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 8/07/2026.
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.
The following rejections are newly applied as necessitated by amendment.
This action is FINAL.
Withdrawn Objections and Rejections
The claim objections made in the previous office action is withdrawn based upon amendments to the claims.
The rejection of the claims under 35 USC 102 and 103 made in the previous office action is withdrawn based upon amendments to the claims.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 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 the “the detection of DNA methylation indicates…derived from colorectal cancer cells”. The phrase is unclear as the step of the claims encompass methylation of any genomic DNA within the recited regions. It is not clear how determination of particular cells is performed base upon any methylation, as methylation in genomic DNA can be detected in a variety of cells including dying and aging cells. As such it appears that the claims are missing steps to correlated methylation to CRC cells.
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)1, 3-7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewin et al. (WO 2017/129716 August 3, 2017) in view of Pan et al. (US Patent 20160160288 Application Publication June 9, 2016), Mansour et al. (US Patent Application Publication 2014/0255418 September 11, 2014) and Ahiquist et al. (US Patent Application Publication 2013/0244235 September 19, 2013).
With regard to claim 1 and 17, Lewin et al. teaches that in figure 3, Lewin et al. al teaches DNA methylation of genomic DNA of ANKRD13B in CRC cells (p 4, 35, 44-46). As such Lewin et al. teaches detection of DNA methylation and CRC cells. However Lewin does not teach EYA4, RASSF2, and SEPT9 or the particular sequences recited.
With regard to claim 3-4, Lewin et al. teaches converting cytosine unmethylated in the 5’ position to uracil and detecting genomic methylation (see definition of methylated and sample in Lewin).
With regard to claim 5-6 and 7, Lewin et al. teaches blood samples that comprises cell free DNA (figure 3 and summary of invention).
With regard to claim 1, and 17 Pan et al. teaches that colorectal cells can be detected by detection methylation of SEPT9 (para 73-76).
With regard to claim 1, and 17 Mansour et al. teaches CRC cells can be detected based upon methylation of RASSF2 (para 7 and 93).
With regard to claim 1, and 17 Ahiquist et al. teaches CRC cells can be detected based upon methylation of Eya4 (para 1-8).
Therefore it would be prima facie obvious at the time of the effective filing date to modify the method of Lewin et al to further screen genes that are known to be methylation in CRC cells such as those taught by Pan, Mansour and Ahiquist.. The ordinary artisan would be motivated to modify the method of Lewin to further screen additional methylated genes whose detection of methylation is associated with CRC cells. Furthermore, as these references teach detection of methylation in the whole genes, it would be obvious to one of ordinary skill in the art that the methylation of regions within those genes would be detected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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