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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 11, 2026 has been entered.
This action is in response to the papers filed March 11, 2026. Currently, claims 1-6, 10-12, 14-16, 18-21, 24, 26, 28, 30, 33-35, 37, 44, 46-47 are pending. Claims 3-6, 10-12, 14-16, 18-21, 24, 26, 28, 30 have been withdrawn as drawn to non-elected subject matter.
Any objections and rejections not reiterated below are hereby withdrawn.
The 102 rejection has been withdrawn in view of the amendments to the claims to require amplifying with primers.
Election/Restrictions
Applicant's election without traverse of ZSCAN12, Claims 1-2, 32-35, 37, 44-47 in the paper filed August 5, 2025 is acknowledged.
In event that the elected species is found to be allowable, the requirement will be reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). Any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
MPEP 608.02, part VIII states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13 ).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
The figures are provided in color. No petition for color drawings has been filed; therefore, the color drawings or color photographs are being objected to as being improper. The specification is also objected to for not reciting the requisite color petition language as the first paragraph of the brief description of the drawings.
The petition filed March 11, 2026 is noted but has not been reviewed by the Office of Petitions.
Information Disclosure Statement
It is noted that the IDS filed January 26, 2024, February 22, 2024, April 3, 2025, June 2, 2025 and August 5, 2025 contains an extremely large number of references for consideration by the Examiner (approximately 35 pages of IDS). If the Applicant and/or Applicant and/or Applicant's representative are aware of any particular reference or portion of a reference in the extensive list which the examiner should pay particular attention to, it is required that it be specifically pointed out in response to this Office action.
Applicant is reminded that "burying" relevant references in a lengthy IDS is discouraged. See, e.g., Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823, 1831 (Fed. Cir. 1995) The court concluded that, by “burying” Wagenseil in a multitude of otherreferences, Hirsh and Smith intentionally withheld it from the PTO because this manner of disclosure was tantamount to a failure to disclose. Citing Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff'd, 479 F.2d 1328, 178 USPQ 577 (5th Cir.), cert. denied, 414 U.S. 874 (1973), the court stated that Hirsh's and Smith's failure to highlight Wagenseil in light of their knowledge of Whitson's actions in the foreign prosecutions violated their duty of candor to the PTO. Citing ourprecedent, Tetron asserts that Smith's and Hirsh's conduct is “inexcusable, fraudulent, and cannot operate to cure Whitson's inequitable conduct.” See Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 220 USPQ 289 (Fed.Cir. 1983), cert. denied, 469 U.S. 851 (1984) (where intentional material misrepresentations have been made, a “cure” through voluntary efforts during prosecution must be demonstrated by clear, unequivocal, and convincing evidence).
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.
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.
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, 33-35, 37, 44, 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandre et al. (WO2022/157369, July 28, 2022, priority January 25, 2021) in view of Taylor et al. (US 2022/106644, April 7, 2022)
Claim(s) 1-2, 33-35, 37, 44, 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandre et al. (US2024/0093305, July 28, 2022, priority January 25, 2021) in view of Taylor et al. (US 2022/106644, April 7, 2022).
Alexandre teaches a method for detecting endometrial or ovarian cancer in a human subject by determining the level of methylation of ZSCAN12 gene in a biological sample from the subject (abstract). Alexandre teaches the methylation value of ZSCAN12 allowed to discriminate endometrial and ovarian cancers (gathered) from all other cancers with an AUC of 0.84 (page 14).
With respect to Claims 33-35, 37, Alexandre teaches the biological sample may be a body fluid, tissue plasma, serum, ascitic or peritoneal fluid, uterine flushing or uterine aspirate (page 5).
With respect to Claim 44, Alexandre teaches the DNA is treated with a bisulfite reagent (page 6).
With respect to Claims 45-46, Alexandre teaches DNA analysis may be by methylation specific PCR (page 6).
Alexandre does not teach methylation analysis of EMX2OS.
However, Taylor teaches detecting endometrial cancer by detection of methylation of EMX2OS (see Figure 1).
Therefore, it would have been prima facie obvious to have determined the methylation profile of ZSCAN12 and EMX2OS for analysis of endometrial samples. The instant invention provides a set of genes that were each previously known to beassociated with endometrial cancer. The claims are not limited to detecting only the elected genes, and in fact encompass detecting any number of genes provided that the elected genes are detected. It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modified the methods Alexandre so as to have surveyed all of the genes known to be differentially methylated in endometrial cancer, in order to provide a more complete picture of the methylation status of a patient for known methylation markers. It is prima facie obvious to combine elements, each of which is taught by the prior art to be useful for the same purpose. See MPEP 2144.06. Here all of the recited genes were known in the prior art to be differentially methylated in endometrial cancer.
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Widschwendter et al. (US2024/0191302, priority to June 17, 2020) teaches ZSCAN12 is a DMR associated with endometrial and ovarian cancer and CIN3 (Table 12).
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.
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 (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
August 24, 2026
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