Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a DIV of 15/084,307 (03/29/2016, now US11535882),
15/084,307 has PRO 62/152,644 (04/24/2015),
15/084,307 has PRO 62/140,360 (03/30/2015).
Status
Claims 1, 5-20 are pending.
Rejections not reiterated in this action are withdrawn.
New 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 6-12 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 6 depends from cancelled claim 2. Claims 7-12 which depend therefrom incorporate the indefiniteness and are also rejected.
New Claim Rejections - 35 USC § 102
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) A person shall be entitled to a patent unless –
(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.
(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.
Claims 1, 5-12, 14-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Seelig et al. (US20160138086, EFD 2014-11-14).
Seelig teaches “methods of uniquely labeling or barcoding molecules within a cell, a plurality of cells” (Abstract) for sequencing ([0052]-[0061]) as shown in Fig. 8:
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wherein the combined tags correspond to the component barcodes of the instant claims, the partitions comprise a single cell, the barcodes are unique, comprise a linker, and are combinations that identify the partitions ([0063]: “providing a plurality of nucleic acid tags to each of the at least two aliquots, wherein each barcode sequence of the plurality of nucleic acid tags introduced into a given aliquot is the same, and wherein a different barcode sequence is introduced into each aliquot”; Example 2; [0030]; [0038]: “linker strand that is configured to hold a nucleic acid tag together with an adjacent nucleic acid”; claims 7 and 24).
Regarding claim 5, Seelig teaches linker sequence between the barcodes thus requiring one less than the corresponding number of barcodes linked (i.e. Fig. 8).
Regarding claim 6, Seelig teaches hybridization to the sample (claims 7 and 24, Fig. 8).
Regarding claim 7, Seelig teaches extension of the hybridized target to produce an extension product comprising the barcode (claims 7 and 24, Fig. 8).
Regarding claim 8, Seelig teaches PCR amplification ([0098]).
Regarding claim 9, Seelig teaches pooling (Example 8; [0098]: “PCR tubes can be combined”).
Regarding claim 10, Seelig teaches pooling the products in multiplex PCR and sequencing (Example 8; [0102]).
Regarding claim 11, Seelig teaches grouping the reads using the barcodes ([0102]: “The products can be sequenced on an ILLUMINA® MISEQ™ using paired end sequencing. The sequencing primers can be the standard TRUSEQ™ multiplex primers. Read 1 can sequence the cDNA sequence, while read 2 can cover the unique molecular identifier as well as the 3 barcode sequences (8 nucleotides each). Index read 1 can be used to sequence sample barcodes, so multiple samples may be sequenced together.”).
Regarding claim 12, Seelig teaches using the assembled sequences in identifying markers and haplotyping ([0045] gene specific primer).
Regarding claim 14, Seelig teaches single cell sequencing using the method as per claim 1 detailed above applied to single cell sequencing (Example 2 and 8; [0083]-[0087]: 96 first-round barcodes).
Regarding claim 15, Seelig teaches extension of the hybridized target to produce an extension product comprising the barcode (Example 8).
Regarding claim 16-17, Seelig teaches pooling the products in multiplex PCR and sequencing (Example 8; [0102]).
Regarding claim 18, Seelig teaches grouping the reads using the barcodes ([0102]: “The products can be sequenced on an ILLUMINA® MISEQ™ using paired end sequencing. The sequencing primers can be the standard TRUSEQ™ multiplex primers. Read 1 can sequence the cDNA sequence, while read 2 can cover the unique molecular identifier as well as the 3 barcode sequences (8 nucleotides each). Index read 1 can be used to sequence sample barcodes, so multiple samples may be sequenced together.”).
Regarding claim 19, Seelig teaches the target is an mRNA ([0043]-[0044]).
Regarding claim 20, Seelig teaches the first primer is oligo-dT ([0043]-[0044]).
Claims 1, 5-12, 14-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nolan et al. (WO2012106385; cited in 2025-11-13 IDS).
Nolan teaches barcoding for multiplex detection of cells (Abstract) as shown in Fig. 4:
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Nolan teaches the method in claims 113-255, including the use of component barcodes, comprising a unique barcode, linker, and that identifies the origin partition. Nolan teaches sequencing to identify the assembled barcodes (claim 154, 174; [0075]; [0190]-[0206]) wherein the target it mRNA ([0059]). Thus, the claims are anticipated.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Seelig et al. (US20160138086, EFD 2014-11-14) in view of Lausted et al. (Genome Biology 2004, 5:R58, 17 pages).
Seelig teaches as detailed in the 35 USC 102 rejection supra and incorporated herein. Seelig also renders these claims obvious because the level of skill in the art is very high and multiplex nucleic acid analysis of single cells using barcoded arrays was well-known in the art.
Regarding claim 13, Seelig does not teach an inkjet printer for introducing component barcodes into the partitions.
Lausted teaches an “oligonucleotide synthesizer and microarrayer” (title) for delivering oligonucleotides to a microarray (abstract). One of ordinary skill in the art would have readily considered using Lausted’s tool in implementing Seelig’s technique as they are in the same field of endeavor and was well within their technical grasp.
The level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
New 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12188010 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12157913 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12084712 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12071617 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11932849 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11932901 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11773436 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of U.S. Patent No. 11661631 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11639517 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11390914 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10927419 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10676779 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9567645 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-26 of U.S. Patent No. 9637799 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10151003 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10253375 in view of Seelig et al. (US20160138086, EFD 2014-11-14) and Lausted et al. (Genome Biology 2004, 5:R58, 17 pages) as detailed in the 35 USC 103 rejection supra and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because they are to an equivalent method of barcoding a sample using oligonucleotides in a substantially similar manner such that in view of the secondary references renders the claims obvious.
Conclusion
No claims allowed.
Applicant's amendment and IDS 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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626