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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 February 2026 has been entered.
3. Applicant's arguments and amendments to the claims presented in the reply of 19 February 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 All rejections not reiterated herein are hereby withdrawn.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 claims 1-2, 9-17, 19-21, and 24 are rejected under 35 U.S.C. 101 under 35 U.S.C. 101 has been obviated by the amendment to claims 1 and 24 to encompass kits and reaction mixtures in which the Flu B probe molecule species comprises SEQ ID NO: 64 and a chemiluminescent moiety, a fluorophore moiety, a quencher or both a fluorophore moiety and a quencher moiety.
Claim Status
4. Claims 1-26 are pending.
Dependent claims 4-8, 18, 19 and 26 are rejoined.
Claims 1-21 and 24-26 have been examined herein.
Claims 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Note also that consideration of rejoinder of withdrawn process claims requires that the process claims include all of the limitations of an allowable product claim.
New Claim Objections
5. Claims 1-21 and 24-26 are objected to because of the following informalities:
Claims 1 and 24 and thereby dependent claims 2-21, and 25-26, recite “and comprises a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety” whereas claims 1 and 24 should recite “and comprises a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, or both a fluorophore moiety and a quencher moiety.”
Appropriate correction is required.
New Claim Rejections - 35 USC § 112(b)
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 10 and 24-26 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 10 is indefinite over the recitation of “the primer pair species” because this phrase lacks proper antecedent basis. While the claim previously refers to a primer pair, the claim does not previously refer to a primer pair species. It is not clear as to whether “the primer pair species” is intended to be the same as or distinct from “the primer pair.”
Claims 24 and 25 are indefinite over the recitation of “the Flu B probe molecule species is about 26 to about 100 contiguous bases in length and comprises the nucleotide sequence of” SEQ ID NO: 64. The elected species of SEQ ID NO: 64 is 29 nucleotides in length. It is thereby unclear as to how a probe that must include the 29 nucleotides of SEQ ID NO: 64 can be 26, 27 or 28 bases/ nucleotides in length, as is encompassed by the claims. It is noted that in the reply of 19 February 2026, Applicant states that claim 24 has been amended “to recite the Flu B probe molecule species is 29 to about 100 contiguous nucleotides in length.” However, claim 24 was amended to recite “26 to about 100 contiguous nucleotides in length.”
Claim 26 is indefinite over the recitation that “the Flu B probe molecule species comprises a target hybridizing sequence consisting of any one of SEQ ID NOs: 31, 33, 35, 41, 43, 55, 59, and 63.” Claim 1 from which claim 26 depends recites that “the Flu B probe molecule species is 29 to about 100 contiguous bases in length, comprises the nucleotide sequence of SEQ ID NO: 64.” Thus, it is unclear as to how the Flu B probe molecule species can comprise SEQ ID NO: 64 and also comprise the sequences of claim 26 of SEQ ID NOs: 31, 33, 35, 41, 43, 55, 59, and 63.
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 4-8, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-10, 13, 17 and 19-22 of copending Application No. 18/625,389 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘389 are both inclusive of kits comprising (a) a Flu B primer pair comprising a first Flu B primer comprising a target hybridizing sequence consisting of the nucleic acid sequence of SEQ ID NO:67 and a second Flu B primer comprising a target hybridizing sequence consisting of the nucleic acid sequence of SEQ ID NO:68; and (b) a Flu B probe molecule species comprising the nucleotide sequence of SEQ ID NO:64 together with one or more Flu A primer pairs;(b) one or more RSV A primer pairs; and(c) one or more RSV B primer pairs selected from the primer pairs and probes set forth in present claims 5 and 7, respectively. See, e.g., claim 1 of ‘389 which recites that the kits comprise two or more combinations of primer pairs and probe molecule species selected from the Flu B primer pair comprising a first primer that comprises SEQ ID NO: 67 and a second primer that comprises SEQ ID NO :68 and a Flu B probe that comprises SEQ ID NO: 4 (see “(c)” of claim 1 of ‘389) in combination with the Flu A primer pair and probe of (a) and/or (b), the RSV A primer pair and probe of (d) and the RSV B primer pair and probe of (e). Present claims 1 and 24, from which claims 4-8, 18 and 19 depend, recite that the probe comprises (one of) a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety. While claim 1 of ‘389 recites that the probe comprises a detectable label, claim 5 of ‘389 recites that the detectable label is selected from a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.8. Claims 4-8, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 and 24-25 of copending Application No. 18/625,354 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘354 are both inclusive of kits comprising (a) a Flu B primer pair comprising a first Flu B primer comprising a target hybridizing sequence consisting of the nucleic acid sequence of SEQ ID NO:67 and a second Flu B primer comprising a target hybridizing sequence consisting of the nucleic acid sequence of SEQ ID NO:68; and (b) a Flu B probe molecule species comprising the nucleotide sequence of SEQ ID NO:64 together with one or more Flu A primer pairs; and (b) a Flu A primer pair comprising SEQ ID NO: 23 and 25 and a probe comprising SEQ ID NO: 7 or 12 and/or a Flu A primer pair comprising SEQ ID NO: 24 and SEQ ID NO: 26 or 27 and a Flu A probe comprising SEQ ID NO: 18, alone or in combination with one of the RSV A primer pairs and probes and/or RSV B primer pairs and probes of claims 3 and 5. See, e.g., claims 1, 3 and 5 of ‘354. which recites that the kits comprise two or more combinations of primer pairs and probe molecule species selected from the Flu B primer pair comprising a first primer that comprises SEQ ID NO: 67 and a second primer that comprises SEQ ID NO :68 and a Flu B probe that comprises SEQ ID NO: 4 (see “(c)” of claim 1 of ‘389) in combination with the Flu A primer pair and probe of (a) and/or (b), the RSV A primer pair and probe of (d) and the RSV B primer pair and probe of (e). Present claims 1 and 24, from which claims 4-8, 18 and 19 depend, recite that the probe comprises (one of) a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety. Claim 1 of ‘354 recites that the Flu A probes comprise a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety and claim 5 of ‘354 recites that the Flu B probe (as well as the RSV A and RSV B probes) comprise a chemiluminescent moiety, a fluorophore moiety, a quencher moiety, and both a fluorophore moiety and a quencher moiety..
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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
Prosecution Insights