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 Group I (claims 39-50) in the reply filed on 8/7/2026 is acknowledged.
3. Claims 39-68 are pending in the application. Claims 51-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 39-50 are currently under examination.
Priority
4. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e), 120, 121, or 365(c) as follows:
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)
Claims 39-50 of the instant application were first presented on 6/29/2022 via a preliminary amendment. The disclosure of each of the prior-filed applications 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 claims 39-50 of this application. Specifically, none of the prior-filed applications provides support for the combination of features as recited in steps (b) and (c) of independent claim 39. In fact, such combination of features was also not even described in the specification as filed on 6/29/2022. Accordingly, instant claims 39-50 are not entitled to the benefit of any of the prior-filed applications, and therefore the instant filing date of 6/29/2022 (when instant claims 39-50 were first presented via preliminary amendment) is the effective filing date for instant claims 39-50.
Claim Objections
5. Claim 45 is objected to because of the following informalities: a period is missing at the end of the claim (see MPEP 608.01(m): “…Each claim begins with a capital letter and ends with a period.”). Appropriate correction is required.
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 39-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39 and 66-87 of copending Application No. 17/412,105 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 39 and 66-87 of copending Application No. 17/412,105 teach or render obvious all the steps and elements as recited in instant claims 39-50. Specifically, claims 39, 74 and 80 of copending Application No. 17/412,105 teach all the steps and elements recited in instant claim 39. In addition, the other features as recited in dependent claims 40-50 are also taught or rendered obvious by claims 39 and 66-87 of copending Application No. 17/412,105.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 39-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-61 of copending Application No. 17/464,341 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 39-61 of copending Application No. 17/464,341 teach or render obvious all the steps and elements as recited in instant claims 39-50. Specifically, claims 39-40 and 42-43 of copending Application No. 17/464,341 teach all the steps and elements recited in instant claim 39. In addition, the other features as recited in dependent claims 40-50 are also taught or rendered obvious by claims 39-61 of copending Application No. 17/464,341.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
9. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
10. Claims 39-50 are rejected under pre-AIA 35 U.S.C. 102(a) and 102(e) as being anticipated by Salk et al. (US 11,047,006 B2).
Regarding claim 39
Salk et al. teach a method of sequencing DNA, the method comprising: (a) preparing a sequence library from a sample comprising a plurality of double-stranded DNA molecules from a biological source, wherein preparing the sequence library comprises ligating adapters to the plurality of double-stranded DNA molecules to generate adapter-DNA molecules having a first strand and a second strand; (b) for each of a plurality of the adapter-DNA molecules: (i) sequencing the first and second strands to produce first-strand sequence reads and distinct yet related second-strand sequence reads; and (ii) comparing the first-strand sequence reads and second-strand sequence reads to identify one or more sequence correspondences between the first- and second-strand sequence reads; and (c) comparing the one or more sequence correspondences to a reference sequence to identify a sequence variation as a true mutation, wherein a true mutation is a sequence variation relative to the reference sequence that is consistent between the first-strand sequence reads and second-strand sequence reads for at least one of the adapter-DNA molecules (see claim 1).
Regarding claim 40
The method according to Salk et al., further comprising identifying non-complementary bases between the first-strand sequence reads and the second-strand sequence reads as resulting from experimental or biological error in one strand (see claim 2).
Regarding claim 41
The method according to Salk et al., wherein prior to comparing the first-strand sequence reads and second-strand sequence reads, the method comprises grouping the first-strand sequence reads and second-strand sequence reads based on at least an adapter bar code sequence (see claim 3).
Regarding claim 42
The method according to Salk et al., wherein the adapters comprise bar code sequences selected from a plurality of distinct bar code sequences (see claim 5).
Regarding claim 43
The method according to Salk et al., wherein each bar code sequence is 6 to 8 nucleotides in length (see claim 6; paragraph bridging columns 6-7).
Regarding claim 44
The method according to Salk et al., wherein each bar code sequence is a double-stranded portion of the respective adapter (see claim 7).
Regarding claim 45
The method according to Salk et al., wherein (i) at least two adapters comprise the same bar code sequence and are ligated to different double-stranded DNA molecules, (ii) end sequences of the double-stranded DNA molecules together with associated bar code sequences form cyphers at both ends of the adapter-DNA molecules; and (iii) individual adapter-target complexes comprise different pairs of cyphers (see claim 8).
Regarding claim 46
The method according to Salk et al., wherein the plurality of double-stranded DNA molecules comprises DNA originating from a circulating tumor cell or a cancer cell (see claim 9).
Regarding claim 47
The method according to Salk et al., wherein the sample comprises a tissue obtained from the biological source (see claim 10).
Regarding claim 48
The method according to Salk et al., wherein prior to sequencing, the method further comprises purifying a plurality of adapter-DNA molecules, wherein the purified adapter-DNA molecules comprise nucleic acid molecules that map to specific genomic regions (see claim 11).
Regarding claim 49
The method according to Salk et al., wherein for each of a plurality of the adapter-DNA molecules prior to sequencing, the method further comprises amplifying each original strand of the adapter-DNA molecules to produce a set of copies of the first strand and a set of copies of the second strand (see claim 12).
Regarding claim 50
The method according to Salk et al., further comprising generating an error-corrected sequence, wherein the error-corrected sequence has only nucleotide bases at which the first-strand sequence reads and second-strand sequence reads are in agreement (see claim 13).
Conclusion
11. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
