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 the Claims
Claims 60-71, 75-76, and 85-88 are pending in the application and are the subject of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5 January 2026 is acknowledged.
Priority
The instant application is a 371 National Stage of PCT/EP2021/064581, filed 31 May 2021 which claims benefit of provisional application 63/032,093 filed 29 May 2020 and provisional application 63/129,375, filed 22 December 2020.
However, it is noted that neither of the claimed provisional applications provide recitation or support for at least the positionable flow arrestor as recited in claim 60. As such, claims 60-71, 75-76, and 85-88 are granted an effective filing date of 31 May 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 November 2022, 30 January 2023, 30 September 2024 (5 IDS filed on this date), and 3 September 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Applicant is advised that should claim 75 be found allowable, claim 86 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b)
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 60-71, 75-76, and 85-88 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 60 is rejected as indefinite. The terminology “corresponding to” in the expressions “conjugates corresponding to a target analyte in a biological sample” and “immobilized antigens corresponding to the target analyte or immobilized antibodies corresponding to the target analyte in the claim is unclear. Does the recitation refer to conjugate, antigens, or antibodies that can specifically bind to the target analyte in the sample? Or does the recitation refer to analyte analogs (that are linked to an enzyme or immobilized)? The terminology “corresponding” encompasses both these possibilities and is therefore ambiguous. Clarification is required.
Claim 60 is rejected as indefinite over the recitation “the first zone including at least one of immobilized antigens corresponding to the target analyte or immobilized antibodies corresponding to the target analyte” wherein the metes and bounds of the term “corresponding” in this context is not clear. For example, Meriam Webster dictionary provides the following definitions for the word “correspond”: “to be in conformity or agreement”; “to compare closely or match”; “to be equivalent or parallel”. Thus, it seems that the recitation could refer either to an antigen/antibody which specifically binds to the target analyte or it could refer to an immobilized antigen/antibody of a species which is in some way very similar to the target analyte (e.g. an antigen equivalent to the target analyte), but the precise meaning of the term in this context and what precise relationship it requires between the immobilized antigen/antibody and the target analyte is unclear. Clarification is required.
Claim 60 states that the porous media “to” propagate a flow of the biological sample, the conjugates with the enzyme, and a liquid buffer along the porous media. This seems to be a recitation of intended use and/or a functional limitation on the claimed device, but the phrasing of the limitation casts doubt on the category and scope of the claim. For instance, it is not clear from this recitation whether the device itself includes the liquid buffer as a physical feature of the claimed device, or whether a liquid buffer is simply intended to be present in the process of using the device. If this indication is merely to specify what the porous carrier is intended for, thus must be rendered clear from the wording of the claim.
Similarly in claim 60, the expressions “to contact”, “to detect” and “to impede” are not clear. It is not clear from these recitations whether process steps are claimed or intended capabilities/purposes of the structural features involved. Thus, it is not clear, for example, whether actual contact between electrodes and porous media is a required structural feature of the claimed device, or whether the electrodes must simply be capable of making contact with the porous media in the process of using the claimed device. Similar considerations apply to the recitations “to detect” and “to impede”. Clarification is required.
Claim 60 asserts that an electrical signal is generated when “the enzyme reacts with the liquid buffer”. This is confusing because buffers are present as “buffers” because they are inert and keep the pH of a reaction mixture stable without reacting with the reactants or the catalyst (in this case the enzyme). In the specification (see, e.g. specification Par. 94) it is stated “when the enzyme reacts with the buffer, (e.g. glucose)”. This does not make sense because glucose is not a buffer. It is understood from specification Par. 57 and 84 that it is intended that components which are present in the reaction mixture such as enzyme substrates (glucose) and redox agents (mediators, etc.) can react with the enzyme. It is however not the buffer in the reaction mixture which reacts with the enzyme as the claim language suggests. The intended meaning must be rendered clear from the wording of the claim alone. For the purposes of applying prior art in the present office action, the limitation “the enzyme reacts with the liquid buffer” is therefore interpreted as “the enzyme reaction with an enzyme substrate present in the liquid buffer”. Clarification is required.
Dependent claims 61-71, 75-76, and 85-88 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
Claim Rejections - 35 USC § 102
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 60-65, 70-71, 75-76, and 85-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long et al (WO 02/10754 A2; IDS entered).
Regarding claim 60, Long teaches:
A lateral flow assay device comprising (Abstract):
A conjugate pad including conjugates corresponding to a target analyte in a biological sample, the conjugate labeled with an enzyme (Abstract: a label pad containing an enzyme antibody or antigen conjugate having affinity for an analyte)
Porous media including first zone and second zone; the porous media to propagate a flow of the biological sample, the conjugates with the enzyme, and a liquid buffer along the porous media (Abstract: lateral flow test strip; e.g. as shown in Fig. 3-3A)
First zone including immobilized antigens corresponding to the target analyte or immobilized antibodies corresponding to the target analyte; a second zone laterally displaced from the first zone along a longitudinal axis of the lateral flow assay device (Abstract: a capture zone having a capture antibody or antigen having affinity for the analyte (i.e. first zone); Fig. 3-3A shows lateral flow device comprising membrane with capture zone (13) (i.e. first zone) and a downstream zone of the membrane connected to absorbent pad (12) (i.e. second zone))
First electrode to contact the porous media in first zone and second electrode to contact the porous media in the second zone (Pg. 2, Par. 3: cartridge contains two sets of electrodes. One pair of carbon interdigitated electrodes are in direct contact with the capture zone (i.e. first zone). A pair of silver electrodes are placed just before the absorbent pad on the membrane (i.e. second zone))
First and second electrodes to detect an electrical signal when the target analyte is present in the biological sample and the enzyme reacts with the liquid buffer (Pg. 2, Par. 2-Pg. 3, Par. 1)
A positionable flow arrestor to impede the flow in the second zone (Figs. 4-5; Pg. 5 last Par.-Pg. 6, Par. 2: the drive arm engages with and drives upper arm 7 towards the floor portion 10 of the base 2. As the upper arm is driven towards the floor portion 10, the actuating portion 18 is drive outwards to straighten the upper arm 7. As the actuating portion 18 is driven outwards, it engages with the sample and label pad and scrapes the sample and label pad away from and out of contact with the strip 3 so as to cut off the supply of sample to the strip).
Regarding claim 61, Long further teaches the device including a wicking pad couple to the porous media, wherein the flow arrestor is to at least one of compress or shear the porous media to at least one of reduce or stop the flow toward the wicking pad (Pg. 6, Par. 2: as the actuating portion 18 is driven outwards, it engages with the sample and label pad and scrapes the sample and label pad away from and out of contact with the strip 3 so as to cut off the supply of sample to the strip; Fig. 4-5; Pg. 7, Par. 4: absorbent pad 12) wherein the action of the actuating portion 18 in disconnecting the sample and label pad is understood to read both on compression of the porous media (i.e. in that there is an application of downward pressure on the media) and on shearing of the porous media (i.e. in that the actuating arm applies force to cut something from the porous media).
Regarding claim 62, Long further teaches the device wherein the flow arrestor includes a switch that is movable from a first position to a second position to at least one or compress or shear the porous media (Pg. 6, Par. 5-Pg. 7, Par. 5: When the fluid reaches the second set of electrodes on 4, the control electronics releases the solenoid to release the driven arm which drives through the open second aperture 30 and drives the arm 7 to push the electrodes into abutment with the strip, the spike 20 to pierce the foil cover, the pad 33 into abutment with the strip 3 and the actuating arm 18 to remove the sample/label pad) (i.e. wherein arm 7 acts as a switch which can create contact between the electrodes and the strip by moving from a first position to a second position and wherein movement of arm 7 from a first position to a second position triggers movement of the actuating arm 18 to compress/shear the porous media).
Regarding claim 63, Long further teaches the device wherein the movement of the switch to the second position causes the first electrode and the second electrode to contact the porous media (Pg. 6, Par. 5-Pg. 7, Par. 5: Arm 7 is driven down towards the porous media. As the arm is driven down, it simultaneously causes the first and second electrode contacts to be driven into contact with the strip 3, the pad 33 on the reagent storage blister 6 to be driven to abut the strip 3, and the arm actuating portion 18 to remove the sample/label pad from the strip).
Regarding claim 64, Long further teaches the device wherein the switch is spaced a first distance from the porous media in the first position and spaced a second distance from the porous media in the second position, the second distance less than the first distance (Figs. 4-5 show movement of the switch (7) from a first position to a second position, wherein the switch is depressed towards the surface of the porous media in the second position).
Regarding claim 65, Long further teaches the device including a circuit board wherein the first electrode and the second electrode are coupled to the circuit board, the switch to move at least a portion of the circuit board proximate to the porous media, wherein the circuit board is pivotable, the switch to pivot the circuit board when the switch is moved (although it is termed an “electrode”, element 4, as shown in Figs. 3-5 is understood to read on a circuit board in that it comprises a number of electrodes in circuit with one another and fixed to a single board/component; Pg. 2, Par. 3: cartridge contains multiple sets of electrodes; Pg. 5, Par. 1: when fitted over the lateral flow strip 3, the electrodes face the upper surface of the lateral flow immunoassay test strip 3 so that the electrode extends to the capture region 13 of the lateral flow test strip 3 and the second electrode is located proximate the absorbent pad 12. A third electrode may be located on the absorbent pad 12; see also Pg. 7, Par. 2 which discusses multiple electrode contacts disposed on element 4; wherein Figs. 4-5 and the description of Pg. 6, Par. 5-Pg. 7, Par. 5 shows that element 4 (the circuit board) pivots in accordance with the movement of the switch (i.e. arm 7) to move at least a portion of the circuit board proximate to the porous media).
Regarding claim 70, Long further teaches the device wherein the electrical signal is generated by an enzymatic reaction (Pg. 2-3, bridging Par.)
Regarding claim 71, Long further teaches the device wherein the lateral flow assay device is batteryless (Long does not teach the use of a battery anywhere in the reference, therefore the device is assumed to be batteryless, absent particular evidence to the contrary).
Regarding claim 75 and 86, Long further teaches the device including a liquid buffer, the switch to cause the reservoir to release the liquid buffer onto the porous media (Figs. 4-5; Pg. 6, Par. 5-Pg. 7, Par. 5: a reagent storage blister 6 (which comprises a liquid buffer comprising an enzyme substrate) is mounted above the strip 3. An arm 7 is provided and is formed with a spike 20 that engages with the reagent blister 6. Movement of the arm 7 causes arm spike 20 to drive the blister spike 36 within the reagent storage blister to pierce its foil cover. As the arm is driven to cause piercing of the foil cover, it simultaneously causes the first and second electrode contacts to be driven into contact with the strip 3, the pad 33 on the reagent storage blister 6 to be driven to abut the strip 3. Substrate fluid from pad 33 then flows along the strip 3 towards absorbent pad 12).
Regarding claim 76, Long further teaches the device wherein the flow arrestor is to shear the porous media by cutting a portion of a depth of the porous media (Figs. 4-5; Pg. 5 last Par.-Pg. 6, Par. 2; wherein the flow arrestor cuts the pad from the porous media thereby impeding flow).
Regarding claim 85, Long further teaches the device wherein the positionable flow arrestor is to impede the flow in the second zone by cutting a portion of a depth of the porous media (Figs. 4-5; Pg. 5 last Par.-Pg. 6, Par. 2; wherein the lateral flow test strip as a whole is understood to read on the porous media, such that removal of the sample and label pad which leaves behind a portion of strip 3 underneath is understood to read on shearing the porous media by cutting a portion of a depth of the porous media) wherein removal of the sample/label pad is understood to read on impeding the flow in the second zone because claim 60 describes the flow comprising the biological sample, and removal of the sample/label pad impedes additional flow of the biological sample.
Claim Rejections - 35 USC § 103
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.
Claims 60, 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al (US 2023/0333118 A1) in view of Hatamian et al (US 2021/0109055 A1).
Regarding claim 60, Laufer teaches:
A lateral flow assay device (Par. 1: present invention combines lateral flow assays with an electrical readout; Par. 164: lateral flow assay test strips) comprising:
A conjugate pad including conjugates corresponding to a target analyte in a biological sample, the conjugate labeled with an enzyme (Par. 29-31: strip comprises a sample pad at a first end of the membrane strip. The strip further comprises a reagent pad at the first end of the membrane strip. Preferably the reagent pad comprises a conjugate. Preferably the conjugate comprises a binding molecule specific to the at least one analyte. Preferably the conjugate further comprises an enzyme which may react with a substrate to form a product);
A porous media including a first zone and a second zone (Par. 10: a transport matrix for transporting the liquid sample; See e.g. Fig. 2 which comprises a membrane 110 comprising a first zone 1121 (one or more test zones) and upstream and a second zone 1120 (control zone) and downstream);
The first zone including at least one of immobilized antigens corresponding to the target analyte or immobilized antibodies corresponding to the target analyte (Par. 10: transport matrix for transporting the liquid sample to at least one immobilization area along the transport matrix. Further comprising at least one capture reagent immobilized in the at least one immobilization area, the capture reagent capable of binding with and thereby capturing the at least one analyte);
The second zone laterally displaced from the first zone along a longitudinal axis of the device (Par. 10: a transport matrix for transporting the liquid sample; wherein the first zone is considered the portion of the matrix which includes the immobilization/test zone and everything upstream, and the second zone is considered the portion of the matrix which includes everything downstream of the test zone; See e.g. Fig. 2 which comprises a membrane 110 comprising a first zone comprising 1121 (one or more test zones) and everything upstream of 1121 and a second zone comprising 1120 (control zone) and everything downstream of 1121);
The porous media to propagate a flow of the biological sample, the conjugate with the enzyme, and a liquid buffer along the porous media (Par. 10);
A first electrode to contact the porous media in the first zone and a second electrode to contact the porous media in the second zone (Par. 10: immunoassay analyzer comprises at least one amperometric and/or potentiometric sensor element comprising at least one working electrode and at least one reference electrode, wherein the working electrode is configured to contact the immobilization area(s) and the reference electrode is configured to contact with a portion of the transport matrix other than the immobilization area(s) (i.e. the second zone); Par. 18: preferably the immobilization area and the portion of the transport matrix other than the at least one immobilization area are spaced from each other in the direction in which the medium flows along the transport matrix. The immobilization area may be located upstream or downstream of the portion of the transport matrix other than the at least one immobilization area (i.e. the reference electrode may be located in the second zone downstream of the first zone); additionally/alternatively, Laufer discloses that the strip may comprise a control immobilization area in the second zone which comprises contact with an additional electrode (see, e.g. Fig.2, control zone 1120));
The first and second electrodes to detect an electrical signal when the target analyte is present in the biological sample and the enzyme reacts with the liquid buffer (Par. 17: the sensor element comprising two or more electrodes may be used to measure differential signals at different locations along the transport matrix).
Laufer teaches that it is advantageous to the accuracy and resolution of the assay to provide a means of preventing the product produced by reaction of the enzyme and substrate from flowing further downstream from its production at the test line, where the substrate contacts the enzyme of the immobilized conjugate (Par. 37: a substrate may be added to or present on the device for the purpose of reacting with the enzyme label of the conjugate to produce a product. It is believed that keeping the product at the position where the reaction occurs (i.e. at the immobilization area) increases the lateral resolution along the transport matrix; Par. 130: lowering the diffusion rate of the product of the enzymatic reaction may increase lateral resolution along the transport matrix).
Laufer differs from the instant claim in that it does not teach a positionable flow arrestor to impede the flow in the second zone.
Regarding claim 60, Hatamian teaches a lateral flow assay device (Abstract), comprising:
A conjugate pad including conjugates corresponding to a target analyte in a biological sample, the conjugate further comprising a label (Par. 57: conjugate pad comprising a conjugate which comprises a labeled antibody);
A porous media including a first zone and a second zone; the porous media to propagate a fluid along the porous media (Abstract: lateral flow device comprising a conjugate pad and a membrane; since there is no structural distinction or description of the first zone and second zone beyond immobilization of particular reagents in the first zone and lateral displacement of the first zone from the second zone, the first zone in Hatamian may comprise the test line, while the second zone may comprise the rest of the porous media);
The first zone including at least one of immobilized antigens corresponding to the target analyte or immobilized antibodies corresponding to the target analyte (Par. 86-87: the test line may contain an unlabeled binding reagent that is immobilized on the test line. The immobilized binding reagent may be an antibody the specifically binds the target analyte);
The second zone laterally displaced from the first zone along a longitudinal axis of the device (see Figures).
Hatamian further teaches the device comprising one or more positionable flow arrestors which may impede the flow in the second zone. The flow arrestors taught by Hatamian may be positioned in one or more locations on the lateral flow device (Par. 59: device may comprise a removable physical barrier between the conjugate pad and the membrane to prevent sample solution from flowing from the conjugate pad into the membrane. After the desired conjugate time is achieved, the barrier may be removed to allow the sample fluid to flow from the conjugate pad into the membrane; Par. 65: the barrier may be removed and reinserted multiple times in the course of the assay for the purpose of controlling fluid flow in the device. A similar technique may be used to remove and reinsert a barrier that prevent the flow of fluid material from the test line towards the control line and/or a barrier that controls the flow of fluid material from the control line towards the wicking pad).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Laufer to further include flow arrestors between the conjugate pad and the porous media and/or between the porous media and the wicking pad as taught by Hatamian. One of ordinary skill in the art would be motivated to include a flow arrestor between the conjugate pad and the porous media, because Hatamian teaches that this mechanism is advantageous in allowing a user to extend or control the incubation time of the sample and the conjugate (i.e. to allow more time for more complete binding of the conjugate to the target analyte before the target analyte reaches the test line) (Hatamian, Par. 56). Alternatively or additionally, one of ordinary skill in the art would be motivated to include a flow arrestor between the porous media and the wicking pad in the device of Laufer, because Laufer teaches that lowering the diffusion rate of the product produced by the reaction of the enzyme label and the substrate at the test line improves the assay by increasing lateral resolution along the transport matrix, wherein one of ordinary skill would recognize that a barrier positioned between the porous media and the wicking pad would reduce the diffusion rate of the product by impeding further flow of fluid from the porous media to the wicking pad. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Laufer and Hatamian are directed to lateral flow assay devices comprising conjugate pads, porous media, and wicking pads.
Regarding claim 70, Laufer further teaches the device wherein the electrical signal is generated by an enzymatic reaction (Par. 130).
Regarding claim 71, Laufer further teaches that the device is batteryless (Laufer contains no recitation or indication of the presence of batteries in the device, and is therefore assumed to encompass embodiments that are batteryless, absent specific evidence to the contrary).
Claims 68-69 and 87-88 are rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al (US 2023/0333118 A1) in view of Hatamian et al (US 2021/0109055 A1) as applied to claim 60 above, and further in view of Nguyen et al (US 2014/0323350 A1; IDS entered).
Regarding claims 68-69 and 87-88, Laufer teaches that the analyzer device comprises a reader instrument which can communicate electrode signals and test results by wireless communication (Par. 138). Laufer teaches that presence of the target analyte is indicated by the provision of an electrical signal corresponding to at least one of a voltage or current generated at the porous media, that at least one of the voltage or the current caused by an enzymatic reaction (Par. 17, 27-28, 101). However, Laufer does not specifically teach including an antenna in circuit with the first electrode and second electrode, the antenna to transmit a wireless signal representative of the electrical signal to an external device.
Regarding claim 68 and 88, Nguyen teaches a lateral flow device comprising a test strip, a region functionalized with an immobilized molecule that specifically binds to a target analyte, and a conjugate comprising a labeled binding partner of the target analyte. Nguyen teaches that the device further comprising a sensing test capacitor having electrodes in contact with the test strip, such that presence of a target analyte is determined by electrical signals from the electrodes (Abstract).
Nguyen teaches the device further comprising an antenna in circuit with the electrodes for transmitting a wireless signal representative of the electrical signal to an external device (Par. 13: communications circuit for communicating data from the electronic circuit to an external device. Communication may be wireless; Par. 42: electrodes are connected to an integrated circuit comprising a circuit for wireless communication circuit which is connected to an antenna for transmitting and receiving signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Laufer in view of Hatamian to further include an antenna in circuit with the first electrode and second electrode to transmit a wireless signal, as taught by Nguyen. One of ordinary skill in the art would be motivated to make this modification because wireless transmission of results allows the device to be easily used with a portable external reader or electronic device such as a computer or mobile phone. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Laufer and Nguyen are directed to lateral flow assays comprising sensing electrodes wherein results of the test are received as electrical signals which may be wirelessly communicated to external devices.
Regarding claims 69 and 87, these are both noted to be largely directed to matters of intended use. That is, many of the claim limitations are directed to particular steps of the process of using the claimed device rather than to structural or physical features of the claimed device itself. Recitations of intended use do not distinguish a product claim over the prior art, since a product claim is defined by what the product is and not what the product is used for. See MPEP 2114-2115. As such, as long as prior art teaches all structural and physical features required by the claim and is understood to be capable of performing the recited intended use, it is sufficient to read on the claim.
As such, in terms of structure and physical features, claim 69 is understood to require that the device comprise: an antenna in circuit with the first electrode and the second electrode which is capable of receiving a power signal form an external device (Laufer in view of Hatamian and Nguyen comprises such an antenna, as described in the rejection of claim 68 above); a sensor capable of receiving a power signal and capable of measuring at least one of a voltage or a current between the first electrode and the second electrode; a processor capable of receiving a power signal to compare the voltage or the current to a threshold (Laufer, Par. 179-180: device comprises a readout circuit configured to determine an electric potential difference between the first working electrode and the reference electrode, and/or a change in an electric current flow through the first working electrode and the reference electrode in order to determine an amount of the target analyte); and an antenna to wirelessly transmit results to the external device (as taught by Nguyen and discussed in the rejection of claim 68 above).
Therefore, Laufer in view of Hatamian and Nguyen is understood to sufficiently read on claim 68.
In terms of structure and physical features, claim 87 is understood to require that the device comprise: an antenna capable of transmitting and receiving signals, and this is understood to be sufficiently taught by the antenna of Laufer in view of Hatamian and Nguyen, as discussed above.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al (US 2023/0333118 A1) in view of Hatamian et al (US 2021/0109055 A1) as applied to claim 60 above, and further in view of Davis et al (US 2009/0203059 A1).
Regarding claim 67 Laufer in view of Hatamian teaches the device of claim 60 as described above, but does not explicitly teach the device wherein the flow arrestor includes a chemical substance that is to form a barrier when wetted.
Regarding claim 67, Davis teaches a lateral flow device (Abstract) comprising a sample receiving zone impregnated with a conjugate that reacts with the sample and a nitrocellulose strip comprising a capture band which comprises a plurality of immobilized antibodies for the target analyte (Par. 62-63). Davis further teaches that the strip may comprise a dissolvable chemical barrier disposed between the zone impregnated with conjugate and the capture band on the nitrocellulose strip wherein the chemical substance provides a barrier when first wetted but is designed to dissolve after a predetermined amount of time (Par. 62-63, 29-31).
Similar to the flow arrestors taught by Hatamian, the chemical flow arrestor taught by Davis is designed to impede flow of sample solution from the conjugate area to the test line for the purpose of increasing the amount of time the sample has to react with the reagents of the conjugate area (Par. 65).
As such, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Laufer in view of Hatamian to use the chemical barrier taught by Davis to provide a barrier between the conjugate zone and the test line. Such modification is obvious because it amounts to simple substitution of known elements to achieve predictable results with a reasonable expectation of success; that is, both the physical barrier taught by Hatamian and the chemical barrier taught by Davis fulfill the same function of delaying flow of sample from the conjugate zone to the test line for the purpose of extending the amount of time the sample has to react with the conjugate reagents.
Subject Matter Free of Prior Art
Claim 66 is rejected as described above, but appears to be free of the prior art.
Regarding claim 66, the closest prior art is Long et al (WO 02/10754 A2), over Laufer et al (US 2023/0333118 A1), and Hatamian et al (US 2021/0109055 A1)
Regarding claim 66, Long teaches the limitations of independent claim 60 above, and teaches the device comprising a first flow arrestor which compresses or shears the porous media in the first zone, as discussed in the rejection of claim 60 above. Long does not teach the device further comprising a second flow arrestor to at least one of compress or shear the porous media in the second zone, wherein the first electrode and the second electrode are positioned between the first flow arrestor and the second flow arrestor.
The teachings of Laufer in view of Hatamian are discussed in the 103 rejection of claim 60 above. Laufer in view of Hatamian teaches a lateral flow device which may comprise a first flow arrestor and second flow arrestor wherein the first electrode and the second electrode are positioned between the first flow arrestor and the second flow arrestor (i.e. as discussed in the 103 rejection above, the modified device may comprise a first flow arrestor positioned between the conjugate pad and the porous media and a second flow arrestor positioned between the control zone and the wicking pad). Laufer in view of Hatamian does not meet instant claim 66 because the flow arrestors taught by Hatamian do not function by either compressing or shearing the porous membrane (instead they are physical barriers impermeable to the sample solution which may be removed and replaced). Neither Laufer nor Hatamian provides teaching or motivation for replacing the flow arrestors taught by Hatamian with flow arrestors which function by either compressing or shearing the porous media.
As discussed above, Laufer provides motivation for the addition of a flow arrestor between the control zone and the wicking pad because it teaches that lowering the diffusion rate of the product produced by the enzyme and substrate increases lateral resolution on the test strip. Similar motivation could be applied to the device of Long which discloses a similar test strip comprising first and second electrodes which are used to measure an electrical signal produced by the reaction of an enzyme and substrate (i.e. one of ordinary skill in the art would conclude that lowering the diffusion rate of the product produced by the enzyme and substrate would increase lateral resolution on the test strip of Long in the same way it would for Laufer). However, the compressing and shearing flow arrestor taught by Long has a very specific structure and positioning within the device, such that it would not be obvious to duplicate that same compressing and shearing flow arrestor to provide a second flow arrestor downstream of the second electrode, and such that there would not be a reasonable expectation of success in duplicating the structure.
Similarly, because the flow arrestor taught by Long is so specific to the particular structure and function of the device of Long, it would not be obvious to one of ordinary skill in the art to modify the flow arrestors of Laufer in view of Hatamian to compressing or shearing flow arrestors such as the one taught by Long.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677