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 .
Response to Amendment
Applicant amendments filed 07/23/2026 have been entered. Applicant amendment overcomes the previous claim objections and 112(b) rejections set forth in the Office Action mailed 03/23/2026, the previous claim objections and 112(b) rejections are withdrawn.
Status of Claims
Claims 1-5, 7-22, 23-45, 56-57 remain pending in the application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7, 9, 31, 56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (US-2020/0164370-A1).
Please note that this rejection is an alternative to the 103 rejection below in the instance where Dority does not teach a syringe bore including a plunger slidably disposed therein.
Regarding claim 1, Zhao teaches a sample cartridge for processing and/or analytical testing of a biological fluid sample, the sample cartridge comprising:
a unitary cartridge body (shell 2) having a plurality of chambers (waste chamber 202, lysis chamber 203, wash chamber 204, eluent chamber 205, primary and secondary PCR reaction solution chambers 2061 and 2062) therein and open at a top side of the cartridge body (2), wherein at least one chamber of the plurality of chambers (202, 203, 204, 205, 2061, 2062) is configured to receive the fluid sample, wherein the unitary cartridge body (2) further comprises ([0109], [0118] see lysis chamber 203 for adding and storing a mixture of sample and lysate, [0131], Figures 3, 4):
a syringe bore (reaction chamber 201) integrally defined within the unitary cartridge body (2), the syringe bore (201) disposed between the plurality of chambers (202, 203, 204, 205, 2061, 2062) and being open at the top side of the unitary cartridge body (2), the syringe bore (201) including a plunger (piston 7) slidably disposed therein ([0115] see piston 7 connected to the reaction chamber 201 moves downward relative to the reaction chamber, [0116] see piston 7 is a hollow piston having a cylindrical shape and when placed in reaction chamber 201 it can be moved up and down along the reaction chamber, Figure 1A);
a valve interface accessible from an underside of the unitary cartridge body (2), wherein the valve interface comprises a plurality of openings (holes 207) in fluid communication with the plurality of chambers (202, 203, 204, 205, 2061, 2062) and a bottom opening of the syringe bore (201) ([0123], see Figure 7 which shows the bottom of the shell 2 where the chambers are seen to be provided with through holes 207, Figure 1A also shows a cutaway view of shell 2 where the holes 207 (not labeled) can be seen); and
a tube mount having one or more fluid ports (input port 208 and discharge port 209) for communication with one or more fluid ports (first and second ports 501 and 502) of a reaction vessel (PCR reaction tube 5) when attached to the sample cartridge and a coupling feature (seal 9 and card slot 401) for securely coupling the reaction vessel (5) to the sample cartridge ([0133], [0137], [0140] see card slot 401 is provided with grooves 402 for accommodating a PCR reaction tube and when inserted the PCR reaction tube 5 and shell 2 are detachably connected, Figures 11-13).
Please note that the reaction vessel nor sample fluid have been positively recited, and are therefore not a part of the claimed sample cartridge. However, Zhao teaches a PCR reaction tube 5 which has been mapped to the reaction vessel for convenience.
Regarding claim 2, Zhao teaches the sample cartridge of claim 1. Zhao further teaches wherein the syringe bore (201) is dimensioned to facilitate flow of the fluid sample therethrough into the plurality of chambers (202, 203, 204, 205, 2061, 2062) such that the sample cartridge is operational to process the fluid sample therein without any separate syringe tube ([0112] see piston 7 is moved up along the reaction chamber the reaction chamber expands in volume and its pressure decreases and the fluid is sucked into the reaction chamber, where when the piston moves downward the reaction chamber shrinks in volume and pressure increases where fluid is pressed into other chambers from the reaction chamber. Therefore, the reaction chamber is dimensioned to facilitate flow of fluid sample therethrough into the plurality of chambers).
Please note that the fluid sample has not been positively recited in the claim, and is therefore not a part of the claimed sample cartridge.
Additionally, it is noted that Zhao does teach a suction column 6, however this is not considered to be a separate syringe tube. Suction column 6 best seen in Figure 1A of Zhao is not a syringe that moves within the waste storage chamber 202.
Regarding claim 3, Zhao teaches the sample cartridge of claim 1. Zhao further teaches wherein the coupling feature (9 and 401) of the tube mount is a snap-fit design such that the reaction vessel (5) is attachable after the sample cartridge is fully assembled ([0140], where the reaction tube 5 slid into the grooves 402 of the card slot 401 may instead be snapped in).
Regarding claim 5, Zhao teaches the sample cartridge of claim 1. Zhao further teaches wherein the unitary cartridge body (2) further comprises a base, wherein the base is integrally formed with the unitary cartridge body (2) (Figure 3 where it can be seen that there is a portion of the shell 2 that extends downward where rotary disk 3 will be inserted into, this downward portion is also seen in Figure 1A and is integral with the shell 2).
Regarding claim 7, Zhao teaches the sample cartridge of claim 5. Zhao further teaches wherein the base includes an opening on an underside configured for receiving a valve assembly (rotary disk 3) within the unitary cartridge body (2) ([0122], Figures 1A, 3).
Regarding claim 9, Zhao teaches the sample cartridge of claim 1. Zhao further teaches further comprising a valve assembly (rotary disk 3) in fluid communication with the bottom opening of the syringe bore (201) and the plurality of openings of the valve interface ([0122] see rotary disk 3 enables the reaction chamber 201 to pass through the plurality of microfluidic channels to achieve fluidic communication with lysis chamber 203, wash chamber 204, eluent chamber 205 or waste storage chamber 202 in sequence).
Regarding claim 31, Zhao teaches the sample cartridge of claim 1. Zhao further teaches the tube mount comprises two fluid ports (208 and 209) that fluidically couple to two ports (501 and 502) of the reaction vessel (5) when attached thereto, wherein only one of the two fluid ports (208) of the tube mount is in fluid communication with the valve interface ([0123] describes Figures 4, 6, 7 which describes where lysis chamber 203, waste chamber 204, eluent chamber 205, and waste storage chamber 202 are provided with a through hole 207, the reaction chamber 201 has a plurality of through holes 207, and as best seen in Figure 7 and 11 only the primary PCR reaction solution chamber 2061 has a through hole 207. Secondary PCR reaction solution chamber 2062 does not have such a through hole. Therefore, discharge port 209 is not in fluid communication with the holes 207).
Regarding claim 56, Zhao teaches the sample cartridge of claim 1. Zhao further teaches wherein the plunger (7) slides along an inner surface of the syringe bore (201) ([0112]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) in view of Boris (US-5031797-A) and Sato (US-2020/0188923-A1).
Regarding claim 4, Zhao teaches the sample cartridge of claim 1. Zhao does not teach wherein the unitary cartridge body has a consistent wall thickness within a range of 0.5-2 mm.
In the analogous art of cartridges with multiple chambers for holding fluidic reagents or chemicals, Boris teaches where the cartridge has a wall and dividing walls (Boris; column 2 lines 9-11, column 3 lines 16-17, 27).
Specifically, Boris teaches where the cartridge has a vertical exterior wall 10 that defines an interior space 20, where a floor 12 closes the bottom of the interior space, and dividing walls 14 and 15 extend vertically from the floor 12 between side portions 10 to separate the interior space into three chambers 16, 17, 18, and a cap 32 closes the top of the interior space (Boris; column 3 lines 16-20, 26-30, 66-68, Figure 2A). Column 4 lines 39-43 describes that the thickness of the exterior wall 10, floor 12, dividing walls 14 and 15, and cap 32 are generally uniform and sized as necessary depending on the material used to provide strength and stability to the cartridge.
It would have been obvious to one skilled in the art to make the walls of the shell, including the walls of the chambers, of Zhao uniform as taught by Boris because Boris teaches that uniformly sized thicknesses provides strength and stability to the cartridge (Boris; column 4 lines 39-43).
However, Zhao nor Boris teach a specific thickness of the walls.
In the analogous art of reagent containers, Sato teaches that a reagent container may have a thickness of about 1 mm (Sato; [0046], [0047]).
Zhao is silent with regards to specific wall thickness for the chambers, therefore, it would have been necessary and thus obvious to look to the prior art for conventional wall thicknesses of chambers. Sato provides this conventional teaching showing that it is known in the art to use a wall thickness of about 1 mm. Therefore, it would have been obvious to one having ordinary skill in the art to make the wall thicknesses of the chambers be 1 mm because it is taught by Sato that this is an effective wall thickness for a container to hold reagents.
Claim(s) 8, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1).
Regarding claim 8, Zhao teaches the sample cartridge of claim 7. [0141] of Zhao describes where a boss 211 is disposed at the connection portion of the bottom of shell 2 and the rotary disk 3 to enhance the sealing effect of the shell 2 and rotary disk 3. The holes 207 on the bottom of the shell are the valve interface, where no disassembly of the shell 2 is required to access the holes 207 as they are at the bottom of the shell 2. One skilled in the art would find it obvious that because there is a boss 211 at the bottom of the shell, there will be a corresponding negative concave surface that is created with the boss.
Regarding claim 33, Zhao teaches the sample cartridge of claim 31. Zhao further teaches wherein the other fluid port of the tube mount is in fluid communication with a channel of a chamber of the plurality of chambers configured to receive the fluid sample, wherein the chamber is closed and includes sufficient headspace for fluid transport through the reaction vessel by application of pressure through the other fluid port (discharge port 209 is in communication with secondary PCR reaction solution chamber 2062, where the opening of the shell 2 to the secondary PCR reaction solution chamber 2062 is a channel. [0108] describes a top cover 1 that has openings for injecting sample or reagents into the respective chambers. [0155] describes where piston 7 is moved downward so that solution in reaction chamber 201 enters primary PCR reaction solution chamber 2061, where when the liquid level of mixed solution in the primary PCR reaction solution chamber 2061 is higher than the input port 208 the mixed solution enters PCR reaction tube 5 until the mixed solution overflows from discharge port 209 of the secondary PCR reaction solution chamber 2062. Even though sample is being added into chamber 2062 this is not adding sample in the way [0108] is understood to be describing and therefore one skilled in the art would find it obvious that the top cover will close chamber 2062).
Claim(s) 10, 11-12, 15-18, 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) in view of Dority (US-2003/0162304-A1).
Regarding claim 10, Zhao teaches the sample cartridge of claim 9. Zhao does not teach wherein the valve assembly includes a valve sealing surface on a top side facing the plurality of chambers, wherein the valve sealing surface is a positive conical or convex shape so as to seal against the valve interface of the unitary cartridge body.
In the analogous art of rotary fluid control valves, Dority teaches a valve (Dority; [0043]).
Specifically, Dority teaches where a valve 16 includes a seal/gasket 26 (Dority; [0043], Figure 4).
Examiner finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., added the gasket to the top surface of the rotary disk), and that in combination, each element merely would have performed the same function as it did separately (i.e., provide sealing of the rotary disk to the housing and allow for fluid connections to be made), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the rotary disk of reference Zhao with the gasket of reference Dority, since the result would have been predictable.
Regarding claim 11, Zhao teaches the sample cartridge of claim 9. Zhao further teaches wherein the valve assembly comprises:
a valve body having a top side facing the plurality of chambers and a bottom side opposing the top side (Zhao; see Figures 9-10 where the rotary disk has a top side and bottom side);
However, Zhao does not teach:
a gasket that is overmolded into the valve body; and
a cap attached to the bottom side of the valve body.
In the analogous art of rotary fluid control valves, Dority teaches a valve (Dority; [0043]).
Specifically, Dority teaches where a valve 16 includes a seal/gasket 26 and a toothed periphery 29 (Dority; [0043], Figure 4). [0057] describes where a stepper motor is typically coupled to the toothed periphery of the valve to rotate it relative to housing 12 for distributing fluid with high precision.
It would have been obvious to one skilled in the art to modify the rotary disk of Zhao such that the bottom includes the toothed periphery as taught by Dority because Dority teaches that the toothed periphery allows for distributing fluid with high precision (Dority; [0057]).
Additionally, Zhao is silent with regards to how the rotary disk is rotated, therefore, it would have been necessary and thus obvious to look to the prior art for conventional means of rotating a rotary valve. Dority provides this conventional teaching showing that it is known in the art to have a rotary valve with a toothed periphery that interacts with a stepper motor for rotation. Therefore, it would have been obvious to one having ordinary skill in the art to have the rotary disk of Zhao include a toothed periphery as taught by Dority because Dority teaches that this configuration is effective for rotating a rotary valve.
The toothed periphery will be attached to the bottom of the rotary disk, and is a cap.
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., added the gasket to the top surface of the rotary disk), and that in combination, each element merely would have performed the same function as it did separately (i.e., provide sealing of the rotary disk to the housing and allow for fluid connections to be made), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the rotary disk of reference Zhao with the gasket of reference Dority, since the result would have been predictable.
The method of a gasket that is overmolded into the valve body is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by modified Zhao (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 12, modified Zhao teaches the sample cartridge of claim 11. Zhao further teaches wherein the valve body is generally circular in shape and comprises a coupling feature along a periphery thereof for coupling with the unitary cartridge body, wherein the coupling feature is configured to allow the valve body to rotate while coupled with the unitary cartridge body (Zhao; [0141] describes where a boss 307 is provided at the connection portion of the rotary disk 3 and base 4 to reduce friction when the rotary disk rotates, where as seen in Figure 15 the boss 307 is located on the rotary disk 3. The boss is a coupling feature that allows the rotary disk to rotate while coupled with the shell).
Regarding claim 15, modified Zhao teaches the sample cartridge of claim 11.
The method of a gasket that is overmolded by injection molding from the top side of the valve body is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by modified Zhao (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 16, modified Zhao teaches the sample cartridge of claim 15. Dority further teaches wherein the gasket comprises a valve sealing surface on a top side thereof that engages the valve interface of the unitary cartridge body when the valve assembly is attached thereto, the valve sealing surface having a plurality of holes that align with selected openings of the plurality of openings of the valve interface when the valve assembly is rotated (Dority; Figures 1-4 and see Figures 9A-9LL that shows the operation of the valve 16 where it is understood that the gasket 26 has a plurality of holes that align with select chamber ports 25 when the valve 16 is rotated, where the gasket of Dority has been added to the rotary valve of Zhao and will work similarly).
Regarding claim 17, modified Zhao teaches the sample cartridge of claim 16. Dority further teaches wherein the valve sealing surface of the gasket is non-level and protrudes toward the plurality of chambers of the unitary cartridge body (Dority; see Figures 9A-9LL where the darker shaded component is the gasket 26, where it is seen that the gasket has portions that are non-level and protrudes towards the chambers 13).
Regarding claim 18, modified Zhao teaches the sample cartridge of claim 17. Dority further teaches wherein the valve sealing surface of the gasket has a convex or positive conical shape (Dority; see Figure 9AA where the protrusions are the valve sealing surfaces that have a positive conical shape).
Regarding claim 57, modified Zhao teaches the sample cartridge of claim 11. Modified Zhao further teaches wherein the valve assembly is configured to rotate independently of the unitary cartridge body.
The rotary disk of Zhao has been modified to include the gasket and toothed periphery as taught by Dority. The modified rotary disk will still operate as described in [0128] of Zhao where the rotary disk is rotated to connect the various chambers. This rotation will be independent of the shell.
Claim(s) 27-28, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) in view of Ermantraut (WO-2021/009373-A1), mapped using Ermantraut (US-2022/0362760-A1).
Regarding claim 27, Zhao teaches the sample cartridge of claim 1. Zhao does not teach wherein the tube mount comprises a single fluid port.
In the analogous art of fluid processing and detection modules, Ermantraut teaches a processing tool (Ermantraut; [0001], [0004]).
Specifically, Ermantraut teaches a housing 3 that includes a plurality of chambers 31, 31’, 31’’, and 31’’’ for holding reagents or receiving liquids, and the housing further including at least one interface 32 for fluidically connecting a separate fluid processing module to the housing (Ermantraut; [0004]). Additionally, Ermantraut describes in [0012] that the housing may include several interfaces (32, 32’, 32’’’) for fluidically connecting a separate fluid processing module to the housing. It is seen in Figure 2 that there is one fluid processing module 4 that connects to two separate ports on the housing, and another fluid processing module 4 that has one connector to the single port.
Examiner further finds that the prior art contained a device/method/product (i.e., a shell) which differed from the claimed device by the substitution of component(s) (i.e., connection surface with first and second ports) with other component(s) (i.e., connection surface that has one port), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., two ports for one port), and the results of the substitution (i.e., delivering substances to a reaction vessel) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the two ports of reference Zhao with a single port of reference Ermantraut, since the result would have been predictable.
Regarding claim 28, modified Zhao teaches the sample cartridge of claim 27. Zhao has been modified such that there is only one port for connection of the reaction vessel.
Ermantraut further teaches a fluid processing module seen in Figures 1-9 that has a single fluidic connection for connecting to the single port of the housing. It is seen that the fluid processing module has one channel leading from the fluidic connection to the first volume (reaction chamber) and a second channel from the second volume to the first volume.
Because the shell of Zhao has been modified to have a single port, it would have been obvious to one skilled in the art to use the fluid processing module taught by Ermantraut because the fluid processing module of Ermantraut interacts with the single port.
Regarding claim 30, modified Zhao teaches the sample cartridge of claim 28.
Ermantraut further teaches wherein the other fluid channel is closed and includes sufficient headspace for fluid transport through the reaction vessel by application of pressure through the single fluid port (Ermantraut; Figure 9B where the channel from the second volume to the first volume is seen to be closed, where this provides the headspace).
The limitation “for fluid transport through the reaction vessel by application of pressure through the single fluid port.” directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Zhao and the apparatus of modified Zhao is capable of fluid transport by application of pressure through the sample port. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Zhao (see MPEP §2114).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) in view of Kho (US-2015/0209789-A1).
Regarding claim 34, Zhao teaches the sample cartridge of claim 1. While Zhao teaches a top cover 1, it is described by [0108] that the cover 1 has openings for injecting samples or reagents into the respective chambers. Therefore Zhao does not teach further comprising a top lid for sealing one or more of the plurality of chambers.
In the same problem solving area of covering reaction chambers, Kho teaches a cover portion (Kho; [0041]).
Specifically, Kho teaches where a cover portion 150 includes a first cover portion 160 and a second cover portion 170 (Kho; [0042], Figure 2). It is described by [0041], [0043]-[0044] of Kho that the first cover portion 160 may be fixed at an upper edge of housing 10, where there are second openings 163, third opening 165, and opening 161 formed, where each of the second openings 163 correspond to each of the reaction chambers 130 and opening 161 is for a fluid moving member to be positioned within. The second cover portion 170 is fixed on the first cover portion 160 and includes a third opening 175 and opening 171, where [0041] describes opening 171 is for the fluid moving member to be positioned within.
It would have been obvious to one skilled in the art to modify the top cover of Zhao such that it is a double structure cover as taught by Kho because Kho teaches that reaction chambers are open when the second cover portion is open, and when materials are not supplied or discharged the reaction chambers can be closed (Kho; [0047]).
Examiner further finds that the prior art contained a device/method/product (i.e., a nucleic acid apparatus) which differed from the claimed device by the substitution of component(s) (i.e., top cover) with other component(s) (i.e., a double structure cover), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., top cover for the double structure cover), and the results of the substitution (i.e., allowing reagents to be added to the respective chambers) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the top cover of reference Zhao with the double structure cover of reference Kho, since the result would have been predictable.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) and Kho (US-2015/0209789-A1) and in further view of translated Sattler (EP-1973658-B1) and Van Workum (WO-2021/123803-A1).
Regarding claim 35, modified Zhao teaches the sample cartridge of claim 34. Zhao nor Kho teach wherein the lid is integrally formed with the unitary cartridge body. Kho does describe where the cover portion may be fixed at an upper edge of the housing (Kho; [0043]), however this is not the same as being integrally formed.
In the same problem solving area of closure lids, Sattler teaches that closure lids are hinged lids that are pivotally attached to a base housing where the base housing and hinged lids are manufactured integrally (Sattler; [0010]).
It would have been obvious to one skilled in the art to modify the double structure cover and shell of modified Zhao such that they are integrally formed and are hinged as taught by Sattler because it is taught by Van Workum that a hinged configuration is advantageous because the lid cannot be separated and lost by the user (Van Workum; page 12 lines 30-33).
Claim(s) 36-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US-2020/0164370-A1) and Kho (US-2015/0209789-A1) and in further view of Gilboa-Geffen (WO-2020/072843-A1) herein Gilboa.
Regarding claim 36, modified Zhao teaches the sample cartridge of claim 34. Zhao does not teach further comprising a thin film seal between the lid and a top surface of the unitary cartridge body.
In the same problem solving area of sealing a body with multiple chambers, Gilboa teaches a top gasket (Gilboa; [0159]).
Specifically, Gilboa teaches where a cup body 320 includes various chambers seen in Figure 5B, where a top gasket 501 is provided to seal the top 310 to the cup body 320 (Gilboa; [0159]).
It would have been obvious to one skilled in the art to modify the shell of Zhao such that it further includes a top gasket as taught by Gilboa because Gilboa teaches that the top gasket provides a seal between a top and body (Gilboa; [0159]).
Regarding claim 37, modified Zhao teaches the sample cartridge of claim 36. Gilboa further teaches wherein the thin film seal is defined by a thin film insert that is disposed between the lid and the top surface of the unitary cartridge body, see claim 36 supra.
Regarding claim 38, modified Zhao teaches the sample cartridge of claim 37. Zhao has been modified by Gilboa to include a top gasket. As seen in Figure 5B of Gilboa, the top gasket 501 is shaped to correspond to the cup body 320 and has a plurality of holes that correspond to the chambers of the cup body 320. Therefore, one skilled in the art would find it obvious to shape the top gasket to match the shape of the shell of Zhao and to have openings corresponding to the chambers 13.
Regarding claim 39, modified Zhao teaches the sample cartridge of claim 37. Zhao has been modified such that the top cover is now a double structure cover as taught by Kho. Therefore, the first cover portion will still have the same openings for injecting samples or reagents into the respective chambers. Additionally, Zhao has been modified by Gilboa to have the top gasket which will have openings corresponding to the openings of the chambers.
Regarding claim 40, modified Zhao teaches the sample cartridge of claim 39. Zhao has been modified such that the top cover is a double structure cover as taught by Kho. The second cover portion will seal the openings (and thus the openings of the top gasket of Gilboa) to the chambers when closed (Kho; [0047]).
Please note the limitations “and/or an additional thin film seal disposed over the lid so as to seal any reagents and/or processing agents disposed within at least some of the plurality of chambers.” are not required due to recitation of “and/or”.
Claim(s) 1-3, 5, 7-12, 14-19, 22, 24-25, 31-32, 34, 41, 43, 56-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) in view of Zhao (US-2020/0164370-A1).
Regarding claim 1, Dority teaches a sample cartridge for processing and/or analytical testing of a biological fluid sample, the sample cartridge comprising:
a unitary cartridge body (housing 12) having a plurality of chambers (chambers 13) therein and open at a top side of the cartridge body (12) ([0043], Figures 1-4), wherein at least one chamber (sample chamber 60) of the plurality of chambers (13) is configured to receive the fluid sample ([0049] where the sample chamber 60 seen in Figure 9A is one of the chambers seen in Figures 1-4), wherein the unitary cartridge body (12) further comprises:
a syringe bore integrally defined within the unitary cartridge body (12), the syringe bore disposed between the plurality of chambers (13) and being open at the top side of the unitary cartridge body (13), the syringe bore including a plunger (piston 54) slidably disposed therein (see Figure 1 where there is a tubular portion 24 sticking out of what is being considered a syringe bore, the tubular portion 24 separated from the syringe tube is best seen in Figure 3, Figure 9AA where it can be seen where the fluid displacement region 50 is within the syringe bore, where based on Figure 8 the piston 54 will be within the fluid displacement region 50 and therefore within the syringe bore);
a valve interface accessible from an underside of the cartridge body (12), wherein the valve interface comprises a plurality of openings (chamber ports 25) in fluid communication with the plurality of chambers (13) and a bottom opening of the syringe bore ([0043], and see Figure 4 which shows the bottom side of the housing 12 where the sunken in area where the chamber ports 25 are located is a valve interface); and
Please note that the fluid sample has not been positively recited in the claim, and is therefore not a part of the claimed cartridge.
While Figure 1 of Dority does show a reaction vessel 18 attached to the housing 12, and [0069] describes that the reaction vessel is conveniently detachable and replaceable, Dority does not specifically describe:
a tube mount having one or more fluid ports for communication with one or more fluid ports of a reaction vessel when attached to the sample cartridge and a coupling feature for securely coupling the reaction vessel to the sample cartridge.
In the same problem solving area of detachably connecting reaction tubes to a housing, Zhao teaches a card slot (Zhao; [0140]).
Specifically, Zhao teaches a nucleic acid extraction apparatus that has a shell 2 that includes various chambers within it, where the chambers are connected to a rotary disk 3 (Zhao; [0109], [0122], Figure 3). Additionally a PCR reaction tube 5 is connected to a PCR reaction solution chamber 206 with a seal 9 seen in Figure 3 (Zhao; [0137]). The seal 9 is shown in more detail in Figures 14A-B, where the seal has two through holes 901 and 902 on the connection surface correspond to ports 501 and 502 of the PCR reaction tube (see Figure 12) (Zhao; [0137]). It is further seen in Figure 13 that there is a card slot 401 that fixes the PCR reaction tube 5, and the card slot 401 is fixedly connected to the outer wall of the PCR reaction solution chamber 206 (Zhao; [0140]).
It would have been obvious to one skilled in the art to modify the housing of Dority such that it further includes the seal and card slot as taught by Zhao because Zhao teaches these components allow for a detachable connection (Zhao; [0140]).
Additionally, Dority is silent with regards to specific connection between the reaction vessel to the housing, therefore, it would have been necessary and thus obvious to look to the prior art for conventional connection types. Zhao provides this conventional teaching showing that it is known in the art to use a seal and card slot. Therefore, it would have been obvious to one having ordinary skill in the art to make the connection between the reaction vessel and housing be a seal and card slot because Zhao teaches that this is an effective way to detachably attach a reaction vessel to a housing.
Further, please note that the reaction vessel has not been positively recited in the claim, and is therefore not a part of the claimed sample cartridge. The reaction vessel 18 of Dority has been mapped to for convenience, however it is not required.
Regarding claim 2, modified Dority teaches the sample cartridge of claim 1. Dority further teaches wherein the syringe bore is dimensioned to facilitate flow of the fluid sample therethrough into the plurality of chambers such that the sample cartridge is operational to process the fluid sample therein without any separate syringe tube (Dority; [0047] see fluid displacement region 50 that is disposed in the tubular portion 24 of the valve, where when piston 54 moves upward it expands the volume of the pumping chamber 50 to provide a suction for drawing fluid into the chamber 50, and when piston 54 moves downward it drives fluid out of the chamber. Therefore the sample tube, in which the component seen in Figure 8 is inserted into, will be dimensioned to facilitate flow of the fluid sample into the plurality of chambers).
As the system of Dority requires the housing 12 and valve 16 that is inserted into the housing 12 and no additional syringe components to move the fluid aside from the valve 16, the fluid is processed without any separate syringe tube to move fluid.
Regarding claim 3, modified Dority teaches the sample cartridge of claim 1. Zhao further teaches wherein the coupling feature of the tube mount is a snap-fit design such that the reaction vessel is attachable after the sample cartridge is fully assembled (Zhao; [0140] where it is understood that the reaction vessel may snap into the grooves of the card slot).
Further, please note that the reaction vessel has not been positively recited, and is therefore not a part of the claimed cartridge.
Regarding claim 5, modified Dority teaches the sample cartridge of claim 1. Dority further teaches wherein the unitary cartridge body further comprises a base, wherein the base is integrally formed with the unitary cartridge body (Dority; see Figure 2 which shows the underside of the housing 12 which is a base, and see that the bottom part is integrally formed with the rest of housing 12).
Regarding claim 7, modified Dority teaches the sample cartridge of claim 5. Dority further teaches wherein the base includes an opening on an underside configured for receiving a valve assembly (valve 16) within the unitary cartridge body (12) (Dority; [0043], Figure 4 showing an opening).
Regarding claim 8, modified Dority teaches the sample cartridge of claim 7. Dority further teaches wherein the valve interface is accessible through the opening on the underside without any disassembly, the valve interface being a negative concave surface (Dority; see Figure 4 where the opening is a concave surface, and has chamber ports 25).
Regarding claim 9, modified Dority teaches the sample cartridge of claim 1. Dority further teaches further comprising a valve assembly (valve 16) in fluid communication with the bottom opening of the syringe bore and the plurality of openings (25) of the valve interface (Dority; [0043], Figures 1-4).
Regarding claim 10, modified Dority teaches the sample cartridge of claim 9. Dority further teaches wherein the valve assembly (16) includes a valve sealing surface (gasket 26) on a top side facing the plurality of chambers (13), wherein the valve sealing surface (26) is a positive convex shape so as to seal against the valve interface of the unitary cartridge body (12) (Dority; see Figures 4 and 5, where gasket 26 will seal against the surface where the chamber ports 25 are located, and has a positive convex shape).
Regarding claim 11, modified Dority teaches the sample cartridge of claim 9. Dority further teaches wherein the valve assembly (16) comprises:
a valve body (disk portion 22) having a top side facing the plurality of chambers (13) and a bottom side opposing the top side (Dority; [0044], Figures 4-5);
a gasket (gasket 26) that is overmolded into the valve body (22) (Dority; [0043], Figures 4-5); and
a cap (outer cover 28) attached to the bottom side of the valve body (22) (Dority; [0043], Figure 4).
The method of a gasket that is overmolded into the valve body is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Dority (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 12, modified Dority teaches the sample cartridge of claim 11. Dority further teaches:
wherein the valve body (22) is generally circular in shape and comprises a coupling feature (toothed periphery 29) along a periphery thereof for coupling with the unitary cartridge body (12), wherein the coupling feature (29) is configured to allow the valve body to rotate while coupled with the unitary cartridge body (12) (Dority; [0057], Figure 4).
The limitation “for coupling with the cartridge body, wherein the coupling feature is configured to allow the valve body to rotate while coupled with the cartridge body.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Dority and the toothed periphery of Dority is capable of coupling the disk 22 to the housing 12 and allow the disk 22 to rotate while coupled to the housing 12. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Dority (see MPEP §2114).
It is understood that the toothed periphery 29 allows for indirect coupling of the disk 22 to the housing 12, as a stepper motor will be coupled to the toothed periphery 29 and thus maintain the disk 22 within the housing 12.
Regarding claim 14, modified Dority teaches the sample cartridge of claim 12. Dority further teaches wherein the coupling feature (29) is a snap-fit feature that extends only partly around the periphery (Dority; [0057] where the tooths are understood to interact with the stepper motor, that will need to snap into corresponding features. And as seen in Figure 4, the teeth do extend around the whole periphery of the disk 22, however the teeth are being considered to not extend around the whole periphery because they would not be tooth features if they had that construction).
Regarding claim 15, modified Dority teaches the sample cartridge of claim 11.
Regarding claim 15, the method of injection molding from the top side of the valve body is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Dority (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 16, modified Dority teaches the sample cartridge of claim 15. Dority further teaches wherein the gasket (26) comprises a valve sealing surface on a top side thereof that engages the valve interface of the unitary cartridge body (12) when the valve assembly (16) is attached thereto, the valve sealing surface having a plurality of holes that align with selected openings of the plurality of openings (25) of the valve interface when the valve assembly (16) is rotated (Dority; Figures 1-4 and see Figures 9A-9LL that shows the operation of the valve 16 where it is understood that the gasket 26 has a plurality of holes that align with select chamber ports 25 when the valve 16 is rotated).
Regarding claim 17, modified Dority teaches the sample cartridge of claim 16. Dority further teaches wherein the valve sealing surface of the gasket is non- level and protrudes toward the plurality of chambers (13) of the unitary cartridge body (Dority; see Figures 9A-9LL where the darker shaded component is the gasket 26, where it is seen that the gasket has portions that are non-level and protrudes towards the chambers 13, see annotated Figure 9AA below where this darker shaded area is within the dashed rectangle).
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Regarding claim 18, modified Dority teaches the sample cartridge of claim 17. Dority further teaches wherein the valve sealing surface of the gasket has a positive conical shape (Dority; see annotated Figure 9AA supra where the protrusions are the valve sealing surfaces that have a positive conical shape).
Regarding claim 19, modified Dority teaches the sample cartridge of claim 11. Dority further teaches wherein the valve assembly (16) further comprises a filter chamber (fluid processing region 30) defined therein between the valve body (22) and the cap (28) (Dority; [0044], Figure 4).
Regarding claim 22, modified Dority teaches the sample cartridge of claim 19. Dority further teaches wherein the gasket (26) further comprises one or more sealing rings disposed adjacent the filter chamber (30) (Dority; see for example annotated Figure 9AA below, herein second annotated Figure 9AA, where there is an outer sealing ring on one side of the gasket 26 and then there will be sealing rings on the other side of the gasket 26 for each of the conical structures best seen in Figure 3).
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Regarding claim 24, modified Dority teaches the sample cartridge of claim 22. Dority further teaches wherein the one or more sealing rings further comprise a sealing ring disposed around a fluid inlet into the filter chamber (30) (Dority; please see second annotated Figure 9AA supra where the upper sealing ring is around a fluid inlet to the processing region 30).
Regarding claim 25, modified Dority teaches the sample cartridge of claim 1. Dority further teaches further comprising a valve body (disk portion 22) comprising a plurality of walls formed integrally with the valve body (22) and protruding from a bottom side of the valve body (22), wherein the plurality of walls partly define a fluid flowpath (first outer conduit 40, second outer conduit 42, first fluid processing channel 34, second fluid processing channel 38) and a filter chamber (fluid processing region 30) (Dority; [0044], [0045], Figure 8, there are walls that form the conduits, channels and fluid processing region).
Regarding claim 31, modified Dority teaches the sample cartridge of claim 1. Dority further teaches wherein the tube mount comprises two fluid ports that fluidically couple to two fluid ports of the reaction vessel when attached therein, wherein only one of the two fluid ports of the tube mount is in fluid communication with the valve interface.
[0056] of Dority describes Figure 9LL where the valve 16 has been rotated to place second external port 46 of the valve in fluidic communication with the first branch 84 and to close first external port 42 where the piston 54 is pushed downward to pressurize the mixture inside the reaction vessel 18. The first branch 84 is described in [0055] and seen in Figure 9KK that connects first external port 42 to the reaction vessel 18, and second branch 86 connects crossover groove 56 with the reaction vessel 18. Because the reaction vessel 18 is pressurized by movement of the piston 54, one skilled in the art would find it obvious that in the configuration seen in Figure 9LL one of the ports connecting to the reaction vessel will not be in fluid communication with the valve interface, because if it was the reaction vessel would not pressurize and instead be connected to another chamber.
Regarding claim 32, modified Dority teaches the sample cartridge of claim 31. As described for claim 31 supra, when in the position seen in Figure 9LL of Dority only one port connecting to the reaction vessel will not be in fluid communication with the valve interface. [0087]-[0088] describes an embodiment of a system 310 where sample fluid enters a processing chamber 314 and the chamber is seen to include a first frit 330 and second frit 332. [0086] describes where frits, such as glass frits, are used to retain material in the processing chamber.
It would have been obvious to one skilled in the art to modify the processing region 30 of Dority such that it includes a frit because it is taught that the frits retain material within a space.
Therefore, the other port will be open to the atmosphere through the frit via the fluid dispensing tube.
Regarding claim 34, modified Dority teaches the sample cartridge of claim 1. Dority further teaches further comprising a top lid for sealing one or more of the plurality of chambers (13) (Dority; [0043] see top cover provided to enclose the chambers 13).
Regarding claim 41, modified Dority teaches the sample cartridge of claim 11. Dority further teaches wherein the valve assembly (22) includes a magnet secured within (Dority; [0092] see the processing region may include magnetic beads).
Regarding claim 43, modified Dority teaches the sample cartridge of claim 41. Dority further teaches wherein the valve assembly (22) further includes a filter (27) and wherein the magnet is disposed between the filter (27) and the cap (28) (Dority; [0092] and Figure 8, where it is understood that as the processing region includes magnetic beads, the magnetic beads will be between the filter 27 and the outer cover 28 as this is where the processing region is located).
Regarding claim 56, modified Dority teaches the sample cartridge of claim 1. Dority further teaches wherein the plunger (54) slides along an inner surface of the syringe bore (Dority; Figure 8 showing the piston 54 within the fluid displacement region 50, [0047] see piston 54 is movably disposed in the pumping chamber 50 both upwards and downwards, Figure 9AA where one skilled in the art would find it obvious that the piston 54 would be within the fluid displacement region 50 and when moving upwards and downwards, the piston 54 is sliding along the inner surface of the syringe bore).
Regarding claim 57, modified Dority teaches the sample cartridge of claim 11. Dority further teaches wherein the valve assembly (16) is configured to rotate independently of the unitary cartridge body (12) (Dority; [0048] see rotary valve 16 is rotated around its axis 52 relative to the housing 12).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1) and in further view of Boris (US-5031797-A) and Sato (US-2020/0188923-A1).
Regarding claim 4, modified Dority teaches the sample cartridge of claim 1. Dority does not teach wherein the unitary cartridge body has a consistent wall thickness within a range of 0.5-2 mm.
In the analogous art of cartridges with multiple chambers for holding fluidic reagents or chemicals, Boris teaches where the cartridge has a wall and dividing walls (Boris; column 2 lines 9-11, column 3 lines 16-17, 27).
Specifically, Boris teaches where the cartridge has a vertical exterior wall 10 that defines an interior space 20, where a floor 12 closes the bottom of the interior space, and dividing walls 14 and 15 extend vertically from the floor 12 between side portions 10 to separate the interior space into three chambers 16, 17, 18, and a cap 32 closes the top of the interior space (Boris; column 3 lines 16-20, 26-30, 66-68, Figure 2A). Column 4 lines 39-43 describes that the thickness of the exterior wall 10, floor 12, dividing walls 14 and 15, and cap 32 are generally uniform and sized as necessary depending on the material used to provide strength and stability to the cartridge.
It would have been obvious to one skilled in the art to make the walls of the housing, including the walls of the chambers, of Dority uniform as taught by Boris because Boris teaches that uniformly sized thicknesses provides strength and stability to the cartridge (Boris; column 4 lines 39-43).
However, Dority nor Boris teach a specific thickness of the walls.
In the analogous art of reagent containers, Sato teaches that a reagent container may have a thickness of about 1 mm (Sato; [0046], [0047]).
Dority is silent with regards to specific wall thickness for the chambers, therefore, it would have been necessary and thus obvious to look to the prior art for conventional wall thicknesses of chambers. Sato provides this conventional teaching showing that it is known in the art to use a wall thickness of about 1 mm. Therefore, it would have been obvious to one having ordinary skill in the art to make the wall thicknesses of the chambers be 1 mm because it is taught by Sato that this is an effective wall thickness for a container to hold reagents.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1) and in further view of Sayles (US-5591401-A).
Regarding claim 13, modified Dority teaches the sample cartridge of claim 12. While Dority does teach where the outer cover 28 may be a rigid shell (Dority; [0043]), Dority does not teach how the outer cover is attached.
In the same problem solving area of attaching lids, Sayles teaches attaching a cover lid to a cup using snap-on friction-fit to securely hold the cover lid on the cup that is fluid-tight (Sayles; column 3 lines 7-12).
It would have been obvious to one skilled in the art to modify the outer cover of Dority such that it attaches to the disk 22 with a snap-on friction-fit as taught by Sayles because Sayles teaches that this type of connection is fluid-tight and securely holds the lid (Sayles; column 3 lines 7-12).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1) and in further view of Masters (US-2009/01094181-A1).
Regarding claim 20, modified Dority teaches the sample cartridge of claim 19. Dority does teach where the fluid processing region 30 has a filter 27 placed within it, however Dority does not teach does not teach wherein the valve body comprises a filter face within the filter chamber that is angled or pitched relative to a horizontal plane to facilitate more uniform fluid flow through a filter disposed therein.
In the same problem solving area of improving fluid flow characteristics in a fluidic system, Masters teaches an angled surface at a first end of a chamber to alter the direction of the fluid flow to produce uniform fluid flow characteristics across a surface (Masters; [0011]).
It would have been obvious to one skilled in the art to modify an angle of the fluid processing region to be angled as taught by Masters because Masters teaches that such an angle can produce uniform fluid flow characteristics across a surface (Masters; [0011]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1) and in further view of Beuchler (US-2004/0077103-A1).
Regarding claim 21, modified Dority teaches the sample cartridge of claim 19. Dority does not teach wherein the valve body comprises filter support ribs that support a filter within the filter chamber, wherein the filter support ribs are angled along a length thereof to facilitate more uniform fluid flow through the filter disposed therein.
In the same problem solving area of chambers to facilitate movement of a sample, Buechler teaches that the surface of a reaction chamber can be comprised of texture structures such as posts or grooves that facilitate movement of sample into the reaction chamber (Beuchler; [0083]).
It would have been obvious to one skilled in the art to modify the processing region of Dority such that it includes the grooves as taught by Beuchler because Beuchler teaches that grooves facilitate uniform fluid flow (Beuchler; [0083]).
It is understood that the grooves in the processing region of Dority will support the filter 27.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1) and in further view of Petersen (WO-0072970-A1).
Regarding claim 26, modified Dority teaches the sample cartridge of claim 25. Dority does describe that the outer cover 28 is a flexible film that is seen to cover the processing region 30 (Dority; [0051], Figure4). However Dority does not teach how the film is secured.
In the same problem solving area of sealing films to a frame, Petersen teaches heat sealing (Petersen; page 24 lines 31-33).
It would have been obvious to one skilled in the art to modify the flexible film of Dority such that it is heat sealed as taught by Petersen because Petersen teaches that heat sealing produces a strong seal without introducing potential contaminants as conventional adhesive or solvent bonding may, and that heat sealing is also simple and inexpensive (Petersen; page 24 lines 31-33, page 25 lines 1-5).
The outer cover 28 as seen in Figure 8 of Dority will now be heat sealed and will define the flowpath and processing region 30.
Claim(s) 27-28, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1), and in further view of Ermantraut (WO-2021/009373-A1), mapped using Ermantraut (US-2022/0362760-A1).
Regarding claim 27, modified Dority teaches the sample cartridge of claim 1. Dority does not teach wherein the tube mount comprises a single fluid port.
In the analogous art of fluid processing and detection modules, Ermantraut teaches a processing tool (Ermantraut; [0001], [0004]).
Specifically, Ermantraut teaches a housing 3 that includes a plurality of chambers 31, 31’, 31’’, and 31’’’ for holding reagents or receiving liquids, and the housing further including at least one interface 32 for fluidically connecting a separate fluid processing module to the housing (Ermantraut; [0004]). Additionally, Ermantraut describes in [0012] that the housing may include several interfaces (32, 32’, 32’’’) for fluidically connecting a separate fluid processing module to the housing. It is seen in Figure 2 that there is one fluid processing module 4 that connects to two separate ports on the housing, and another fluid processing module 4 that has one connector to the single port.
Examiner further finds that the prior art contained a device/method/product (i.e., a housing) which differed from the claimed device by the substitution of component(s) (i.e., connector that has two ports) with other component(s) (i.e., connector that has one port), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., two ports for one port), and the results of the substitution (i.e., delivering substances to a reaction vessel) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the two ports of reference Dority with a single port of reference Ermantraut, since the result would have been predictable.
Regarding claim 28, modified Dority teaches the sample cartridge of claim 27. Dority has been modified such that now there is only one port for connection of the reaction vessel.
Ermantraut further teaches a fluid processing module seen in Figures 1-9 that has a single fluidic connection for connecting to the single port of the housing. It is seen that the fluid processing module has one channel leading from the fluidic connection to the first volume (reaction chamber) and a second channel from the second volume to the first volume.
Because the housing of Dority has been modified to have a single port, it would have been obvious to one skilled in the art to use the fluid processing module taught by Ermantraut because the fluid processing module of Ermantraut interacts with the single port.
Regarding claim 30, modified Dority teaches the sample cartridge of claim 28. Ermantraut further teaches wherein the other fluid channel is closed and includes sufficient headspace for fluid transport through the reaction vessel by application of pressure through the single fluid port (Ermantraut; Figure 9B where the channel from the second volume to the first volume is seen to be closed, where this provides the headspace).
The limitation “for fluid transport through the reaction vessel by application of pressure through the single fluid port of the reaction vessel.” directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Dority and the apparatus of Dority is capable of fluid transport by application of pressure through the sample port of the reaction vessel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Dority (see MPEP §2114).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1) and Zhao (US-2020/0164370-A1), and in further view of translated Sattler (EP-1973658-B1) and Van Workum (WO-2021/123803-A1).
Regarding claim 35, modified Dority teaches the sample cartridge of claim 34. While Dority does teach a top cover (Dority; [0043]), Dority does not teach wherein the lid is integrally formed with the unitary cartridge body.
In the same problem solving area of closure lids, Sattler teaches that closure lids are hinged lids that are pivotally attached to a base housing where the base housing and hinged lids are manufactured integrally (Sattler; [0010]).
It would have been obvious to one skilled in the art to modify the top cover and body of Dority such that they are integrally formed and are hinged as taught by Sattler because it is taught by Van Workum that a hinged configuration is advantageous because the lid cannot be separated and lost by the user (Van Workum; page 12 lines 30-33).
Claim(s) 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1), Zhao (US-2020/0164370-A1), translated Sattler (EP-1973658-B1) and Van Workum (WO-2021/123803-A1), and in further view of Gilboa-Geffen (WO-2020/072843-A1), herein Gilboa.
Regarding claim 36, modified Dority teaches the sample cartridge of claim 34. Dority does not teach further comprising a thin film seal between the lid and a top surface of the unitary cartridge body.
In the same problem solving area of sealing a body with multiple chambers, Gilboa teaches a top gasket (Gilboa; [0159]).
Specifically, Gilboa teaches where a cup body 320 includes various chambers seen in Figure 5B, where a top gasket 501 is provided to seal the top 310 to the cup body 320 (Gilboa; [0159]).
It would have been obvious to one skilled in the art to modify the device of Dority such that it further includes a top gasket as taught by Gilboa because Gilboa teaches that the top gasket provides a seal between a top and body (Gilboa; [0159]).
Regarding claim 37, modified Dority teaches the sample cartridge of claim 36. Dority has been modified by Gilboa to include a top gasket which will be placed between the top surface of the housing 12 and the top cover.
Regarding claim 38, modified Dority teaches the sample cartridge of claim 37. Dority has been modified by Gilboa to include a top gasket. As seen in Figure 5B of Gilboa, the top gasket 501 is shaped to correspond to the cup body 320 and has a plurality of holes that correspond to the chambers of the cup body 320. Therefore, one skilled in the art would find it obvious to shape the top gasket to match the shape of the body 12 of Dority and to have openings corresponding to the chambers 13.
Claim(s) 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dority (US-2003/0162304-A1), Zhao (US-2020/0164370-A1), translated Sattler (EP-1973658-B1), Van Workum (WO-2021/123803-A1), and Gilboa-Geffen (WO-2020/072843-A1), herein Gilboa, and in further view of Kho (US-2015/0209789-A1).
Regarding claim 39, modified Dority teaches the sample cartridge of claim 37. Dority does not teach wherein the lid comprises one or more openings including a major opening, wherein the major opening is disposed over at least one opening of the plurality of openings of the thin film insert to receive the fluid sample therethrough.
In the analogous art of processing apparatuses with a plurality of chambers and a valve below the housing that rotates, Kho teaches a cover portion (Kho; [0007], [0034], [0041]).
Specifically, Kho teaches where a cover portion 150 covers reaction chambers 130 provided on housing 10, where the cover portion includes a first cover portion 160 and second cover portion 170 (Kho; [0041], [0042], Figure 1). There is a fluid moving member 180 that passes through an opening 171 seen in the second cover portion 170, where the fluid moving member may be a plunger or a piston (Kho; [0041], Figure 1).
It would have been obvious to one skilled in the art to modify the top cover of Dority to include an opening for the tubular piston as taught by Kho because Kho teaches that the opening allows the plunger/piston to be actuated (Kho; [0100], see Figure 4 where the fluid moving member 180 is seen passing through the cover).
This opening will be over the chamber that holds the tubular portion 24 seen in Figure 1 of Dority, and will therefore be over one of the openings of the top gasket as taught by Gilboa. Additionally, this chamber is understood to receive fluid sample as the plunger/piston activates to draw sample up and down.
Regarding claim 40, modified Dority teaches the sample cartridge of claim 39. Dority has been modified by Gilboa to include a top gasket, where the gasket will have openings corresponding to the chambers 13 of Dority. These openings will be sealed by the top cover of Dority.
Please note that the reagents and/or processing agents disposed within at least some of the multiple chambers is not positively recited, therefore the reagents and/or processing agents are not a part of the claimed cartridge.
Allowable Subject Matter
Claims 29, 42, 44-45 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 29, the closest prior art of record is Dority (US-2003/0162304-A1) in view of Zhao (US-2020/0164370-A1) and Ermantraut (WO-2021/009373-A1). However, it would not be obvious to one skilled in the art to modify the fluid processing module of Ermantraut to include a frit.
Additionally, an alternative rejection has been set forth in view of Zhao (US-2020/0164370-A1), where Zhao was similarly modified with Ermantraut to include the fluid processing module. Similar to above, it would not be obvious to modify the fluid processing module of Ermantraut to include a frit.
Regarding claim 42, the closest prior art of record is Dority (US-2003/0162304-A1) in view of Zhao (US-2020/0164370-A1). While Dority does teach magnetic beads in the fluid processing region, it would not be obvious to one skilled in the art to change the location of the magnetic beads to instead be between the filter (27) and valve body (22).
Regarding claim 44, the closest prior art of record is Dority (US-2003/0162304-A1) in view of Zhao (US-2020/0164370-A1). However, it would not be obvious to one skilled in the art to modify the area where chamber ports 25 are located (valve interface) to further include a magnetic capture chamber.
Claim 45 is dependent on claim 44, and would therefore be allowable by virtue of being dependent on an allowable claim.
Response to Arguments
Applicant arguments filed 07/23/2026 have been fully considered, but are not persuasive.
Due to applicant amendments to the claims, adding the limitation regarding the syringe bore including a plunger slidably disposed therein, the rejection in view of Dority under 35 USC 103 have been modified to address this amendment.
Additionally, due to applicant amendments to the claims with regards to the syringe bore, and alternative rejection is set forth in view of Zhao under 35 USC 102(a)(1). It is noted that Zhao was previously cited in the Office Action mailed 03/23/2026.
Applicant argues on page 11 that Dority provides that the plunger or piston 54 is disposed within the fluid displacement region 50 in the valve 16, where Dority does not teach where the mapped “syringe bore” includes a plunger slidably disposed therein. Rather the plunger or piston 54 of Dority is disposed within the fluid displacement region 50.
Examiner does agree that the plunger 54 is within the fluid displacement region 50 and that the fluid displacement region is placed into the housing. However, currently as the claim is phrased, it does not exclude an additional component, such as the fluid displacement tube 50, from being present. Therefore, the piston/plunger 54 is still disposed within the mapped “syringe bore”.
Applicant argues on page 15 that Zhao discloses a plunger piston and that the plunger piston is “fixedly filled at the top of the primary PCR reaction solution chamber” [0138] and therefore the plunger piston of Zhao is not at least “slidably disposed” as claimed.
Examiner respectfully disagrees. It is respectfully noted that the paragraph that applicant has cited to as evidence that the plunger piston is fixed is not stating this, rather it is referring to high density hydrophobic cotton that is in the PCR reaction solution chamber 2061, where it is the cotton that is “fixedly filled at the top of the primary PCR reaction solution chamber in a form of a plunger piston.” Please see [0112] which describes piston 7 being movably placed in the reaction chamber.
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.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
