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 10/03/2025.
Applicant’s election of Group I and the species of IFFO1, CA125, SEQ ID NO. 80-81 in the reply filed on 5/09/2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). It is noted that the election of species has been deleted and as such the next species is searched.
Claims 1-2, 6, 10, 15-16, 19, 23-24, 28, 32-33, 35-36, 39 and 42-43 are pending. Claims 23-24, 28, 32-33, 35-36, 39 and 42 are withdrawn as being drawn to nonelected species or groups. Claims 3-4, 7-9, 11-14, 17-18, 20-22, 25-27, 29-31, 34, 37-38, 40-41 have been cancelled.
The following rejections for claims 1-2, 6, 10, 15-16, 19, 43 are newly applied necessitated by amendment, in particular the one or more methylation markers have been amended.
This action is FINAL.
Withdrawn Rejections
The 35 USC 103(a) rejection made in the previous office action is withdrawn based upon the amendments of the genes used in the combination. It is noted that Campan et al. was used in the previous office action, however, the response to arguments does not address any deficiencies in Campan et al. other than not measuring methylation of one or more of the listed markers.
Modified 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.
Claim 43 is 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.
Claim 43 is indefinite over the “wherein one or more methylated markers”. In particular it is not clear if this is in addition to the methylation markers of claim 1 or if this limitation is intending to be instead of the methylation markers of claim 1. In particular Claim 1 requires a different combination of “one or more methaytlion markers”. As such it is not clear if claim 43 requires a further “one or more methylation maker” or how claim 43 limits the required methylation markers of claim 1.
Newly Applied 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) 1-2, 6, 10, 15-16, 19, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campan et al. (PLOS One December 7, 2011 Vol 6 e28141 previously recited ) in view of Zwarthoff et al (US Patent Application 2016/0273053 September 2016)
With regard to claim 1, and 43 Campan et al. teaches a method of using bisulfite reagent for treating (p. 3 2nd paragraph). Campan et al. teaches a method of measuring the methylation level of IFFO1 and the protein expression level of CA125 (p 3 1st paragraph and last paragraph). However, Campan et al. does not teach the second methylation marker detection. Campan et al. teaches methylation markers higher than controls (figure 4).
With regard to claim 2, Campan et al. teaches measuring methylation level and expression level and comparting to control samples (p 3 last para and 5 first parpaghra). The comparisons are towards ovarian cancers, which would encompass “without a specific type” as it would encompass any type of ovarian cancer types.
With regard to claim 6, Campan et al. teaches a method of using bisulfite reagent (p. 3 2nd paragraph).
With regard to claim 10, Campan et al. teaches that the treated DNA is amplified with primers (p. 3 5th para).
With regard to claim 15, Campan et al. teaches a method of using methylation specific PCR (P. 3 5th parpaghra).
With regard to claim 16, Campan et al. teaches a method of measuring CpG sites (p. 3 4th paragraph).
With regard to claim 19, Campan et al. teaches that the sample is a blood sample from a human with ovarian cancer (p. 3 1st paragraph).
However, Campan et al. does not teach the second methylation marker detection.
With regard to claim 1 and 43, Zwarthoff et al teaches a method of DNA methylation markers for detecting ovarian cancer that includes ZNF569 (Table 2 and para 37). As such Zwarthoff et al teaches methylation markers which can be detected in the same populations as Campan et al. teaches with IFFO1.
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 Campan et al. to screen other known methylation biomarkers including the markers recited in Zwarthoff et al. The ordinary artisan would be motivated to screen the methylation biomarkers of Zwarthoff et al as Zwarthoff et al suggest that ZNF569 methylated biomarkers are associated with ovarian cancers (para 37 and table 2). Therefore the ordinary artisan would be motivated to screen any methylated biomarkers associated with ovarian cancers in order to determine differences in methylation in ovarian samples.
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 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 1682Am