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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments submitted 12 February 2026.
Claims 1-9 and 11-29 are pending.
Claim 10 is canceled.
No claims are withdrawn.
No claims are newly added.
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, 3, 5-9, 15, 17-19, 21, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 2010/0291588 A1), hereinafter “McDevitt, in view of Maul et al. (US PAT 5,955,377 A), hereinafter “Maul”, and Linton et al. (US PAT 7,682,565 B2), hereinafter “Linton”.
Regarding Claim 1, McDevitt teaches a liquid biological sample test cartridge ([0009-0010]), comprising:
a tray 114 (Fig. 2);
a chemical reaction pad 122 (“reagent region 122”) supported by the tray 114 ([0129]: “A cartridge may include one or more reagent regions…a reagent region includes one or more reagents, detectable labels, and/or buffers that are disposed on one or more reagent pads…” -- [0225]: “Directly flowing sample over and/or through a reagent region may reduce the time required for reaction between sample and reagents and/or detectable labels.”);
a chemical reaction pad cover 110/112 disposed over the chemical reaction pad 122 and coupled to the tray 114 (Fig. 2 and [0142]: “Layers may be coupled, sealed, welded or bonded together to form the cartridge.”),
the chemical reaction pad cover 110/112 having a sample opening 120/102 to facilitate depositing a liquid biological sample at a predetermined location on the chemical reaction pad 122 (Fig. 2 and [0146]: “Sample layer 114 may include collection region 102…” – [0160]: Said sample opening/collection region 102 communicates with channel 106 to flow sample over the top of reagent pad 122, the top of the pad being the predetermined location on the pad. -- [0138]: “A sample may be placed in collection region 102.”);
and an outer cover 104 operable to at least partially form an enclosure about the chemical reaction pad (Fig. 1 and [0140]: “Cover 104 may seal the sample collection region and inhibit contaminants from entering the sample collection region.” – Sealing of the opening 120/102 operably encloses the reagent pad 122 within the device.), as in Claim 1.
Further regarding Claim 1, McDevitt does not specifically teach the test cartridge discussed above further comprising a tray base configured to removably couple to the tray, and wherein the outer cover is configured to interface with the tray base, as in Claim 1.
However, Maul teaches a respective biological sample test cartridge wherein a tray base 34 (“lower half 34”) is configure to interface with an outer cover 32 (“upper half 32”) to form an enclosure about a chemical reaction pad 26 (“test surface 26”) to form an enclosure around the chemical reaction pad 26 (Fig. 8E). Maul further teaches the benefit of this assembly in col. 34, line 14: “These plastic covers provide protection to the end-user by preventing exposure to the wash solution and excess sample contained within the absorbent materials.”
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt with a tray base configured to interface with an outer cover such as taught by Maul so as to contain the inner components and reagents housed therein to prevent user exposure, given that McDevitt is similarly concerned with fully containing reagents inside the device via a cover 104 ([0140]).
Further regarding Claim 1, McDevitt does not specifically teach the test cartridge discussed above wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction through the tray base, as in Claim 1.
However, Linton teaches a cartridge device for sample processing comprising an outer cover 22 and a tray 23 forming a microfluidic space 24 through gasket 21, wherein the cover 22 is configured to interface with a heat source and transfer heat to the tray 23 via conduction ([col. 12, line 16]: “One of the top 22 or bottom 23 may be made of an opaque material such as a metal, with the other side permitting optical readout. The opaque part may be advantageously made from a heat conducting material such as stainless steel, which may be placed adjacent a heat source, such as a Peltier device, during thermal cycling.” – See also [col. 25, line 5].). Therein, this arrangement provides rapid and even heating during PCR analysis, as similarly contemplated by McDevitt ([0384]), so as to reduce errors due to insufficient heating operation.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Mcdevitt wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction, such as suggested by Linton, so as to provide rapid and even heating during PCR analysis, thereby reducing error due to improper heating, and would have a reasonable expectation of success therein.
Further, when combined with the tray base of Maul, said tray base would transfer heat to the tray as heat is provided to the outer cover as in Linton, and the outer cover interfaces with the tray base, thereby transferring heat therebetween and to the tray.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the chemical reaction pad cover is at least partially optically transparent or translucent to facilitate optical inspection of the chemical reaction pad to determine a test result (While McDevitt does not specifically recite the reaction pad cover 110/112 as optically transparent, given that para. [0291] teaches light 304 from light source 286 as entering the cartridge 100 and reaching detection region 108, which is positioned below the reaction pad cover 110/112, said reaction pad cover 110/112 must then necessarily be at least partially optically transparent to enable said light 304 to enter the cartridge and reach the detection region 108. – See Fig. 36.), as in Claim 3.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the chemical reaction pad cover 110/112 comprises a capillary channel 106 in fluid communication with the sample opening 120/102 to distribute the liquid biological sample along the chemical reaction pad 122 (Fig. 2 and [0156]: “Sample deposited in collection region 102 may flow through channel 106 toward detection region 108.” – [0169]: “Fluid from reagent region 122 flows through channel 128, enters into channel 106, and then enters detection region 108. In some embodiments, channel 128 and channel 106 are the same channel.” – Fig. 2 further shows that thew channel 106 is formed on top of and is open to reagent pad 122, thus distributing sample travelling through the channel 106 along the reagent pad 122.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the capillary channel 106 comprises at least one of a linear configuration, a cross-configuration, or an X configuration (Fig. 2 shows the capillary channel 106 as comprising a linear configuration.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the sample opening 120/102 is a plurality of sample openings ([0122]: “A cartridge body may include one or more openings designed to receive one or more components used to facilitate analyte detection. Components include, but are not limited to, a collection region (e.g., a sample collection pad)…” -- The sample collection pad must necessarily be associated with an opening, such as shown by Fig. 2, in order to receive a sample, thus as McDevitt teaches multiple collection pads, McDevitt inherently also teaches multiple openings.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the outer cover 104 is at least partially optically transparent or translucent to facilitate optical inspection of the chemical reaction pad 122 to determine a test result ([0140]: “In some embodiments, the cover 104 may include… a swinging window…” – A window is interpreted as an optically transparent structure, therefore the outer cover is at least partially optically transparent.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the outer cover 104 comprises one or more optically transparent or translucent windows ([0140]: “In some embodiments, the cover 104 may include… a swinging window…”), as in Claim 9.
Regarding Claim 15, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above further comprising a latch operable to facilitate latching the outer cover to the tray base, as in Claim 15.
However, Maul teaches the tray base and cover discussed above wherein a latch 22 (“clip 22”) is operable to facilitate latching the outer cover 32 to the tray base 34.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the test cartridge of McDevitt, as modified with a tray base configured to interface with the outer cover as discussed above, with a latch such as taught by Maul so as to provide a suitable structure to facilitate fastening of the outer cover with the tray base and prevent its opening, so as to further protect a user from exposure to harmful reagents contained within the device or contamination thereof by preventing accidental opening of the enclosure.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the outer cover 104 is operable with the tray 114 to form the enclosure about the chemical reaction pad 122 (Figs. 1 and 2, and [0142]: “Layers may be coupled, sealed, welded or bonded together to form the cartridge.” – McDevitt provides a cover operable with a tray commensurately as claimed.), as in Claim 17.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, McDevitt teaches the test cartridge discussed above wherein:
the outer cover is pivotally coupled to the tray ([0140]: “Cover 104 may be a flap coupled to the cartridge that may be moved to uncover or cover the collection region, as desired….In some embodiments, the cover may include…a swinging window…” – A “swinging” window is interpreted as being pivotally coupled to the tray 114 given that said tray is the thickest of the layers, wherein the other layers are thin films and would not be able to support a swinging member coupled thereto. Swinging is interpreted as equivalent to pivoting.), as in Claim 18.
Regarding Claim 19, the prior art meets the limitations of Claim 17 as discussed above. Further, McDevitt teaches the test cartridge discussed above further comprising:
a seal operable with the tray 114 and the outer cover to seal the enclosure about the chemical reaction pad 122 (McDevitt teaches an embodiment wherein the outer cover is a reservoir 154 comprising a seal 202 operable with said outer cover reservoir 154 to seal the enclosure, wherein the tray forms a bottom seal and the combination of the two fully encloses the device and reaction pad 122 contained therein. – See Fig. 15.), as in Claim 19.
Regarding Claim 21, the prior art meets the limitations of Claim 17 as discussed above. Further, McDevitt teaches the test cartridge discussed above further comprising:
a seal operable with the outer cover to seal the enclosure about the chemical reaction pad 122 (McDevitt teaches an embodiment wherein the outer cover is a reservoir 154 comprising a seal 202 operable with said outer cover reservoir 154 to seal the enclosure, wherein the tray forms a bottom seal and the combination of the two fully encloses the device and reaction pad 122 contained therein. – See Fig. 15.), as in Claim 21.
Regarding Claim 24, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt teaches a method for facilitating testing of a liquid biological sample, comprising:
supporting a chemical reaction pad 122 with a tray 114 (Fig. 2);
disposing a chemical reaction pad cover 110/112 over the chemical reaction pad 122 and coupling the chemical reaction pad cover 110/112 to the tray 114 (Fig. 2 and [0142]: “Layers may be coupled, sealed, welded or bonded together to form the cartridge.”);
facilitating depositing a liquid biological sample at a predetermined location on the chemical reaction pad (Fig. 2 and [0146]: “Sample layer 114 may include collection region 102…” – [0160]: Said sample opening/collection region 102 communicates with channel 106 to flow sample over the top of reagent pad 122, the top of the pad being the predetermined location on the pad. -- [0138]: “A sample may be placed in collection region 102.”);
and providing an outer cover 104 operable to at least partially form an enclosure about the chemical reaction pad 122 (Fig. 1 and [0140]: “Cover 104 may seal the sample collection region and inhibit contaminants from entering the sample collection region.” – Sealing of the opening 120/102 operably encloses the reagent pad 122 within the device.), as in Claim 24.
Further regarding Claim 24, McDevitt does not specifically teach the test cartridge discussed above wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction through the tray base, as in Claim 24.
However, Linton teaches a cartridge device for sample processing comprising an outer cover 22 and a tray 23 forming a microfluidic space 24 through gasket 21, wherein the cover 22 is configured to interface with a heat source and transfer heat to the tray 23 via conduction ([col. 12, line 16]: “One of the top 22 or bottom 23 may be made of an opaque material such as a metal, with the other side permitting optical readout. The opaque part may be advantageously made from a heat conducting material such as stainless steel, which may be placed adjacent a heat source, such as a Peltier device, during thermal cycling.” – See also [col. 25, line 5].). Therein, this arrangement provides rapid and even heating during PCR analysis, as similarly contemplated by McDevitt ([0384]), so as to reduce errors due to insufficient heating operation.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Mcdevitt wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction, such as suggested by Linton, so as to provide rapid and even heating during PCR analysis, thereby reducing error due to improper heating, and would have a reasonable expectation of success therein.
Further, when combined with the tray base of Maul, said tray base would transfer heat to the tray as heat is provided to the outer cover as in Linton, and the outer cover interfaces with the tray base, thereby transferring heat therebetween and to the tray.
Regarding Claim 25, the prior art meets the limitations of Claim 24 as discussed above. Further, McDevitt teaches the method for facilitating testing of a liquid biological sample discussed above wherein:
facilitating depositing a liquid biological sample at a predetermined location on the chemical reaction pad 122 comprises providing a sample opening 120/102 in the chemical reaction pad cover 110/112 (Fig. 2 and [0146]: “Sample layer 114 may include collection region 102…” – [0160]: Said sample opening/collection region 102 communicates with channel 106 to flow sample over the top of reagent pad 122, the top of the pad being the predetermined location on the pad. -- [0138]: “A sample may be placed in collection region 102.”), as in Claim 25.
Regarding Claim 26, the prior art meets the limitations of Claim 25 as discussed above. Further, McDevitt teaches the method for facilitating testing of a liquid biological sample discussed above wherein:
facilitating depositing a liquid biological sample at a predetermined location on the chemical reaction pad 122 further comprises providing a capillary channel 106 in fluid communication with the sample opening 120/102 to distribute the liquid biological sample along the chemical reaction pad 122 (Fig. 2 and [0156]: “Sample deposited in collection region 102 may flow through channel 106 toward detection region 108.” – [0169]: “Fluid from reagent region 122 flows through channel 128, enters into channel 106, and then enters detection region 108. In some embodiments, channel 128 and channel 106 are the same channel.” – Fig. 2 further shows that thew channel 106 is formed on top of and is open to reagent pad 122, thus distributing sample travelling through the channel 106 along the reagent pad 122.), as in Claim 26.
Regarding Claim 27, the prior art meets the limitations of Claim 24 as discussed above. Further, McDevitt teaches the method for facilitating testing of a liquid biological sample discussed above further comprising:
facilitating sealing the enclosure about the chemical reaction pad (Fig. 1 and [0140]: “Cover 104 may seal the sample collection region and inhibit contaminants from entering the sample collection region.” – Sealing of the opening 120/102 operably encloses the reagent pad 122 within the device.), as in Claim 27.
Regarding Claim 28, the prior art meets the limitations of Claim 27 as discussed above. Further, McDevitt teaches the method for facilitating testing of a liquid biological sample discussed above wherein:
facilitating sealing the enclosure about the chemical reaction pad comprises providing a seal operable with the outer cover (McDevitt teaches an embodiment wherein the outer cover is a reservoir 154 comprising a seal 202 operable with said outer cover reservoir 154 to seal the enclosure, wherein the tray forms a bottom seal and the combination of the two fully encloses the device and reaction pad 122 contained therein.), as in Claim 28.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Paek et al. (US 2018/0141041 A1), referred to hereinafter as “Paek.”
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above wherein the chemical reaction pad comprises at least one of a cellulose material, a paper material, or a fiber material, as in Claim 2.
However, Paek teaches a respective biological sample test cartridge comprising a biochemical reaction pad 60/70 (Fig. 5) wherein said biochemical reaction pad 60/70 is made of cellulose ([0096]). Paek further discusses biochemical reagents that facilitate the test reaction being absorbed into the biochemical reaction pad 60/70 ([0065]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to fabricate the reaction pad taught by McDevitt using a cellulose material, such as taught by Paek in the analogous art of absorbent reaction pad biological assay cartridges, so as to provide a suitable absorbent material for absorbing biochemical reagents for the test reaction, as well as the liquid biological sample itself.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above wherein the chemical reaction pad cover comprises one or more optically transparent or translucent windows, as in Claim 4.
However, Paek teaches a respective biological sample test cartridge comprising a top plate 400a having a transparent viewing window 420 through which color changes to the test reaction zones 50 and 60 can be viewed by a user ([0068]). Colorimetric and fluorescent detection is similarly contemplated by McDevitt ([0331]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge of McDevitt with or more optically transparent or translucent windows, such as taught by Paek, to provide a suitable structure to allow a user to observe a colorimetric result related to the test reaction used by the cartridge.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Freedman et al. (US 2019/0092536 A1), referred to hereinafter as “Freedman.”
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt/Maul does not specifically the test cartridge discussed above wherein the tray base comprises a seal operable with the outer cover to seal the enclosure about the chemical reaction pad, as in Claim 11.
However, Freedman teaches a moisture tight container for holding moisture sensitive items ([0001]) comprising a lid 119 and a base 155 (Fig. 1), wherein the base 155 comprises an elastomeric seal 210a ([0035] and Fig. 2) preferably constructed as an annular ring disposed on the base 155. Freedman describes the benefit of this arrangement as protecting material inside the container, such as diagnostic test strips such as similarly used by McDevitt and Maul, from moisture, preserving their usability and accuracy.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the diagnostic test device of McDevitt/Maul with a moisture-tight seal, such as taught by Freedman, so as to protect the diagnostic test substrate contained therein from moisture, thus preserving said substrate’s usability and testing accuracy.
Regarding Claim 14, the prior art meets the limitations of Claim 11 as discussed above. Further, McDevitt/Maul does not specifically the test cartridge discussed above wherein the seal comprises an elastomeric material, as in Claim 14.
However, Freedman teaches a moisture tight container for holding moisture sensitive items ([0001]) comprising a lid 119 and a base 155 (Fig. 1), wherein the base 155 comprises an elastomeric seal 210a ([0035] and Fig. 2) preferably constructed as an annular ring disposed on the base 155. Freedman describes the benefit of this arrangement as protecting material inside the container, such as diagnostic test strips such as similarly used by McDevitt and Maul, from moisture, preserving their usability and accuracy.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide a seal to McDevitt/Maul as an elastomeric seal, such as taught by Freedman, so as to provide a suitable seal-forming material to enable the sought moisture-tight seal.
See further the 35 USC 112b/2nd section above regarding antecedent basis for the terms “the seal” and “the handle.”
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Khattak et al. (US 2017/0248622 A1), referred to hereinafter as “Khattak.”
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt/Maul does not specifically the test cartridge discussed above further comprising a handle coupled to the tray base to facilitate grasping the test cartridge by a user, as in Claim 12.
However, Khattak teaches a respective biological sample test cartridge comprising a handle 540; and describes the benefit of said handle 540 as allowing a user to grasp and manipulate the sample collection device ([0109] and Fig. 5).
While Khattak does not specifically teach the handle 540 as coupled to a tray base, the device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said handle – see MPEP 2144.04 (VI)(C). Herein, one of ordinary skill in the art would find it obvious to attach the handle to the tray base so as to provide the handle to a structure which encloses other components of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt/Maul with a handle, such as taught by Khattak, so as to provide a suitable structure to allow a user to grasp and manipulate the sample collection device without disturbing the testing substrate, thus preserving the usability and testing accuracy of the substrate.
Regarding Claim 13, the prior art meets the limitations of Claim 12 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above wherein the tray base is coupled to the tray via a reduced cross-sectional area portion to reduce conductive heat transfer from the tray to the handle, as in Claim 13.
However, Khattak teaches a respective biological sample test cartridge comprising a handle 640 (Fig. 6). Further, Fig. 4A shows said handle 640 as attached to the collection head 420 (the cartridge body) via a shaft 410 having a reduced cross-sectional area with respect to the handle.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the test cartridge of McDevitt with a handle attached to the cartridge body via a reduced cross-sectional area, such as taught by Khattak, so as to provide a suitable structure for attaching a handle.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Mielke et al. (US 2015/0353919 A1), referred to hereinafter as “Mielke.”
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above wherein the outer cover comprises at least one of a key or a keyway operable to facilitate proper alignment of the test cartridge with a heating device, as in Claim 16.
However, Mielke teaches a respective biological sample test cartridge 200 wherein various notches (keyways) and protrusions (keys), may serve to align the reaction cartridge 200 with the cartridge reader. While Mielke does not teach alignment of the cartridge 200 with a heater, said heater is merely an intended workpiece and does not hold patentable weight.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt with at least one of a key or keyway, such as taught by Mielke, so as to allow a user to properly align the test cartridge with a cartridge reader.
See further the 35 USC 112b/2nd section above regarding the terms “key” and “keyway.”
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Khattak. Khattak has been discussed above.
Regarding Claim 20, the prior art meets the limitations of Claim 1 as discussed above. Further, McDevitt does not specifically the test cartridge discussed above further comprising a handle coupled to the tray base to facilitate grasping the test cartridge by a user, as in Claim 20.
However, Khattak teaches a respective biological sample test cartridge comprising a handle 540; and describes the benefit of said handle 540 as allowing a user to grasp and manipulate the sample collection device ([0109] and Fig. 5).
While Khattak does not specifically teach the handle 540 as coupled to a tray base, the device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said handle – see MPEP 2144.04 (VI)(C). Herein, one of ordinary skill in the art would find it obvious to attach the handle to the tray so as to provide the handle to a structure which encloses other components of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt with a handle, such as taught by Khattak, so as to provide a suitable structure to allow a user to grasp and manipulate the sample collection device without disturbing the testing substrate, thus preserving the usability and testing accuracy of the substrate.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul, Linton, Freedman, and Khattak. Maul, Linton, Freedman, and Khattak have been discussed above.
Regarding Claim 22, McDevitt teaches a liquid biological sample test cartridge, comprising:
a tray 114 (Fig. 2);
a chemical reaction pad 122 supported by the tray 114 ([0129]: “A cartridge may include one or more reagent regions…a reagent region includes one or more reagents, detectable labels, and/or buffers that are disposed on one or more reagent pads…” -- [0225]: “Directly flowing sample over and/or through a reagent region may reduce the time required for reaction between sample and reagents and/or detectable labels.”);
a chemical reaction pad cover 110/112 disposed over the chemical reaction pad 122 and coupled to the tray 114 (Fig. 2 and [0142]: “Layers may be coupled, sealed, welded or bonded together to form the cartridge.”),
the chemical reaction pad cover 110/112 having a sample opening 120/102 to facilitate depositing a liquid biological sample at a predetermined location on the chemical reaction pad 122 (Fig. 2 and [0146]: “Sample layer 114 may include collection region 102…” – [0160]: Said sample opening/collection region 102 communicates with channel 106 to flow sample over the top of reagent pad 122, the top of the pad being the predetermined location on the pad. -- [0138]: “A sample may be placed in collection region 102.”);
and a capillary channel 106 in fluid communication with the sample opening 120/102 to distribute the liquid biological sample along the chemical reaction pad 122 (Fig. 2 and [0156]: “Sample deposited in collection region 102 may flow through channel 106 toward detection region 108.” – [0169]: “Fluid from reagent region 122 flows through channel 128, enters into channel 106, and then enters detection region 108. In some embodiments, channel 128 and channel 106 are the same channel.” – Fig. 2 further shows that thew channel 106 is formed on top of and is open to reagent pad 122, thus distributing sample travelling through the channel 106 along the reagent pad 122.);
an outer cover 104 operable to form an enclosure about the chemical reaction pad (Fig. 1 and [0140]: “Cover 104 may seal the sample collection region and inhibit contaminants from entering the sample collection region.” – Sealing of the opening 120/102 operably encloses the reagent pad 122 within the device.)
Further regarding Claim 22, McDevitt does not specifically teach the test cartridge discussed above further comprising a tray base coupled to the tray, wherein the tray base is configured to interface with the outer cover to form the enclosure about the chemical reaction pad, as in Claim 22.
However, Maul teaches a respective biological sample test cartridge wherein a tray base 34 (“lower half 34”) is configure to interface with an outer cover 32 (“upper half 32”) to form an enclosure about a chemical reaction pad 26 (“test surface 26”) to form an enclosure around the chemical reaction pad 26 (Fig. 8E). Maul further teaches the benefit of this assembly in col. 34, line 14: “These plastic covers provide protection to the end-user by preventing exposure to the wash solution and excess sample contained within the absorbent materials.”
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt with a tray base configured to interface with an outer cover such as taught by Maul so as to contain the inner components and reagents housed therein to prevent user exposure, given that McDevitt is similarly concerned with fully containing reagents inside the device via a cover 104 ([0140]).
Further regarding Claim 22, McDevitt does not specifically the test cartridge discussed above wherein the tray base has a seal operable with the outer cover to seal the enclosure about the chemical reaction pad, as in Claim 22.
However, Freedman teaches a moisture tight container for holding moisture sensitive items ([0001]) comprising a lid 119 and a base 155 (Fig. 1), wherein the base 155 comprises an elastomeric seal 210a ([0035] and Fig. 2) preferably constructed as an annular ring disposed on the base 155. Freedman describes the benefit of this arrangement as protecting material inside the container, such as diagnostic test strips such as similarly used by McDevitt and Maul, from moisture, preserving their usability and accuracy.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the diagnostic test device of McDevitt with a moisture-tight seal, such as taught by Freedman, so as to protect the diagnostic test substrate contained therein from moisture, thus preserving said substrate’s usability and testing accuracy.
Further regarding Claim 22, McDevitt does not specifically the test cartridge discussed above further comprising a handle coupled to the tray base, as in Claim 22.
However, Khattak teaches a respective biological sample test cartridge comprising a handle 540; and describes the benefit of said handle 540 as allowing a user to grasp and manipulate the sample collection device ([0109] and Fig. 5).
While Khattak does not specifically teach the handle 540 as coupled to a tray base, the device having the claimed relative arrangement of parts would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said handle – see MPEP 2144.04 (VI)(C). Herein, one of ordinary skill in the art would find it obvious to attach the handle to the tray base so as to provide the handle to a structure which encloses other components of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the test cartridge taught by McDevitt with a handle, such as taught by Khattak, so as to provide a suitable structure to allow a user to grasp and manipulate the sample collection device without disturbing the testing substrate, thus preserving the usability and testing accuracy of the substrate.
Further regarding Claim 22, McDevitt does not specifically teach the test cartridge discussed above wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction through the tray base, as in Claim 22.
However, Linton teaches a cartridge device for sample processing comprising an outer cover 22 and a tray 23 forming a microfluidic space 24 through gasket 21, wherein the cover 22 is configured to interface with a heat source and transfer heat to the tray 23 via conduction ([col. 12, line 16]: “One of the top 22 or bottom 23 may be made of an opaque material such as a metal, with the other side permitting optical readout. The opaque part may be advantageously made from a heat conducting material such as stainless steel, which may be placed adjacent a heat source, such as a Peltier device, during thermal cycling.” – See also [col. 25, line 5].). Therein, this arrangement provides rapid and even heating during PCR analysis, as similarly contemplated by McDevitt ([0384]), so as to reduce errors due to insufficient heating operation.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Mcdevitt wherein a portion of the outer cover is configured to interface with a heat source and transfer heat to the tray via conduction, such as suggested by Linton, so as to provide rapid and even heating during PCR analysis, thereby reducing error due to improper heating, and would have a reasonable expectation of success therein.
Further, when combined with the tray base of Maul, said tray base would transfer heat to the tray as heat is provided to the outer cover as in Linton, and the outer cover interfaces with the tray base, thereby transferring heat therebetween and to the tray.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Mcdevitt in view of Maul and Linton, as applied to Claims 1, 3, 5-9, 15, 17-19, 21, and 24-28 above, and in further view of Dixon et al. (US2018/0313743A1), referred to hereinafter as “Dixon.”
Regarding Claim 23, the prior art meets the limitations of the test cartridge Claim 1 as discussed above. Further, McDevitt does not specifically teach the biological sample test cartridge as a member of a kit comprising: a pouch; and the liquid biological sample test cartridge sealed within the pouch, as in Claim 23.
However, Dixon teaches a respective liquid biological sample test cartridge ([0002]), and a kit wherein said test cartridge is sealed within a pouch ([0151]). Providing test cartridges within an airtight sealed container is known in the art to protect the cartridge from humidity and other contaminants, preserving the usability of the cartridge and the accuracy of test results. By this, providing a test cartridge within a sealed container thus provides a form able to be stored for extended periods prior to use and to be distributed to consumers without worry that outside contaminants will damage the cartridge prior to use.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to package the biological sample test cartridge of McDevitt within a sealed pouch, such as taught by Dixon, so as to inhibit or prevent excess humidity from damaging the test sensor and/or altering the test results and provide a form for storage and distribution to the end-user.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over McDevitt in view of Maul, Linton, and Khattak, as applied to Claims 12-13 above, and in further view of Kenney (US PAT 6,240,791 B1), referred to hereinafter as “Kenney”.
Regarding Claim 29, McDevitt/Maul/Khattak does not specifically teach the test cartridge discussed above wherein the handle comprises an elastomeric material, as in Claim 29.
However, Kenney teaches a laboratory device comprising a handle wrapped in a handle wrap comprising a this, pliable sheet of elastomeric material, wherein this arrangement provides an ergonomic non-slip gripping surface for a user to grasp, thereby reducing the risk of dropping and damaging the device (col. 2, line 3).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the cartridge of McDevitt/Maul/Khattak such that the handle comprises an elastomeric material, such as suggested by Kenney, so as to provide an ergonomic non-slip gripping surface for a user to grasp, thereby reducing the risk of dropping and damaging the device; and would have a reasonable expectation of success therein.
Note that the reference of Kenney is not utilized to provide a handle or cartridge, wherein these elements are provided by the references of McDevitt/Maul/Khattak. Kenney is merely utilized for providing an elastomeric material to the cartridge of McDevitt/Maul/Khattak. Further, elastomer-coated gripping handles are well-known in the art of laboratory devices and apparatuses, wherein one of ordinary skill in the art would find it obvious to apply this knowledge to the cartridge of McDevitt/Maul/Khattak to achieve the benefit of a more reliable grip.
Response to Arguments
35 USC 112
Applicant’s cancellation of Claim 10 renders moot the rejection of Claim 10 as indefinite under 35 USC 112(b). As such, the rejection of Claim 10 under 35 USC 112(b) is withdrawn.
35 USC 103
Applicant’s arguments regarding independent Claims 1, 22, and 24 are on the alleged grounds that Linton teaches away from conductive heat transfer, wherein the heat array of Linton does not contact the surfaces of the sample holder and thereby does not satisfy the heat transfer through conduction claim requirements. Applicant further alleges that Linton does not provide guidance as to conduction through a tray base to a tray.
Applicant’s arguments are not persuasive. While Applicant is correct in pointing out that Linton teaches “shims, bumps, and/or posts so that the [heating] array does not contact the surfaces” (col. 12, line 29), this is merely one specific embodiment of Linton. Linton further teaches embodiments wherein the heating array (thermal-cycling block) is in contact with the surfaces of the sample-containing device: “It is therefore advantageous to include one or more additional thermal contact means between the case and the thermal-cycling block. The thermal contact means may include a means for applying pressure to the case such as clips. Other embodiments that further increase heat transfer include use of a flexible heat transfer pad, grease, or paste. For example, a heat transfer pad 215, grease or paste may be placed between the flat block 212 (or the cycling head if a fluidic thermal cycler is used) and the case 211 holding the array.”. (col. 18 line 67 – col. 19 line 9). As this thermal contact satisfies a means for conductive heat transfer, the prior art of Linton meets the requirements of the instant claims.
Further, regarding the tray and tray base, the prior art of Linton is combined with the primary reference of McDevitt (providing the tray) and Maul (providing the tray base coupled to the outer cover and the tray). When these references are taken as a whole, the combination provides for contact/coupling between the outer cover, the tray base (coupled to the outer cover), and the tray (coupled to the tray base). As these elements of the combination would all be in contact with another, heating of the outer cover would conduct heat to the tray base and to the tray therethrough. As such, the combination of McDevitt, Maul, and Linton provides for all the limitations of the amended independent Claims 1, 22, and 24.
Thus, Examiner maintains the rejection of Claims 1, 22, and 24, and dependents thereof, under 35 USC 103 over at least McDevitt in view of Maul and Linton, as discussed above in the body of the action.
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.
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/B.J.K./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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