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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/29/2025 has been entered.
Withdrawn Rejections
The rejection of claims 152-156 and 161-166 under 35 U.S.C. 103 as being unpatentable over Hully et al. (WO 2011/035322; published March 24, 2011) has been withdrawn in view of applicant’s amendments to the claims to recite that the kit further comprises a primer pair and probe for detecting the presence of an avian influenza MP gene.
The rejection of claims 157-159 under 35 U.S.C. 103 as being unpatentable over Hully et al. (WO 2011/035322; published March 24, 2011), and further in view of Armes et al. (U.S. Patent Application No. 2012/0258456; published October 11, 2012) has been withdrawn in view of applicant’s amendments to claim 152 to recite that the kit further comprises a primer pair and probe for detecting the presence of an avian influenza MP gene and in view of the cancelation of claim 159.
The rejection of claim 160 under 35 U.S.C. 103 as being unpatentable over Hully et al. (WO 2011/035322; published March 24, 2011) and Fan et al. (Clinical Infectious Diseases, 1998, 26(6):1397-1402) has been withdrawn in view of applicant’s amendments to the claims to recite that the kit further comprises a primer pair and probe for detecting the presence of an avian influenza MP gene.
Double Patenting
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 152-154, 157 and 160-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-11 of U.S. Patent No. 10480036, and further in view of Fan et al. (Clinical Infectious Diseases, 1998, 26(6):1397-1402).
The instant claims are directed to a kit for detecting the presence of influenza in a sample from a human subject comprising a primer pair and probe for detecting the presence of an influenza B NS gene in the sample, wherein the primer pair comprises a first primer comprising a sequence that is identical to at least 18 contiguous nucleotides of SEQ ID NO: 14 and a second primer comprising a sequence that is complementary to at least 18 contiguous nucleotides of SEQ ID NO: 14; and wherein the probe comprises a sequence that is identical or complementary to at least 18 contiguous nucleotides of SEQ ID NO: 14, and wherein the probe comprises a detectable label; and further comprising a primer pair and probe for detecting the presence of an avian influenza MP gene, wherein the avian influenza MP probe comprises a sequence that is identical or complementary to at least 18 contiguous nucleotides of SEQ ID NO: 11, and at least one of the avian influenza MP primers comprises a sequence that is at least 90% identical or complementary to at least 18 contiguous nucleotides of SEO ID NO: 11.
The patented claims are directed to a composition or kit comprising primers and probes for detecting influenza A genes (PA, MP and PB2) and avian influenza MP gene (patented claim 1). The kit or composition can further comprise a primer pair for detecting the avian HA gene (patented claim 6) and the influenza B NS gene (patented claim 7, which depends from claim 6). The primer pair for detecting the influenza B NS gene is at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 35, and at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 36 (see patented claim 7). The primer pair for detecting the avian MP gene is at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 26, and at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 27. SEQ ID NO: 26 is within instant SEQ ID NO: 11 and SEQ ID NO: 27 is complementary to a portion of instant SEQ ID NO: 11 (see below; where SEQ ID NO: 26 is in bold and SEQ ID NO: 27 is underlined)
Instant SEQ ID NO: 11
caagaccaat cctgtcacct ctgactaagg ggattttagg gtttgtgttc acgctcaccg
tgcccagtga gcgaggactg cagcgtagac g
The patented kit or composition further comprises a primer pair for detecting RSV A or B (patented claim 8). The patented claims use a process control (patented claims 9 and 10).
The patented claims do not teach a probe for detecting influenza B NS or RSV. However, Fan et al. discloses a multiplex assay for detecting Respiratory Syncytial Viruses A and B, Influenza Viruses A and B, and Human Parainfluenza Virus Types 1, 2, and 3a. The assay uses primers and probes that originated from highly conserved regions of each viral genome.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented kit or compositions and include a probe for detecting influenza B NS or RSV. One would have been motivated to do so and there would have been a reasonable expectation of success given the teachings and findings of Fan et al. outlined above.
Although the conflicting claims are not identical, they are not patentably distinct from each other.
Claims 152-154, 157 and 160-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11-13 and 19-20 of U.S. Patent No. 11306366, and further in view of Fan et al. (Clinical Infectious Diseases, 1998, 26(6):1397-1402).
The instant claims are directed to a kit for detecting the presence of influenza in a sample from a human subject comprising a primer pair and probe for detecting the presence of an influenza B NS gene in the sample, wherein the primer pair comprises a first primer comprising a sequence that is identical to at least 18 contiguous nucleotides of SEQ ID NO: 14 and a second primer comprising a sequence that is complementary to at least 18 contiguous nucleotides of SEQ ID NO: 14; and wherein the probe comprises a sequence that is identical or complementary to at least 18 contiguous nucleotides of SEQ ID NO: 14, and wherein the probe comprises a detectable label; and further comprising a primer pair and probe for detecting the presence of an avian influenza MP gene, wherein the avian influenza MP probe comprises a sequence that is identical or complementary to at least 18 contiguous nucleotides of SEQ ID NO: 11, and at least one of the avian influenza MP primers comprises a sequence that is at least 90% identical or complementary to at least 18 contiguous nucleotides of SEO ID NO: 11.
The patented claims are directed to a method for detecting influenza A genes (PA, MP and PB2) and the avian influenza MP gene (patented claims 1 and 9). The method further comprises a primer pair for detecting the HA gene (patented claim 11) and the influenza B MP and NS genes (patented claim 12, which depends from claim 11). The primer pair for detecting the NS gene is at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 35, and at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 36. The primer pair for detecting the avian MP gene is at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 26, and at least 90% identical to at least 15 contiguous nucleotides of SEQ ID NO: 27. SEQ ID NO: 26 is within instant SEQ ID NO: 11 and SEQ ID NO: 27 is complementary to a portion of instant SEQ ID NO: 11 (see below; where SEQ ID NO: 26 is in bold and SEQ ID NO: 27 is underlined).
Instant SEQ ID NO: 11
caagaccaat cctgtcacct ctgactaagg ggattttagg gtttgtgttc acgctcaccg
tgcccagtga gcgaggactg cagcgtagac g
The patented method further comprises a primer pair for detecting RSV A or B (patented claim 13). The patented method uses a process control (patented claims 19 and 20).
The patented claims do not teach a probe for detecting influenza B NS or RSV. However, Fan et al. discloses a multiplex assay for detecting Respiratory Syncytial Viruses A and B, Influenza Viruses A and B, and Human Parainfluenza Virus Types 1, 2, and 3a. The assay uses primers and probes that originated from highly conserved regions of each viral genome.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patented kit or compositions and include a probe for detecting influenza B NS or RSV. One would have been motivated to do so and there would have been a reasonable expectation of success given the teachings and findings of Fan et al. outlined above.
Although the conflicting claims are not identical, they are not patentably distinct from each other.
Response to Arguments
In the reply dated 7/23/2025, applicant states that the double patenting rejections will be addressed upon the indication of allowable subject matter. The double patenting rejections will be maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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