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 .
Election/Restrictions
Applicant’s election without traverse of Group II and E2-E10 in the reply filed on 9/23/2025 is acknowledged.
Claims 1-33 are pending. Claims 1-18 and 29-33 are withdrawn as the claims are drawn to nonelected inventions.
An action on the merits for claims 19-28 is set forth below.
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 19-28 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.
In analyzing the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note that with regard to genus/species situations, a “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 of the elements possessed by the members of the genus in view of the species disclosed.” (See: Federal Register: December 21, 1999 (Volume 64, Number 244), revised guidelines for written description.)
To ascertain whether the written description requirement is met for a genus claim, it is first determined whether a representative number of species have been described by their complete structure. It is then determined whether a representative number of species have been defined by other identifying characteristics.
In the present situation, the claims are drawn to methods of treating a cancer in a subject comprising detecting an ESR1/CCDC170 gene fusion and administering a therapeutically effective amount of a HER inhibitor and/or a SRC inhibitor. Therefore the claims are drawn to treating any cancer.
The specification teaches treating luminal B and metastatic breast tumors (p. 41). However, the claims are drawn to treating any cancer. There is no description on the effective amount of HER inhibitors or SRC inhibitors in any type of cancers. For example, the specification does not describe the effective amount of an HER inhibitor which is typically used for breast cancer as a treatment for lung cancer.
Thus, applicant has established possession of only the specific cancers and the recited treatments, but did not have possession of a representative number of “any cancer” in a genus which comprises effective amounts of HER inhibitor and/or SRC inhibitor. .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 19-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ray et al. (US Patent Application Publication 2018/0142305 May 24, 2018) in view of Veeraraghavan et al. (Nature communications August 2014 cited on IDS)
With regard to claim 19, Ray et al. teaches treating a luminal subtype breast cancer subject with an effective amount of lapatinib (HER2 inhibitor) (para 118). However, Ray et al. does not teach that the luminal subtype breast cancer subject has a ESR1/CCDC170 gene fusion.
With regard to claims 20-21, Ray et al. further teaches the administration of tamoxifen (estrogen receptor antagonist) (para 118).
With regard to claims 24-25, Ray et al. teaches that the subject has luminal B breast cancer (para 118).
With regard to claims 26-27, Ray et al taches a HER2 inhibitor of lapatinib (para 118).
With regard to claim 19, the claims do not require that the treatment is based upon the detection of the recited fusion gene, rather, that a subject that is treated has the recited fusion gene. Veeraraghavan et al. teaches that subjects with luminal subtype breast cancer can have a ESR1-CCDC170 fusion (p. 5).
With regard to claim 22, Veeraraghavan et al. teaches that the gene fusion is E2-E10 (figure 1 p 2).
With regard to claim 23, Veeraraghavan et al. does not teach the sequence of SEQ ID No. 41, however, as Veeraraghavan et al. teaches the gene fusion that encompasses this sequence Veeraraghavan et al. suggests the E2-E10 fusion.
Therefore it would be prima facie obvious to one of ordinary skill at the time of the effective filing date that the treatment of known subjects would luminal subtype breast cancer can encompass a fusion of ESR1-CCDC170 as taught by Veeraraghavan et at. The ordinary artisan would be motivated to treat a population of subjects with breast cancer with known treatments and as suggested by Veeraraghavan et al. these would encompass samples that encompass a fusion of ESR1-CCDC170.
Claim(s) 19,22-25,28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilmer et al. (US Patent Application Publication 20120035183 February 9, 2012) in view of Veeraraghavan et al. (Nature communications August 2014 cited on IDS)
With regard to claim 19, Gilmer et al. teaches treating a luminal subtype breast cancer subject with an effective amount of dasatinib (SRC inhibitor)) (para 71). However, Gilmer et al. does not teach that the luminal subtype breast cancer subject has a ESR1/CCDC170 gene fusion.
With regard to claims 24-25, Gilmer et al. teaches that the subject has luminal B breast cancer (para 71).
With regard to claims 28, Gilmer et al. taches a SRC of dasatinib (para 71).
With regard to claim 19, the claims do not require that the treatment is based upon the detection of the recited fusion gene, rather, that a subject that is treated has the recited fusion gene. Veeraraghavan et al. teaches that subjects with luminal subtype breast cancer can have a ESR1-CCDC170 fusion (p. 5).
With regard to claim 22, Veeraraghavan et al. teaches that the gene fusion is E2-E10 (figure 1 p 2).
With regard to claim 23, Veeraraghavan et al. does not teach the sequence of SEQ ID No. 41, however, as Veeraraghavan et al. teaches the gene fusion that encompasses this sequence Veeraraghavan et al. suggests the E2-E10 fusion.
Therefore it would be prima facie obvious to one of ordinary skill at the time of the effective filing date that the treatment of known subjects would luminal subtype breast cancer can encompass a fusion of ESR1-CCDC170 as taught by Veeraraghavan et at. The ordinary artisan would be motivated to treat a population of subjects with breast cancer with known treatments and as suggested by Veeraraghavan et al. these would encompass samples that encompass a fusion of ESR1-CCDC170.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682