DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 29, 2025 was filed after the mailing date of the office action on December 4, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 should refer to “a first amount of the plurality of nucleic acid molecules” and “a second amount of the plurality of nucleic acid molecules.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 13, 14, 20, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 depends from claim 1 and requires comparison to “a human reference genome” in line 6 of the claim. Claim 1, however, is open to any “subject from which the biological sample is obtained.” It is unclear whether claim 5 intends to narrow the scope of the “subject” to a human or not.
Claim 13 refers to a cancer “selected from a group consisting of [various choices].” It is unclear whether the claim is limited to the items on the list or whether there may be another group within the claim’s scope. Claims 14, 20, and 21 suffer similar deficiencies and are likewise indefinite.
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 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 11,479,825 in view of Carey (US 20150317490). This application is a CON of the application that issued as ’825, so the provisions of 35 U.S.C. 121 do not apply. Although the claims at issue are not identical, they are not patentably distinct from each other because the ’825 patent is drawn to a system comprising a detector and a logic system that itself comprises one or more processors, memory, and an interface configured to receive the data signals [from the detector], wherein the logic system is configured to use the data signals for a set of measurement and determination steps identical to that performed by the system controlled by the computer product of the examined application.
The ’825 patent does not specify that the memory that uses the data signals is a non-transitory computer-readable medium.
Carey teaches that one type of memory used in genomic analysis is non-transitory computer-readable media. (Paragraphs 25, 169; Figure 1.) Carey teaches that the memory controls the operation of a data-processing system. (Paragraph 169.) It would have been obvious to select Carey’s non-transitory computer-readable media as the memory in the system of the ’825 patent because Carey teaches that non-transitory computer-readable media is capable of controlling a system.
Claims 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,633,703 in view of Carey (US 20150317490). This application is a CON of the application that issued as ’703, so the provisions of 35 U.S.C. 121 do not apply. Although the claims at issue are not identical, they are not patentably distinct from each other because the ’703 patent is drawn to a method comprising a set of measurement and determination steps identical to that performed by the system controlled by the computer product of the examined application.
The ’703 patent does not claim a computer product comprising a non-transitory computer-readable medium storing the steps as instructions to be executed by a processor.
Carey teaches that one type of memory used in genomic analysis is non-transitory computer-readable media. (Paragraphs 25, 169; Figure 1.) Carey teaches that the memory controls the operation of a data-processing system. (Paragraph 169.) It would have been obvious to automate the method of the ’703 patent using the system and non-transitory computer-readable medium of Carey because Carey teaches that that non-transitory computer-readable media is capable of controlling a system that processes genomic data. See also MPEP 2144.04(III) (automating a manual activity prima facie obvious).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE M. GUSSOW whose telephone number is (571)272-6047. The examiner can normally be reached Monday to Friday 7am to 4pm, alternate Fridays off.
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/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683