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 .
Status of the Application
The Amendment and Response filed December 24, 2025 is acknowledged.
Claims 7-9, 11-12 and 17-21 were pending. Claims 7-9, 11-12 and 21 are being examined on the merits. Claims 17-20 remain withdrawn.
Response to Arguments
Applicant’s arguments filed December 24, 2025 have been fully considered.
The following rejections are WITHDRAWN in view of Applicant’s arguments and claim amendments:
Rejection of claims 7-9, 11-12 and 21 under 35 USC § 112(a), lack of enablement
Claim Objections
Claim 7-9, 11-12 and 21 are objected to because of the following informalities:
In claim 7, the limitation “(c) remove cleaved” should be “(c) removing cleaved”.
Claims 8-9, 11-12 and 21 depend from and thus incorporate the informalities of claim 7.
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 11-12 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.
Claim 11 recites the limitation “wherein an absence of a change in absorbance …”, while
claim 12 similarly recites the limitation “wherein a change in the absorbance …”. The meaning of each of these limitations is unclear because they do not identify what the change or absence of change is relative to – e.g., a no candidate compound control? an earlier step in the assay? Since the ordinary artisan would not be able to determine the metes and bounds of the claims, they are indefinite.
Prior Art and Withdrawn Claims
Independent claim 7 is free of the art. The closest prior art is Woo (A nonradioactive DNA methyltransferase assay adaptable to high-throughput screening, Analytical Biochemistry, 340(2): 336-340, 2005) in view of Leary1 (Rapid and sensitive colorimetric method for visualizing biotin-labeled DNA probes hybridized to DNA or RNA immobilized on nitrocellulose: Bio-blots, Proc. Natl. Acad. Sci. USA, 80, 4045-4049, 1983) and Mitchell2 (US Patent App. Pub. No. 2011/0009412 A1).
Woo teaches a method of screening candidate compounds for inhibitors of enzyme activity comprising: (a) immobilizing an amine modified target DNA on a surface (Fig. 2; p. 336, right col., para. 2: high-throughput screening for inhibitors of methyltransferases; p. 338, left col., para. 4); (b) incubating the target DNA with an enzyme and a candidate inhibitor, wherein the target DNA will be cleaved if the candidate compound is not an inhibitor (Fig. 2; enzymes: Mtase and restriction endonuclease; target DNA is cleaved by restriction endonuclease if the inhibitor is not an inhibitor of Mtase); (c) removing cleaved target DNA (Fig. 2); (e) detecting uncleaved target DNA by a colorimetric assay, thereby screening for inhibitors of enzyme activity (Fig. 2; p. 338, left col., para. 2: pNPP).
Mitchell teaches that MIF is a cytokine and has hormone-like activities. Mitchell also teaches the importance of MIF expression in pre-malignant, malignant and metastatic tumors, and inflammatory disorders, and teaches screening candidate MIF inhibitor compounds against targets to identify therapeutics to treat such diseases (paras. 5-6, 51, 184, 189; Example 8).
Leary teaches hybridizing target DNA with a complementary biotinylated DNA and detecting the target DNA hybridized to the complementary biotinylated DNA (Figs. 1-2; p. 4047, right col., para. 4).
Thus, the components of the claim 7 assay were known in the art, as was the existence of MIF and its importance in various diseases. However, prior to the effective filing date of the instant invention, it was not known in the art that, in addition to its cytokine and hormone-like functionality, MIF also has nuclease activity for single-stranded DNA targets. Thus, there would have been neither a motivation nor a reasonable expectation of success for the ordinary artisan to modify the Woo assay to test for inhibitors of MIF nuclease activity with single-stranded DNA targets.
Further, regarding the nucleic acids in claim 21, some of these sequences are comprised within larger sequences that are known in the art, but none of those sequences are known to be targets of MIF nuclease activity.
Consequently, independent claim 7 and its dependent claims are free of the art.
Withdrawn claims 17-20 are not eligible for rejoinder. The Examiner suggests canceling the withdrawn claims.
Conclusion
Claims 7-9, 11-12 and 21 are being examined. Claims 11-12 are rejected and objected to. Claims 7-9 and 21 are objected to, but are otherwise directed to allowable subject matter. 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 CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 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, Gary Benzion can be reached at 571-272-0782. 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.
/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Leary was cited in the PTO-892 Notice of References cited mailed June 21, 2024.
2 Mitchell was cited in the Information Disclosure Statement submitted February 18, 2022.
Prosecution Insights