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 .
DETAILED ACTION
Responsive to claim set of 22JUL2024
Claims pending 1,2,4,6,13-23,42-46
Claims currently under consideration 1,2,4,6,13-23,42-46
Priority
The present application has been published as published as 20240352448.
This application has an actural filing date of 01/24/2024; and is a 371 of
PCT/US2022/053883 (aka WO2023122309) filed 12/22/2022
PCT/US2022/053883 has PRO 63/293,589 12/23/2021
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 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.
Claims 1,2,4,6,13-23,42-46 are rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Steemers (WO 2019/236599 aka PCT/US2019/035422 – IDS entry 4/18/2024) as evidenced by the Takara SMARTer™ PCR cDNA Synthesis Kit User Manual (included with this action as an appendix)
Steemers teaches throughout the document and especially paragraph 00317, the abstract and p 65+, next generation nucleic acid sequencing featuring combinatorial indexing of a heterogeneous plurality of single cells (sci-RNA-seq). More specifically in figures 2 & 4 as described in the detailed description starting with paragraph 0097 at p 29 as well as exemplified in the examples, Steemers: provides a first set of cellular source sub-portions, each sub-portion comprising multiple cellular sources of an initial plurality of cellular sources (e.g. lysed mouse embryo cell nuclei at various stages of development and/or tissues thereof); generates first identifier tagged nucleic acids in the multiple cellular sources of each sub-portion of the first set using amplification, ligation, tagmentation and/or optionally a template switching mediated reaction employing a template switch oligonucleotide (TSO)* comprising a first identifier (index), wherein the first identifier of the template switch oligonucleotides employed in the different sub-portions of the first set is the same within a given sub-portion but differs between the different sub-portions; pools the cellular sources of the sub-portions just generated to provide a first pool of cellular sources comprising first identifier tagged nucleic acids; apportions the first pool of cellular sources into a second set of sub-portions each comprising multiple cellular sources comprising first identifier tagged nucleic acids; and finally produces cell-source identifiable nucleic acids from the multiple cellular sources in each sub-portion of the second set that include both a first identifier and a second identifier, wherein the second identifiers of each sub-portion of the second set are the same within a given sub-portion but different between different sub-portions - all in an effort to prepare a plurality of cell-source identifiable collections of nucleic acids from the initial plurality of cellular sources, such that nucleic acids of each cell-source identifiable collection of nucleic acids comprise a unique combination of first and second identifiers that indicates the cellular source of the nucleic acids.
The foregoing reads on claims: 1,2,4,14*,15,16,17,18,20,21,22,43*,44,45,46. Further respectively, in paragraphs 00159; 00108; and 0013, like claims 6 & 13;19 & 42; and 23, Steemers teaches indices with a compartment index + UMIs (unique molecular identifiers); three or more pooling followed by indexing steps; and immune cell sources.
* The SMARTer™ kit referred to by Steemers in paragraph 00137 at p 43 inherently produces a second cDNA strand (with an index copied from Steemers’ TSO): see figure 1 and p 12 therein the Takara manual
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684