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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 08/11/2026 is acknowledged.
Claims 15-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/11/2026.
Claims Status
Claims 1-25 are pending with claims 1-14 being examined, claims 15-25 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 2 of claim 1, “porated” should read as –porous--.
Appropriate correction is required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fiechtner et al. (US 20210148906 A1; hereinafter “Fiechtner”).
Regarding claim 1, Fiechtner teaches a device for supporting lateral flow of a liquid, comprising a support layer comprising a fluid impervious material (Fiechtner ;fig. 3A. 210; and [0058]) having a porated region with one or more pores (Fiechtner; [0139]), and
a membrane layer (Fiechtner; fig. 1. 214) adhered to the support layer and comprising (Fiechtner; fig. 3A. 210, 214) a matrix of bonded microparticles (Fiechtner; [0080] “spun bonded polyester membrane”).
Regarding claim 2, Fiechtner teaches the device of claim 1 (see above), where the matrix comprises interstitial space between the bonded microparticles to allow lateral liquid flow through the membrane (Fiechtner; [0073] fluid sample flows substantially out of the bottom surface of the membrane 214”).
Regarding claim 3, Fiechtner teaches the device of claim 1 (see above), wherein the matrix comprises glass microparticles or polyethylene microspheres (Fiechtner; [0080]).
Regarding claim 5, Fiechtner teaches the device of claim 1 (see above), wherein the matrix comprises a water-insoluble binder that bonds the microparticles and adheres the microparticles to the support layer (Fiechtner; [0080] “latex acrylic binder membrane”).
Regarding claim 6, Fiechtner teaches the device of claim 5 (see above), wherein the binder comprises a polyurethane or water emulsified latex (Fiechtner; [0080] “latex acrylic binder membrane”).
Regarding claim 7, Fiechtner teaches the device of claim 1 (see above), wherein the membrane layer comprises a sample application zone and a detection zone (Fiechtner; fig. 3A. 217) in fluid communication and laterally spaced from the sample application zone (Fiechtner; fig. 3A. 215).
Regarding claim 8, Fiechtner teaches the device of claim 7 (see above), wherein the sample application zone further comprises a dried conjugate reagent that is solubilized by the sample upon addition of a liquid sample to the membrane layer (Fiechtner; [0043] “separation membrane includes gold nanoparticlde conjugate”, [0048] “the labeled conjugate dissolves or solubilizes in the sample”).
Regarding claim 9, Fiechtner teaches the device of claim 7 (see above), wherein the detection zone comprises an immobilized binding partner for an analyte (Fiechtner; [0012] “an agent configured to specifically bind to the analyte”).
Regarding claim 11, Fiechtner teaches the device of claim 1 (see above), wherein the device is configured to accept a whole blood sample (Fiechtner; [0014]).
Regarding claim 12, Fiechtner teaches the device of claim 1 (see above), wherein a sample volume is less than 200 microliters (Fiechtner; [0014] “50 to 100 microliter”).
Regarding claim 13, Fiechtner teaches the device of claim 1 (see above), further comprising a sample of undiluted whole blood (Fiechtner; [0014] “undiluted whole blood”).
Regarding claim 14, Fiechtner teaches the device of claim 1 (see above), further comprising a filter laminated to a portion of the membrane layer (Fiechtner; [0079] “the separation membrane comprises a filter”) comprising a sample application zone (Fiechtner; fig. 3A. 215).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fiechtner et al. (US 20210148906 A1; hereinafter “Fiechtner”).
Regarding claim 4, Fiechtner teaches the device of claim 3 (see above) to include a membrane layer comprising a matrix of bonded microparticles wherein the matrix comprises glass microparticles (see above).
Fiechtner does not explicitly teach the glass microparticles are soda lime glass microparticles.
However, it is well known in the art that soda lime is the most common material in glass manufacturing and glass fiber membranes. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use soda lime glass microparticles to produce a membrane layer because soda lime is known to be chemical resistant.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fiechtner et al. (US 20210148906 A1; hereinafter “Fiechtner”) in view of Feistel (US 20020094548 A1; hereinafter “Feistel”).
Regarding claim 10, Fiechtner teaches the device of claim 1 (see above) to include a membrane (see above).
Fiechtner fails to teach wherein the membrane supports bilateral liquid flow.
However, Feistel teaches the analogous art of a device for supporting lateral flow of a liquid (Feistel; fig. 1A. 1) that includes a membrane (Feistel; fig. 6A. 34) that supports bilateral liquid flow (Feistel; [0091]).
To one of ordinary skill in the art before the effective filing date of the claimed invention it would have been obvious to modify Feichtner’s membrane to support bilateral liquid flow as taught by Feistel because Feistel teaches a device for supporting lateral flow of a liquid (Feistel; fig. 1A. 1) that includes a membrane (Feistel; fig. 6A. 34) that supports bilateral liquid flow (Feistel; [0091]).
The modification enhances the ability of the test strip to increase cell wash out (Feistel [ 0096]).
Conclusion
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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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