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 .
DETAILED ACTION
1. The Applicant’s response to the office action filed on June 02, 2026 is acknowledged.
Status of the Application
2. Claim 10 is pending under examination. New claims 11-22 are added. Claims 1-9 are canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-Withdrawn
3. The objection to the trademarks has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-Withdrawn
4. The rejection of claims under 35 USC 103 as being obvious over Ding et al. in view of Bodepudi et al. has been withdrawn in view of the persuasive arguments.
Double Patenting-Maintained and restated to address the amendment
5. 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.
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A. Claims 10-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US patent US 10,513,727 (hereafter the ‘727) in view of Bodepudi et al. (US 2007/0219361).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 10-22 within the scope of the claims 1-16 of the patent ‘727. Specifically, the multiplex pyrophosporolysis using plurality (first and second) of 3’-blocked primers of the claim 10 -22 are within the scope of the claims 1-16 of the patent ‘727. However, the claims in the patent ‘727 did not teach that the blocked primer comprising fluorophore at 5’ end and a quencher at 3’ end of the primers.
Bodepudi et al. teach one or more blocked primers, each comprising a 3’ blocked primer comprising deoxyribonucleotides complementary to a template and anneals to it for pyrophosphorolysis activated PCR, wherein the primer comprises detectable labels a fluorophore and a quencher wherein one detectable label is attached to a non-extendable nucleotide at 3’ end of the primer (para 0107-0109, 0124-0126, 0132, 0227-0246, 0080-0081).
It would have been prima facie obvious to one of the ordinary person skilled in the art before the effective filing date of the invention to modify the blocked primers of the claims in the patent ‘727 with fluorophore and quencher labels the blocked primers with fluorophore and quencher as taught by Bodepudi et al. to improve the sensitivity of primers in amplification reactions. The ordinary person skilled in the art would have motivated to combine the 3’ blocked primers of the claims in the patent ‘727 with fluorophore and quencher labels as taught by Bodepudi et al. to have reasonable expectation of success that the combination would result in distinguishing and detecting specific target nucleic acids because Bodepudi et al. explicitly taught attaching a detectable label to a 3’ non-extendable nucleotide that can be activated by a polymerase and improve the real-time detection of the target during pyrophosphorolysis activated polymerase chain reaction and measure target nucleic acid quantitatively
(para 0227-0229) and such a modification the claims in the patent ‘727 is considered obvious over the cited prior art. For all the above the claim is rejected under obviousness type of double patenting.
B. Claim 10 is rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-2 of US patent 11,268,140 (hereafter the ‘140) in view of
Bodepudi et al. (US 2007/0219361).
Although the claims at issue are not identical, they are not patentably distinct
from each other because the claim 10 is within the scope of the claims 1-2 of the patent
‘140. Specifically, the multiplex pyrophosporolysis using plurality (first and second) of 3’-
blocked primers of the claim 10 is within the scope of the claims 1-2 of the patent ‘140.
However, the claims 1-2 in the patent ‘140 did not teach that the blocked primer
comprising fluorophore at 5’ end and a quencher at 3’ end of the primers.
Bodepudi et al. teach one or more blocked primers, each comprising a 3’ blocked
primer comprising deoxyribonucleotides complementary to a template and anneals to it
for pyrophosphorolysis activated PCR, wherein the primer comprises detectable labels
a fluorophore and a quencher wherein one detectable label is attached to a non-
extendable nucleotide at 3’ end of the primer (para 0107-0109, 0124-0126, 0132, 0227-
0246, 0080-0081).
It would have been prima facie obvious to one of the ordinary person skilled in
the art before the effective filing date of the invention to modify the blocked primers of
the claims in the patent ‘140 with fluorophore and quencher labels the blocked primers
with fluorophore and quencher as taught by Bodepudi et al. to improve the sensitivity of
primers in amplification reactions. The ordinary person skilled in the art would have
motivated to combine the 3’ blocked primers of the claims in the patent ‘140 with
fluorophore and quencher labels as taught by Bodepudi et al. to have reasonable
expectation of success that the combination would result in distinguishing and detecting
specific target nucleic acids because Bodepudi et al. explicitly taught attaching a
detectable label to a 3’ non-extendable nucleotide that can be activated by a
polymerase and improve the real-time detection of the target during pyrophosphorolysis
activated polymerase chain reaction and measure target nucleic acid quantitatively
(para 0227-0229) and such a modification the claims in the patent ‘140 is considered
obvious over the cited prior art. For all the above the claim is rejected under
obviousness type of double patenting.
Response to Arguments:
With reference to the rejection of claim 10 over the claims in US patent 10,513,727 in view of Bodepudi et al.; and the rejection of claim 10 over the claims 1-2 of US patent 11, 268,140 in view of Bodepudi, the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to no teaching of 3’ blocked primers and multiplex-pap. The arguments have been fully considered and found unpersuasive. First, the method of claim 10 require plurality of 3’ blocked primers for multiplex PAP. Second, claims in the patent ‘727 teach a plurality of blocked primer pairs for multiplex-PAP and disclose the function of said blocked primer in PAP amplification as required by claim 10. With reference to the Applicant’s arguments drawn to no teaching of labeled 3’ terminator blocked primer comprising a quencher and a fluorophore by Bodepudi et al., the arguments have been fully considered and found unpersuasive because Bodepudi et al. teach 3’ terminator oligonucleotides comprising FRET labels comprising 3’ terminated dual labeled primer or at least a quencher and/or fluorophore (para 0228-0232, 0124: indicating dual labeled 3’ terminated oligonucleotide primer wherein 5’ terminus is labeled internally with FAM and the oligonucleotide 3’ terminus comprises a Quencher). As discussed in the rejection it would have been obvious to modify the method by dual labeled oligonucleotide blocked primers as taught by Bodepudi et al to improve the method for monitoring in real-time. For all the above the rejection has been maintained and restated to address the amendment.
C. Claims 10-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US patent US 11,921,049 (hereafter the ‘049).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 10-22 are within the scope of the claims 1-8 of the patent ‘049. Specifically, the multiplex pyrophosporolysis using plurality (first and second) of 3’-blocked primers of the claim 10-22 are within the scope of the claims 1-8 of the patent ‘049. The claims in the patent ‘049 differ from the claims 10-22, in reciting plurality of blocked primers, which is considered obvious over the claims 10-22 reciting use of said primers. For all the above the claims are rejected under obviousness type of double patenting.
Response to Arguments:
With reference to the rejection of claim 10 over the claims in the US 11,921,049, the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to same invention, the arguments were found unpersuasive because the instant application is a CIP of the patent ‘049 and as discussed in the rejection the claims in the patent ‘049 reciting plurality of primers which is considered as obvious variation over the claim 10 reciting a method using said primer pairs. For all the above the rejection has been maintained and restated to address the amendment.
Conclusion
No claims are allowable.
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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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