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 .
Status of the Application
2. Applicant's response filed on June 17, 2026 has been entered.
Claims 1-20 are pending. Claims 1-14 were examined previously. As discussed in section 3 below, claim 1 is allowable. Accordingly, the lack of unity requirement set forth previously has been reconsidered, and claims 15-19 have been rejoined and fully examined for patentability. Claim 20 remains withdrawn as being drawn to a non-elected invention.
The following objections and rejection have been withdrawn as moot in view of Applicant’s response, which includes amendments to the claims as well as a substitute specification: (1) the objection to the substitute specification; (2) the objections to claims 1-4 and 9; and (3) the rejection of claims 1-14 under 35 U.S.C. 112(b). Applicant’s arguments regarding these matters have been considered, but they are moot since the objections and rejection have been withdrawn.
The prior art rejections made previously have been withdrawn in view of Applicant’s arguments on pages 17-18 of the Remarks in point (i) regarding Rickert and also in view of Applicant’s arguments on pages 20-21 of the Remarks in point (iii) regarding Li. As discussed by Applicant in these portions of the Remarks, neither Rickert nor Li teaches or suggests the universal detection probe required by the instant claims. As to Rickert, it is noted that the last Office action pointed to Table 1 of Rickert for disclosure of such a probe. Table 1 of Rickert does disclose the use of an L1-tailed primer to detect different targets, but the reference fails to teach performing this detection in the same reaction mixture as required by the instant claims (see claim 1, where the “first primer set” must contain two primer pairs, each specific for a different target nucleic acid). Li is deficient for the same reason. Applicant’s additional arguments concerning the prior art rejections have been considered, but they are moot since the rejections have been withdrawn for the aforementioned reasons.
Election/Restrictions
3. Claim 1 is allowable. The lack of unity requirement between Inventions I and II, as set forth in the Office action mailed on August 27, 2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The lack of unity requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the lack of unity requirement of August 27, 2025 has been withdrawn in part.
Claims 15-19, directed to a composition comprising the primer set recited in claim 1 are no longer withdrawn from consideration because the claims require all the limitations of an allowable claim. However, claim 20, directed to a kit comprising the primer set of claim 1 remains withdrawn from consideration because it does not require all the limitations of an allowable claim. And more specifically as to claim 20, the claim remains withdrawn because, unlike in claims 1 and 15-19, the components of the primer set in the kit of claim 20 need not be provided in a single reaction mixture or composition.
In view of the above noted partial withdrawal of the lack of unity requirement, Applicant is advised that if any claim presented in a 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 a 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.
Substitute Specification
4. The substitute specification filed on June 17, 2026 has been entered.
Claim Objections
5. Claim 15 is objected to because of the following minor informality. Inserting the word “wherein” after the semicolon in line 9 is suggested. As well, the word “the” before “amplified products” in lines 18-19 should be deleted.
Claim 16 is objected to because the word “wherein” should be inserted before “the second primer set” at the beginning of line 3 and also after the semicolon following “respectively” in the fifth from last line of the claim.
Claim 17 is objected to because the word “the” before “amplified products” in line 2 should be deleted.
Claim 18 is objected to by way of its dependency on claim 15.
Claim 19 is objected to because the word “the” should be inserted before “3’ ends” in the last two lines of the claim so that the claim reads “the 3’ ends of the first probe and the second probe…”
Claim Rejections - 35 USC § 112
6. 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 12 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 12 is indefinite because there is insufficient antecedent basis for “the third detection group” and “the fourth detection group.” These limitations are recited in lines 2 and 3, respectively. Since claim 10, from which claim 12 depends, was amended in the response to depend from claim 1, there is no longer sufficient antecedent basis for the aforementioned terms in claim 12.
Allowable Subject Matter
7. Claims 1-11, 13, and 14 are allowed. Rejoined claims 15-19 also contain allowable subject matter.
The prior art references cited previously (i.e., Rothmann, Li, Rickert, and Tyagi) constitute the closet prior art. As discussed above, Applicant’s response includes arguments sufficient to overcome the rejections made previously citing these references and the claim amendments address the issues raised previously under 35 U.S.C. 112 as well as the claim objections.
Zhang et al. (CN 103276094 A; IDS reference) is also cited as a prior art reference of interest. This reference discloses a method that comprises amplification and melting curve analysis (abstract and paras. 7-21; see also Embodiment 2 at paras. 48-58). The method uses an upstream primer and a downstream primer for each different target nucleic acid to be detected (paras. 48-55; see also Figure 1). The method also uses a single labeled probe for detection of all of three different target nucleic acids (paras. 57-58 and Figs. 1-2). As can be seen in Figure 1, Zhang uses a singly labeled linear probe rather than the dual-labeled probe with a particular secondary structure required by the instant claims. There is no proper rationale to modify the method of Zhang to arrive at the claimed invention for at least the following reasons. First, it is not clear that probes with the secondary structure required by the instant claims will function in the same way as the linear probe used by Zhang. Second, there is no proper motivation or rationale to replace the two-oligonucleotide detection system used by Zhang (see Fig. 1) with the required single-oligonucleotide system required by the instant claims.
In view of the foregoing, claims 1-11, 13, and 14 are allowed. And, claims 15-19 contain allowable subject matter since they are drawn to the allowable reaction mixture used in the method of claim 1.
Conclusion
8. Claims 1-11, 13, and 14 are allowed. Claim 12 is rejected. Claims 15-19 are objected to. Claim 20 remains withdrawn from consideration as being drawn to a non-elected invention.
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 Angela Bertagna whose telephone number is (571)272-8291. The examiner can normally be reached 8-5, M-F.
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/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
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