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 1-19 are pending and will be examined.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61395850, 61398159, 61426208, 61462972, 61448547, US Patent 8825412 and 61516996 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. While each of these priority documents include support for cell free nucleic acids and multiplex, none of these priority documents include sufficient (or any) support for multiplex at a specific number of loci, or the inclusion of nested amplification, as claimed.
Therefore, as the priority documents of 61542508, for example, provide support, the claims are afforded an earliest priority of October 3, 2011.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 27, 2025 and January 17, 2025 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.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,557,172. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘172 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of ten targets simultaneously followed by a nested amplification. The main difference between the claims of the instant application and the claims of the ‘172 patent is the inclusion of a range of targets that includes 10 to 20,000 target specific primers in multiplex amplification as claimed. Further, the dependent claims of the instant application and the ‘172 patent are almost identical, as well. For example, compare claims 13-14 of the ‘172 patent to claims 14-15 where the length of the annealing step is described. Also compare claims 9-10 of the ‘172 patent to claims 10-11 of the instant claims where specific range of number of barcodes are described, as claimed. Also compare claims 11-12 of ‘172 patent to claims 12-13 of the instant claims where concentration of primers are the focus of the claims.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,538,814 (‘814 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘814 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of at least ten targets simultaneously followed by a nested amplification. When you compare claims of the application to claims 7-10 of the ‘814 patent to the instant claims, it is clear that while the claims are not identically recited, the claims fall within overlapping ranges of the number of targets that are amplified simultaneously in the method, as the instant claims encompass a range of 10 to 20,000 primers amplified simultaneously. It would have therefore been obvious to include these ranges of numbers of amplified targets within the method, as claimed. Further compare claims 15-16 of the ‘814 patent to claims 14-15 where the length of the annealing step is described. Also compare claims 11-12 of the ‘814 patent to claims 10-11 and 30-31 of the instant claims where specific range of number of barcodes are described, as claimed and compare claims 18 and 21 of ‘814 patent to claims 2 and 18 of the instant claims where sample types are identically described, as well.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,731,220 (‘220 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘220 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of ten targets simultaneously followed by a nested amplification. The main difference between the claims of the instant application and the claims of the ‘220 patent is the inclusion of at least 10 primers in multiplex amplification while the instant claims which include a range of 10 to 20,000 primers. Further compare claims 14-15 of the ‘220 patent to instant claims 14-15 where the length of the annealing step is described. Also compare claims 10-11 of the ‘220 patent to claims 10-11 of the instant claims where specific range of number of barcodes are described, as claimed and compare claims 17 and 20 of ‘220 patent to claims 17-18 of the instant claims where sample types are identically described, as well.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 11,332,793 (‘793 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘793 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of ten targets simultaneously followed by a nested amplification. Further compare claims 13-14 and 35-36 of the ‘793 patent to claims 14-15 where the length of the annealing step is described. Also compare claims 9-10 and 31-32 of the ‘793 patent to claims 10-11 of the instant claims where specific range of number of barcodes are described, as claimed and compare claims 16, 19, 38, 41 of ‘793 patent to claims 17-18 of the instant claims where sample types are identically described, as well.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,509,730 (‘730 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘730 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of ten to 1000 targets simultaneously followed by a nested amplification and encompassing while amplification of ten to 20,000 targets is included in the instant claims. Further compare claims 14-15 of the ‘730 patent to instant claims 14-15 where the length of the annealing step is described. Also compare claims 10-11 of the ‘730 patent to claims 11-12 of the instant claims where specific range of number of barcodes are described, as claimed and compare claims 17 and 21 of ‘730 patent to claims 17-18 of the instant claims where sample types are described, as well.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,545,960 (‘960 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘960 patent and the instant application claim extremely similar methods, including a method of amplification and sequencing and including a first simultaneous amplification of ten targets simultaneously followed by a nested amplification. The main difference between the claims of the instant application and the claims of the ‘960 patent is the inclusion of a range of targets that includes 10 to 1000 primers in ‘960 patent to 10 to 20,000 loci in multiplex amplification as claimed. For example, compare 20 to 500 loci (compare claim 5-8 of the ‘960 patent to claim 6-9 of the instant claims), one sided nested PCR (compare claim 4 of the ‘960 patent to claim 4 of the instant claims). Further compare claims 13-14 of the ‘960 patent to claims 13-14 where the length of the annealing step is described. Also compare claims 10-11 of the ‘960 patent to claims 10-11 of the instant claims where specific range of number of barcodes are described.
Claims 1-19 are free of the art. There are references that teach aspects of the method but would not render the claims obvious over these references because there is no motivation to modify a reference like Chowdary et al. (US PgPub 20080305473; December 2008) or Gocke et al (US Patent 6,156,504; December 2000) to include both multiplex using universal or common primers and a second step of nested amplification on the same multiplex amplified targets.
Conclusion
No claims are allowed. All claims stand rejected.
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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