DETAILED CORRESPONDENCE
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 the papers filed November 14, 2025. Currently, claims 20-35 are pending. Claims 20, 22-23, 30 have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The 101 rejection has been withdraw in view of the amendments to the claims to require each of the probes is either labeled or attached to an array.
Election/Restrictions
Applicant's election of oligonucleotide probes and the combination of genes in Claim 24 without traverse, Claims 21, 24-29, 31-34 in the paper filed July 23, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
Claim Rejections - 35 USC § 103
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.
Claims 21, 24-29, 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiv et al. (WO2015/103166, July 9, 2015) in view of Shiv-2014 (WO2014/025810, February 13, 2014) and Wang et al. (Neoplasia, Vol. 14, No. 10, pages 905-914, October 2012).
Shiv-2015 teaches kits for use in diagnosing or prognosing prostate cancer comprising a plurality of probes with no more than 500 different genes (para 14). Shiv teaches the probes may be for detecting COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3 (para 14-16).
With respect to Claim 25, Shiv teaches the plurality of probes is a plurality of oligonucleotide probes (para 15).
With respect to Claim 26, 28, 31-32, Shiv teaches the plurality of probes contains probes for no more than 500, 100, 50, 25, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 genes (para 16).
With respect to Claim 27, Shiv teaches an array comprising a substrate and a plurality probes immobilized on the substrate for detecting the expression of human genes (para 17).
With respect to Claim 28, 33, 34, Shiv teaches the polynucleotide probes may be labeled (para 116-117).
Shiv does not teach the prostate cancer kit may include HOXC6, PCGEM1 or CTBP1 probes.
However, Shiv-2014 teaches kits for use in diagnosing or prognosing prostate cancer comprising a plurality of probes with no more than 500 different genes (para 7). Shiv teaches the probes may be for detecting ERG, HOXC6, PCGEM1 (para 7, 40). Shiv teaches 5-gene panels including ERG, PSGR, PCGEM1 (para 25).
Wang teaches CTBP1 is overexpressed in metastatic prostate cancer and demonstrated the functional significance of CTBP1 in prostate progression (abstract). Wang teaches CTBP1 gene expression may be analyzed via microarray data analysis (page 906, col. 2).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have designed a kit comprising probes for COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1. The Shiv-2015 and Shiv-2014 each teach kits comprising probes for prostate diagnosis and prognosis. The art also teaches CTBP1 expression is associated with prostate cancer and may be detected using probes. Designing a kit with probes to known genes associated with prostate cancer would have been obvious in view of the teachings in the art. The combination of references suggests designing kits with probes for prostate cancer analysis with less than 500 different genes or less than 15 genes. The ordinary artisan would have been motivated to have included probes known to be associated with diagnosing prostate cancer in the same kit to provide diagnostic and prognostic information. The art teaches COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1 are each associated with prostate cancer. It would have been obvious to choose from the finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143(e)). Here, the selection of 10 genes to design probes including at least COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1 would be obvious to try. The references disclose a multitude of effective combinations of genes that may be used for prostate diagnosis. This does not render any particular combination of genes less obvious. Picking and choosing may be entirely proper in the making of a 103, obviousness rejection (see In re Arkley, 455 F.2d 586,587 (CCPA 1972). The record does not identify a secondary consideration demonstrating criticality or anything unexpected about the combination of probes for the recited genes in a kit. Instead, this is a situation of obvious to try. The selection of probes for a kit useful for diagnosis of prostate cancers was an art recognized problem that many skilled artisans were studying, including studying expression profiles of COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1. Thus, there was an art recognized problem. The art teaches a finite number of markers. The cited art here specifically identifies COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1 as associated with prostate cancer. Given these references, it would have been obvious to select the genes that were found to be expressed in prostate cancer for diagnosis and prognosis.
Response to Arguments
The response traverses the rejection. The response asserts Shiv-2015 does not disclose the specific combination of COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, and NKX2-3. This argument has been considered. It is noted that Shiv-2015 and Shiv-2014 are Applicant’s own work more than a year prior to the provisional application in the instant application filed in 2017. Shiv-2015 teaches each of these genes are associated with prostate cancer and probes to the genes may be included in a kit. The ordinary artisan would have been motivated to have selected genes to include in a kit based upon their desired use of the kit. The ordinary artisan my have selected genes that are useful for diagnosing or prognosing prostate cancer in indifferent ethnic populations to achieve a better picture of a particular group they are studying. The art teaches COL10A1, HOXC4, ERG, PCA3, PSGR, DLX1, NKX2-3, HOXC6, PCGEM1 and CTBP1 are each associated with prostate cancer. It would have been obvious to choose from the finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143(e)). Picking and choosing may be entirely proper in the making of a 103, obviousness rejection (see In re Arkley, 455 F.2d 586,587 (CCPA 1972). The record does not identify a secondary consideration demonstrating criticality or anything unexpected about the combination of probes for the recited genes in a kit. Instead, this is a situation of obvious to try as discussed above.
The response argues that Shiv-2014 does not specifically highlight the markers ERG, HOXC6 and PCGEM1. This argument has been reviewed but not deemed persuasive. As provided by MPEP 2123, “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” The reference need not “specifically highlight” the markers to be a teaching they are associated with prostate cancer diagnosis. MPEP 2123 also provides “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”
The response argues there are potentially limitless combinatorial possibilities and there is no teaching or suggestion in the cited references that would have lead one of ordinary skill in the art to the specific combination at the exclusion of other genes mentioned in the references. This argument has been reviewed but is not persuasive. The claims are not directed to a particular combination at the exclusion of other genes. The claims are directed to a kit “comprising a plurality of probes” which encompasses additional probes to additional genes. The claim is not limited to a “consisting of” composition. The art already identified each of the genes as genes useful for diagnosing or prognosing prostate cancer in a patient. Picking and choosing may be entirely proper in the making of a 103, obviousness rejection (see In re Arkley, 455 F.2d 586,587 (CCPA 1972). The record does not identify a secondary consideration demonstrating criticality or anything unexpected about the combination of probes for the recited genes in a kit.
Thus for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable over the art.
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 JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
December 1, 2025