DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 May 2026 has been entered. 3. Applicant's arguments and amendments to the claims presented in the reply filed on 26 May 2026 have been fully considered but do not place the application in condition for allowance. All rejections not reiterated herein are hereby withdrawn. In particular, the previous rejection of the claims under 35 U.S.C. 101 has been obviated by the amendment to the claims. Claims 7 and 11 as amended are not considered to recite a judicial exception.
Election/Restrictions
4. In the reply of 26 August 2025, Applicant elected without traverse Group II and the species of miR-425-5p. With respect to the elected species, in the reply filed on 23 December 2025, the claims were amended to require measuring the expression of both miR-425-5p and miR-145-5p and the elected species was then considered to be the combination of miR-425-5p and miR-145-5. The claims were amended in the reply of 26 May 2026 to recite only miR-425-5p. . Accordingly, the elected species is now considered to be limited to miR-425-5p..
Claim Status
5. Claims 1-7 and 11 are pending.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 7 and 11 read on the elected invention and have been examined herein.
New Claim Rejections - 35 USC § 103
6. 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 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tewari, M. (U.S. 20110160290; cited in the Office action of 09/23/2025).
Tewari teaches a method comprising measuring an expression level of miR-425- 5p in a sample obtained from a subject having or suspected of having ovarian cancer; and comparing the measured expression level with an expression level of miR-425-5p in a sample from a normal control subject / group (e.g., abstract, para [0020], [0117], [0207-0208] and Table 12). For example, Tewari (para [0020]) teaches:
“Diagnosis can be based on the level of a miRNA in a given individual relative to a set threshold, or relative to a standard, where expression, absence of expression, and/or relative abundance of one or more miRNA is indicative of epithelial cell cancer, including, but not limited to, prostate cancer and ovarian cancer. miRNAs for use in this method can include, but are not limited to, mir-100, miR-135b, miR-141, miR-148a, miR-200a, miR-200c, miR-210, miR-222, miR-375, miR-425-5p and miR-429, or a combination thereof.”
The subject having or suspected of having ovarian cancer is considered to be a subject suspected of having ovarian hypofunction since having ovarian cancer will negatively affect the subject’s ovaries. Tewari teaches that miR-425-5p was not detected in normal plasma samples but was detected in plasma samples from patients having ovarian cancer and prostate cancer (para [0207-0208] and Table 12).
Regarding the limitation that the sample is a serum sample, Tewari teaches that the sample to be assayed for miRNA levels is a serum sample. See, e.g., para [0007]: “The biological sample can be blood and fractions thereof, blood serum.” See also para [0029-0030], [0049], [0107] and claim 56.
Regarding the limitation of “isolating circulating miRNA,” Tewari teaches that the miRNA is isolated from the body fluid sample (e.g., para [0050-0051]) and thereby from the serum sample.
Regarding the limitation of “contacting the isolated circulating miRNA with a polynucleotide primer,” Tewari teaches that the measuring step is accomplished by PCR and includes contacting the miRNA with specific primers (e.g., para [0056-0059]), and thereby a primer complementary to the target miR-425-5p nucleic acid.
Tewari teaches that the subject is a human subject (e.g., para [0006]).
Tewari does not specifically recite that the serum sample is obtained from a female subject.
However, Tewari does teach obtaining plasma samples from female human subjects having ovarian cancer and normal healthy “50 age- and menopausal status-matched, healthy female patients (para [0189]), which menopausal female patients are also expected to have (would be suspected of having) some degree of ovarian hypofunction. Further, the ordinary artisan would have recognized that it is subjects in the female population that have ovaries and are at risk of ovarian cancer.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically obtained the serum sample from a female subject since it is subjects in the female population that would be suspected of having ovarian cancer.
Regarding claim 11, Tewari teaches that the miRNA is detected by performing PCR (e.g., para [0037] and [0056-0059]).7. Claim(s) 7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al (U.S. 20120309645).
Keller teaches a method comprising measuring an expression level of miR-425 (which is conventionally referred to as “miR-425- 5p”) in a sample obtained from a subject having or suspected of having ovarian cancer (e.g., para [0148-0149], and Fig. 11, entry No. 22). Keller exemplifies methods wherein an increase in the expression level of miR-425 distinguishes ovarian cancer from Wilms tumor (Fig. 11, entry No. 22)
The subject having or suspected of having ovarian cancer is considered to be a subject suspected of having ovarian hypofunction since having ovarian cancer will negatively affect the subject’s ovaries.
Regarding the limitation that the sample is a serum sample, Keller teaches that the sample to be assayed for miRNA levels is a serum sample. See, e.g., para [0056]: “the biological sample preferably is a blood or a serum sample.” See also para [0068] and [0070].
Regarding the limitation of “isolating circulating miRNA,” Keller teaches that the miRNA is isolated from a serum sample from the patient (e.g., para [0070]).
Regarding the limitation of “contacting the isolated circulating miRNA with a polynucleotide primer,” Keller teaches that the measuring step is accomplished by PCR (e.g.., para [0042], [0065] and [0233]) and that the PCR includes contacting the miRNA with specific primers (e.g., para [0217], [0240], [0246]), and thereby a primer complementary to the target miR-425-5p nucleic acid.
Keller teaches that the subject is a human subject (e.g., para [0217] and [0252]).
Keller does not specifically recite that the serum sample is obtained from a female subject.
However, Keller does teach “Comparing blood-borne miRNA profiles from 15 patients with ovarian cancer (OvCA) and 15 age- and sex-matched healthy controls “ (para [0196]). See also para [0198]. Further, the ordinary artisan would have recognized that it is subjects in the female population that have ovaries and are at risk of ovarian cancer.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the method of Keller using serum samples obtained from a female subject since it is subjects in the female population that would be suspected of having ovarian cancer.
Regarding claim 11, as discussed above, Keller teaches that the miRNA is detected by performing PCR (e.g., para [0042], [0065] and [0233]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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 571-272-0731. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARLA J MYERS/Primary Examiner, Art Unit 1682
Prosecution Insights