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 .2. This action is in response to the papers filed on 18 December 2025 and 27 April 2026. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance.
All objections and rejections not reiterated herein are hereby withdrawn.
In particular, the previous rejection of claims 1 and 2 under 35 U.S.C. 112(b) has been obviated by the amendments to the claims.
The previous rejection of claims 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Avsar et al has been obviated by the declaration under 37 CFR 1.130(a) filed on 18 December 2025. The declaration establishes that the Avsar reference is a 102(b)(1) exception.
Receipt is acknowledged of the certified English translation of priority document TR2020/05788.
Receipt is acknowledged of a complete copy, including Figure 1, of the Avsar et al. reference ("Rapid and Ultra-sensitive intraoperative IDH mutation detection system in glial tumors." Congress of Neurological Surgeons (CNS), 2018 Annual Meeting, held October 6-10, 2018). The Requirement for Information under 37 CFR 1.105, set forth in the Office actions of 22 August 2025 and 27 February 2026, has been met.
Claim Status
3. Claims 1-8 are pending.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The elected species of claim 1 – i.e., SEQ ID NO: 1 and 2 – is allowable over the prior art.
In the reply of 22 July 2025, Applicant elected, without traverse, Group I and the species of the IDH1 gene R132H mutation and the primer pair of SEQ ID NO: 1 and 2. . In view of the allowability of the elected species in Group I, the previously withdrawn subject matter of the Group I of the additionally recited species of IDH2 and the primers of SEQ ID NO: 3-10 is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because the species previously withdrawn from consideration has been rejoined, the election of species requirement as set forth in the Office action mailed on 23 May 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. 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.
New Claim Rejections - 35 USC § 112 – New Matter
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to recite a “primer pair for intraoperatively or postoperatively detecting isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) gene mutations in glioma tumors wherein the primer pair comprises a forward primer and a reverse primer and the forward primer and reverse primer comprise the polynucleotide sequence set forth in…SEQ ID NO: 3 and 5, respectively.”
The originally filed disclosure does not provide support for this limitation. SEQ ID NO: 3 is characterized in Table 1 as a forward primer to detect the R132G mutation in IDH1. SEQ ID NO: 5 is characterized in Table 1 as a forward primer to detect the R132C mutation in IDH1. Table 1 identifies the 3’ nucleotides in SEQ ID NO: 3 and 5 which have been modified so as to ensure amplification of only the mutated allele when the primers are used with a reverse primer in an ARMS assay. The disclosure does not teach that SEQ ID NO: 5 may be used as a reverse primer and can be used with the forward primer of SEQ ID NO: 3 to detect an IDH1 gene mutation. Rather, the disclosure teaches using the forward primer of SEQ ID NO: 3 with the reverse primer of SEQ ID NO: 4 to detect the R132G mutation in IDH1.
If Applicant maintains that the originally filed disclosure provides basis for the amended claims, Applicant should point to specific teachings (e.g., by paragraph number) in the present application to establish basis for each of the recitations set forth in the claims.
See MPEP 2163 II at “(b) New Claims, Amended Claims, or Claims Asserting Entitlement to the Benefit of an Earlier Priority Date or Filing Date under 35 U.S.C. 119, 120, 365, or 386” which states:
“To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, 365, or 386, each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure.”
New Claim Rejections - 35 USC § 112(b)
5. 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 3 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 3 is indefinite over the recitation of “wherein the forward primer and reverse primer comprise the polynucleotide sequence set forth in SEQ ID NO: 3 and 4” because it is not clear as to how this claim is intended to further limit the primer pair of claim 1 since claim 1 does not refer to a primer comprising a polynucleotide sequence of SEQ ID NO: 4.
Conclusion
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 CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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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.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
