DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions. 2. This action is in response to the amendment filed on 24 February 2026. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections and objections not reiterated herein are hereby withdrawn. In particular, the amendment to the specification filed on 24 February 2026 has been entered and obviates the prior objection to the specification. The previous rejections of the claims under 35 U.S.C. 112(a) and 112(b) have been obviated by the amendments to the claims.
Claim Status
3. Claims 97-126 are pending and have been examined herein.
4. As set forth in the prior Office action, Applicant is advised that should claim 112 be found allowable, claim 113 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Maintained / Modified Double Patenting
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.
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 97-126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-114 of copending Application No. 19/270,341 in view of Hohaus et al (Annals of Oncology. 2009. 20: 1408-1483; cited in the IDS).
The present claims and the claims of ‘341 are both directed to methods of detecting somatic mutations in a sample of cfDNA of a subject suffering from a cancer, wherein the somatic mutation is associated with cancer, the method comprising: (i) obtaining a first cell-free DNA (cfDNA) sample comprising circulating tumor DNA (ctDNA) comprising somatic mutations from the subject, (ii) performing hybrid capture on the first cfDNA sample using a selector set comprising a plurality of oligonucleotides to enrich for cfDNA corresponding to genomic regions known to contain tumor-specific somatic mutations identified in (b) to produce a hybrid captured first cfDNA sample, (iii) sequencing the hybrid captured first cfDNA sample to generate sequencing information; and (iv) analyzing the sequence information of the hybrid captured first cfDNA sample to detect ctDNA in the sample; wherein the method is capable of detecting a percentage of ctDNA that is less than or equal to 2% of total cfDNA, and the selector set is produced according to a method comprising: (a) performing a sequencing reaction on a plurality of tumor samples and a plurality of non-tumor samples from a population of subjects suffering from the cancer; (b) comparing the sequencing information of the plurality of tumor samples to sequencing information from the plurality of non-tumor samples from the population of subjects to identify fifty or more somatic mutations specific to the sequencing information of the plurality of tumor samples; and (c) producing the selector set corresponding to the 50 one or more genomic regions comprising the one or more mutations specific to the sequencing information of the comprising the one or more mutations specific to the sequencing information of the plurality of tumor samples. Dependent claims 98-114 of ‘341 recite the same limitations as present claims 98-111 and 114-126.
The claims of ‘341 differ from the present claims in that they recite that the method is one in which the cancer is lung cancer, whereas the present claims recite that the cancer is a lymphoma (claims 97-111), and particularly non-Hodgkin lymphoma (claims 112-126).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the methods claimed in ‘341 to other types of cancers, including lymphomas, and specifically non-Hodgkin lymphoma, since it was well known in the prior art that ctDNA is present in cfDNA of patients having other types of cancers. In particular, Hohaus teaches methods of analyzing cell-free DNA (cfDNA) from patients having diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL; see abstract). Hohaus (p. 1408, col. 1) states “Circulating DNA in the blood of patients with cancer contains tumor-derived DNA, as shown by the presence of concordant genetic and epigenetic alterations both in the primary tumor and in plasma, offering a noninvasive mean to obtain surrogate tumor material.” It is reported that elevated cfDNA levels were detected in plasma of lymphoma patients, including DLBCL patients, and were correlated with adverse prognostic factors (p. 1410, col. 2 and p. 1412, col. 2). Hohaus (p. 1412, col. 2) also states that “Circulating DNA does not reflect only tumor burden but also reflects dynamic states including proliferation, necrosis, and apoptosis.”
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the method claimed in ‘341 so as to have applied the method for detecting somatic mutations in a sample of cfDNA from a subject having cancer to subjects having lymphoma and specifically diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL). One would have been motivated to have done so in view of the teachings of Hohaus that ctDNA is present in plasma samples of DLBCL patients and that cfDNA levels are increased in DLBCL and correlated with adverse prognostic factors. Such a modification of the methods claimed in ‘341 would have provided the advantage that ctDNA could be detected in lymphomas and particularly DLBCL for monitoring the quantity of ctDNA as indicative of tumor burden and response to treatment (e.g., claims 111-114 of ‘341).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks:
The response states:
“Applicants request that the rejection over co-pending 19/270,331 application be held in abeyance until patentable subject matter is identified in the present application or the co-pending 19/270,331 application. Since this rejection is provisional, this request is proper..”
It is first noted that the rejection is over co-pending application 19/270,341. Further, Applicant’s arguments are not persuasive because a complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance.
The rejection over the claims as amended is maintained for the reasons set forth above.
Conclusion
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 CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on 571-272-0731. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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