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 .
Response to Amendment
The amendment filed December 23, 2025 has been entered.
Claims 1-5 and 8-22 remain pending in the application. Claims 6-7 are canceled.
Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed July 23, 2025.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/26/2023 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is 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.
Regarding claim 22, 8th to Last Ln. – 7th to Last Ln. recites, “a fluid compartment that holds a fluid adapted to stabilize a property of a sample”. However, it is unclear if this is the same as or different from the “a compartment which holds a fluid adapted to stabilize a property of the biological sample” previously recited in claim 22. For purposes of compact prosecution, the above limitation has been examined as, “the compartment that holds the fluid adapted to stabilize the property of the sample”.
Claim Rejections - 35 USC § 103
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 1-5, 8-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zougman et al. (WO Pub. No. 2021/042070; hereinafter Zougman; already of record) in view of Becker et al. (US Pub. No. 2013/0164738; hereinafter Becker; already of record) and Smith (US Pub. No. 2017/0129666).
Regarding claim 1, Zougman discloses a sample collection device (spin-column assembly 113; [0173]; Figs. 10-14). The device comprises:
a sample container (inner vial 101; [0174]; Figs. 10-14) having a housing (wherein inner vial 101 has a housing, i.e., a vial body; [0174]; Figs. 10-14) that forms an opening for receiving a sample (wherein sample of liquids and/or solids are deposited through opening 129; [0174]; Figs. 10-14), and that encloses a space for holding the sample (space 122; [0174]; Figs. 10-14).
A solid phase binding material disposed within the space enclosed by the housing of the sample container and adapted, when the sample contains an analyte, to bind specifically to the analyte (interpreted as matrix 117 which is adapted to capture and retain particles of molecules of interest, where the matrix 117 sits within space 122; [0027], [0174], [0184]; Figs. 10-14).
A container sealing component removably attachable to the sample container at the opening thereof, wherein the container sealing component is adapted, when attached to the sample container, to form a seal around the opening of the sample container (lid 237 is removably attachable at opening 129 to open or close the opening, and is adapted to form a seal around the opening 129 of inner vial 101; [0174]; Figs. 10-14).
The container sealing component is a container cap ([0174]; Figs. 10-14).
Zougman fails to explicitly disclose:
The opening is defined by a threaded portion of the housing;
The container cap includes a membrane which forms at least part of a fluid compartment that holds a fluid adapted to stabilize a property of the sample; and
The threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing when the container cap is attached to the sample container.
Becker, in the analogous art of sample collection systems, teaches an opening that is defined by a threaded portion of a housing (thread set system 8; [0057]; Figs. 1-3), and a sample collection device (receiving vessel 1 and sealing cap 2 collectively interpreted as the sample collection device; [0057]; Figs. 1-3) comprising a container sealing component (sealing cap 2; [0057]; Figs. 1-3) that forms a fluid compartment (liquid tight reservoir 12; [0057]; Figs. 1-3) that holds a fluid adapted to stabilize a property of a sample (wherein liquid tight reservoir 12 contains a fluid solution having a stabilizing compound to stabilize matter of a biological sample; [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Zougman with the teachings of Becker so that the opening is defined by a threaded portion of the housing, and the container cap includes a membrane which forms at least part of a fluid compartment that holds a fluid adapted to stabilize a property of the sample for the benefit of eliminating extra steps, such as measuring, pouring, calculating, etc., needed to preserve/stabilize a sample and simplifying the process so that it can be accomplished by an unskilled user (Becker, [0069]). Additionally, including a thread set system will allow the container to couple to the cap (Becker; [0057]).
Modified Zougman fails to explicitly disclose:
The threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing when the container cap is attached to the sample container.
Smith, in the analogous field of liquid container systems ([0005]; Fig. 1-4), teaches a threaded portion of a housing that is sufficiently sharp to pierce a membrane to cause a fluid within a fluid compartment to be released into a space enclosed by the housing when a container cap is attached to a container having the housing (cutter 20 is adjacent to threaded portion 23a on container 3, and is therefore considered part of the threaded portion [0005], [0028]-[0031], [0035]; Figs. 1-4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of modified Zougman with the teachings of Smith so that the threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing when the container cap is attached to the sample container in order to release the liquid contents from the container sealing component into the sample container ([0005], [0028]-[0031], [0035]; Figs. 1-4).
Note: The instant Claims contain a large amount of functional language (ex: “adapted…to form a seal…”, “adapted to stabilize a property of the sample…”, “adapted…to allow the eluent to move…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 2, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the housing of the sample container forms a tube or a column (wherein housing, i.e., a vial body, of inner vial 101 forms a tube or column; [0181]; Figs. 10-14).
Regarding claim 3, modified Zougman discloses the sample collection device of claim 2 as discussed above. Zougman further discloses wherein the tube or column has a volume that is in a range from 1 mL to 20 mL (contemplated forms include standard sizes used in laboratory and analytical settings such as tubes from 0.2 mL to 2 mL and including 0.5 and 1.7 mL sizes, as well as conical tubes such as a 15 and 50 mL conical tube; [0181]).
Regarding claim 4, modified Zougman discloses the sample collection device of claim 2 as discussed above. Zougman further discloses wherein the tube or column has a volume that is in a range from 50 µL to 1 mL (contemplated forms include standard sizes used in laboratory and analytical settings such as tubes from 0.2 mL to 2 mL and including 0.5 and 1.7 mL sizes; [0181]).
Regarding claim 5, modified Zougman discloses the sample collection device of claim 2 as discussed above. Zougman further discloses wherein the tube or column has a volume that is greater than 20 mL (contemplated forms include standard sizes used in laboratory and analytical settings such as a 50 mL conical tube; [0181]).
Regarding claim 8, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the opening of the sample container is a first opening (wherein opening 129 is a first opening; [0174]; Figs. 10-14), and is located at a first end of the sample collection device (wherein opening 129 is located at a top end, which is interpreted as the first end, of inner vial 101; [0174]; Figs. 10-14), and wherein the container sealing component is a first container sealing component (lid 237 is adapted to form a seal around opening 129 of inner vial 101 and is interpreted as the first container sealing component; [0174], [0178]; Figs. 10-14),
wherein the sample container has a second opening (inner vial 101 has bottom opening 269, which is interpreted as the second opening; [0174]; Figs. 10-14) located at a second end of the sample collection device (wherein bottom opening 269 is located at a bottom end, which is interpreted as the second end, of inner vial 101; [0174]; Figs. 10-14),
wherein the sample collection device has a second container sealing component (bottom of outer vial 109 and D-pin 145 are collectively interpreted as the second container sealing component; [0174]-[0175]; Figs. 10-14) which is removably attached to the second end of the sample container (wherein bottom of outer vial 109 and D-pin 145 are removably attachable to the bottom end of inner vial 101; [0174]-[0175]; Figs. 10-14) and is adapted to seal the second opening of the sample container (wherein bottom of outer vial 109 and D-pin 145 are adapted to seal bottom opening 269; [0174]-[0175]; Figs. 12 and 14), and
wherein the sample container is adapted, when an eluent is delivered into the sample container, to allow the eluent to move from the first opening toward the second opening of the sample container (treatment reagents, such as elution solution, are added to the interior of the inner vial 101 via opening 129 into space 122 and allowed to move toward bottom opening 269; [0184]-[0185]).
Regarding claim 9, modified Zougman discloses the sample collection device of claim 8 as discussed above. Zougman further discloses wherein the solid phase binding material is disposed between the first opening and the second opening of the sample container (matrix 117 sits within space 122 between opening 129 and bottom opening 269; [0174]; Figs. 10-14), and
wherein the sample collection device further comprises a retention material disposed between the solid phase binding material and the second opening of the sample container (a secondary matrix, which is interpreted as the retention material, is disposed between a primary matrix, e.g., matrix 117, and an outlet, e.g., bottom opening 269; [0110], [0113], [0158]),
wherein the retention material is adapted to retain the solid phase binding material within the sample container when the eluent is moving through the sample container (wherein the secondary matrix functions as a mechanical support for, i.e., adapted to retain, a primary matrix, e.g., matrix 117, when the eluent is moving through inner vial 101; [0113], [0155], [0158]).
Regarding claim 10, modified Zougman discloses the sample collection device of claim 9 as discussed above. Zougman further discloses wherein the retention material includes a porous frit (matrices, such as the secondary matrix, are porous frits; [0108]) having pore sizes which are in a range from 0.1 µm to 400 µm (pore sizes such as 0.2 micron, 2 micron, and 20 micron are within the range from 0.1 µm to 400 µm; [0108]).
Regarding claim 11, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman does not explicitly disclose wherein the solid phase binding material is adapted to cause a concentration of the analyte in the solid phase binding material to be higher than a concentration of the analyte in the sample.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman wherein the solid phase binding material is adapted to cause a concentration of the analyte in the solid phase binding material to be higher than a concentration of the analyte in the sample as a result of routine optimization. See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). Specifically, Zougman teaches that the matrix is adapted to capture and retain particles of molecules of interest from a medium as is flows from the inlet to the outlet (see [0027], [0098]-[0104], [0119]). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in adapting the matrix, i.e., solid phase binding material, to cause a concentration of the analyte in the solid phase binding material to be higher than a concentration of the analyte in the sample.
Regarding claim 12, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the solid phase binding material is formed by particles (matrix or matrices, e.g., matrix 117, is formed by particles, such as beads or powders; [0108]). However, Zougman does not explicitly disclose wherein the particles have particle sizes which are in a range from 1 µm to 400 µm.
Zougman teaches that the particle size is a recognized result-effective variable to control the force required to move solvent through said matrix material (see [0108]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman wherein the particles have particle sizes which are in a range from 1 µm to 400 µm to achieve a desired force required to move solvent through said matrix material (see Zougman, [0108]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman wherein the particles have particle sizes which are in a range from 1 µm to 400 µm as a result of routine optimization. See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Regarding claim 13, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the solid phase binding material includes a ligand (wherein matrices, such as matrix 117, employ a ligand, e.g., protein A; [0019], [0086], [0109]).
Regarding claim 14, modified Zougman discloses the sample collection device of claim 1 as discussed above. However, Zougman does not explicitly disclose a funnel for aiding collection of the sample, wherein the funnel is adapted to fit around the opening of the sample container, and to increase in width or diameter as the funnel extends in a direction away from the opening.
Becker further teaches a funnel for aiding collection of the sample (a funnel for a user to easily spit into a device and the received saliva will be conveyed into a small aperture of a receiving vessel; [0014]), wherein the funnel is adapted to fit around the opening of the sample container (wherein the funnel is coupled to a receiving vessel so that received saliva from a user will be conveyed into the small aperture, interpreted as an opening, of the receiving vessel; [0014]), and to increase in width or diameter as the funnel extends in a direction away from the opening (wherein a large end of the funnel is at its top and therefore the funnel extends in a direction away from the opening; [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman to incorporate a funnel as in the further teachings of Becker for the benefit of collecting sample, e.g., a user’s saliva, into a small opening of a sample container (Becker, [0014]).
Regarding claim 15, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the solid phase binding material is configured, when the analyte in the sample are antibodies, to bind specifically to the antibodies (wherein matrices, such as matrix 117, employ antibody based capture materials such as protein A or G, which are capable of binding antibodies when the analyte in the sample are antibodies; [0109]).
Regarding claim 16, modified Zougman discloses the sample collection device of claim 15 as discussed above. Zougman further discloses wherein the solid phase binding material is configured to bind to at least one of: IgG antibodies, IgA antibodies, or IgM antibodies (wherein matrices, such as matrix 117, employ antibody based capture materials such as protein A or G, which are capable of binding antibodies, such as at least one of IgG antibodies, IgA antibodies, or IgM; [0109]).
Regarding claim 17, modified Zougman discloses the sample collection device of claim 16 as discussed above. Zougman further discloses wherein the solid phase binding material includes at least one of protein A or protein A/G (wherein matrices, such as matrix 117, employ antibody based capture materials such as protein A or G; [0109]).
Regarding claim 18, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman further discloses wherein the solid phase binding material forms a first pad disposed in the sample container (matrix 117, which is disposed within inner vial 101, is adapted to capture and retain particles of molecules of interest and is therefore interpreted as a first pad; [0027], [0174], [0184]; Figs. 10-14), and wherein the sample collection device includes a second pad formed from an absorbent material (a secondary matrix is capable of capturing particles/molecules and is interpreted as being formed from an absorbent material; [0110], [0113], [0158]), the second pad also being disposed in the sample container (wherein the secondary matrix, which is interpreted as the retention material, is disposed between a primary matrix, e.g., matrix 117, and an outlet, e.g., bottom opening 269; [0110], [0113], [0158]),
wherein the first pad is disposed on top of the second pad when the sample container has an orientation in which the opening of the sample container is located at a top of the sample container (wherein the secondary matrix, which is interpreted as the retention material, is disposed between a primary matrix, e.g., matrix 117, and an outlet, e.g., bottom opening 269; [0110], [0113], [0158]).
Regarding claim 19, modified Zougman discloses the sample collection device of claim 18 as discussed above. Zougman further discloses wherein the second pad does not specifically bind to the analyte in the sample (wherein eluted molecules and fragments, which contain the previously captured sample/particles of molecules of interest, pass through the secondary matrix and therefore the secondary matrix does not specifically bind to the analyte in the sample; [0019], [0101], [0113]). However, Zougman does not explicitly disclose wherein the second pad is bigger than the first pad.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman wherein the second pad is bigger than the first pad as a result of routine optimization. See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). Zougman teaches that primary and secondary matrices, i.e., pads, can be composed of two or more layers of material (e.g., depth filter or hydrophobic silica) to provide a desired total depth and hence volume and capacity of the matrices (see [0159]). One of ordinary skill in the art would have had a reasonable expectation of success in providing a second pad that is bigger than a first pad to achieve a desired total depth and hence volume and capacity for the pads (see [0159]).
Regarding claim 22, Zougman discloses a sample collection device (spin-column assembly 113; [0173]; Figs. 10-14). The device comprises:
a sample container (inner vial 101; [0174]; Figs. 10-14) having a housing (wherein inner vial 101 has a housing, i.e., a vial body; [0174]; Figs. 10-14) that forms a first opening for receiving a biological sample (wherein sample of liquids and/or solids are deposited through opening 129; [0174]; Figs. 10-14), and that encloses a space for holding the biological sample (space 122; [0174]; Figs. 10-14), wherein the first opening of the sample container is located at a first end thereof (opening 129; [0174], Figs. 10-14), and wherein the housing further forms a second opening at a second and opposite end of the sample container (inner vial 101 has bottom opening 269, which is interpreted as the second opening; [0174]; Figs. 10-14).
A solid phase binding material disposed within the space enclosed by the housing of the sample container and adapted, when the biological sample contains antibodies, to bind to the antibodies (interpreted as matrix 117 which is adapted to capture and retain particles of molecules of interest, where the matrix 117 sits within space 122; and the matrices, such as matrix 117, employ antibody based capture materials such as protein A or G, which are capable of binding antibodies when the biological sample contains antibodies; [0027], [0109], [0174], [0184]; Figs. 10-14).
A first container sealing component removably attachable to the sample container at the first opening thereof, wherein the first container sealing component is adapted, when attached to the sample container, to form a seal around the first opening of the sample container (lid 237 is removably attachable at opening 129 to open or close the opening, and is adapted to form a seal around the opening 129 of inner vial 101; [0174]; Figs. 10-14).
A second container sealing component removably attachable to the sample container at the second opening thereof and adapted, when attached to the sample container, to form a seal around the second opening of the sample container (bottom of outer vial 109 and D-pin 145 are collectively interpreted as the second container sealing component, where bottom of outer vial 109 and D-pin 145 are removably attachable to inner vial 101 at bottom opening 269, and the bottom of outer vial 109 and D-pin 145 are adapted to seal bottom opening 269; [0174]-[0175], Figs. 10-14).
The first container sealing component is a container cap ([0174]; Figs. 10-14).
The sample container is adapted, when an eluent is delivered into the sample container, to allow the eluent to move from the first opening toward the second opening of the sample container (treatment reagents, such as elution solution, are added to the interior of the inner vial 101 via opening 129 into space 122 and allowed to move toward bottom opening 269; [0184]-[0185]).
Zougman fails to explicitly disclose:
the first opening is defined by a threaded portion of the housing,
the first container sealing component forms a compartment which holds a fluid adapted to stabilize a property of the biological sample,
the container cap includes a membrane which forms at least part of the compartment that holds the fluid adapted to stabilize the property of the sample, and
wherein the threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing of the sample container when the container cap is attached to the sample container.
Becker, in the analogous art of sample collection systems, teaches an opening that is defined by a threaded portion of a housing (thread set system 8; [0057]; Figs. 1-3), and a sample collection device (receiving vessel 1 and sealing cap 2 collectively interpreted as the sample collection device; [0057]; Figs. 1-3) comprising a container sealing component (sealing cap 2; [0057]; Figs. 1-3) that forms a fluid compartment (liquid tight reservoir 12; [0057]; Figs. 1-3) that holds a fluid adapted to stabilize a property of a sample (wherein liquid tight reservoir 12 contains a fluid solution having a stabilizing compound to stabilize matter of a biological sample; [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Zougman with the teachings of Becker so that the opening is defined by a threaded portion of the housing, the first container sealing component forms a compartment which holds a fluid adapted to stabilize a property of the biological sample, and the container cap includes a membrane which forms at least part of the compartment that holds the fluid adapted to stabilize the property of the sample for the benefit of eliminating extra steps, such as measuring, pouring, calculating, etc., needed to preserve/stabilize a sample and simplifying the process so that it can be accomplished by an unskilled user (Becker, [0069]). Additionally, including a thread set system will allow the container to couple to the cap (Becker; [0057]).
Modified Zougman fails to explicitly disclose:
The threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing when the container cap is attached to the sample container.
Smith, in the analogous field of liquid container systems ([0005]; Fig. 1-4), teaches a threaded portion of a housing that is sufficiently sharp to pierce a membrane to cause a fluid within a fluid compartment to be released into a space enclosed by the housing when a container cap is attached to a container having the housing (cutter 20 is adjacent to threaded portion 23a on container 3, and is therefore considered part of the threaded portion [0005], [0028]-[0031], [0035]; Figs. 1-4). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of modified Zougman with the teachings of Smith so that the threaded portion of the housing is sufficiently sharp to pierce the membrane to cause the fluid within the fluid compartment to be released into the space enclosed by the housing when the container cap is attached to the sample container in order to release the liquid contents from the container sealing component into the sample container ([0005], [0028]-[0031], [0035]; Figs. 1-4).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zougman in view of Becker and Smith, as applied to claims 1-5, 8-19, and 22 above, and further in view of James (WO Pub. No. 2016/144192; already of record).
Regarding claim 20, modified Zougman discloses the sample collection device of claim 1 as discussed above. However, Zougman does not explicitly disclose a one-way air valve adapted, when the container sealing component has formed the seal around the opening of the sample container and the sample is in a liquid passing from a top of the sample container to a bottom of the sample container, to equalize an amount of air pressure at a first portion of the sample container above the liquid with an amount of air pressure at a second portion of the sample container below the liquid.
James, in the analogous art of devices for preparing, extracting, separating and/or purifying biological samples, teaches a device comprising a valve (valve 150; [0093]; Fig. 1) located at the base of the body. James further teaches that the valve is a one-way air valve, such as a pressure relief valve (see [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman to incorporate a one-way valve as taught by James within the housing of the sample container to provide pressure relief (see James, [0027]). The combination of Zougman and James teaches a one-way air valve is capable of being adapted, when the container sealing component has formed the seal around the opening of the sample container and the sample is in a liquid passing from a top of the sample container to a bottom of the sample container, to equalize an amount of air pressure at a first portion of the sample container above the liquid with an amount of air pressure at a second portion of the sample container below the liquid (the air valve of Zougman in view of James is capable of performing the intended use of pressure equalizing Zougman’s sample container) (Examiner’s Note — a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; see Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device does”); see also MPEP 2114(II)).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Zougman in view of Becker and Smith, as applied to claims 1-5, 8-19, and 22 above, and further in view of Voegelin et al. (U.S. Pub. No. 2006/0263273; hereinafter Voegelin; already of record).
Regarding claim 21, modified Zougman discloses the sample collection device of claim 1 as discussed above. Zougman does not explicitly disclose a tube that permits flow of air from a bottom of the sample container to a top of the sample container, wherein the tube is adapted, when the container sealing component has formed the seal around the opening of the sample container and the sample is in a liquid passing from a top of the sample container to a bottom of the sample container, to equalize an amount of air pressure at a first portion of the sample container above the liquid with an amount of air pressure at a second portion of the sample container below the liquid, and wherein the tube is disposed within the sample container, or is external to the sample container.
Voegelin, in the analogous art of reaction vessels, teaches a sample container (a reaction chamber space 3; [0036], Fig. 1a) and a tube (discharge channel 5; [0036]; Fig. 1a) that permits flow of air from a bottom of the sample container to a top of the sample container (wherein discharge channel 5 is capable of permitting a flow of air from a bottom of reaction chamber space 3 to a top of reaction chamber space 3; [0036], [0041], [0089]; Fig. 1a) (Examiner’s Note — a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; see Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device does”); see also MPEP 2114(II)), wherein the tube is adapted, wherein the tube is disposed within the sample container, or is external to the sample container (discharge channel 5 is external to a reaction chamber space 3; [0036]; Fig. 1a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of modified Zougman to incorporate a tube as taught by Voegelin for the benefit of equalizing pressure differences (Voegelin, [0041], [0089]). The combination of Zougman and Voegelin teaches wherein the tube is adapted, when the container sealing component has formed the seal around the opening of the sample container and the sample is in a liquid passing from a top of the sample container to a bottom of the sample container, to equalize an amount of air pressure at a first portion of the sample container above the liquid with an amount of air pressure at a second portion of the sample container below the liquid (the tube of Zougman in view of Voegelin is capable of performing the intended use function of pressure equalizing Zougman’s container) (Examiner’s Note — a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; see Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device does”); see also MPEP 2114(II)).
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments filed on 12/23/2025 have been considered but are moot because applicant’s arguments are towards the amended claims and not the current grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Primary Examiner, Art Unit 1798
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