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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-21, in the reply filed on 02/05/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/20/2023, 03/01/2024, 10/15/2024 and 02/09/2026 have been considered and made of record.
Regarding information disclosure statements (IDS) submitted on 10/15/2024, it should be noted that the document numbers of the cited U.S. Patent Publications US-2003/030184, US 2011-014688, US-2014-322806, US-2015-247112, US-2016-032229, US-2019-054461, appear to be incomplete/incorrect document numbers.
Claim Objections
Claims 2-21 are objected to because of the following informalities: In claims 2-21, “The assembly of claim” should read -- The micro-well array plate (MWAP) assembly of claim -- for consistency. Appropriate correction is required.
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.
Claim(s) 1-5 and 9-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varadarajan (already of record, US 2019/0054461).
Regarding claim 1, Varadarajan discloses micro-well array plate (MWAP) assembly comprising: a top plate having a plurality of macro-wells arranged in an array (top frame having a plurality of micro-wells; the micro-wells can be mm-sized; see [0035] and FIG. 2 of Varadarajan, annotated and reproduced below);
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a bottom plate operable to be secured to the top plate, the bottom plate having a
plurality of micro-wells (bottom plate having a plurality of nano-wells; the nano-wells can be µm-sized; see [0035] and FIG. 2 of Varadarajan, annotated and reproduced above); and a well grid formed when the bottom plate is secured to the top plate, the well grid defined via the plurality of macro-wells and the plurality of micro-wells with each of the
plurality of macro-wells isolating a set of the plurality of micro-wells from another set of the
plurality of micro-wells (top plate is coupled to the bottom plate such that each macro-well of the macro-wells is aligned with a set of micro-wells of the micro-wells; see FIGS. 2 and 3A-3B; [0035]).
Regarding claim 2, the plurality of micro-wells of Varadarajan are structurally the same as the instant plurality of micro-wells and thus considered to be are operable to provide varying degrees of three-dimensional (3D) spatial confinement
Regarding claim 3, Varadarajan further discloses wherein, each of the plurality of macro-wells includes a cavity surrounded by a perimeter
wall extending from a bottom surface of the top plate to a top surface of the top plate (see annotated FIG. 2 above: wells of the top plate is surrounded by a wall extending between a top surface of the plate and a bottom surface of the plate),
and two neighboring ones of the plurality of macro-wells share a portion of the perimeter wall (see annotated FIG. 2 above).
Regarding claim 4, Varadarajan further discloses wherein, at least a portion of the plurality of micro-wells includes one or more triangular
micro-wells, square pyramids with a bottom surface, or pyramids with a bottom common
point to provide asymmetric confinement (microwells of the bottom plate can be square frustum-shaped; see [0035]-[0036], [0039], and claims 8-9), and each of the plurality of micro-wells includes a micro-well perimeter wall with an
upper perimeter of a first length equal to or longer than a second length of a lower
perimeter (microwells of the bottom plate can be square frustum-shaped).
Regarding claim 5, Varadarajan further discloses wherein the isolating causes the set of the plurality of micro-wells to be fluidly sealed from the another set of the plurality of micro-wells (as shown in FIG. 2 above, when the top plate and bottom are coupled together, a plurality of sets of microwells on the bottom plate are separated from one another; see also [0026]).
Regarding claim 9, Varadarajan further discloses wherein the top plate and the bottom plate are permanently bonded together (e.g., by adhesive or thermal bonding; [0032]).
Regarding claim 10, Varadarajan further discloses wherein at least a portion of the plurality of microwells includes straight sidewalls or slanted sidewalls and a same depth (FIG. 2 and [0042]).
Regarding claim 11, Varadarajan further discloses wherein at least a portion of the plurality of microwells has straight sidewalls with bottom surfaces at varying depths (at least two microwells with different depth; see FIGS. 2 and 4, [0042] and [0049]).
Regarding claim 12, Varadarajan further discloses wherein each of the plurality of micro-wells includes straight sidewalls extending
perpendicular to a base with a bottom surface or slanted sidewalls extending oblique to the base without the bottom surface (see FIG. 2 and [0035], [0039]: square microwells with a base).
Regarding claim 13, Varadarajan further discloses wherein each of the plurality of micro-wells is defined by a plurality of sidewalls extending
perpendicular to a bottom surface, and the plurality of sidewalls have varying depths among different ones of the plurality
of micro-wells thereby defining varying depths among the different ones of the plurality of micro-wells (at least two microwells with different depth; see FIGS. 2 and 4, [0042] and [0049]).
Regarding claim 14, the MWAP assembly of Varadarajan are structurally the same as the instant MWAP assembly and thus considered to be a single cell MWAP assembly operable to spatially induce dormancy of tumor cells as a dormancy assay.
Regarding claim 15, Varadarajan further discloses wherein the micro-wells have a cross-section dimension ranging from 8 to 25 μm (20-500 microns; [0042]).
Regarding claim 16, the MWAP assembly of Varadarajan are structurally the same as the instant MWAP assembly and thus considered to be are operable to “generate clonal multi-cellular tumor spheroids (MCTS) of a fixed size as a spheroid assay.”
Regarding claim 17, Varadarajan further discloses wherein the micro-wells have a cross-section dimension ranging from 26 to 300 μm (20-500 microns; [0042]).
Regarding claim 18, the MWAP assembly of Varadarajan are structurally the same as the instant MWAP assembly and thus considered to be are operable to “quantify effects of tumor drugs and radiation therapy to disrupt growth of a single tumor cell with at least one of a plurality of drugs into a colony of clonal cells as a Clonogenic Assay, each of the plurality of macro-wells is operable to be seeded with the single tumor cell with the at least one of the plurality of drugs.” the plurality of micro-wells includes 96 sets of micro-wells ([0037], [0045]).
Regarding claim 19, Varadarajan further discloses wherein each of the plurality of micro-wells is a square micro-well (see [0035]-[0036], [0039], and claim 8).
Regarding claim 20, the plurality of micro-wells of Varadarajan are structurally the same as the instant plurality of micro-wells and thus considered to be are operable “to hold 50 or more clonal cells.”
Regarding claim 21, Varadarajan further discloses wherein the plurality of micro-wells includes 2000 to 5000 micro-wells such that the MWAP assembly is operable to have a high throughput ([0057])
Therefore, Varadarajan meets and anticipates the limitations set forth in claim(s) 1-5 and 9-21.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Varadarajan as applied to claim 1 above, and further in view of Deutsch et al. (already of record, US 2011/0014688; hereinafter “Deutsch”).
Regarding claims 6-8, Varadarajan discloses the micro-well array plate (MWAP) assembly according to claim 1. Varadarajan discloses wherein the claimed grid is formed when the bottom plate is secured to the top plate (see FIG. 2). As shown in FIG. 2 of Varadarajan, the top plate includes a lower circumferential perimeter surrounding each of the plurality of macro-wells, and the bottom plate includes an upper circumferential perimeter surrounding a different set of the plurality of micro-wells (see also [0039]). Varadarajan does not explicitly disclose wherein the lower circumferential perimeters of the macro-wells of the top plate abut to the plurality of upper circumferential perimeters of the plurality of micro-wells of the bottom plate. Deutsch discloses an assembly comprising a substrate having a plurality of wells (FIGS. 9-10) and walls (14) defining a well and having a wall perimeter edge is affixed along a perimeter edge of the substrate (FIGS. 9-10; [0048]). In view of Deutsch, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the micro-well array plate assembly of Varadarajan with the assembly of Deutsch such that the lower circumferential perimeters of the top plate abut to the upper circumferential perimeters, to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to reduce the volume of the microwells, thereby conserving the amount of media used, a consideration of particular importance when expensive media is employed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Beebe et al (US 2020/0190454) discloses a top plate with a well and a bottom plate with a plurality of wells.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799