DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of the species “a Klenow DNA polymerase” (from the list in claim 42), the species “next-generation sequencing (NGS)” (from the list in claim 50), and the species “using the one or more rare variants to detect the presence or absence of a cancer” (from the list in claim 52) in the reply filed on 6/29/2026 is acknowledged. However, upon further consideration, the species election requirement has been withdrawn.
3. Claims 30-55 are currently pending and under examination.
Statutory Double Patenting
4. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
5. Claim 30 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 2 of prior U.S. Patent No. 11,414,656; claim 31 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 3 of prior U.S. Patent No. 11,414,656; claim 44 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 15 of prior U.S. Patent No. 11,414,656; claim 49 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 16 of prior U.S. Patent No. 11,414,656; claim 52 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 17 of prior U.S. Patent No. 11,414,656; claim 53 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 18 of prior U.S. Patent No. 11,414,656; claim 54 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 19 of prior U.S. Patent No. 11,414,656; and claim 55 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of prior U.S. Patent No. 11,414,656. This is a statutory double patenting rejection.
Nonstatutory Double Patenting
6. 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.
7. Claims 32-43, 45-48 and 50-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,414,656. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of U.S. Patent No. 11,414,656 teach or render obvious all the features as recited in instant claims 32-43, 45-48 and 50-51.
Specifically, claims 1-2 and 4 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 32; claims 1-2 and 4-5 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 33; claims 1-2 and 6 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 35; claims 1-2 and 7 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 36; claims 1-2 and 8 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 37; claims 1-2 and 9 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 38; claims 1-2 and 10 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 39; claims 1-2 and 10-11 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 40; claims 1-2, 10 and 12 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 41; claims 1-2, 10 and 13 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 42; claims 1-2, 10 and 13-14 of U.S. Patent No. 11,414,656 teach all the steps and elements recited in instant claim 43.
Regarding claim 34 which recites a list of possible choices for the test sample, the specification of U.S. Patent No. 11,414,656 (see column 3, lines 18-22) discloses that “the test sample comprises whole blood, a blood fraction, plasma, serum, urine, fecal matter, saliva, a tissue biopsy, pleural fluid, pericardial fluid, cerebral spinal fluid, peritoneal fluid, or any combination thereof.” Regarding claims 45-48, claim 15 of U.S. Patent No. 11,414,656 teaches that “the consensus sequence comprises a sequence of nucleotide bases, wherein each base is identified at a given position in the sequence when a specific base is present in a majority of the sequence reads of the family.” According to the specification of U.S. Patent No. 11,414,656 (see column 3, lines 42-50), “a majority of the sequence reads of the family” may be “at least 70%, 80%, 90% or 95% of the sequence reads comprising the family.” Regarding claims 50-51 which specify how the sequence reads are obtained, the specification of U.S. Patent No. 11,414,656 (see column 3, lines 55-64) discloses the following: “In some embodiments, the sequence reads are obtained from next-generation sequencing (NGS). In some embodiments, the sequence reads are obtained from massively parallel sequencing using sequencing-by-synthesis. In some embodiments, the sequence reads are obtained from paired-end sequencing. In some embodiments, the sequence reads comprise a read pair, wherein each read pair comprises a first read of the forward strand sequence and second read of the reverse complement strand sequence.” According to MPEP 804(II)(B)(1), “those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.”
Conclusion
8. No claim is allowed.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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