DETAILED ACTION
Claims 1-20, 25, and 26 are pending in the present application.
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 .
Priority
The claim to priority as a CON of PCT/CN23/91482 filed on April 28, 2023 is acknowledged in the present application. While the further claim to priority to PCT/CN22/90343 filed on April 29, 2022 is acknowledged, it cannot be granted as a certified copy has not been received and there is intervening art.
Claim Rejections - 35 USC § 112
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 25 and 26 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.
The present claims are drawn to a method of treating a disease or disorder associated with CDK4 in a patient by administering a compound of claim 1. The disease or disorder to be treated can be any disease or disorder as long as there is some association with CDK4.
The present specification only provides description with respect to inhibiting CDK4 in order to treat diseases such as cancer. See Aspects 21-26, page 41 of the present specification as filed. There is no description as to how additional diseases and disorders that are associated with agonizing CDK4 can be treated the presently claimed compounds.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The genus or the treatment diseases or disorders associated with CDK4 in general is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing. Namely, that the definitions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP 2163 goes on to describe what a "representative number of species" is:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.). Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
The specie of the inhibition of CDK4 in order to treat disease in the specification does not cover the entire genus such that it is a representative sample of the genus as the species only describes an extremely small portion of the claimed genus or treatment disease or disorder associated with CDK4. Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, 7-18, 20, 25, and 26 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pham et al. (WO 2022/236256).
Pham et al. teaches the following compound as a CDK4 inhibitor:
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126
262
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. This compound reads on the claims where m is 0, R6 and R8 are fluorine (halogen,) R4 is C3 alkyl, CyA is a 6-membered ring comprising 1 nitrogen atom, n is 1, R10 is heterocyclyl, and all other substituents are hydrogen. See compound 181, page 61.
With respect to claims 12-14, the identity of the moiety
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is met as m is 0. Therefore, any moiety would be anticipated as long as m is 0.
With respect to claims 25 and 26, a method of treating CDK4 implicated cancers is taught. See paragraph 116, pages 89-90.
Allowable Subject Matter
Claims 2, 4, 6, and 19 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
Claims 1, 3, 5, 7-18, 20, 25, and 26 are rejected. Claims 2, 4, 6, and 19 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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/JOSEPH R KOSACK/Primary Examiner, Art Unit 3991
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