different chemical stability; it is generally observed that a more thermodynamically stable polymorph is more chemically stable than a metastable polymorph [24]. The optimized orientation of molecules, hydrogen bonds, and non-hydrogen bonds in the crystal lattice play an important role in imparting thermodynamic stability to crystal structures. Even small changes in the crystal packing may lead to significant differences in the chemical reactivity of the two polymorphs of the same drug [24]. Between the crystalline form and amorphous forms of the same drug, the amorphous form is less stable due to the lack of a three dimensional crystal structure, free volume, and greater molecular mobility [24].
Accordingly, a person of ordinary skill preparing pharmaceutical compositions comprising the compound of instant formula (II) as taught by Li et al. would have been motivated to explore polymorphically pure crystalline forms of the compound, such as those wherein the crystalline formula of formula (II) makes up 50% or more by weight of the crystalline composition, in order to obtain a more stable form of the compound that is ideal for formulation.
Allowable Subject Matter
Claims 15-24 and 28-30 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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/A.A.C./Examiner, Art Unit 1626
/JOSEPH K MCKANE/Supervisory Patent Examiner, Art Unit 1626
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