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 .
Status of Claims
Claims 1-10 are pending in the instant application.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the CN202110768781.9 application filed in the People’s Republic of China on July 7th, 2021.
Information Disclosure Statement
The Information Disclosure Statement received January 7th, 2024 has been fully considered by the examiner, except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
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 1-5 and 7 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 a compound of formula I’ in which R1 is a 6 or 9-10 membered heteroaryl containing 1-3 heteroatoms selected from N or S in which any hydrogen atom on R1 is optionally substituted by halogen, =O, hydroxyl-substituted C1-C4 alkyl, -C(O)(C1-C4 alkylene)OH, C1-C6 alkyl, or C1-C6 haloalkyl, R2 is H, amino, CH2OH, -CH(CH3)OH, -C(CH3)2OH, halomethyl, CONH2, CF2OH, NHSO2Me, or CH2NHSO2Me, R3 is H or methyl, and Ring A is monocyclic or bicyclic 6 or 8-11 membered heterocycloalkyl containing 1-3 heteroatoms selected from N and O where any hydrogen atom on ring A is unsubstituted or substituted by (CH2)nNHR’, (CH2)nOH, C1-C6 alkyl, halogen, or amino where R’1 is H and N is 1-3, does not reasonably provide enablement for compounds of formula I’ in which these variables are otherwise defined. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a compound of the formula I’:
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Breadth of the invention:
The scope of the claimed invention is broad, as it is drawn to any compound of the above formula, allowing for myriad combinations of the variables as defined, for example, at instant Claim 1.
State of the prior art and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
The compound core depicted with specific substituents represents a narrow subgenus for which applicant has provided sufficient guidance to make and use; however, the disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working examples of any compound of formula I’ in which R1, R2, R3, and Ring A were not defined as noted above in the instant application.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples of the description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.1(p).
MPEP § 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). That conclusion is clearly justified here that Applicant is not enabled for making these compounds.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to a “use” without positively reciting any steps to a process thereof.
Per MPEP 2173.05(q), “”Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of the patentable inventions specified in 35 U.S.C. § 101 “).”
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.
Claim(s) 1, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/148010 A1 (application filing date of January 22nd, 2021; cited on Applicant’s Information Disclosure Statement filed January 7th, 2024; machine translation provided hereinafter referred to as WO ‘010).
At Page 35, Claim 17, WO ‘010 teaches compounds that read on a compound of formula I’.
The second compound in the second row recited by WO ‘010 at Claim 17 is:
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This reads on a compound of formula I’ when the variables are defined as follows:
R1 is 6-membered heteroaryl containing 1 N, substituted by C1-haloalkyl, wherein C1-haloalkyl is CF3.
R2 is CH2OH.
R3 is hydrogen.
Ring A is a bicyclic 10 membered heterocycloalkyl containing N and O, substituted with amino and C1 alkyl.
The third compound in the second row recited by WO ‘010 at Claim 17 is:
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This compound reads on a compound of formula I’ when the variables are defined as follows;
R1 is 6-membered heteroaryl containing 1 N, substituted by halogen, wherein halogen is chloro and amino.
R2 is CH2OH.
R3 is hydrogen.
Ring A is a bicyclic 10 membered heterocycloalkyl containing N and O, substituted with amino and C1 alkyl.
Regarding Claim 7, at Page 30 of the provided machine translation, under “2.4 Compound preparation,” WO ‘010 teaches the test compounds are dissolved in DMSO, inclusive of the compounds mentioned above. Therefore, this reads on the limitation of Claim 7 of a pharmaceutical composition.
Allowable Subject Matter
Claim 6 is 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 1-5 and 7-10 are rejected.
Claim 6 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624