DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
2. Applicant’s election without traverse of “prior to and during the conducting of step (b)” (see claim 30), “a body fluid” (from the list in claim 31), and “a body fluid” (from the list in claim 36) as the species for current examination in the reply filed on 8/24/2026 is acknowledged.
3. Claims 21-40 are pending in the application. Claims 28-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (i.e., non-elected species), there being no allowable generic or linking claim. Claims 21-27 and 30-40 are currently under examination.
Double Patenting
4. 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.
5. Claims 21-27 and 30-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,084,717 in view of Shendure et al. (Nat. Biotechnol. 2008, 26:1135-1145) and Totoki et al. (Nat. Genet. 2011, 43:464-469, with 2 pages of Online Methods and 49 pages of Supplementary Information).
Regarding claim 21
Claim 1 of U.S. Patent No. 12,084,717 discloses all the steps and elements as recited in instant claim 21, except the following: 1) how the genome sequencing is done (i.e., the genome sequencing is done by “sequencing by synthesis”), and 2) the alternative use of digital PCR (as opposed to a second sequencing assay used in instant claim 21) to analyze polymorphisms. Please note that nucleic acid sequencing information yielded from whole genome sequencing would necessarily comprise low mean coverage regions, as well as high mean coverage regions.
However, Shendure et al. teach that many commercially available sequencing platforms rely on “sequencing by synthesis” (see page 1136, column 2, paragraph 2: “The platforms that are discussed here all rely on sequencing by synthesis, that is, serial extension of primed templates…”; Table 1).
Additionally, Totoki et al. teach that digital PCR may be used to quantitatively analyze polymorphisms (see the whole document, particularly the “Digital PCR Genotyping” section spanning pages 4-5 of the Supplementary Information).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use any of the many commercially available sequencing platforms relying on “sequencing by synthesis”, as taught by Shendure et al., to perform the first sequencing assay in the claimed method of U.S. Patent No. 12,084,717, because such sequencing platforms relying on “sequencing by synthesis” were “widely available” and would enable “inexpensive” and “routine” sequencing analysis (see Shendure et al., Abstract). It would also have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to substitute the second sequencing assay (for analyzing polymorphisms) used in the claimed method of U.S. Patent No. 12,084,717 with digital PCR as taught by Totoki et al., because: 1) substituting equivalents known for the same purpose (i.e., same purpose of analyzing polymorphisms) is prima facie obvious (see MPEP 2144.06.II), and 2) digital PCR would offer the benefit of quantitative analysis capability.
Regarding claims 22-27 and 30-40
The additional features as recited in instant claims 22-27 and 30-40 are taught or rendered obvious by claims 1-27 of U.S. Patent No. 12,084,717.
Conclusion
6. No claim is allowed.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
