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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/21/2026 was filed before the mailing date of the non-final. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-9, 19-20, 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy et al (US20100136554A1 published 06/03/2010; hereinafter Parthasarathy) in view of Montagu et al (US20110207621A1 published 08/25/2011; hereinafter Montagu).
Regarding claim 1, Parthasarathy teaches a lyophilized reagent: substrate system comprising:
a diagnostic device (a device 10 – Figs. 4-6) comprising a chamber having a bottom surface (a chamber 50 with a bottom surface – Figs. 4-6); and
a lyophilized reagent:substrate complex (a support film coated with a reagent layer 100 – Figs. 4-6) (drying methods such as freeze drying – paragraph 83) comprising:
a solid phase substrate (a support film 120 having a first side and a second side opposite the first side – Figs. 4-6) having a first side and a second side opposite the first side, wherein the first side comprises a surface having a reagent deposit zone (a first side of the support film 120 with a reagent layer 110 – Figs. 4-6), wherein the substrate is a flexible membrane (a matrix material of a water soluble polymer – paragraph 70), film (support film 120 – Figs. 4-6), or mesh;
a lyophilized reagent disposed on the first side of the solid phase substrate (the reagent layer 110 on the first side of the support film 120 – Figs. 4-6), wherein a maximum height of the lyophilized reagent is less than an outer diameter of the lyophilized reagent (a maximum height of the reagent layer 110 is less than an outer diameter of the reagent layer 110 – Figs. 4-6),
an adhesive layer disposed on the second side of the solid phase substrate (an adhesive layer 130 on the second side of the support film 120 – Figs. 4-6),
wherein the adhesive layer attaches the lyophilized reagent:substrate complex to the bottom surface of the chamber of the diagnostic device (the adhesive layer 130 attached the support film 120 to the chamber 50 – Figs. 4-6).
Although Parthasarathy does not teach the entire upper surface of the lyophilized reagent is convex, Parthasarathy teaches that the shape of the dry reagent layer and support film can be any shape (paragraph 46). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the support film 120 to a convex surface (see MPEP2144.04 IV B. Changes in Shape).
However, Parthasarathy does not teach the first side comprises a hydrophilicity-enhanced surface.
Montagu teaches a cassette with a freeze dried reagent (paragraph 164) wherein substrate comprises a hydrophilicity-enhanced surface (a hydrophilic foam or frit, such that biological molecules can be dried and preserved on it in a releasable manner – paragraph 46). Montagu teaches that a hydrophilic surface allows liquefying desiccated molecules to achieve approximately homogeneous properties within a specific fluid volume to speed up molecular coupling (paragraph 162).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surface of the support film, as taught by Parthasarathy, with the hydrophilic surface, taught by Montagu, to speed up molecular coupling. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Parthasarathy and Montagu teach analysis devices with freeze dried reagents.
Regarding claim 3, Parthasarathy, modified by Montagu, teaches the system according to claim 1,wherein the lyophilized reagent comprises a substantially flat bottom surface (the reagent layer 110 on the first side of the support film 120 – Parthasarathy Figs. 4-6).
Regarding claim 5, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the complex is defined by a maximum height and an outer diameter (the support film coated with the reagent layer 100 having a maximum height and an outer diameter – Parthasarathy Figs. 4-6), wherein the maximum height is equal to or less than about 50% of the outer diameter (the support film coated with the reagent layer 100 the maximum height is equal to or less than about 50% of the outer diameter – Parthasarathy Figs. 4-6).
Regarding claim 6, Parthasarathy, modified by Montagu, teaches the system according to claim 1, where the complex has a disc shape (a circular disc, a ring, a rectangle, a square, or the like – Parthasarathy paragraph 47).
Regarding claim 7, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the lyophilized reagent comprises a moisture content of less than about 10% by weight (the dry reagent layer contains not more than 10%, 5%, or 1% by weight water – Parthasarathy paragraph 126).
Regarding claim 8, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the lyophilized reagent is formed from a volume of liquid reagent of about 5000 µL or less prior to lyophilization (the reagent layer 110 is capable of being formed from a volume of liquid reagent of about 5000 µL or less prior to lyophilization – Parthasarathy Figs. 4-6) (the reagent layer reads on the limitation “formed from a volume of liquid reagent of about 5000 µL or less prior to lyophilization” because per MPEP2113 the patentability of a product (the reagent layer) does not depend on its method of production).
Regarding claim 9, Parthasarathy, modified by Montagu, teaches the system according to claim 8, wherein at least the reagent deposit zone of the hydrophilicity-enhanced surface of the substrate is treated to stabilize the lyophilized reagent (a hydrophilic foam or frit, such that biological molecules can be dried and preserved on it in a releasable manner – Montagu paragraph 46).
Regarding claim 19, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the flexible membrane or mesh is a polymer flexible membrane or mesh (the matrix material is a water soluble polymer – Parthasarathy paragraph 70).
Regarding claim 20, Parthasarathy, modified by Montagu, teaches the system according to claim 19, wherein the polymer flexible membrane or mesh is water soluble (the matrix material is a water soluble polymer – paragraph 70).
Regarding claim 22, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the diagnostic device is a lateral flow diagnostic device (the device 10 is capable of being used for a lateral flow diagnostic – Parthasarathy Figs. 4-6).
Regarding claim 23, Parthasarathy, modified by Montagu, teaches the system of claim 1, wherein the first side is a top side of the substrate (the support film 120 having a first side wherein the first side is a top side – Parthasarathy Figs. 4-6).
Regarding claim 24, Parthasarathy, modified by Montagu, teaches the system of claim 23, wherein the top side of the substrate comprises a planar surface (the top side of the support film 120 is a planar surface – Parthasarathy Figs. 4-6).
Regarding claim 25, Parthasarathy, modified by Montagu, teaches the system of claim 23, wherein the second side is a bottom side of the substrate (a support film 120 having a second side wherein the second side is a bottom side – Parthasarathy Figs. 4-6).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy, modified by Montagu, in view of Shkolnikov et al (WO2021221629A1 published 11/04/2021; hereinafter Shkolnikov).
Regarding claim 12, Parthasarathy, modified by Montagu, teaches the system according to claim 8.
However, Parthasarathy, modified by Montagu, does not teach wherein the complex further comprises a second lyophilized reagent layered on top of the lyophilized reagent disposed on the reagent deposit zone, wherein the second lyophilized reagent comprises a formulation that differs from that of the lyophilized reagent disposed on the reagent deposit zone of the hydrophilicity-enhanced surface of the substrate.
Shkolnikov teaches a PCR system wherein the complex (surface of the chamber particle 100 – paragraph 31) (reagent mixture may include some or all of the reagents used to perform a PCR amplification – paragraph 25) further comprises a second lyophilized reagent layered on top of the lyophilized reagent disposed on the reagent deposit zone (two layers of reagents, the primer layer 302 and the additional reagent layer 304 – Shkolnikov paragraph 37 and Fig. 3) (a delayed delivery film 400 may be formed by introducing a solution containing the film material to the chamber 102 and lyophilizing the solution – paragraph 41), wherein the second lyophilized reagent comprises a formulation that differs from that of the lyophilized reagent disposed on the reagent deposit zone of the hydrophilicity-enhanced surface of the substrate (the primer layer 302 and the additional reagent layer 304 are different formulations – Shkolnikov paragraph 37 and Fig. 3). Shkolnikov teaches to use pre-treated chamber of different reagent layers to allow simultaneous analysis of a nucleic acid sample by multiple primers in a single assay (paragraph 16) and the delayed delivery film 400 to reduce risk of cross talk between chamber particles with different primer sets (paragraph 42).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reagent layer 100 in each chamber 50, as taught by Parthasarathy as modified by Montagu, with different reagent layers and the delayed delivery film 400, taught by Shkolnikov, to gain the ability for simultaneous analysis of a nucleic acid sample by multiple primers in a single assay. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Parthasarathy, Montagu, and Shkolnikov microfluidic assay devices with dried reagents.
Regarding claim 13, Parthasarathy, as modified by Montagu modified by Shkolnikov, teaches the system according to claim 12, wherein the complex further comprises at least one more lyophilized reagent layer on top of the second lyophilized reagent (a delayed delivery film 400 may be formed by introducing a solution containing the film material to the chamber 102 and lyophilizing the solution – Shkolnikov paragraph 41), wherein the at least one more lyophilized reagent layer has a different reagent formulation from the first and second lyophilized reagents (Suitable films include sucrose, dextrose, trehalose, or a mixture thereof and is different from the primer layer 302 and the additional reagent layer 304 – Shkolnikov paragraph 41).
Claims 15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Parthasarathy, modified by Montagu, in view of Zhou et al (US20140322099 published 10/30/2014; hereinafter Zhou)
Regarding claim 15, Parthasarathy, modified by Montagu, teaches the system according to claim 1, wherein the reagent deposit zone has a periphery that is bounded by a perimeter region of the substrate (the first side of the support film 120 is bounded by a perimeter region of the support film 120 Parthasarathy Figs. 4-6).
However, Parthasarathy, modified by Montagu, does not teach wherein the perimeter region comprises one or more recessed portions that extend partially or entirely through the substrate so that the lyophilized reagent:substrate complex can be detached from the substrate.
Zhou teaches a microfluidic device with dry reagent inserts 1107 comprising a perimeter region comprises one or more recessed portions (a perimeter of a perforated cover strip 1105 – Figs. 11a-b) that extend partially or entirely through the substrate (apertures 1115 extending through the cover strip 1105 – Figs. 11a-b) so that a reagent:substrate complex can be detached from the substrate (membrane disks 1110 are provided with chemical and/or biological agents are capable of being detached from the cover strip 1105 – Figs. 11a-b). Zhou teaches to use the membrane disks 1110 to reduce risk of contamination between different membrane disks 1110, thus allowing tighter packing to improved space efficiency for on-chip processing (paragraph 90).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the support film 120, as taught by Parthasarathy as modified by Montagu, with the tighter packing of reagent insert 1107, taught by Zhou, to improved space efficiency for on-chip processing. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success Parthasarathy, Montagu, and Zhou teach microfluidic assay devices with dried reagents.
Regarding claim 21, Parthasarathy, modified by Montagu, teaches the system according to claim 15, wherein the one or more recessed portions extend at least about 50% or more through the substrate (apertures 1115 extending through the cover strip 1105 – Zhou Figs. 11a-b).
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.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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