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 .
Preliminary Remarks
The amendment filed on 02/24/2026 has been entered. Claims 1-3 have been amended, claims 7-8 are withdrawn from consideration, no claims have been canceled, and no claims have been added. Therefore, claims 1-8 remain pending in the application.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0399571 A1-Deutsch et al. (hereinafter Deutsch, has an effective filing date as of the provisional application), and further in view of US 2019/0369090 A1-Weener et al (hereinafter Weener).
Regarding claim 1, Deutsch teaches an evaluation instrument for a compound produced by a cell (para. [0001], lines 1-5; device 10, para. [0101], line 2, Fig. 1A), comprising: a holding space (macro-well 12, para. [0102], line 2, Fig. 1A) for holding a suspension containing the cell, and a through hole (through-hole 14, para. [0102], line 2, Fig. 1A) that is formed at a bottom of the holding space, wherein the through hole is filled with a substance (through-hole 14 is filled with a hydrogel matrix 16, para. [0102], line 2, Fig. 1A) that is impermeable to the cell and allows the compound to move therethrough. However, Deutsch does not explicitly teach a through hole having an inlet and outlet, wherein the through hole is formed vertically below the holding space, and wherein an opening are of the inlet is larger than an opening of the outlet.
Weener teaches a method of performing an assay for a compound using a device (390) comprising with a plurality of wells (340), said plurality of wells (340) containing cells and liquid is transferred from the wells (340) to a substrate (abstract; para. [0001]-[0005]). Further, Weener teaches a through hole (through-holes 370, para. [0080], line 3, Fig. 3P) having an inlet and outlet (shown below in annotated Fig. 3P below), wherein the through hole (hole 370, Fig. 3P) is formed vertically below the holding space and wherein an opening of the inlet is larger than an opening of the outlet, also shown below in annotated Fig. 3P below), which reads on the instant claim limitation of a through hole having an inlet and outlet, wherein the through hole is formed vertically below the holding space, and wherein an opening are of the inlet is larger than an opening of the outlet.
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It would have been obvious to one of ordinary skill, in the art at the time, to further include a through hole having an inlet and outlet, wherein the through hole is formed vertically below the holding space, and wherein an opening are of the inlet is larger than an opening of the outlet as taught by Weener. Also, Weener teaches the device (390, Fig. 3P) comprises a plurality of wells (340, Fig. 3P), each comprising a through-hole (370) which extends from the well (340, which has a larger opening than the outlet of through-hole (370); and Weener teaches the substrate allows for a greater rate of transport of liquid in a direction transverse to the main plane of the substrate than in a direction parallel to the main plane. This helps to avoid cross-contamination and to keep the compound from a particular well with in more localized area of the substrate (para. 0037], lines 7-12).
Regarding claim 2, Deutsch teaches wherein the holding space is provided as a plurality of holding spaces (a plurality of micro-chambers 17, para. [0102], lines 3-4, Fig. 1A).
Regarding claim 3, Deutsch teaches a through hole and holding spaces. However, Deutsch does not explicitly teach the through hole is provided as a plurality of through holes each of which is independently for each corresponding one of the holding spaces.
Weener teaches a method of performing an assay for a compound using a device (390) comprising with a plurality of wells (340), said plurality of wells (340) containing cells and liquid is transferred from the wells (340) to a substrate (abstract; para. [0001]-[0005]). Further, Weener teaches a through hole (through-holes 370, para. [0080], line 3, Fig. 3P), where annotated Fig. 3P above shows the through holes (370) are formed independently for each corresponding one of the holding spaces (wells 340), which reads on the instant claim limitation of the through hole is provided as a plurality of through holes each of which is independently for each corresponding one of the holding spaces.
It would have been obvious to one of ordinary skill, in the art at the time, to further include through hole is provided as a plurality of through holes each of which is independently for each corresponding one of the holding spaces as taught by Weener, because Weener teaches the substrate allows for a greater rate of transport of liquid in a direction transverse to the main plane of the substrate than in a direction parallel to the main plane. This helps to avoid cross-contamination and to keep the compound from a particular well with in more localized area of the substrate (para. 0037], lines 7-12).
Regarding claim 4, Deutsch teaches wherein the holding spaces are connected to each other (Fig. 1A of Deutsch shows holding spaces—micro-chambers 17, are connected to each other, also shown in Fig. 1B).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0399571 A1-Deutsch et al. (hereinafter Deutsch, has an effective filing date as of the provisional application), in view of US 2019/0369090 A1-Weener et al (hereinafter Weener) as applied to claim 1 above, and further in view of US 2011/0020179 A1-Yue et al. (hereinafter Yue).
Regarding claim 5, modified Deutsch teaches the invention discussed above in claim 5. Further, modified Deutsch teaches the loading of a cell suspension of the multi-well plate (para. [0087], lines 4-7). Also, modified Deutsch teaches a holding space, also discussed above. However, Deutsch does not explicitly teach a holding space connected to a flow path.
For claim 5, Yue teaches a system for distribution of a biological sample including a substrate with a plurality of sample chambers, a sample introduction channel for each sample chamber, and a venting channel for each sample chamber, wherein the substrate is constructed of detection-compatible and assay-compatible materials (para. [0005], lines 1-7) and Yue teaches a sample is introduced in sample ports 60 which flows to main channels 70 (para. [0109], line 10-12, Fig. 2B); holding space (sample chambers 80—para. [0109], line 9-10), which reads on the instant claim limitation of a holding space connected to a flow path.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the modified multi-well plate and holding spaces of Deutsch and further include a holding space connected to a flow path as taught by Yue. Further, Yue teaches the introduction of sample via ports 60 allows flow to main channels 110 into sample chambers 80—holding spaces, para. [0109], lines 10-12, Fig. 2B), where Yue suggests the sample is able to be distributed through the device for testing.
Regarding claim 6, modified Deutsch teaches the invention discussed above in claim 5. Further, modified Deutsch teaches holding spaces, also discussed above. However, modified Deutsch does not explicitly teach a flow path extending linearly and holding spaces connected to either side of the flow path.
For claim 6, Yue teaches a system for distribution of a biological sample including a substrate with a plurality of sample chambers, a sample introduction channel for each sample chamber, and a venting channel for each sample chamber, wherein the substrate is constructed of detection-compatible and assay-compatible materials (para. [0005], lines 1-7) and Yue teaches main channels 70, para. [0109], lines 10-12, where Figs. 2A-B show channels 70 extending linearly), and Yue shows sample chambers 80 are connected to either side of the flow path—main channels 70), which reads on the instant claim limitation of a flow path extending linearly and holding spaces connected to either side of the flow path.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the modified multi-well plate and holding spaces of Deutsch and further include a flow path extending linearly and holding spaces connected to either side of the flow path, as taught by Yue. Further, Yue teaches the system allows for distribution of a biological sample that includes a means for distributing the sample to a plurality of sample chambers (para. [0009], lines 2-4).
Response to Arguments
Applicant’s arguments with respect to claim 1 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. More specifically, the current rejection above pertains to new reference(s) relied upon to address the newly amended claim limitations; the arguments filed rely on the reference or combination of references not currently being used in the present Office Action.
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 LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799