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 .
Claims 1-20 are pending in the application.
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 19 and 20 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 treating breast cancer and sarcoma, does not reasonably provide enablement for treating every known cancer, inflammatory disease, autoimmune disease, infectious disease, angiogenesis and benign neoplasm. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
The instant specification teaches inhibitory effect of instant compounds on CDK7 activity as shown in table 1 on pages 367-371. The specification also teaches inhibitory effect of instant compounds in vitro cell lines of breast cancer and sarcoma as shown in table 2 on pages 372-375. Based on these teachings, the instant compounds will have therapeutic utility for treating specific disease conditions where CDK7 inhibitors are well known in the prior art to have therapeutic utility such as treating breast cancer, ovarian cancer and sarcoma. However, there is no teaching or guidance present either in the specification or prior art references provided showing well established utility of CDK7 inhibitors for treating every known cancer, inflammatory disease, autoimmune disease, infectious disease, angiogenesis and benign neoplasm in the art. There are no working examples present showing efficacy of instant compounds in vitro cell lines of every known tissue representing every known cancer in the art and animal models of every known inflammatory disease, autoimmune disease, infectious disease, angiogenesis and benign neoplasm in the art. The instant compounds of formula I encompasses hundreds of thousands of compounds based on the values of variables R1-R4 and A and therefore, in absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant compounds in vitro cell lines of every known tissue representing every known cancer in the art and animal models of every known inflammatory disease, autoimmune disease, infectious disease, angiogenesis and benign neoplasm in the art and hence their utility for treating these disease conditions.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 19, specific diseases associated with aberrant activity of CDK7, are not defined.
Claim Rejections - 35 USC § 102
(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.
Claims 1-2, 5-13 and 18-20 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Ratcliffe (WO 2006/038001 A1, cited on applicant’s form 1449).
Ratcliffe discloses Aminopyrimidine derivatives as JNK inhibitors for treating autoimmune and inflammatory diseases. The compounds disclosed in examples 417, 418 and 419 with RN 882567-04-6, 882566-82-7 and 882566-83-8 (see pages 143-144) by Ratcliffe anticipate the instant claims when instant variable R1 represents C1 alkylene-heteroaryl or C(O)O-alkyl group in the instant compounds of formula I.
Claims 1-2, 5-13 and 18-20 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Sprott (WO 2015/154039 A2, cited on applicant’s form 1449).
Sprott discloses inhibitors of CDK7 for treating cancer and inflammatory diseases. The compounds 141 and 1048 (see page 155) disclosed by Sprott anticipate the instant claims when instant variable R4 represents Cl and variable R1 represents alkyl-heterocycle in the instant compounds of formula I.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 and 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,738,067. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds and pharmaceutical compositions of the cited patent anticipate the instant claims when variable R4 represents CF3, R5’ represents H, R1 is H and variable R7 represents CN and P(O)alkyl2 group in the instant compounds of formula I.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-19 of U.S. Patent No. 11,311,542. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, pharmaceutical compositions and methods of treatment of the cited patent anticipate the instant claims when variable R4 represents CF3 and variable R7 represents heteroaryl group in the instant compounds of formula I.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621