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 7/25/2025.
Applicant’s election without traverse of Group I in the reply filed on 4/17/2024 is acknowledged.
Claims 69,72,76,78,85-86,91-92, 94-99 are pending. Claims 1-68,70-71,73-75,77,79-84,87-88, 93 have been cancelled.
Claims 69,72,76,78,85 are withdrawn as being drawn to a nonelected invention.
The following rejections for claims 86,91-92, 94-99 are newly applied as necessitated by amendment. The claims have been amended to require the first component being a SDHA inhibitor comprising siRNA or shRNA.
This action is FINAL.
Withdrawn Rejections and Objections
The objection to the claims made in the previous office action is withdrawn based upon amendments to the claims.
The 35 USC 103(a) rejection to the claims made in the previous office action is withdrawn based upon amendments to the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 86, 92, 94, 95, 96, 98-99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernhagen et al. (US Patent Application Publication 2011/0044988 Feb 24, 2011 cited previously) in view of DeBrabander et al. (US Patent Application Publication 2018/0354909 December 13, 2018) and Zhang et al. (US Patent Application 2017/0175202 June 22, 2017 previously cited).
With regard to claim 86, Bernhagen et al. teaches components comprising MIF inhibitor and primers and probes for MIF (paragraph 214 and 219-221). Although Bernhagen et al. does not teach containers, it would be obvious that the components of MIF inhibitors, primers and probes would need to be in containers for storage prior to use. Bernhagen et al. teaches that the inhibitor is used to treat cancer (para 113).
However, Bernhagen et al. does not teach SDHA inhibitors
With regard to claim 86, DeBrabander et al. suggests using SDHA siRNA inhibitors to treat tumors (para 635). DeBrabander et al. suggest using probes and primers that can be capable of determining expression (para 599-600). However, DeBrabander et al. does not teach primers and probes of SDHA.
With regard to claim 86, Zhang et al. teaches that primers and probes can be designed for expression detection of SDHA (para 123).
With regard to the limitation of the instant application’s Claims 92, 94, 95 and 98-99, that the kit contain instructions, the inclusion of instructions is not considered to provide a patentable limitation on the claims because the instructions merely represent a statement of intended use in the form of instructions in a kit. See In re Ngai, 367 F.3d 1336, 70 U.S.P.Q.2d 1862 (Fed. Cir. 2004) (holding that an inventor could not patent known kits by simply attaching new set of instructions to that product). As such the cited prior art provides all the recited structural limitations required by the claim to a kit as the kit comprises the structural components set forth in the claims.
With regard to claim 96, Zhang et al. teaches reagents for RT-PCR (para 21).
Therefore it would be prima facie obvious to one of ordinary skill in the art to modify the structure of Bernhagen et al. to further include a container with SDHA inhibitor as taught by DeBrabander et al. and primers and probes to detect regions of SDHA as taught by Zhang et al. The ordinary artisan would be motivated to modify the method of Bernhagen et al. as DeBrabander et al. and Zhang et al. teaches that SDHA can also be used for treating tumors. Furthermore it would be obvious to the ordinary artisan to design primers and probes in order to screen the target region of the inhibitor of SDHA in order to detect the region and make determinations of expression. The ordinary artisan would have a reasonable expectation of placing known inhibitors in containers.
Response to arguments
The arguments in the reply are summarized below, although the rejection is newly applied the response where applicable is responded to in the reply. Response to arguments are provided following. The reply asserts that the present methods are based on the inventors discovery that elected levels of SDHA and MIF are associated with lowest survival rates (p. 5-6). The reply asserts that the references do not teach or suggest the administration of the combination of an SDHA inhibitor with a MIF inhibitor as well as proves to detect SHDA and MIR expression to treat uveal melanoma patients (p. 7).
These arguments have been reviewed but have not been found persuasive.
It is noted that the arguments towards the method steps is not found persuasive as this arguetmsn is not directed to the structure that is claimed in the product claims examined herein. Further, the claims are not directed to using both of the inhibitors together, but rather a kit that comprises the two inhibitors. As these inhibitors are known in the prior art, it would be obvious that one of ordinary skill in the art can place two inhibitors in the same kit. The claims therefore are not commensurate in scope with the arguetmsn provided as it appears that the arguments are directed to method steps and not the claimed structure.
Claim(s) 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernhagen et al. (US Patent Application Publication 2011/0044988 Feb 24, 2011) and DeBrabander et al. (US Patent Application Publication 2018/0354909 December 13, 2018) Zhang et al. (US Patent Application 2017/0175202 June 22, 2017 previously cited) as applied to claims 86, 92, 94, 95, 96, 98-99 in view of Al-Abed et al. (Journal of biological chemistry 2005 Vol 280 p. 36541-36544).
Bernhagen et al. teaches components comprising MIF inhibitor and primers and probes for MIF (paragraph 214 and 219-221). Although Bernhagen et al. does not teach containers, it would be obvious that the components of MIF inhibitors, primers and probes would need to be in containers for storage prior to use. Bernhagen et al. teaches that the inhibitor is used to treat cancer (para 113). DeBrabander et al. suggests using SDHA (nucleic acid miRNA inhibitors) inhibitors to treat tumors.
However Bernhagen and DeBrabander et al. and Zhang do not teach that the MIF inhibitor is ISO-1.
With regard to claim 91, Al-Abed et al. teaches that ISO-1 is an inhibitor of MIF (p. 36541).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the product of Bernahgen and DeBrabander et al. and Zhang et al to place the structure of one of the finite number of MIF inhibitors (taught by Al-Abed) in a container. The ordinary artisan would be motivated to use any of the known MIF inhibitors including ISO-1 with a reasonable expectation of designing a product with a MIF inhibitor that can be used to inhibit MIF expression.
Claim(s) 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernhagen et al. (US Patent Application Publication 2011/0044988 Feb 24, 2011) and DeBrabander et al. (US Patent Application Publication 2018/0354909 December 13, 2018), Zhang et al. (US Patent Application 2017/0175202 June 22, 2017 previously cited) as applied to claims 86, 92, 94, 95, 96, 98-99 in view of Hornung et al. (US Patent Application 20170175197 effective filing date 1/29/2015).
Bernhagen et al. teaches components comprising MIF inhibitor and primers and probes for MIF (paragraph 214 and 219-221). Although Bernhagen et al. does not teach containers, it would be obvious that the components of MIF inhibitors, primers and probes would need to be in containers for storage prior to use. Bernhagen et al. teaches that the inhibitor is used to treat cancer (para 113). DeBrabander et using SDHA (nucleic acid miRNA inhibitors) inhibitors to treat tumors.
However Bernhagen and DeBrabander et al. and Zhang do not teach that further including primers or probes to BAP1.
With regard to claim 97, Hurnung et al. teaches use of SDHA, MIF, and BAP1 in screening for cancer. As such Hurnung et al. teaches probes for BAP1.
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the container composition of Bernhagen et al. and DeBrabander et al. and Zhang to further have probe structures of BAP1. The ordinary artisan would be motivated to place the structure in the composition to screen the cancer populations to detect other known markers for cancer status within known samples. The ordinary artisan would be motivated to screen known biomarkers in order to make an assessments of the patient with regard to known markers associated with cancer.
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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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682