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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-8, 10, 13-18 are is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Toner et al. (US 2007/0264675 A1).
Regarding claim 1, Toner et al. teach:
1. A method comprising:
providing a substrate comprising a manifold comprising an inlet (see annotated Fig. 1 & Sample input port in Fig. 25 for example), a branching fluidic pathway coupled to the inlet, and a plurality of outlets (see annotated Figs. 1 & 25; see also output channels (¶ 0055) in Figs. 1, 4, 7, 25 for example),
a sample processing portion comprising a plurality of cell capture subarrays (e.g., cell binding/capture sites; see i.e., B. Cell Binding [...] by binding the cells to the surfaces of the device. The surfaces of such a device contain substances, e.g., antibodies or ligands for cell surface receptors, that bind a particular subpopulation of cells. This step in method may employ positive selection, i.e., the desired cells are bound to the device [...] ¶ 0070+; Combination of Devices The devices of the invention may be used alone or in any combination. In addition, the steps of the methods described herein may be employed in any order. A schematic representation of a combination device for detecting and isolating fetal red blood cells is shown in FIG. 25. ¶ 0107; The methods of the invention may be carried out on one integrated device containing regions for cell lysis, cell binding, arraying, and size based separation. ¶ 0108) coupled to a plurality of flow paths and disposed between the branching fluidic pathway and the plurality of outlets, wherein the sample processing portion is fluidically coupled to the inlet and the plurality of outlets (see annotated Figs. 1 & 25 for example);
flowing a sample comprising cells into the inlet and through the branching fluidic pathway and the plurality of flow paths of the sample processing portion (¶ 0009+),
thereby capable of distributing the cells substantially uniformly into the plurality of cell capture subarrays in the sample processing portion (see i.e., the chambers may have a cross-sectional area equal to the combined areas of any input (or output channels) in order to ensure a uniform velocity of flow through the device ¶ 0057; see also An entrance region devoid of obstacles is then incorporated into the design to ensure that blood cells are uniformly distributed when they reach the region where the obstacles are located. Similarly, the outlet is designed with an exit region devoid of obstacles to collect the exiting cells uniformly without damage. ¶ 0080); and
capturing cells at the cell capture subarrays (see B. Cell Binding ¶ 0070+ for example).
Regarding the limitation “flowing a sample [...] thereby distributing the cells substantially uniformly into the plurality of cell capture subarrays in the sample processing portion”, the limitation is directed to the results obtainable from the step of flowing a sample comprising cells into the inlet and through the branching fluidic pathway and the plurality of flow paths of the sample processing portion, and the outcome is dependent on various conditions, such as the fluid properties, flow rate, the sampling chip surface chemistry, etc. The limitation merely states the result of flowing the sample, and therefore, adds nothing to the patentability or substance of the claim. Thus, the reference anticipates the subject matter of the claimed invention.
Annotated Fig. 1 of Toner et al. (US 2007/0264675 A1)
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Annotated Fig. 25 of Toner et al. (US 2007/0264675 A1)
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Regarding claims 2, 3, 5-8, 10, 13-18, Toner et al. teach:
2. The method of claim 1, further comprising, after capturing the cells, preparing the captured cells for analysis by delivering at least one processing reagent to the cells (see i.e., the population of cells containing the desired cells is collected for analysis or further processing. ¶ 0070; see also ¶ 0094, 0110).
3. The method of claim 1, wherein the sample containing cells is a biological fluid sample (¶ 0009+).
5. The method of claim 1, wherein the branching fluidic pathway comprises a symmetrical bifurcating network (see Figs. 1, 25 for example).
6. The method of claim 1, further comprising the step of staining the captured cells within the cell capture subarrays (see ¶ 0094 for example).
7. The method of claim 6, wherein staining the captured cells comprises applying a fluorescent stain (see ¶ 0094, 0110 for example).
8. The method of claim 1, further comprising performing a molecular assay on the captured cells within the sample processing portion (see ¶ 0094, 0097, 0110 for example).
10. The method of claim 8, wherein the molecular assay is a fluorescence detection assay (see ¶ 0094, 0110 for example).
13. The method of claim 1, further comprising heating the sample processing portion to a predetermined temperature after the capturing step (e.g., fluorescence in situ hybridization (FISH) ¶ 0094, 0110; PCR ¶ 0097. Both analysis require heating to a predetermined temperature).
14. The method of claim 1, further comprising lysing one or more cells captured at the cell capture subarrays (see ¶ 0107 for example).
15. The method of claim 1, wherein the cell capture subarrays comprise a plurality of wells (e.g., Reaction and Dilution Chambers ¶ 0057).
16. The method of claim 1, wherein capturing cells at the cell capture subarrays comprises capturing the cells in single cell format (see ¶ 0010-0011 & Fig. 19 for example).
17. The method of claim 1, further comprising providing affinity molecules configured to bind components of interest at the substrate (see ¶ 0010-0011 for example).
18. The method of claim 1, wherein the sample comprises one or more white blood cells (see ¶ 0068 for example).
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
The amendments have been considered and the 35 USC § 112 rejections have been withdrawn.
In response to the Applicant's argument that “Toner does not recite the claimed device. Toner's lysis device has distribution channels feeding into serpentine mixing chambers. Toner's cell binding device has a flat-plate obstacle channel with one inlet and one outlet. Neither device positions a sample processing portion comprising cell capture subarrays between a branching fluidic pathway and a plurality of outlets.”, Examiner disagrees.
Toner et al. teach, among other things, a sample processing portion comprising a plurality of cell capture subarrays (e.g., cell binding/capture sites; see i.e., B. Cell Binding [...] by binding the cells to the surfaces of the device. The surfaces of such a device contain substances, e.g., antibodies or ligands for cell surface receptors, that bind a particular subpopulation of cells. This step in method may employ positive selection, i.e., the desired cells are bound to the device [...] ¶ 0070+; Combination of Devices The devices of the invention may be used alone or in any combination. In addition, the steps of the methods described herein may be employed in any order. A schematic representation of a combination device for detecting and isolating fetal red blood cells is shown in FIG. 25. ¶ 0107; The methods of the invention may be carried out on one integrated device containing regions for cell lysis, cell binding, arraying, and size based separation. ¶ 0108) coupled to a plurality of flow paths and disposed between the branching fluidic pathway and the plurality of outlets, wherein the sample processing portion is fluidically coupled to the inlet and the plurality of outlets (see annotated Figs. 1 & 25 for example). As noted by the Court, "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001).
Applicant’s arguments to claim 4 are moot since the claim has been cancelled.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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