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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 April 2026 has been entered.
3. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections and objections not reiterated herein are hereby withdrawn. In particular, the previous rejection of claims 1, 2, 6, 7 and 16 are rejected under 35 U.S.C. 101 has been obviated by the amendment to claims 1 and 16 to recite that the RSV A probe molecule species is about 32 to about 100 contiguous bases in length, comprises the nucleic acid sequence of SEQ ID NO:75, and comprises a detectable label, wherein the detectable label comprises a chemiluminescent moiety or a fluorophore moiety
Claim Status
4. Claims 1, 2, 4, 6-9, 11, 13, 14, 16 and 18 are pending.
Claims 1, 2, 4, 6-9, 13, 16 and 18 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 11 and 14, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 09 May 2025 is hereby withdrawn.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 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Accordingly, claims 1, 2, 4, 6-9, 11, 13, 14, 16 and 18 have been examined herein.
Claims 11 and 14 are rejected for the reasons set forth below.
Claims 1, 2, 4, 6-9, 13, 16 and 18 are allowed. It is noted that claim 13 recites “(i) the first RSV A (RSV A) primer”. It is suggested that “(RSV A)” because this appears to be duplicative of the phrase “RSV A”.
New Claim Objections
5. Claims 11 and 14 are objected to because of the following informalities:
Claim 11 recites at (b) “RSA V amplicon” whereas the claim should recite “RSV A amplicon”.
Claim 14 recites “A method for the determining the presence” whereas the claim should recite “A method for determining the presence”.
Appropriate correction is required.
New Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claims 11 and 14 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.
A. Claim 11 is indefinite over the recitation of “(c) contacting the biological sample with a RSV A probe molecule species, …wherein the RSV A amplicon, if present, forms a probe:target duplex with the labeled RSV A probe molecule species.” In this context, it is unclear as to what constitutes the biological sample - i.e., the original biological sample that is contacted with the RSV A primer pair or the biological sample formed following step (b). Note that the original biological sample to which the RSV A primer pair is added will not contain an RSV A amplicon. At the same time, the product of step (b) is no longer the same as “the biological sample” of step (a). Note that paragraphs [0092] and [0095] of the specification teach that the probe is added to the biological sample together with the primer pair.
Additionally, claim 11 is indefinite over the recitation of “the RSV A nucleic acid molecule” because this phrase lacks proper antecedent basis.
These rejections may be obviated by amendment of claim 11 to recite:
“…(a) contacting the biological sample with an RSV A primer pair comprising…SEQ ID NO: 92; and with a labeled RSV A probe molecule species, wherein the labeled RSV A probe molecule species is about 32 to about 100 contiguous bases in length, comprises the nucleic acid sequence of SEQ ID NO: 75, and comprises a detectable label, wherein the detectable label comprises a chemiluminescent moiety or a fluorophore moiety; (b) performing a nucleic acid amplification reaction, wherein a RSV A nucleic acid molecule, if present in the biological sample, is amplified to generate an RSV A amplicon; and (c) detecting the presence or absence of a probe:target duplex formed between the labeled RSV A probe molecule species and the RSV A amplicon, wherein detecting the presence of the probe:target duplex indicates the presence of RSV A in the sample.”
B. Claim 14 is indefinite over the recitation of “contacting the sample with the kit of claim 1.” Absent a clear definition for “kit” in the specification, a “kit” is conventionally considered to be a container or box or tube in which reagents (here, the primer pair and probe) are packaged. It is thereby unclear as to what is intended to be encompassed by contacting the sample with the kit per se. This rejection may be obviated by amendment of claim 14 to recite:
“…(A) providing the kit of claim 1 and contacting the sample with the RSV A primer pair and the RSV A probe molecule species of the kit of claim 1; (B)…”.
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