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 .
Claim Status
Claims 1-20 are pending and are examined.
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.
Claims 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen (WO 2015/160419; previously cited).
Regarding Claim 1, Shen teaches a test device, comprising: a sample treatment chamber used for treating a sample; a sample reaction chamber used for sample reaction, wherein a reaction product of the sample is obtained in the sample reaction chamber; and a test chamber used for detecting the reaction product; wherein the sample treatment chamber has a first position, a second position and a third position; wherein the sample reaction chamber has a first position and a second position; and when the sample treatment chamber and the sample reaction chamber are located in the respective first portions, the sample treatment chamber, the sample reaction chamber and the test chamber are not in fluidic communication with each other (Fig. 8B [0082] Layers can comprise additional passageways for pressure balance or equalization rather than liquid handling. Such passageways can be distributed around the edge or circumference of the layer. For example, FIG. 8A-8D shows a layer with five passageways: a lysis chamber 321, a wash chamber 322, an elution chamber 323, and two pressure balance passageways 324, 325. Inclusion of one or more pressure balance passageways can prevent or mitigate pinching of one side of a device relative to the other, which could lead to gapping or leakage. The examiner notes that the term preceding “chamber” is directed to intended use and is not further limited if there is not additional structure positively recited).
wherein when the sample treatment chamber moves to the second position from the first position, the sample reaction chamber is located in the first position; when the sample treatment chamber moves to the third position from the second position, the sample reaction chamber is located in the second position, or the sample reaction chamber moves to the second position from the first position ([00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer.).
Regarding Claim 2, Shen teaches the test device according to claim 1, wherein when the sample treatment chamber is located in the second position, the sample treatment chamber is in fluidic communication with the sample reaction chamber, and the sample reaction chamber is not in fluidic communication with the test chamber ([00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer.).
Regarding Claim 3, Shen teaches the test device according to claim 2, wherein when the sample treatment chamber is located in the third position, the sample reaction chamber is in fluidic communication with the test chamber ([00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer.).
Regarding Claim 5, Shen teaches the test device according to claim 1, wherein when the sample reaction chamber is located in the second position, the sample reaction chamber is in fluidic communication with the test chamber [00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer..
Regarding Claim 6, Shen teaches the test device according to claim 1, wherein the sample reaction chamber moves to the second position from the first position while the sample treatment chamber moves to the third position from the second position; or the sample treatment chamber and the sample reaction chamber move simultaneously, thus driving the sample treatment chamber to move to the third position from the second position and driving the sample reaction chamber to move to the second position from the first position ([00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer.).
Regarding Claim 7, Shen teaches the test device according to claim 1, wherein the sample treatment chamber, the sample reaction chamber and the test chamber are disposed from top to bottom successively ([0078] Layers can comprise one or more passageways. A passageway can be a channel, conduit, chamber, or other structure in which at least one complete path traverses the layer.).
Regarding Claim 8, Shen teaches the test device according to claim 1, wherein transformation of the sample treatment chamber and the sample reaction chamber is achieved by rotation in different positions ([00138] One aspect provides methods method of isolating a molecule of interest from a sample, the method comprising: a) providing a device comprising a pressure cap, a central shaft, and a plurality of coaxially arranged layers, including a reagent layer, a separation layer and a receiving layer (see, e.g., FIG. 8A); b) loading the reagent layer with a lysis solution, wash solution and elution solution, each solution occupying a separate passageway having an upstream entry and downstream outlet, wherein each of the downstream outlets of the passageways is occluded in a first position of the device; c) combining a sample with the lysis solution in the reagent layer to form a lysed mixture; d) rotating the central shaft to a second position; e) rotating the central shaft to a third position; and f) rotating the central shaft to a fourth position. Rotating the central shaft to a second position (see, e.g., FIG. 8B): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the lysed mixture with the upstream entry of a passageway in the separation layer, said passageway in the separation layer being occluded by a separation material capable of binding the molecule of interest; and 2) moves the pressure cap toward the plurality of coaxially arranged layers, thereby applying positive pressure to the lysed mixture and forcing the lysed mixture onto and through the separation material. Rotating the central shaft to a third position (see, e.g., FIG. 8C): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the wash solution with the upstream entry of the passageway in the separation layer occluded by the separation material; and 2) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the wash solution through the separation material. Rotating the central shaft to a fourth position (see, e.g., FIG. 8D): 1) rotates the reagent layer relative to the separation layer to align the outlet of the passageway holding the elution solution with the upstream entry of the passageway in the separation layer occluded by the separation material; 2) rotates the separation layer relative to the receiving layer to align the outlet of the passageway occluded with the separation material with the upstream entry of a first passageway in the receiving layer; and 3) moves the pressure cap further toward the plurality of coaxially arranged layers, thereby applying additional positive pressure to force the elution solution through the separation material to detach the molecule of interest from the separation material and collect the elution solution and molecule of interest in the passageway of the receiving layer.).
Regarding Claim 9, Shen teaches the test device according to claim 8, comprising two rotations, wherein the first rotation causes the sample treatment chamber to move to the second position from the first position; and the sample reaction chamber and the test chamber keep still; at the end of the first rotation, the sample treatment chamber is in fluidic communication with the sample reaction chamber, and the sample reaction chamber is not in fluidic communication with the test chamber ([0063] A rotational device can be configured to increase pressure within the device as the cap is rotated. For example, FIG. 2 shows a cap designed to add additional pressure by each rotation step (e.g., 201, 202, 203, 204, and 205). This pressure can be generated by the decreasing internal volume of a compartment within the device as the cap lowers toward the base. In some examples, such a device comprises a center shaft (e.g., 380, FIG. 3A-3E) with a thread, allowing a central column on the cap to thread onto the central shaft and screw down with rotation. In other examples, an outer part of the housing or base can comprise threads onto which the cap can thread and screw down with rotation. In some cases, one or more posts, knobs, grooves, guiderails, or other features can guide the motion of the cap. In one implementation, the pressure cap comprises a key or keyseat that engages with a complementary keyseat or key in the housing thereby inhibiting rotation of the pressure cap relative to the housing. The motion of the cap can be characterized by a smooth motion of combined rotation and downward motion relative to the base. In other examples, the motion of the cap can be characterized by variable rate motion, e.g. a first 15° rotation resulting a quarter- inch downward motion of the cap and a second 15° rotation resulting in a half-inch downward motion of the cap.).
Regarding Claim 10, Shen teaches the test device according to claim 9, wherein the second rotation causes the sample treatment chamber to move to the third position from the second position; and meanwhile, the sample reaction chamber moves to the second position from the first position; at the end of the second rotation, the sample treatment chamber, the sample reaction chamber and the test chamber are in fluidic communication with each other ([0063] A rotational device can be configured to increase pressure within the device as the cap is rotated. For example, FIG. 2 shows a cap designed to add additional pressure by each rotation step (e.g., 201, 202, 203, 204, and 205). This pressure can be generated by the decreasing internal volume of a compartment within the device as the cap lowers toward the base. In some examples, such a device comprises a center shaft (e.g., 380, FIG. 3A-3E) with a thread, allowing a central column on the cap to thread onto the central shaft and screw down with rotation. In other examples, an outer part of the housing or base can comprise threads onto which the cap can thread and screw down with rotation. In some cases, one or more posts, knobs, grooves, guiderails, or other features can guide the motion of the cap. In one implementation, the pressure cap comprises a key or keyseat that engages with a complementary keyseat or key in the housing thereby inhibiting rotation of the pressure cap relative to the housing. The motion of the cap can be characterized by a smooth motion of combined rotation and downward motion relative to the base. In other examples, the motion of the cap can be characterized by variable rate motion, e.g. a first 15° rotation resulting a quarter- inch downward motion of the cap and a second 15° rotation resulting in a half-inch downward motion of the cap.).
Regarding Claim 11, Shen teaches the test device according to claim 1, wherein the sample treatment chamber is used for extracting nucleic acid substances from the sample (the sample treatment chamber is capable of being used for extracting nucleic acid substances).
Regarding Claim 12, Shen teaches the test device according to claim 11, wherein the sample reaction chamber is used for amplifying the nucleic acid substances, thus producing an amplified product (the sample treatment chamber is capable of being used for amplifying nucleic acid substances).
Regarding Claim 13, Shen teaches the test device according to claim 12, wherein the test chamber is used for detecting the number of the amplified product or detecting the presence or absence of the amplified product (the test chamber is capable of being used for detecting).
Regarding Claim 14, Shen teaches the test device according to claim 13, wherein the sample reaction chamber comprises a reagent for nucleic acid amplification, and the reagent exists in a dry state ([00141] In some implementations, reagents or samples can be added partway through the operation (e.g., rotation and pressurization) of a device.).
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.
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.
Claims 15, 16, 17, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shen (WO 2015/160419; previously cited), in view of Ayyub (US Pub 2017/0198329; previously cited).
Regarding Claims 15, 16, and 17, Shen teaches the test device according to claim 14.
Shen is silent to the test chamber comprises a transverse flow test strip, and the transverse flow test strip is used for detecting the number of the amplified product or detecting the presence or absence of the amplified product, the sample treatment chamber is provided with a sample inlet; a sampling channel is connected below the sample inlet; a nucleic acid adsorption membrane is fixed at the bottom of the sampling channel, and the nucleic acid adsorption membrane is used for adsorbing nucleic acid in the sample, the sample reaction chamber is provided with a reaction chamber and a filter paper storage slot; the filter paper storage slot is provided with filter paper used for adsorbing excessive samples; the reaction chamber is provided with a nucleic acid amplification membrane or fixed with a nucleic acid amplification drying agent; the test chamber is provided with a sampling hole, and the reaction product flows into the transverse flow test strip from the sampling hole to start testing.
Ayyub teaches in the related art of a biosensor. [0017] The present disclosure also relates to a kit comprising a biosensor disclosed herein. In some embodiments, the reaction surface comprises a test strip or filter paper contained within a removable housing having at least one fluid inlet, and a set of instructions, optionally accessible remotely through an electronic medium. The examiner notes the limitation following “is used” is directed to intended use of the device. [0039] FIG. 16 depicts a paper microfluidic test strip chamber which separates plasma from whole blood, then draws the plasma onto a test strip. [0150] In some embodiments, the one or more test strips, filter papers or microfluidic chambers are attached to a solid phase support. [0168] To separate out interfering small molecules, proteins and cells a filter membrane is utilized which allows for permeation of phenylalanine but prevents interfering species. A two part paper test strip will be investigated consisting of a plasma separating membrane and a paper fluidic for sample distribution and mixing with the PheDh enzyme. The plasma separating membrane utilizes increasingly smaller pores in the cross-section of the paper that draw up plasma through increasing capillary pressure while leaving blood cells behind. Separated plasma can then be extracted by use of the paper fluidic and distributed to sections for both reference and analyte measurements. In claim 31, wherein the reaction surface comprises a test strip or filter paper contained within a removable housing having at least one fluid inlet.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the test chamber comprises a transverse flow test strip, and the sample treatment chamber is provided with a sample inlet; a sampling channel is connected below the sample inlet; a nucleic acid adsorption membrane is fixed at the bottom of the sampling channel, the sample reaction chamber is provided with a reaction chamber and a filter paper storage slot; the filter paper storage slot is provided with filter paper used for adsorbing excessive samples; the reaction chamber is provided with a nucleic acid amplification membrane or fixed with a nucleic acid amplification drying agent; the test chamber is provided with a sampling hole, and the reaction product flows into the transverse flow test strip from the sampling hole to start testing, as taught by Ayyub, in the device of Shen, to allow for on site analyte detection.
Regarding Claim 18, modified Shen teaches the test device according to claim 17, wherein when the sample treatment chamber, the sample reaction chamber and the test chamber are not in fluid communication, the sample inlet of the sample treatment chamber is in vertical communication with the filter paper storage slot; when the sample treatment chamber is in fluid communication with the sample reaction chamber, the sample inlet of the sample treatment chamber is in vertical communication with the reaction chamber of the sample reaction chamber; when the sample treatment chamber, the sample reaction chamber and the test chamber are in fluidic communication, the sample inlet of the sample treatment chamber, the reaction chamber of the sample reaction chamber and the sampling hole of the test chamber are in vertical fluidic communication with each other ([0063] A rotational device can be configured to increase pressure within the device as the cap is rotated. For example, FIG. 2 shows a cap designed to add additional pressure by each rotation step (e.g., 201, 202, 203, 204, and 205). This pressure can be generated by the decreasing internal volume of a compartment within the device as the cap lowers toward the base. In some examples, such a device comprises a center shaft (e.g., 380, FIG. 3A-3E) with a thread, allowing a central column on the cap to thread onto the central shaft and screw down with rotation. In other examples, an outer part of the housing or base can comprise threads onto which the cap can thread and screw down with rotation. In some cases, one or more posts, knobs, grooves, guiderails, or other features can guide the motion of the cap. In one implementation, the pressure cap comprises a key or keyseat that engages with a complementary keyseat or key in the housing thereby inhibiting rotation of the pressure cap relative to the housing. The motion of the cap can be characterized by a smooth motion of combined rotation and downward motion relative to the base. In other examples, the motion of the cap can be characterized by variable rate motion, e.g. a first 15° rotation resulting a quarter- inch downward motion of the cap and a second 15° rotation resulting in a half-inch downward motion of the cap.).
Regarding Claim 19, modified Shen teaches the test device according to claim 18, wherein a first rotary buckle is disposed on the outer wall of the sample treatment chamber, and a hollow first rotary slot is disposed on the side wall of the sample reaction chamber; in case of the first rotation, the first rotary buckle moves from one end of the first rotary slot to another end of the first rotary slot; the number of the first rotary buckle and the number of the first rotary slot are more than one ([0063] In some cases, one or more posts, knobs, grooves, guiderails, or other features can guide the motion of the cap. In one implementation, the pressure cap comprises a key or keyseat that engages with a complementary keyseat or key in the housing thereby inhibiting rotation of the pressure cap relative to the housing. The motion of the cap can be characterized by a smooth motion of combined rotation and downward motion relative to the base. In other examples, the motion of the cap can be characterized by variable rate motion, e.g. a first 15° rotation resulting a quarter- inch downward motion of the cap and a second 15° rotation resulting in a half-inch downward motion of the cap.).
Regarding Claim 20, modified Shen teaches the test device according to claim 19, wherein a hollow second rotary slot is disposed on the side wall of the test chamber; a second rotary buckle is disposed on the outer wall of the sample reaction chamber; in case of the second rotation, the second rotary buckle moves from one end of the second rotary slot to another end of the second rotary slot; the number of the second rotary buckle and the number of the second rotary slot are more than one [0063] In some cases, one or more posts, knobs, grooves, guiderails, or other features can guide the motion of the cap. In one implementation, the pressure cap comprises a key or keyseat that engages with a complementary keyseat or key in the housing thereby inhibiting rotation of the pressure cap relative to the housing. The motion of the cap can be characterized by a smooth motion of combined rotation and downward motion relative to the base. In other examples, the motion of the cap can be characterized by variable rate motion, e.g. a first 15° rotation resulting a quarter- inch downward motion of the cap and a second 15° rotation resulting in a half-inch downward motion of the cap.).
Response to Arguments
Applicant’s arguments, see page 6, filed 12/11/25, with respect to the 112b rejection have been fully considered and are persuasive. The 112b rejection has been withdrawn.
Applicant's arguments, see pages 6-8, filed 12/11/25 have been fully considered but they are not persuasive.
First, Applicant argues that the prior art of Shen does not disclose or suggest the specific coordinated positional relationship as recited in claim 1. On page 7, the applicant argues that in the prior art of Shen the fluidic pathways are established by rotating a single central shaft that simultaneously shifts all layers in a fixed sequence. There is no independent or staged control. Applicant further argues that Shen’s operation is monolithic and it lacks the two-stage staggered alignment logic.
In response, the examiner notes that the prior art of Shen teaches [0083] Each layer can include at least one passageway that opens to both the upstream and downstream surfaces of the layer. Additionally, the openings can encompass channels or apertures arranged on the surface that form conduits and/or chambers when mated to adjacent layer(s). The claim is directed to a test device and not a method. The prior art of Shen teaches these claimed first, second positions for the (sample reaction) chamber, and the first, second, and third positions for the (sample reaction) chamber. In applicant’s remarks, the “staggered alignment” is not a limitation of the claim since the device is not limited by a specific structure to that particular alignment or movement. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798