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 Claims
Claims 1-11, 13-15, 25, 27, 29, 31-32 and 37 are pending. Claims 1-6, 9, 11, 13, 25, 27, 29, 31-32 and 37 have been amended. Claims 1-11, 13-15, 25, 27, 29, 31-32 and 37 have been examined.
Information Disclosure Statement
The Information Disclosure Statements filed 10/08/2025, 01/02/2026 and 03/26/2026 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 13-15, 25, 27, 29, 31-32 and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it recites “assay reagents disposed upon the substrate layer” and later states “wherein the reaction chamber contains the assay reagents” and it is unclear which layer contains the assay reagents. For further prosecution, the claim will be interpreted as either the substrate layer or the reaction layer can contain the assay reagents.
Claim 1 is indefinite because it states that “the reaction chamber contains the assay reagents” but since the reaction layer contains a first reaction chamber and a second reaction chamber, it is unclear which chamber is being referenced to contain the assay reagents.
Claim 25 is indefinite because it states that the circuitous channel is downstream from the reaction chamber but it is unclear which reaction chamber (first or second) is being referenced.
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.
Claim(s) 1-3, 5-11, 13-15, 25, 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (WO 2016/065300, IDS) in view of Babiel et al. (WO 2020/160472, IDS) and Rammohan et al. (US 2018/0161772, IDS).
Regarding claim 1, Eshoo teaches throughout the publication microfluidic cartridges configured to process a biological sample (abstract) and more specifically, a multi-layered microfluidic assay device comprising a cassette (cartridge) comprising a plurality of layers (page 32, lines 20-25) comprising:
a substrate layer (page 32, lines 26-34, membrane layer 1);
a microfluidic layer comprising a channel layer comprising a continuous channel (Eshoo, page 33, lines 6-29, layers 4-5) and a reaction layer in fluid communication with the channel layer, the reaction layer comprising a reaction chamber comprising a first reaction chamber, a second reaction chamber, and a mixing channel fluidly coupling the first reaction chamber to the second reaction chamber, wherein the reaction chamber contains the assay reagents (Eshoo, page 25, lines 18-31, chambers connected by microchannels; Eshoo, page 33, lines 6-29, layers 4-5).
While Eshoo does not teach that the substrate layer comprises a substrate layer comprising a non-fouling polymer layer coated on a glass substrate, Babiel teaches throughout the publication optimized surface chemistry to allow for optimum protein microarray adhesion and assay detection for immunoassay development (paragraph 0122). More specifically, Babiel teaches a chip (paragraphs 0131 and 0136) comprising a substrate layer comprising a non-fouling polymer layer coated on a glass substrate (paragraphs 0018, 0144 and 0147), wherein assay reagents can be disposed on the substrate layer (paragraph 0018 and 0184).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the substrate of Eshoo to incorporate a non-fouling polymer layer on the substrate as taught by Babiel because it would have been desirable to prevent background binding to the substrate (Babiel, paragraph 0119) by allowing for optimum protein adhesion (Babiel, paragraph 0122).
While Eshoo and Babiel does not specifically teach that the continuous channel is a continuous circuitous channel, Rammohan teaches a microfluidic device wherein the device comprises a circuitous channel for flow of reagents, samples or other materials or fluids (paragraph 0048).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the continuous channel of Eshoo with a circuitous channel as taught by Rammohan because it would have been desirable to agitate or otherwise affect the flow of fluid to encourage mixing (Rammohan, paragraph 0048).
Regarding claim 2, Eshoo in view of Babiel teach the device further comprising a cover layer affixed to the microfluidic layer (layer 7, page 34, lines 1-3), wherein the reaction layer is disposed between the channel layer and the cover layer and wherein the substrate layer forms a base layer adjacent the channel layer (Eshoo, page 33, line 6 – page 34, line 3)
Regarding claim 3, while Eshoo does not specifically teach that the mixing channel is offset from the first reaction chamber, Rammohan teaches that chambers of the microfluidic device can be connected with zigzag patterns (paragraph 0048) and therefore it would be obvious to one skilled in the art to incorporate a zigzag channel as taught by Rammohan between the chambers of Eshoo because it would have been desirable to encourage mixing and fluid flow (Rammohan, paragraph 0048).
Regarding claim 5, Eshoo in view of Babiel teaches the device wherein the assay reagents comprise one or more detection reagents and one or more capture reagents that are spatially separated and disposed on the non- fouling polymer layer to align with the first and second reaction chambers (Eshoo, page 26, lines 17; Babiel, paragraphs 0024, 0165).
Regarding claim 6, Eshoo in view of Babiel teaches the device wherein the detection reagents are placed on layers of a water soluble excipient, disposed on the substrate spatially at a position corresponding to the first reaction chamber, and wherein the capture reagents are disposed on the substrate spatially at a position corresponding to the second reaction chamber (Babiel, paragraphs 0163-0164).
Regarding claim 7, Eshoo teaches the device wherein the cover layer is attached to the reaction layer via an adhesive layer (Eshoo, page 31, lines 5-17).
Regarding claim 8, Eshoo teaches the device wherein the channel layer, the reaction layer, and the cover layer are interconnectedly vented to ambient atmospheric pressure (Eshoo, page 33, line 6 – page 34, line 4).
Regarding claim 9, Eshoo teaches the device wherein the cover layer (7) comprises an inlet that is in fluid communication with an outlet disposed on the reaction layer, the inlet and outlet being in fluid communication with the plurality of layers and a reservoir disposed at the inlet and an absorbent waste pad disposed at the outlet on the reaction layer (Eshoo, page 33, line 31 – page 34, line 3; page 38, line 30 – page 39, line 8; page 58, lines 6-17).
Regarding claim 10, Eshoo in view of Babiel teaches the device wherein the non-fouling polymer layer is a poly(oligoethylene glycol methyl ether methacrylate) (POEGMA) (Babiel, paragraph 0130).
Regarding claim 11, Eshoo teaches the device wherein the channel layer is an adhesive layer or an injection molded plastic layer (Eshoo, page 19, lines 10-12 and page 33, lines 6-29).
Regarding claim 13, Modified Eshoo in view of Rammohan teaches the device wherein the continuous circuitous channel comprises a first channel and a second channel in fluid communication with the first channel that is oriented transverse to the first channel (Rammohan, paragraph 0048; for example see zig zag pattern of Figure 2). While Rammohan does not explicitly teach that the first channel is oriented parallel to the reaction chamber, it would be obvious to modify the relative position of chambers and channels as an obvious matter of design choice unless a new and unexpected result is produced (see MPEP 2144.04).
Regarding claim 14, Eshoo teaches the device wherein the device is configured to operate in a substantially vertical orientation aligned with gravity (page 32, lines 26-30).
Regarding claim 15, Eshoo in view of Babiel teach the device wherein the device is configured to operate via gravity-assisted capillary flow for sample transit through the microfluidic layer (Eshoo, page 32, lines 26-30 and Babiel, paragraph 0131).
Regarding claim 25, Eshoo in view of Babiel and Rammohan teach the device wherein the continuous circuitous channel is downstream from the reaction chamber (Eshoo, page 33, lines 6-29, layers 3-5) and wherein the first channel and second channel each comprises one or a plurality of loops (Rammohan, paragraph 0047, round, curved or more specifically, curved or U-shaped). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the continuous channel of Eshoo with looped shaped channel as taught by Rammohan because it would have been desirable to agitate or otherwise affect the flow of fluid to encourage mixing (Rammohan, paragraph 0048) and since Rammohan teaches that channel shape can be optimized based on the desired application and function of the channels (paragraph 0047).
Regarding claim 27, Eshoo teaches the device further comprising a sample inlet on the reaction layer configured to deliver a sample directly into the second reaction chamber (page 38, line 30-32 and page 39, lines 19-22).
Regarding claim 29, Eshoo teaches the device further comprising a sample inlet configured to deliver the sample directly into the first reaction chamber (page 38, line 30-32 and page 39, lines 19-22).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (WO 2016/065300) in view of Babiel et al. (WO 2020/160472) and Rammohan et al. (US 2018/0161772), as applied to claim 1 above (hereinafter “Modified Eshoo”), and further in view of Proper et al. (US 2011/0303303, IDS).
Regarding claim 4, Modified Eshoo teaches the device as described above but fails to teach that the offset mixing channel comprises a P-trap bend to prevent clogging.
Proper teaches throughout the publication fluidic control structures (abstract) and more specifically teaches a channel that comprises a P-trap bend (150) to prevent clogging (Figure 10 and paragraph 0042).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the mixing channel in the device of Modified Eshoo, a P-trap bend as taught by Proper because it would have been desirable to prevent clogging and ensure any unwanted fluid materials are prevented from clogging the channel (Proper, paragraph 0042).
Claim(s) 37 are rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (WO 2016/065300) in view of Babiel et al. (WO 2020/160472) and Rammohan et al. (US 2018/0161772, IDS), as applied to claim 1 above (hereinafter “Modified Eshoo”), and further in view of Unger et al. (US 2003/0138829, IDS).
Regarding claim 37, Modified Eshoo teaches the device as described above. Furthermore, Modified Eshoo teaches a method for analyzing a biological sample, the method comprising:(a) orienting the device of claim 1 (described above) with gravity with the sample inlet at the top (Eshoo, page 33, lines 1-4, input channel); (b) loading a sample into the sample inlet (Eshoo, page 38, lines 30-32 and page 39, lines 18-24); (c) loading a wash buffer into the wash reservoir of the device (Eshoo, page 54, lines 1-6); (d) allowing the sample and wash buffer to enter and traverse completely through the device (Eshoo, page 58, lines 6-9 and page 68, lines 7-25); (e) imaging the device to measure a signal for the target analytes and controls (Eshoo, page 62, lines 23-25).
While Modified Eshoo does not specifically teach measuring the concentration of the analyte, Unger teaches microfluidic devices (abstract). More specifically, Unger teaches determining the concentration of the analyte (paragraph 0157).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Modified Eshoo, a concentration measurement step as taught by Unger because it would have been desirable to provide a more detailed metric of analyte detection (Unger, paragraph 0014).
Response to Arguments
Applicant’s arguments filed 12/31/2025 have been considered but are not found to be persuasive. Applicant’s arguments are generally drawn to the assertion that “Eshoo and Babiel do not teach, suggest or render obvious the newly added features of amended independent claim 1”. This argument is found to be moot in view of the new grounds of rejection applied to the amended claims. As described above, Eshoo teaches chambers connected by channels and when incorporating the teaching of Rammohan of a circuitous channel, the claimed invention remains unpatentable. Examiner recommends providing more structural language regarding the relative placement of device components (e.g. how the non-fouling polymer layer contributes to any assay/reactions), clarifying the placement of assay reagents and/or further specifying how layers and components within the layers are connected to other components or other layers.
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 REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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