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 .
Double Patenting
2. 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.
3. Claims 32-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,467,153. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-30 of U.S. Patent No. 11,467,153 teach or render obvious all the steps and elements as recited in instant claims 32-58. Specifically, claim 1 of U.S. Patent No. 11,467,153 discloses a method that has all the steps and elements recited in instant claim 32 and is more specific. In addition, the other features as recited in dependent claims 33-58 are also taught or rendered obvious by claims 1-30 of U.S. Patent No. 11,467,153.
Claim Rejections - 35 USC § 102
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5. The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 32-58 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Belhocine et al. (US 2018/0340171 A1).
Regarding claim 32
Belhocine et al. teach a method comprising: (a) providing: (i) a tagmented fragment of a deoxyribonucleic acid (DNA) molecule, (ii) a nucleic acid barcode molecule (e.g., the top strand of the partially double-stranded barcode oligonucleotide molecules as shown in Figure 29B or 29C) comprising a barcode sequence (e.g., barcode sequence “BC”) and an overhang sequence (e.g., overhang/adaptor sequence “P5”), (iii) a splint molecule (e.g., the bottom strand of the partially double-stranded barcode oligonucleotide molecules as shown in Figure 29B or 29C), wherein the splint molecule comprises a first sequence (e.g., “R1rc” sequence) complementary to a sequence (e.g., “R1” sequence) of the tagmented fragment and a second sequence complementary to the overhang sequence of the nucleic acid barcode molecule; and (b) hybridizing the first sequence of the splint molecule to the sequence of the tagmented fragment, and hybridizing the second sequence of the splint molecule to the overhang sequence of the nucleic acid barcode molecule to generate a barcoded nucleic acid product comprising: (i) the sequence of the tagmented fragment or a complement thereof and (ii) the barcode sequence or a complement thereof (see the whole document, particularly paragraphs [0024], [0032], [0290]-[0297] and [0322]-[0328]; Figures 29B and 29C).
Regarding claim 33
The method according to Belhocine et al., further comprising providing a biological particle, wherein the biological particle comprises the tagmented fragment of the DNA molecule (see paragraphs [0024], [0028], [0032]-[0033] and [0322]).
Regarding claim 34
The method according to Belhocine et al., wherein said biological particle is a cell, a cell bead, or a cell nucleus (see paragraphs [0028], [0033] and [0322]).
Regarding claim 35
The method according to Belhocine et al., further comprising, prior to (b), lysing or permeabilizing the biological particle (see paragraphs [0295] and [0326]).
Regarding claim 36
The method according to Belhocine et al., further comprising, prior to (a), processing an open chromatin structure of the biological particle with a transposase to yield the tagmented fragment of the DNA molecule (see paragraphs [0096]-[0097] and [0322]-[0328]).
Regarding claim 37
The method according to Belhocine et al., wherein the transposase is included in a transposase-nucleic acid complex that comprises one or more transposon end oligonucleotide molecules (see paragraphs [0009], [0024] and [0032]).
Regarding claim 38
The method according to Belhocine et al., wherein the one or more transposon end oligonucleotide molecules comprise one or more sequencing primer sequences (see paragraphs [0097], [0248] and [0290]).
Regarding claim 39
The method according to Belhocine et al., wherein the transposase is included in a transposase-nucleic acid complex that comprises:(i) a first nucleic acid molecule comprising: (A) a sequence comprising (I) a first transposon end sequence and (II) a first sequencing primer sequence, or (B) a sequence comprising (I) a complement of the first transposon end sequence and (II) a complement of the first sequencing primer sequence; and (ii) a second nucleic acid molecule comprising: (A) a sequence comprising (I) a second transposon end sequence and (II) a second sequencing primer sequence, or (B) a sequence comprising (I) a complement of the second transposon end sequence and (II) a complement of the second sequencing primer sequence (see paragraphs [0097], [0248], [0277] and [0290]).
Regarding claim 40
The method according to Belhocine et al., wherein the first transposon end sequence and the second transposon end sequence have a different sequence, and wherein the first transposon end sequence and the second transposon end sequence are each hybridized to complementary sequences (see paragraphs [0097], [0248], [0277] and [0290]).
Regarding claim 41
The method according to Belhocine et al., wherein the first transposon end sequence and the second transposon end sequence have a same sequence, and wherein the first transposon end sequence and the second transposon end sequence are each hybridized to complementary sequences (see paragraphs [0097], [0248], [0277] and [0290]).
Regarding claim 42
The method according to Belhocine et al., wherein the nucleic acid barcode molecule comprises a sequencing primer sequence or a complement thereof (see paragraphs [0016], [0246], [0252], [0260], [0265], [0275], [0307], [0310], [0315] and [0318]).
Regarding claims 43-45
The method according to Belhocine et al., wherein (b) comprises (i) extending the splint molecule hybridized to the tagmented fragment to generate the barcoded nucleic acid product and ligating the nucleic acid barcode molecule to the tagmented fragment to generate the barcoded nucleic acid product (see paragraphs [0021], [0159], [0292]-[0293] and [0296]-[0297]; Figure 29C).
Regarding claim 46
The method according to Belhocine et al., wherein the nucleic acid barcode molecule comprises (i) a flow cell sequence or a complement thereof, or (ii) a unique molecular identifier sequence, or a combination thereof (see paragraphs [0017], [0023], [0031] and [0140]-[0141]).
Regarding claim 47
The method according to Belhocine et al., wherein the tagmented fragment of the DNA molecule comprises one or more gaps, and further comprising subjecting the tagmented fragment of the DNA molecule to an extension process to fill the one or more gaps (see paragraphs [0293] and [0297]; Figure 29C).
Regarding claim 48
The method according to Belhocine et al., wherein (i) the tagmented fragment of the DNA molecule, (ii) the nucleic acid barcode molecule, and (iii) the splint molecule are provided in a partition among a plurality of partitions (see paragraphs [0290]-[0297]; Figure 29C).
Regarding claim 49
The method according to Belhocine et al., wherein (b) occurs within the partition (see paragraphs [0290]-[0297]; Figure 29C).
Regarding claim 50
The method according to Belhocine et al., wherein the partition is a droplet and the plurality of partitions is a plurality of droplets (see paragraphs [0290]-[0297]; Figure 29C).
Regarding claim 51
The method according to Belhocine et al., further comprising recovering the barcoded nucleic acid product from the partition (see paragraph [0297]; Figure 29C).
Regarding claim 52
The method according to Belhocine et al., wherein the partition is a droplet and wherein the recovering comprises breaking or disrupting the droplet (see paragraph [0297]; Figure 29C).
Regarding claim 53
The method according to Belhocine et al., further comprising performing one or more nucleic acid amplification reactions using the barcoded nucleic acid product to generate a plurality of amplification products (see paragraphs [0017], [0023], [0031], [0039], [0300] and [0321]).
Regarding claim 54
The method according to Belhocine et al., further comprising attaching one or more flow cell sequences to the barcoded nucleic acid product or a derivative thereof (see paragraphs [0017], [0023], [0031], [0039] and [0140]).
Regarding claim 55
The method according to Belhocine et al., wherein the nucleic acid barcode molecule is coupled to a bead (see paragraphs [0027], [0035], [0291]-[0292] and [0323]-[0324]).
Regarding claim 56
The method according to Belhocine et al., wherein the nucleic acid barcode molecule is releasably coupled to the bead (see paragraphs [0149], [0156]-[0157] and [0194]).
Regarding claim 57
The method according to Belhocine et al., wherein the nucleic acid barcode molecule is coupled to the bead via a labile bond (see paragraphs [0156]-[0158] and [0194]).
Regarding claim 58
The method according to Belhocine et al., wherein the bead is a gel bead (see paragraphs [0027], [0035], [0291]-[0292] and [0323]-[0324]).
Conclusion
7. 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