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 .
Claims 1-11 are pending and will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 3, 2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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Claims 1-11 are rejected under the judicially created doctrine of obviousness-type
double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,280,455.
Although the conflicting claims are not identical, they are not patentably distinct from
each other because the claims of U.S. Patent No. 10,280,455 represent a narrower
species of the current claims and this species anticipates the current, more generic
claims. Both sets of claims teach a plurality of mixture partitions, the individual mixture
partitions comprising:
a mutation specific 5' tailed primer pair, a wild-type specific 5' tailed primer pair,
a mutation specific flanking primer pair, a wild-type specific flanking primer pair, and a thermostable polymerase, wherein at least some of the mixture partitions of the plurality of mixture partitions contain a target DNA template molecule, and at least some of the mixture partitions of the plurality of mixture partitions do not contain the target DNA template molecule. The claims of U.S. Patent No. 10,280,455 also teach that the 3' hybridization regions of the primers of the mutation-specific 5' tailed primer pair and the wild-type specific 5' tailed primer pair are 10 to 30 nucleotides in length, and that the mutation specific 5' tail region and wild-type specific tail region of the primers are also 10 to 30 nucleotides in length.
In addition, the claims of the '455 patent teach that at least 1-10 of the mixture partitions of the plurality of mixture partitions contain a target DNA template molecule, and at least 3-10 of the mixture partitions of the plurality of mixture partitions do not contain the target template
molecule.
Of note, both claim sets include the language “if present” regarding both the mutant sequence and the wild type sequence for binding the primers of the method, as claimed. As the instant claims and the claims of the ‘455 patent encompass entirely overlapping subject matter, the instant claims are not patentably distinct.
Conclusion
No claims are allowed. All claims stand rejected.
The claims are free of the art but stand rejected for other reasons. While tailed primers are known in the art, none of the prior art teaches individual partitions comprise two sets of 5' -tailed primer pairs that amplify a site within a mutant or wild-type sequence, and two separate sets of flanking primer pairs that hybridize to and amplify amplicons comprising the 5' tail regions of the respective mutation-specific or wild-type specific tailed primer pairs. The prior art reference Hart et al. (U.S. Patent Pub. No. 2006/0057561; March 2006) is the closest to the method and partitions, as claimed. However, Hart does not teach or suggest the partitions used in the manner claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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