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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7, 9-11, 13-15, 18-22, 25, 35, 38, and 39 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended independent claim 1 to include additional limitations regarding the cell extraction module and the micropore capillary, and argued that the combination of Kellogg et al., in view of Ricicova et al., (cited in the previous Office Action) do not meet the claim limitations. After further consideration, the Examiner has found Applicant’s arguments to be persuasive, thus the combination of Kellogg et al., in view of Ricicova et al., is no longer relied upon. However, as detailed below, independent claim 1 now stands rejected under 35 U.S.C. 102 as being anticipated by Handique et al., (US 2013/0190212). Because reference to Handique et al., is newly cited, the Examiner will not argue the merits of its teachings here, but will instead rely on the rejection detailed below.
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, 7, 9, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Handique et al., (US 2013/0190212).
For claim 1, Handique et al., teach a cell capture system comprising an array (planar wafer, paragraph 0032) having a cell receiving side (paragraph 0032, top portion of figure 1 where fluid enters array), a fluid evacuating side (paragraph 0035), a plurality of pores (cell extraction module, paragraph 0032, figure 1 #222) wherein each pore comprises a chamber (well) on the cell receiving side (paragraph 0032) and a pore channel (micropore capillary, paragraph 0032) on the fluid evacuating side (paragraph 0035) wherein the plurality of pores can include 10,000 pores (paragraph 0036). Handique et al., also teach the well of the chambers being wider than the pore channels (figure 1) and adapted to trap cells while allowing fluid flow (paragraph 0035), and the pore capillary open to the cell receiving side (figure 1), adapted to allow fluid flow (paragraph 0035), and having a dimension at the first end ranging from 1 to 25 microns (paragraph 0038).
For claim 7, Handique et al., teach multiple arrays wherein one array has a large pore channel, a second array has a medium pore channel, and a third array having a small pore channel for capturing large, medium, and small cells (paragraph 0033).
For claim 9, Handique et al., teach the pores capturing a single cell (paragraph 0035).
For claim 20, Handique et al., teach a planar substrate made of silicon (paragraph 0058).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-4, 10, 11, 13-15, 21, 22, 25, 35, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al., (US 2013/0190212) in view of Handique et al., (US 2014/0357511).
Regarding claims 2 and 3, Handique et al., ‘212 do not teach a planar disc having a surface with a roughened Wenzel pattern.
Handique et al., ‘511 teach a system for isolating cells comprising a planar surface (paragraph 0023) being textured and having any suitable feature to facilitate cell reception and/or retention (paragraph 0026). Handique et al., teach that it is advantageous to provide a textured surface as a means of facilitating desired fluid flow behavior to attract or repel a particle type (paragraph 0026).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 wherein a hydrophilic surface is roughened in a Wenzel pattern in order to facilitate the desired fluid flow behavior to attract or repel a particle type as taught by Handique et al., ‘511.
Regarding claims 4 and 21, Handique et al., ‘212 teach rotating the cell capture system (paragraph 0101). With respect to claim 21, the Examiner notes that the predetermined angular speed and centrifugal force exerted on the sample are intended use limitations that do not impart structure to the claimed device.
Regarding claims 10, 11, 13, and 22, Handique et al., ‘511 do not teach affinity moieties coated on a well surface.
Handique et al., ‘212 teach a system for isolating cells wherein wells are coated with affinity moieties (paragraph 0051). Handique et al., teach that it is advantageous to provide affinity moieties as a means of attracting a cell of interest towards a well (paragraph 0051).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 wherein cells are coated with affinity moieties in order to provide a means of attracting a cell of interest towards a well as taught by Handique et al., ‘511.
Regarding claims 14 and 15, Handique et al., ‘212 do not teach a cell extraction module comprising a pair of electrodes.
Handique et al., ‘511 teach a system for isolating cells comprising electrodes located at a well surface (paragraph 0032). Handique et al., ‘511 teach that it is advantageous to provide electrodes at a well surface in order facilitate detection of bioelectrical signals and to stimulate the contents of the well (paragraph 0032).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 wherein electrodes are provided at a well surface in order to facilitate detection of bioelectrical signals and to stimulate the contents of a well as taught by Handique et al., ‘511.
For claim 25, Handique et al., ‘212 teach the cell capture system comprising a pump (paragraph 0068).
Regarding claim 35, Handique et al., ‘212 teach applying a fluid sample to a cell extraction device (paragraph 0031) and extracting a cell from the sample (paragraph 0031). Handique et al., ‘212 do not teach rotating the device such that centrifugal force is exerted on the fluid sample.
Handique et al., ‘511 teach a system for isolating cells wherein a substrate is rotated such that fluid is pushed toward the wells of an array by centripetal force to capture cells in the wells (paragraphs 0039, 0056). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Handique et al., ‘511 clearly teach that centripetal force can be utilized to capture cells in a well, thus one of ordinary skill in the art would have found it obvious from the teachings of Handique et al., ‘511 that rotation of a device can be utilized to exert centripetal force on a fluid in order to capture cells in a well. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 to capture cells in a well by rotating the device and applying centripetal force to a sample taught by Handique et al., ‘511 as combining prior art elements according to known methods requires only routine skill in the art.
Regarding claim 39, Handique et al., ‘212 teach applying a negative pressure at an outlet manifold (paragraphs 0031, 0056).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al., (US 2013/0190212) in view of Handique et al., (US 2014/0357511) as applied to claim 14 above, and further in view of Marshall et al., (US 11,874,288).
Regarding claim 18, Handique et al., ‘212 in view of Handique et al., ‘511 do not teach an antenna disposed in a well.
Marshall et al., teach well plates having antenna embedded in the well and inserted into the well plate (column 13 lines 2-11). Marshall et al., teach that it is advantageous to provide antenna located in, or in proximity to wells in order to enable fluid level sensing, inter-well signal sensing, and identification of a well plate type (column 12 lines 62-67).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 in view of Handique et al., ‘511 to provide antenna located in, or in proximity to the wells in order to enable fluid level sensing, inter-well signal sensing, and identification of a well plate type as taught by Marshall et al.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al., (US 2013/0190212) in view of Blainey et al., (US 2018/0071738).
Regarding claim 19, Handique et al., do not teach a well labelled with a unique identification tag.
Blainey et al., teach a microplate (paragraph 0044) wherein each well of the microplate comprises a unique barcode (paragraphs 0045, 0046). Blainey et al., teach that it is advantageous to provide unique barcodes for each well as a means of identifying which molecular species are present in merged droplets (paragraph 0045).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., ‘212 in view of Handique et al., ‘511 to provide wells having a unique identification tagin order to identify molecular species in a droplet or merged droplets as taught by Blainey et al.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al., (US 2013/0190212) in view of Fan et al., (US 2016/0289669).
Regarding claim 38, Handique et al., teach optical interrogation of the cell capture system (paragraph 0106), but do not teach utilizing a laser diode and a photodiode array.
Fan et al., teach a system for barcoding nucleic acid targets in single cells wherein the device comprises a laser diode(paragraph 0413). and a photodiode array (paragraph 0415). Fan et al., teach that it is advantageous to provide an optical imaging capability as a means of determining whether the microwells are uniformly and optimally populated with cells (paragraph 0408).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Handique et al., to provide an optical sensor comprising a laser diode and a photodiode array in order to determine whether the microwells are uniformly and optimally populated with cells as taught by Fan et al.
Conclusion
Applicant's amendment 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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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