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
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 .
Status of the Claims
Claims 1-21 are pending. Claims 1 and 4-7 are the subject of this NON-FINAL Office Action.
Election/Restrictions
Applicants’ election of Group I with traverse in the reply filed on 07/22/2026 is acknowledged. Applicants argue that unity of invention exists between the groups, and no search burden exists. First, claim 8 does not require the method of claim 1; rather a product (“obtained” by the method of claim 1, or product-by-process). Thus, the product is all that matters. Second, search burden is immaterial to unity of invention. Thus, the lack of unity conclusions are maintained.
Claims 2-3 and 8-21 are withdrawn.
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; or
(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 and 4-7 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by SCHNALL-LEVIN (US 20200407781).
As to claim 1, SCHNALL-LEVIN teaches a method for labelling individual cells or organelles within a tissue sample with a localisation nucleic acid (Title; Abstract), the method comprising: a) providing a nucleic acid array comprising a substrate and localisation nucleic acids, wherein each localisation nucleic acid comprises, from the 5′ end to the 3′ end: i. a first constant sequence; ii. a localisation sequence that is indicative of the position of the nucleic acid on the nucleic acid array; and iii. a second constant sequence; wherein the localisation nucleic acid is attached, covalently or non covalently, to the substrate of the nucleic acid array (Figs. 9-11; paras. 0336, 0349, 0360); b) contacting the nucleic acid array with a tissue sample so that the localisation nucleic acids are at the interface between the nucleic acid array and the tissue sample (Figs. 9-11); c) releasing all or part of the localization nucleic acids comprising all or part of the first constant sequence, the localization sequence, and all or part of the second constant sequence or a nucleic acid complementary thereto (Figs. 2 & 11; paras. 0271ff, 0360, 0724-25); d) binding of the released nucleic acids comprising the localisation sequence or its complementary sequence, to cells or organelles of the tissue sample via a ligand bound to a receptor or receptors of cells or organelles in the tissue sample (Fig. 10); e) dissociating the tissue sample and recovering individualized cells or organelles, wherein at least a sub-population of the individualised cells or organelles is labelled with the nucleic acid comprising the localisation sequence or its complementary sequence (Fig. 2). To summarize, SCHNALL-LEVIN teaches spatial analyses using capture probes (with spatial barcodes and “constant sequences”) immobilized on solid supports, which are released to interact with analyte capture agents, which bind to cell structures using ligands such as antibodies.
As to claim 4, SCHNALL-LEVIN teaches the ligand binds to a receptor or receptors at the surface of or inside the cells, or the surface of or inside an organelle of the cells (paras. 0350ff).
As to claim 5, SCHNALL-LEVIN teaches the 5′ end or the 3′ end of the localisation nucleic acid is attached, covalently or non-covalently, optionally via a spacer sequence and/or linker, to the substrate of the nucleic acid array (solid support of e.g. Fig. 10 can be array; paras. 0225, 0242ff).
As to claim 6, SCHNALL-LEVIN teaches the receptor or receptors at the surface or inside the cells or any organelles of the cells bound by the ligand is ubiquitously present at the surface or inside all or most of the cells or any organelles of the cells in the tissue sample (paras. 0350ff).
As to claim 7, SCHNALL-LEVIN teaches the localisation nucleic acids form spots at the surface of the nucleic acid array, and all localisation nucleic acids of a same spot comprise a same localisation sequence which is specific for one or more spots (spatial barcode 1008 of e.g. Fig. 10; paras. 0005, 0086).
SCHNALL-LEVIN also teaches to compartmentalize the barcoded cells into emulsion droplets or nanowells that contain compartment barcoded oligos (e.g. Figs. 15-20).
Allowable Subject Matter
The following subject matter found in the specification is allowable: the combination of claims 1, 8 and 10, amended to correct the dependency issue in claim 8. Claims 8 and 10 require the additional features of a cell trapping technique before the well-known spatial analysis technique of claim 1, all on the same array of claim 1. The cell trapping technique uses actuatable hydrogel compartments with compartment barcode oligos to track single cells of a tissue as shown in Figures 25-28. This allows single-cell resolution that can be mapped back to the tissue. This cell-trapping technique is not present in the prior art cited herein.
Prior Art
The following prior art is also pertinent: US 20210155982 (Figs. 2, 40-41 & 46); US 20150148239; US 20180057873; US 20180305681; US 20200370105; US 20220010367; US 20200332351; US 20200370095; US 20210062272; US 20220326251; US 20210199660; US 20210222242; US 20230143569.
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/YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
