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 .
This action is in response to papers filed 5/06/2026.
Applicant’s election without traverse of Group II and E2-E10 in the reply filed on 9/23/2025 is acknowledged.
Claims 1-23, 25-33 are pending. Claims 1-18 and 29-33 are withdrawn as the claims are drawn to nonelected inventions.
The following rejections are maintained or newly applied as necessitated by amendment. Response to arguetmsn follows.
This action is final.
Withdrawn Rejections
The 35 USC 112a rejection made in the previous office action is withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 112
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.
Claims 19-23, 25-28 are 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.
Claims 19-23, 25-28 are indefinite over the wherein clause of step a of claim 19. The term “increased resistance” in claim 19 is a relative term which renders the claim indefinite. The term “increased resistance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no comparison step, it is not clear which resistance would be considered increased.
Modified 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) 19-23, 25-27 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). Ray et al. teaches that the subject has breast cancer (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 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.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is set forth below with response to arguments following.
The reply asserts that Ray does not teach treating with lapatinib or tamoxifen when the sample is luminal subtype (p. 2). The reply asserts that therefore one would not treat lapatinib and tamoxifen as Ray teaches that such treatments are not effective against luminal (p. 2). This argument has been reviewed but have not been found persuasive. Rather Ray teaches that luminal subtypes can become resistant, not necessarily that one would not treat these subtypes. Furthermore, the independent claim is not limited to luminal breast cancer types. 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.
Claim(s) 19,22-23, 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. Gilmer et al. teaches that the subject has luminal B breast cancer (para 71).
With regard to claims 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.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is set forth below with response to arguments following.
The reply asserts that Gilmer et al. teaches problems with luminal subtype breast cancer being resistant (p. 4). The reply asserts that there is no teaching of “increased sensitivity” or “reduce endocrine therapy”. This argument has been reviewed but have not been found persuasive. Rather Gilmer teaches that luminal subtypes can become resistant, not necessarily that one would not treat these subtypes. Furthermore, the independent claim is not limited to luminal breast cancer types. 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. The limitations for “increased” and “reduce” are encompassed by wherein clauses that are the result of detection and administering. Therefore the art does not necessarily need to teach these intended results as the combination teaches the positive active steps of detects and administering.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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