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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/03/2026 has been entered.
Claims 2-7, 9-17, 19-26 are pending. Claim 1, 10, 18 have been cancelled.
Claims 19-21 are withdrawn as being drawn to nonelected invention.
The following actions are newly applied as necessitated by amendment. It is noted that the combination of genes has been amended to require ITPRIPL1 .
This action is NONFINAL.
Withdrawn Objections and Rejections
The 35 USC 112b rejection made in the previous office action is withdrawn based upon amendments to the claims.
Claim Objection
Claim 13 is objected to as being dependent on a rejected claim. It is suggested that the claim be amended to independent language to place the claim in condition for allowance.
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) 2-7,9-12,14-17, 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skog et al. (US Patent Application Publication 20140045915 Feb 13, 2014) in view of An et al. (US Patent Application Publication 2012/0264640 October 18, 2012) and Tapscott et al. (US Patent Application Publication 2010/0273151 October 28, 2010 previously cited)
The claims as amended do not require detection of prostate cancer, rather require detection in patients that have or are suspected of having prostate cancer. Furthermore the claims have been amended to require a different combination of genes.
With regard to claim 2, Skog et al. teaches a method of treating DNA to detect methylation using primers specific to genes to detect CpG (para 104-107). Skog et al. suggests that the DNA can be derived from a patient with prostate cancer (para 102). Skog et al. teaches screening DNA samples for methylation in ITPRIPL1 (para 330-340). Skog et al. suggests bisulfite methylation (para 105). However, Skog et al. does not teach a combination with CHST11.
With regard to claim 2, An et al. teaches methods of screening methylation in cancer cells (para 6-9). An et al. teaches that these cells can include samples from prostate cancer (para 6-9). An et al. teaches that CHST11 can be screened (para 170 and table 1). Although An et al. does not teach using prostate cancer samples and detecting methylation of CHST11, An et al. suggests that sample including prostate cancer samples can be screened with methylation differences in genes.
With regard to Claim 2, Tapscott et al. teaches a method of treating DNA with bisulfite (paragraphs 103). Tapscott et al. teaches amplifying with primers for GRASP and CHST11 and determining methylation level (table 3 and 98-101). Tapscott et al. teaches determination of methylation in WNT3A (table 7). Tapscott et al. teaches using PCR based methylation (para 98). Tapscott teaches a sample that comprises tissue, blood (paragraphs 41 and 62). Tapscott teaches the sample comprises tissue from prostate (para 41). Tapscott suggests that the subject has prostate cancer as Tapscott teaches that samples from patients can be normal tissue or prostate tumors (para 62). Although Tapscott does not teach the data of methylation in prostate cancer, it would be obvious absent secondary considerations to screen other cancer types including prostate cancer with genes that are known to have methylation differences.
With regard to claim 3, Tapscott et al further teaches KCNB2 for methylation analysis (table 3).
With regard to claim 4, Tapscott teaches amplifying treated genomic DNA using primers specific for a CpG site of GRASP and CHST11 (table 3, paragraphs 97-100).
With regard to claims 5-7, Tapscott teaches a sample that comprises tissue, blood (paragraphs 41 and 62). Tapscott teaches the sample comprises tissue from prostate (para 41).
With regard to claim 9, Tapscott teaches a method wherein at least one CpG is in a regulatory region (para 6).
With regard to claim 10-11, Tapscott teaches a method of using a bisulfite reagent that comprises bisulfite (para 97).
With regard to claim 12, Tapscott teaches a method of determining methylation level for GRASP and CHST11 and WNT3A (table 3, table 7, para 36 and 43).
With regard to claims 14-15, Tapscott et al. teaches a method of determining methylation level for GRASP and CHST11 and additional genes (table 3, table 7, para 36 and 43) and as it is not clear which levels are considered increased or altered (see rejection of 35 USC 112b) these levels of Tapscott et al. would be encompassed by the claims.
With regard to claims 16, Tapscott et al. teaches determining methylation levels of GRASP and CHST11 in a control reference (table 3, paragraph 47, 57).
With regard to claim 17, Tapscott teaches that this control reference can encompass a normal sample that does not have cancer (para 41 and 44).
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 method of Skog et al. to screen other methylation genes in prostate samples including CHST11 of An et al. and Tapscott et al. The ordinary artisan would have a reasonable expectation of success as An et al. teaches that methylation differences can be measured in these genes in patients prostate cancer. It would be obvious to screen known genes to determine any methylation differences in populations to determine which methylation patterns in patient populations absent secondary considerations.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached on 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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