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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-45, in the reply filed on 01/06/2026 is acknowledged.
Claim 46 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026.
Please note that claim 46 has been cancelled.
Status of Claims
Claims 1-45 remain pending in the application.
Claim Objections
Claims 20, 31 are objected to because of the following informalities:
Claim 20 recites “angled or pitched relative a horizontal plane” where it is suggested to amend to recite “angled or pitched relative to a horizontal plane” to help the claim read more smoothly.
Claim 31 recites “wherein only one fluid port is in fluid communication with the valve interface.” on lines 3-4, where it is suggested to amend the claim to recite “wherein only one of the fluid ports is in fluid communication” as this makes it more clear that it is referring to the two fluid ports recited on line 2.
This also helps clarify claims 32 and 33 which recite “the other fluid port”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a fluid sample” on line 4, where it is unclear if this fluid sample is the same or different from the biological fluid sample described on lines 1-2.
For examination, it will be interpreted that they are the same.
It is suggested to amend line 4 to recite “[[a]] the fluid sample”
Line 4 also recites “wherein at least one chamber is configured to receive a fluid sample” where it is unclear if the chamber is the same or different from the plurality of chambers recited previously.
It is suggested to amend line 4 to recite “wherein at least one chamber of the plurality of chambers is configured to receive a fluid sample”
Claims 2-45 are rejected by virtue of being dependent on a rejected claim.
Claim 2 recites “a fluid sample” on line 3, where it is unclear if this fluid sample is the same or different from the one described in claim 1.
For examination, it will be interpreted that they are the same.
It is suggested to amend claim 2 to recite “[[a]] the fluid sample”
Claim 7 recites “the valve assembly” on line 2, where there is insufficient antecedent basis for this limitation, as no valve assembly has been recited prior.
It is noted that claim 9 describes a valve assembly, however making claim 7 be dependent on claim 9 would cause antecedent issues for the base. Therefore, it is suggested to amend claim 7 to recite “a valve assembly”
Claim 8 is rejected by virtue of being dependent on a rejected claim.
Claim 8 recites “a valve interface” on lines 1-2, where it is unclear if this valve interface is the same or different from the one described on line 8 of claim 1.
For examination, it will be interpreted that it is the same valve interface as described in claim 1, and it is suggested to amend claim 8 to recite:
“body includes [[a]] the valve interface”
Claim 21 recites “the filter” on line 2 where there is insufficient antecedent basis for this limitation, and further line 3 recites “a filter” where it is unclear if this filter is the same or different from the one described prior.
It is suggested to amend claim 21 to recite “that supports a filter within the filter chamber,… facilitate more uniform fluid flow through [[a]] the filter disposed therein.”
Claim 22 recites “the filter chamber.” on line 2 where there is insufficient antecedent basis for this limitation, as no filter chamber has been recited prior.
It is noted that claim 19 describes a filter chamber, therefore for examination claim 22 will be examined as being dependent on claim 19.
Claims 23-24 are rejected by virtue of being dependent on a rejected claim.
Claim 28 recites “a reaction vessel” on line 2, where it is unclear if this reaction vessel is the same or different from the one described in claim 1.
For examination, it will be interpreted that they are the same reaction vessel.
It is suggested to amend claim 28 to recite “[[a]] the reaction vessel”
Claims 29-30 are rejected by virtue of being dependent on a rejected claim.
Claim 29 recites “wherein the other fluid channel is open to atmosphere”, where this is unclear because while claim 28 does describe two fluid channels, claim 28 does not describe what one of the fluid channels is connected to, therefore the phrasing is unclear as it appears that another channel’s connection should have been described.
For examination, as long as one of the channels is open to the atmosphere through a frit it will read on claim 29.
Claim 30 similarly recites “wherein the other fluid channel” and is unclear for the same reasons described in claim 29.
For examination, as long as one of the channels is closed and includes sufficient headspace for fluid transport it will read on claim 30.
Further, line 3 recites “the single fluid port” where it is unclear if it is referring to the single fluid port of the tube mount or the single fluid port of the reaction vessel.
Claim 31 recites “only one fluid port” on line 3, where it is unclear if it is referring to the fluid port of the tube mount or the fluid port of the reaction vessel.
For examination, it will be interpreted that the fluid port is referring to the one on the reaction vessel.
Claims 32-33 are rejected by virtue of being dependent on a rejected claim.
Claim 32 recites “the sample chamber” where there is insufficient antecedent basis for this limitation, as no sample chamber has been recited previously.
Claim 1 does describe at least one chamber configured to receive a fluid sample, however based on the limitations of claim 32 it does not appear that this is the chamber being referred to. Is there a sample chamber on the reaction vessel? Because claim 28 describes that a reaction vessel has a reaction chamber, it will be interpreted that the sample chamber described in claim 32 is referring to a component of the reaction vessel.
Further, it is unclear if the fluid port of claim 32 is referring to the fluid port of the tube mount or the fluid port of the reaction vessel.
For examination, it will be interpreted that the fluid port is referring to the one on the reaction vessel.
Claim 33 recites “the fluid sample chamber” on line 2, where there is insufficient antecedent basis for this limitation. For examination, it will be interpreted that it is referring back to the sample chamber of claim 32.
Further it is unclear if the other fluid port of claim 33 is referring to the fluid port of the tube mount or the fluid port of the reaction vessel.
For examination, it will be interpreted that the fluid port is referring to the one on the reaction vessel.
Claim 40 recites “within at least some of the multiple chambers.” where there is insufficient antecedent basis for this limitation, as multiple chambers have not been recited prior.
For examination, it will be interpreted that the multiple chambers are referring to the plurality of chambers described in claim 1.
It is suggested to amend claim 40 to recite “within at least some of the plurality of chambers”
Claim 42 recites “the filter and the valve body” where there is insufficient antecedent basis for both of these terms.
It is unclear what claim 42 should depend from, as currently claims 20 and 21 describe both a valve body and a filter.
Claim 43 recites “the filter and the cap” where there is insufficient antecedent basis for both of these terms.
It is unclear what claim 43 should depend from, as currently claims 20 or 21 could provide antecedent basis for claim 43.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-12, 14-19, 22-25, 31-34, 41-43 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 is configured to receive a fluid sample (sample chamber 60) ([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 tube integrally defined within the cartridge body (12), the syringe tube disposed between the plurality of chambers (13) and being open at the top side of the cartridge body (13) (see Figure 1 where there is a tubular portion 24 sticking out of what is being considered a syringe tube, the tubular portion 24 separated from the syringe tube is best seen in Figure 3);
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 tube ([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
The limitations “a sample cartridge for processing and/or analytical testing of a biological fluid sample”, “at least one chamber is configured to receive a fluid sample” are 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 apparatus of Dority is capable of processing and/or analytical testing of a biological fluid and at least one chamber is capable of receiving a fluid sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Dority (see MPEP §2114).
Additionally, 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 cartridge and a coupling feature for securely coupling the reaction vessel to the 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 tube is dimensioned to facilitate flow of the fluid sample therethrough into the plurality of chambers such that the sample cartridge is operational to process a 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).
Further, please note that the fluid sample has not been positively recited, and is therefore not a part of the claimed cartridge.
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 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 (12) further includes a base of the cartridge (Dority; Figure 2 which shows the underside of the housing 12 which is a base).
Regarding claim 6, modified Dority teaches the sample cartridge of claim 5. Dority further teaches wherein the base is integrally formed with the cartridge body (12) (Dority; see Figure 2 where the bottom part is integrally formed with the rest of the 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 the valve assembly (valve 16) within the cartridge body (12) (Dority; [0043], Figure 4 showing an opening).
The limitation “an opening on an underside configured for receiving the valve assembly within 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 apparatus of Dority is capable of receiving the valve assembly within the cartridge body. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Dority (see MPEP §2114).
Regarding claim 8, modified Dority teaches the sample cartridge of claim 7. Dority further teaches wherein the cartridge body (12) includes a valve interface accessible through the opening in 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 tube 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 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. Doirty 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 cartridge body (12), wherein the coupling feature (29) is configured to allow the valve body to rotate while coupled with the 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 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 is non- level and protrudes toward the plurality of chambers (13) of the cartridge (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 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 (please see 112b section supra regarding dependency). 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 23, modified Dority teaches the sample cartridge of claim 22. Dority further teaches wherein the one or more sealing rings comprises a sealing ring disposed around the filter chamber (30) (Dority; please see second annotated Figure 9AA supra, where the sealing ring indicated on the lower side is around the processing region 30).
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 of the sample cartridge comprises two fluid ports that fluidically couple to two fluid ports of the reaction vessel when attached thereto (Dority; see Figure 9KK where reaction vessel 18 is seen to be connected to the housing 12, where there will therefore be two fluid ports of the housing that connect to two fluid ports of the reaction vessel 18).
Please note that the reaction vessel has not been positively recited, and is therefore not a part of the claimed cartridge. Therefore, the limitation regarding “wherein only one fluid port is in fluid communication with the valve interface” is considered to be met because the fluid ports of the reaction vessel has not been positively recited.
Regarding claim 32, modified Dority teaches the sample cartridge of claim 31.
The limitations of claim 32 are directed to the reaction vessel, which has not been positively recited. Therefore the limitation “wherein the other fluid port of the sample chamber is open to atmosphere through a frit of the sample cartridge.” is considered to be met.
Regarding claim 33, modified Dority teaches the sample cartridge of claim 31. The limitations of claim 33 are directed to the reaction vessel, which has not been positively recited. Therefore the limitation “wherein the other fluid port of the sample chamber is in fluid communication with a channel of the fluid sample chamber that is closed and includes sufficient headspace for fluid transport through the reaction vessel by application of pressure through the other fluid port.” is considered to be met.
Regarding claim 34, modified Dority teaches the sample cartridge of claim 1. Dority further teaches wherein the sample cartridge (12) further comprises 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 9. 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 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).
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 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 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 the filter within the filter chamber, wherein the filter support ribs are angled along a length thereof to facilitate more uniform fluid flow through a 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.” 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. 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 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 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 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 further 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.
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759