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 03/02/2026 have been entered. Applicant amendments overcomes the previous claim objections and 112(b) rejections set forth in the Office Action mailed 11/26/2025, the previous claim objections and 112(b) rejections are withdrawn.
Status of Claims
Claims 1-20 remain pending, with claims 1-17 being examined and claims 18-20 being withdrawn pursuant to the election filed 11/22/2024.
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) 1-9, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1) in view of “The Advantages of Pneumatic Ball Valve” from Adamant Valves, herein Adamant Valves.
Regarding claim 1, Chen teaches a testing device comprising:
a microfluidic chip (Figure 17) comprising:
at least one input port (sample port) fluidically connected to at least two test zones by at least one microfluidic guide, wherein the at least one input port (sample port) is configured to hold a sample ([0148], see where there is one branch that undergoes PCR reaction and then sample is transported to a lateral flow strip for visualization. The PCR reaction is a first test zone and the lateral flow strip is a second test zone, where in Figure 17 it is seen that there is a chamber for PCR and a chamber for a lateral flow strip); and
wherein at least one test zone of the at least two test zones is configured to perform a lateral flow assay test and at least one test zone of the at least two test zones is configured to perform a polymerase chain reaction (PCR) test ([0148], Figure 17, the branch described in [0148] has a PCR test and a lateral flow assay test);
a testing device interface zone (slot for cassette) configured to receive the microfluidic chip (Figure 17) ([0143]-[0145] describes Figures 7a-d where a cassette that has separate fluid reservoirs and a lateral flow strip is inserted into an actuator seen in Figures 7d and 18g specifically, where the slot for the cassette is seen in Figure 18e. The cassette seen in Figure 17 will similarly be placed in an actuator, where the slot for the cassette is the testing device interface zone); and
The limitations “wherein the at least one input port is configured to hold a sample”, “a testing device interface zone configured to receive the microfluidic chip”, “wherein at least one test zone of the at least two test zones is configured to perform a lateral flow assay test and at least one test zone of the at least two test zones is configured to perform a polymerase chain reaction (PCR) test or a cytometry test.” 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 Chen and the apparatus of Chen is capable of holding a sample, receiving the microfluidic chip, and performing a lateral flow assay test and a PCR test or cytometry test. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Chen (see MPEP §2114).
Further, the sample has not been positively recited in the claim, and is therefore not a part of the claimed testing device.
Chen does teach where there are valves located in Figure 17. [0075] of Chen describes that by actuating one or more valves that control entry and exit of fluid from the channels allows the user to effect fluid flow in a specific direction. [0076] describes where valves may include a ball valve, where valves may be actuated by application of external force.
Chen does not specifically state what type of ball valve is used.
In the analogous art of valves, Adamant Valves teaches ball valves.
Specifically, Adamant Valves teaches where pneumatic ball valves are advantageous because of their easy operation and quick opening and closing (Adamant Valves; point 4).
It would have been obvious to one skilled in the art to make the ball valve of Chen a pneumatic ball valve as taught by Adamant Valves because pneumatic ball valves have the advantage of having quick opening and closing (Adamant Valves; point 4).
A pneumatic ball valve will have a pneumatic port. Further, the actuator of Chen will now be a pneumatic system that will connect to and control the pneumatic ball valves to move the sample through the device seen in Figure 17.
The limitation “a pneumatic system configured to connect to the pneumatic port, wherein the pneumatic system is configured to control pneumatic actuation to move the sample from the at least one input port through the at least one microfluidic guide to at least one of the at least two test zones;” 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 modified Chen and the apparatus of modified Chen is capable of connecting to the pneumatic ports and controlling pneumatic actuation to move sample from the input port through the at least one microfluidic guide to at least one of the at least two test zones. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Further, the sample is not positively recited in the claim, and is therefore not a part of the claimed testing device.
Regarding claim 2, modified Chen teaches the testing device of claim 1. Chen further teaches the microfluidic chip further comprising a component selected from the group consisting of an additional test zone (Chen; Figure 17, [0149] describes a branch that has a sample contacted with an antibody or antigen and then the sample is labeled and visualized on a lateral flow strip, where this is an additional test zone to the branch described in [0148]).
Regarding claim 3, modified Chen teaches the testing device of claim 2. The limitation “wherein the sample processing port is positioned in the microchannel upstream from at least one test zone of the at least two test zones.” is not required because Chen teaches an additional test zone, please see claim 2 supra.
Regarding claim 4, modified Chen teaches the testing device of claim 1. Modified Chen further teaches wherein at least two of the at least two test zones are not fluidically connected (Chen; Figure 17 see where there is a valve (now pneumatic ball valve of Adamant Valves) between the PCR chamber and the lateral flow strip chamber in the branch described by [0148] where when the valve is closed the PCR test zone and lateral flow strip are not fluidically connected).
Regarding claim 5, modified Chen teaches the testing device of claim 1. Modified Chen further teaches wherein at least two of the at least two test zones are fluidically connected (Chen; Figure 17 see where there is a valve (now pneumatic ball valve of Adamant Valves) between the PCR chamber and lateral flow strip chamber in the branch described by [0148] where when the valve is open the PCR test zone and the lateral flow strip are fluidically connected).
Note: under a different interpretation, Chen teaches where there are at least two of the at least two test zones that are fluidically connected because the first branch with the PCR test zone and lateral flow strip and the other branch with the lateral flow strip share a common input port.
Regarding claim 6, modified Chen teaches the testing device of claim 1. Chen further teaches wherein the at least two test zones comprise at least three test zones (Chen; [0149] see where there is a separate branch that has a lateral flow strip for visualization of a sample contacted with an antibody or antigen where the branch with the lateral flow strip is a third test zone in addition to the branch with the PCR test zone and lateral flow strip described in [0148]).
Regarding claim 7, modified Chen teaches the testing device of claim 1. Chen further teaches wherein the microfluidic chip (Figure 17) comprises at least two polymeric layers (Chen; [0009] describes where the present invention comprises a substrate with first and second surfaces with a fluid reservoir at the first surface and a deformable capping layer sealing the fluid reservoir. [0068] describes where the deformable capping layer may be a polymer, and [0140] describes where a cassette was prepared by forming depressions in a polymeric substrate where the depressions were then capped by a flexible elastomeric membrane where the cassette also includes the lateral flow strip. It is understood that the flexible elastomeric membrane may be a polymer from [0068]. Therefore, the cassette seen in Figure 17 will similarly be a polymeric substrate capped by a polymer, in other words the cassette will have at least two polymeric layers).
Regarding claim 8, modified Chen teaches the testing device of claim 1. Chen further teaches wherein the microfluidic chip (Figure 17) comprises a single polymeric layer (Chen; [0009] describes where the present invention comprises a substrate with first and second surfaces with a fluid reservoir at the first surface and a deformable capping layer sealing the fluid reservoir. [0068] describes where the deformable capping layer may be a metal, and [0140] describes where a cassette was prepared by forming depressions in a polymeric substrate where the depressions were then capped by a flexible elastomeric membrane where the cassette also includes the lateral flow strip. It is understood that the flexible elastomeric membrane may be a metal from [0068]. Therefore, the cassette seen in Figure 17 will similarly be a polymeric substrate capped by a metal, in other words the cassette will have a single polymeric layer.)
Regarding claim 9, modified Chen teaches the testing device of claim 1. Chen further teaches wherein at least one test zone of the at least two test zones is configured to perform the lateral flow assay test and at least one test zone of the at least two test zones is configured to perform the polymerase chain reaction (PCR) test, please see claim 1 supra.
Regarding claim 14, modified Chen teaches the testing device of claim 1. Chen further teaches wherein the at least two test zones further comprises at least one test zone configured to perform a test selected from the group consisting of a lateral flow assay test (Chen; Figure 17, [0149] see where a separate branch has the sample contacted with an antibody or antigen where the sample is then visualized on a lateral flow strip, where the lateral flow strip of the branch described by [0149] is in addition to the PCR test zone and lateral flow strip of the branch described by [0148]).
Claim(s) 2-4 is/are alternatively rejected and claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1) and “The Advantages of Pneumatic Ball Valve” from Adamant Valves, herein Adamant Valves, and in further view of Pulitzer (US-2018/0174689-A1).
Regarding claim 2, modified Chen teaches the microfluidic chip of claim 1. If it is determined that Chen does not teach an additional test zone, in the analogous art of systems and methods for collection and testing of a biological sample, Pulitzer teaches a testing device (Pulitzer; abstract).
Specifically, Pulitzer teaches where in one embodiment of a testing device, there is a sample well 308 that allows a user to deposit a biologic into the housing 302, where there are a plurality of strips 304 that are testing for antigens using that particular biologic sample type (Pulitzer; [0065], Figure 3). In another embodiment, Pulitzer teaches a testing device 500 that has a plurality of test strips 504 where there are a plurality of sample wells 508, with each sample well 508 being associated with one of the plurality of test strips 504 (Pulitzer; [0068], Figure 5).
Examiner further finds that the prior art contained a device/method/product (i.e., a cassette with two branches) which differed from the claimed device by the substitution of component(s) (i.e., single sample port) with other component(s) (i.e., multiple sample ports), 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., single sample port for multiple sample ports), and the results of the substitution (i.e., delivery of sample to various components) 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 single sample port of reference Chen with multiple sample ports of reference Pulitzer, since the result would have been predictable.
It is understood that there will now be a sample port for the first branch seen in Figure 17 of Chen that has the PCR test zone and lateral flow strip, and then another sample port that will be have the lateral flow strip.
Regarding claim 3, modified Chen teaches the microfluidic chip of claim 2. The limitation “wherein the sample processing port is positioned in the microchannel upstream from at least one test zone of the at least two test zones.” is not required because modified Chen teaches an additional input port, see claim 2 supra.
Regarding claim 4, modified Chen teaches the microfluidic chip of claim 1. If it is determined that the closed valves do not teach wherein at least two of the at least two test zones are not fluidically connected, in the analogous art of systems and methods for collection and testing of a biological sample, Pulitzer teaches a testing device (Pulitzer; abstract).
Specifically, Pulitzer teaches where in one embodiment of a testing device, there is a sample well 308 that allows a user to deposit a biologic into the housing 302, where there are a plurality of strips 304 that are testing for antigens using that particular biologic sample type (Pulitzer; [0065], Figure 3). In another embodiment, Pulitzer teaches a testing device 500 that has a plurality of test strips 504 where there are a plurality of sample wells 508, with each sample well 508 being associated with one of the plurality of test strips 504 (Pulitzer; [0068], Figure 5).
Examiner further finds that the prior art contained a device/method/product (i.e., a cassette with two branches) which differed from the claimed device by the substitution of component(s) (i.e., single sample port) with other component(s) (i.e., multiple sample ports), 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., single sample port for multiple sample ports), and the results of the substitution (i.e., delivery of sample to various components) 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 single sample port of reference Chen with multiple sample ports of reference Pulitzer, since the result would have been predictable.
It is understood that there will now be a sample port for the first branch seen in Figure 17 of Chen that has the PCR test zone and lateral flow strip, and then another sample port that will be have the lateral flow strip. Therefore, the first branch with the PCR test zone and lateral flow strip will not be fluidically connected to the branch with the lateral flow strip. As such, at least two of the test zones are not fluidically connected.
Regarding claim 11, modified Chen teaches the testing device of claim 1. Chen does not teach wherein the at least one input port comprises at least two input ports.
In the analogous art of systems and methods for collection and testing of a biological sample, Pulitzer teaches a testing device (Pulitzer; abstract).
Specifically, Pulitzer teaches where in one embodiment of a testing device, there is a sample well 308 that allows a user to deposit a biologic into the housing 302, where there are a plurality of strips 304 that are testing for antigens using that particular biologic sample type (Pulitzer; [0065], Figure 3). In another embodiment, Pulitzer teaches a testing device 500 that has a plurality of test strips 504 where there are a plurality of sample wells 508, with each sample well 508 being associated with one of the plurality of test strips 504 (Pulitzer; [0068], Figure 5).
Examiner further finds that the prior art contained a device/method/product (i.e., a cassette with two branches) which differed from the claimed device by the substitution of component(s) (i.e., single sample port) with other component(s) (i.e., multiple sample ports), 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., single sample port for multiple sample ports), and the results of the substitution (i.e., delivery of sample to various components) 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 single sample port of reference Chen with multiple sample ports of reference Pulitzer, since the result would have been predictable.
It is understood that there will now be a sample port for the first branch seen in Figure 17 of Chen that has the PCR test zone and lateral flow strip, and then another sample port that will be have the lateral flow strip.
Regarding claim 12, modified Chen teaches the testing device of claim 11. Chen has been modified with Pulitzer such that there are now two sample ports, therefore it is understood that there will be one sample port for the PCR test zone and lateral flow strip, and a separate sample port connected to the other lateral flow strip as seen in Figure 17 of Chen.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1) and “The Advantages of Pneumatic Ball Valve” from Adamant Valves, herein Adamant Valves, and in further view of Cheng (WO-2013/177953-A1).
Regarding claim 10, modified Chen teaches the testing device of claim 1. Chen does teach wherein at least one test zone of the at least two test zones is configured to perform a lateral flow assay test (Chen; [0148], Figure 17 see the lateral flow strip in the branch described by [0148]). It is noted that in Figure 17 of Chen, there is a total of three test zones: the PCR test zone and lateral flow strip of the first branch, and then the lateral flow strip of the other branch.
However Chen does not teach at least one test zone of the at least two test zones is configured to perform a cytometry test.
In the analogous art of monitoring microfluidic reactions, Cheng teaches the detection of target antibodies and/or antigens (Cheng; [0002], [0082]).
Specifically, Cheng teaches where the detection of antibodies and/or antigens may be achieved by immunoassays, where the polypeptide-antibody complex may be assessed by a format selected from the group consisting of flow cytometry assay and lateral flow immunoassay (Cheng; [0082]).
Examiner further finds that the prior art contained a device/method/product (i.e., a cassette) which differed from the claimed device by the substitution of component(s) (i.e., lateral flow assay) with other component(s) (i.e., flow cytometry), 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., lateral flow assay for flow cytometry), and the results of the substitution (i.e., detecting antibodies and/or antigens) 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 lateral flow strip of reference Chen with flow cytometry of reference Cheng, since the result would have been predictable.
It is understood that the lateral flow strip in the branch described by [0149] of Chen will now be detecting antibodies and/or antigens via flow cytometry.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1) and “The Advantages of Pneumatic Ball Valve” from Adamant Valves, herein Adamant Valves, and Pulitzer (US-2018/0174689-A1), and in further view of translated Protzek Ges Fuer Biomedizinische Technik GMBH (DE-202018102600-U1), herein Protzek.
Regarding claim 13, modified Chen teaches the microfluidic chip of claim 11. Chen has been modified by Pulitzer such that the two branches seen in Figure 17 of Chen will be supplied by two separate input ports. Chen in view of Pulitzer does not teach wherein each input port of the at least two input ports is fluidically connected to at least two test zones of the at least two test zones that are configured to perform the same testing mode of the at least two test zones.
In the analogous art of devices for the visual detection of analytes, Protzek teaches a device that provides a yes/no result as well as providing if a drug is within a first and second limit or above a second limit (Protzek; [0001], [0006]).
Specifically, Protzek teaches where a device consists of a carrier plate 1 that is connected to a cover plate 2 that has four test strips 3 that are each provided with the same reagents in different dosages such that the neighbor of a test strip 3 has a higher threshold value than the test strip 3 (Protzek; [0015], Figure 1). It is further seen in detailed Figure 2 of the test strip 3 that there is a sample receiving section 32, where adjacent to the sample receiving section 32 is antibody coating 33 that contains antibodies that are conjugated with gold particles and match the analyte to be detected or an antigen of the analyte that enters an immunological reaction (Protzek; [0016]). [0017] of Protzek describes where the sample receiving section 32 of each of the test strips 3 are connected to a common reservoir.
It would have been obvious to one skilled in the art to modify the test branches of Chen such that there are multiple lateral flow strips with different dosages as taught by Protzek because Protzek teaches that this allows for not only a yes/no indication of the presence of an analyte, but also allows for the determination of the concentration of the analyte to be below, between, or above set thresholds (Protzek; [0006]).
So now the PCR product in the branch described by [0148] will have both a PCR test zone and multiple lateral flow strips, and the branch described by [0149] will have multiple lateral flow strips.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1) in view of “The Advantages of Pneumatic Ball Valve” from Adamant Valves, herein Adamant Valves and Arlett (US-2018/0021783-A1).
Regarding claim 15, Chen teaches a testing device comprising:
a test card comprising:
a microfluidic chip (Figure 17) comprising:
at least one input port (sample port) fluidically connected to at least two test zones by at least one microfluidic guide, wherein the at least one input port (sample port) is configured to hold a sample ([0148], see where there is one branch that undergoes PCR reaction and then sample is transported to a lateral flow strip for visualization. The PCR reaction is a first test zone and the lateral flow strip is a second test zone, where in Figure 17 it is seen that there is a chamber for PCR and a chamber for a lateral flow strip); and
wherein at least one test zone of the at least two test zones is configured to perform a lateral flow assay test and at least one test zone of the at least two test zones is configured to perform a polymerase chain reaction (PCR) test ([0148], Figure 17, the branch described in [0148] has a PCR test and a lateral flow assay test); and
a chip carrier (actuator) coupled to the microfluidic chip (Figure 17) ([0143]-[0145] describes Figures 7a-d where a cassette that has separate fluid reservoirs and a lateral flow strip is inserted into an actuator seen in Figures 7d and 18g specifically. It is understood that the cassette seen in Figure 17 will similarly be placed in an actuator, where the actuator is a chip carrier);
The limitations “wherein the at least one input port is configured to hold a sample”, “wherein at least one test zone of the at least two test zones is configured to perform a lateral flow assay test and at least one test zone of the at least two test zones is configured to perform a polymerase chain reaction (PCR) test or a cytometry test.” 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 Chen and the apparatus of Chen is capable of holding a sample, and performing a lateral flow assay test and a PCR test or cytometry test. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Chen (see MPEP §2114).
Further, the sample has not been positively recited in the claim, and is therefore not a part of the claimed testing device.
Chen does teach where there are valves located in Figure 17. [0075] of Chen describes that by actuating one or more valves that control entry and exit of fluid from the channels allows the user to effect fluid flow in a specific direction. [0076] describes where valves may include a ball valve, where valves may be actuated by application of external force.
Chen does not specifically state what type of ball valve is used.
In the analogous art of valves, Adamant Valves teaches ball valves.
Specifically, Adamant Valves teaches where pneumatic ball valves are advantageous because of their easy operation and quick opening and closing (Adamant Valves; point 4).
It would have been obvious to one skilled in the art to make the ball valve of Chen a pneumatic ball valve as taught by Adamant Valves because pneumatic ball valves have the advantage of having quick opening and closing (Adamant Valves; point 4).
A pneumatic ball valve will have a pneumatic port. Further, the actuator of Chen will now be a pneumatic system that will connect to and control the pneumatic ball valves to move the sample through the device seen in Figure 17.
The limitation “a pneumatic system configured to connect to the pneumatic port, wherein the pneumatic system is configured to control pneumatic actuation to move the sample from the at least one input port through the at least one microfluidic guide to at least one of the at least two test zones;” 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 modified Chen and the apparatus of modified Chen is capable of connecting to the pneumatic ports and controlling pneumatic actuation to move sample from the input port through the at least one microfluidic guide to at least one of the at least two test zones. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Further, the sample is not positively recited in the claim, and is therefore not a part of the claimed testing device.
Chen does not teach a testing device interface zone configured to receive the test card.
In the analogous art of fluidic cartridges, Arlett teaches a cartridge reader (Arlett; [0001]).
Specifically, Arlett teaches a cartridge reader 200 that includes an outer housing 201, a cartridge drawer 202, touchscreen display 203, and power button 204 (Arlett; [0237], Figures 11a-b). The reader 200 seen in Figure 14 shows the subsystems of the reader, which includes a power control module 215, an electronics control module 216, a thermal module 217, a pneumatics block 218 that manages the delivery of fluid pressure to a cartridge during a test, a cartridge handling module 219 (Arlett; [0244]).
It would have been obvious to one skilled in the art to place the cassette and actuator of modified Chen inside a reader housing as taught by Arlett because Arlett teaches that a reader housing contains the required modules for carrying out a test on a cartridge (Arlett; [0244]).
The location where the cassette (test card comprising a microfluidic chip) and actuator (chip carrier, part of the test card) are placed within the reader housing will define a testing device interface zone.
The limitation “a testing device interface zone configured to receive the test card” 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 modified Chen and the reader housing of modified Chen is capable of receiving the cassette and actuator. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Regarding claim 16, modified Chen teaches the testing device of claim 15. Chen further teaches wherein the chip carrier comprises a heater positioned underneath a component of the microfluidic chip selected from the group consisting of at least one test zone of the at least two test zones (Chen; [0145] describes where temperature cycling of the PCR chamber is accomplished with multiple individual heaters that are brought into contact with the PCR reactor for desired time intervals, movement of a camshaft actuates a cycling heater to enhance the progress of the PCR reaction, where [0143] describes Figure 18g having an actuator comprising a camshaft and several hinged members that are capable of actuating individual or multiple hinged members such that the members contact different portions of the cassette. It is understood that therefore the actuator (chip carrier) has heaters that will be under the PCR test zone).
Regarding claim 17, modified Chen teaches the testing device of claim 15. Chen further teaches wherein the chip carrier is coupled to the microfluidic chip with a coupling mechanism selected from the group consisting of mechanical couplings (Chen; [0143] it is understood that as the cassette is inserted into the actuator, and from Figure 18g that the cassette does not fall out of the actuator, that the actuator and cassette are coupled to each other with mechanical couplings).
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
On page 9 applicant states that it would be facially simple to suggest that the teachings of Adamant Valves would have motivated a person having ordinary skill in the art to modify the ball valve of Chen to be a pneumatic ball valve consistent with Adamant Valves, but that such modifications would alter the principle of operation of Chen. That is, Chen would necessarily need to be altered from mechanical actuation to pneumatic actuation. Applicant further argues on page 10 that Chen unequivocally states that its principle of operation is a “Mechanically actuated diagnostic device”, and that the suggested combination of references would require change in the basic principle under which Chen was designed to operate.
Examiner respectfully disagrees. While examiner does agree that the actuator of Chen will now be a pneumatic system, this is not changing the basic principle of the overall device. This is because the valves will still be working the same way in either the mechanical or pneumatic system, i.e. they will be controlling fluid flow between components. Therefore, the obviousness rejection is maintained.
Applicant further argues that the claims recite that the pneumatic system is configured to control pneumatic actuation to move the sample from the at least one inlet port through the at least one microfluidic guide to at least one of the at least two test zones, and that as such it would not have been obvious to one skilled in the art to entirely change the mode of operation of Chen in order to arrive at the present claims, even in view of Adamant Valves.
Examiner respectfully disagrees. When changing the ball valves to be more specifically the pneumatic ball valves with a corresponding pneumatic system to actuate the valves, the pneumatic system will be capable of controlling pneumatic actuation.
Additionally, with regards to the limitation “the pneumatic system is configured to control pneumatic actuation to move the sample”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759