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 I and the sequence combination of SEQ ID Nos 1,56,61,81,86,141,146 in the reply filed on 10/24/2025 is acknowledged.
Claims 1, 3-7 and 17 are pending. Claims 2, 8-16 and 18 have been cancelled.
An action on the merits is set forth below.
Claim Objections
Claims 1, 3-7 and 17 are objected to because of the following informalities: Claim 1 includes SEQ ID Numbers. SEQ ID No. 1 includes the gene name in parentheses. The applicant should include the gene name for each of the recited sequences so that the nomenclature in the claim is constant. claims 3-7 and 17 are objected as being dependent on an objected claims. Appropriate correction is required.
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 1, 3-7 and 17 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 1, 3-7 and 17 are indefinite over “genomic DNA may comprise DNA derived from colorectal cancer cells”. This phrase is indefinite as it is not clear the metes and bounds of this phrase. In particular it is not clear if this intends to be optional language or if the claims are requiring particular limitations of the genomic DNA that has not been recited.
Claim 7 is indefinite over the phrase “”suspected of having CRC”. In particular it is not clear the metes and bounds of the term “suspected”. In particular it is not clear if the term is intending a particular symptom or symptoms of CRC. In other words, it is not clear how the term “suspected” changes the genus of the subject from any subject as this term is not defined by the specification or by the prior art.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1,3,4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carrell et al. (US Patent Application Publication 2019/0112659 April 18, 2019)
With regard to claim 1, Carrell et al. teaches a method of detecting methylation within genomic DNA (para 46). Carrell et al.. teaches detection of methylation in ANKRD13B, EYA4, RASSF2, SEPT9 (Table 2). Although Carrell et al. does not specifically recite SEQ ID Numbers 1, 56, 61,81,86,141,146, the broadest reasonable interpretation of the claim is detection of methylation of a genomic region that encompasses these sequences. As Carrell et al. teaches genome wide methylation of the genes that encompass these sequences (para 36), Carrell anticipates the step. Carrell et al. teaches genomic DNA (para 37). The limitation of “may comprise DNA derived from CRC cells” is interpreted as an optional limitation that is not required by the claim language.
With regard to claim 3, Carrell et al. teaches the use of bisulfite steps of converting cytosine unmethylated in the 5’ position to uracil and detecting DNA methylation within the genomic DNA by detecting unconverted cytosine (para 46-50).
With regard to claim 4, Carrell et al. teaches detecting the amount of methylated genomic DNA (para 40-41).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrell et al. (US Patent Application Publication 2019/0112659 April 18, 2019) in view of Chittenden et al. (WO 2019/079647 April 25, 2019)
Carrell et al. teaches a method of detecting methylation within genomic DNA (para 46). Carrell et al.. teaches detection of methylation in ANKRD13B, EYA4, RASSF2, SEPT9 (Table 2). Although Carrell et al. does not specifically recite SEQ ID Numbers 1, 56, 61,81,86,141,146, the broadest reasonable interpretation of the claim is detection of methylation of a genomic region that encompasses these sequences. As Carrell et al. teaches genome wide methylation of the genes that encompass these sequences (para 36), Carrell anticipates the step. Carrell et al. teaches genomic DNA (para 37). The limitation of “may comprise DNA derived from CRC cells” is interpreted as an optional limitation that is not required by the claim language.
Carrell et al. is intending to screen semen samples. Therefore Carrell et al. does not teach that the subjects is related to CRC.
With regard to claim 7, Chittenden et al. suggests that the recited gene areas are associated with colorectal cancer and as such teaches subjects that are suspected of having CRC (para 117 and Appendix A)
Therefore it would be prima facie obvious at the time of the effective filing date to modify the method of Carrell et al to further screen using the method of Carrell methylation to determine associations of these genes with other known phenotypes including colorectal cancer as taught by Chittenden et al. The ordinary artisan would be motivated to modify the method of Carrell to further screen additional subject types and further phenotype relationships using a method of detecting methylation amounts in known genes.
Claim(s) 5-6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrell et al. (US Patent Application Publication 2019/0112659 April 18, 2019) and Chittenden et al. (WO 2019/079647 April 25, 2019) as applied to claim 7 and further in view of An et al. (US Patent 10266900 April 23, 2019)
Carrell et al. teaches a method of detecting methylation within genomic DNA (para 46). Carrell et al.. teaches detection of methylation in ANKRD13B, EYA4, RASSF2, SEPT9 (Table 2). Although Carrell et al. does not specifically recite SEQ ID Numbers 1, 56, 61,81,86,141,146, the broadest reasonable interpretation of the claim is detection of methylation of a genomic region that encompasses these sequences. As Carrell et al. teaches genome wide methylation of the genes that encompass these sequences (para 36), Carrell anticipates the step. Carrell et al. teaches genomic DNA (para 37). The limitation of “may comprise DNA derived from CRC cells” is interpreted as an optional limitation that is not required by the claim language. Chittenden et al. suggests that the recited gene areas are associated with colorectal cancer and as such teaches subjects that are suspected of having CRC (para 117 and Appendix A)
However, Carrell and Chittenden do not teaches that the samples are cell free or from blood.
With regard to claims 5,6,17, An et al. teaches methods of detecting colorectal cancer associations with methylated genes in cell free tumor DNA from blood (para 12).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to use a known sample type that can measure methylation amounts using known assay methods from Carrell and Chittenden as taught by An et al. The ordinary artisan would be motivated to use cfDNA as the ordinary artisan would be aware that cfDNA extraction from a subject is less invasive than tumor selection. Therefore it would be obvious to the ordinary artisan to use the sample type of An et al. to detect the methylation amounts of Carrell and Chittenden et al.
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